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

Chinese herbal medicine (CHM) formulas are the major components of traditional Chinese medicine (TCM) interventions. The general reporting quality of randomized controlled trials (RCTs) of CHM formulas is disappointing, although CONSORT (Consolidated Standards of Reporting Trials) Statement extensions for herbal medicinal interventions and acupuncture interventions are available. A group of TCM clinical experts, methodologists, epidemiologists, and editors has developed this CONSORT Extension for CHM Formulas (CONSORT-CHM Formulas 2017) through a comprehensive process, including publication of the draft version, solicitation of comments, revision, and finalization. The CONSORT 2010 Statement was extended by introducing the idea of TCM Pattern and the features of CHM formulas. One new checklist subitem, keywords, was added to facilitate indexing and data searching. Seven of the 25 CONSORT checklist items, namely title and abstract, background and objectives, participants, interventions, outcomes, generalizability, and interpretation, are now elaborated, and the explanation of harms specific to CHM formulas is revised. Illustrative examples and explanations are also provided. The group hopes that CONSORT-CHM Formulas 2017 can improve the reporting quality of RCTs of CHM formulas.

[1]  John P. A. Ioannidis,et al.  What does research reproducibility mean? , 2016, Science Translational Medicine.

[2]  J. Kellow,et al.  Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial. , 2015, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[3]  Can-Xing Yuan,et al.  Efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder: a randomized, double-blind, controlled trial. , 2015 .

[4]  H. Ge,et al.  The beneficial effects of the herbal medicine Di-huang-yin-zi (DHYZ) on patients with ischemic stroke: A Randomized, Placebo controlled clinical study. , 2015, Complementary therapies in medicine.

[5]  Chong-Zhi Wang,et al.  The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial , 2015, PloS one.

[6]  Lin-lin Zhang,et al.  Cognitive Improvement during Treatment for Mild Alzheimer’s Disease with a Chinese Herbal Formula: A Randomized Controlled Trial , 2015, PloS one.

[7]  X. Tong,et al.  Chinese herbal medicine for obesity: a randomized, double-blinded, multicenter, prospective trial. , 2014, The American journal of Chinese medicine.

[8]  Li Ming,et al.  Xiaoyao pill for treatment of functional dyspepsia in perimenopausal women with depression. , 2014, World journal of gastroenterology.

[9]  X. Zhong,et al.  Xuan Bai Cheng Qi formula as an adjuvant treatment of acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs: a multicenter, randomized, double-blind, placebo-controlled clinical trial , 2014, BMC Complementary and Alternative Medicine.

[10]  J. Wyatt,et al.  Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide , 2014, BMJ : British Medical Journal.

[11]  Xiao-yin Chen,et al.  Effect of modified taohongsiwu decoction on patients with chemotherapy-induced hand-foot syndrome. , 2014, Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan.

[12]  Huimin Yan,et al.  Effects of Chinese herbs in children with Henoch-Schonlein purpura nephritis: a randomized controlled trial. , 2014, Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan.

[13]  Jianpin Liu,et al.  Bibliometric and content analysis of the Cochrane Complementary Medicine Field specialized register of controlled trials , 2013, Systematic Reviews.

[14]  David Moher,et al.  Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane reviewa , 2012, Systematic Reviews.

[15]  B. Cao,et al.  Oseltamivir Compared With the Chinese Traditional Therapy Maxingshigan–Yinqiaosan in the Treatment of H1N1 Influenza , 2011, Annals of Internal Medicine.

[16]  Youhua Yu,et al.  To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome:a randomized group sequential comparative trial , 2011, BMC gastroenterology.

[17]  B. Brinkhaus,et al.  Efficacy of individualized Chinese herbal medication in osteoarthrosis of hip and knee: a double-blind, randomized-controlled clinical study. , 2011, Journal of alternative and complementary medicine.

[18]  D. Moher,et al.  Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation and future development , 2011, Frontiers of medicine.

[19]  Guanjian Liu,et al.  Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional chinese medicine RCTs: A review of 3159 RCTs identified from 260 systematic reviews , 2011, Trials.

[20]  C. Witt,et al.  Traditional Japanese Kampo Medicine: Clinical Research between Modernity and Traditional Medicine—The State of Research and Methodological Suggestions for the Future , 2011, Evidence-based complementary and alternative medicine : eCAM.

[21]  Justin C.Y. Wu,et al.  Efficacy of a Chinese Herbal Proprietary Medicine (Hemp Seed Pill) for Functional Constipation , 2011, The American Journal of Gastroenterology.

[22]  D. Moher,et al.  Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement , 2010, Acupuncture in medicine : journal of the British Medical Acupuncture Society.

[23]  D. Moher,et al.  CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. , 2010, Obstetrics and gynecology.

[24]  D. Cobbin,et al.  A novel approach to evaluate Traditional Chinese Medicine treatment outcomes using pattern identification. , 2010, Journal of alternative and complementary medicine.

[25]  D. Moher,et al.  CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials , 2010, BMJ : British Medical Journal.

[26]  D. Moher,et al.  CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials , 2010, PLoS medicine.

[27]  D. Moher,et al.  Randomized trials published in some Chinese journals: how many are randomized? , 2009, Trials.

[28]  V. Scheid,et al.  Chinese Herbal Medicine. Formulas & Strategies , 2009 .

[29]  D. Moher,et al.  Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. , 2008, Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine.

[30]  D. Moher,et al.  Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine. , 2008, Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine.

[31]  D. Moher,et al.  Precise reporting of traditional Chinese medicine interventions in randomized controlled trials. , 2008, Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine.

[32]  D. Moher,et al.  CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration , 2008, PLoS medicine.

[33]  D. Moher,et al.  Consolidated Standards for Reporting Trials of Traditional Chinese Medicine (CONSORT for TCM) (For Solicitation of Comments) , 2007 .

[34]  G. Wang,et al.  The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China. , 2007, Clinical therapeutics.

[35]  Wei Wang,et al.  Adjunctive herbal medicine with carbamazepine for bipolar disorders: A double-blind, randomized, placebo-controlled study. , 2007, Journal of psychiatric research.

[36]  David Moher,et al.  Critical appraisal of clinical studies in Chinese herbal medicine. , 2006, Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine.

[37]  D. Moher,et al.  Improving the quality of randomized controlled trials in Chinese herbal medicine, part III: quality control of Chinese herbal medicine used in randomized controlled trials. , 2006, Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine.

[38]  D. Moher,et al.  Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design. , 2006, Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine.

[39]  David Moher,et al.  Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement , 2006, Annals of Internal Medicine.

[40]  J. Ioannidis,et al.  Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement , 2004, Annals of Internal Medicine.

[41]  N. Black.  CONSORT , 1996, The Lancet.

[42]  Yan Cheng,et al.  A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial. , 2016, Journal of Child Psychology and Psychiatry and Allied Disciplines.

[43]  Can-Xing Yuan,et al.  Efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder: a randomized, double-blind, controlled trial. , 2015, Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan.

[44]  J. Tao,et al.  Traditional Chinese medicine compound ShengJinRunZaoYangXue granules for treatment of primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled clinical trial. , 2014, Chinese medical journal.

[45]  W. Yao,et al.  A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. , 2013, Journal of the American College of Cardiology.

[46]  J. Park,et al.  Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA) : Extending the CONSORT Statement , 2010 .

[47]  T. Wachs,et al.  CONSORT for reporting randomised trials in journal and conference abstracts , 2008 .

[48]  Consort Grou.  Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement , 2006 .

[49]  T. Kaptchuk,et al.  Chinese Herbal Medicine: Materia Medica , 1986 .