Quality and Risk of Bias in Panax ginseng Randomized Controlled Trials: A Review

2013 ◽  
Vol 41 (02) ◽  
pp. 231-252 ◽  
Author(s):  
Johannah L. Shergis ◽  
Anthony L. Zhang ◽  
Wenyu Zhou ◽  
Charlie C. Xue

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.

2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Qin-hong Zhang ◽  
Jin-huan Yue ◽  
Ming Liu ◽  
Zhong-ren Sun ◽  
Qi Sun ◽  
...  

Objectives. This study aims to assess the effectiveness and safety of moxibustion for the correction of nonvertex presentation.Methods. Records without language restrictions were searched up to February 2013 for randomized controlled trials (RCTs) comparing moxibustion with other therapies in women with a singleton nonvertex presentation. Cochrane risk of bias criteria were used to assess the methodological quality of the trials.Results. Seven of 392 potentially relevant studies met the inclusion criteria. When moxibustion was compared with other interventions, a meta-analysis revealed a significant difference in favor of moxibustion on the correction of nonvertex presentation at delivery (risk ratio (RR) 1.29, 95% confidence interval (CI) 1.12 to 1.49, andI2=0). The same findings applied to the cephalic presentation after cessation of treatment (RR 1.36, 95% CI 1.08 to 1.71, andI2=80%). A subgroup analysis that excluded two trials with a high risk of bias also indicated favorable effects (RR 1.63, 95% CI 1.42 to 1.86, andI2=0%). With respect to safety, moxibustion resulted in decreased use of oxytocin.Conclusion. Our systematic review and meta-analysis suggested that moxibustion may be an effective treatment for the correction of nonvertex presentation. Moreover, moxibustion might reduce the need for oxytocin.


2019 ◽  
Vol 42 (4) ◽  
pp. 434-440 ◽  
Author(s):  
Francesco Bortolotti ◽  
Livia Solidoro ◽  
Maria Lavinia Bartolucci ◽  
Serena Incerti Parenti ◽  
Corrado Paganelli ◽  
...  

Summary Background Surgically assisted rapid maxillary expansion (SARME) is a surgical technique developed to correct transverse discrepancies in skeletally mature patients. However, there is limited evidence concerning the immediate skeletal and dental changes obtained only due to SARME. Objective The aim of the present systematic review is to investigate the immediate skeletal and dental effects of SARME in adult patients with transverse maxillary hypoplasia. Search Methods An electronic search of the literature in MEDLINE, The Cochrane Library, Lilacs and Scopus databases was performed. Selection Criteria Only randomized controlled trials (RCTs) studies investigating the skeletal and dental effects of SARME procedures in adult patients were included. Data Collection and Analysis The included studies received a methodological quality scoring according to the revised Cochrane risk-of-bias tool for randomized trials. The quality of evidence was assessed by means of the Grading Recommendation Assessment, Development and Evaluation (GRADE) system. For each included study and for each analysed parameter, the difference in means and 95 per cent confidence interval was calculated between baseline and immediate post-expansion. A meta-analysis of original outcome data, if possible, was conducted. Results Nine articles were selected. The methodological quality ratings indicated that one study was at low risk of bias, seven presented some concerns and only one was at high risk of bias. In all the included studies, the SARME procedure resulted in a significant expansion of the maxillary transverse dimension. The meta-analysis compared skeletal and dental inter-molar width before and after treatment: the mean difference was of 3.3 mm (2.8–3.9) and 7.0 mm (6.1–7.8), respectively (P-value less than 0.001). The quality of evidence was low-moderate. Conclusions SARME is effective in obtaining a significant expansion of the maxillary transverse dimension. However, the immediate SARME effect is mainly a molar expansion rather than a pure bone transverse widening of the maxilla. Registration The review protocol was registered at PROSPERO database with the registration number CRD42018117967.


Author(s):  
Susan Armijo-Olivo ◽  
Michele Patrini ◽  
Ana Izabela S de Oliveira-Souza ◽  
Liz Dennett ◽  
Chiara Arienti ◽  
...  

2013 ◽  
Vol 258 (2) ◽  
pp. 199-207 ◽  
Author(s):  
Usama Ahmed Ali ◽  
Pieter C. van der Sluis ◽  
Yama Issa ◽  
Ibrahim Abou Habaga ◽  
Hein G. Gooszen ◽  
...  

2015 ◽  
Vol 101 (1) ◽  
pp. e1.66-e1
Author(s):  
Rym Boulkedid ◽  
Armiya Yousouf Abdou ◽  
Emilie Desselas ◽  
Marlène Monegat ◽  
Corinne Alberti ◽  
...  

BackgroundApproximately 15 to 30% of children and adolescents suffer from daily pain persistent over more than 3 months and there is evidence supporting that the prevalence of chronic pain is steadily increasing in this population. Chronic pain is known to have a negative impact on children's development and social behaviour, leading often to severe psychological distress and physical disability. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials (RCTs) on pharmacological and non-pharmacological therapies in chronic and recurrent pain in the paediatric population.MethodsWe performed a systematic search of PubMed, Embase and the Cochrane Library up to March 2014. Bibliographies of relevant articles were also hand-searched. We included all RCTs that involved children and adolescents (age 0 to 18 years) and evaluated the use of a pharmacological agent or a non-pharmacological approach in the context of chronic or recurrent pain. The latter was defined as pain persisting for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias Tool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality.ResultsA total of 52 randomized controlled trials were selected and included in the analysis. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 45 (34–57) participants. Almost 50% of the RCTs included both adults and children with a median age at inclusion of 13 years. Non-pharmacological approaches were more commonly tested whereas evaluation of pharmacological agents concerned less than 30% of RCTs. Abdominal pain and headache were the most common types of chronic pain experienced among trial participants. Overall, the methodological quality was poor and did not parallel the number of RCTs that increased over the years. The risk of bias was high or unclear in 70% of the trials.ConclusionsThis is the first systematic review of RCTs conducted to evaluate pharmacological and non-pharmacological therapies in chronic and recurrent pain in children and adolescents. Although, management of pain in adults has significantly improved over the years due to the evaluation of numerous analgesic therapies, our results highlight the existing knowledge gap with regards to children and adolescents. Therapeutic strategies, in particular pharmacological agents, applied to relieve chronic or recurrent pain in children and adolescents are not evaluated through high quality RCTs. The need to improve analgesic therapy in children and adolescents with chronic pain is still unmet. We discuss possible research constraints and challenges related to this fact as well as adequate methodologies to circumvent them.


2020 ◽  
Author(s):  
Caiyun Zheng ◽  
Hengfen Dai ◽  
Chun Lin ◽  
Yan Zhang ◽  
Hong Zhang ◽  
...  

BACKGROUND An increasing number of patients have received prophylactic or therapeutic oral anticoagulants (OACs) for thromboembolic complications of diseases. The use of OACs is associated with both clinical benefits and risks. Considering the challenges imposed by this class of drugs, as well as the enormous progress made in portable device technology, it is possible that technology-based interventions may improve clinical benefits for patients and optimize anticoagulation management. OBJECTIVE This study was designed to comprehensively evaluate the role of technology-based interventions in the management of OACs. METHODS We searched 6 databases—PubMed, EMBASE, Cochrane, Cumulative Index to Nursing and Allied Health Literature, Scopus, and PsycINFO—to retrieve relevant studies published as of November 1, 2019, to evaluate the effect of technology-based interventions on oral anticoagulation management. RevMan (version 5.3; Cochrane) software was used to evaluate and analyze clinical outcomes. The methodological quality of studies was assessed by the Cochrane risk of bias tool. RESULTS A total of 15 randomized controlled trials (RCTs) were selected for analysis. They reported data for 2218 patients (1110 patients in the intervention groups and 1108 patients in the control groups). A meta-analysis was performed on the effectiveness and safety data reported in the RCTs. Technology-based interventions significantly improved the effectiveness of oral anticoagulation management (mean difference [MD]=6.07; 95% CI 0.84-11.30; I<sup>2</sup>=72%; <i>P</i>=.02). The safety of oral anticoagulation management was also improved, but the results were not statistically significant. Bleeding events were reduced (major bleeding events MD=1.02; 95% CI 0.78-1.32; I<sup>2</sup>=0%; <i>P</i>=.90; minor bleeding events MD=1.06, 95% CI 0.77-1.44; I<sup>2</sup>=41%; <i>P</i>=.73) and thromboembolism events were reduced (MD=0.71; 95% CI 0.49-1.01; I<sup>2</sup>=0%; <i>P</i>=.06). In general, patients were more satisfied with technology-based interventions, which could also improve their knowledge of anticoagulation management, improve their quality of life, and reduce mortality and hospitalization events. CONCLUSIONS Using technology to manage OACs can improve the effectiveness and safety of oral anticoagulation management, result in higher patient satisfaction, and allow greater understanding of anticoagulation.


2015 ◽  
Vol 210 (5) ◽  
pp. 922-929 ◽  
Author(s):  
Stavros A. Antoniou ◽  
Alexandros Andreou ◽  
George A. Antoniou ◽  
Oliver O. Koch ◽  
Gernot Köhler ◽  
...  

Author(s):  
Thi Mai Nguyen ◽  
Thi Thanh Toan Do ◽  
Tho Nhi Tran ◽  
Jin Hee Kim

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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