Dataset Information

Assessment of the reporting quality of randomized controlled trials on the treatment of diabetes mellitus with traditional chinese medicine: a systematic review.

ABSTRACT:

Background

After the publication of the CONSORT 2010 statement, few studies have been conducted to assess the reporting quality of randomized clinical trials (RCTs) on treatment of diabetes mellitus with Traditional Chinese Medicine (TCM) published in Chinese journals.

Objective

To investigate the current situation of the reporting quality of RCTs in leading medical journals in China with the CONSORT 2010 statement as criteria.

Methods

The China National Knowledge Infrastructure (CNKI) electronic database was searched for RCTs on the treatment of diabetes mellitus with TCM published in the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica from January to December 2011. We excluded trials reported as "animal studies", "in vitro studies", "case studies", or "systematic reviews". The CONSORT checklist was applied by two independent raters to evaluate the reporting quality of all eligible trials after discussing and comprehending the items thoroughly. Each item in the checklist was graded as either "yes" or "no" depending on whether it had been reported by the authors.

Results

We identified 27 RCTs. According to the 37 items in the CONSORT checklist, the average reporting percentage was 45.0%, in which the average reporting percentage for the "title and abstract", the "introduction", the "methods", the "results", the "discussion" and the "other information" was 33.3%, 88.9%, 36.4%, 54.4%, 71.6% and 14.8%, respectively. In the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica the average reporting percentage was 42.2%, 56.8%, and 46.0%, respectively.

Conclusions

The reporting quality of RCTs in these three journals was insufficient to allow readers to assess the validity of the trials. We recommend that editors require authors to use the CONSORT statement when reporting their trial results as a condition of publication.

SUBMITTER: Wang P

PROVIDER: S-EPMC3722156 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

Assessment of the reporting quality of randomized controlled trials on the treatment of diabetes mellitus with traditional chinese medicine: a systematic review.

Wang Ping P Xu Qin Q Sun Qi Q Fan Fang-Fang FF Guo Xue-Rui XR Guo Fei F

PloS one 20130724 7

<h4>Background</h4>After the publication of the CONSORT 2010 statement, few studies have been conducted to assess the reporting quality of randomized clinical trials (RCTs) on treatment of diabetes mellitus with Traditional Chinese Medicine (TCM) published in Chinese journals.<h4>Objective</h4>To investigate the current situation of the reporting quality of RCTs in leading medical journals in China with the CONSORT 2010 statement as criteria.<h4>Methods</h4>The China National Knowledge Infrastru ...[more]

PMID: 23894675

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Project description:BackgroundMultiple sclerosis (MS) is the most common non-traumatic disabling disease affecting young adults. A definitive curative treatment is currently unavailable. Many randomized controlled trials (RCTs) have reported the efficacy of Chinese herbal medicine (CHM) on MS. Because of the uncertain quality of these RCTs, the recommendations for routine use of CHM for MS remain inconclusive. The comprehensive evaluation of the quality of RCTs of CHM for MS is urgent.MethodsNine databases, namely, PubMed, Embase, Web of Science, Cochrane Library, EBSCO, Sinomed, Wanfang Database, China National Knowledge Infrastructure, and VIP Database, were searched from inception to September 2023. RCTs comparing CHM with placebo or pharmacological interventions for MS were considered eligible. The Consolidated Standards of Reporting Trials (CONSORT) and its extension for CHM formulas (CONSORT-CHM Formulas) checklists were used to evaluate the reporting quality of RCTs. The risk of bias was assessed using the Cochrane Risk of Bias tool. The selection criteria of high-frequency herbs for MS were those with cumulative frequency over 50% among the top-ranked herbs.ResultsA total of 25 RCTs were included. In the included RCTs, 33% of the CONSORT items and 21% of the CONSORT-CHM Formulas items were reported. Eligibility title, sample size calculation, allocation concealment, randomized implementation, and blinded description in CONSORT core items were reported by less than 5% of trials. For the CONSORT-CHM Formulas, the source and authentication method of each CHM ingredient was particularly poorly reported. Most studies classified the risk of bias as "unclear" due to insufficient information. The top five most frequently used herbs were, in order, Radix Rehmanniae Preparata, Radix Rehmanniae Recens, Herba Epimedii, Scorpio, and Poria. No serious adverse effect had been reported.ConclusionsThe low reporting of CONSORT items and the unclear risk of bias indicate the inadequate quality of RCTs in terms of reporting completeness and result validity. The CONSORT-CHM Formulas appropriately consider the unique characteristics of CHM, including principles, formulas, and Chinese medicinal substances. To improve the quality of RCTs on CHM for MS, researchers should adhere more closely to CONSORT-CHM Formulas guidelines and ensure comprehensive disclosure of all study design elements.

Project description:Objective: The aim of this study is to critically appraise whether published systematic reviews/meta-analyses of traditional Chinese medicine for adults with ischemic stroke are of sufficient quality and to rate the quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Method: A literature search was performed in the Cochrane Library, PubMed, Chinese National Knowledge Infrastructure, and SinoMed databases by March 2022. The inclusion criteria were systematic reviews/meta-analyses of traditional Chinese medicine in adults who suffered from ischemic stroke. A Measurement Tool to Access Systematic Reviews 2 (AMSTAR-2) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Abstract (PRISMA-A) statements were used to assess the methodological and reporting quality of the included reviews. The Grading of Recommendations, Assessment, Development, and Evaluation system was utilized to assess each report’s evidence level. Results: Of the 1,908 titles and abstracts, 83 reviews met the inclusion criteria. These studies were published between 2005 and 2022. The results of AMSTAR-2 showed that 51.4% of the items were reported, but the registration, reasons for the inclusion of study design, the list of excluded studies, and funding information were ignored in the majority of the reviews. The results of PRISMA-A showed that 33.9% of items were reported, and the information on registration, limitation, and funding was not available in many publications. The assessment of the evidence with the Grading of Recommendations, Assessment, Development, and Evaluation showed that more than half (52/83) of the included studies had either low or very low levels of evidence. Conclusion: The reporting quality in the abstract of systematic reviews/meta-analyses on traditional Chinese medicine for ischemic stroke is poor and does not facilitate timely access to valid information for clinical practitioners. Although the methodological quality is of a medium level, this evidence lacks certainty, especially with a high risk of bias in individual studies.

Project description:Background Numerous randomized controlled trials (RCTs) conducted in China have shown that jinlida granules are a promising traditional Chinese medicine (TCM) for the treatment of persons with type 2 diabetes mellitus (T2DM). Controversial results have been reported in different RCTs. The aim of our study was to evaluate the adjuvant hypoglycemic effect of jinlida granules on persons with T2DM and to explore the source of heterogeneity between these RCTs. Materials and methods Medical article databases were individually searched by two authors for RCTs that provided data regarding the effect of jinlida granules in the treatment of T2DM before 1 June 2022. The methodological quality of the included RCTs was comprehensively assessed by two authors. Data from RCTs with low risk of bias were pooled using Stata SE 12.0 (random-effects model). Evidence derived from the meta-analysis will be assessed according to the GRADE system. Results Twenty-two RCTs were eventually included in the systematic review and three RCTs with low risk of bias were analyzed in the meta-analysis. Compared with the control groups, significant changes were found in lowering glycosylated hemoglobin a1c (mean difference -0.283 with 95% CI -0.561, -0.004; P=0.046), and were not found in lowering 2-hour postprandial glucose (mean difference -0.314 with 95% CI -1.599, 0.972; P=0.632) and fasting blood glucose (mean difference -0.152 with 95% CI -0.778, -0.474; P=0.634) in the jinlida groups. The GRADE-assessed evidence quality for the outcomes was moderate. Conclusion The adjuvant hypoglycemic effect of jinlida granules on adult Chinese persons with T2DM was statistically found in lowering HbA1c and was not statistically found in lowering FPG and 2h-PG. Evidence grading should be considered moderate, and the results should be interpreted cautiously. Whether the efficacy of HbA1c-lowering related to clinical significance remains to be investigated in future RCTs. Differences in HbA1c, FPG and 2h-PG at baseline and high risk of bias were important source of heterogeneity between these RCTs. In order to objectively evaluate the efficacy of jinlida granules on T2DM, it is urgently needed that high-quality RCTs evaluating the hypoglycemic effect of jinlida granules in the treatment of qi-yin deficiency pattern T2DM. Systematic review registration https://www.crd.york.ac.uk/prospero/, identifier CRD42018085135.

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Dataset Information

Assessment of the reporting quality of randomized controlled trials on the treatment of diabetes mellitus with traditional chinese medicine: a systematic review.

Background

Objective

Methods

Results

Conclusions

Publications

Assessment of the reporting quality of randomized controlled trials on the treatment of diabetes mellitus with traditional chinese medicine: a systematic review.

Similar Datasets

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