scholarly journals A Systematic Review and Meta-Analysis Estimating the Expected Dropout Rates in Randomized Controlled Trials on Yoga Interventions

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Holger Cramer ◽  
Heidemarie Haller ◽  
Gustav Dobos ◽  
Romy Lauche

A reasonable estimation of expected dropout rates is vital for adequate sample size calculations in randomized controlled trials (RCTs). Underestimating expected dropouts rates increases the risk of false negative results while overestimating rates results in overly large sample sizes, raising both ethical and economic issues. To estimate expected dropout rates in RCTs on yoga interventions, MEDLINE/PubMed, Scopus, IndMED, and the Cochrane Library were searched through February 2014; a total of 168 RCTs were meta-analyzed. Overall dropout rate was 11.42% (95% confidence interval [CI] = 10.11%, 12.73%) in the yoga groups; rates were comparable in usual care and psychological control groups and were slightly higher in exercise control groups (rate = 14.53%; 95% CI = 11.56%, 17.50%; odds ratio = 0.82; 95% CI = 0.68, 0.98;p=0.03). For RCTs with durations above 12 weeks, dropout rates in yoga groups increased to 15.23% (95% CI = 11.79%, 18.68%). The upper border of 95% CIs for dropout rates commonly was below 20% regardless of study origin, health condition, gender, age groups, and intervention characteristics; however, it exceeded 40% for studies on HIV patients or heterogeneous age groups. In conclusion, dropout rates can be expected to be less than 15 to 20% for most RCTs on yoga interventions. Yet dropout rates beyond 40% are possible depending on the participants’ sociodemographic and health condition.

2020 ◽  
Vol 37 (1) ◽  
pp. 19-27 ◽  
Author(s):  
Hong Je Ko ◽  
Jae Hee Yoo ◽  
Min Wook Kim ◽  
Jeong Cheol Shin

The effectiveness of fire needling or warm needling treatment in clinical studies for the treatment of ankle sprains was reviewed using 4 international (PubMed, Cochrane library, EMBASE, CNKI) and 5 Korean databases (NDSL, RISS, KISS, OASIS, KTKP). Randomized controlled trials, that performed fire needling or warm needling treatment for ankle sprains until October, 2018 were retrieved (<i>n</i> = 8). All studies were performed in China, and 7 out of 8 studies were published within the last 5 years. There were 4 studies that used fire needling treatment, 3 studies used warm needling treatment, and 1 study used fire and warm needling treatment. The ashi-points and gallbladder meridian were the most frequently selected acupoint and meridian each. All intervention groups in the 8 studies showed statistically significant beneficial effects compared with control groups. The results of this study could provide preliminary data as the basis for welldesigned randomized controlled trials on fire needling or warm needling treatment for ankle sprains.


Author(s):  
Lijuan Guo ◽  
Zhaowei Kong ◽  
Yanjie Zhang

This current meta-analysis review was conducted to examine the effectiveness of Qigong-based therapy on individuals with major depressive disorder. Six electronic databases (PubMed, PsycINFO, Cochrane Library, and Web of Science, Chinese National Knowledge Infrastructure, and Wangfang) were employed to retrieve potential articles that were randomized controlled trials. The synthesized effect sizes (Hedges’ g) were computerized to explore the effectiveness of Qigong-based therapy. Additionally, a moderator analysis was performed based on the control type. The pooled results indicated that Qigong-based therapy has a significant benefit on depression severity (Hedges’ g = −0.64, 95% CI −0.92 to −0.35, p < 0. 001, I2 = 41.73%). Specifically, Qigong led to significantly reduced depression as compared to the active control groups (Hedges’ g = −0.47, 95% CI −0.81 to −0.12, p = 0.01, I2 = 22.75%) and the passive control groups (Hedges’ g = −0.80, 95% CI −1.23 to −0.37, p < 0.01, I2 = 48.07%), respectively. For studies which reported categorical outcomes, Qigong intervention showed significantly improved treatment response rates (OR = 4.38, 95% CI 1.26 to 15.23, p = 0.02) and remission rates (OR = 8.52, 95% CI 1.91 to 37.98, p = 0.005) in comparison to the waitlist control group. Conclusions: Qigong-based exercises may be effective for alleviating depression symptoms in individuals with major depressive disorder. Future well-designed, randomized, controlled trials with large sample sizes are needed to confirm these findings.


2020 ◽  
Vol 2020 ◽  
pp. 1-8 ◽  
Author(s):  
Qiu-Shuang Wang ◽  
Ya Liu ◽  
Xiang-Ni Zou ◽  
Yan-Ling Ma ◽  
Gen-Li Liu

Background. It is essential to determine a safe and effective method for treating constipation after stroke. Massage has been widely used in recent years. However, meta-analysis data on the efficacy of massage for the treatment of constipation experienced after stroke are almost nonexistent. Objective. This review aimed to examine the effectiveness of using massage therapy to treat constipation in patients who suffered a stroke event. Methods. This systematic review adhered to the reporting guidelines for Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Electronic databases, including Cochrane Library, PubMed, EMBASE, Web of Science, China Biology Medicine, Wan Fang Data, VIP Database for Chinese Technical Periodicals, and National Knowledge Infrastructure, were searched for relevant studies on the efficacy of massage for the treatment of poststroke constipation. Rev-Man 5.3 software was used to analyze the study data. Results. A total of 11 randomized controlled trials with 1045 patients were included. A statistically significant difference in the total effective rates was found between the massage and control groups (OR = 4.96; 95% confidence interval (CI): 2.81, 8.76; P<0.001). Compared with the control groups, the massage group had markedly reduced incidences of constipation (OR = 0.34; 95% CI: 0.25, 0.47; P<0.001) and of four symptoms of discomfort (P<0.001). The frequency of defecation on day two and day three in the massage group was significantly higher than that in the control group (P<0.001). Conclusion. Our results strongly suggest that massage can effectively reduce the incidence and severity of constipation after stroke. However, large, multicenter, long-term, and high-quality randomized controlled trials need to be conducted to establish a definitive conclusion.


2019 ◽  
Author(s):  
Jia-Pei Wu ◽  
Liao Peng ◽  
Xiao Zeng ◽  
Hao Li ◽  
Hong Shen ◽  
...  

Abstract Purpose Previous study included limited number of randomized controlled trials (RCTs) and compared limited parameters post the treatment of imidafenacin and other anticholinergic drugs (ADs) for overactive bladder syndrome (OAB) and controversy about the superiority of those ADs still remains. We aim to update the evidence and provide better clinical guidance. Methods A systematic search in PubMed, Embase, ClinicalTrial.gov, and Cochrane Library Central Register of Controlled Trials was conducted from January 2007 to April 2019. Meta-analysis of all published RCTs comparing imidafenacin with other ADs in patients with OAB was performed. The primary outcomes were the changes in OAB symptoms and OAB Symptom Score (OABSS). Secondary outcomes included adverse events (AEs) and dropout rate related to AEs. Results A total of 6 studies including 7 RCTs involving 1,430 patients with mean follow-up of 23.43 weeks were included. All ADs improved OAB symptoms. In regard to efficacy, those drugs had similar efficacy in voids, urgency episodes, urgency incontinence episodes, incontinence episodes and in OABSS. However, Imidafenacin had a better performance in the reduction of nocturia episodes (MD=-0.24, 95%CI -0.44 to-0.04, P=0.02). Moreover, Imidafenacin was associated with statistically lower dry mouth rate (RR=0.87, 95%CI 0.75-1.00, P=0.04), lower constipation rate (RR=0.68, 95%CI 0.50-0.93, P=0.01) and lower AE-related withdrawal rate (RR=0.51, 95%CI 0.29-0.89, P=0.02). There was no significant difference in terms of other complications. Conclusions In conclusion, Imidafenacin was comparable with other ADs in the treatment of OAB. Moreover, imidafenacin presented lower dry mouth rate, lower constipation rate and higher adherence and persistence.


2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.


Cancers ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2984
Author(s):  
Stepan M. Esagian ◽  
Christos D. Kakos ◽  
Emmanouil Giorgakis ◽  
Lyle Burdine ◽  
J. Camilo Barreto ◽  
...  

The role of adjuvant transarterial chemoembolization (TACE) for patients with resectable hepatocellular carcinoma (HCC) undergoing hepatectomy is currently unclear. We performed a systematic review of the literature using the MEDLINE, Embase, and Cochrane Library databases. Random-effects meta-analysis was carried out to compare the overall survival (OS) and recurrence-free survival (RFS) of patients with resectable HCC undergoing hepatectomy followed by adjuvant TACE vs. hepatectomy alone in randomized controlled trials (RCTs). The risk of bias was assessed using the Risk of Bias 2.0 tool. Meta-regression analyses were performed to explore the effect of hepatitis B viral status, microvascular invasion, type of resection (anatomic vs. parenchymal-sparing), and tumor size on the outcomes. Ten eligible RCTs, reporting on 1216 patients in total, were identified. The combination of hepatectomy and adjuvant TACE was associated with superior OS (hazard ratio (HR): 0.66, 95% confidence interval (CI): 0.52 to 0.85; p < 0.001) and RFS (HR: 0.70, 95% CI: 0.56 to 0.88; p < 0.001) compared to hepatectomy alone. There were significant concerns regarding the risk of bias in most of the included studies. Overall, adjuvant TACE may be associated with an oncologic benefit in select HCC patients. However, the applicability of these findings may be limited to Eastern Asian populations, due to the geographically restricted sample. High-quality multinational RCTs, as well as predictive tools to optimize patient selection, are necessary before adjuvant TACE can be routinely implemented into standard practice. PROSPERO Registration ID: CRD42021245758.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Lijun Shi ◽  
Haiyun Zhu ◽  
Jinhui Ma ◽  
Li-Li Shi ◽  
Fuqiang Gao ◽  
...  

Abstract Objective We aimed to evaluate the safety and efficacy of intra-articular (IA) magnesium (Mg) for postoperative pain relief after arthroscopic knee surgery. Methods We searched PubMed, Embase, Medline, Cochrane library, and Web of Science to identify randomized controlled trials that compared postoperative pain outcomes with or without IA Mg after knee arthroscopy. The primary outcomes were pain intensity at rest and with movement at different postoperative time points and cumulative opioid consumption within 24 h after surgery. Secondary outcomes included the time to first analgesic request and side effects. Results In total, 11 studies involving 677 participants met the eligibility criteria. Pain scores at rest and with movement 2, 4, 12, and 24 h after surgery were significantly lower, doses of supplementary opioid consumption were smaller, and the time to first analgesic requirement was longer in the IA Mg group compared with the control group. No significant difference was detected regarding adverse reactions between the groups. Conclusions Intra-articular magnesium is an effective and safe coadjuvant treatment for relieving postoperative pain intensity after arthroscopic knee surgery. Protocol registration at PROSPERO: CRD42020156403.


Author(s):  
Nagita Devi ◽  
Chandrasekhar Boya ◽  
Manik Chhabra ◽  
Dipika Bansal

AbstractObjectivesThe objective of this study is to explore the efficacy and safety of N-acetyl-cysteine (NAC) as adjuvant therapy in female infertility.ContentWe performed a systematic literature search of PubMed, Cochrane Library, Embase, and Ovid databases through April 2019 for Randomized Controlled Trials (RCTs) evaluating the effectiveness and safety of NAC as adjuvant therapy in female infertility. The outcomes assessed were rates of ovulation, pregnancy, miscarriage and multiple pregnancy, presented as pooled odds ratio with 95% confidence interval (CI) using the random-effects model. Heterogeneity and inconsistency of the measurements were identified through Cochrane’s Q statistic and I2 statistic. We also performed a sensitivity analysis, publication bias (using funnel plot and Begg’s test), and subgroup analysis.SummaryFifteen RCTs recruiting 2330 female receiving NAC were included. The pooled estimate showed the statistically insignificant improvement in outcomes; clinical pregnancy rate 1.55 (95% CI 0.98–2.47; I2=68%; p<0.01), ovulation rate 1.77 (95% CI 0.76–4.14; I2=90%; p<0.01), multiple pregnancy rate 0.83 (95% CI 0.34–1.99; I2=10%; p=0.31) and miscarriage rate 0.76 (95% CI= 0.37, 1.53; I2=0%; p=0.69) . NAC was found less efficacious and safe than metformin in all outcomes. Overall, NAC showed statistically insignificant (OR=0.98–2.47).OutlookNAC can be an effective adjuvant in PCOS related and unexplained female infertility. The effect could be more profound in women with high BMI, insulin resistance, and oxidative stress. However, the findings need further confirmation in well-designed randomized controlled trials to examine clinical outcomes such as live birth rate in more extended follow-up periods.


Author(s):  
Rahele Tavakoly ◽  
Amir Hadi ◽  
Nahid Rafie ◽  
Behrouz Talaei ◽  
Wolfgang Marx ◽  
...  

AbstractThe possible effect of probiotic interventions on immunological markers in athletes is inconclusive. Therefore, to synthesize and quantitatively analyze the existing evidence on this topic, systematic literature searches of online databases PubMed, Scopus, Cochrane Library, and ISI Web of Sciences was carried out up to February 2021 to find all randomized controlled trials (RCTs) concerning the immunological effects of probiotics in athletes. In the random-effects model, weighted mean difference (WMD) and 95% confidence interval (CI) explained the net effect. The authors assessed the likelihood of publication bias via Egger’s and Begg’s statistics. A total of 13 RCTs (836 participants) were retrieved. Probiotic consumption reduced lymphocyte T cytotoxic count significantly (WMD=−0.08 cells×109/L; 95% CI: −0.15 to −0.01; p=0.022) with evidence of moderate heterogeneity (I 2=59.1%, p=0.044) and monocyte count when intervention duration was ≤ 4 weeks (WMD=−0.08 cells×109/L; 95% CI: −0.16 to −0.001; I 2=0.0%). Furthermore, leukocyte count was significantly elevated (WMD=0.48 cells×109/L; 95% CI: 0.02 to 0.93; I 2=0.0%) when multi-strain probiotics were used. Probiotic supplements may improve immunological markers, including lymphocyte T cytotoxic, monocyte, and leukocyte in athletes. Further randomized controlled trials using diverse strains of probiotics and consistent outcome measures are necessary to allow for evidence-based recommendations.


2015 ◽  
Vol 172 (3) ◽  
pp. R93-R101 ◽  
Author(s):  
Zhenru Huang ◽  
Hong Tao ◽  
Qingdong Meng ◽  
Long Jing

ObjectiveTo review the published literature on the effects of telecare intervention in patients with type 2 diabetes and inadequate glycemic control.Design and methodsA review of randomized controlled trials on telecare intervention in patients with type 2 diabetes, and a search of electronic databases such as The Cochrane Library, PubMed, EBSCO, CINAHL, Science Direct, Journal of Telemedicine and Telecare, and China National Knowledge Infrastructure (CNKI), were conducted from December 8 to 16, 2013. Two evaluators independently selected and reviewed the eligible studies. Changes in HbA1c, fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), BMI, and body weight were analyzed.ResultsAn analysis of 18 studies with 3798 subjects revealed that telecare significantly improved the management of diabetes. Mean HbA1c values were reduced by −0.54 (95% CI, −0.75 to −0.34; P<0.05), mean FPG levels by −9.00 mg/dl (95% CI, −17.36 to −0.64; P=0.03), and mean PPG levels reduced by −52.86 mg/dl (95% CI, −77.13 to −28.58; P<0.05) when compared with the group receiving standard care. Meta-regression and subgroup analyses indicated that study location, sample size, and treatment-monitoring techniques were the sources of heterogeneity.ConclusionsPatients monitored by telecare showed significant improvement in glycemic control in type 2 diabetes when compared with those monitored by routine follow-up. Significant reduction in HbA1c levels was associated with Asian populations, small sample size, and telecare, and with those patients with baseline HbA1c greater than 8.0%.


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