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Hasso Plattner Institute 22

BACKGROUND Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. METHODS Objective: To determine whether intracranial stenting (using the Wingspan self-expanding nitinol stent, Boston Scientific) and intensive medical therapy is superior to intensive medical therapy alone for preventing stroke in recently symptomatic patients with severe intracranial atherosclerotic stenosis. Design: Phase III, multi-center, randomized, open label, clinical trial. Setting: 50 sites in the US Subjects: Patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery. Intervention: Eligible patients were randomized to receive either aggressive medical medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. Outcomes: The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. Patients in the medical arm who undergo angioplasty for recurrent TIAs (i.e. crossovers) and who have a stroke or death within 30 days will also meet this endpoint. RESULTS Of the 451 patients who underwent randomization, 227 were assigned to the medical management group and 224 to the PTAS group. The 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P = 0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P = 0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. CONCLUSIONS In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected.

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BACKGROUND Caudal analgesia is a common method for postoperative pain management in pediatric patients. Additive agents such as opioids and α 2 agonists have been used to enhance the analgesic effects of local anesthetics for caudal block. OBJECTIVES The aim of this study was to compare the additive effects of dexmedetomidine and fentanyl on bupivacaine-induced caudal analgesia in pediatric patients who had undergone elective inguinal hernia repair. METHODS This randomized, double-blind clinical trial included children aged 1 - 5 years who were divided into three groups: the bupivacaine group (Group B) received 0.25% bupivacaine (1 ml/kg), the bupivacaine-dexmedetomidine group (Group BD) received 0.25% bupivacaine (1 mL/kg) plus 2 µg/kg dexmedetomidine, and the bupivacaine-fentanyl group (Group BF) received 0.25% bupivacaine (1 mL/kg) plus 2 µg/kg fentanyl. The hemodynamic variables (heart rate, systolic blood pressure, respiratory rate, and peripheral arterial oxygen saturation) were measured perioperatively. Pain, sedation and motor block scores and adverse events (nausea and vomiting, pruritis, hypotension, bradycardia, urinary retention and respiratory depression) were documented at 30 and 60 minutes, and the 1st, 2nd, 4th, 6th, 12th and 24th hours after the operation. The other recordings include the duration of surgery and analgesic requirement. RESULTS A total of 61 patients were analyzed. The lowest pain scores were found in the BD group at all time points (P < 0.001). The sedation scores were higher in the BD group than in the other two groups at all time points (P < 0.001). No motor block was observed after the operation. Only three patients required analgesic administration 2 to 6 hours after the operation in group B. No side effects were observed in any of the groups, and there was no significant difference in the duration of surgery among the three groups. CONCLUSIONS The results show that the analgesic and sedative effects were better when dexmedetomidine was added to bupivacaine than when fentanyl was added or bupivacaine alone was administered in the pediatric population studied here that underwent elective inguinal hernia repair.

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BACKGROUND AND OBJECTIVE The use of sedative medications may be effective in the success and facilitation of the intussusception non-surgical treatment. Therefore, the purpose of this study was to examine the effect of midazolam on decreasing the duration of intussusception hydrostatic reduction in children. MATERIALS AND METHODS In a double-blind clinical trial, 32 children were diagnosed with ileocolic intussusception based on sonographic findings, were studied and randomly divided into two groups. After obtaining written informed consent from the parents, 5 minutes before reduction, an intravenous Midazolam at the concentration of 1.0 mg/kg (up to 3 mg) was infused, and then barium reduction was performed under fluoroscopy guideline. In the control group, sterile water was injected as placebo and the remaining reduction steps were performed compared with the experiment group. RESULTS Of 16 patients that received Midazolam, 15 patients demonstrated successful reduction; and of 16 patients that received distilled water, only 11 patients showed successful reduction (P=0.07). The mean duration of a successful reduction in the Midazolam group and placebo was 34.8±11.35 and 32.73±19.2 min, respectively (P=0.733). CONCLUSIONS The use of Midazolam as a benzodiazepine with known sedative and muscle relaxant effects can increase the success rate of enema reduction in intussusception.

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BACKGROUND Mobility impairment is a common disability in MS and negatively impacts patients' lives. OBJECTIVE Evaluate the effect of prolonged-release (PR) fampridine (extended-release dalfampridine in the United States) on self-assessed walking disability, dynamic/static balance and safety in patients with MS. METHODS MOBILE was a randomised, double-blind, exploratory, placebo-controlled trial. Patients with progressive/relapsing-remitting MS and Expanded Disability Status Scale score of 4.0-7.0 were treated with PR-fampridine or placebo twice daily for 24 weeks. Efficacy endpoints included change from baseline in the 12-item MS Walking Scale (MSWS-12), Timed Up and Go (TUG) test and Berg Balance Scale (BBS). RESULTS 132 patients were randomised at 24 sites in six countries. PR-fampridine therapy resulted in greater median improvements from baseline in MSWS-12 score, TUG speed and BBS total score versus placebo over 24 weeks. A higher proportion of patients receiving PR-fampridine versus placebo experienced significant improvements at MSWS-12 improvement thresholds ⩾7 (p = 0.0275), ⩾8 (p = 0.0153) and ⩾9 points (p = 0.0088) and TUG speed thresholds ⩾10% (p = 0.0021) and ⩾15% (p = 0.0262). PR-fampridine was well tolerated. CONCLUSIONS PR-fampridine therapy resulted in early and sustained improvements in broad measures of walking and balance over six months.

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BACKGROUND Phototherapy may alter the morphologic features of melanocytic nevi. Dermoscopy is a non-invasive method for evaluation of skin lesions, specifically melanocytic nevi. AIMS AND OBJECTIVES This study was designed to evaluate the effects of narrowband ultraviolet B (NB-UVB) and psoralen-ultraviolet A (PUVA) therapy on the dermoscopic features of nevi. METHODS A total of 74 melanocytic nevi were randomly selected from 20 patients. Out of those, 54 nevi received NB-UVB, while 20 received PUVA. 50% of the nevi in each group were exposed to radiation, while the remaining nevi were covered with an opaque tape. All nevi were demoscopically evaluated before and after 30 or 60 sessions of phototherapy. RESULTS Overall demoscopic changes were observed in 34/37 (91.8%) of the uncovered nevi compared to 16/37 (43.2%) of the covered nevi (P value 0.0001). The most common changes were new dot/globule formation (62.1%), darkening (32.4%), nevus enlargement (27%), and patchy pigmentation (18.8%). Compared to NB-UVB, dermoscopic changes were more frequent in both covered and uncovered nevi of the PUVA group. (P values 0.041 and 0.0172, respectively). New dot/globule formation was observed more frequently in the covered and uncovered nevi of PUVA group. CONCLUSION PUVA and NB-UVB induce dermoscopic changes in the majority of the irradiated nevi. However, PUVA is associated with higher frequency of dermoscopic changes in both covered and uncovered nevi.

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BACKGROUND Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. METHODS 62 children with autism recruited from 6 centers, ages 2-7 years (mean 4.92 +/- 1.21), were randomly assigned to 40 hourly treatments of either hyperbaric treatment at 1.3 atmosphere (atm) and 24% oxygen ("treatment group", n = 33) or slightly pressurized room air at 1.03 atm and 21% oxygen ("control group", n = 29). Outcome measures included Clinical Global Impression (CGI) scale, Aberrant Behavior Checklist (ABC), and Autism Treatment Evaluation Checklist (ATEC). RESULTS After 40 sessions, mean physician CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0008), receptive language (p < 0.0001), social interaction (p = 0.0473), and eye contact (p = 0.0102); 9/30 children (30%) in the treatment group were rated as "very much improved" or "much improved" compared to 2/26 (8%) of controls (p = 0.0471); 24/30 (80%) in the treatment group improved compared to 10/26 (38%) of controls (p = 0.0024). Mean parental CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0336), receptive language (p = 0.0168), and eye contact (p = 0.0322). On the ABC, significant improvements were observed in the treatment group in total score, irritability, stereotypy, hyperactivity, and speech (p < 0.03 for each), but not in the control group. In the treatment group compared to the control group, mean changes on the ABC total score and subscales were similar except a greater number of children improved in irritability (p = 0.0311). On the ATEC, sensory/cognitive awareness significantly improved (p = 0.0367) in the treatment group compared to the control group. Post-hoc analysis indicated that children over age 5 and children with lower initial autism severity had the most robust improvements. Hyperbaric treatment was safe and well-tolerated. CONCLUSION Children with autism who received hyperbaric treatment at 1.3 atm and 24% oxygen for 40 hourly sessions had significant improvements in overall functioning, receptive language, social interaction, eye contact, and sensory/cognitive awareness compared to children who received slightly pressurized room air. TRIAL REGISTRATION clinicaltrials.gov NCT00335790.

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RATIONALE Disturbances in the subjective experience of time have been observed both in schizophrenia and following acute administration of ketamine. However, effects of ketamine on more objective timing tasks have not yet been measured in humans, nor has it been established that timing effects are not merely secondary to a more general dysfunction in working memory (WM). OBJECTIVE AND METHODS In a double-blind placebo-controlled crossover study, we characterised the effects of ketamine (100 ng/ml blood plasma level) on performance of perceptual timing and colour discrimination tasks, which were matched for WM and attentional demands. To test the ubiquity of ketamine's effects on timing, we also examined two distinct measures of temporal predictability. RESULTS Ketamine significantly distorted the subjective experience of time as measured by the Clinician-Administered Dissociative States Scales. Critically, ketamine also impaired accuracy on the perceptual timing task while having no effect on performance of the colour perception task. Although ketamine did not impair the ability to use prelearned temporal (or spatial) cues to predict target onset (or location), it did slow reaction times at long delays following non-informative neutral cues, suggesting an impaired ability to use the unidirectional flow of time itself to make temporal predictions. CONCLUSIONS Ketamine induced selective impairments in timing, which could not be explained by more fundamental effects on the ability to hold information in WM. Rather our collected findings suggest that ketamine may disturb timing by selectively impairing the way in which information is temporally manipulated within WM.

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BACKGROUND Nurses at The Norwegian Radium Hospital have reported that some patients notice an unpleasant smell or taste in accordance with flushing of intravenous lines with commercially available prefilled syringes. We have conducted a study in healthy volunteers to investigate the occurrence, consistency and intensity of this phenomenon. METHODS A randomised, blinded, crossover study comparing commercial available prefilled saline 9 mg/ml syringes to saline 9 mg/ml for injection in polyethylene package was performed in 10 healthy volunteers. The volunteers were given intravenous injections of varying volume and speed. Data were analysed using descriptive statistics, and also Wilcoxon Signed Rank Test to compare groups. RESULTS After intravenous injection, 2 of 15 recordings demonstrated any sensation of smell or taste after injection of saline from polyethylene package, while 14 of 15 recordings noted a sensation after injection of saline from prefilled syringes. The intensity of the unpleasant sensation was rated significantly higher after injection of saline from prefilled syringes compared to saline from polyethylene (p = 0.001). CONCLUSIONS Injection of saline from prefilled syringes in healthy volunteers resulted in an experience of bad taste or smell. It is important that nurses and health workers are aware of the phenomenon as described in this article in order to choose the preferred product for a given patient.

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PURPOSE This randomized controlled, clinical prospective interventional trial was aimed at exploring the effect of patient empowerment on short- and long-term outcomes after major oncologic surgery in elderly cancer patients. METHODS This trial was performed from February 2011 to January 2014 at two tertiary medical centers in Germany. The study included patients aged 65 years and older undergoing elective surgery for gastro-intestinal, genitourinary, and thoracic cancer. The patients were randomly assigned to the intervention group, i.e. patient empowerment through information booklet and diary keeping, or to the control group, which received standard care. Randomization was done by block randomization in blocks of four in order of enrollment. The primary outcome were 1,postoperative length of hospital stay (LOS) and 2. long-term global health-related quality of life (HRQoL) one year postoperatively. HRQoL was assessed using the EORTC QLQ C30 questionnaire. Secondary outcomes encompassed postoperative stress and complications. Further objectives were the identification of predictors of LOS, and HRQoL at 12 months. RESULTS Overall 652 patients were included. The mean age was 72 ± 4.9 years, and the majority of patients were male (68.6%, n = 447). The ^median of postoperative length of stay was 9 days (IQR 7-14 day). There were no significant differences between the intervention and the control groups in postoperative LOS (p = 0.99) or global HRQoL after one year (women: p = 0.54, men: p = 0.94). While overall complications and major complications occurred in 74% and 24% of the cases, respectively, frequency and severity of complications did not differ significantly between the groups. Patients in the intervention group reported significantly less postoperative pain (p = 0.03) than the control group. Independent predictors for LOS were identified as severity of surgery, length of anesthesia, major postoperative complications, nutritional state, and pre-operative physical functional capacity measured by the Timed Up and Go-test by multiple robust regressions. CONCLUSION Patient empowerment through information booklet and diary keeping did not shorten the postoperative LOS in elderly onco-surgical patients, but improved quality of care regarding postoperative pain. Postoperative length of stay is influenced by pre-operative nutritional state, pre-operative functional impairment, severity of surgery, and length of anesthesia. TRIAL REGISTRATION Clinicaltrials.gov. Identifier NCT01278537.

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BACKGROUND Sexual violence is associated with a multitude of poor physical, emotional, and social outcomes. Despite reports of stigma by sexual violence survivors, limited evidence exists on effective strategies to reduce stigma, particularly in conflict-affected settings. We sought to assess the effect of group Cognitive Processing Therapy (CPT) on stigma and the extent to which stigma might moderate the effectiveness of CPT in treating mental health problems among survivors of sexual violence in the Democratic Republic of Congo. METHODS Data were drawn from 405 adult female survivors of sexual violence reporting mental distress and poor functioning in North and South Kivu. Women were recruited through organizations providing psychosocial support and then cluster randomized to group CPT or individual support. Women were assessed at baseline, the end of treatment, and again six months later. Assessors were masked to women's treatment assignment. Linear mixed-effect regression models were used to estimate (1) the effect of CPT on feelings of perceived and internalized (felt) stigma, and (2) whether felt stigma and discrimination (enacted stigma) moderated the effects of CPT on combined depression and anxiety symptoms, posttraumatic stress, and functional impairment. RESULTS Participants receiving CPT experienced moderate reductions in felt stigma relative to those in individual support (Cohen's D = 0.44, p  = value = 0.02) following the end of treatment, though this difference was no longer significant six-months later (Cohen's D = 0.45, p  = value = 0.12). Neither felt nor enacted stigma significantly moderated the effect of CPT on mental health symptoms or functional impairment. CONCLUSIONS Group cognitive-behavioral based therapies may be an effective stigma reduction tool for survivors of sexual violence. Experiences and perceptions of stigma did not hinder therapeutic effects of group psychotherapy on survivors' mental health. TRIAL REGISTRATION ClinicalTrials.gov NCT01385163.

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AIM To report the efficacy of intravitreal ziv-aflibercept injections in eyes with macular edema due to retinal vein occlusions (RVOs). METHODS Consecutive patients with persistent or recurrent macular edema (central macula thickness >250 μm) due to RVO were enrolled in this prospective study. Study eyes received intravitreal injections of ziv-aflibercept (1.25 mg/0.05 mL) at baseline. Patients were reassessed monthly for 4 months and given additional injections pro re nata for worsening best-corrected visual acuity (BCVA), intraretinal edema or subretinal fluid seen on spectral domain optical coherence tomography, or central macular thickness (CMT) measurements >250 μm. The primary endpoint was improvement in mean CMT at 4 months. Secondary endpoints included improvement in mean BCVA, and ocular and systemic safety signals. RESULTS Nine eyes (five central and four branch RVOs) of nine patients were enrolled. The mean ± standard deviation CMT decreased from 604±199 μm at baseline to 319±115 μm ( P =0.001) at 1 month and to 351±205 μm ( P =0.026) at 4 months. The mean BCVA did not improve significantly from baseline (1.00 LogMAR) to the 1-month (0.74 LogMAR ; P =0.2) and 4-month (0.71 LogMAR ; P =0.13) visits. No safety signals were noted. CONCLUSION In this small prospective study, intravitreal ziv-aflibercept significantly improved mean CMT in eyes with persistent or recurrent macular edema due to RVOs. Prospective, randomized trials comparing ziv-aflibercept with standard pharmacotherapy are needed to better define efficacy and safety.

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BACKGROUND The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. OBJECTIVE To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. METHODS This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. RESULTS We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: -2.1, SD 3.3 kg, enhanced: -3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: -2.0, SD 3.5 cm, enhanced: -3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: -0.01, SD 0.02, enhanced: -0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. CONCLUSIONS A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033.

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BACKGROUND The aim of this study was to evaluate the therapeutic effect of autogenous semitendinosus graft and endobutton technique, and compare with hook plate in treatment of Rockwood type III acromioclavicular (AC) joint dislocation. METHODS From April 2012 to April 2013, we treated 46 patients with Rockwood type III AC joint dislocation. Patients were randomly divided into two groups: Group A was treated using a hook plate and Group B with autogenous semitendinosus graft and endobutton technique. All participants were followed up for 12 months. Radiographic examinations were performed every 2 months postoperatively, and clinical evaluation was performed using the Constant-Murley score at the last follow-up. RESULTS Results indicated that patients in Group B showed higher mean scores (90.3±5.4) than Group A (80.4±11.5) in terms of Constant-Murley score (P=0.001). Group B patients scored higher in terms of pain (P=0.002), activities (P=0.02), range of motion (P<0.001), and strength (P=0.004). In Group A, moderate pain was reported by 2 (8.7%) and mild pain by 8 (34.8%) patients. Mild pain was reported by 1 (4.3%) patient in Group B. All patients in Group B maintained complete reduction, while 2 (8.7%) patients in Group A experienced partial reduction loss. Two patients (8.7%) encountered acromial osteolysis on latest radiographs, with moderate shoulder pain and limited range of motion. CONCLUSION Autogenous semitendinosus graft and endobutton technique showed better results compared with the hook plate method and exhibited advantages of fewer complications such as permanent pain and acromial osteolysis.

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OBJECTIVES Our aim was to study whether the acute care of frail elderly patients directly admitted to a comprehensive geriatric assessment (CGA) unit is superior to the care in a conventional acute medical care unit in terms of patient satisfaction. DESIGN TREEE (Is the TReatment of frail Elderly patients Effective in an Elderly care unit?) is a clinical, prospective, controlled, one-center intervention trial comparing acute treatment in CGA units and in conventional wards. SETTING This study was conducted in the NÄL-Uddevalla county hospital in western Sweden. PARTICIPANTS In this follow-up to the TREEE study, 229 frail patients, aged ≥75 years, in need of acute in-hospital treatment, were eligible. Of these patients, 139 patients were included in the analysis, 72 allocated to the CGA unit group and 67 to the conventional care group. Mean age was 85 years and 65% were female. INTERVENTION Direct admittance to an acute elderly care unit with structured, systematic interdisciplinary CGA-based care, compared to conventional acute medical care via the emergency room. MEASUREMENTS The primary outcome was the satisfaction reported by the patients shortly after discharge from hospital. A four-item confidential questionnaire was used. Responses were given on a 4-graded scale. RESULTS The response rate was 61%. In unadjusted analyses, significantly more patients in the intervention group responded positively to the following three questions about the hospitalization: "Did you get the nursing from the ward staff that you needed?" ( p =0.003), "Are you satisfied with the information you received on your diseases and medication?" ( p =0.016), and "Are you satisfied with the planning before discharge from the hospital?" ( p =0.032). After adjusted analyses by multiple regression, a significant difference in favor of the intervention remained for the first question ( p =0.027). CONCLUSION Acute care in a CGA unit with direct admission was associated with higher levels of patient satisfaction compared with conventional acute care via the emergency room.

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OBJECTIVE We examined metabolic and endocrine responses during rest and exercise in moderate hypoxia over a 7.5 h time courses during daytime. METHODS Eight sedentary, overweight men (28.6 ± 0.8 kg/m2) completed four experimental trials: a rest trial in normoxia (FiO2 = 20.9%, NOR-Rest), an exercise trial in normoxia (NOR-Ex), a rest trial in hypoxia (FiO2 = 15.0%, HYP-Rest), and an exercise trial in hypoxia (HYP-Ex). Experimental trials were performed from 8:00 to 15:30 in an environmental chamber. Blood and respiratory gas samples were collected over 7.5 h. In the exercise trials, subjects performed 30 min of pedaling exercise at 60% of VO2max at 8:00, 10:30, and 13:00, and rested during the remaining period in each environment. Standard meals were provided at 8:30, 11:00, and 13:30. RESULTS The areas under the curves for blood glucose and serum insulin concentrations over 7.5 h did not differ among the four trials. At baseline, %carbohydrate contribution was significantly higher in the hypoxic trials than in the normoxic trials (P<0.05). Although exercise promoted carbohydrate oxidation in the NOR-Ex and HYP-Ex trials, %carbohydrate contribution during each exercise and post-exercise period were significantly higher in the HYP-Ex trial than in the NOR-Ex trial (P<0.05). CONCLUSION Three sessions of 30 min exercise (60% of VO2max) in moderate hypoxia over 7.5 h did not attenuate postprandial glucose and insulin responses in young, overweight men. However, carbohydrate oxidation was significantly enhanced when the exercise was conducted in moderate hypoxia.

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PURPOSE To compare the safety and efficacy of tamsulosin and tamsulosin with the phosphodiesterase-5 inhibitor tadalafil in combination with prednisolone as medical expulsive therapies for lower ureteric stones. MATERIALS AND METHODS Between July 2011 and December 2012, 62 adult patients presenting with distal ureteric stones sized 5 to 10 mm were randomized equally to treatment with tamsulosin (group A) or tamsulosin with tadalafil (group B). Therapy was given for a maximum of 6 weeks. In addition, patients in groups A and B were given 5-mg prednisolone once daily (maximum 1 week). The stone expulsion rate, time to stone expulsion, analgesic use, number of hospital visits for pain, follow-up and endoscopic treatment, and adverse effects of the drugs were noted. Statistical analyses were done by using Student t-test and chi-square test. RESULTS There was a higher expulsion rate (83.9% in group B and 74.2% in group A) and a lower time to expulsion in both treatment groups than in historical controls used in earlier studies. However, these results were not statistically significant (p=0.349, p=0.074, respectively). Statistically significant differences were noted in hospitalization for colic and analgesic requirement, which were less in group B than in group A. There were no serious adverse events. Another important finding was improvement in erectile function in group B. CONCLUSIONS Medical expulsive therapy for distal ureteric stones using tamsulosin and tadalafil with prednisolone is safe and efficacious. Also, the prescription of tadalafil in cases of erectile dysfunction with the development of lower ureteric stones may provide additional advantages.

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BACKGROUND Stress-related mucosal disease occurs in many critically ill-patients within 24 h of admission. Proton pump inhibitor therapy has been documented to produce more potent inhibition of gastric acid secretion than histamine 2 receptor antagonists. This study aimed to compare extemporaneous preparations of omeprazole, pantoprazole oral suspension and intravenous (IV) pantoprazole on the gastric pH in intensive care unit patients. MATERIALS AND METHODS This was a randomized single-blind-study. Patients of ≥ 16 years of age with a nasogastric tube, who required mechanical ventilation for ≥ 48 h, were eligible for inclusion. The excluded patients were those with active gastrointestinal bleeding, known allergy to omeprazole and pantoprazole and those intolerant to the nasogastric tube. Fifty-six patients were randomized to treatment with omeprazole suspension 2 mg/ml (40 mg every day), pantoprazole suspension 2 mg/ml (40 mg every day) and IV pantoprazole (40 mg every day) for up to 14 days. Gastric aspirates were sampled before and 1-2.5 h after the drug administration for the pH measurement using an external pH meter. Data were analyzed using SPSS (version 21.0). RESULTS In this study, 56 critically ill-patients (39 male, 17 female, mean age: 61.5 ± 15.65 years) were followed for the control of the gastric pH. On each of the 14 trial days the mean of the gastric pH alteration was significantly higher in omeprazole and pantoprazole suspension-treated patients than in IV pantoprazole-treated patients (P < 0.001). CONCLUSION Omeprazole and pantoprazole oral suspension are more effective than IV pantoprazole in increasing the gastric pH.

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BACKGROUND Ultrasound-guided paravertebral blocks during breast surgeries with in-plane needle approaches can be challenging due to difficult needle visualization. The purpose of this study was to assess the usefulness of using a needle guide while performing in-plane parasagittal approach paravertebral block for breast surgery. PATIENTS AND METHODS Eighty patients, American Society of Anesthesiologists physical status I-III, aged 20-40 years with breast mass scheduled for simple mastectomy surgery, were involved in prospective, controlled, randomized study, and were randomly divided by closed envelope method into two groups: Group I (n = 40): Scheduled for ultrasound-guided paravertebral block or group II (n = 40): Scheduled for ultrasound-guided paravertebral block using the needle guide. Both techniques compared as regards: (i) Needle visibility and block performance time; (ii) number of needle passes; (iii) duration of the block; (iv) doctor and patient satisfaction; and (v) incidence of complications. RESULTS Needle visibility score was better in group II (2.92 ± 0.26 vs. 1.9 ± 0.44, P < 0.0001). Block performance time was shorter in group II (90.92 ± 15 vs. 128.25 ± 16s, P < 0.0001). A number of needle passes were less in group II (1.27 ± 0.45 vs. 2.2 ± 0.68, P < 0.0001). Doctor and patient satisfaction were better in group II (P = 0.015). No differences were found regarding the duration of the block and incidence of complications between groups. CONCLUSION A needle guide can help reduce the time needed to perform a parasagittal in-plane thoracic paravertebral block, with a significant reduction in the block performance time, the number of needle passes, better needle visibility and better doctor and patient's satisfaction. However, there was no significant difference regarding the duration of the block or incidence of complications.

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PURPOSE To investigate the potential benefit of post-race wearing of unstable shoes (Masai Barefoot Technology [MBT]) on recovery from marathon race-induced fatigue. PATIENTS AND METHODS Forty-five runners who participated in a full marathon race were divided into three groups: 1) MBT shoes, 2) trail running shoes, and 3) control (CON). Participants ran a full marathon with their own running shoes, and then put on the assigned shoes immediately after the race. They continued to wear the assigned shoes for the ensuing 3 days. The CON group wore their usual shoes. Estimates of post-race fatigue were made by the participants on questionnaires that utilized a visual analog scale. Estimates were made just after the race, as well as for the next 3 days. RESULTS The subjective fatigue of the MBT group was lower than that of the CON (P<0.05) or trail running shoe groups (P<0.05) on day 3. CONCLUSION MBT shoe intervention can promote recovery from the fatigue induced by running a full marathon.

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BACKGROUND The Laryngeal Tube Suction Disposable (LTS-D) and the Supreme Laryngeal Mask Airway (SLMA) are second generation supraglottic airway devices (SADs) with an added channel to allow gastric drainage. We studied the efficacy of these devices when using pressure controlled mechanical ventilation during general anesthesia for short and medium duration surgical procedures and compared the oropharyngeal seal pressure in different head and-neck positions. METHODS Eighty patients in each group had either LTS-D or SLMA for airway management. The patients were recruited in two different institutions. Primary outcome variables were the oropharyngeal seal pressures in neutral, flexion, extension, right and left head-neck position. Secondary outcome variables were time to achieve an effective airway, ease of insertion, number of attempts, maneuvers necessary during insertion, ventilatory parameters, success of gastric tube insertion and incidence of complications. RESULTS The oropharyngeal seal pressure achieved with the LTS-D was higher than the SLMA in, (extension (p=0.0150) and right position (p=0.0268 at 60 cm H 2 O intracuff pressures and nearly significant in neutral position (p = 0.0571). The oropharyngeal seal pressure was significantly higher with the LTS-D during neck extension as compared to SLMA (p= 0.015). Similar oropharyngeal seal pressures were detected in all other positions with each device. The secondary outcomes were comparable between both groups. Patients ventilated with LTS-D had higher incidence of sore throat (p = 0.527). No major complications occurred. CONCLUSIONS Better oropharyngeal seal pressure was achieved with the LTS-D in head-neck right and extension positions , although it did not appear to have significance in alteration of management using pressure control mechanical ventilation in neutral position. The fiberoptic view was better with the SLMA. The post-operative sore throat incidence was higher in the LTS-D. TRIAL REGISTRATION ClinicalTrials.gov ID: NCT02856672 , Unique Protocol ID:BnaiZionMC-16-LG-001, Registered: August 2016.

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PURPOSE Many postmenopausal women desire non-pharmaceutical alternatives to hormone therapy for protection against osteoporosis. Soybean isoflavones, especially genistein, are being studied for this purpose. This study examined the effects of synthetic genistein in combination with other potential bone-protective dietary molecules on bone mineral density (BMD) in early postmenopausal women. METHODS In this 6-month double-blind pilot study, 70 subjects were randomized to receive daily either calcium only or the geniVida™ bone blend (GBB), which consisted of genistein (30 mg/days), vitamin D3 (800 IU/days), vitamin K1 (150 μg/days) and polyunsaturated fatty acids (1 g polyunsaturated fatty acids as ethyl ester: eicosapentaenoic acid/docosahexaenoic acid ratio = ~2/1). Markers of bone resorption and formation and BMD at the femoral neck, lumbar spine, Ward's triangle, trochanter and intertrochanter, total hip and whole body were assessed. RESULTS Subjects supplemented with the GBB (n = 30) maintained femoral neck BMD, whereas in the placebo group (n = 28), BMD significantly decreased (p = 0.007). There was also a significant difference (p < 0.05) in BMD between the groups at Ward's triangle in favor of the GBB group. Bone-specific alkaline phosphatase and N-telopeptide significantly increased in the GBB group in comparison with those in baseline and in the placebo group. The GBB was well tolerated, and there were no significant differences in adverse events between groups. CONCLUSIONS The GBB may help to prevent osteoporosis and reduce fracture risk, at least at the hip, in postmenopausal women. Larger and longer-term clinical trials are warranted.

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AIM This study aimed to evaluate the effects of vitamin D intake on COPD exacerbation and FEV1 in the patients with severe and very severe COPD. METHODS This double blind placebo control randomized clinical trial study was done in the Ashayer university hospital in Khorramabad in 2012. Eighty eight patients with severe and very severe COPD were randomly selected from those who recoursed to the internal medicine clinic of Ashayer hospital. They were randomly allocated to case and placebo group. The patients received routine treatment for COPD. Along with the routine treatment, placebo group received 100,000 IU of oral vitamin D per month, for 6 months. Data was analyzed using SPSS computer software, paired t-test, independent t-test, non parametric t-test and Pearson correlation coefficients. RESULTS In each group, there were 44 patients. After the intervention, there were significant differences in FEV1 and the number of COPD exacerbation between the case and control group patients. Also, after the study, in the case group, FEV1 was increased and the number of COPD exacerbation was decreased significantly. CONCLUSION Vitamin D intake decreased COPD exacerbation and improved FEV1 in the patients with severe and very severe COPD. It is suggested that baseline serum vitamin D levels will recorded in similar studies and the effect of vitamin D intake will evaluated regarding the baseline serum vitamin D levels.

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BACKGROUND Substance abuse or drug addiction is one of the most important health issues in every society, which can lead to physical and mental problems. OBJECTIVES This study aimed to compare the efficacy of tramadol plus gabapentin versus methadone use in the treatment of opiate withdrawal. PATIENTS AND METHODS Consenting male subjects who fulfilled the DSM-4 criteria for opiate dependence syndrome (opium, residue, and heroin) were randomly assigned in two groups to receive tramadol plus gabapentin or methadone. Assessment tools were Adjective Rating Scale for Withdrawal (ARSW), Clinical Opiate Withdrawal Scale (COWS) and Visual Analogue craving Scale (VAS). Fifty-nine subjects were enrolled and evaluated on days 1, 2, 3, 4, 6, and 8 during their 10 days of admission. Twenty-nine participants received methadone and the other 30 received tramadol plus gabapentin for their treatment. RESULTS Mean (SD) age of the patients in methadone group and tramadol plus gabapentin group were 33.9 (7.1) and 32.4. (8.1), respectively (P = 0.462). The overall ARSW (P value = 0.263) and COWS (P = 0.862) scores between the two groups were comparable. The differences in the VAS score for craving between the two groups was marginally significant (P = 0.057). The highest VAS score was at the third day of admission in both groups and it was generally higher in methadone group. CONCLUSIONS The severity of withdrawal syndrome in two groups was not significantly different. The craving was higher in the group receiving methadone from the second day of admission even though the usage amount was higher in the tramadol plus gabapentin group. The findings of this study suggest that the combination of tramadol plus gabapentin is an efficient method for opioid detoxification.

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BACKGROUND Meta-analyses suggest that reboxetine may be less effective than other antidepressants. Such comparisons may be biased by lower adherence to reboxetine and subsequent handling of missing outcome data. This study illustrates how to adjust for differential non-adherence and hence derive an unbiased estimate of the efficacy of reboxetine compared with citalopram in primary care patients with depression. METHOD A structural mean modelling (SMM) approach was used to generate adherence-adjusted estimates of the efficacy of reboxetine compared with citalopram using GENetic and clinical Predictors Of treatment response in Depression (GENPOD) trial data. Intention-to-treat (ITT) analyses were performed to compare estimates of effectiveness with results from previous meta-analyses. RESULTS At 6 weeks, 92% of those randomized to citalopram were still taking their medication, compared with 72% of those randomized to reboxetine. In ITT analysis, there was only weak evidence that those on reboxetine had a slightly worse outcome than those on citalopram [adjusted difference in mean Beck Depression Inventory (BDI) scores: 1.19, 95% confidence interval (CI) -0.52 to 2.90, p = 0.17]. There was no evidence of a difference in efficacy when differential non-adherence was accounted for using the SMM approach for mean BDI (-0.29, 95% CI -3.04 to 2.46, p = 0.84) or the other mental health outcomes. CONCLUSIONS There was no evidence of a difference in the efficacy of reboxetine and citalopram when these drugs are taken and tolerated by depressed patients. The SMM approach can be implemented in standard statistical software to adjust for differential non-adherence and generate unbiased estimates of treatment efficacy for comparisons of two (or more) active interventions.

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BACKGROUND Active-assistive range of motion exercises to gain shoulder elevation have been subdivided into gravity-minimized and upright-assisted exercises, yet no study has evaluated differences in muscular demands. HYPOTHESIS Compared with gravity-minimized exercises, upright-assisted exercises will generate larger electromyographic (EMG) activity. Compared with all active-assistive exercises, upright active forward elevation will generate more EMG activity. STUDY DESIGN Controlled laboratory study. METHODS Fifteen healthy individuals participated in this study. The supraspinatus, infraspinatus, and anterior deltoid were evaluated. The independent variables were 11 exercises performed in random order. The dependent variable was the maximum EMG amplitude of each muscle that was normalized to a maximal voluntary isometric contraction (MVIC). RESULTS Each muscle demonstrated significant differences between exercises (P < .001), with upright active forward elevation producing the greatest EMG for all muscles (95% confidence interval [CI], 12% to 50% MVIC). The orders of exercise varied by muscle, but the 5 gravity-minimized exercises always generated the lowest EMG activity. The upright-assisted exercises (95% CI, 23% to 42% MVIC) for the anterior deltoid generated more EMG activity than did the gravity-minimized exercises (95% CI, 9% to 21% MVIC) (P < .05). The infraspinatus and supraspinatus demonstrated increasing trends in EMG activity from gravity minimized to upright assisted (P > .05). CONCLUSION The results suggest a clear distinction between gravity-minimized exercises and upright-assisted exercises for the anterior deltoid but not for the supraspinatus and infraspinatus. Between the 2 types of assisted exercises, the results also suggest a clear distinction in terms of active elevation of the arm for the supraspinatus and anterior deltoid but not for the infraspinatus. CLINICAL RELEVANCE Muscle activation levels increase as support is removed, but subdivision of active-assistive range of motion to protect the supraspinatus and infraspinatus may not be necessary.

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BACKGROUND Our main objective was to evaluate the ability of cranberry phytochemicals to modify immunity, specifically γδ-T cell proliferation, after daily consumption of a cranberry beverage, and its effect on health outcomes related to cold and influenza symptoms. METHODS The study was a randomized, double-blind, placebo-controlled, parallel intervention. Subjects drank a low calorie cranberry beverage (450 ml) made with a juice-derived, powdered cranberry fraction (n = 22) or a placebo beverage (n = 23), daily, for 10 wk. PBMC were cultured for six days with autologous serum and PHA-L stimulation. Cold and influenza symptoms were self-reported. RESULTS The proliferation index of γδ-T cells in culture was almost five times higher after 10 wk of cranberry beverage consumption (p <0.001). In the cranberry beverage group, the incidence of illness was not reduced, however significantly fewer symptoms of illness were reported (p = 0.031). CONCLUSIONS Consumption of the cranberry beverage modified the ex vivo proliferation of γδ-T cells. As these cells are located in the epithelium and serve as a first line of defense, improving their function may be related to reducing the number of symptoms associated with a cold and flu.

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BACKGROUND AND AIM Induced hypotension limits intra-operative blood loss to provide better visibility of the surgical field and diminishes the incidence of major complications during functional endoscopic sinus surgery (FESS). We aimed at comparing nitroglycerine, esmolol and dexmedetomidine for inducing controlled hypotension in patients undergoing FESS. MATERIAL AND METHODS One hundred and fifty American Society of Anesthesiologists physical status I or II adult patients undergoing FESS under general anesthesia were randomly allocated to three groups of 50 patients each. Group E received esmolol in a loading and maintenance dose of 1 mg/kg over 1 min and 0.5-1.0 mg/kg/h, respectively. Group D received a loading dose of dexmedetomidine 1 μg/kg over 10 min followed by an infusion 0.5-1.0 μg/kg/h, and group N received nitroglycerine infusion at a dose of 0.5-2 μg/kg/min so as to maintain mean arterial pressure (MAP) between 60 and 70 mmHg in all the groups. The visibility of the surgical field was assessed by surgeon using Fromme and Boezaart scoring system. Hemodynamic variables, total intra-operative fentanyl consumption, emergence time and time to first analgesic request were recorded. Any side-effects were noted. The postoperative sedation was assessed using Ramsay Sedation Score. RESULT The desired MAP (60-70 mmHg) could be achieved in all the three study groups albeit with titration of study drugs during intra-operative period. No significant intergroup difference was observed in Fromme's score during the intra-operative period. The mean total dose of fentanyl (μg/kg) used was found to be significantly lower in group D compared to groups E and N (1.2 ± 0.75 vs. 3.6 ± 1.3 and 2.9 ± 1.1 respectively). The mean heart rate was significantly lower in group D compared to groups E and N at all times of measurement (P < 0.05). The MAP was found to be significantly lower in group D compared to groups E and N after infusion of study drugs, after induction, just after intubation and 5 min after intubation (P < 0.05). The Ramsay Sedation Scores were significantly higher in group D (score 3 in 46%) when compared to group E (score 2 in 50%) and group N (score 2 in 54%) (P < 0.001). The emergence time was significantly lower in group E and group N compared to group D. Time to first analgesic request was significantly longer in group D. CONCLUSION Dexmedetomidine and esmolol provided better hemodynamic stability and operative field visibility compared to nitroglycerin during FESS. Dexmedetomidine provides an additional benefit of reducing the analgesic requirements and providing postoperative sedation.

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BACKGROUND Lutein is a carotenoid that may play a role in eye health. Human milk typically contains higher concentrations of lutein than infant formula. Preliminary data suggest there are differences in serum lutein concentrations between breastfed and formula-fed infants. AIM OF THE STUDY To measure the serum lutein concentrations among infants fed human milk or formulas with and without added lutein. METHODS A prospective, double-masked trial was conducted in healthy term formula-fed infants (n = 26) randomized between 9 and 16 days of age to study formulas containing 20 (unfortified), 45, 120, and 225 mcg/l of lutein. A breastfed reference group was studied (n = 14) and milk samples were collected from their mothers. Primary outcome was serum lutein concentration at week 12. RESULTS Geometric mean lutein concentration of human milk was 21.1 mcg/l (95% CI 14.9-30.0). At week 12, the human milk group had a sixfold higher geometric mean serum lutein (69.3 mcg/l; 95% CI 40.3-119) than the unfortified formula group (11.3 mcg/l; 95% CI 8.1-15.8). Mean serum lutein increased from baseline in each formula group except the unfortified group. Linear regression equation indicated breastfed infants had a greater increase in serum lutein (slope 3.7; P < 0.001) per unit increase in milk lutein than formula-fed infants (slope 0.9; P < 0.001). CONCLUSIONS Breastfed infants have higher mean serum lutein concentrations than infants who consume formula unfortified with lutein. These data suggest approximately 4 times more lutein is needed in infant formula than in human milk to achieve similar serum lutein concentrations among breastfed and formula fed infants.

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INTRODUCTION Alcohol has renowned behavioral disinhibitory properties which are suggested to involve reductions in frontal lobe functioning as a result of diminished interhemispheric connectivity. METHODS To examine sex differences in frontal interhemispheric connectivity in response to alcohol, 12 female and ten male healthy volunteers received a single administration of 0.5 per thousand alcohol in a placebo-controlled counterbalanced crossover design. Paired-pulse transcranial magnetic stimulation was applied to measure transcallosal inhibition (TCI) between the left and right primary motor cortex (M1). RESULTS Results showed significant reductions in TCI after alcohol administration in female participants exclusively. DISCUSSION These findings provide the first evidence that moderate doses of alcohol differentially affect frontal interhemispheric connectivity in males and females. The present data may shed new light on the physiological mechanisms underlying sex differences in the susceptibility to alcohol.

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BACKGROUND Vitiligo, a common disorder of depigmentation, is often difficult to treat. Corticosteroids are known to be effective, but with modest results. Although simvastatin has been reported to be effective for immunorelated dermatologic disorders including vitiligo, controlled trials are lacking. This study was conducted to compare the efficacy of topical betamethasone valerate 0.1% cream (as a standard method of treatment for vitiligo) versus a combination of betamethasone valerate plus oral simvastatin in the treatment of vitiligo. MATERIALS AND METHODS Eighty-eight subjects with symmetric vitiligo who had body surface involvement up to 20% were divided randomly into two groups. Group A were treated with betamethasone valerate 01% cream twice daily and Group B with betamethasone valerate 01% cream twice daily and oral simvastatin 80 mg daily for 12 weeks. Finally, 46 patients completed treatment after 12 weeks in both groups. The results were evaluated by a blind dermatologist using Vitiligo Area Scoring Index (VASI) score at baseline, 4 th , 8 th , and 12 th week of treatment. In a similar way, subjective assessment performed by patients based on photo evaluation at the end of the study. RESULTS Despite a continuous reduction in VASI score in both groups, according to both physician ( P = 0.13) and patient ( P = 0.374) assessment oral simvastatin was not statistically more effective than conventional treatment of vitiligo. CONCLUSION This study indicates that oral simvastatin is not associated with significant impacts in the treatment of vitiligo as compared to other inflammatory dermatologic conditions such as psoriasis. Indeed, other studies should be initiated regarding exact molecular and cellular effects of statins in the treatment of vitiligo.

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OBJECTIVES This in situ study evaluated the effect of saliva, associated or not with fluoride, on enamel previously submitted to prophylaxis using sodium bicarbonate. METHODS The study was conducted on enamel blocks submitted to in vitro prophylaxis using sodium bicarbonate. The blocks were randomly divided into 2 groups (G1/G2) and mounted on intraoral appliances wore by 10 volunteers. G1 blocks were directly exposed to saliva in situ, while blocks in G2 were exposed to saliva with fluoride (rinsing with 0.2% NaF solution during the initial minute). Enamel alterations were evaluated using surface microhardness and profilometry. Enamel hardness data were analyzed by ANOVA and Tukey tests and surface wear was evaluated using paired t test (P<.05). RESULTS No significant differences were found between G1 and G2 for enamel hardness and wear. The wear after prophylaxis was not different from the wear after the in situ stage. Baseline mean values of enamel hardness, after prophylaxis and after the in situ stage were 340±16.6, 329±35.7 and 354±37.8 for G1 and 338±15.6, 312±46.3 and 340±21.8 for G2, respectively. CONCLUSIONS It was concluded that saliva alone exhibited a similar effect to saliva associated with fluoride; after 4h of in situ remineralization, there was no recovery in height of the enamel structure that had been lost due to the application of sodium bicarbonate.

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BACKGROUND Self-reported weight and height is frequently used to quantify overweight and obesity. It is however, associated with limitations such as bias and poor agreement, which may be a result of social desirability or difficulties with recall. Methods to reduce these biases would improve the accuracy of assessment of overweight and obesity using patient self-report. The level of agreement between self-reported and measured weight and height has not been widely examined in general practice patients. METHODS Consenting patients, presenting for care within four hour sessions, were randomly allocated to the informed or uninformed group. Participants were notified either a) prior to (informed group), or b) after (uninformed group) reporting their weight and height using a touchscreen computer questionnaire, that they would be measured. The differences in accuracy of self-report between the groups were examined by comparing mean differences, intraclass correlations (ICCs), Bland Altman plot with limits of agreement (LOAs) and Cohen's kappa. Overall agreement was assessed using similar statistical methods. RESULTS Of consenting participants, 32% were aged between 18-39 years, 42% between 40-64 years and 25% were 65 years and above. The informed group (n = 172) did not report their weight and height more accurately than the uninformed group (n = 160). Mean differences between self-reported and measured weight (p = 0.4004), height (p = 0.5342) and body mass index (BMI) (p = 0.4409) were not statistically different between the informed and uninformed group. Overall, there were small mean differences (-1.2 kg for weight, 0.8 for height and -0.6 kg/m2 for BMI) and high ICCs (>0.9) between self-reported and measured values. A substantially high kappa (0.70) was obtained when using self-reported weight and height relative to measured values to quantify the proportion underweight, normal weight, overweight or obese. While the average bias of self-reported weight and height as estimates of the measured quantities is small, the LOAs indicate that substantial discrepancies occur at the individual level. CONCLUSIONS Informing patients that their weight and height would be measured did not improve accuracy of reporting. The use of self-reported weight and height for surveillance studies in this setting appears acceptable; however this measure needs to be interpreted with care when used for individual patients.

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BACKGROUND This study aimed to compare two doses of Mitomycin C in reducing haze formation after photorefractive keratectomy. METHODS 170 eyes of 85 patients enrolled; in each patient one eye randomly assigned to be treated by low dose intraoperative MMC (LDMMC) and other eye by standard dose MMC (SDMMC). Then the patients were followed up to 6 months and refraction, Uncorrected Distant Visual Acuity (UCDVA), Best Corrected Distant Visual Acuity (BCDVA) and haze formation submitted in each postoperative exam. RESULTS The mean preoperative refraction in LDMMC eyes was -3.08 (SD 1.65) sphere and 0.92 (SD 0.88) cylinder. These values for SDMMC eyes were -3.25 (SD 1.80) sphere and 0.81 (SD 0.84) cylinder. Mean postoperative sphere in LDMMC group was -0.132 (SD 0.503) and -0.138 (SD 0.484) in 3 and 6 months after PRK. These results was -0.041 (SD 0.501) and -0.076 (SD 0.489) for SDMMC group. Mean postoperative cylinder 3 and 6 month after PRK was 0.435 (SD 0.218) and 0.423 (SD 0.255). In LDMMC group and 0.435 (SD 0.247) and 0.426 (SD 0.261) in SDMMC group. In third month 14 eyes in LDMMC group presented with grade 1 score of clinical haze. From these eyes only 2 still had this haze after 6 month. 7 eyes in SDMMC group had grade 1 clinical haze at third month- but no clinical haze was seen at the end of 6(th) month. CONCLUSION The results of the two doses of Mitomycin C were not significant. We suggest to use the lower dose to reduce its side effects.

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OBJECTIVES Local anesthetic wound infiltration is widely used as an effective adjunct during multimodal postoperative pain management. The aim of this study was to evaluate the effectiveness of continuous wound infusion of ropivacaine in postoperative pain relief, opioid sparing, incidence of nausea and vomiting, and bowel and liver function improvement in patients undergoing open hepatectomy. METHODS Forty patients undergoing open hepatectomy were enrolled in this prospective, randomized, double-blinded, placebo-controlled trial. Patients were divided into 2 groups: the 0.9% saline continuous infusion group (the control group; n=20) and the ropivacaine continuous infusion group (the Ropi group; n=20). Outcomes measured postoperatively were pain score at rest and on movement, sufentanil consumption, incidence of nausea and vomiting, and sedation score across 48 postoperative hours. Time to bowel recovery, liver function change, mean length of hospitalization, patient satisfaction, and other data after 48 postoperative hours were collected until hospital discharge. RESULTS Pain scores at rest were lower for the ropivacaine group and reached significance after 8 and 16 hours (P<0.01). Sufentanil consumption (41.50±21.80 vs. 89.70±35.22 μg; P<0.01) after 48 hours, time to bowel recovery (1.80±0.70 vs. 3.15±1.04 d; P<0.01), incidence of nausea and vomiting (1.75±0.72 vs. 2.40±0.68; P<0.05), and mean length of hospitalization (5.6±2.44 vs. 7.35±2.85 d; P<0.01) were significantly reduced, and the sedation score and liver function change were also comparable between the 2 groups. There was no difference with respect to pain scores on movement, nor with respect to patient satisfaction. CONCLUSIONS Surgical wound infusion with ropivacaine after hepatectomy can improve pain relief at rest and accelerate recovery and discharge.

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INTRODUCTION A significant number of mania patients fail to respond to current pharmacotherapy, thereby there is need for novel augmentation strategies. The results of some early studies showed the effectiveness of cholinomimetics in the treatment of mania. One open case series suggested the efficacy of donepezil in the treatment of bipolar disorder. Our aim was to explore whether an oral cholinesterase inhibitor, donepezil, administered during a 4-week treatment period, would benefit patients with acute mania. METHODS We conducted a 4-week double-blind, placebo-controlled trial of donepezil as an adjunctive treatment to lithium in patients with acute mania. Eligible subjects were randomly assigned to receive donepezil or placebo in addition to lithium. Donepezil was started at 5 mg/day, and increased to 10 mg/day in the first week. Patients were rated with the Young Mania Rating Scale (YMRS) and Brief Psychiatric Rating Scale (BPRS) at baseline, day 1, week 1, week 2, and week 4. RESULTS Out of the 30 patients who were enrolled, 15 were on donepezil and 15 were on placebo. All patients completed the 4-week trial. On the first day, there was a difference of 1.97 units on the psychomotor symptoms scale of the YMRS in the donepezil group as compared to the placebo group (t = 2.39, P = 0.02). There was a difference of 0.57 units (t = 2.09, P = 0.04) in the speech item and a difference of 0.29 units in the sexual interest item (t = 2.11, P = 0.04) in the donepezil group as compared to the placebo group. The total YMRS difference on the first day approached the conventional significance level (1.97 units, t = 1.84, P = 0.07). Over the course of 4 weeks, we failed to find that donepezil produced any significant difference in the YMRS (6.71 units difference, t = -1.44, P = 0.16) or the BPRS scale (1.29 units difference, t = -0.33, P = 0.75) as compared to placebo. Ten subjects (66.67%) in both groups met the criteria for clinical response (Fisher's exact P = 1.00). Five subjects (33.33%) in the donepezil group met the criteria for clinical remission while nine subjects (60.00%) in the placebo group met the remission criteria (Fisher's exact P = 0.27). CONCLUSION Use of the oral anticholinergic donepezil had some benefit in the augmentation of lithium treatment on the first day, but did not provide any significant benefits in the long-term.

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OBJECTIVE After intensive insulin treatment, many obese African American patients with new-onset diabetic ketoacidosis (DKA) and severe hyperglycemia are able to achieve near-normoglycemia remission. The optimal treatment to prevent hyperglycemic relapses after remission is not known. RESEARCH DESIGN AND METHODS This prospective, 4-year, placebo-controlled study randomly assigned 48 African American subjects with DKA and severe hyperglycemia to metformin 1,000 mg daily (n = 17), sitagliptin 100 mg daily (n = 16), or placebo (n = 15) after normoglycemia remission. Hyperglycemic relapse was defined as fasting glucose >130 mg/dL (7.2 mmol/L) and HbA 1c >7.0% (53 mmol/mol). Oral glucose tolerance tests were conducted at randomization and at 3 months and then every 6 months for a median of 331 days. Oral minimal model and incremental area under the curve for insulin (AUCi) were used to calculate insulin sensitivity (Si) and β-cell function, respectively. Disposition index (DI) was calculated as a product of Si and incremental AUCi. RESULTS Relapse-free survival was higher in sitagliptin and metformin (P = 0.015) compared with placebo, and mean time to relapse was significantly prolonged in the metformin and sitagliptin groups compared with the placebo group (480 vs. 305 days, P = 0.004). The probability of relapse was significantly lower for metformin (hazard ratio 0.28 [95% CI 0.10-0.81]) and sitagliptin (0.31 [0.10-0.98]) than for placebo. Subjects who remained in remission had a higher DI (P = 0.02) and incremental AUCi (P < 0.001) than those with hyperglycemia relapse without significant changes in Si. CONCLUSIONS This study shows that near-normoglycemia remission was similarly prolonged by treatment with sitagliptin and metformin. The prolongation of remission was due to improvement in β-cell function.

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OBJECTIVE Elevated white blood cell (WBC) count is considered to be prospectively and positively associated with cardiovascular diseases, particularly hypertension. Also, the positive role of exercise in the management of hypertension has been well and long established. However the relationship between WBC count and hypertensive management particularly in the nonpharmacological technique is ambiguous and unclear. Therefore the purpose of the present study was to determine the effect of interval training program on WBC count and cardiovascular parameters in male hypertensive patients. MATERIALS AND METHODS A total of 245 male patients with mild to moderate (systolic blood pressure (SBP) between 140 mmHg and 179 mmHg and diastolic blood pressure (DBP) between 90 mmHg and 109 mmHg) essential hypertension were age matched and grouped into experimental and control groups. The experimental (n=140; 58.90±7.35 years) group involved in an 8-week interval training (60-79% HR max reserve) program of between 45 minutes to 60 minutes, while the age-matched controls hypertensive (n=105; 58.27±6.24 years) group remain sedentary during this period. Cardiovascular parameters (SBP, DBP, and VO(2) max) and WBC count were assessed. Student's t and Pearson correlation tests were used in data analysis. RESULTS Findings of the study revealed a significant effect of the interval training program on VO2max, SBP, and DBP and WBC count at P<0.05 and VO2max is negatively related to the WBC count (r=-0.339) at P<0.01. CONCLUSIONS It was concluded that the interval training program is an effective adjunct nonpharmacological management of hypertension and the therapeutic effect of exercise programs may be mediated through suppression of inflammatory (WBC count) reaction.

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OBJECTIVES The main goal of this study was to evaluate the fracture resistance of maxillary second premolar teeth with standard and conservative mesio-occluso-distal (MOD) cavity designs. METHODS Sixty maxillary second premolars were randomly divided into 6 Groups of 10 teeth. G1 consisted of intact teeth. G2 was prepared with separated proximal boxes that were designed to be 1 mm approximately above the cement-enamel junction for the cervical margins. The occlusal outline of the proximal was performed as approximately half of the intercuspal distance buccolingually and one-third of the mesiodistal dimension. The proximal preparation was standardized in all tested groups. G3 was prepared with an occlusal extension that extended approximately one-third of buccolingual width and 2 mm in depth. G4 was prepared with the occlusal extension of 1mm in depth and width. G5: The occlusal extension was 1mm in depth and 2 mm in width. G6: The occlusal extension was 2 mm in depth and 1 mm in width. Samples were restored with composite resin and subjected to load to failure test to evaluate the fracture resistance. RESULTS G1 showed the highest fracture resistance value (1737.1 N) while G3 had the lowest mean value (522.9 N). Furthermore, the fracture resistance of G4 and G5 was significantly higher than G3 and G6 ( P < 0.05), where in both groups, the preparation of the occlusal extension mostly remained in the enamel layer. CONCLUSION Modified MOD cavity designs with 1 mm depth in the enamel layer have significantly higher fracture resistance than the standard MOD cavity.

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BACKGROUND Migraine is a painful neurological disorder that affects over 10% of the general population. Frovatriptan and rizatriptan are antimigraine agents belonging to the triptan class. Although previous studies have independently compared the efficacy of these agents, contemporaneous data examining both pharmacokinetic (PK) properties and efficacy in parallel have not previously been available. MATERIALS AND METHODS In this single-center double-blind study, 18 subjects (ten female) were treated for a single migraine attack with frovatriptan 2.5 mg or rizatriptan 10 mg. Plasma concentrations were measured predose and at 2, 4, 6, 12, 24, 48, and 72 hours after drug administration. The primary end point of this study was to evaluate the association between PK parameters and efficacy measures and recurrence rate. Secondary end points were pain-free and pain-relief episodes at 2 and 4 hours, recurrent episodes within 48 hours, and cumulative hazard of recurrence within 72 hours. RESULTS At baseline, approximately 17% of patients had mild migraine, while 83% had moderate-severe migraine. Although the time to maximum concentration was similar for both drugs (2.7 versus 2.3 hours), the terminal half-life for frovatriptan was longer than rizatriptan (29.3 versus 3.2 hours, P<0.0001). The proportion of patients who were pain-free at 4 hours without rescue medication was higher in the frovatriptan-treated group, (38.9 versus 5.6%, P=0.045). The cumulative hazard of recurrence over 72 h was reduced by frovatriptan compared to rizatriptan-treated patients (log-rank test, P=0.04). Pain-free and pain-relief episodes for the study period were positively correlated with the concentration:maximum concentration (Cmax) ratio for frovatriptan (r=0.52, P=0.028), but not rizatriptan. Recurrence rate was negatively correlated with the concentration:Cmax ratio for both frovatriptan (r=-0.96, P=0.0024) and rizatriptan (r=-0.98, P=0.0004). Fewer adverse events were observed for frovatriptan compared to rizatriptan (one versus eight, P=0.021). CONCLUSION This pilot study indicates that a similar extent of initial pain relief is afforded by both triptans in migraine treatment. The longer duration of action of frovatriptan parallels and correlates with its PK profile.

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BACKGROUND Vitamin D (Vit D) deficiency is a common disorder in diabetic patients and may be a risk factor for ischemic heart disease and exacerbation of diabetic nephropathy(DN). OBJECTIVES The aim of this study was to evaluate the effect of Vit D3 therapy on protein uriain type 2 diabetic patients with deficient or insufficient serum Vit D. PATIENTS AND METHODS In a double blind clinical trial, 60 type 2 diabetic patients with proteinuria greater than 150 mg/day who had Vit D deficiency or insufficiency were randomly enrolled in two equal groups. Pearl of Vit D as 50 000 IU/week and placebo (1 tablet per week) were prescribed in patients of case and control groups respectively for 8 weeks. At the beginning and 2 months later, 24 hours urine protein was checked in all patients. RESULTS There is no difference between serums Vit D level in case and control group at the beginning of the study, however at the end of the study serum Vit D level was significantly higher in the case group. There is no difference in proteinuria between case and control group at the beginning and the end of the study, while a significant difference between the changes of proteinuria before and after the study was seen in two groups ( P = 0.028). CONCLUSIONS Vit D deficiency may exacerbate protein uric and DN, hence correction of Vit D deficiency may decrease proteinuria in diabetic patients with nephropathy.

1significant effect

BACKGROUND Maintenance monotherapy with the poly(ADP-ribose) polymerase inhibitor olaparib significantly prolongs progression-free survival over placebo in patients with platinum-sensitive relapsed serous ovarian cancer, with greatest benefit seen in patients with a BRCA1/2 mutation (BRCAm). Preservation of health-related quality of life (HRQoL) is important during maintenance therapy; we evaluated the effect of olaparib on HRQoL in this Phase II trial (NCT00753545, Study 19). METHODS Patients received olaparib 400 mg b.i.d. (capsules) or placebo until progression. Patient-reported HRQoL and disease-related symptoms were evaluated using the FACT-Ovarian (FACT-O) questionnaire (completed at baseline and every 28 days until progression), the FACT/NCCN Ovarian Symptom Index (FOSI) and the Trial Outcome Index (TOI). TOI of the FACT-O was the primary measure. RESULTS Overall, 265 women were randomised to maintenance olaparib (n=136) or placebo (n=129). Compliance for HRQoL assessment was high (∼80% over time). Most patients in both arms reported a best response of 'no change' on TOI (81%) and other HRQoL measures. There were no statistically significant differences in time to worsening or improvement rates of TOI, FOSI and FACT-O scores in the overall, BRCAm and germline BRCAm populations. CONCLUSIONS Maintenance treatment with olaparib was well tolerated and had no adverse impact on HRQoL in this study of patients with platinum-sensitive relapsed serous ovarian cancer who had responded to their most recent platinum-based therapy (partial or complete response). Interpretation of the HRQoL results in this population may differ from patients who have not responded to their most recent platinum-based therapy.

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AIM A double-blind randomized controlled trial to determine whether dietary supplementation with fruit/vegetable/berry juice powder concentrates, simultaneously with non-surgical periodontal therapy, improved 2-month treatment outcomes. METHODS Volunteers with chronic periodontitis were randomly assigned to one of three groups: fruit/vegetable (FV), fruit/vegetable/berry (FVB) or placebo. Supplements were taken daily during non-surgical debridement and maintenance and outcomes assessed at 2, 5 and 8 months after completion. Primary outcomes were mean probing pocket depth (PPD), clinical attachment gain, % sites bleeding on probing (% BOP) at 2 months. Adherence and plasma β-carotene were determined. RESULTS Sixty-one nutritionally replete (by serum biochemistry) volunteers enrolled and 60 (n = 20 per arm) completed the 2-month review. Clinical outcomes improved in all groups at 2 months, with additional improvement in PPD versus placebo for FV (p < 0.03). Gingival crevicular fluid volumes diminished more in supplement groups than placebo (FVB; p < 0.05) at 2 months, but not at later times. The % BOP (5 months) and cumulative plaque scores (8 months) were lowered more in the FV group (p < 0.05). CONCLUSIONS Adjunctive juice powder concentrates appear to improve initial pocket depth reductions in nutritionally replete patients, where plasma micronutrient bioavailability is attainable. Definitive multicentre studies in untreated and treated patients are required to ascertain the clinical significance of such changes.

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AIM The aim of this study is to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block or local wound infiltration. MATERIAL AND METHODS In this prospective interventional clinical study, the anesthesia and recovery profile was assessed in sixty pediatric patients undergoing inguinal hernia repair. Enrolled children were randomly assigned to either Group Caudal or Group Local infiltration. For caudal blocks, Caudal Group received 1 ml/kg of 0.25% bupivacaine; Local Infiltration Group received 0.2 ml/kg 0.25% bupivacaine. Investigator who was blinded to group allocation provided postoperative care and assessments. Postoperative pain was assessed. Motor functions and sedation were assessed as well. RESULTS The two groups did not differ in terms of patient characteristic data and surgical profiles and there weren't any hemodynamic changes between groups. Regarding the difference between groups for analgesic requirement there were two major points - on one hand it was statistically significant p < 0.05 whereas on the other hand time to first analgesic administration was not statistically significant p = 0.40. There were significant differences in the incidence of adverse effects in caudal and local group including: vomiting, delirium and urinary retention. CONCLUSIONS Between children undergoing inguinal hernia repair, local wound infiltration insures safety and satisfactory analgesia for surgery. Compared to caudal block it is not overwhelming. Caudal block provides longer analgesia, however complications are rather common.

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BACKGROUND Increasing numbers of reports show the beneficial effects of listening to Mozart music in decreasing epileptiform discharges as well as seizure frequency in epileptic children. There has been no effective method to reduce seizure recurrence after the first unprovoked seizure until now. In this study, we investigated the effect of listening to Mozart K.448 in reducing the seizure recurrence rate in children with first unprovoked seizures. METHODS Forty-eight children who experienced their first unprovoked seizure with epileptiform discharges were included in the study. They were randomly placed into treatment (n = 24) and control (n = 24) groups. Children in the treatment group listened to Mozart K.448 daily before bedtime for at least six months. Two patients in the treatment group were excluded from analysis due to discontinuation intervention. Finally, forty-six patients were analyzed. Most of these patients (89.1%) were idiopathic in etiology. Seizure recurrence rates and reduction of epileptiform discharges were compared. RESULTS The average follow-up durations in the treatment and control groups were 18.6 ± 6.6 and 20.1 ± 5.1 months, respectively. The seizure recurrence rate was estimated to be significantly lower in the treatment group than the control group over 24 months (37.2% vs. 76.8%, p = 0.0109). Significant decreases in epileptiform discharges were also observed after 1, 2, and 6 months of listening to Mozart K.448 when compared with EEGs before listening to music. There were no significant differences in gender, mentality, seizure type, and etiology between the recurrence and non-recurrence groups. CONCLUSIONS Although the case number was limited and control music was not performed in this study, the study revealed that listening to Mozart K.448 reduced the seizure recurrence rate and epileptiform discharges in children with first unprovoked seizures, especially of idiopathic etiology. We believe that Mozart K.448 could be a promising alternative treatment in patients with first unprovoked seizures and abnormal EEGs. Further large-scaled study should be conducted to confirm the effect. TRIAL REGISTRATION NCT01892605, date: June-19-2013.

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BACKGROUND Heart failure is one of the most important and prevalent diseases that may have negative effects on the quality of life (QOL). Today, the promotion of QOL in patients with heart failure is important in nursing care programs. This research aimed to determine the efficacy of hope-promoting interventions based on religious beliefs on the QOL of patients with congestive heart failure (CHF). MATERIALS AND METHODS In this randomized clinical trial (IRCT2014100619413N1) conducted in Isfahan, Iran, 46 adult patients with CHF were selected and randomly assigned to study and control groups. Ferrans and Powers Quality of Life Index (QLI) was completed by both groups before, immediately after, and 1 month after the intervention. For the study group participants and their families, 60-min sessions of hope-promoting interventions based on religious beliefs were held twice a week for 3 weeks. Independent t, repeated measures analysis of variance (ANOVA), Chi-square, Mann-Whitney, and Fisher's exact tests were adopted for data analysis. RESULTS The mean (standard deviation) overall QOL score in the area of satisfaction significantly increased in the study group, compared to the controls, immediately [70.7 (8.5) vs. 59.2 (12.5)] and 1 month after the intervention [75.2 (7.4) vs. 59.4 (12.9)] (P < 0.05). There was also a similar difference between the two groups in the area of importance immediately [73.6 (5.8) vs. 65.7 (7.5)] and 1 month after the intervention [76.3 (8.1) vs. 66.8 (8.5)] (P < 0.05). CONCLUSIONS Hope-promoting intervention based on religious beliefs is a useful method for improving QOL in patients with CHF.

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BACKGROUND Integrated Infectious Diseases Capacity Building Evaluation (IDCAP) teams designed and implemented two health worker in-service training approaches: 1) an off-site classroom-based integrated management of infectious diseases (IMID) course with distance learning aspects, and 2) on-site support (OSS), an educational outreach intervention. We tested the effects of OSS on workload and 12 facility performance indicators for emergency triage assessment and treatment, HIV testing, and malaria and pneumonia case management among outpatients by two subgroups: 1) mid-level practitioners (MLP) who attended IMID training (IMID-MLP) and 2) health workers who did not (No-IMID). METHODS Thirty-six health facilities participated in the IDCAP trial, with 18 randomly assigned to Arm A and 18 to Arm B. Two MLP in both arms received IMID. All providers at Arm A facilities received nine monthly OSS visits from April to December 2010 while Arm B did not. From November 2009 to December 2010, 777,667 outpatient visits occurred. We analyzed 669,580 (86.1 %) outpatient visits, where provider cadre was reported. Treatment was provided by 64 IMID-MLP and 1,515 No-IMID providers. The effect of OSS was measured by the difference in pre/post changes across arms after controlling for covariates (adjusted ratio of relative risks = a RRR). RESULTS The effect of OSS on patients-per-provider-per-day (workload) among IMID-MLP (aRRR = 1.21; p = 0.48) and No-IMID (aRRR = 0.90; p = 0.44) was not statistically significant. Among IMID-MLP, OSS was effective for three indicators: malaria cases receiving an appropriate antimalarial (aRRR = 1.26, 99 % CI = 1.02-1.56), patients with negative malaria test result prescribed an antimalarial (aRRR = 0.49, 99 % CI = 0.26-0.92), and patients with acid-fast bacilli smear negative result receiving empiric treatment for acute respiratory infection (aRRR = 2.04, 99 % CI = 1.06-3.94). Among No-IMID, OSS was effective for two indicators: emergency and priority patients admitted, detained or referred (aRRR = 2.12, 99 % CI = 1.05-4.28) and emergency patients receiving at least one appropriate treatment (aRRR = 1.98, 99 % CI = 1.21-3.24). CONCLUSION Effects of OSS on workload were not statistically significant. Significant OSS effects on facility performance across subgroups were heterogeneous. OSS supported MLP who diagnosed and treated patients to apply IMID knowledge. For other providers, OSS supported team work to manage emergency patients. This evidence on OSS effectiveness could inform interventions to improve health workers' capacity to deliver better quality infectious diseases care.

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BACKGROUND The safety of the immune complexes composed of yeast-derived hepatitis B surface antigen (HBsAg) and antibodies (abbreviated as YIC) among healthy adults and chronic hepatitis B patients has been proved in phase I and phase IIa trial. A larger number of patients for study of dosage and efficacy are therefore needed. METHODS AND PRINCIPAL FINDINGS Two hundred forty two HBeAg-positive chronic hepatitis B patients were immunized with six injections of either 30 microg YIC, 60 microg of YIC or alum adjuvant as placebo at four-week intervals under code. HBV markers and HBV DNA were monitored during immunization and 24 weeks after the completion of immunization. The primary endpoint was defined as loss of HBeAg, or presence of anti-HBe antibody or suppression of HBV DNA, while the secondary endpoint was both HBeAg seroconversion and suppression of HBV DNA. Statistical significance was not reached in primary endpoints four weeks after the end of treatment among three groups, however, at the end of follow-up, HBeAg sero-conversion rate was 21.8% (17/78) and 9% (7/78) in the 60 microg YIC and placebo groups respectively (p = 0.03), with 95% confidence intervals at 1.5% to 24.1%. Using generalized estimating equations (GEEs) model, a significant difference of group effects was found between 60 microg YIC and the placebo groups in terms of the primary endpoint. Eleven serious adverse events occurred, which were 5.1%, 3.6%, and 5.0% in the placebo, 30 microg YIC and 60 microg YIC groups respectively (p>0.05). CONCLUSIONS Though statistical differences in the preset primary and secondary endpoints among the three groups were not reached, a late and promising HBeAg seroconversion effect was shown in the 60 microg YIC immunized regimen. By increasing the number of patients and injections, the therapeutic efficacy of YIC in chronic hepatitis B patients will be further evaluated. TRIAL REGISTRATION ChiCTR.org ChiCTR-TRC-00000022.

1significant effect

BACKGROUND Exhaustive exercise causes muscle damage accompanied by oxidative stress and inflammation leading to muscle fatigue and muscle soreness. Lemon verbena leaves, commonly used as tea and refreshing beverage, demonstrated antioxidant and anti-inflammatory properties. The aim of this study was to investigate the effects of a proprietary lemon verbena extract (Recoverben®) on muscle strength and recovery after exhaustive exercise in comparison to a placebo product. METHODS The study was performed as a randomized, placebo-controlled, double-blind study with parallel design. Forty-four healthy males and females, which were 22-50 years old and active in sports, were randomized to 400 mg lemon verbena extract once daily or placebo. The 15 days intervention was divided into 10 days supplementation prior to the exhaustive exercise day (intensive jump-protocol), one day during the test and four days after. Muscle strength (MVC), muscle damage (CK), oxidative stress (GPx), inflammation (IL6) and volunteer-reported muscle soreness intensity were assessed pre and post exercise. RESULTS Participants in the lemon verbena group benefited from less muscle damage as well as faster and full recovery. Compared to placebo, lemon verbena extract receiving participants had significantly less exercise-related loss of muscle strength ( p  = 0.0311) over all timepoints, improved glutathione peroxidase activity by trend ( p  = 0.0681) and less movement induced pain ( p  = 0.0788) by trend. Creatine kinase and IL-6 didn't show significant discrimmination between groups. CONCLUSION Lemon verbena extract (Recoverben®) has been shown to be a safe and well-tolerated natural sports ingredient, by reducing muscle damage after exhaustive exercise. TRIAL REGISTRATION The trial was registered in the clinical trials registry (clinical trial.gov NCT02923102). Registered 28 September 2016.

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BACKGROUND High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. METHODS A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. RESULTS A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). CONCLUSIONS This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

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BACKGROUND Currently, there is an increased prevalence of diabetes mellitus among the elderly. To minimize adverse effects on glycemic control, prevention and management of general and oral complications in diabetic patients is essential. The purpose of the present study is to assess the effectiveness of a Lifestyle Change plus Dental Care (LCDC) program to improve glycemic and periodontal status in the elderly with type 2 diabetes. METHODS A quasi-experimental study was conducted in Health Centers 54 (intervention) and 59 (control) from October 2013 to January 2014. 66 diabetic patients per health center were included. At baseline, the intervention group attended a 20 minute lifestyle and oral health education program, individual lifestyle counseling using motivational interviewing (MI), application of self regulation manual, and individual oral hygiene instruction. The intervention group received booster education every visit by viewing a 15 minute educational video. The control group received a routine program. Participants were assessed at baseline and 3 month follow up for glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), body mass index (BMI), periodontal status, knowledge, attitude and practice of oral health and diabetes mellitus. Data were analyzed by using descriptive statistic, Chi-square test, Fisher's exact test, t-test, and multiple linear regression. RESULTS After the 3 month follow up, a multiple linear regression analysis showed that the intervention group was significantly negatively correlated in both glycemic and periodontal status. Participants in the intervention group had significantly lower glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), plaque index score, gingival index score, pocket depth, clinical attachment level (CAL), and percentage of bleeding on probing (BOP) when compared to the control group. CONCLUSIONS The combination of lifestyle change and dental care in one program improved both glycemic and periodontal status in the elderly with type 2 diabetes. TRIAL REGISTRATION ClinicalTrials.in.th: TCTR20140602001.

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BACKGROUND Mycobacterial identification in active pulmonary tuberculosis (APTB) is confirmative, even though successful rates using self-expectorated sputum are limited. Sputum specimens collected by hypertonic saline nebulization showed higher bacteriologic diagnostic sensitivities over those of self-expectoration, mostly studied in smear-negative or sputum-scarce patients. The efficacy of induced sputum was rarely assessed in real clinical settings. METHODS A prospective randomized case-control study was performed in one hospital. The subjects highly suspicious of APTB were asked to provide 3 pairs of sputum specimens in 3 consecutive days. The first pairs of the specimens were obtained either by self-expectoration (ES) from the next day of the visit or sputum induction with 7% saline nebulization in clinic (SI), and the other specimens were collected in the same way. The samples were tested in microscopy, culture, and polymerase chain reaction (PCR). The outcomes of the bacteriological diagnosis were compared. RESULTS Seventy six patients were assigned to either ES (38 subjects, median age of 51, 65.8% male) or SI (38 subjects, median age of 55, 52.6% male). APTB was clinically confirmed in 51 patients (70.8%), 27 in ES and 24 in SI. Among the APTB, more adequate specimens were collected from SI (41/65, 63.1%) than ES (34/80, 42.5%) (p=0.01). Bacteriological confirmation was achieved in 14 (58.3%) patients in SI, and 13 (48.1%) in ES (p=0.46). In the same-day bacteriological diagnosis with microscopy and PCR, there were positive results for 9 patients (37.5%) in SI and 7 patients (25.9%) in ES (p=0.37). CONCLUSION Sputum induction improves sputum specimen adequacy. It may be useful for the same-day bacteriological diagnosis with microscopic examination and PCR.

1significant effect

BACKGROUND Hypertension in pregnancy is one of the prevalent disorder resulting in maternal death. The aim of this study was to investigate the effect of stretching exercise and walking on changes of blood pressure in nulliparous women during pregnancy. MATERIALS AND METHODS This was a quasi-experimental trial that consisted three groups of women who took part in pre- and post-tests. We used a simple randomized sample, including 118 pregnant females (walking: 29 subjects, stretching exercise: 30 subjects control: 59 subjects). The data were collected using the demographic checklist and blood pressure was measured every week. SPSS 16 was used to analyze the data by one-way analysis of variance (ANOVA) and repeated measure ANOVA. RESULTS No significant difference was found in the demographic characteristics of the three groups of women. Mean systolic and diastolic blood pressure in the three groups (stretching exercises, walking, and routine care) at three intervals (pre-test, first post-test, and second post-test) were significantly different (P < 0.05). In this case, Tukey's test showed significant improvement of systolic and diastolic blood pressure in stretching exercise group. Walking and control groups showed no change or significant reduction (P < 0.05). No significant difference was found between the walking and control groups (P > 0.05). CONCLUSIONS The results of the study showed that stretching exercise versus walking reduces systolic and diastolic blood pressure in the second trimester of pregnancy and controls it in the third trimester of pregnancy. In contrast, walking has no effect on blood pressure during pregnancy.

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BACKGROUND Increased circulating cathepsin S levels have been linked to increased risk of cardiometabolic diseases and cancer. However, whether cathepsin S is a modifiable risk factor is unclear. We aimed to investigate the effects of a prudent diet on plasma cathepsin S levels in healthy individuals. FINDINGS Explorative analyses of a randomized study were performed in 88 normal to slightly overweight and hyperlipidemic men and women (aged 25 to 65) that were randomly assigned to ad libitum prudent diet, i.e. healthy Nordic diet (ND) or a control group (habitual Western diet) for 6 weeks. Whereas all foods in the ND were provided, the control group was advised to consume their habitual diet throughout the study. The ND was in line with dietary recommendations, e.g. low in saturated fats, sugars and salt, but high in plant-based foods rich in fibre and unsaturated fats.The ND significantly decreased cathepsin S levels (from 20.1 (+/-4.0 SD) to 19.7 μg/L (+/-4.3 SD)) compared with control group (from 18.2 (+/-2.9 SD) to 19.1 μg/L (+/-3.8 SD)). This difference remained after adjusting for sex and change in insulin sensitivity (P = 0.03), and near significant after adjusting for baseline cathepsin S levels (P = 0.06), but not for change in weight or LDL-C. Changes in cathepsin S levels were directly correlated with change in LDL-C. CONCLUSIONS Compared with a habitual control diet, a provided ad libitum healthy Nordic diet decreased cathepsin S levels in healthy individuals, possibly mediated by weight loss or lowered LDL-C. These differences between groups in cathepsin S were however not robust and therefore need further investigation.

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BACKGROUND A high strength of beclomethasone/formoterol fumarate (BDP/FF) in a pressurised metered dose inhaler (pMDI), which contains extrafine BDP (200 μg/actuation) and FF (6 μg/actuation) has been developed to treat those asthmatics who are not adequately controlled on previous treatments. METHODS A 12-week, randomized, double-blind, parallel group study was performed to compare the efficacy and safety of pMDI BDP/FF 200/6 (two actuations bid) with BDP 100 μg (four actuation bid) in a population of 376 randomized adult asthmatics not adequately controlled with high dose of inhaled corticosteroids (ICS) or medium dose of ICS plus long acting β 2 agonists (LABA). RESULTS The primary endpoint [change from baseline over the entire treatment period in average pre-dose morning peak expiratory flow (PEF)] demonstrated the superiority of BDP/FF over BDP monotherapy, with an adjusted mean difference of 19 L/min, which is above the minimal important clinical difference reported for this parameter. Overall, BDP/FF and BDP showed a similar improvement of symptom-based parameters and of the use of rescue medication after 3-month treatment. The safety profile of the two drugs was comparable, although BDP monotherapy, but not BDP/FF, slightly reduced the levels of serum cortisol. CONCLUSIONS The study proved that pMDI BDP/FF 200/6 μg was superior to BDP alone in improving lung function with comparable safety profiles. Therefore it may be considered as an effective treatment for adults with asthma not adequately controlled with high dose of ICS monotherapy or medium dose of ICS/LABA combinations. TRIAL REGISTRATION ClinicalTrials.gov: NCT01577082 , date 06/04/2012.

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BACKGROUND AND AIMS Transversus abdominis plane (TAP) block has been shown to provide postoperative pain relief following various abdominal and inguinal surgeries, but few studies have evaluated its analgesic efficacy for intraoperative analgesia. We evaluated the efficacy of TAP block in providing effective perioperative analgesia in total abdominal hysterectomy in a randomized double-blind controlled clinical trial. MATERIALS AND METHODS A total of 90 adult female patients American Society of Anesthesiologists physical status I or II were randomized to Group B (n = 45) receiving TAP block with 0.25% bupivacaine and Group N (n = 45) with normal saline followed by general anesthesia. Hemodynamic responses to surgical incision and intraoperative fentanyl consumption were noted. Visual analog scale (VAS) scores were assessed on the emergence, at 1, 2, 3, 4, 5, 6 and 24 h. Time to first rescue analgesic (when VAS ≥4 cm or on demand), duration of postoperative analgesia, incidence of postoperative nausea-vomiting were also noted. RESULTS Pulse rate (95.9 ± 11.2 bpm vs. 102.9 ± 8.8 bpm, P = 0.001) systolic and diastolic BP were significantly higher in Group N. Median intraoperative fentanyl requirement was significantly higher in Group N (81 mcg vs. 114 mcg, P = 0.000). VAS scores on emergence at rest (median VAS 3 mm vs 27 mm), with activity (median 8 mm vs. 35 mm) were significantly lower in Group B. Median duration of analgesia was significantly higher in Group B (290 min vs. 16 min, P = 0.000). No complication or opioid related side effect attributed to TAP block were noted in any patient. CONCLUSION Preincisional TAP block decreases intraoperative fentanyl requirements, prevents hemodynamic responses to surgical stimuli and provides effective postoperative analgesia.

1significant effect

BACKGROUND Recent research has indicated that pomegranate extract (POMx) may improve performance during aerobic exercise by enhancing the matching of vascular oxygen (O 2 ) provision to muscular requirements. POMx is rich in ellagitannin polyphenols and nitrates (NO 3 - ), which are both associated with improvements in blood flow and O 2 delivery. Primarily, this study aimed to determine whether POMx improves performance in a cycling time trial to exhaustion at 100%VO 2max (TTE100%) in highly-trained cyclists. In addition, we investigated if the O 2 cost (VO 2 ) of submaximal exercise was lower with POMx, and whether any changes were greater at high altitude where O 2 delivery is impaired. METHODS Eight cyclists exercised at three submaximal intensities before completing a TTE100% at sea-level (SEA) and at 1657 m of altitude (ALT), with pre-exercise consumption of 1000 mg of POMx or a placebo (PLAC) in a randomized, double-blind, crossover design. Data were analysed using a three way (treatment x altitude x intensity) or two-way (treatment x altitude) repeated measures ANOVA with a Fisher's LSD post-hoc analysis. Significance was set at p  ≤ 0.05. The effect size of significant interactions was calculated using Cohen's d. RESULTS TTE100% performance was reduced in ALT but was not influenced by POMx ( p  > 0.05). Plasma NO 3 - were 10.3 μmol greater with POMx vs. PLAC (95% CI, 0.8, 19.7, F 1,7  = 7.83, p  < 0.04). VO 2 measured at five minutes into the TTE100% was significantly increased in ALTPOMx vs. ALTPLAC (+3.8 ml.min -1 kg -1 , 95% CI, -5.7, 9.5, F 1,7  = 29.2, p  = 0.001, ES = 0.6) but unchanged in SEAPOMx vs. SEAPLAC ( p  > 0.05). Submaximal VO 2 values were not affected by POMx ( p  ≥ 0.05). CONCLUSIONS The restoration of SEA VO 2 values at ALT is likely driven by the high polyphenol content of POMx, which is proposed to improve nitric oxide bioavailability. Despite an increase in VO 2 , no change in exercise performance occurred and therefore this study does not support the use of POMx as an ergogenic supplement.

1significant effect

BACKGROUND Induced hypothermia for treatment of traumatic brain injury is controversial. Since many pathways involved in the pathophysiology of secondary brain injury are temperature dependent, regional brain hypothermia is thought capable to mitigate those processes. The objectives of this study are to assess the therapeutic effects and complications of regional brain cooling in severe head injury with Glasgow coma scale (GCS) 6-7. MATERIALS AND METHODS A prospective randomized controlled pilot study involving patients with severe traumatic brain injury with GCS 6 and 7 who required decompressive craniectomy. Patients were randomized into two groups: Cooling and no cooling. For the cooling group, analysis was made by dividing the group into mild and deep cooling. Brain was cooled by irrigating the brain continuously with cold Hartmann solution for 24-48 h. Main outcome assessments were a dichotomized Glasgow outcome score (GOS) at 6 months posttrauma. RESULTS A total of 32 patients were recruited. The cooling-treated patients did better than no cooling. There were 63.2% of patients in cooling group attained good GOS at 6 months compared to only 15.4% in noncooling group (P = 0.007). Interestingly, the analysis at 6 months post-trauma disclosed mild-cooling-treated patients did better than no cooling (70% vs. 15.4% attained good GOS, P = 0.013) and apparently, the deep-cooling-treated patients failed to be better than either no cooling (P = 0.074) or mild cooling group (P = 0.650). CONCLUSION Data from this pilot study imply direct regional brain hypothermia appears safe, feasible and maybe beneficial in treating severely head-injured patients.

0no significant effect

BACKGROUND Misoprostol is very effective in cervical ripening and is used for termination of pregnancy. A similar effect on the nonpregnant uterus will facilitate gynecological operations, and hence we assessed the effect of misoprostol on the nonpregnant uterus of premenopausal women. MATERIALS AND METHODS In a prospective double-blinded randomized controlled trial, 280 women were randomly allocated into two groups (12 women did not complete the intervention). Study (A) and control (B) group received 400 μg of misoprostol or 400 mg of metronidazole tablets (as a placebo) respectively in the posterior vaginal wall 6 h prior to gynecological procedures. RESULTS The mean cervical dilatation was significantly higher (P < 0.0001) in misoprostol compared to placebo group (4.6 ± 0.96 mm vs. 3.6 ± 0.82 mm), benefit were also observed on secondary outcome measures which were need for further dilatation, time taken for further dilatation, ease of dilatation, subjective assessment of pain by visual analog scale. Only 3.61% patients complained of intolerable pain during dilatation in the study group while in control group 48.74% complained of intolerable pain and required anesthesia. Most common side effects of misoprostol were abdominal pain and mild vaginal bleeding. CONCLUSION Misoprostol was effective in cervical ripening of nonpregnant premenopausal uterus to facilitate gynecological procedures.

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OBJECTIVE We evaluated the incidence of acute pancreatitis and pancreatic cancer in patients with type 2 diabetes and cardiovascular disease who were treated with sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i). RESEARCH DESIGN AND METHODS In the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study, a cardiovascular safety study of sitagliptin, all suspected cases of acute pancreatitis and pancreatic cancer were collected prospectively for 14,671 participants during a median follow-up time of 3 years, and were adjudicated blindly. RESULTS Baseline differences were minimal between participants confirmed to have no pancreatic events, acute pancreatitis, or pancreatic cancer. Among those participants randomized to receive sitagliptin, 23 (0.3%) (vs. 12 randomized to receive placebo [0.2%]) had pancreatitis (hazard ratio 1.93 [95% CI 0.96-3.88], P = 0.065; 0.107 vs. 0.056/100 patient-years), with 25 versus 17 events, respectively. Severe pancreatitis (two fatal) occurred in four individuals allocated to receive sitagliptin. Cases of pancreatic cancer were numerically fewer with sitagliptin (9 [0.1%]) versus placebo (14 [0.2%]) (hazard ratio 0.66 [95% CI 0.28-1.51], P = 0.32; 0.042 vs. 0.066 events/100 patient-years). Meta-analysis with two other DPP-4i cardiovascular outcome studies showed an increased risk for acute pancreatitis (risk ratio 1.78 [95% CI 1.13-2.81], P = 0.01) and no significant effect for pancreatic cancer (risk ratio 0.54 [95% CI 0.28-1.04], P = 0.07). CONCLUSIONS Pancreatitis and pancreatic cancer were uncommon events with rates that were not statistically significantly different between the sitagliptin and placebo groups, although numerically more sitagliptin participants developed pancreatitis and fewer developed pancreatic cancer. Meta-analysis suggests a small absolute increased risk for pancreatitis with DPP-4i therapy.

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INTRODUCTION Spinal anesthesia is preferred technique of choice in infraumbalical surgeries. Limitation of this technique is shorter duration of analgesia, so various adjuvants have been used with intrathecal bupivacaine such as fentanyl, clonidine, and dexmedetomidine. Dexmedetomidine is a highly selective alpha 2 adrenergic agonist. The aim of our study was to know the effect of different doses of dexmedetomidine on intrathecal bupivacaine. MATERIALS AND METHODS The prospective, randomized, double-blind study was conducted in tertiary health care center, on ninety patients of the American Society of Anesthesiology Class I and II, of age group 18-60 years of either sex. They were randomly allocated into three groups. Group BD 5 ( n = 30): intrathecal bupivacaine 12.5 mg (2.5 ml) + dexmedetomidine 5 μg (0.5 ml), Group BD 10 ( n = 30): intrathecal bupivacaine 12.5 mg (2.5 ml) + dexmedetomidine 10 μg (0.5 ml), Group BD 15 ( n = 30): intrathecal bupivacaine 12.5 mg (2.5 ml) + dexmedetomidine 15 μg (0.5 ml) administered intarthecally. The onset and maximum level of sensory block, time to reach maximum level of sensory block, time of two-segment sensory regression, the total duration analgesia, time of rescue analgesia, onset and duration of motor block and heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, and oxygen saturation were recorded at various intervals. Moreover, any adverse effects such as bradycardia, hypotension, nausea, vomiting, and sedation were recorded. RESULTS The onset time of sensory block in Group D 5 -2.76 ± 1.32, Group D 10 -2.45 ± 1.50, and Group D 15 -1.86±0.93, which is statistically significant ( P = 0.025). The time taken for two-segment sensory regression Group D 5 -96.66 ± 33.67, Group D 10 -116.80 ± 36.27, and Group D 15 120.96 ± 30.24, ( P = 0.014). The time taken for complete sensory recovery in Group D 5 -319.83 ± 61.41, Group D 10 -336.13 ± 61.38, and Group D 15 -415.20 ± 96.6, which is statistically highly significant ( P = 0.000). Time for rescue analgesia in Group D 5 -377.46 ± 60.05, in Group D 10 -401.60 ± 61.11, and in Group D 15 -517.96 ± 97.30, which is statistically highly significant ( P < 0.000). CONCLUSION We concluded that there was decrease in onset of sensory and motor blockade with the prolongation of duration of anesthesia and analgesia in a dose-dependent manner.

1significant effect

BACKGROUND Different combination of gonadotropin preparation has been introduced with no definite superiority of one over others in in vitro fertilization (IVF), but individualized regimens for each patient are needed. OBJECTIVE The aim of the present study was to investigate the effect of controlled ovarian stimulation with recombinant- follicle stimulating hormone (r-FSH) plus recombinant-luteinizing hormone (rLH) versus human menopausal gonadotropin (HMG) plus r-FSH on fertility outcomes in IVF patients. MATERIALS AND METHODS This is a randomized clinical trial study that was performed from October 2014-April 2016 on 140 infertile patients with a set of inclusion criteria that referred to infertility clinics in Vali- asr and Gandhi Hospital in Tehran. The women were randomly divided into two treatment groups. The first group (n=70) received rFSH from the second day of cycle and was added HMG in 6 th day and the 2 nd group (n=70), received rFSH from the second day of cycle and was added recombinant-LH in 6 th day. Then ovum Pick-Up and embryo transfer were performed. In this study, we assessed the outcomes such as; chemical and clinical pregnancy rate, live birth and abortion rate. RESULTS Number of follicles in ovaries, total number of oocytes or M 2 oocytes and quality of fetuses has no significant differences between two groups (p>0.05). Total number of fetuses were significantly higher in patients who received rFSH + HMG (p=0.02). Fertility outcomes consisted of: live birth rate, chemical pregnancy and clinical pregnancy rate were higher in rFSH + HMG group in comparison to rFSH +r-LH group (p<0.05). CONCLUSION It seems that in IVF patients, HMG + rFSH used for controlled ovarian hyperstimulation have better effects on fertility outcomes, but in order to verify the results, it is recommended to implement studies on more patients.

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BACKGROUND Type 2 diabetes mellitus is a complex, progressive disease which requires a variety of quality improvement strategies. Limited information is available on the feasibility and effectiveness of interdisciplinary diabetes care teams (IDCT) operating on the interface between primary and specialty care. A first study hypothesis was that the implementation of an IDCT is feasible in a health care setting with limited tradition in shared care. A second hypothesis was that patients who make use of an IDCT would have significantly better outcomes compared to non-users of the IDCT after an 18-month intervention period. A third hypothesis was that patients who used the IDCT in an Advanced quality Improvement Program (AQIP) would have significantly better outcomes compared to users of a Usual Quality Improvement Program (UQIP). METHODS This investigation comprised a two-arm cluster randomized trial conducted in a primary care setting in Belgium. Primary care physicians (PCPs, n = 120) and their patients with type 2 diabetes mellitus (n = 2495) were included and subjects were randomly assigned to the intervention arms. The IDCT acted as a cornerstone to both the intervention arms, but the number, type and intensity of IDCT related interventions varied depending upon the intervention arm. RESULTS Final registration included 67 PCPs and 1577 patients in the AQIP and 53 PCPs and 918 patients in the UQIP. 84% of the PCPs made use of the IDCT. The expected participation rate in patients (30%) was not attained, with 12,5% of the patients using the IDCT. When comparing users and non-users of the IDCT (irrespective of the intervention arm) and after 18 months of intervention the use of the IDCT was significantly associated with improvements in HbA1c, LDL-cholesterol, an increase in statins and anti-platelet therapy as well as the number of targets that were reached. When comparing users of the IDCT in the two intervention arms no significant differences were noted, except for anti-platelet therapy. CONCLUSION IDCT's operating on the interface between primary and specialty care are associated with improved outcomes of care. More research is required on what team and program characteristics contribute to improvements in diabetes care. TRIAL REGISTRATION NTR 1369.

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OBJECTIVE We investigated whether supplementation of the active form of vitamin D (calcitriol) in recent-onset type 1 diabetes can protect beta-cell function evaluated by C-peptide and improve glycemic control assessed by A1C and insulin requirement. RESEARCH DESIGN AND METHODS Thirty-four subjects (aged 11-35 years, median 18 years) with recent-onset type 1 diabetes and high basal C-peptide >0.25 nmol/l were randomized in a double-blind trial to 0.25 microg/day calcitriol or placebo and followed-up for 2 years. RESULTS At 6, 12, and 24 months follow-up, A1C and insulin requirement in the calcitriol group did not differ from the placebo group. C-peptide dropped significantly (P < 0.001) but similarly in both groups, with no significant differences at each time point. CONCLUSIONS At the doses used, calcitriol is ineffective in protecting beta-cell function in subjects (including children) with recent-onset type 1 diabetes and high C-peptide at diagnosis.

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BACKGROUND Induction of anesthesia is the most crucial period of general anesthesia. Inhalational induction is the most commonly used technique in pediatric anesthesia. Tracheal intubation can be done after reaching the deep levels of anesthesia. The depth of anesthesia is often difficult to be judged. Bispectral index is a measure of the effects of anesthesia on brain. This study was designed to evaluate the efficacy of bispectral index (BIS) in clarifying suitable depth of anesthesia for tracheal intubation during inhalational induction of anesthesia. METHODS In a clinical trial, ninety patients, ASA I & II, 1 to 6 years old, scheduled for elective surgery were enrolled into the study. After starting BIS monitoring, patients randomly were divided into three groups. Then, anesthesia was induced by gradual increase of halothane in 50% mixture of oxygen (O(2)) and N(2)O and continued until target BIS (60 ± 2, 50 ± 2 and 40 ± 2) achieved. After tracheal intubation, the duration of laryngoscopy and the presence of laryngospasm, bronchospasm, laryngoscopy failure, the movement of extremities and the changes in SpO2 and BIS were recorded. The data were analyzed by chi-square and ANOVA at 0.05 level of significance. RESULTS BIS could not determine the appropriate level of anesthesia for tracheal intubation in this setting. There were no differences in laryngoscopy duration and the occurrence of laryngospasm, bronchospasm, laryngoscopy failure, extremity movement and awakening time among three groups. CONCLUSIONS These results confirmed that there was no significant difference in the incidence of complications related to intubation at different BIS values (from 60 to 40) during inhalation induction, and probably to achieve an adequate or more reliable depth of anesthesia, the lower values of BIS is required.

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BACKGROUND Low-dose aspirin is widely recommended for patients at high risk for cardiovascular disease (CVD); however, it remains uncertain whether long-term treatment adversely affects renal function in patients with diabetes. We investigated whether long-term low-dose aspirin affects renal dysfunction in patients with diabetes. METHODS We conducted a randomized controlled trial (RCT), the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial, to evaluate low-dose aspirin as primary prevention for CVD in patients with type 2 diabetes. We followed the patients with negative urine dipstick albumin of the JPAD trial in a cohort study after the RCT period was completed. Patients were randomly allocated to receive aspirin (81 mg or 100 mg daily, aspirin group) or no aspirin (no aspirin group). After the RCT, the treating physician decided whether to administer aspirin. We evaluated the incidence of positive urine dipstick albumin and annual changes in estimated glomerular filtration rate (eGFR). RESULTS Positive urine dipstick albumin developed in 297 patients in the aspirin group (n = 1,075) and 270 patients in the no aspirin group (n = 1,098) during follow-up (median, 8.5 years). Intention-to-treat analysis showed low-dose aspirin did not increase the incidence of positive urine dipstick albumin (hazard ratio [HR], 1.17; 95% confidence interval [CI], 0.995-1.38). On-treatment analysis yielded similar results (HR, 1.08; 95% CI, 0.92-1.28). Multivariable analysis showed the incidence of positive urine dipstick albumin was higher among the elderly and those with elevated serum creatinine, high hemoglobin A1c, or high blood pressure; however, low-dose aspirin did not increase the risk of positive urine dipstick albumin. There were no significant differences in annual changes in eGFR between the groups (aspirin, -0.8 ± 2.9; no aspirin, -0.9 ± 2.5 ml/min/1.73 m(2)/year). CONCLUSION Long-term low-dose aspirin does not affect eGFR and positive urine dipstick albumin in patients with type 2 diabetes.

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BACKGROUND AND AIMS Midazolam-fentanyl (MDZ:FEN) combination has been routinely used for intravenous sedation in ophthalmic surgeries. Dexmedetomidine (DEX), a recent α2 adrenoreceptor agonist indicated for sedation for ophthalmic use at a loading dose of 0.5 μg/kg over 10 min, can cause deeper plane of sedation and surgeon dissatisfaction. Therefore, we proposed to evaluate the efficacy and safety of two different loading doses of DEX. METHODS In a prospective study, 60 patients aged 50-70 years, scheduled for retinal surgery under peribulbar block were divided equally to receive either MDZ:FEN or DEX 0.5 μg/kg (DEX full) or DEX 0.25 μg/kg (DEX half) loading dose over 10 min followed by titrated maintenance dose of DEX 0.25-0.4 μg/kg/h. Vital parameters, level of sedation (Ramsay Sedation Scale 1-6), effect on respiration and surgeon satisfaction were assessed at regular intervals. Surgeon satisfaction score (0-3) was noted. RESULTS 'DEX half' group patients had predominantly stable haemodynamics, level 3 sedation and surgeon satisfaction score of 2-3 (good to excellent operating conditions). This group had no vomiting and no respiratory depression. 'DEX full' group had a higher incidence of bradycardia, hypotension, level 4 sedation (Ramsay Sedation Scale) and lower surgeon satisfaction. Incidence of nausea and vomiting was higher in MDZ:FEN group compared to other two groups. CONCLUSION DEX 0.25 μg/kg loading dose over 10 min followed by titrated maintenance dose is an effective alternative to MDZ:FEN and provides controlled (level 3) sedation and stable haemodynamics maximising surgeon satisfaction. Avoiding narcotic analgesics with its associated post-operative nausea and vomiting is an additional benefit.

1significant effect

BACKGROUND Intracranial-pressure (ICP) monitoring is considered standard care for severe traumatic brain injury and is used frequently, but the efficacy of treatment based on monitoring in patients with hemorrhagic stroke has not been rigorously assessed. In this study, we investigated the clinical value of ICP monitoring in patients with hemorrhagic stroke. METHODS We conducted a randomized, unblinded, controlled trial in which 90 patients with hemorrhagic stroke were randomly assigned to ICP monitoring or a control group. The primary outcome was a composite of incidence rate of hematoma enlargement and secondary brain herniation. The secondary outcome was neurological status assessed using the Glasgow Outcome Scale scores at 6 months post-onset. Characteristics of the patients at baseline and outcome measurements were also compared between the two groups. RESULTS There was no significant between-group difference in the incidence of hematoma enlargement (control group, 38.6% vs. ICP monitoring group, 32.6%; P > 0.05). The incidence rate of secondary brain herniation in the ICP monitoring group was significantly lower compared with the control group (10.9% vs. 20.5%, P = 0.04). Six-month mortality was 6.5% in the ICP group and 9.1% in the control group (P < 0.05), and neurological outcome was better in the ICP group compared with the control group (P < 0.05). CONCLUSION The dynamic ICP value may be more sensitive and effective in preventing secondary brain herniation in patients with hemorrhagic stroke compared with guidance directed by clinical signs and radiological indicators.

1significant effect

BACKGROUND Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options. This randomized placebo-controlled trial investigated the efficacy of a capsaicin 8% cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy pain. METHODS Forty-six patients with persistent inguinal postherniorrhaphy pain were randomized to receive either a capsaicin 8% patch or a placebo patch. Pain intensity (Numerical Rating Scale [NRS 0-10]) was evaluated under standardized conditions (at rest, during movement, and during pressure) at baseline and at 1, 2 and 3 months after patch application. Skin punch biopsies for intraepidermal nerve fiber density (IENFD) measurements were taken at baseline and 1 month after patch application. Quantitative sensory testing was performed at baseline and at 1, 2, and 3 months after patch application. The primary outcome was comparisons of summed pain intensity differences (SPIDs) between capsaicin and placebo treatments at 1, 2 and 3 months after patch application (significance level P < 0.01). RESULTS The maximum difference in SPID, between capsaicin and placebo treatments, was observed at 1 month after patch application, but the pain reduction was not significant (NRS, mean difference [95% CI]: 5.0 [0.09 to 9.9]; P = 0.046). No differences in SPID between treatments were observed at 2 and 3 months after patch application. Changes in IENFD on the pain side, from baseline to 1 month after patch application, did not differ between capsaicin and placebo treatment: 1.9 [-0.1 to 3.9] and 0.6 [-1.2 to 2.5] fibers/mm, respectively (P = 0.32). No significant changes in sensory function, sleep quality or psychological factors were associated with capsaicin patch treatment. CONCLUSIONS The study did not demonstrate significant differences in pain relief between capsaicin and placebo treatment, although a trend toward pain improvement in capsaicin treated patients was observed 1 month after patch application. TRIAL REGISTRATION Clinicaltrialsregister.eu 2012-001540-22 ClinicalTrials.gov NCT01699854.

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BACKGROUND Irritable bowel syndrome (IBS) is a common gastrointestinal disorder. Recent studies suggest the importance of gut flora in the pathophysiology of it. Therefore, antibiotics have demonstrated a substantial benefit to reduce gut flora. Having few side effects, and applying one-dose per day, we studied the effect of azithromycin to treat IBS. MATERIALS AND METHODS One hundred and twenty-six patients enrolled a randomized, double-blind, placebo-controlled study. The treatment group received azithromycin in addition to common treatment. Patients were followed for 12 weeks. Patients completed daily diaries documenting their symptoms. RESULTS One hundred and thirteen patients completed the study. The onset of relief occurred significantly sooner, and duration of relief was significantly longer in azithromycin group. Movement, abdominal pain, bloating, and gas were significantly better in azithromycin group. Monthly results showed superior relief in bloating, gas, overall symptom, and overall bloating during 3 months. Significantly more patients in azithromycin group felt relief in bloating and gas and had greater consistency relief in almost all weeks. CONCLUSION In our study, azithromycin significantly relieved most symptoms, such as abdominal pain, bloating, and gas. Overall symptom and overall bloating were relieved significantly in more patients in the intervention group in all weeks.

1significant effect

OBJECTIVE To evaluate whether the acute pain experienced during in-hospital recovery from thoracotomy can be effectively reduced by the use of intraoperative measures (dissection of the neurovascular bundle prior to the positioning of the Finochietto retractor and preservation of the intercostal nerve during closure). METHODS We selected 40 patients who were candidates for elective thoracotomy in the Thoracic Surgery Department of the Federal University of São Paulo/Paulista School of Medicine, in the city of São Paulo, Brazil. The patients were randomized into two groups: conventional thoracotomy (CT, n = 20) and neurovascular bundle preservation (NBP, n = 20). All of the patients underwent thoracic epidural anesthesia and muscle-sparing thoracotomy. Pain intensity was assessed with a visual analog scale on postoperative days 1, 3, and 5, as well as by monitoring patient requests for/consumption of analgesics. RESULTS On postoperative day 5, the self-reported pain intensity was significantly lower in the NBP group than in the CT group (visual analog scale score, 1.50 vs. 3.29; p = 0.04). No significant differences were found between the groups regarding the number of requests for/consumption of analgesics. CONCLUSIONS In patients undergoing thoracotomy, protecting the neurovascular bundle prior to positioning the retractor and preserving the intercostal nerve during closure can minimize pain during in-hospital recovery.

1significant effect

OBJECTIVE To assess the effect of pioglitazone on renal outcome, including urinary albumin excretion and estimated glomerular filtration rate (eGFR), in diabetic patients. DESIGN A prospective, randomized, open-labeled, controlled study. SETTING Taipei Veterans General Hospital. PATIENTS Sixty type 2 diabetic patients treated with sulfonylureas and metformin, whose glycated hemoglobin (HbA1c) levels were between 7% and 10% and eGFR was between 45 and 125 mL/min/1.73 m2. INTERVENTION The patients were randomized to receive acarbose or pioglitazone and followed up for 6 months. Thirty patients were randomly assigned to receive acarbose, and 30 patients were assigned to receive pioglitazone. MEASUREMENTS The primary study endpoint was the changes in the urinary albumin-to-creatinine ratio (UACR). The secondary endpoint was the changes in eGFR and other parameters. RESULTS After 6 months of treatment, the mean changes in UACR were -18 ± 104 and 12 ± 85 (p = 0.25, between groups) for the acarbose and pioglitazone groups, respectively. The mean changes in eGFR were 0 ± 14 and -7 ± 16 mL/min/1.73 m2 (p = 0.09, between groups) for the acarbose and pioglitazone groups, respectively. The reductions in HbA1c were similar in both groups. Fasting blood glucose was lower in the pioglitazone group than in the acarbose group. Significant body weight gain was observed in the pioglitazone group as compared with the acarbose group (1.3 ± 2.8 vs. -0.6 ± 1.5 kg, p = 0.002). CONCLUSION In type 2 diabetic patients who were treated with sulfonylureas and metformin and possessed HbA1c levels between 7% and 10%, additional acarbose or pioglitazone for 6 months provided similar glycemic control and eGFR and UACR changes. In the pioglitazone group, the patients exhibited significant body weight gain. TRIAL REGISTRATION ClinicalTrials.gov NCT01175486.

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BACKGROUND Alzheimer's disease (AD) is a slowly progressive neurodegenerative disease which cannot be cured at present. The aim of this study was to assess whether the combined application of β-asarone and tenuigenin could improve the efficacy of memantine in treating moderate-to-severe AD. PATIENTS AND METHODS One hundred and fifty-two patients with moderate-to-severe AD were recruited and assigned to two groups. Patients in the experiment group received β-asarone 10 mg/d, tenuigenin 10 mg/d, and memantine 5-20 mg/d. Patients in the control group only received memantine 5-20 mg/d. The Mini Mental State Examination (MMSE), Clinical Dementia Rating Scale (CDR), and Activities of Daily Living (ADL) were used to assess the therapeutic effects. The drug-related adverse events were used to assess the safety and acceptability. Treatment was continued for 12 weeks. RESULTS After 12 weeks of treatment, the average MMSE scores, ADL scores, and CDR scores in the two groups were significantly improved. But, compared to the control group, the experimental group had a significantly higher average MMSE score ( p <0.00001), lower average ADL score ( p =0.00002), and lower average CDR score ( p =0.030). Meanwhile, the rates of adverse events were similar between the two groups. Subgroup analysis indicated that the most likely candidates to benefit from this novel method might be the 60-74-years-old male patients with moderate AD. CONCLUSION These results demonstrated that the combined application of β-asarone and tenuigenin could improve the efficacy of memantine in treating moderate-to-severe AD. The clinical applicability of this novel method showed greater promise and should be further explored.

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OBJECTIVE To investigate the effect of extracorporeal shock wave therapy (ESWT) on myofascial pain syndrome (MPS). METHOD Thirty patients with MPS in trapezius muscle were randomly divided into two groups, ESWT group (n=15), and trigger point injections (TPI)+transcutaneous electrical nerve stimulation (TENS) group (n=15). For a total of 3 weeks, ESWT was undertaken with 1,500 pulse each time at one week interval totaling 4,500 pulse, TPI for once a week totaling three times and TENS for five times a week totaling three weeks. RESULTS The changes in pain threshold (lb/cm(2)) showed the values of 6.86±1.35 before first therapy, 11.43±0.27 after first therapy, and 12.57±0.72 after third therapy, while TPI+TENS group showed the values of 6.20±1.92 before first therapy, 8.80±0.48 after first therapy, and 9.60±2.19 after third therapy, and the changes between the groups were significantly different (p=0.045). The changes in visual analog scale were estimated to be 6.86±0.90 before first therapy, 2.86±0.90 after first therapy, and 1.86±0.69 after third therapy in case of ESWT group, whereas the figures were estimated to be 7.20±1.30 before first therapy, 4.60±0.55 after first therapy, and 2.80±0.84 after third therapy in case of TPI+TENS group, and the changes between the groups were significantly different (p=0.010). The changes in McGill pain questionnaire (p=0.816) and pain rating scale (p=0.644) between the groups were not significantly different. The changes in neck ROM were also not significantly different between the groups (p>0.05). CONCLUSION The ESWT in patients with MPS in trapezius muscle are as effective as TPI and TENS for the purpose of pain relief and improving cervical range of motion.

1significant effect

BACKGROUND Considerable reports concerned the framing effect in medical situations. But quite few of them noticed to explore the differences among the various kinds of framing effects. OBJECTIVES In the present study, five different types of framing effects were examined and the effect sizes of them were compared. MATERIALS AND METHODS Medical decision making problems concerning medicine effect evaluation, patient's compliance, treatment and doctor options selection were established. All the problems were described in both positive and negative frames. 500 undergraduates as participants were randomly divided into ten groups. Participants from each group were asked to finish one decision making task. RESULTS ALL THE FRAMES THAT WERE EXAMINED LEADED TO SIGNIFICANT FRAMING EFFECTS: When the Asia Disease Problem was described in a positive frame, the participants preferred the conservative frame than the risky one, while if in a negative frame, the preference reversed (P < 0.01). If the drug effect was described as "of 100 patients taking this kind of medicine, 70 patients became better", people tended to make more positive evaluations, compared with described as "of 100 patients taking this kind of medicine, 30 patients didn't become better" (P < 0.01). Doctors' advices were respectively described in a baneful or beneficial frame and the former one resulted in a better compliance (P < 0.05). If treatment options were described with a survival rate, people tended to choose risky option, while if described with a mortality rate, people tended to choose conservative option (P < 0.05). The number sized framing effect was also tested to be significant (P < 0.01). The five types of framing effects were small to big in effect size. CONCLUSIONS Medical decision making can be affected by frame descriptions. Attentions should be paid on the standardization of description in medical practice.

1significant effect

BACKGROUND Improving adherence to ocular hypertension (OH)/glaucoma therapy is highly likely to prevent or reduce progression of optic nerve damage. The present study used a behaviour change counselling intervention to determine whether education and support was beneficial and cost-effective in improving adherence with glaucoma therapy. METHODS A randomised controlled trial with a 13-month recruitment and 8-month follow-up period was conducted. Patients with OH/glaucoma attending a glaucoma clinic and starting treatment with travoprost were approached. Participants were randomised into two groups and adherence was measured over 8 months, using an electronic monitoring device (Travalert® dosing aid, TDA). The control group received standard clinical care, and the intervention group received a novel glaucoma education and motivational support package using behaviour change counselling. Cost-effectiveness framework analysis was used to estimate any potential cost benefit of improving adherence. RESULTS Two hundred and eight patients were recruited (102 intervention, 106 control). No significant difference in mean adherence over the monitoring period was identified with 77.2% (CI, 73.0, 81.4) for the control group and 74.8% (CI, 69.7, 79.9) for the intervention group (p = 0.47). Similarly, there was no significant difference in percentage intraocular pressure reduction; 27.6% (CI, 23.5, 31.7) for the control group and 25.3% (CI, 21.06, 29.54) for the intervention group (p = 0.45). Participants in the intervention group were more satisfied with information about glaucoma medication with a mean score of 14.47/17 (CI, 13.85, 15.0) compared with control group which was 8.51 (CI, 7.72, 9.30). The mean intervention cost per patient was GB£10.35 (<US$16) and not cost-effective. CONCLUSIONS Adherence with travoprost was high and not further increased by the intervention. Nevertheless, the study demonstrated that provision of information, tailored to the individual, was inexpensive and able to achieve high patient satisfaction with respect to information about glaucoma medication. Measurement of adherence remains problematic since awareness of study participation may cause a change in participant behaviour. TRIAL REGISTRATION Current Controlled Trials, ISRCTN89683704.

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BACKGROUND AND OBJECTIVES Increased bleeding rates with standard dose prasugrel have led to increased questions about the effectiveness and safety of the lower maintenance dose. We compared platelet inhibitory efficacy between low dose prasugrel and standard dose clopidogrel in patients on maintenance dose dual antiplatelet therapy. SUBJECTS AND METHODS Forty-three patients who underwent percutaneous coronary intervention were randomized to receive 75 mg clopidogrel (n=23) or 5 mg prasugrel (n=20). Another 20 patients were allocated to 10 mg prasugrel as a reference comparison group. All patients (weight, ≥60 kg; age, <75 years) had been receiving 100 mg aspirin and 75 mg clopidogrel daily. The platelet function test was performed at baseline and 30 days after randomization. The primary endpoint was P2Y12 reaction unit (PRU) at 30 days between 5 mg prasugrel and 75 mg clopidogrel. RESULTS No differences in baseline PRU values were observed among the three groups. The prasugrel (5 mg) group had a significantly lower PRU value compared with that of 75 mg clopidogrel (174.6±60.2 vs. 223.4±72.9, p=0.022) group at 30 days, whereas the 10 mg prasugrel group showed a lower PRU value (71.9±34.4) compared with that of the 5 mg prasugrel (p<0.001). The rate of high on-treatment platelet reactivity (PRU >235) was significant lower in the 5 mg prasugrel group than that in the 75 mg clopidogrel group (15.0% vs. 56.5%, p=0.010). CONCLUSION Prasugrel (5 mg) is more potent antiplatelet therapy than 75 mg clopidogrel in non-low body weight and non-elderly patients on a maintenance dose dual antiplatelet therapy.

1significant effect

BACKGROUND To evaluate the intensity of pain, swelling and trismus after the removal of impacted lower third molars comparing two different suture techniques of the triangular flap: the complete suture of the distal incision and relieving incision and the partial suture with only one suture knot for closure of the corner of the flap and the closure of the distal incision, without suturing the relieving incision. MATERIAL AND METHODS A prospective, randomized, cross-over clinical trial was conducted in 40 patients aged from 18 to 45 years who underwent surgical extraction of impacted lower third molars at the Department of Oral Surgery in the Odontological Hospital of the University of Barcelona during the year 2011. Patients were randomly divided in 2 groups. Two different techniques (hermetical closure and partial closure of the wound) were performed separated by a one month washout period in each patient. Postoperative pain, swelling and trismus were evaluated prior to the surgical procedure and also at 2 and 7 days postoperatively. RESULTS No statistically significant differences were observed for pain (p<0.06), trismus (p<0.71) and swelling (p<0.05) between the test and the control group. However, the values of the three parameters related to the test group were lower than those for the control group. CONCLUSIONS Partial closure of the flap without suturing the relieving incision after surgical extraction of lower third molars reduces operating time and it does not produce any postoperative complications compared with complete closure of the wound.

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BACKGROUND The aetiology of bacterial vaginosis (BV) is still unclear but it is currently considered to be a synergistic polymicrobial syndrome. BV can often arise as a chronic or recurrent disease. The reason for such recurrences is not well elucidated. Previous studies have suggested that vaginal vitamin C may be a useful treatment in reducing recurrence rate, by increasing vaginal acidification and thereby making up for the decrease in hydrogen peroxide that results from a reduction in the number of lactobacilli present. Based on the above-mentioned consideration, a study was performed that aimed to evaluate the effect of vitamin C in the prophylaxis of BV relapses. METHODS This was a randomised, double-blind, placebo-controlled, parallel-group clinical trial. One hundred and forty-two women, after having been cured from a recent episode of BV by either metronidazole or clindamycin, were randomised to receive vitamin C (74 patients) or placebo (68 patients) as prophylaxis for six monthly cycles, starting within 24 hours of the determination of 'BV cure'. The patients applied one vaginal tablet once a day for 6 consecutive days per month after menses. RESULTS The rate of BV recurrence during the first 3 months was considerably lower in the vitamin C group (6.8%) than in the placebo (14.7%) group. Considering a 6-month treatment period, the recurrence rate in the vitamin C group (16.2%) was significantly lower (P = 0.024) than in the placebo group (32.4%). Moreover, at the same time point, the survival analysis of Kaplan Meyer was significant in favour of the vitamin C group compared with the placebo group (P = 0.029). CONCLUSIONS The study showed that regular use of 250 mg ascorbic acid vaginal tablets on 6 days per month for 6 months after successful treatment of bacterial vaginosis halves the risk of recurrence from 32.4% to 16.2% (P = 0.024).

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BACKGROUND Patient-reported outcomes are important measures when assessing the efficacy of aesthetic procedures. OBJECTIVE To compare outcomes between 2 volumizing hyaluronic acid fillers. MATERIALS AND METHODS Subjects with moderate-to-severe volume loss in the cheeks were randomized in a split-face design to malar enhancement with Cohesive Polydensified Matrix 26 mg/ml HA (CPM-26) and Vycross 20 mg/ml HA (VYC-20). The same injection technique and injection volume were applied for both sides of the face. Anesthetics, overcorrection, and touch-ups were not permitted. Blinded subjects assessed aesthetic improvements using the Global Aesthetic Improvement Scale and treatment satisfaction by confirming their willingness to repeat treatment or recommend it to friends. Follow-up was 18 months. RESULTS A total of 45 subjects received a single 2 mL injection of CPM-26 on one side and VYC-20 on the contralateral side of the face. The proportion of subjects reporting improvement on the Global Aesthetic Improvement Scale compared with baseline for CPM-26 and VYC-20 was 97.7% and 88.6%, respectively, at 3 months, 73.8% and 71.1% at 12 months, and 61.0% and 56.7% at 18 months. Treatment satisfaction was high, with the majority of subjects stating that they would repeat treatment and recommend it to friends, but at each time point, a higher proportion of subjects was more satisfied with the CPM-26-treated side of the face. CONCLUSIONS In this first direct comparison of CPM-26 and VYC-20, the majority of subjects were satisfied with both treatments throughout the study. Patient-reported outcome measures identified a trend in favor of CPM-26.

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BACKGROUND Opioid induced hyperalgesia (OIH) is related with high opioid dosage, a long duration of opioid administration, and abrupt discontinuation of infused opioids in anesthetic settings. Ketamine is known to attenuate OIH efficiently, but methods of administration and methods to quantify and assess a decrease in OIH vary. We demonstrated the existence of remifentanil-induced hyperalgesia and investigated the ability of ketamine to attenuate OIH. METHODS Seventy-five patients undergoing laparoscopic gynecologic surgery under remifentanil-based anesthesia were assigned to one of the following groups: (1) group RL (remifentanil 0.05 µg/kg/min), (2) group RH (remifentanil 0.3 µg/kg/min), or (3) group KRH (remifentanil 0.3 µg/kg/min + ketamine 0.5 mg/kg bolus with 5 µg/kg/min infusion intraoperatively). Desflurane was administered for maintenance of anesthesia to target bispectral index scores (40-60) and hemodynamic parameters (heart rate and blood pressure < ± 20% of baseline values). All parameters related to OIH and its attenuation induced by ketamine were investigated. RESULTS There was no significant difference among the three groups related to demographic and anesthetic parameters except the end-tidal concentration of desflurane. Additional analgesic consumption, numerical rating scale scores at 6 and 24 h, and cumulative fentanyl dose were significantly higher in group RH than in the other two groups. The value difference of the Touch-Test sensory evaluation was significantly higher negative in group RH than in the other two groups. CONCLUSIONS Remifentanil-induced hyperalgesia is significantly attenuated by intraoperative bolus and infusion of ketamine. Ketamine also decreased tactile sensitization, as measured by Touch-Test sensory evaluation.

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BACKGROUND The cardiovascular (CV) and metabolic health benefits or risks associated with consumption of multi-ingredient performance supplements (MIPS) in conjunction with periodized resistance training (RT) in resistance-trained men are unknown. This population is a major target audience for performance supplements, and therefore, the purpose of this study was to investigate the combined effect of RT and commercially available pre- and post-exercise performance supplements on CV health and body fat in resistance-trained men. METHODS Twenty-four resistance-trained men completed six weeks (three times/week) of periodized RT while either ingesting SHOT 15-min pre-exercise and SYN immediately post-exercise (multi-ingredient performance supplement group: MIPS) or an isocaloric maltodextrin placebo 15-min pre-exercise and immediately post-exercise (Placebo group). Before and after six weeks of RT and supplementation, resting heart rate (HR), blood pressure (BP), total body fat, android fat, gynoid fat, fat-free mass (FFM) and fasting blood measures of glucose, lipids, nitrate/nitrite (NOx), cortisol and high sensitivity C-reactive protein (hs-CRP) were measured. Statistical analysis was conducted using a one-way ANOVA for baseline differences and a 2 × 2 (group × time) repeated measures ANOVA and Tukey post-hoc tests where appropriate. Significance was set at p < 0.05. RESULTS There was no group × time interaction for HR, BP, blood glucose, lipids, NOx, hs-CRP, cortisol concentrations or body fat. However, there was a time effect where significant decreases in body fat (mean ± SD; MIPS: -1.2 ± 1.2%; Placebo: -0.9 ± 1.1%), android fat (MIPS: -1.8 ± 2.1%; Placebo: -1.6 ± 2.0%), and gynoid fat (MIPS: -1.3 ± 1.6%; Placebo: -1.0 ± 1.4%) for both groups were observed. FFM increased in both groups, and a group × time interaction was observed with MIPS increasing significantly more than the Placebo group (4.2% vs. 1.9%). CONCLUSIONS Six weeks of MIPS ingestion and periodized RT does not alter CV health parameters or blood indices of health or body fat more than a Placebo treatment in healthy, resistance-trained men. However, MIPS significantly increased FFM more than Placebo.

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PURPOSE To compare the visual performance of prototype contact lenses which extend depth-of-focus (EDOF) by deliberate manipulation of multiple higher-order spherical aberration terms and a commercially-available center-near lens (AIR OPTIX Aqua Multifocal, AOMF). METHODS This was a prospective, cross-over, randomized, single-masked (participant), short-term clinical trial where 52 participants (age 45-70 years) were stratified as low, medium or high presbyopes and wore EDOF and AOMF on different days. Objective measures comprised high and low contrast visual acuity (HCVA/LCVA, logMAR), and contrast sensitivity (log units) at 6m; HCVA at 70cm, 50cm and 40cm and stereopsis (seconds of arc) at 40cm. HCVA at 70cm, 50cm and 40cm were measured as "comfortable acuity" rather than conventional resolution acuity. Subjective measures comprised clarity-of-vision and ghosting at distance, intermediate and near, overall vision satisfaction and ocular comfort (1-10 numeric rating scale) and lens purchase (yes/no response). Statistical analysis included repeated measures ANOVA, paired t-tests and McNemar's test. RESULTS Significant differences between lens types were independent of strata (p≥0.119). EDOF was significantly better than AOMF for HCVA at 40cm (0.42±0.18 vs. 0.48±0.22, p=0.024), stereopsis (98±88 vs. 141±114, p<0.001), clarity-of-vision at intermediate (8.5±1.6 vs. 7.7±1.9, p=0.006) and near (7.3±2.5 vs. 6.2±2.5, p=0.005), lack-of-ghosting (p=0.012), overall vision satisfaction (7.5±1.7 vs. 6.4±2.2, p<0.001) and ocular comfort (9.0±1.0 vs. 8.3±1.7, p=0.002). Significantly more participants chose to only-purchase EDOF (33% vs. 6%, p=0.003).). There were no significant differences between lens types for any objective measure at 6m or clarity-of-vision at distance (p≥0.356). CONCLUSIONS EDOF provides better intermediate and near vision performance in presbyopes than AOMF with no difference for distance vision during short-term wear.

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BACKGROUND Chlorhexidine (CHX) is the most effective antiseptic mouthwash to date. Essential oil such as thymol, have inhibitory and biocidal effects a range of bacteria. OBJECTIVE To determine the effect of mouthwash containing CHX and thymol on plaque induced gingivitis. METHODS This double-blind randomized clinical trial study was performed on 60 patients with plaque induced gingivitis who were randomly divided into two groups: Group I (CHX/thymol mouthwash-Vi-one) and Group II (CHX mouthwash-Behsa). Patients in each group underwent scaling and root planning and polishing, then were educated about BASS-Method brushing, and were recommended Oral-B toothbrushes and Pooneh toothpaste. The two groups were asked to rinse their mouths for 60 seconds twice a day, once in the morning and once at night, after brushing their teeth. Plaque index, gingival index, bleeding index and stain index were evaluated at baseline and 14 days later in Ramfjord teeth. Data analysis was conducted using SPSS version 21. Independent-samples t-test and paired-samples t-test were used for data analysis. RESULTS The results showed that plaque index and gingival index significantly reduced in two groups (p<0.001). However, group I was significantly more efficient than group II (p<0.001, p=0.021 respectively). Similar results were observed in terms of bleeding index with the difference that the two groups did not differ significantly from each other (p=0.879). Both groups significantly increased the stain index. No remarkable difference was also observed between the two groups (p=0.754). CONCLUSION Based on the results of this study, we can conclude that the CHX/thymol mouthwash can be offered to patients with dental plaque-induced gingivitis, because it appears to be more effective in controlling dental plaque and gingivitis. TRIAL REGISTRATION The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the Irct ID: IRCT201602231760N45. FUNDING This study was part of a thesis and research project (Grant No: 9440921) supported and funded by Babol University of Medical Sciences. The authors received no financial support from Behsa pharmaceutical company (Behsa mouthwash manufacturer) or Rojin cosmetic laboratory (Vi-one mouthwash manufacturer) for this study.

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BACKGROUND The effect of legume-based hypocaloric diet on cardiovascular disease (CVD) risk factors in women is unclear. This study provides an opportunity to find effects of high-legume diet on CVD risk factors in women who consumed high legumes at baseline. METHODS This randomized controlled trial was undertaken in 34 premenopausal women with central obesity. After 2 weeks of a run-in period on an isocaloric diet, subjects were randomly assigned into two groups: (1) hypocaloric diet enriched with legumes (HDEL) (n = 17) (two servings per day) and (2) hypocaloric diet without legumes (HDWL) (n = 17) for 6 weeks. The following variables were assessed before intervention, 3, and 6 weeks after it: Waist to hip ratio (WHR), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-sensitive-C-reactive protein (hs-CRP), total antioxidant capacity (TAC), nitric oxides (NOx), and Malondialdehyde (MDA). RESULTS Both hypocaloric diets reduced hs-CRP in 3 weeks and returned it to basal values after 6 weeks (P = 0.004). HDWL significantly reduced WHR [P = 0.010 (3.2%)] and increased TC [P < 0.001 (6.3%)]. Despite the significant effect of HDEL on increasing TAC in 3 weeks [P = 0.050 (4%)], the level of TAC remained the same in 6 weeks. None of the diets had any significant effects on NOx and MDA. CONCLUSION The study indicated that beneficial effects of legumes on TC, LDL-C, and hs-CRP were achieved by three servings per week, and consuming more amounts of these products had no more advantages.

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INTRODUCTION Governments throughout the world are using or considering various front-of-package (FOP) food labeling systems to provide nutrition information to consumers. Our web-based study tested consumer understanding of different FOP labeling systems. METHODS Adult participants (N = 480) were randomized to 1 of 5 groups to evaluate FOP labels: 1) no label; 2) multiple traffic light (MTL); 3) MTL plus daily caloric requirement icon (MTL+caloric intake); 4) traffic light with specific nutrients to limit based on food category (TL+SNL); or 5) the Choices logo. Total percentage correct quiz scores were created reflecting participants' ability to select the healthier of 2 foods and estimate amounts of saturated fat, sugar, and sodium in foods. Participants also rated products on taste, healthfulness, and how likely they were to purchase the product. Quiz scores and product perceptions were compared with 1-way analysis of variance followed by post-hoc Tukey tests. RESULTS The MTL+caloric intake group (mean [standard deviation], 73.3% [6.9%]) and Choices group (72.5% [13.2%]) significantly outperformed the no label group (67.8% [10.3%]) and the TL+SNL group (65.8% [7.3%]) in selecting the more healthful product on the healthier product quiz. The MTL and MTL+caloric intake groups achieved average scores of more than 90% on the saturated fat, sugar, and sodium quizzes, which were significantly better than the no label and Choices group average scores, which were between 34% and 47%. CONCLUSION An MTL+caloric intake label and the Choices symbol hold promise as FOP labeling systems and require further testing in different environments and population subgroups.

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BACKGROUND It has been reported that high intensity long term training in elite athletes may increase risk of immune function. OBJECTIVES This study is to examine training effects on immunoglobulin and changes of physiological stress and physical fitness level induced by increased cold stress during 12-week winter off-season training in elite Judoists. PATIENTS AND METHODS Twenty-nine male participants (20 ± 1 years) were assigned to only Judo training (CG, n = 9), resistance training combined with Judo training (RJ, n = 10), and interval training combined with Judo training (IJ, n = 10). Blood samples collected at rest, immediately after all-out exercise, and 30-minute recovery period were analyzed for testing IgA, IgG, and IgM, albumin and catecholamine levels. RESULTS VO2max and anaerobic mean power in IJ (P < 0.05) and anaerobic power in RJ (P < 0.05) were significantly increased after 12-week training compared to CG. There was no significant interaction effect (group × period) in albumin after 12-week training; however, there was a significant interaction effect (group × period) in epinephrine after 12-week training (F (4, 52) = 3.216, P = 0.002) and immediately after all-out exercise and at 30-minute recovery (F (2, 26) = 14.564, P = 0.008). There was significantly higher changes in epinephrine of RJ compared to IJ at 30-minute recovery (P = 0.045). There was a significant interaction effect (group × period) in norepinephrine after 12-week training (F (4, 52) = 8.141, P < 0.0001), at rest and immediately after all-out exercise (F (2, 26) = 9.570, P = 0.001), and immediately after all-out exercise and at 30-minute recovery (F (2, 26) = 8.862, P = 0.001). CONCLUSIONS Winter off-season training of IJ increased physical fitness level as well as physical stress induced by overtraining. Along with increased physical stress, all groups showed reduced trend of IgA; however, there was no group difference based on different training methods.

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PURPOSE Painful bladder syndrome/interstitial cystitis (PBS/IC) is a disabling disease of the urinary bladder, and its etiology and treatment are not yet established. Current medications used in the treatment of PBS/IC have shown limited efficacy. This prospective study investigated the efficacy of intravesical resiniferatoxin (RTX) in PBS/IC refractory to medical treatment. METHODS Patients with proven PBS/IC refractory to traditional medical treatment were enrolled. By randomized trial, a total of 18 consecutive patients were divided into two groups: treatment with hydrodistention and intravesical RTX (group 1) or treatment with hydrodistension only (group 2). We assessed bladder pain by use of a visual analogue pain scale, the maximal urine flow rate, post-void residual urine volume, and a voiding diary before and 3 months after treatment. RESULTS The median age of the 18 patients was 55.8±6.9 years, and the median duration of symptoms before diagnosis was 3.6±1.6 years. Frequency, functional bladder capacity, and score on a 5-point pain scale were significantly improved at 3-month after treatment in both groups. Intravesical RTX instillation plus hydrodistention, compared with hydrodistention only, did not have a significant effect on the voiding symptoms or uroflowmetry of the patients but significantly improved scores on the pain scale. CONCLUSIONS Intravesical RTX instillation plus hydrodistention was effective in relieving pain but was not effective in improving lower urinary tract symptoms. Further larger studies are needed to clarify the efficacy of combination treatment of intravesical RTX instillation and hydrodistention.

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AIM Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated. METHODS AND RESULTS A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 ± 1.50 vs. 0.62 ± 1.25; P < 0.005), more non-office-based contacts (1.95 ± 3.29 vs. 1.01 ± 2.64; P < 0.001), more Internet sessions (11.02 ± 15.28 vs. 0.06 ± 0.31; P < 0.001) and more in-clinic discussions (1.84 ± 4.20 vs. 1.28 ± 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 ± 1.18 vs. 0.85 ± 1.43, P = 0.23) and shorter length-of-stay (6.31 ± 15.5 vs. 8.26 ± 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): €204 (169-238) vs. €213 (182-243); range for difference (€-36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of €408 (327-489) vs. €400 (345-455); range for difference (€-104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different. CONCLUSION For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation.

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BACKGROUND No standard treatment for locally advanced pancreatic cancer (LAPC) is defined. PATIENTS AND METHODS Within a multi-centre, randomised phase II trial, 95 patients with LAPC were assigned to three different chemoradiotherapy (CRT) regimens: patients received conventionally fractionated radiotherapy of 50 Gy and were randomised to concurrent 5-fluorouracil (350 mg m(-2) per day on each day of radiotherapy, RT-5-FU arm), concurrent gemcitabine (300 mg m(-2)), and cisplatin (30 mg m(-2)) on days 1, 8, 22, and 29 (RT-GC arm), or the same concurrent treatment followed by sequential full-dose gemcitabine (1000 mg m(-2)) and cisplatin (50 mg m(-2)) every 2 weeks (RT-GC+GC arm). Primary end point was the overall survival (OS) rate after 9 months. RESULTS The 9-month OS rate was 58% in the RT-5-FU arm, 52% in the RT-GC arm, and 45% in the RT-GC+GC arm. Corresponding median survival times were 9.6, 9.3, and 7.3 months (P=0.61) respectively. The intent-to-treat response rate was 19, 22, and 13% respectively. Median progression-free survival was estimated with 4.0, 5.6, and 6.0 months (P=0.21). Grade 3/4 haematological toxicities were more frequent in the two GC-containing arms, no grade 3/4 febrile neutropaenia was observed. CONCLUSION None of the three CRT regimens tested met the investigators' definition for efficacy; the median OS was similar to those previously reported with gemcitabine alone in LAPC.

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BACKGROUND Fluorodeoxyglucose-positron emission tomography (PET)/computed tomography (CT) is reported to have a significant advantage over CT for staging esophageal cancer (EC). However, whether PET/CT may play a useful role in guiding surgical approach remains undetermined. METHODS Patients with potentially resectable squamous cell EC were randomized into either PET/CT group or CT group. The surgical data and survival outcomes were compared. RESULTS Compared to the CT group, the right-sided approach was more frequently used (42.6% versus 25.5%, P=0.065) in the PET/CT group in order to allow surgical access to radiographically suspicious lymph nodes inaccessible from the left, thus enabling the removal of more involved lymph nodes (2.83 versus 1.76; P=0.039) as well as their stations (1.65 versus 1.08; P=0.042). Although the overall survival between the two groups was similar, the PET/CT group had a longer disease-free survival (DFS) than the CT group (27.1 months versus 18.9 months; P=0.019), especially in the subgroup of node-positive patients (22.5 months versus 13.5 months; P=0.02). Preoperative imaging arm was the only prognostic factor found to independently influence DFS. CONCLUSION For patients with middle-to-lower EC, surgical approaches directed by PET/CT may increase the likelihood of complete resection and affect DFS.

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BACKGROUND Banana is a staple food in many regions with high iron deficiency and may be a potential vehicle for iron fortification. However, iron absorption from bananas is not known. OBJECTIVE The objective of this study was to evaluate total iron absorption from raw and cooked bananas. DESIGN Thirty women (34.9±6.6 years) from rural Mexico were randomly assigned to one of two groups each consuming: 1) 480 g/day of raw banana for 6 days, or 2) 500 g/day of cooked banana for 4 days. Iron absorption was measured after extrinsically labeling with 2 mg of (58)Fe and a reference dose of 6 mg (57)Fe; analysis was done using ICP-MS. RESULTS Iron content in cooked bananas was significantly higher than raw bananas (0.53 mg/100 g bananas vs. 0.33 mg/100 mg bananas, respectively) (p<0.001). Percent iron absorption was significantly higher in raw bananas (49.3±21.3%) compared with cooked banana (33.9±16.2%) (p=0.035). Total amount of iron absorbed from raw and cooked bananas was similar (0.77±0.33 mg vs. 0.86±0.41 mg, respectively). CONCLUSION Total amount of absorbed iron is similar between cooked and raw bananas. The banana matrix does not affect iron absorption and is therefore a potential effective target for genetic modification for iron biofortification.

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OBJECTIVES To compare anti-inflammatory effect of atorvastatin and rosuvastatin in patients of acute coronary syndrome. MATERIALS AND METHODS The study was a prospective, open-labeled, randomized and single-center study conducted on 100 patients of acute coronary syndrome. Patients were assigned to atorvastatin 40 mg daily or rosuvastatin 20 mg daily for 4 weeks. C-reactive protein (CRP) levels, lipid profiles, erythrocyte sedimentation rate (ESR) and adverse effects were measured at beginning and at the end of 4 weeks. RESULTS Baseline parameters and clinical profile did not differ between the two groups. CRP levels significantly decreased from beginning to the end of 4 weeks in both atorvastatin and rosuvastatin groups (from 35.48 to 23.07 mg/l and from 35.88 to 19.91 mg/l respectively, both P < 0.001). However, there was significant difference between the levels of CRP in patients of the rosuvastatin group as compared to the atorvastatin group (19.91 ± 6.32 vs 23.07 ± 7.47, P < 0.05). In addition, both the drugs were associated with a reduction in total cholesterol, LDL levels and ESR at the end of 4 weeks as compared to the beginning (P < 0.001 for all comparisons). CONCLUSION Both atorvastatin (40 mg) and rosuvastatin (20 mg) are effective in decreasing CRP and LDL cholesterol levels even in a short duration of 4 weeks. Rosuvastatin was found to be more effective in decreasing CRP levels.

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BACKGROUND Autism is associated with impairments that have life-time consequences for diagnosed individuals and a substantial impact on families. There is growing interest in early interventions for children with autism, yet despite the substantial economic burden, there is little evidence of the cost-effectiveness of such interventions with which to support resource allocation decisions. This study reports an economic evaluation of a parent-mediated, communication-focused therapy carried out within the Pre-School Autism Communication Trial (PACT). METHODS 152 pre-school children with autism were randomly assigned to treatment as usual (TAU) or PACT + TAU. Primary outcome was severity of autism symptoms at 13-month follow-up. Economic data included health, education and social services, childcare, parental productivity losses and informal care. RESULTS Clinically meaningful symptom improvement was evident for 53 % of PACT + TAU versus 41 % of TAU (odds ratio 1.91, p = 0.074). Service costs were significantly higher for PACT + TAU (mean difference £4,489, p < 0.001), but the difference in societal costs was smaller and non-significant (mean difference £1,385, p = 0.788) due to lower informal care rates for PACT + TAU. CONCLUSIONS Improvements in outcome generated by PACT come at a cost. Although this cost is lower when burden on parents is included, the cost and effectiveness results presented do not support the cost-effectiveness of PACT + TAU compared to TAU alone. TRIAL REGISTRATION Current Controlled Trials ISRCTN58133827.

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INTRODUCTION We investigated the potential benefits of early tracheotomy performed before day eight of mechanical ventilation (MV) compared with late tracheotomy (from day 14 if it still indicated) in reducing mortality, days of MV, days of sedation and ICU length of stay (LOS). METHODS Randomized controlled trial (RCT) including all-consecutive ICU admitted patients requiring seven or more days of MV. Between days five to seven of MV, before randomization, the attending physician (AP) was consulted about the expected duration of MV and acceptance of tracheotomy according to randomization. Only accepted patients received tracheotomy as result of randomization. An intention to treat analysis was performed including patients accepted for the AP and those rejected without exclusion criteria. RESULTS A total of 489 patients were included in the RCT. Of 245 patients randomized to the early group, the procedure was performed for 167 patients (68.2%) whereas in the 244 patients randomized to the late group was performed for 135 patients (55.3%) (P <0.004). Mortality at day 90 was similar in both groups (25.7% versus 29.9%), but duration of sedation was shorter in the early tracheotomy group median 11 days (range 2 to 92) days compared to 14 days (range 0 to 79) in the late group (P <0.02). The AP accepted the protocol of randomization in 205 cases (42%), 101 were included in early group and 104 in the late group. In these subgroup of patients (per-protocol analysis) no differences existed in mortality at day 90 between the two groups, but the early group had more ventilator-free days, less duration of sedation and less LOS, than the late group. CONCLUSIONS This study shows that early tracheotomy reduces the days of sedation in patients undergoing MV, but was underpowered to prove any other benefit. In those patients selected by their attending physicians as potential candidates for a tracheotomy, an early procedure can lessen the days of MV, the days of sedation and LOS. However, the imprecision of physicians to select patients who will require prolonged MV challenges the potential benefits of early tracheotomy. TRIAL REGISTRATION Controlled-Trials.com ISRCTN22208087 . Registered 27 March 2014.

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BACKGROUND Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). But a fewer smoking cessation measures were conducted in communities for smokers with COPD in China. The aim of our study was to assess the preventive effects of behavioral interventions for smoking cessation and potential impact factors in smokers with COPD in China. METHODS In a randomised controlled smoking cessation trial 3562 patients with COPD who were current smoker were allocated to intervention group received behavioral intervention and control group received the usual care for two years. The primary efficacy endpoint was the complete and continuous abstinence from smoking from the beginning of month 24 to the end of month 30. Participants were followed up at month 48. RESULTS Continuous smoking abstinence rates from month 24 to 30 were significantly higher in participants receiving behavioral intervention than in those receiving usual care (46.4% vs 3.4%, p < 0.001). Continuous abstinence rates from months 24 to 36 (45.8% vs 4.0%) and months 24 to 48 (44.3% vs 5.1%) were also higher in participants receiving behavioral intervention than in those control group. Family members or family physicians/nurses smoking were first identified to influence smoking cessation. CONCLUSIONS Behavioral intervention doubled the smoking cessation rate in patients with COPD and was complied well by the general practitioners. The family members and family physicians/nurses smoking were the main risk factors for smoking cessation. TRIAL REGISTRATION Chinese Clinical Trials Registration (ChiCTR-TRC-12001958).

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BACKGROUND The underlying etiology of recurrent aphthous stomatitis (RAS) is unclear and treatment aims to provide symptomatic and faster relief. This study compared the efficacy of diode laser, a herbal combination of Acacia nilotica and Licorice (A and L) and Amlexanox in the management of RAS. MATERIAL AND METHODS Sixty patients with minor aphthae were selected and randomly divided into four groups of 15 each. Group I and II received adhesive preparations of a herbal mixture of A and L and a 2 mg Amlexanox paste respectively, group III received diode laser and the fourth group (control) used a placebo. Ulcer size, pain score were recorded on days 1, 2 and 5. RESULTS Laser group showed the statistically highest mean percentage (%) of reduction in pain scores and ulcer size than the other groups. The mean % of reduction in pain scores was 43.3+20.0 at day 2 and 67.8+21.5 % at day 5 in the laser group while Amlexanox group demonstrated a 29.8 +11.3 and 61.9+24.5 mean % of reduction in pain scores at day 2 and 5 respectively. A and L group showed a lower mean % of reduction in pain scores than laser and Amlexanox groups with a 22.2+10.5 and 43.4+15.8 mean % reduction in pain scores at day 2 and day 5 respectively. Similarly the highest mean % of reduction in ulcer size was seen in the laser group being 52.7+19.8 at day 2 and 85.1+22.0 at day 5, while it was 48.1+16.5 at day 2 and 77.8+28.7 at day 5 in the Amlexanox group and 42.0+11.5 at day 2 and 63.0+20.5 at day 5 in the A and L group. CONCLUSIONS All treatment modalities reduced pain and ulcer size than placebo group. Laser therapy demonstrated the highest percentage of reduction of pain score and ulcer size. Key words: Aphthous stomatitis, laser, herbal plants, Acacia nilotica, Licorice.

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BACKGROUND Patient decision aids (P-DAs) inform medical decision making, but longer term effects are unknown. This article describes extended follow-up from a thyroid cancer treatment P-DA trial. METHODS In this single-center, parallel-design randomized controlled trial conducted at a Canadian tertiary/quaternary care center, early-stage thyroid cancer patients from a P-DA trial were contacted 15 to 23 months after randomization/radioactive iodine (RAI) decision making to evaluate longer term outcomes. It was previously reported that the use of the computerized P-DA in thyroid cancer patients considering postsurgical RAI treatment significantly improved medical knowledge in comparison with usual care alone. The P-DA and control groups were compared for the following outcomes: feeling informed about the RAI treatment choice, decision satisfaction, decision regret, cancer-related worry, and physician trust. In a subgroup of 20 participants, in-depth interviews were conducted for a qualitative analysis. RESULTS Ninety-five percent (70 of 74) of the original population enrolled in follow-up at a mean of 17.1 months after randomization. P-DA users perceived themselves to be significantly more 1) informed about the treatment choice (P = .008), 2) aware of options (P = .009), 3) knowledgeable about treatment benefits (P = .020), and 4) knowledgeable about treatment risks/side effects (P = .001) in comparison with controls. There were no significant group differences in decision satisfaction (P = .142), decision regret (P = .199), cancer-related worry (P = .645), mood (P = .211), or physician trust (P = .764). In the qualitative analysis, the P-DA was perceived to have increased patient knowledge and confidence in decision making. CONCLUSIONS The P-DA improved cancer survivors' actual and long-term perceived medical knowledge with no adverse effects. More research on the long-term outcomes of P-DA use is needed.

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BACKGROUND The purpose of the present study was to compare the image quality of spinal magnetic resonance (MR) imaging performed on a high-field horizontal open versus a short-bore MR scanner in a randomized controlled study setup. METHODS Altogether, 93 (80% women, mean age 53) consecutive patients underwent spine imaging after random assignement to a 1-T horizontal open MR scanner with a vertical magnetic field or a 1.5-T short-bore MR scanner. This patient subset was part of a larger cohort. Image quality was assessed by determining qualitative parameters, signal-to-noise (SNR) and contrast-to-noise ratios (CNR), and quantitative contour sharpness. RESULTS The image quality parameters were higher for short-bore MR imaging. Regarding all sequences, the relative differences were 39% for the mean overall qualitative image quality, 53% for the mean SNR values, and 34-37% for the quantitative contour sharpness (P<0.0001). The CNR values were also higher for images obtained with the short-bore MR scanner. No sequence was of very poor (nondiagnostic) image quality. Scanning times were significantly longer for examinations performed on the open MR scanner (mean: 32±22 min versus 20±9 min; P<0.0001). CONCLUSIONS In this randomized controlled comparison of spinal MR imaging with an open versus a short-bore scanner, short-bore MR imaging revealed considerably higher image quality with shorter scanning times. TRIAL REGISTRATION ClinicalTrials.gov NCT00715806.

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INTRODUCTION Although pharmacogenomics has evolved substantially, a predictive test for chemotherapy toxicity is still lacking. We compared the toxicity of adjuvant dose-dense doxorubicin-cyclophosphamide (ddAC) and docetaxel-doxorubicin-cyclophosphamide (TAC) in a randomized multicenter phase III trial and replicated previously reported associations between genotypes and toxicity. RESULTS 646 patients (97%) were evaluable for toxicity (grade 2 and higher). Whereas AN was more frequent after ddAC ( P < 0.001), TAC treated patients more often had PNP ( P < 0.001). We could replicate 2 previously reported associations: TECTA (rs1829; OR 4.18, 95% CI 1.84-9.51, P = 0.001) with PNP, and GSTP1 (rs1138272; OR 2.04, 95% CI 1.13-3.68, P = 0.018) with PNP. MATERIALS AND METHODS Patients with pT1-3, pN0-3 breast cancer were randomized between six cycles A60C600 every 2 weeks or T75A50C500 every 3 weeks. Associations of 13 previously reported single nucleotide polymorphisms (SNPs) with the most frequent toxicities: anemia (AN), febrile neutropenia (FN) and peripheral neuropathy (PNP) were analyzed using logistic regression models. CONCLUSIONS In this independent replication, we could replicate an association between 2 out of 13 SNPs and chemotherapy toxicities. These results warrant further validation in order to enable tailored treatment for breast cancer patients.

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INTRODUCTION Diastolic dysfunction is an important predictor of poor outcome after myocardial infarction. Metformin treatment improved diastolic function in animal models and patients with diabetes. Whether metformin improves diastolic function in patients presenting with ST-segment elevation myocardial infarction (STEMI) is unknown. METHODS The GIPS-III trial randomized STEMI patients, without known diabetes, to metformin or placebo initiated directly after PCI. The previously reported primary endpoint was left ventricular ejection fraction at 4 months, which was unaffected by metformin treatment. This is a predefined substudy to determine an effect of metformin on diastolic function. For this substudy trans-thoracic echocardiography was performed during hospitalization and after 4 months. Diastolic dysfunction was defined as having the combination of a functional alteration (i.e. decreased tissue velocity: mean of septal e' and lateral e') and a structural alteration (i.e. increased left atrial volume index (LAVI)). In addition, left ventricular mass index and transmitral flow velocity (E) to mean e' ratio (E/e') were measured to determine an effect of metformin on individual echocardiographic markers of diastolic function. RESULTS In 237 (63%) patients included in the GIPS-III trial diastolic function was measured during hospitalization as well as at 4 months. Diastolic dysfunction was present in 11 (9%) of patients on metformin and 11 (9%) patients on placebo treatment (P = 0.98) during hospitalization. After 4 months 22 (19%) of patients with metformin and 18 (15%) patients with placebo (P = 0.47) had diastolic dysfunction. In addition, metformin did not improve any of the individual echocardiographic markers of diastolic function. CONCLUSIONS In contrast to experimental and observational data, our randomized placebo controlled trial did not suggest a beneficial effect of short-term metformin treatment on diastolic function in STEMI patients.

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