Transparency and reporting characteristics of randomized controlled trials with Chinese herbal medicine formulas interventions

References

[1] Cheng CW, Wu TX, Shang HC, Li YP, Altman DG, Moher D, Bian ZX; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med 2017; 167(2): 112–121

[2] Li M, Zhou B, Zhou L, Li L. Reporting quality of randomized controlled trials for the treatment of eczema with Chinese patent medicine based on the CONSORT-CHM Formulas 2017. Evid Based Complement Alternat Med 2020; 2020: 2949125

[3] Zhang XJ, Wang YJ, Lu X, Ying PJ, Qian SY, Liang J, Zheng GQ. The quality of reporting of randomized controlled trials of HuatuoZaizao pill for stroke. Front Pharmacol 2023; 13: 1106957

[4] Yu XW, Guo J, Yu W, Yan B, Du G, Wang H, Zhang J. Quality evaluation and consideration of randomized controlled clinical trials report on traditional Chinese medicine (TCM) treatment of prostate cancer. J Xinjiang Med Univ (Xinjiang Yi Ke Da Xue Xue Bao) 2022; 45(7): 776–779

[5] Tian Y, Guo D, Peng W, Zhou P, Liu YC, Fan MX, Lu F. Evaluation of the clinical evidence-body of Chinese patent medicine in the treatment of essential hypertension. Chin J Hypertens (Zhonghua Gao Xue Ya Za Zhi) 2022; 30(10): 956–963

[6] Yan B, Liu SJ, Deng YJ, Guo J, Guo J. Research characteristics and quality evaluation of randomized controlled trial report of Chinese patent drug in the treatment of male infertility. Chin J Hum Sex (Zhongguo Xing Ke Xue) 2023; 32(2): 109–113

[7] Xu YQ, Cai QH, Wang H, Hu SY. Evaluation on methodological and reporting quality of randomized controlled trials of Chinese patent medicines for acute upper respiratory infection in children based on Cochrane risk bias assessment tool and CONSORT-CHM Formulas. Tianjin J Tradit Chin Med (Tianjin Zhong Yi Yao) 2020; 37(3): 308–312

[8] Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hróbjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S, McGuinness LA, Stewart LA, Thomas J, Tricco AC, Welch VA, Whiting P, Moher D. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372: n71

[9] Wang J, Cheng CW, Jiao Y, Shi D, Wang Y, Li H, Wang N, Wang X, Li Y, Liang F, Luo S, Han F, Li J, Wang P, Lyu A, Bian Z, Zhang X. Evaluation of compliance of CONSORT-CHM formula 2017 in randomized controlled trials of Chinese herbal medicine formulas: protocol of a five-year review. Front Pharmacol 2024; 15: 1287262

[10] Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c332

[11] Group DSM. The Russian pharmaceutical market. 2014. Available at the website of dsm. ru/docs/analytics/spravka_may_2014.pdf (in Russian)

[12] Ipsos Reid. Natural Health Product Tracking Survey – 2010. Final Report. Prepared for Health Canada. 2011. Available at the related website

[13] Wang HL, Zeng H, Xu MB, Zhou XL, Rong PQ, Jin TY, Wang Q, Zheng GQ. Efficacy and safety of Chinese herbal medicine for primary intracerebral hemorrhage: a systematic review of randomized controlled trials. Front Pharmacol 2019; 10: 1139

[14] Wang Y, Liu Y, Yan X, Wang D. An overview of systematic reviews on the effectiveness of Wenxin Keli in the treatment of atrial fibrillation. Evid Based Complement Alternat Med 2022; 2022: 6973151

[15] Hu J, Cheng M, Li Y, Shi B, He S, Yao Z, Jiang J, Yu H, He Z, Zhao Y, Zheng H, Hua B, Liu R. Ginseng-containing traditional medicine preparations in combination with fluoropyrimidine-based chemotherapy for advanced gastric cancer: a systematic review and meta-analysis. PLoS One 2023; 18(4): e0284398

[16] World Health Organization. Traditional Medicine Strategy (2002–2005). Licence: WHO/EDM/TRM/2002.1. Available at the website of WHO

[17] Pan QJ, Zeng JB, Wan CJ, Wu BL. Based on Cochrane bias evaluation tool and consort traditional Chinese medicine compound evaluation Buyang Huanwu Decoction in the treatment of chronic heart failure randomized controlled trial methodology and report quality evaluation. J Jiangxi Univ Chin Med (Jiangxi Zhong Yi Yao Da Xue Xue Bao) 2022; 34(05): 42–46,49

[18] Liu C, Guo DA, Liu L. Quality transitivity and traceability system of herbal medicine products based on quality markers. Phytomedicine 2018; 44: 247–257

[19] World Health Organization. WHO international standard terminologies on traditional Chinese medicine. 2022. Licence: CC BY-NC-SA 3.0 IGO. Available at the website of WHO

[20] Cobo E, Cortés J, Ribera JM, Cardellach F, Selva-O’Callaghan A, Kostov B, García L, Cirugeda L, Altman DG, González JA, Sànchez JA, Miras F, Urrutia A, Fonollosa V, Rey-Joly C, Vilardell M. Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical journal: masked randomised trial. BMJ 2011; 343: d6783

[21] Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, Schulz KF, Plint AC, Moher D. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Libr 2012; 11: MR000030

Acknowledgements

The authors thank all the financial supports from Center for Evidence Based Traditional Chinese Medicine (CCEBTM, No. 2020YJSZX-5); Chinese Medicine Development Fund (No. 20B2/027A); Donation Funding of EQUATOR China Centre; National Natural Science Foundation of China (No. 81704198); Donation Funding of Vincent V.C. Woo Chinese Medicine Clinical Research Institute; and Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (No. ITC RC/IHK/4/7).

Electronic Supplementary Material

Supplementary materials are available in the online version of this article at https://doi.org/10.1007/s11684-024-1092-4 and is accessible for authorized users.

Compliance with ethics guidelines

Conflicts of interest Juan Wang, Dongni Shi, Yaochen Wang, Xuanqi Zhang, Han Li, Xihong Wang, Shufeng Luo, Lihan Hu, Jiashuai Deng, Lin Zhang, Chung Tai Lau, Chung Wah Cheng, Fei Han, Ji Li, Ping Wang, Aiping Lyu, Zhaoxiang Bian, and Xuan Zhang declare that they have no conflict of interest.

This manuscript is a comment and does not involve a research protocol requiring approval by the relevant institutional review board or ethics committee

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