| Background:Tai Chi, as an important part of traditional Chinese medicine, combines the essences of Chinese culture, breathing techniques, classic yin-yang principle and the channel theory of traditional Chinese medicine. It has been a popular exercise around the whole world. Recently, an increasing number of Tai Chi clinical studies have been published, covering a variety of diseases/conditions and involving many Tai Chi types and forms. A large number of studies show that Tai Chi has beneficial effects on health promotion or disease prevention, treatment and rehabilitation. However, the overall status of Tai Chi clinical studies is still unclear.The reporting quality of Tai Chi clinical studies is generally poor, especially information related to Tai Chi intervention. Though there are some internationally accepted reporting guidelines such as CONSORT statement and its expansions, they cannot provide guidance for the reporting of some specific contents related to Tai Chi intervention. Like acupuncture, the STRICTA for improving the reporting quality of acupuncture interventions in clinical trials of acupuncture is focus on acupuncture intervention and set a good example for tai chi.Objectives:The objectives of this study are to comprehensively search clinical studies on Tai Chi, summary and analyze the current status of clinical studies on Tai Chi, understand their trend, characteristics and limitation, in order to provide evidence-based support for future clinical application of Tai Chi and researches on Tai Chi. In addition, we aim to developing a reporting standard of Tai Chi intervention in clinical studies, based on the organization and experience of STRICTA and CONSORT and its expansion, in order to improve the reporting quality of Tai Chi intervention in clinical trials to facilitate the clinical decision-making and clinical practice, and to provide model and basis for further revision of the guideline.Methods:The author conducted a comprehensive literature search, extracted data, analyzed data, and reported the results. The details are as follows:Study search:A comprehensive search was conducted for all clinical studies on Tai chi in PubMed, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Sino-Med, and Wanfang Database from their inception to July 2013.Inclusion/exclusion criteria:All types of clinical studies using Tai Chi as the intervention for any disease/condition or healthy participants, including systematic review, randomized clinical trial, non-randomized controlled clinical studies, case series and case report were included. Any type of Tai Chi, regardless of the forms was included. Anecdotes, which were not written by doctors or researchers and not published in academic journals, were excluded. Reports published in abstract, or complex intervention involving Tai Chi but no detailed description on Tai Chi were also excluded.Data extraction and analysis:Two authors designed a structured data extraction form. The following information was extracted:publication information; disease/condition; Tai Chi intervention; outcomes and overall conclusions. Seven reviewers participated in data extraction, and all the extraction was verified by one author. Any discrepancies were discussed with the other authors for consensus. Data analysis was conducted using SPSS 17.0, presenting as counts, percentage and frequency.We developed the proposed reporting standard by summarizing items from the review, organizing group discussions, standard revision and consensus meeting. At last, the reporting items, explanation and examples were determined by the research team.Results:A total of 507 clinical studies were included in this review, including 43 systematic reviews of clinical studies,255 randomized clinical trials,90 non-randomized controlled clinical studies,115 case series and 4 case reports. The main findings are as follows:(1) There has been a large amount of clinical studies on Tai Chi, covering a systematic body of study designs including systematic reviews, randomized clinical trials, non-randomized controlled clinical studies, case series and case reports.(2) Tai Chi is a hot research topic. The publication number of clinical studies, especially high quality evidence such as randomized controlled trials is increasing with years. Tai Chi is oriented in China, and has been studied in 20 countries including developed and developing countries funded by governments.(3) A variety of diseases/conditions have been studied in Tai Chi clinical studies. A total of 15 systems with 93 diseases/conditions were involved. The majority of diseases/conditions were in the circulatory system and the musculoskeletal system and connective tissue. The top 10 diseases/conditions included hypertension, diabetes, osteoarthritis, osteoporosis or osteopenia, breast cancer, heart failure, chronic obstructive pulmonary disease, coronary heart disease, schizophrenia, and depression.(4) Different types and forms of Tai Chi were applied, among them the most commonly applied were Yang style Tai Ch, especially 24-form Simplified Yang style. The intensity and frequency were various, and three 1-hour sessions per week and twice 1-hour sessions per week were most popular. The most common duration was 12 weeks.(5) In the majority of studies participants learned Tai Chi under the guidance of Tai Chi instructors. However, only several studies reported the qualification of Tai Chi instructors and few studies reported the years of Tai Chi teaching experience. Participants practiced Tai Chi during class under the guidance and supervision of instructors were most popular method of practicing Tai Chi.(6) In more than half of studies Tai Chi intervention was used alone. The most frequently reported outcomes were physical performance, symptoms and psychological well-being. No adverse events related to Tai Chi intervention were reported. The majority of studies reported positive results of Tai Chi interventions.The proposed reporting standard of Tai Chi intervention in clinical trials includes 7 items and 16 sub-items. The 7 items are as follows:Tai Chi rationale, details of learning and practicing, treatment regimen, other components of treatment, instructor background, requirements, and control or comparator interventions.Conclusions:Tai Chi has been a hot research topic, and currently 20 countries have published Tai Chi clinical studies, covering all kinds of clinical study designs and including a variety of diseases. In addition, the number of clinical studies is increasing with years. There are many kinds of Tai Chi styles and forms, varying from intensity, frequency and duration. More studies are still warranted to recommend optimized Tai Chi intervention for specific diseases. No adverse events related to Tai Chi interventions were reported. The majority of studies reported positive results of Tai Chi interventions.The reporting of Tai Chi intervention in clinical studies is needed to be improved. This study proposed a reporting standard of Tai Chi intervention in clinical studies on Tai Chi based on current international reporting guidelines. |
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