Randomized Controlled Trials Articles Research Articles

Summary of Evidence on the Impact of Mindfulness Training on Anxiety Levels of Pregnant Women

Background: Mental health during pregnancy is a global health problem, the percentage of pregnant women with antenatal anxiety or mood disorders ranges from 15% and 25%, with generalized anxiety disorder as the most common factor in the illness. Most of the research findings show a relationship between mothers’ psychological distress and poor prognosis for either the mother or the infant. Low well-being during pregnancy has significant adverse impacts on both mother and infant. Therefore, it is important to focus on antenatal anxiety and psychological stress in pregnant women. Mindfulness training, defined as an intentional and non-judgmental awareness of experience in the present moment, it is the most common intervention for antenatal education. Although the impact of positive thinking interventions on antenatal maternal well-being has been increasingly examined, the results still have not been systematically evaluated. Aim: This paper aims to systematically evaluate the effects of positive thinking interventions on evidence of antenatal anxiety in pregnant women and current research methods with a population of pregnant women by evaluating five studies of Randomized Controlled Trials (RCTs) using the CASP checklist tool. Summarize the implications of the evaluation results for future studies, and finally provide practical insights and research recommendations. Methods: Firstly, the research topic is identified: patient/problem: pregnancy anxiety; intervention: intervention in positive thinking; comparison: usual care. A complete internet-based search of five databases was conducted through Academic Search Complete, Medical Line, CINAHL, Health Source: Nursing/Academic Edition and Google Scholar to identify randomized controlled trials assessing positive thinking training versus postnatal depression controls. To select higher quality and relevant articles, the author rechecked titles and abstracts exclusion criteria and manually searched five peer-reviewed RCT articles from the last five years by further evaluating reference lists, while focusing on assessing interventions, measurement scale outcomes, study sample results, strengths and limitations. Secondly, randomized controlled trials were assessed using the CASP Randomized Controlled Trial Criteria Checklist. This version has now been updated to the 2020 Access Guide. Results: This paper provides a specific review of five RCT studies by using the CASP assessment tool, and concludes that positive thinking training shows potential benefits in terms of prenatal depression, anxiety and negative affect levels. From a comparison of the five intervention modalities of the positive thinking intervention, Mindfulness-integrated Cognitive Behavior Therapy (MICBT) had the broadest range of interventions and the most comprehensive curriculum. Most of the studies had small sample sizes of participants and an increase in sample size and longer follow-up time through comparative analysis would be beneficial to generalizability, therefore a sample size of 50 people on average between the intervention and control groups was chosen as appropriate, with a follow-up time of at least one month and three months. Also, the presence of potential bias was mentioned in these studies, by comparing randomized classification methods it was found that the smaller the base difference present through computer allocation and single-blind allocation, the less systematic bias there was. The choice of measurement instruments did not conflict with the sample size, the cultural background of the population and the findings. However, positive effects on anxiety and stress during pregnancy were less consistent with the assessment tool for the intervention group. Self-report instruments are highly sensitive and idiosyncratic, coupled with the tendency of participants to interact with researchers to produce bias. Therefore, when selecting a measurement tool, the best approach is to combine a self-report instrument with a researcher’s assessment. The literature highlights the increased interest in this area in recent years. Coupled with the prevalence of methodological issues and variation between studies, the current review is timely and necessary to determine intervention effects and best practice for future research. Findings: Mindfulness training is a useful intervention for improving anxiety and stress during pregnancy, but future research recommendations must follow robust methodological criteria with expanded sample sizes and longer follow-ups to examine the effects of positive thinking interventions during pregnancy.

Quality evaluation of the literature on randomized controlled clinical trials of traditional Chinese medicine for treatment of gastric precancerous lesions in last 20 years.

To evaluate the methodological quality of randomized controlled trials (RCTs) of traditional Chinese medicines for the treatment of gastric precancerous lesions in the past 20 years. The studies of RCTs on traditional Chinese medicines for gastric precancerous lesions were searched from the Chinese full-text journal database, Wanfang database, VIP database, PubMed, and Embase from January 2001 to December 2021. The retrieved articles were screened, extracted and evaluated based on the 2010 edition of CONSORT statement, Cochrane Risk of Bias Assessment Scale and additional indicators. A total of 840 papers were included. According to the Cochrane Risk of Bias Assessment Scale, the high risk of bias in the application of randomized methods was 5.95%; the concealed risk of uncertainty in the allocation scheme was 98.93%; the low risk of bias for blinding of patients or testers was 1.30%; the risk of bias for blinding of the outcome assessor was 100.00%; the risk of bias for completeness of the outcome data was 2.86%; and the risk of uncertainty for selective reporting was 98.44%. The CONSORT statement evaluating the quality of reporting showed that 100.00% of the RCT articles reported the 8 entries of introduction, objectives and interventions; 36.79% of the literature mentioned the method of randomized sequence generation, but only 27.62% of the literature implemented a randomized program, 1.07% of the literature hid the randomized program and 1.31% of the literature was blinded; 36.67% of the literature reported adverse reactions; no literature reported sample size prediction methods; additional evaluation indicators showed that 17.02% of the studies had ethical approval; 43.81% of the literature specified Chinese medicine evidence; 16.55% of the studies excluded severe heterotrophic hyperplasia; 7.26% of the studies conducted follow-up; and 65.12% of the literature used composite efficacy indicators; 46.67% of the literature applied pathological histological evaluation; 2.62% of the literature applied quality of life evaluation, etc. The overall risk of bias in RCTs of traditional Chinese medicines for gastric precancerous lesions is high, and the quality of most of the study reports needs to be improved. In the future, it is necessary to strengthen the study design of RCTs and refer to appropriate traditional Chinese medicines evidence grading standards, select study protocols according to different purposes, provide objective and strong evidence of clinical studies on traditional Chinese medicines, and carry out clinical study design and result reporting suitable for traditional Chinese medicines according to the CONSORT principle.

Effect of Acupoint Stimulation on Improving Gastrointestinal Motility in Patients After Gastrectomy: A Systematic Review and Meta-Analysis.

Introduction: Gastrointestinal immobility is experienced by many patients who undergo gastric surgery. This complication delays enteral nutrition, prolongs hospitalization, and causes discomfort. Acupoint stimulation is a popular alternative nonpharmacological treatment for gastrointestinal immobility. This study aimed to explore the effects of acupoint stimulation on gastrointestinal immobility after gastrectomy. Design: Systematic review and meta-analysis. Methods: Databases (PubMed, Cochrane, Joanna Briggs Institute EBP Database, Medline, CINAHL Complete, and Airiti library) were searched from their inception to April 2022 for relevant articles. Articles in Chinese and English were included, without limitations on year, region, or country. The inclusion criteria were studies with participants >18 years of age, postgastric surgery, and hospitalization. In addition, randomized controlled trials (RCTs) were included. Data were analyzed using random effects models, and data heterogeneity was investigated using subgroup analysis. Meta-analysis was performed using Review Manager 5.4 software. Results: We included 785 participants from six studies. Invasive and noninvasive acupoint stimulation reduced the time of gastrointestinal mobility better than usual care. In the control group, the time of first flatus was 43.56 ± 9.57 h to 108 ± 19.2 h, and the time of first defecation was 77.27 ± 22.67 h to 139.2 ± 24 h. In the experimental group, the time of first flatus and defecation was 36.58 ± 10.75 h to 79.97 ± 37.31 h and 70.56 ± 15.36 h to 108.55 ± 10.75 h, respectively. Subgroup analysis showed that invasive acupoint stimulation with acupuncture reduced the time of first flatus and defecation to 15.03 h (95% confidence interval [CI] = -31.06 to 1.01) and 14.12 h (95% CI = -32.78 to 4.54), respectively. Noninvasive acupoint stimulation, including acupressure and transcutaneous electrical acupoint stimulation (TEAS), reduced the time of first flatus and defecation to 12.33 h and (95% CI = -20.59 to -4.06) and 12.20 h (95% CI = -24.92 to 0.52), respectively. Conclusions: Acupoint stimulation improved the gastrointestinal immobility of postgastrectomy. In the included RCT articles, invasive and noninvasive stimulations were effective. However, noninvasive acupoint stimulation, such as with TEAS and acupressure, was more efficient and convenient than invasive stimulation. Overall, health care professionals with adequate training or under the supervision of an acupuncturist can effectively perform acupoint stimulation to improve the quality of postgastrectomy care. They can select commonly used and effective acupoints to enhance gastrointestinal motility. Clinical relevance: Acupoint stimulation, such as acupressure, electrical acupoint stimulation, or acupuncture, can be included in postgastrectomy routine care to improve gastrointestinal motility and reduce abdominal discomfort.

A meta-analysis of intravenous thrombolysis versus bridging therapy for ischemic stroke.

Background:The purpose of this study was to perform a pooled analysis of randomized controlled trials (RCT) of intravenous thrombolysis (IVT) versus bridging therapy of intravenous thrombolysis and mechanical thrombectomy (IVMT), comparing the efficacy and safety of the two in patients with acute ischemic stroke (AIS).Methods:All eligible RCT articles from database establishment to December 8, 2021 were searched in databases such as PubMed, Ovid, Embase, Web of science, Cochrane Library, etc. Efficacy outcomes were assessed by modified RANKIN scal (mRS) score, complete recanalization or reperfusion (TICI), National Institute of Health Stroke Scal (NIHSS) score, 90-day mortality, 24 to 36 h incidence of symptomatic intracranial hemorrhage (sICH).Results:Our study included 6 RCT involving 1717 patients. The proportion of the primary efficacy outcome (mRS score 0‐2 at 90 days) was significantly different between IVT and IVMT (OR 0.51; 95% CI 0.35‐0.76). For the secondary efficacy outcome, the study found a significant difference in the proportion of TICI (pooled OR was 0.055, 95% CI 0.07‐0.33). There was a significant difference in the 24 h NIHSS score between the IVT group and the IVMT group (pooled MD was 3.25, 95% CI 0.80‐5.70). There were no significant differences in the NIHSS score at 90 days, the death rate at 90 days, and the sICH at 24 to 36 hours between the two groups.Conclusions:This study confirms that IVMT is more effective and safe than IVT alone in patients with AIS. However, more and higher-quality randomized clinical trials comparing IVMT to IV alone are warranted for validation.

Unclear Insomnia Concept in Randomized Controlled Trials and Systematic Reviews: A Meta-Epidemiological Study.

There are two possible ways to conceptualize the term “insomnia”: insomnia disorder and insomnia symptoms, which are often poorly reported. The purpose of this study was to examine the proportion of randomized controlled trials (RCTs) and systematic reviews (SRs) that mention insomnia in their abstracts and cannot distinguish between insomnia disorder and insomnia symptoms from the abstract. We included RCT and SR articles that included the word “insomnia” in the methods or results sections of their structured abstracts, published after 2010. We searched PubMed using English language restrictions on 10 March 2022. From 1580 PubMed articles, we obtained 100 random samples each for eligible RCTs and SRs. The unclear insomnia concept accounted for 88% of the RCT abstracts and 94% of the SR abstracts. Among the RCT and SR abstracts with unclearness, the concept of insomnia was unclear in 27% of RCTs and 57% of SRs after investigating the full text. The concept of insomnia has been unclear in many RCTs and SRs abstracts. The authors of RCTs and SRs are recommended to state “insomnia disorder” or “insomnia symptoms” in the methods and results sections of their abstracts.

Effects of Different Surgical Procedures on the Therapeutic Effects, Prognosis, and Major Complications of Acetabular Fractures in the Elderly of China: A Systematic Review and Meta-Analysis.

Objective Different surgical approaches were systematically evaluated to provide an evidence-based medical rationale for the application and promotion of acetabular fractures in the elderly of China. Methods Randomized controlled trials (RCT) of different surgical methods in the treatment of elderly acetabular fractures were searched in the PubMed, EMBASE, ScienceDirect, Cochrane Library, China Knowledge Network Database (CNKI), China VIP Database, Wanfang Database, and China Biomedical Literature Database (CBM). The search time threshold was set from the time the database was created to the current time. Investigators obtained data independently, and the bias risk of each included writing was reviewed using the Cochrane Manual 5.1.0 criterion. The meta data was analyzed using RevMan 5.4 statistical package. Results 6 RCT articles were included in the end. A total of 445 samples were analyzed by meta. All the six RCT literatures included in this meta-analysis reported the baseline status of patients, only 3 RCT mentioned “random assignment” without any explanation, and the rest did not mention “random” information. The five studies included all gave detailed intervention measures. The number and reasons of blind method and lost follow-up or withdrawal were not described in detail in 6 RCT articles. Through the meta-analysis excellent and good rate between the experimental group and the control group through 6 RCT studies, the heterogeneity test results were chi2 = 6.11, df = 4, P = 0.19 > 0.05, and I2 = 35%, without obvious heterogeneity at Z = 2.68 and P = 0.007. These results suggested that the total hip arthroplasty application has the same excellent rate as other surgical treatment methods, indicating that total hip arthroplasty has a significant effect on the treatment of elderly acetabular fractures. Through the meta-analysis hip-joint function score, the heterogeneity test results were chi2 = 56.16, df = 4, P < 0.00001, and I2 = 93%, with obvious heterogeneity. The great difference was discovered in hip function score between total hip arthroplasty and other surgical methods, showing that total hip arthroplasty can greatly improve hip-joint function. Then, the incidence of hip complications between the experimental cases and the control cases was calculated by meta. The heterogeneity test results were chi2 = 3.17, df = 4, P = 0.53 > 0.05, and I2 = 0%, without remarkable heterogeneity at Z = 3.05 and P = 0.002. This demonstrated that a significant difference was observed in the complication incidence, indicating that total hip arthroplasty displayed a lower incidence of hip-joint functional complications. Conclusion Total hip arthroplasty has a good prognosis and a low complication rate in the treatment of acetabular fractures in the elderly. However, more studies and longer follow-ups are needed to further validate the findings of this study.

Clinical Efficacy and Safety of Chondroitin Combined with Glucosamine in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-Analysis.

Objective This analysis was aimed at providing evidence-based medicine basis for systematic evaluation of chondroitin combined with glucosamine in the treatment of knee osteoarthritis. Methods The randomized controlled trials (RCTs) of chondroitin combined with glucosamine in the treatment of knee osteoarthritis (KOA) were searched in PubMed, EMBASE, ScienceDirect, Cochrane Library, China Knowledge Network Database (CNKI), China VIP Database, Wanfang Database, and China Biomedical Literature Database (CBM) online database. The retrieval time ranges from the database creation to the present. Two investigators gathered the information individually. The risk of bias was assessed using the criteria of the Cochrane back review group. RevMan5.4 statistical software analyzed the selected data. Results A total of 6 RCT articles were obtained. Overall, 764 samples were evaluated by meta-analysis. The clinical efficacy of chondroitin combined with glucosamine was significantly better than that of routine treatment by meta-analysis. The confidence interval of 95% was (4.86, 17.08) (Z = 6.89, P < 0.00001). The scores of joint pain, tenderness, swelling, and dysfunction in patients with knee osteoarthritis treated with chondroitin combined with glucosamine were significantly lower than those treated with routine treatment. There was no significant difference in the incidence of adverse reactions between chondroitin combined with glucosamine and single treatment of KOA. Due to the small number of documents included in the analysis, it is not suitable to make a funnel chart, but there may be some publication deviation in the analysis. Conclusion Chondroitin combined with glucosamine is more effective than chondroitin or glucosamine alone in the treatment of KOA and deserves clinical promotion. However, this conclusion still needs to be supported by multicenter, high-quality, double-blind, large-sample randomized controlled clinical trials due to the limitations of the six trials included.

Effects of vitamin D supplementation on metabolic parameters of women with polycystic ovary syndrome: a meta-analysis of randomized controlled trials

Objective The purpose of this meta-analysis was to evaluate the effects of vitamin D supplementation on metabolic parameters of women with polycystic ovary syndrome (PCOS). Methods We performed a literature search of databases and identified randomized controlled trials (RCTs) published prior to December 2019. A meta-analysis was conducted using RevMan 5.3 and Stata 12.0 software. We compared the effects of vitamin D supplementation alone to the administration of placebos on metabolic parameters of PCOS women with vitamin D deficiency. Results Ten articles of RCTs were included and analyzed in this meta-analysis, which included a total of 520 PCOS women. Our meta-analysis results showed no significant effects of vitamin D supplementation on BMI (p = .43), systolic blood pressure (p = .05), diastolic blood pressure (p = .87), fasting insulin concentration (p = .86), HOMA-IR (p = .47), HDL-C (p = .76), LDL-C (p = .23) and triglyceride (p = .77). Both low dose vitamin D supplementation (<4000 IU/day) and high dose vitamin D supplementation (≥4000 IU/day) were found to significantly decreased the fasting glucose concentration (p = .01, p = .001, respectively). Vitamin D supplementation significantly decreased total cholesterol concentration (p = .03). Conclusions The results of this meta-analysis suggested that vitamin D supplementation decreases fasting glucose concentration and total cholesterol concentration in PCOS women with vitamin D deficiency.

No consistent evidence of data availability bias existed in recent individual participant data meta-analyses: a meta-epidemiological study

ObjectivesThe objective of the study was to assess trial-level factors associated with the contribution of individual participant data (IPD) to IPD meta-analyses, and to quantify the data availability bias, namely the difference between the effect estimates of trials contributing IPD and those not contributing IPD in the same systematic reviews (SRs). Study Design and SettingWe included SRs of randomized controlled trials (RCTs) with IPD meta-analyses since 2011. We extracted trial-level characteristics and examined their association with IPD contribution. To assess the data availability bias, we retrieved odds ratios from the original RCT articles, calculated the ratio of odds ratios (RORs) between aggregate data (AD) meta-analyses of RCTs contributing IPD and those of RCTs not contributing IPD for each SR, and meta-analytically synthesized RORs. ResultsOf 728 eligible RCTs included in 31 SRs, 321 (44%) contributed IPD, whereas 407 (56%) did not. A recent publication year, larger number of participants, adequate allocation concealment, and impact factor ≥10 were associated with IPD contribution. We found the SRs yielded widely different estimates of RORs. Overall, there was no significant difference in the pooled effect estimates of AD meta-analyses between RCTs contributing and not contributing IPD (ROR 1.01, 95% confidence interval, 0.86–1.19). ConclusionsThere was no consistent evidence of a data availability bias in recent IPD meta-analyses of RCTs with dichotomous outcomes. Higher methodological qualities of trials were associated with IPD contribution.

A Scoping Review of The Efficacy of Virtual Reality and Exergaming on Patients of Musculoskeletal System Disorder.

To assess the effects of virtual reality on patients with musculoskeletal disorders by means of a scoping review of randomized controlled trials (RCTs). The databases included PubMed, IEEE, and the MEDLINE database. Articles involving RCTs with higher than five points on the Physiotherapy Evidence Database (PEDro) scale were reviewed for suitability and inclusion. The methodological quality of the included RCT was evaluated using the PEDro scale. The three reviewers extracted relevant information from the included studies. Fourteen RCT articles were included. When compared with simple usual care or other forms of treatment, there was significant pain relief, increased functional capacity, reduced symptoms of the disorder, and increased joint angles for the virtual reality treatment of chronic musculoskeletal disorders. Furthermore, burn patients with acute pain were able to experience a significant therapeutic effect on pain relief. However, virtual reality treatment of patients with non-chronic pain such as total knee replacement, ankle sprains, as well as those who went through very short virtual reality treatments, did not show a significant difference in parameters, as compared with simple usual care and other forms of treatment. Current evidence supports VR treatment as having a significant effect on pain relief, increased joint mobility, or motor function of patients with chronic musculoskeletal disorders. VR seems quite effective in relieving the pain of patients with acute burns as well.

Machine learning to help researchers evaluate biases in clinical trials: a prospective, randomized user study

ObjectiveAssessing risks of bias in randomized controlled trials (RCTs) is an important but laborious task when conducting systematic reviews. RobotReviewer (RR), an open-source machine learning (ML) system, semi-automates bias assessments. We conducted a user study of RobotReviewer, evaluating time saved and usability of the tool.Materials and methodsSystematic reviewers applied the Cochrane Risk of Bias tool to four randomly selected RCT articles. Reviewers judged: whether an RCT was at low, or high/unclear risk of bias for each bias domain in the Cochrane tool (Version 1); and highlighted article text justifying their decision. For a random two of the four articles, the process was semi-automated: users were provided with ML-suggested bias judgments and text highlights. Participants could amend the suggestions if necessary. We measured time taken for the task, ML suggestions, usability via the System Usability Scale (SUS) and collected qualitative feedback.ResultsFor 41 volunteers, semi-automation was quicker than manual assessment (mean 755 vs. 824 s; relative time 0.75, 95% CI 0.62–0.92). Reviewers accepted 301/328 (91%) of the ML Risk of Bias (RoB) judgments, and 202/328 (62%) of text highlights without change. Overall, ML suggested text highlights had a recall of 0.90 (SD 0.14) and precision of 0.87 (SD 0.21) with respect to the users’ final versions. Reviewers assigned the system a mean 77.7 SUS score, corresponding to a rating between “good” and “excellent”.ConclusionsSemi-automation (where humans validate machine learning suggestions) can improve the efficiency of evidence synthesis. Our system was rated highly usable, and expedited bias assessment of RCTs.

The Role of Stents as Bridge to Surgery for Acute Left-Sided Obstructive Colorectal Cancer: Meta-Analysis of Randomized Controlled Trials.

The role of self-expanding metallic stents (SEMS) as a bridge to surgery for acute left-sided obstructive colorectal cancer has remained controversial. To study the efficacy of this approach, we performed a meta-analysis at the gastrointestinal surgery center of Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital (Eastern Hospital). Two PubMed and science-direct electronic databases were searched up to December 30, 2017. Eligible studies were randomized controlled trials (RCTs). We selected 8 RCTs articles, which included 497 cases. The directly stoma rates were significantly lower in the stent group (odds ratio [OR] = 0.46, 95% confidence intervals [CIs] = 0.30-0.70, p = 0.0003). The successful primary anastomosis rates were significantly higher in the stent group (OR = 2.29, 95% CIs = 1.52-3.45, p < 0.0001). The post-procedural complication rates were significantly lower in the stent group (OR = 0.39, 95% CI = 0.18-0.82, p = 0.01). However, tumor recurrence rates were significantly higher in the stent group (OR = 1.79, 95% CI = 1.09-2.93, p = 0.02). Conclusions This meta-analysis confirms that SEMS placement could reduce direct stoma rate and increases the successful primary anastomosis rate; however, it was associated with a seemingly higher incidence of tumor recurrence.

PO-256 Influences of Exercise on Circulating Irisin in Overweight or Obese Individuals: a system review

Objective Irisin is a newly identified myokine, which is mainly secreted by skeleton muscle, adipose and cerebellar. It is shown to be related to some physiology process. The aim of this study is to evaluate the influence of exercise on circulating irisin concentrations in overweight or obese individuals&#x0D; Methods Searches were performed on nine online electronic databases including PubMed, EMbase, The Cochrane Library, web of science, Ebsco, CNKI, VIP, CBM and Wan-Fang Data databases. The search items were irisin, fibronectin type Ⅲ domain-containing protein 5, FNDC5, exercise, training, physical activity, obesity, overweight, obese, body mass index, BMI, adiposity and fat. Randomized controlled trials (RCT) or clinical controlled trials about the effect of exercise on circulating irisin concentrations in overweight or obese individuals in English or Chinese were eligible for the study. The trials compare exercise intervention with no intervention, or combined interventions of exercise and other with other intervention(s), and the exercise intervention is not one acute time. Besides, the trial objects belong to overweight or obese regardless of the judgement’s indicator. According to the criteria, the data extracted by two research independently. If there was disagreement, discussion between all the authors were used to settle. The risk of bias among the included studies was assessed by the Cochrane Collaboration Risk-of-Bias tool, which consists of seven domains and each one was judged to ‘unclear risk’ ‘low risk’, or ‘high risk’ following the recommendations detailed of the Cochrane handbook. Lastly an analysis about the final studies was done. &#x0D; Results The search identified a total of 855 possible articles. Of those, 364 were removed as duplicates, and the remaining 491 were screened for the titles and abstracts. The full-texts of 56 trials were retrieved to assess for eligibility. After the evaluation, four articles of RCTs were retained for the final system review from the year of 2015 to 2017, producing 6 study estimates. The assessments class of methods quantality of them are A. All the research subjects are more than 18 years old, and in one study subjects are men, men and women in two, women in three. The types of exercise intervention are dissimilar, such as strengthen or endurance exercise (including high intensity interval training, HIIT). In the duration of exercise, three studies are 8 weeks, and two for 12 weeks, one for 24 weeks. In circulating irisin, the detection methods of all is enzyme-linked immunosorbent assay, and three are in plasm, three in serum. Furthermore, the concentration unit in five studies is ng/ml, and one is µg/ml. Bonefate suggests that aerobic exercise with the frequency of 3 times per week for 24 week maintains plasma FNDC5/irisin of middle-age obese men, same as 8 weeks aerobic exercise for overweight/obese adults by Kim, but three is an opposite result from Wu, which proved that aerobic exercise of twelve weeks ascends serum irisin of young obese women. HIIT of eight or twelve weeks ascends serum irisin in sedentary obese women or young obese women according to Tofighi or Wu suggestion. Moreover, resistance exercise of 8 weeks significantly increases plasma irisin of overweight/obese adults From Kim’s study.&#x0D; Conclusions The study about effect of exercise on circulating irisin levels in overweight or obese individuals is not sufficient to come to a positive result, although the quality assessments of current evidences are high. Basing on the available literatures, exercise can maintain or improve circulating irisin levels in overweight or obese individuals. The effect needs to be illustrated by further RCTs with large sample size.&#x0D;

Use of Kampo diagnosis in randomized controlled trials of Kampo products in Japan: a systematic review.

BackgroundThe Committee for Evidence-based Medicine (EBM) of the Japan Society for Oriental Medicine started compiling Evidence Reports of Kampo Treatment (EKAT) in 2007. EKAT is a compilation of structured abstracts of randomized controlled trials (RCTs), along with comments by a third party reviewer. As of 31 December, 2012, there were 378 RCTs of Kampo medicines in Japan. The primary research question of this study is “How frequently is Kampo diagnosis used in RCTs of Kampo medicines?” The secondary research question is “When is Kampo diagnosis used in RCTs?”Materials and MethodsThe structured abstract (SA) of each RCT article was reviewed to examine how Kampo diagnosis was used in RCTs, especially how Kampo diagnosis was used in the randomization process.ResultsKampo diagnosis was used before randomization in 27 RCTs (7.1%), after randomization in 31 RCTs (8.2%), and not used in 320 RCTs (84.7%). Before randomization, Kampo diagnosis was used as a criterion for inclusion in 10 RCTs, criterion for exclusion in 9 RCTs, and criteria for both inclusion and exclusion in 2 RCTs. Kampo formulas were determined according to Kampo diagnosis in 7 RCTs. After randomization, subgroup analyses according to Kampo diagnosis were done in 27 RCTs, and grade of disease severity at Kampo diagnosis was used for analysis as an endpoint in 4 RCTs.ConclusionsKampo diagnosis was used before randomization only in approximately 15% of RCTs, and the number of RCT articles using Kampo diagnosis after randomization was almost the same as that before randomization. Further studies to determine the good RCTs conforming to CONSORT requirements and good systematic reviews conforming to PRISMA requirements are needed to clarify the significance of Kampo diagnosis.

Are concomitant treatments confounding factors in randomized controlled trials on intensive blood-glucose control in type 2 diabetes? a systematic review.

BackgroundOpen-label, randomized controlled trials (RCTs) are subject to observer bias. If patient management is conducted without blinding, a difference between groups may be explained by other factors than study treatment. One factor may come from taking concomitant treatments with an efficacy on the studied outcomes. In type 2 diabetes, some antihypertensive or lipid-lowering drugs are effective against diabetic complications. We wanted to determine if these concomitant treatments were correctly reported in articles of RCTs on type 2 diabetes and if they might have influenced the outcome.MethodsWe performed a systematic review using Medline, Embase, and the Cochrane Library (from January 1950 to July 2010). Open-label RCTs assessing the effectiveness of intensive blood-glucose control in type 2 diabetes were included. We chose five therapeutic classes with proven efficacy against diabetes complications: angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor antagonists (AIIRAs), fibrates, statins, and aspirin. Differences between concomitant treatments were considered statistically significant when p < 0.05.ResultsA total of eight open-label RCTs were included, but only three (37.5%) of them published concomitant treatments. In two studies (ACCORD and ADVANCE), a statistically significant difference was observed between the two groups for aspirin (p = 0.02) and ACEIs (p = 0.02).ConclusionsFew concomitant treatments were published in this sample of open-label RCTs. We cannot completely eliminate an observer bias for these studies. This bias probably influenced the results to an extent that has yet to be determined.

Development of a Core Set of Outcomes for Randomized Controlled Trials with Multiple Outcomes – Example of Pulp Treatments of Primary Teeth for Extensive Decay in Children

ObjectivesEvidence-based comparisons of interventions can be challenging because of the diversity of outcomes in randomized controlled trials (RCTs). We aimed to describe outcomes in RCTs assessing pulp treatments for primary teeth and to develop a core set of component outcomes to be part of composite outcome defining the failure of a pulp treatment.MethodsWe systematically reviewed articles of RCTs comparing pulp treatments for primary molars published up to February 2012. We abstracted all outcomes assessed in each trial, then used a small-group consensus process to group similar outcomes, which were reduced to a composite outcome of failure of a pulp treatment by a 3-round Delphi process involving expert authors and dentists.ResultsWe included 47 reports of RCTs in the review, for 83 reported outcomes (median 11 outcomes per RCT). These outcomes were grouped into 24 overarching outcome categories. We contacted 210 experts for the Delphi process and 25% to 30% participated. The process identified the following 5 component outcomes as part of a composite outcome of failure of a pulp treatment: soft-tissue pathology, pain, pathologic mobility, pathologic radiolucency and pathologic root resorption.ConclusionsRCTs of pulp treatments for primary teeth investigate diverse outcomes. Our consensus process, involving clinicians but no patient, allowed for compiling a core set of component outcomes to define the composite outcome failure of a pulp treatment for primary teeth.

Assessment of the quality of clinical therapeutic research published in Chinese Journal of Pediatrics

To evaluate the methodological qualities of clinical therapeutic research papers published in Chinese Journal of Pediatrics and find out the weaknesses and defects in the literature of clinical therapeutic research in China. The clinical therapeutic research articles from Chinese Journal of Pediatrics, which were published in the years 1999, 2000, 2001, 2009, 2010 and 2011, were analyzed manually, after dividing into randomized controlled trials (RCT) and non-randomized controlled trials. The methodological quality of RCT articles were evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scale, while non-RCT reports were assessed by specific evaluation standard criteria and analytical table. And the group A (1999 - 2001) and group B (2009 - 2011) of the quality documents were compared and analyzed. Seventeen RCTs were included. Based on the items in the CONSORT statement, the reporting quality of sample size determination, demographic baseline, random principle, blinding, lost to follow-up were all lower than 50%. Fourteen (82.4%) in the 17 RCTs mentioned 'eligibility criteria for participants', 11 (64.7%) RCTs mentioned 'details of the interventions', 15 (88.2%) RCTs mentioned 'adverse effects'. Compared with RCT reports in the year of 1999, 2000 and 2001, the methodological qualities of those in 2009, 2010 and 2011 were not improved. In the 17 RCTs, the total score achieved based on the Jadad scale, only 11.8% (2 out of 17) were high-quality trials (≥ 3 points). Analysis of the 28 non-RCTs, which were included and assessed by evaluation criteria and evaluation table, also showed some disadvantages on some key items. The methodological quality of clinical therapeutic research reports should be consistent with the standards of international evaluation, pediatric clinicians should improve know ledge in clinical epidemiology, clinical trial methodology, and improve the quality of research reports.

Erythropoietin treatment in patients with acute myocardial infarction: A meta-analysis of randomized controlled trials

In experimental models of acute myocardial infarction (AMI), erythropoietin (EPO) reduces infarct size and improves left ventricular (LV) function. However, in the clinical setting, the effect of EPO in AMI was unclear. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) of EPO to explore the safety and therapeutic effects of EPO in patients with AMI. We identified reports of RCTs comparing EPO to placebo for AMI in adult humans in PubMed, Cochrane Central Register of Controlled Trials, and EMBASE. Outcomes included all-cause mortality, major cardiovascular events, cardiac function by LV ejection fraction and infarct size. We included 13 articles of RCTs with data for 1,564 patients. Erythropoietin therapy did not improve LV ejection fraction (weighted mean difference [WMD] 0.33, 95% CI -1.90 to 1.24, P = .68) and had no effect on infarct size, as measured by cardiac magnetic resonance imaging (WMD -0.12, -2.16 to 1.91, P = .90) or serum peak value of creatine kinase-MB (WMD -2.01, -25.70 to 21.68, P = .87). Erythropoietin treatment did not decrease the risk of total adverse cardiac events (relative risk [RR] 1.02, 0.65-1.61, P = .92). Erythropoietin treatment also failed to decrease the risk of heart failure (RR, 0.69, 0.27-1.72, P = .42) and all-cause mortality (RR 0.55, 0.22-1.33, P = .18). Moreover, EPO had no effect on the risk of stent thrombosis (RR, 0.69, 0.29-1.64, P = .40). Erythropoietin in patients with AMI seems to have no clinical benefit for heart function or reducing infarct size, cardiovascular events, and all-cause mortality. Erythropoietin may not be a choice for patients with AMI.

Is funding source related to study reporting quality in obesity or nutrition randomized control trials in top-tier medical journals?

Faithful and complete reporting of trial results is essential to the validity of the scientific literature. An earlier systematic study of randomized controlled trials (RCTs) found that industry-funded RCTs appeared to be reported with greater quality than non-industry-funded RCTs. The aim of this study was to examine the association between systematic differences in reporting quality and funding status (that is, industry funding vs non-industry funding) among recent obesity and nutrition RCTs published in top-tier medical journals. Thirty-eight obesity or nutrition intervention RCT articles were selected from high-profile, general medical journals (The Lancet, Annals of Internal Medicine, JAMA and the British Medical Journal) published between 2000 and 2007. Paired papers were selected from the same journal published in the same year, one with and the other without industry funding. The following identifying information was redacted: journal, title, authors, funding source and institution(s). Then three raters independently and blindly rated each paper according to the Chalmers method, and total reporting quality scores were calculated. The inter-rater reliability (Cronbach's alpha) was 0.82 (95% confidence interval = 0.80-0.84). The total mean (M) and s.d. of Chalmers Index quality score (out of a possible 100) for industry-funded studies were M = 84.5, s.d. = 7.04 and for non-industry-funded studies they were M = 79.4, s.d. = 13.00. A Wilcoxon matched-pairs signed-ranks test indicates no significant rank difference in the distributions of total quality scores between funding sources, Z = -0.966, P = 0.334 (two tailed). Recently published RCTs on nutrition and obesity that appear in top-tier journals seem to be equivalent in quality of reporting, regardless of funding source. This may be a result of recent reporting of quality statements and efforts of journal editors to raise all papers to a common standard.

Sample size calculations in surgery: Are they done correctly?

Background. Randomized controlled trials (RCTs) are considered the gold standard for evidence-based clinical research, but prior work has suggested that there may be poor reporting of sample sizes in the surgical literature. Sample size calculations are essential for planning a study to minimize both type I and type II errors. We hypothesized that sample size calculations may not be performed consistently in surgery studies and, therefore, many studies may be “underpowered.” To address this issue, we reviewed RCTs published in the surgical literature to determine how often sample size calculations were reported and to analyze each study's ability to detect varying degrees of differences in outcomes. Methods. A comprehensive MEDLINE search identified RCTs published in Annals of Surgery, Archives of Surgery, and Surgery between 1999 and 2002. Each study was evaluated by two independent reviewers. Sample size calculations were performed to determine whether they had 80% power to detect differences between treatment groups of 50% (large) and 20% (small), with one-sided test, alpha = 0.05. For the underpowered studies, the degree to which sample size would need to be increased was determined. Results. One hundred twenty-seven RCT articles were identified; of these, 48 (38%) reported sample size calculations. Eighty-six (68%) studies reported positive treatment effect, whereas 41 (32%) found negative results. Sixty-three (50%) of the studies were appropriately powered to detect a 50% effect change, whereas 24 (19%) had the power to detect a 20% difference. Of the studies that were underpowered, more than half needed to increase sample size by more than 10-fold. Conclusions. The reporting of sample size calculations was not provided in more than 60% of recently published surgical RCTs. Moreover, only half of studies had sample sizes appropriate to detect large differences between treatment groups. (Surgery 2003;134:275-9.)