Acupuncture accelerates recovery after general anesthesia:a prospective randomized controlled trial

BACKGROUND: Acupuncture anesthesia was created in the 1950’s in China and continues to be used there today during most major surgeries. It is widely used in China for such complex operations as brain, heart, and abdominal surgery. It is popular in China because it is economical, practical, and beneficial to the patients. With acupuncture anesthesia there is less bleeding during surgery and there is also quicker post-operative recovery.OBJECTIVE: This randomized prospective study aims at comparing the effect of two acupoints(Yongquan, KI1 and Renzhong, DU26) with sham acupuncture and no acupuncture on the time to recovery of consciousness after general anesthesia by means of the Bispectral Index monitor(BIS).DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This is a prospective randomized controlled study. We randomly assigned 50 patients to 5 groups during recovery from surgical anesthesia. Four groups had acupuncture on KI1(group A), DU26(groups B), both KI1 and DU26(group C), and sham points(group D), and one had no acupuncture(group E).MAIN OUTCOME MEASURES: Bispectral Index(BIS), time to spontaneous eye opening, time to tracheal extubation, and time to following commands were measured as the main outcome measures.RESULTS: Time to spontaneous eye opening differed among groups(P=0.002), as well as time to tracheal extubation(P<0.000 1) and time to following commands(P=0.000 6). BIS values differed significantly among groups both 5 and 10 min after the end of anesthesia(P<0.000 1 and P=0.000 4,respectively). BIS values of groups D and E were lower than those of the other groups and those of group C were higher. The same pattern was observed also 15 and 30 min after the end of anesthesia, although the difference among groups was not significant at these time points(P=0.164 and P=0.104, respectively).CONCLUSION: Acupuncture on DU26 and KI1 accelerates recovery of consciousness after general anesthesia. Moreover, a possible synergistic effect of DU26 and KI1 is suggested. This issue may play a role in the optimization of operating room management and raise interest about the usefulness of acupuncture on unconsciousness states of different nature.     

Effects of exercises on knee cartilage volume in young healthy adults: a randomized controlled trial

Background Acute effects of physical exercise on the deformational behavior of knee articular cartilage and changes in cartilage volume are definite.However,conclusive effects of different exercises on the loss of articular cartilage volume have not been proved.In this parallel-group randomized controlled trial,we tested whether 12 weeks of swimming,powerstriding,cycling,and running exercises would decrease the cartilage volume significantly and whether there would be a difference in the loss of cartilage volume after different types of exercises.Methods From October 2012 to January 2013 we evaluated 120 healthy volunteer students in Biomechanics Laboratory of Tongji University.Body mass index （BMI）,right lower limb strength,and right knee cartilage magnetic resonance imaging （MRI） were obtained before exercise.MRI were conducted in East Hospital.The study was approved by Tongji University Ethical Committee,all subjects were randomly assigned to the running,powerstriding,cycling,swimming,and control groups by a drawing of lots.Each group contained 24 samples.At the end of 12 weeks of regular exercises,the same measurement procedures were applied.Cartilage volume was calculated with OSIRIS software based on the quantitative-MRI.Pre-and post-exercise comparisons were carried out using paired t-tests and one-way analysis of variance （ANOVA） was used to compare differences of cartilage volume loss between groups with Student-Newman-Keuls procedure for multiple comparisons.Results Running,cycling,and swimming groups resulted in a significant decrease in BMI.The quadriceps peak torque increased significantly in the swimming and cycling groups.Total cartilage volume significantly decreased in the running and cycling groups after 12 weeks of training,without any significant change in the nonimpact swimming,low-impact powerstriding,and control groups.Loss of total cartilage volume in the running and cycling groups were 2.21％ （3.03） and 1.50％ （0.42）.Conclusions Twelve weeks of regular physical exerc     

坤泰胶囊与激素替代疗法对绝经早期妇女认知功能及心理状态影响的随机对照临床研究

背景：结合雌激素（conjugated equine estrogen,CEE）是激素替代疗法常用药物之一,在围绝经期和绝经后妇女中应用由于安全性问题而受到限制。对于有激素替代疗法禁忌证和慎用证的患者,中药治疗成为另一选择。目的：比较中成药坤泰胶囊和CEE对绝经早期妇女认知功能及心理状态的影响并评估其安全性。设计、场所、对象和干预措施：收集四川大学华西妇女儿童医院绝经早期门诊患者57例,将其随机分为坤泰组28例和激素组29例,治疗并观察1年。坤泰组给予坤泰胶囊（每粒0.5 g）,2 g/次,3次/d;激素组给予CEE 0.6 mg/d与0.3 mg/d交替使用（平均0.45 mg/d）,有子宫者,加用醋酸甲羟孕酮,2 mg/d。主要结局指标：自给药日起每3个月评价一次认知功能及心理状态,记录不良反应,以意向性分析（intentionto treat,ITT）法和符合方案集（per-protoeol set,PPS）法分别分析。结果：两组治疗后各时点简易智能精神状态量表（Mini-Mental State Examination,MMSE）的认知功能、Kupperman指数及绝经后生存质量（quality of life,QOL）量表的心理状态评分与治疗前相比,差异有统计学意义（P〈0.05）,但激素组与坤泰组治疗后上述评分比较,差异无统计学意义（P〉0.05）。两组MMSE评分呈逐步上升趋势,Kupperman指数与QOL心理症状评分呈逐步下降趋势。治疗过程中两组均无严重不良事件发生,除阴道出血发生率激素组（39.3%）高于坤泰组（11.1%）,且差异有统计学意义（x~2=5.750,P=0.029）,其余不良反应比较,两组差异均无统计学意义。结论：坤泰胶囊与CEE在维持绝经早期妇女的正常认知功能和改善心理症状方面有一定作用。     

围术期规范化疼痛管理对全膝关节置换术后疼痛的控制效果

目的探讨围术期规范化疼痛管理对全膝关节置换（TKA）术后疼痛控制的效果。方法选择全膝关节置换术患者60例,按照随机原则分为研究组和对照组,每组30例。对照组予骨科常规护理,研究组实施围术期规范化疼痛管理,对比2组患者术后不同时间点的疼痛程度、Ramsay镇静评分,并比较2组的不良反应、患者对疼痛管理的满意度。结果研究组在术后48h内疼痛评分均低于对照组（P〈0．05）,对疼痛管理的满意度高于对照组（P〈0．05）,不良反应低于对照组（P〈0．05）,Ramsay镇静评分2组差异无统计学意义（P〉0．05）。结论通过完善疼痛评估体系,制定个体化、多元化、分阶梯镇痛治疗方案,规范围术期的疼痛管理,能够有效地缓解全膝关节置换患者的术后疼痛,提高患者疼痛管理满意度,提高临床护理质量,促进患者康复。     

全膝关节置换术后膝关节肿胀、疼痛程度对膝关节功能的影响及护理

目的探讨全膝关节置换术后膝关节肿胀、疼痛程度对膝关节功能的影响,评价护理干预对全膝关节置换术患者的临床疗效。方法选取我院2008年1月～2011年6月采用全膝关节置换术治疗的患者122例,随机分为两组,采用全膝关节置换术联合常规护理治疗的患者为对照组（61例）,在对照组治疗基础上采用健康教育、心理护理、综合功能锻炼等护理干预配合治疗的患者为观察组（61例）。分别比较两组患者术后第1天、第3天、第7天的膝关节肿胀和疼痛程度,术后治疗2周后对所有患者进行美国膝关节学会评分（AKSS）、膝关节活动范围（ROM）、视觉模拟评分（VAS）。结果在术后第1天、第3天、第7天观察组膝关节屈曲度数明显大于对照组（P〈0.05）;无论是对照组还是观察组,患者在第3天膝关节肿胀和疼痛程度最为严重;在术后第1天、第3天、第7天观察组膝关节肿胀人数和疼痛人数均明显少于对照组（P〈0.05）,观察组AKSS评分和VAS评分明显高于对照组,而ROM评分明显低于对照组,差异有统计学意义（P〈0.05）。结论全膝关节置换术后膝关节肿胀、疼痛程度对膝关节功能恢复有一定影响,膝关节肿胀、疼痛程度越严重恢复越慢,做好消除肿胀和疼痛的护理,预防静脉血栓的形成,及时补充营养,同时采取有效的综合护理干预可以提高患者术后的膝关节功能恢复效果,是一种安全有效的治疗方法,值得临床推广使用。     

Enzyme replacement therapy in Fabry disease: a randomized controlled trial

CONTEXT: Fabry disease is a metabolic disorder without a specific treatment, caused by a deficiency of the lysosomal enzyme alpha-galactosidase A (alpha-gal A). Most patients experience debilitating neuropathic pain and premature mortality because of renal failure, cardiovascular disease, or cerebrovascular disease. OBJECTIVE: To evaluate the safety and efficacy of intravenous alpha-gal A for Fabry disease. DESIGN AND SETTING: Double-blind placebo-controlled trial conducted from December 1998 to August 1999 at the Clinical Research Center of the National Institutes of Health. PATIENTS: Twenty-six hemizygous male patients, aged 18 years or older, with Fabry disease that was confirmed by alpha-gal A assay. INTERVENTION: A dosage of 0.2 mg/kg of alpha-gal A, administered intravenously every other week (12 doses total). MAIN OUTCOME MEASURE: Effect of therapy on neuropathic pain while without neuropathic pain medications measured by question 3 of the Brief Pain Inventory (BPI). RESULTS: Mean (SE) BPI neuropathic pain severity score declined from 6.2 (0.46) to 4.3 (0.73) in patients treated with alpha-gal A vs no significant change in the placebo group (P =.02). Pain-related quality of life declined from 3.2 (0.55) to 2.1 (0.56) for patients receiving alpha-gal A vs 4.8 (0.59) to 4.2 (0.74) for placebo (P =.05). In the kidney, glomeruli with mesangial widening decreased by a mean of 12.5% for patients receiving alpha-gal vs a 16.5% increase for placebo (P =.01). Mean inulin clearance decreased by 6.2 mL/min for patients receiving alpha-gal A vs 19.5 mL/min for placebo (P =.19). Mean creatinine clearance increased by 2.1 mL/min (0.4 mL/s) for patients receiving alpha-gal A vs a decrease of 16.1 mL/min (0.3 mL/s) for placebo (P =.02). In patients treated with alpha-gal A, there was an approximately 50% reduction in plasma glycosphingolipid levels, a significant improvement in cardiac conduction, and a significant increase in body weight. CONCLUSION: Intravenous infusions of alpha-gal A are safe and have widespread therapeutic efficacy in Fabry disease.     

电针对腹部手术后胃肠道功能恢复影响的随机对照研究

目的探讨电针是否能够促进腹部手术后胃肠道功能恢复。方法选取62例行开腹手术治疗的病人随机分为对照组和电针组,每组31例。对照组按照加速康复外科（ERAS）模式给予常规围手术期护理,电针组在常规ERAS模式围手术期护理的基础上,术后每天1次、连续5 d进行电针刺激穴位。观察术后病人肠鸣音恢复时间、首次排气、排便时间、术后腹胀情况及术后住院时间。结果在肠鸣音恢复时间、首次排气时间、首次排便时间方面,电针组均短于对照组（P < 0.01）,在术后住院时间方面2组差异无统计学意义（P>0.05）。术后第3天2组腹胀情况差异无统计学意义（P>0.05）,术后第5天电针组腹胀情况优于对照组（P < 0.05）。结论电针干预可缩短腹部手术术后病人首次排气排便时间,改善术后腹痛、腹胀、胃肠反应,减轻病人术后不适。采用电针干预对术后胃肠功能康复能起到明显疗效,值得临床推广应用。     

Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial

Context  Hip fractures are common in the elderly, and despite standard rehabilitation, many patients fail to regain their prefracture ambulatory or functional status. Objective  To determine whether extended outpatient rehabilitation that includes progressive resistance training improves physical function and reduces disability compared with low-intensity home exercise among physically frail elderly patients with hip fracture. Design, Setting, and Patients  Randomized controlled trial conducted between August 1998 and May 2003 among 90 community-dwelling women and men aged 65 years or older who had had surgical repair of a proximal femur fracture no more than 16 weeks prior and had completed standard physical therapy. Intervention  Participants were randomly assigned to 6 months of either supervised physical therapy and exercise training (n = 46) or home exercise (control condition; n = 44). Main Outcome Measures  Primary outcome measures were total scores on a modified Physical Performance Test (PPT), the Functional Status Questionnaire physical function subscale (FSQ), and activities of daily living scales. Secondary outcome measures were standardized measures of skeletal muscle strength, gait, balance, quality of life, and body composition. Participants were evaluated at baseline, 3 months, and 6 months. Results  Changes over time in the PPT and FSQ scores favored the physical therapy group (P = .003 and P = .01, respectively). Mean change (SD) in PPT score for physical therapy was +6.5 (5.5) points (95% confidence interval [CI], 4.6-8.3), and for the control condition was +2.5 (3.7) points (95% CI, 1.4-3.6 points). Mean change (SD) in FSQ score for physical therapy was +5.2 (5.4) points (95% CI, 3.5-6.9) and for the control condition was +2.9 (3.8) points (95% CI, 1.7-4.0). Physical therapy also had significantly greater improvements than the control condition in measures of muscle strength, walking speed, balance, and perceived health but not bone mineral density or fat-free mass. Conclusion  In community-dwelling frail elderly patients with hip fracture, 6 months of extended outpatient rehabilitation that includes progressive resistance training can improve physical function and quality of life and reduce disability compared with low-intensity home exercise.      

早期推拿对全膝关节置换患者术后股四头肌表面肌电影响的随机对照研究

背景：全膝关节置换是晚期膝关节疾病常用的手术方法,如何促进患者术后早期康复,提高膝关节功能,对提高手术疗效和患者的满意度有重要意义。目的：观察类风湿关节炎患者全膝关节置换术后早期进行推拿康复对股四头肌表面肌电的影响。设计、场所、对象和干预措施：研究病例为复旦大学附属华山医院骨科和上海市长宁区光华中西医结合医院骨科2010年6月～2011年9月行全膝关节置换的类风湿关节炎患者,采用随机对照试验设计方法,将66名接受全膝关节置换术的患者随机分为对照组和推拿组,每组33例。对照组行持续被动活动训练（continue passivemotion,CPM）,推拿组行CPM结合推拿康复,共治疗4周。 主要结局指标：在术前和术后4周,采用美国Western Ontario和McMaster大学骨关节炎指数（Western Ontario and McMaster Universities Osteoarthritis Index,WOMAC）问卷进行评分,采用等速肌力下表面肌电图测试来评价早期推拿治疗后膝关节功能和膝关节周围肌肉的生物电特性。 结果：经过4周的推拿综合康复干预后,推拿组的WOMAC问卷评分较对照组下降（P〈0．01）;推拿组股直肌、股内侧肌表面肌电图中位频率、积分肌电较对照组显著升高（P〈0．01）。 结论：推拿可促进全膝关节置换患者恢复,通过提高股四头肌肌电募集水平,延缓肌肉疲劳。     

Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial

Context  Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection. Objective  To test the hypothesis that supplemental oxygen reduces infection risk in patients following colorectal surgery. Design, Setting, and Patients  A double-blind, randomized controlled trial of 300 patients aged 18 to 80 years who underwent elective colorectal surgery in 14 Spanish hospitals from March 1, 2003, to October 31, 2004. Wound infections were diagnosed by blinded investigators using Centers for Disease Control and Prevention criteria. Baseline patient characteristics, anesthetic treatment, and potential confounding factors were recorded. Interventions  Patients were randomly assigned to either 30% or 80% fraction of inspired oxygen (FIO₂) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Main Outcome Measures  Any surgical site infection (SSI); secondary outcomes included return of bowel function and ability to tolerate solid food, ambulation, suture removal, and duration of hospitalization. Results  A total of 143 patients received 30% perioperative oxygen and 148 received 80% perioperative oxygen. Surgical site infection occurred in 35 patients (24.4%) administered 30% FIO₂ and in 22 patients (14.9%) administered 80% FIO₂ (P=.04). The risk of SSI was 39% lower in the 80% FIO₂ group (relative risk [RR], 0.61; 95% confidence interval [CI], 0.38-0.98) vs the 30% FIO₂ group. After adjustment for important covariates, the RR of infection in patients administered supplemental oxygen was 0.46 (95% CI, 0.22-0.95; P = .04). None of the secondary outcomes varied significantly between the 2 treatment groups. Conclusions  Patients receiving supplemental inspired oxygen had a significant reduction in the risk of wound infection. Supplemental oxygen appears to be an effective intervention to reduce SSI in patients undergoing colon or rectal surgery. Trial Registration  ClinicalTrials.gov Identifier: NCT00235456      

Effectiveness of acupuncture versus spinal-epidural anesthesia on labor pain: a randomized controlled trial

Objective

To evaluate the effectiveness of acupuncture analgesia (AA) compared with combined spinal-epidural anesthesia (CSEA) for labor pain relief and labor outcomes.

Effects of hormone replacement therapy and antioxidant vitamin supplements on coronary atherosclerosis in postmenopausal women: a randomized controlled trial

Context  Hormone replacement therapy (HRT) and antioxidant vitamins are widely used for secondary prevention in postmenopausal women with coronary disease, but no clinical trials have demonstrated benefit to support their use. Objective  To determine whether HRT or antioxidant vitamin supplements, alone or in combination, influence the progression of coronary artery disease in postmenopausal women, as measured by serial quantitative coronary angiography. Design, Setting, and Patients  The Women's Angiographic Vitamin and Estrogen (WAVE) Trial, a randomized, double-blind trial of 423 postmenopausal women with at least one 15% to 75% coronary stenosis at baseline coronary angiography. The trial was conducted from July 1997 to January 2002 in 7 clinical centers in the United States and Canada. Interventions  Patients were randomly assigned in a 2 x 2 factorial design to receive either 0.625 mg/d of conjugated equine estrogen (plus 2.5 mg/d of medroxyprogesterone acetate for women who had not had a hysterectomy), or matching placebo, and 400 IU of vitamin E twice daily plus 500 mg of vitamin C twice daily, or placebo. Main Outcome Measure  Annualized mean (SD) change in minimum lumen diameter (MLD) from baseline to concluding angiogram of all qualifying coronary lesions averaged for each patient. Patients with intercurrent death or myocardial infarction (MI) were imputed the worst rank of angiographic outcome. Results  The mean (SD) interval between angiograms was 2.8 (0.9) years. Coronary progression, measured in mean (SD) change, worsened with HRT by 0.047 (0.15) mm/y and by 0.024 (0.15) mm/y with HRT placebo (P = .17); and for antioxidant vitamins by 0.044 (0.15) mm/y and with vitamin placebo by 0.028 (0.15) mm/y (P = .32). When patients with intercurrent death or MI were included, the primary outcome showed an increased risk for women in the active HRT group (P = .045), and suggested an increased risk in the active vitamin group (P = .09). Fourteen patients died in the HRT group and 8 in the HRT placebo group (hazard ratio [HR], 1.8; 95% confidence interval [CI], 0.75-4.3), and 16 in the vitamin group and 6 in the vitamin placebo group (HR, 2.8; 95% CI, 1.1-7.2). Death, nonfatal MI, or stroke occurred in 26 HRT patients vs 15 HRT controls (HR, 1.9; 95% CI, 0.97-3.6) and in 26 vitamin patients and 18 vitamin controls (HR, 1.5; 95% CI, 0.80-2.9). There was no interaction between the 2 treatment interventions. Conclusion  In postmenopausal women with coronary disease, neither HRT nor antioxidant vitamin supplements provide cardiovascular benefit. Instead, a potential for harm was suggested with each treatment.      

Geriatric care management for low-income seniors: a randomized controlled trial

Steven R. Counsell, MD; Christopher M. Callahan, MD; Daniel O. Clark, PhD; Wanzhu Tu, PhD; Amna B. Buttar, MD, MS; Timothy E. Stump, MS; Gretchen D. Ricketts, BSW

JAMA. 2007;298(22):2623-2633.

Context  Low-income seniors frequently have multiple chronic medical conditions for which they often fail to receive the recommended standard of care.

Objectives  To test the effectiveness of a geriatric care management model on improving the quality of care for low-income seniors in primary care.

Design, Setting, and Patients  Controlled clinical trial of 951 adults 65 years or older with an annual income less than 200% of the federal poverty level, whose primary care physicians were randomized from January 2002 through August 2004 to participate in the intervention (474 patients) or usual care (477 patients) in community-based health centers.

Intervention  Patients received 2 years of home-based care management by a nurse practitioner and social worker who collaborated with the primary care physician and a geriatrics interdisciplinary team and were guided by 12 care protocols for common geriatric conditions.

Main Outcome Measures  The Medical Outcomes 36-Item Short-Form (SF-36) scales and summary measures; instrumental and basic activities of daily living (ADLs); and emergency department (ED) visits not resulting in hospitalization and hospitalizations.

Results  Intention-to-treat analysis revealed significant improvements for intervention patients compared with usual care at 24 months in 4 of 8 SF-36 scales: general health (0.2 vs –2.3, P = .045), vitality (2.6 vs –2.6, P < .001), social functioning (3.0 vs –2.3, P = .008), and mental health (3.6 vs –0.3, P = .001); and in the Mental Component Summary (2.1 vs –0.3, P < .001). No group differences were found for ADLs or death. The cumulative 2-year ED visit rate per 1000 was lower in the intervention group (1445 [n = 474] vs 1748 [n = 477], P = .03) but hospital admission rates per 1000 were not significantly different between groups (700 [n = 474] vs 740 [n = 477], P = .66). In a predefined group at high risk of hospitalization (comprising 112 intervention and 114 usual-care patients), ED visit and hospital admission rates were lower for intervention patients in the second year (848 [n = 106] vs 1314 [n = 105]; P = .03 and 396 [n = 106] vs 705 [n = 105]; P = .03, respectively).

Conclusions  Integrated and home-based geriatric care management resulted in improved quality of care and reduced acute care utilization among a high-risk group. Improvements in health-related quality of life were mixed and physical function outcomes did not differ between groups. Future studies are needed to determine whether more specific targeting will improve the program's effectiveness and whether reductions in acute care utilization will offset program costs.

Trial Registration  clinicaltrials.gov Identifier: NCT00182962

     

Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial

BACKGROUND: The effectiveness of massage therapy for low-back pain has not been documented. This randomized controlled trial compared comprehensive massage therapy (soft-tissue manipulation, remedial exercise and posture education), 2 components of massage therapy and placebo in the treatment of subacute (between 1 week and 8 months) low-back pain. METHODS: Subjects with subacute low-back pain were randomly assigned to 1 of 4 groups: comprehensive massage therapy (n = 25), soft-tissue manipulation only (n = 25), remedial exercise with posture education only (n = 22) or a placebo of sham laser therapy (n = 26). Each subject received 6 treatments within approximately 1 month. Outcome measures obtained at baseline, after treatment and at 1-month follow-up consisted of the Roland Disability Questionnaire (RDQ), the McGill Pain Questionnaire (PPI and PRI), the State Anxiety Index and the Modified Schober test (lumbar range of motion). RESULTS: Of the 107 subjects who passed screening, 98 (92%) completed post-treatment tests and 91 (85%) completed follow-up tests. Statistically significant differences were noted after treatment and at follow-up. The comprehensive massage therapy group had improved function (mean RDQ score 1.54 v. 2.86-6.5, p < 0.001), less intense pain (mean PPI score 0.42 v. 1.18-1.75, p < 0.001) and a decrease in the quality of pain (mean PRI score 2.29 v. 4.55-7.71, p = 0.006) compared with the other 3 groups. Clinical significance was evident for the comprehensive massage therapy group and the soft-tissue manipulation group on the measure of function. At 1-month follow-up 63% of subjects in the comprehensive massage therapy group reported no pain as compared with 27% of the soft-tissue manipulation group, 14% of the remedial exercise group and 0% of the sham laser therapy group. INTERPRETATION: Patients with subacute low-back pain were shown to benefit from massage therapy, as regulated by the College of Massage Therapists of Ontario and delivered by experienced massage therapists.     

Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial

Context  Pediatric obesity has escalated to epidemic proportions, leading to an array of comorbidities, including type 2 diabetes in youth. Since most overweight children become overweight adults, this chronic condition results in serious metabolic complications by early adulthood. To curtail this major health issue, effective pediatric interventions are essential. Objective  To compare effects of a weight management program, Bright Bodies, on adiposity and metabolic complications of overweight children with a control group. Design  One-year randomized controlled trial conducted May 2002-September 2005. Setting  Recruitment and follow-up conducted at Yale Pediatric Obesity Clinic in New Haven, Conn, and intervention at nearby school. Participants  Random sample of 209 overweight children (body mass index [BMI] >95th percentile for age and sex), ages 8 to 16 years of mixed ethnic groups were recruited. A total of 135 participants (60%) completed 6 months of study, 119 (53%) completed 12 months. Intervention  Participants were randomly assigned to either a control or weight management group. The control group (n = 69) received traditional clinical weight management counseling every 6 months, and the weight management group (n = 105) received an intensive family-based program including exercise, nutrition, and behavior modification. Intervention occurred biweekly the first 6 months, bimonthly thereafter. The second randomization within the weight management group assigned participants (n = 35) to a structured meal plan approach (dieting), but this arm of the study was discontinued while enrollment was ongoing due to a high dropout rate. Main Outcome Measures  Change in weight, BMI, body fat, and homeostasis model assessment of insulin resistance (HOMA-IR) at 6 and 12 months. Results  Six-month improvements were sustained at 12 months in weight management vs control, including changes in the following (mean [95% confidence interval]): weight (+0.3 kg [–1.4 to 2.0] vs +7.7 kg [5.3 to 10.0]); BMI (–1.7 [–2.3 to –1.1] vs +1.6 [0.8 to 2.3]); body fat (–3.7 kg [–5.4 to –2.1] vs +5.5 kg [3.2 to 7.8]); and HOMA-IR (–1.52 [–1.93 to –1.01] vs +0.90 [–0.07 to 2.05]). Conclusion  The Bright Bodies weight management program had beneficial effects on body composition and insulin resistance in overweight children that were sustained up to 12 months. Trial Registration  clinicaltrials.gov Identifier: NCT00409422      

Aspirin combined with mechanical measures to prevent venous thromboembolism after total knee arthroplasty: a randomized controlled trial

Background Venous thromboembolism （VTE） is an important complication after major orthopedic surgery.Pharmaceutical methods represent the main strategy of VTE prevention.The use of aspirin in VTE prevention is still controversial worldwide,especially in China.The purpose of this study was to evaluate the role of aspirin combined with mechanical measures in the prevention of VTE after total knee arthroplasty （TKA）.Methods Between January 2012 and May 2013 and in accordance with the inclusion criteria,120 patients undergoing TKA were randomly allocated to two groups.To prevent VTE,patients in group A received aspirin combined with mechanical measures postoperatively,while patients in group B received low-molecular-weight heparin （LMWH） sodium and rivaroxaban sequentially in combination with mechanical measures postoperatively.All surgeries were performed by one surgeon using a posterior-stabilized cemented prosthesis.The two groups were followed up and compared for the incidence of deep vein thrombosis （DVT） by duplex ultrasound scan and clinical VTE events.The adverse events,the blood loss index,and the cost of VTE prevention were also compared.Results DVT was detected in 10 of 60 patients in group A （16.7％,95％ CI：7.3％-26.1％） compared with 11 of 60 in group B （18.3％,95％ CI：8.5％-27.8％） （P=0.500）.There is no statistical evidence supporting the inferior effect of aspirin in preventing DVT as compared with the other medications.There were no cases of symptomatic VTE or death during the follow-up period.Area of ecchymosis was lower in group A than in group B,and the differences were statistically significant.Patients in group A had the lower blood loss index as compared with patients in group B.No transfusion cases were found in both groups.The differences were statistically significant.The cost of VTE prevention analysis indicated a cost reduction using aspirin in group A compared with using LMWH and rivaroxaban in group B.Conclusion Aspirin combined with mechanical measu     

Effect of magnetic vs sham-magnetic insoles on plantar heel pain: a randomized controlled trial

Context  Despite anecdotal reports, rigorous scientific evidence of the effectiveness of magnetic insoles for the pain of plantar fasciitis is lacking. Objective  To determine whether magnetic insoles provide greater subjective improvement for treatment of plantar heel pain compared with identical nonmagnetized insoles. Design, Setting, and Participants  Randomized, double-blind, placebo-controlled trial conducted from February 12, 2001, to November 9, 2001, of a volunteer sample of 101 adults with diagnoses of plantar heel pain for at least 30 days from a multispecialty group practice clinic in Rochester, Minn. Daily pain diaries were kept for 8 weeks. Interventions  Cushioned insoles, with either active bipolar magnets or sham magnets, which were worn daily by the participants for 8 weeks. Main Outcome Measures  Reported average daily foot pain (by metered visual analog scale [VAS] and by categorical response of change from baseline) at 4 and 8 weeks, and impact of insoles on employment performance and enjoyment. Results  No significant between-group differences were found on any outcome variables studied when comparing active vs sham magnets. Both the nonmagnetic and magnetic groups reported significant improvements in morning foot pain intensity, with mean (SD) VAS scores improving from 6.9 (2.3) and 6.7 (2.0), respectively, at baseline to 3.9 (2.6) for each group at 8 weeks (P = .94). At 8 weeks, 33% of the nonmagnetic group and 35% of the magnetic group reported being all or mostly better (P = .78). At baseline, foot pain interfered moderately with participants' employment enjoyment (mean VAS, 4.2) and improved in both groups by 8 weeks (1.3 and 1.5, respectively; P = .68). Conclusion  Static bipolar magnets embedded in cushioned shoe insoles do not provide additional benefit for subjective plantar heel pain reduction when compared with nonmagnetic insoles.