Risk of bias assessments and reporting quality of systematic reviews and randomized controlled trials examining acupuncture for depression: An overview and meta‐epidemiology study

Panax ginseng is one of the most frequently used herbs in the world. Numerous trials have evaluated its clinical benefits. However, the quality of these studies has not been comprehensively and systematically assessed. We reviewed randomized controlled trials (RCTs) of Panax ginseng to evaluate their quality and risk of bias. We searched four English databases, without publication date restriction. Two reviewers extracted details about the studies' methodological quality, guided by the Consolidated Standards of Reporting Trials (CONSORT) checklist and its extension for herbal interventions. Risk of bias was determined using the Cochrane Risk of Bias tool. Of 475 potentially relevant studies, 58 met our inclusion criteria. In these 58 studies, 48.3% of the suggested CONSORT checklist items and 35.9% of the extended herbal items were reported. The quality of RCTs published after the CONSORT checklist improved. Until 1995 (before CONSORT) (n = 4), 32.8% of the items were reported in studies. From 1996–2006 (CONSORT published and revised) (n = 30), 46.1% were reported, and from 2007 (n = 24), 53.5% were reported (p = 0.005). After the CONSORT extension for herbal interventions was published in 2006, RCT quality also improved, although not significantly. Until 2005 (n = 34), 35.2% of the extended herbal items were reported in studies; and from 2006 onwards (n = 24), 37.3% were reported (p = 0.64). Most studies classified risk of bias as "unclear". Overall, the quality of Panax ginseng RCT methodology has improved since the CONSORT checklist was introduced. However, more can be done to improve the methodological quality of, and reporting in, RCTs.

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Tools to Assess the External Validity of Randomized Controlled Trials in Systematic Reviews: a Systematic Review of Measurement Properties

10.21203/rs.3.rs-830181/v1 ◽

2021 ◽

Author(s):

Andres Jung ◽

Julia Balzer ◽

Tobias Braun ◽

Kerstin Luedtke

Keyword(s):

Randomized Controlled Trials ◽

Systematic Reviews ◽

External Validity ◽

Measurement Properties ◽

Controlled Trials ◽

Measurement Instruments ◽

Health Measurement ◽

Quality Of Evidence ◽

Randomized Controlled

Abstract Background: Internal and external validity are the most relevant components when critically appraising randomized controlled trials (RCTs) for systematic reviews. However, there is no gold standard to assess external validity. This might be related to the heterogeneity of terminology as well as to unclear evidence of the measurement properties of available tools. The aim of this review was to identify tools to assess the external validity of RCTs in systematic reviews and to evaluate the quality of evidence regarding their measurement properties.Methods: A two-phase systematic literature search was performed in four databases: MEDLINE via PubMed, Scopus, PsycINFO via OVID, and CINAHL via EBSCO. First, tools to assess the external validity of RCTs were identified. Second, studies aiming to investigate the measurement properties of these tools were selected. The measurement properties of each included tool were appraised using an adapted version of the COnsensus based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.Results: 34 publications reporting on the development or validation of 26 included tools were included. For 62% of the included tools, there was no evidence of any measurement property. For the remaining tools, reliability was assessed most frequently. Reliability was judged as “sufficient” for three tools (very low quality of evidence). Content validity was rated as “sufficient” for one tool (moderate quality of evidence).Conclusions: Based on these results, no available tool can be fully recommended to assess the external validity of RCTs in systematic reviews. Several steps are required to overcome the identified difficulties to either adapt and validate available tools or to develop a new one. There is a need for more research for this purpose.Trial registration: Prospective registration at Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/PTG4D

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Exercise and Quality of Life in Women with Menopausal Symptoms: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17197049 ◽

2020 ◽

Vol 17 (19) ◽

pp. 7049

Author(s):

Thi Mai Nguyen ◽

Thi Thanh Toan Do ◽

Tho Nhi Tran ◽

Jin Hee Kim

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trials ◽

Risk Of Bias ◽

Menopausal Symptoms ◽

Cochrane Library ◽

Controlled Trials ◽

Study Objective ◽

Positive Effects ◽

Randomized Controlled

Menopausal symptoms are associated with deterioration in physical, mental, and sexual health, lowering women’s quality of life (QoL). Our study objective is to examine the effect of exercise on QoL in women with menopausal symptoms. After initially identifying 1306 studies published on PubMed, Web of Science, Scopus, and Cochrane Library before June 2020, two researchers independently selected nine randomized controlled trials (RCTs) in which any type of exercise was compared with no active treatment. We assessed the risk of bias in the included studies using the Cochrane risk-of-bias 2.0 tool for RCTs and computed the converged standardized mean difference with a 95% confidence interval. We found evidences for the positive effects of exercise on physical and psychological QoL scores in women with menopausal symptoms. However, there was no evidence for the effects of exercise on general, social, and menopause-specific QoL scores. The most common interventions for women with menopausal and urinary symptoms were yoga and pelvic floor muscle training (PFMT), respectively. In our meta-analyses, while yoga significantly improved physical QoL, its effects on general, psychological, sexual, and vasomotor symptoms QoL scores as well as the effect of PFMT on general QoL were not significant. Our findings suggest that well-designed studies are needed to confirm the effect of exercise on QoL in women with menopausal symptoms.

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An evaluation of randomized controlled trials on nutraceuticals containing traditional Chinese medicines for diabetes management: a systematic review

Chinese Medicine ◽

10.1186/s13020-019-0276-3 ◽

2019 ◽

Vol 14 (1) ◽

Cited By ~ 2

Author(s):

Junnan Shi ◽

Hao Hu ◽

Joanna Harnett ◽

Xiaoting Zheng ◽

Zuanji Liang ◽

...

Keyword(s):

Blood Glucose ◽

Randomized Controlled Trials ◽

Diabetes Management ◽

Fasting Blood Glucose ◽

Risk Of Bias ◽

Controlled Trials ◽

Glucose Levels ◽

Randomized Controlled ◽

Blood Glucose Levels

Abstract Background Nutraceuticals containing traditional Chinese medicine (TCM) are promoted for use in the management of diabetes. The evidence to support such use is largely unknown. This study aimed to summarise and evaluate the literature reporting the results of randomized controlled trials (RCTs) investigating the effects of nutraceuticals in people living with diabetes. Methods Literature from four electronic databases (PubMed, Scopus, CINAHL and Web of Science) was searched following PRISMA guidelines to yield RCT publications on nutraceutical for diabetes management published since 2009. The quality of reporting was assessed using the CONSORT 2010 checklist statement. Risk-of-bias for each study was assessed using the Cochrane risk of bias tool. Results Out of 1978 records identified in the initial search, 24 randomized, double/triple-blinded, controlled trials that investigated the effect of nutraceuticals covering 17 different TCM herbs for diabetes management were selected. Participants included people who were diabetic (n = 16), pre-diabetic (n = 3) or predisposed to diabetes (n = 5). Sample sizes ranged between 23 and 117 for 2 arms, or 99–165 for 3 arms. Comparisons were made against placebo (n = 22), conventional medicine (n = 1), or regular diet (n = 1) for a duration between 4 and 24 weeks. All but one study tested the effect on fasting blood glucose levels (n = 23) or glycated haemoglobin levels (n = 18), and/or postprandial 2-h blood glucose levels (n = 4) as the primary outcomes. Nineteen studies reported some statistically significant reductions in the respective measures while 5 studies showed no effect on primary or secondary outcomes. None of the included studies met all the criteria for the CONSORT guidelines. Incomplete reporting about randomization and blinding, and a lack of ancillary analyses to explore other influential factors and potential harms associated with the use were repeatedly noted. Based on the Cochrane risk-of-bias tool, 19 studies were deemed to have a high risk of bias mainly attributed to sponsor bias. Conclusions There is some evidence to suggest positive clinical outcomes in response to the administration of a range of nutraceuticals containing TCM in the management of diabetes. However, these results must be interpreted with caution due to the overall low quality of the trials.

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Reporting Quality of Journal Abstracts for Surgical Randomized Controlled Trials Before and After the Implementation of the CONSORT Extension for Abstracts

World Journal of Surgery ◽

10.1007/s00268-019-05064-1 ◽

2019 ◽

Vol 43 (10) ◽

pp. 2371-2378 ◽

Cited By ~ 3

Author(s):

Benjamin Speich ◽

Kimberly A. Mc Cord ◽

Arnav Agarwal ◽

Viktoria Gloy ◽

Dmitry Gryaznov ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Reporting Quality ◽

Controlled Trials ◽

Randomized Controlled ◽

Before And After

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Methodological and Reporting Quality of Noninferiority Randomized Controlled Trials Comparing Antibiotic Therapies: A Systematic Review

Clinical Infectious Diseases ◽

10.1093/cid/ciaa1353 ◽

2020 ◽

Author(s):

Anthony D Bai ◽

Adam S Komorowski ◽

Carson K L Lo ◽

Pranav Tandon ◽

Xena X Li ◽

...

Keyword(s):

Systematic Review ◽

Pharmaceutical Industry ◽

Randomized Controlled Trials ◽

Reporting Quality ◽

Controlled Trials ◽

Intention To Treat ◽

Randomized Controlled ◽

Noninferiority Trials ◽

Noninferiority Margin

Abstract Background Antibiotic noninferiority randomized controlled trials (RCTs) are used for approval of new antibiotics and making changes to antibiotic prescribing in clinical practice. We conducted a systematic review to assess the methodological and reporting quality of antibiotic noninferiority RCTs. Methods We searched MEDLINE, Embase, the Cochrane Database of Systematic Reviews, and the Food and Drug Administration drug database from inception until November 22, 2019, for noninferiority RCTs comparing different systemic antibiotic therapies. Comparisons between antibiotic types, doses, administration routes, or durations were included. Methodological and reporting quality indicators were based on the Consolidated Standards of Reporting Trials reporting guidelines. Two independent reviewers extracted the data. Results The systematic review included 227 studies. Of these, 135 (59.5%) studies were supported by pharmaceutical industry. Only 83 (36.6%) studies provided a justification for the noninferiority margin. Reporting of both intention-to-treat (ITT) and per-protocol (PP) analyses were done in 165 (72.7%) studies. The conclusion was misleading in 34 (15.0%) studies. The studies funded by pharmaceutical industry were less likely to be stopped early because of logistical reasons (3.0% vs 19.1%; odds ratio [OR] = 0.13; 95% confidence interval [CI], .04–.37) and to show inconclusive results (11.1% vs 42.9%; OR = 0.17; 95% CI, .08–.33). The quality of studies decreased over time with respect to blinding, early stopping, reporting of ITT with PP analysis, and having misleading conclusions. Conclusions There is room for improvement in the methodology and reporting of antibiotic noninferiority trials. Quality can be improved across the entire spectrum from investigators, funding agencies, as well as during the peer-review process. There is room for improvement in the methodology and reporting of antibiotic noninferiority trials including justification of noninferiority margin, reporting of intention-to-treat analysis with per-protocol analysis, and having conclusions that are concordant with study results. PROSPERO registration number CRD42020165040.

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Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/9728957 ◽

2019 ◽

Vol 2019 ◽

pp. 1-21

Author(s):

Meng-Qi Yang ◽

Yong-Mei Song ◽

Huan-Yu Gao ◽

Yi-Tao Xue

Keyword(s):

Heart Failure ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Efficacy And Safety ◽

High Quality ◽

Randomized Controlled ◽

Link Type

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.

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