CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration

Cheng, Chung Wah; Wu, Taixiang; Shang, Hongcai; Li, Youping; Altman, Douglas G.; Moher, David; Bian, Zhaoxiang

doi:10.7326/m16-2977

Cited by 220 publications

(171 citation statements)

References 37 publications

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“…To our knowledge, in the field of TCM for gout, it is the first time that a clinical study was presented according to the CONSORT Extension for Chinese Herbal Medicine Formulas 2017 ([21], Additional file 1). Although the modification of 2WHP may vary greatly due to the large number of TCM, this study is of clinical importance to those many TCM professionals who want to prescribe or receive the formulae modified, based on 2WHP .…”

Section: Discussionmentioning

confidence: 99%

“Yellow-dragon Wonderful-seed Formula” for hyperuricemia in gout patients with dampness-heat pouring downward pattern: a pilot randomized controlled trial

Deng³

et al. 2018

Trials

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BackgroundIn Traditional Chinese Medicine (TCM) theories, the typical clinical manifestations of gout are attributed to the “dampness-heat pouring downward.” Therefore, TCM practitioners always consider prescribing the formulae which are believed to clear heat and drain dampness for the management of gout. This clinical trial aims: (1) to determine the hypouricemic effect of “Yellow-dragon Wonderful-seed Formula” (YWF) decoction in gout patients with dampness-heat pouring downward pattern and (2) to determine if gypsum could provide additional significant benefits to YWF.MethodsA total of 72 hyperuricemic individuals with gout and dampness-heat pouring downward pattern were included with 62 of them completing the trial. Participants were randomly assigned to the YWF group, the YWF + gypsum group, or the allopurinol group. YWF and YWF + gypsum decoctions were orally administered for four weeks. Allopurinol was also orally administered for four weeks as the active control. Serum uric acid (sUA) level was the primary outcome measure. Urine urate level, scores on the SF-36 scale, erythrocyte sedimentation rate (ESR), X ray film, and C reactive protein (CRP) level were the secondary outcome measures.ResultsCompared with the values at week 0, YWF and YWF + gypsum did not significantly decrease the sUA level at each weekend reading. YWF, YWF + gypsum, and allopurinol decreased the urine urate levels and there were significant differences between the YWF group and the YWF + gypsum group. All the changes in the eight structures of SF-36 during the intervention period were not significantly different among the three groups and there was no significant difference in the CRP level among the three groups at each weekend reading.ConclusionsYWM, which modified on the basis of Two Wonderful Herbs Powder (2WHP), does not show significant hypouricemic effect. There is a possibility that Gypsum Fibrosum may provide additional effects to YWF in decreasing the urine urate levels but cannot add benefits to YWF in other outcome measures.Trial registrationChinese Clinical Trial Registry, ChiCTR-TRC-12001933. Registered on 10 February 2012.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2917-8) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

“Yellow-dragon Wonderful-seed Formula” for hyperuricemia in gout patients with dampness-heat pouring downward pattern: a pilot randomized controlled trial

Deng³

et al. 2018

Trials

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“…There is a need for highquality trials to evaluate the clinical value of FCSQ theory and answer whether TCM diagnoses and treatments based on FCSQ theory are beneficial for improving effectiveness. Effectiveness evaluation of five circuits and six qi We strongly recommend that future research follow the relevant international guidelines for clinical research design and reporting (e.g., the Consolidated Standards of Reporting Trials [CONSORT] statement 25 or CONSORT for TCM 26 ), to avoid various biases and to obtain reliable outcomes. Furthermore, the particularity of FCSQ clinical research should be fully considered.…”

Section: Discussionmentioning

confidence: 99%

Does the traditional Chinese medicine theory of five circuits and six qi improve treatment effectiveness? A systematic review of randomized controlled trials

Tang

Song

et al. 2018

Journal of Traditional Chinese Medical Sciences

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Objective: To evaluate whether the traditional Chinese medicine (TCM) theory of five circuits and six qi (FCSQ) is beneficial in terms of improving clinical effectiveness. Methods: Randomized controlled trials (RCTs) evaluating the clinical value of FCSQ theory were reviewed. Multiple databases (China Network Knowledge Infrastructure, Chinese Scientific Journals Database, Wanfang Data, SinoMed, Cochrane Library, PubMed, and Embase) were systematically searched from inception to June 12, 2018. Two authors independently extracted the data and performed a methodological quality assessment of the RCTs. RevMan 5.3 software was used for the data analysis. The effect sizes for the primary outcome measures were expressed as relative risks or mean differences with 95% confidence intervals. Results: A total of 13 RCTs were selected, involving 12 types of diseases and 4695 patients. The methodological quality of the RCTs was generally low. Five studies compared the effectiveness of TCM treatments guided by FCSQ theory with conventional TCM therapies, and the remaining eight studies compared the effectiveness of TCM treatments guided by FCSQ theory with biomedical treatments. All of the RCTs reported that the effectiveness of the treatment intervention was better than that of the intervention in the control group. Conclusion: Because of many methodological problems in existing clinical studies, it remains impossible to definitively conclude that FCSQ theory can improve clinical effectiveness. It is difficult to unify the clinical application of FCSQ theory. The feasibility and repeatability of FCSQ as an intervention should be given more attention in future clinical research. Future work should also follow international norms for clinical research implementation and reporting to provide high-quality evidence for evaluating the clinical value of FCSQ theory.

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“…The absence of the herbal scientific names will introduce the difficulties to researchers in determining which kinds of species were observed. Moreover, this incompleteness may impede dissemination of information from clinical trials of CHM formulas and discourage the clinical practice [84]. Future studies of Chinese herb formulas should comply with the recommendations of the CONSORT Extension for Chinese herbal medicine formulas [84,85].…”

Section: Implications For Researchmentioning

confidence: 99%

“…Moreover, this incompleteness may impede dissemination of information from clinical trials of CHM formulas and discourage the clinical practice [84]. Future studies of Chinese herb formulas should comply with the recommendations of the CONSORT Extension for Chinese herbal medicine formulas [84,85]. Efforts on the standardized reporting of clinical trials will promote data quality, Fig.…”

Section: Implications For Researchmentioning

confidence: 99%

Comparative effectiveness of six Chinese herb formulas for acute exacerbation of chronic obstructive pulmonary disease: a systematic review and network meta-analysis

Liu

Chen

Zuo

et al. 2019

BMC Complement Altern Med

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Background: Six Chinese herb formulas, namely, the Weijing decoction (WJ), the Maxingshigan decoction (MXSG), the Yuebijiabanxia decoction (YBBX), the Qingqihuatan decoction (QQHT), the Dingchuan decoction (DC) and the Sangbaipi decoction (SBP), are commonly used, along with routine pharmacotherapy, to manage the acute exacerbation of chronic obstructive pulmonary disease (AECOPD). In this study, we conducted a systematic review to summarize the efficacy of these six formulas, and we also conducted a network meta-analysis (NMA) to rank these formulas. Methods: We searched five English databases and four Chinese databases, with dates ranging from the starting dates of these databases to December 2016. Randomized controlled trials that evaluated any of the six Chinese herb formulas combined with the use of pharmacotherapy for AECOPD were identified. Results: Fifty-five studies involving 4560 participants were included. The pairwise meta-analyses showed that WJ and QQHT had superior effects on the improvement of lung function (forced expiratory volume in 1 seconds; FEV1) (mean difference (MD): 0.25, 95% confidence interval (CI): 0.19-0.30 and 0.34, 95%CI: 0.10-0.58). MXSG, WJ and QQHT were found to be more effective for improving arterial blood gases (PaO2 and PaCO2). In terms of effective rates, all of these formulas had additional favourable effects compared to routine pharmacotherapy. The results of the NMA analyses indicated that only MXSG showed superior add-on effects for the improvement of FEV1 (MD: 0.37, 95% credible interval (CrI): 0.03-0.72). Most of the formulas combined with routine pharmacotherapy were superior to pharmacotherapy alone for the improvement of arterial blood gases and effective rates. The ranking tests suggested that QQHT and MXSG combined with routine pharmacotherapy might be optimal options for the treatment of AECOPD. Conclusions: This NMA indicated that QQHT and MXSG might be more effective treatment regimens for AECOPD. Further well-designed studies that specifically examine the direct comparisons of these formulas are needed to support our conclusions.

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CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration

Cited by 220 publications

References 37 publications

“Yellow-dragon Wonderful-seed Formula” for hyperuricemia in gout patients with dampness-heat pouring downward pattern: a pilot randomized controlled trial

“Yellow-dragon Wonderful-seed Formula” for hyperuricemia in gout patients with dampness-heat pouring downward pattern: a pilot randomized controlled trial

Does the traditional Chinese medicine theory of five circuits and six qi improve treatment effectiveness? A systematic review of randomized controlled trials

Comparative effectiveness of six Chinese herb formulas for acute exacerbation of chronic obstructive pulmonary disease: a systematic review and network meta-analysis

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