[1] YANG Liansheng ZHOU Danfeng ZHANG Kun ZHENG Shuzhen ZHUANG Ziqi,.Study on Optimal Design of Clinical Trial of Acupuncture in Treatment of Facial Paralysis [J]. Modern Traditional Chinese Medicine, 2022, 1(01): 53-59. [doi: 10.13424/j.cnki.mtcm.2022.01.009]
Study on Optimal Design of Clinical Trial of Acupuncture
in Treatment of Facial Paralysis
- Article number:
- 1672-0571(2022)01-0053-07
- Keywords:
- Key words：Acupuncture; Facial paralysis; Randomized controlled trial; Randomized controlled trial; Optimal design
- ZTFLH:
- R245
- Code:
- A
- Abstract:
- Abstract：Objective To explore the optimal scheme of clinical research design of acupuncture in the treatment of facial paralysis based on international high-quality RCT. Methods The subject word search was used on PubMed to screen the clinical randomized controlled studies supporting the effectiveness of acupuncture with influencing factors ≥ 10 in recent 5 years. The relevant factors of trial design were extracted by two people, the design characteristics of high-quality acupuncture clinical trials were summarized, and the clinical research optimization scheme of acupuncture in the treatment of facial paralysis was discussed. Results Eight eligible literatures were retrieved. The study used multicenter group randomization (8/8), subject (6/8) and / or outcome evaluator, data collector and statistician blind method (7/8), sham acupuncture comfort control (7/8) and/or positive control (2/8), evaluation method combining primary and secondary outcome indicators (8/8), sample size evaluation based on pilot study (8/8), intention to treat analysis (8/8). Conclusion Based on the high-quality clinical research design of acupuncture, we can use the randomized design of regional groups, the standardized acupuncture intervention scheme dominated by electroacupuncture, fixed non acupoint points for false acupuncture comfort control without penetrating the skin, the design and implementation of blind method, with the recovery time of facial nerve function as the main outcome,and the comprehensive efficacy evaluation design with self rating depression and anxiety scale as secondary outcomes.So as to improve the level of acupuncture clinical research.
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Memo
基金项目：广东省中医药管理局科研项目（20203014）