In clinical trials on acupuncture, the description of experimental intervention and controlled treatment are not usually reported adequately, for example, the acupoints and needles used, manipulation applied, duration of treatment, and other ancillary interventions and so on. This would limit the replication of the trial findings and application of the effective therapy. In 2001, an international group of acupuncture researchers discussed the problems in design and reporting of acupuncture clinical trials, and developed a standard for reporting intervention of the controlled clinical trials, abbreviated as 'STRICTA' recommendation, which contains 6 items to describe the rational of treatment, needling details, treatment regimen, co-interventions, practitioner' s background, and control intervention. This essay intends to introduce the standard and take two internationally published randomized trials of acupuncture as examples to illustrate the details.
Acupuncture Therapy ; standards ; Humans ; Randomized Controlled Trials as Topic ; standards

The concepts and relations of explanatory clinical trials and pragmatic clinical trials on randomized controlled trials of acupuncture are stated. The explanatory clinical trials and pragmatic clinical trials are different in the purpose of study, the controlled method, the treatment method and the solution problems. The explanatory clinical trials may enhance the understanding of the mechanism of a treatment; the findings of pragmatic clinical trials may be applied immediately in clinical practice. This paper explains that these clinical trials are of great importance to the methodology and practices of clinical effective evaluation of acupuncture based on TCM theory.
Acupuncture Therapy ; standards ; Humans ; Randomized Controlled Trials as Topic ; methods ; standards

Based on detailed explanation of the herbal CONSORT statement, and the consideration of the character of traditional Chinese drugs, to discuss the standardization of reporting traditional Chinese drug trials. The standards of reporting traditional Chinese drug trials are not consolidated yet. In the year 2006, Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement was developed by the CONSORT group and published. This herbal CONSORT statement includes 5 parts, and totally 22 items, in which the items of participant criteria, intervention, control setting and outcomes, et al. are elaborated to be adaptable to herbal intervention trials. This herbal CONSORT statement has provided valuable basis for the development of standards of reporting traditional Chinese drug trials, though it is not completely adaptive to be the reporting standards in consideration of the background theory and the animal drugs and mineral drugs that traditional Chinese drugs contain. The proper reporting standards of traditional Chinese drug trials should take the different types of drugs and the different purposes of trials into consideration. The trial reports of drugs that must be applied under the instruction of traditional Chinese medicine (TCM) theory should report participant criteria that include TCM syndrome differentiation and other important characters of TCM interventions.
Clinical Trials as Topic ; standards ; Medicine, Chinese Traditional ; standards ; Publishing ; standards ; Randomized Controlled Trials as Topic ; standards

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM), in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.
Clinical Trials as Topic ; methods ; standards ; Humans ; Moxibustion ; methods ; standards ; Randomized Controlled Trials as Topic ; Research Design ; standards

Humans ; Medicine, Chinese Traditional ; Randomized Controlled Trials as Topic ; standards

OBJECTIVE: To evaluate the report quality of Chinese and English randomized controlled trials (RCTs) of acupuncture based on the CONSORT statement and STRICTA checklist. METHODS: The Chinese and English RCTs of acupuncture published from January 1, 2015 to December 31, 2019 were searched in 7 databases including PubMed. The report quality of the included RCTs was evaluated with the CONSORT 2010 statement and STRICTA checklist. RESULTS: A total of 506 Chinese RCTs and 76 English RCTs were included. According to the CONSORT statement, in Chinese RCTs, the items with report rate less than 50% accounted for 78.38% of all items, and the report rate of 25 items, such as background and reason, study design, outcome index, and sample size, was less than 10%. In English RCTs, the items with report rate less than 50% accounted for 35.14% of all items, and 5 items had a report rate of less than 10%. The difference of the report rate of 15 items, such as background, reason and study design, was more than 50% between Chinese and English RCTs. The report rate of all items of STRICTA checklist was relatively high in both Chinese and English RCTs. In Chinese RCTs, the items with report rate less than 50% accounted for 29.41% of all items, which included acupuncture rationale and depth of insertion. In English RCTs, only two items had a report rate less than 50%, which were acupuncture rationale, setting and context of treatment. The report rate of five items, including needle retention time, frequency and duration of treatment sessions, details of other interventions administered to the acupuncture group, setting and context of treatment, and precise description of the control or comparator in Chinese RCTs, were higher than in English RCTs. CONCLUSION The report quality of Chinese acupuncture RCT needs to be improved urgently, and corresponding measures should be taken to further standardize the writing and reporting of acupuncture clinical research.
Humans ; Acupuncture Therapy ; Checklist ; Randomized Controlled Trials as Topic/standards*

Acupuncture Therapy ; methods ; standards ; Guidelines as Topic ; Humans ; Randomized Controlled Trials as Topic ; methods ; standards ; Research Design ; standards

Evaluation Studies as Topic ; Humans ; Medicine, Chinese Traditional ; Publishing ; standards ; Quality Control ; Randomized Controlled Trials as Topic ; standards

To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.
Acupuncture Therapy ; standards ; China ; Humans ; Quality Control ; Randomized Controlled Trials as Topic ; standards ; Research Design ; standards

Randomized controlled trials (RCT) is the source of the raw data of evidence-based medicine. Blind method is adopted in most of the high-quality RCT. Sham acupuncture is the main form of blinded in acupuncture clinical trial. In order to improve the quality of acupuncture clinical trail, based on the necessity of sham acupuncture in clinical research, the current situation as well as the existing problems of sham acupuncture, suggestions were put forward from the aspects of new way and new designation method which can be adopted as reference, and factors which have to be considered during the process of implementing. Various subjective and objective factors involving in the process of trial should be considered, and used of the current international standards, try to be quantification, and carry out strict quality monitoring.
Acupuncture Therapy ; standards ; Biomedical Research ; standards ; Evidence-Based Medicine ; Humans ; Randomized Controlled Trials as Topic ; standards