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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

Postal Subscription Code 80-967

2018 Impact Factor: 1.847

Front Med    2011, Vol. 5 Issue (2) : 171-177     DOI: 10.1007/s11684-011-0132-z
REVIEW |
Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation and future development
Zhaoxiang Bian1(), Baoyan Liu2, David Moher3, Taixiang Wu4, Youping Li4, Hongcai Shang5, Chungwah Cheng1
1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China; 2. China Academy of Chinese Medical Sciences, Beijing 100700, China; 3. Chalmers Research Group, Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada; 4. Department of Clinical Epidemiology, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China; 5. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
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Abstract  

The reporting standards for randomized controlled trials were first published in 1996 by a group of scientists under the name “CONSORT,” which means consolidated standards of reporting trials. Revisions followed in 2001 and 2010. A draft of the CONSORT for traditional Chinese medicine (TCM) was published in both Chinese and English in 2007. After publication of the draft, comments were solicited from the medical community. Some papers did raise concerns about which items should be included in the CONSORT for TCM such as the rationale of the trial design, intervention, outcome assessment, and adverse events. We have now reached the next step which is the finalization of the CONSORT for TCM. Three tasks remain. First, the major changes in CONSORT statement 2010 should be integrated into the CONSORT for TCM. Second, Chinese drugs from minerals and animals should be included in the guidelines. Finally, agreement must be reached among the working groups. Once the draft is finalized, wide dissemination and co-publication will be considered.

Keywords CONSORT for TCM      reporting standards      future development     
Corresponding Authors: Bian Zhaoxiang,Email:bzxiang@hkbu.edu.hk   
Issue Date: 05 June 2011
URL:  
http://academic.hep.com.cn/fmd/EN/10.1007/s11684-011-0132-z     OR     http://academic.hep.com.cn/fmd/EN/Y2011/V5/I2/171
PAPER SECTION And topicItemDescriptor
TITLE & ABSTRACT1Title: State the interventions, name of disease and study design. Clearly specify whether the intervention is a single herb or compound formulation. Recommendation: Intervention A versus intervention B in the treatment (prevention) of disease (condition): a randomized, double-blind controlled trial (the words underlined could be replaced by the actual study design)
Abstract: Include study design, participants, treatment and control interventions, primary results and conclusions.
INTRODUCTIONBackground2Scientific background and explanation of rationale.
Explain the rationale of compound formulation with CM theories and the action of each active ingredient with modern pharmacological evidence.
For any TCM herb used, whether singly or as an ingredient in a compound formulation, three names must be given: Chinese (preferably in PinYin), Latin and English. The names used must be those standardized used, and it is recommended to use those authorized by WHO. All measurements should be given in metric units (e.g. grams, milliliters). In any formulation the amounts of each ingredient should be given.
Objectives3Specific objectives and hypotheses.
Give the purpose(s) of a study, i.e. to assess the effectiveness of a TCM herb or formulation 1) for a particular disease, 2) for a particular disease in a particular TCM ‘zheng,’ or 3) for a particular TCM ‘zheng.’ In the last case i.e. if studying a particular ‘zheng,’ the associated diseases should be specified.
METHODS Participants4Eligibility criteria for participants and the settings and locations where the data were collected.
According to the study design, whether treatment targets diseases or TCM ‘zheng’ imbalances, clearly state 1) the diagnostic criteria for diseases and/or TCM ‘zheng’ imbalances; 2) the inclusion and exclusion criteria based on disease symptoms and/or TCM ‘zheng’ characteristics. All criteria used should be universally recognized.
Interventions5Precise details of the interventions intended for each group.
For compound formulations, list its ingredients, the relative amount of each ingredient and where it was cultivated, processing method, and quality control surveillance. For single herbs or formulations, administration route, treatment regimen and dosage should be specified.
For patent prescriptions, list manufacturer, lot number, production date, expiry date and crude constituents.
For custom formulations, such as those derived from ancient formulas, explain the rationale of formulation and modification, and state the dosage form, production process, constituent proportion and quality control measures.
For control interventions, explain the rationale of the control group design. If placebo is used, the formulation and quality control measures taken should be clearly stated.
Outcomes6One or two endpoint outcomes, for which the definition are the same in both TCM and conventional medicine, should be selected as the primary outcomes (e.g. mortality, survival).
Outcomes should be defined clearly, as should be the methods and the standards of assessment. When applicable, any methods used to enhance the quality of measurement (e.g. multiple observation, training of assessors) should be described.
Set particular and precise time(s) for taking outcome measures and set the principle when study should be terminated
Type of study design7Specify the type of design of the study; there are three types: ‘equivalence,’ ‘non-inferiority,’ and ‘superiority.’
Sample size8Explain how the sample size was determined.
Randomization – Sequence generation9Describe the method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification).
Randomization – Allocation concealment10Describe the method used to implement the random allocation sequence. Clearly state whether there was one or more generating sequences and whether concealment was involved in the implementation of randomization.
Randomization – Implementation11State who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.
Blinding (masking)12State whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If blinding was carried out, describe how it was done and the similarity of interventions and procedures, if relevant (e.g. the implementation details of double dummy design and of the unblinding process).
Statistical methods13Describe the statistical methods used to compare groups for outcomes of different categories, such as for quantitative measures, qualitative measures, survival analyses or ordinal measures. Describe the methods used for any additional analyses, such as subgroup analyses and/or adjusted analyses.
RESULTS Participant flow14Indicate how participants moved through the study over time; a flow diagram is recommended. Specifically, for each group, report the numbers of participants: randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from the study as planned, together with reasons.
Recruitment15Give the settings, dates, durations and methods used for data collection defining the periods of recruitment and follow-up.
Baseline data16Give baseline demographic and clinical characteristics of each group. For study of a TCM formulation for a particular disease with a TCM ‘zheng,’ a clear description for the type of TCM ‘zheng’ in each group is needed.
Numbers analysis17Give the number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention-to-treat.” State the results in absolute numbers when feasible (e.g. 10/20, not 50%).
Outcomes and estimation18Describe the results for each group with the sequence of measurement of primary and secondary outcomes, and the estimated effect size and its precision (e.g., 95% CI).
Ancillary analyses19Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those pre-specified and those exploratory. For studies on an intervention in the treatment of a particular disease or/and TCM ‘zheng,’ correlation analyses between the effectiveness and TCM ‘zheng’ is encouraged.
Adverse events20Describe any and all important adverse events or side effects in each intervention group.
DISCUSSION Interpretation21Interpret results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes. Discussion of the effectiveness of compound formulation for TCM ‘zheng’ is encouraged.
Generalizability22Discuss the internal and external validity of the trial findings.
Overall evidence23Give a general interpretation of the results in the context of current evidence. Statement of any conflict of interest for any investigator in the study is required, particularly, for example, whether the investigator was the TCM formulation provider or not.
Tab.1  CONSORT for TCM checklist of information to include when reporting a randomized trial of TCM intervention
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