Chung-wah Cheng, MPH; Tai-xiang Wu, MPH; Hong-cai Shang, MD, PhD; You-ping Li, MPH; Douglas G. Altman, PhD; David Moher, PhD; Zhao-xiang Bian, MD, PhD;; for the CONSORT-CHM Formulas 2017 Group (*)
Acknowledgment: The authors thank all those who contributed to the development of CONSORT-CHM Formulas, both in its draft and final forms (Appendix 1). They also thank Mr. Liang Dai for analyzing the citation and endorsements of the draft version of CONSORT-CHM Formulas and collecting publications that demonstrated good reporting, Dr. Martha Dahlen for her critical English editing, and Dr. Liz Chee for her back translation from Chinese to English.
Financial Support: The development of CONSORT-CHM Formulas 2017 was funded in part from the Hong Kong Hospital Authority, HKSAR (HA/09-10/01).
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-2977.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Requests for Single Reprints: Zhao-xiang Bian, MD, PhD, Chair Professor, Director, Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, 3/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Hong Kong SAR, China; e-mail, firstname.lastname@example.org.
Current Author Addresses: Ms. Cheng: Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong SAR, P.R. China.
Prof. Wu: Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.
Prof. Shang: Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, P.R. China.
Prof. Li: Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.
Prof. Altman: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.
Prof. Moher: Clinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
Author Contributions: Conception and design: Z.X. Bian, Y.P. Li, D. Moher, T.X. Wu.
Analysis and interpretation of the data: Z.X. Bian, C.W. Cheng, D. Moher, T.X. Wu.
Drafting of the article: Z.X. Bian, C.W. Cheng, D. Moher, T.X. Wu.
Critical revision for important intellectual content: D.G. Altman, Z.X. Bian, C.W. Cheng, Y.P. Li, D. Moher, H.C. Shang.
Final approval of the article: D.G. Altman, Z.X. Bian, C.W. Cheng, Y.P. Li, D. Moher, H.C. Shang, T.X. Wu.
Obtaining of funding: Z.X. Bian.
Administrative, technical, or logistic support: Y.P. Li, T.X. Wu.
Collection and assembly of data: Z.X. Bian, C.W. Cheng.
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.
Fundamental principles of traditional Chinese medicine theory.
Therapeutic principles of traditional Chinese medicine.
Chinese herbal medicine formulas.
Chinese medicinal substances.
Table. Checklist of Items for Reporting Trials of Chinese Herbal Medicine Formulas*
Efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder: a randomized, double-blind, controlled trial. (39)
Objective: To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder. (39)
In Chinese medicine, the primary syndrome type of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is phlegm-heat obstructing the lungs. The actions of Xuan Bai Cheng Qi formula are to clear lung heat and dissipate phlegm, so for this reason it is commonly prescribed for AECOPD. … Xuan Bai Cheng Qi is a classical prescription dating to the Qing Dynasty (late 1700s) text Systematic Differentiation of Warm Pathogen Diseases by Wu Jutong. Our previous studies found that Xuan Bai Cheng Qi improves oxidant/antioxidant imbalance, pulmonary inflammation in the rat model of COPD. Clinical studies have postulated that Xuan Bai Cheng Qi is effective as a supplementary remedy for treating AECOPD or respiratory failure. (40)
We performed a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Xuan Bai Cheng Qi in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) of the syndrome type phlegm-heat obstructing the lungs. (40)
Patient selection and diagnostic criteria … The TCM standard for diagnosing syndromes was worked out with reference to the standard for diagnosing the type of liver stagnation and spleen deficiency in the guidelines of diagnosing and treating functional dyspepsia. Major symptoms are stomach pain or discomfort and anorexia and loose stools. Minor symptoms include: (1) abdominal distention and pain; (2) impatience; (3) insomnia and dreamful sleep; (4) belching and acid reflux; (5) physical and mental fatigue; and (6) abdominal distention after eating. Patients with all the major symptoms and two or more minor symptoms were diagnosed as suffering from the syndrome of liver depression and spleen deficiency. … Inclusion and exclusion criteria … To be included in the study, patients had to meet the following inclusion criteria … (41)
Our group developed a Chinese herbal formula Yishen Huazhuo decoction (YHD) to treat mild Alzheimer's disease (AD) … (42)
The treatment group received ShengJinRunZaoYangXue granules … Maidong 10 g (Dwarf Lilyturf Tuber, Raidix Ophiopogonis), Shihu 10g (Dendrobium, Herba Dendrobii) … and Zhigancao 6 g (Prepared Liauorice Root, Radix Glycyrrhizae preparata). (43)
All crude herbal materials were obtained from a local company of herbal supply. The identity of each herbal material, including habitat, harvest seasons, and the preparation of crude material, were authenticated by a senior Chinese herbalist. A sample specimen was kept in Department of Psychiatry, the First Hospital of Xian Jiaotong University. (44)
Zhenjingdingzhi decoction was extracted by the late Professor Jianhua Hu, Shanghai famous specialist of TCM, originating from the therapy theory of tranquilizing mind by nourishing the heart. It was based on the famous prescription Ganmaidazao decoction from Prescriptions of the Jin Kui Yao Lue•Fu Ren Za Bing of Zhang Zhongjing, adding Danshen (Radix Salviae Miltiorrhizae). … Danshen (Radix Salviae Miltiorrhizae) has the property of nourishing blood and tranquilizing mind. … Compatibility of all the medicine makes therapeutic effect on nourishing heart, tranquilizing, mind, resuscitation and relieve stasis. (39)
Our own and prior studies suggest the potential efficacy of Chinese herbal medicine (CHM) for IBS. By their complex pharmacologic nature CHM formulations offer a novel approach by addressing the multifactorial nature of IBS. (45)
Modern pharmacologic research shows that saikoside has anti-inflammatory, immunoregulatory and liver protective functions, but can also inhibit cholinesterase, act as a quasi-choline sample and adjust the digestive and nervous systems. … White atractylodes rhizome can activate the muscarinic receptors of the gastrointestinal tract and acetylcholine receptors, and accelerate gastrointestinal motility and evacuation. Poria cocos can increase 5-HT levels, indicating that the Xiaoyao pill can alter central monoamine neurotransmitter and hormone levels … (41)
Xuan Bai Cheng Qi granules … produced and packaged by Jiang Yin Tian Jiang Pharmaceutical Co. Ltd. (Jiangsu, China) under good manufacturing practice regulations of China (Approval Number: 0905301–4). Xuan Bai Cheng Qi granules were prepared by decocting the four herbs together, resulting in a concentrated liquid and extraction and capture of the volatile oils. The concentrated liquid was spray-dried on a starch base powder to obtain the final product. Each package of granules was 4.5 g. (40)
Formulation stability and shelf-life testing was conducted across 36 months, ensuring the formulation did not deteriorate (45)
The XJXGF formula (Xin-Ju-Xiao-Gao-Fang formula) mainly consists of rhubarb, coptis, semen cassia and citrus aurantium. Abundant compounds within XJXGF have been separated and identified by HPLC chromatography (Fig. 1). The detected compounds include gallic acid, geniposidic acid, verbascoside, naringin, berberine, aurantio-obtusin, aloeemodin, rhein, emodin, chrysophanol, and physcion. (46)
The finished product was certified to comply with pesticide residue levels, microbiological contaminants, and heavy metals to TGA (Australian Therapeutic Goods Administration) standards. (45)
The dose of 7.5g b.i.d. showed better therapeutic effect than that of 2.5 and 5.0 b.i.d. among 96 subjects (32 per arm) in trial I and was therefore selected for comparison with placebo in trial II. (47)
The decoction was used (group A) to soak affected hands and feet, and hot water was added to keep the decoction hotter than 39 °C during soaking, once a day, for 30 min each time, with 7 days as one course. (48)
The study intervention was planned by the investigator in cooperation with experienced TCM herbalists (Yun Xiao Chen, Kassel, Germany and Andreas Holl, Vienna, Austria). Four expected “clinical patterns” and matching herbal formulae were defined (Table 1). … [T]he basic formulae were constituted (7-10 herbs). … The exact combination and dosage of herbs in the formulae reflected the clinical opinion and experience of the investigator and the supervising doctors. … During follow-up visits, the basic formulae could be substituted for one another or be adapted according to symptoms by adding predefined herbs to the basic formulae (Table 1). (49)
The Jinlida consists of 17 Chinese medicinal herbs, including ginseng, polygonati, atractylodis lanceae, sophorae flavescentis, ophiopogon japonicus, rehmanniae, polygoni multiflori, dogwood, poria, perrin, coptis chinensis, anemarrhena, epimedium, salvia, puerariae, semen litchi, and cortex lycii radicis. The quality of these herbs and decoction preparation was in accordance with the Chinese Pharmacopoeia (2005). (50)
5-Ling Granule (5-LGr) … were prepared by Tasly Pharmaceuticals Inc. (Tianjin, China) (batch no.: 2007B01/2008101 for 5-LGr; … The detailed manufacturing procedure of 5-LGr has been posted in the website of the China Patent Inquiry System and carried out in strict compliance with the standards of Good Manufacturing Practice (GMP). Raw weight and ratio of herbal materials of 5-LGr are listed in Table 1. (51)
Qili qiangxin capsules were approved by China Food and Drug Administration for the treatment of heart failure in 2004. The current study evaluated the effects of qili qiangxin capsules in patients with chronic heart failure. (52)
An inert placebo was designed matching CHM capsules in size, weight, color, taste, and smell, consisting of cornstarch (80.48%), caramel (11.39%), citric acid (7.10%), coloring (lemon yellow powder [H1794] 0.60% and brown powder [H9885]. (45)
Both the placebo and herbal tablets were identical in shape, size, color and taste. Furthermore, to minimize the effect of the distinctive smell of herbal preparations on double blinding, the herbal tablets and placebo were all contained in blister packs made from plastic film and aluminium foil, with six tablets in each blister pack. (53)
Herbs of the control group were routinely examined to be free of contaminants by a professional company (Mag. Ph.R. Kottas-Heldenberg und Söhne, Dragenhandel GesmbH, Vienna, Austria). (49)
Three bags (15g in granule) and 4.5 bags (22.5g in granule) of 5-LGr or matching placebo granules per day were given to patients aged 5-12 and 13-18 years, respectively. The assigned amount of granules (1 or 1.5 bag) was dissolved into 120-150ml of hot water and taken three times daily. (51)
5-Ling Granule and placebo granules used in this study were prepared by Tasly Pharmaceuticals Inc. (Tianjin, China) (batch no.: 2007B01/2008101 for 5-LGr; 2007C01/2007L01 for placebo granules). (51)
We assessed each patient's symptoms before and after treatment by means of a rating scale (See Additional File 1), which was completed by the treating physicians when they interviewed their patients before and after treatment (at baseline and week 4). The rating scale consisted of 11 items (2 for the main symptoms, 7 for the accompanying symptoms and 2 for tongue and pulse) with 2 (yes or no) or 4 options (absent, mild, moderate or severe) for each item. Each option was represented by a fixed score, the higher the score, the more sever the symptom, and vice versa. The total score of the rating scale was called syndrome integral. (54)
Two patients in the maxingshigan–yinqiaosan group had nausea and vomiting. No side effects were observed in the control, oseltamivir, or combination therapy group. No difference in complications after treatment was observed among the 4 groups: 1 case of pulmonary tuberculosis in the control group, 2 cases of pneumonia in the oseltamivir group, 1 case of bronchitis in the maxingshigan–yinqiaosan group, and no complications in the combination therapy group. (55)
In TCM, syndromes are the foundations for therapeutic principles, and the same method of treatment can be applied to patients with the same syndrome, no matter what disease, as defined in Western terms, they have. In the present study, the significance of the syndrome was maintained by recruiting only subjects with not only functional constipation (a disease diagnosed by conventional medicine) but also the “excessive” syndrome (a syndrome pattern diagnosed by TCM). Therefore, the results of this study are useful for making clinical recommendations. (47)
Henoch-Schonlein purpura nephritis (HSPN) in children is mainly caused by damp-heat and will further impair spleen and kidney. According to the pathogenesis of HSPN, removing heat, promoting diuresis, nourishing kidney, and consolidating essence can treat HSPN. Considering the physiological and pathological characteristics of child patients, medicinal materials were selected to be slightly purging and nourishing to strengthen body resistance and eliminate pathogenic factors. Chinese herbs were used in this study to treat damp-heat syndrome. After treatment for 4 and 12 weeks, the obvious decline in the total score of damp-heat confirms that Chinese herbs have a good curative effect on alleviating syndromes and signs of damp-heat in the acute stage (within 4 weeks) of the disease. From TCM theory, the accumulation of dampness can affect spleen function and deficiency of spleen Qi causes failure of the body to absorb nutrients. … Hematuria is mainly caused by obstruction of collaterals by stasis and heat. The therapy puts more stress on clearing damp-heat and attaches less importance to removing heat from blood, promoting blood circulation, or removing blood stasis. However, this may clarify that internal accumulation of damp-heat is the main syndrome of early-stage child HSPN. With a long course of treatment, the improvement in total score for syndromes and the total effective rate of urinary protein and urinary red cells were higher in the Chinese herb group. This indicates that the internal accumulation of damp-heat is the main cause for lingering illness and the therapy of clearing away heat, promoting diuresis, and removing heat from blood should be adopted throughout the treatment. (56)
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In this video, Prof. Zhao-xiang Bian, MD, PhD, offers additional insight into the article, "CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration."
Chung-wah Cheng, Tai-xiang Wu, Hong-cai Shang, You-ping Li, Douglas G. Altman, David Moher, et al. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017;167:112–121. doi: 10.7326/M16-2977
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Published: Ann Intern Med. 2017;167(2):112-121.
Published at www.annals.org on 2 May 2017
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