Factors influencing the quality of acupuncture clinical trials: a qualitative interview of stakeholders.

OBJECTIVE: To investigate the influencing factors on the quality of acupuncture clinical trials from the stakeholders, and to provide references for improving the quality of acupuncture clinical trials. METHODS: A qualitative study based on semi-structured interviews was performed. Experts, acupuncturists, editors, and patients were interviewed. The interview results were thematically analyzed from transcribed audio recordings. RESULTS: A total of 38 stakeholders were interviewed, including 12 experts, 14 acupuncturists, 2 editors, and 10 patients. There were 25 tree nodes and 106 sub-nodes, with 1141 reference points. The key factors influencing the quality of acupuncture clinical trials could be divided into five core theme frameworks: a) trial design, b) trial conduction, c) research results reporting and publication, d) research evidence dissemination, and e) research evidence transformation and application. CONCLUSIONS: The results reveal that to improve the quality of acupuncture trials, it should consider each step of trial design, trial conduction, research results reporting and publication, research evidence dissemination, and research evidence transformation and application. A guideline for quality control of the whole process of acupuncture clinical trials is needed.

Observational studies of traditional Chinese medicine may provide evidence nearly consistent with the randomized controlled trials: A meta-epidemiological study.

Background: In traditional Chinese medicine (TCM) field, the benefits of observational studies was more significant. Whether the evidence from observational studies agreed with RCTs in the field of TCM was still unclear. Methods: A meta-epidemiological study was conducted. Meta-analyses and systematic reviews including cohort studies and case-control studies of TCM were included. Ratio of odds ratio (ROR) of randomized controlled trials and observational studies were calculated individually and intercomparisons were conducted by pool analysis. Results: A total of 11 studies and 30 outcome pairs were included in the pool analysis. Using results from the observational studies as the reference group, the polled ROR comparing randomized controlled trials with observational studies was 1.23 (95% confidence interval 1.05 to 1.44, and 95% prediction interval 0.90 to 1.68). The ROR by subgroup analysis were 1.15 (95% confidence interval 0.96 to 1.38; 95% prediction interval 0.95 to 1.39) and 1.12 (95% confidence interval 0.86 to 1.46; 95% prediction interval 0.51 to 2.47) for cohort studies and case-control studies, respectively. Conclusions: There is difference in pooled results between randomized controlled studies and observational studies on TCM. However, the prediction interval shows the difference is small, which suggests observational studies of TCM can be included in data analysis to provide evidence for TCM. Future studies are needed to verify the above conclusion.

Clinical Application of Traditional Chinese Medicine Therapy for Type 2 Diabetes Mellitus: An Evidence Map.

Type 2 diabetes mellitus (T2DM), a common disease with a complex etiology in the world, is an important risk factor for severe cardiovascular and cerebrovascular diseases. However, treatments of T2DM are mainly based on Western medicine, whose severe side effects make traditional Chinese medicine (TCM) therapy more appealing to patients and clinicians. The overall clinical evidence for different TCM therapies in the treatment of T2DM is still unclear. This study aimed to adopt the evidence-mapping method and integrate the evidence from various researches on this topic, to depict the whole picture of TCM therapies for T2DM. This review included searches of PubMed, Embase, Web of Science, and three major Chinese literature databases (CNKI, VIP, and Wanfang) from inception to November 18, 2021. Two independent reviewers screened the literature, extracted information, and evaluated the quality of all included studies. A systematic review was subsequently performed. In total, 47 studies were reviewed, of which 46 studies (97.9%) were from China and 1 (2.1%) was from Canada. The evidence map was conducted according to different TCM therapies, including herbs or herbal extracts, compounds, powders, decoctions, pills, external treatment, basic theories and treatment principles of TCM, proprietary Chinese medicines, and unspecified TCM integrated therapies. According to the AMSTAR-2 scoring results, 4 papers were rated as high quality, 11 were low quality, and 32 were very low quality. Outcome indicators mainly focused on FBG, HbA1c, 2-h PBG, TC, TG, LDL-C, etc. The results showed that different types of TCM treatment had different improvement effects on the outcome indicators of T2DM. More consistent benefits were observed in the improvement of FBG, HbA1c, and 2-h PBG with treatment regimens based on basic theories and treatment principles of TCM, decoctions and pills, and unspecified TCM integrated therapies. Among herbs, ginger and Coptis root showed more improvement in all outcomes. Compounds, powders, and external treatment showed relatively consistent beneficial effects on the improvement of FBG. No serious adverse events were reported. Overall, the current evidence map provided an intuitive overview of the beneficial effects of TCM therapies in the treatment of type 2 diabetes. This study can be used as a reference for the clinical application of traditional Chinese medicine in T2DM, but due to the low-quality level of the included studies, it should be treated with caution in clinical practices.