针刺治疗原发性失眠的文献质量评价

Evaluation on Acupuncture Treatment of Primary Insomnia

目的:对针刺治疗失眠的临床随机对照研究文献进行文献质量评价。方法:以"针刺""失眠"为检索词,计算机检索中文及英文数据库,手工检索《中国针灸》等中医杂志及有关学术会议论文汇编。对纳入文献的方法学,诊断及纳入、排除标准,针刺、对照组干预措施,疗效评价标准及随访等方面进行评价。结果:共纳入20篇随机对照研究文献,其中4篇为高质量研究,16篇为低质量研究。国外研究多采用量表评价疗效,国内研究则主要自拟疗效评价标准。结论:目前国内尚无高质量的针刺治疗原发性失眠的临床研究报道,迄今所发表研究采用的疗效评价方法不能恰当评价针刺治疗原发性失眠的疗效。今后应从临床试验设计及实施角度,严格按照现代医学研究模式,设计出更为科学的试验方案。

Acupuncture treatment of insomnia has been reported for many years, but its validity remains controversial up to now. In the present review, the authors took ＂Acupuncture＂, ＂Insomnia＂ as the key words to do a literature search from databases in both Chinese and English via computer retrieval system and also conducted a hand-made retrieval from journals of Chinese medicine as Chinese Acu-moxibustion, and collections of theses of the related academic conferences. Then, they made a systemic evaluation on the original articles from methodology, diagnosis, criteria for the enlisted and excluded patients, intervention methods of acupuncture and control groups, standards for assessing the curative efficacy, follow-up visit, etc. Of the retrieved 80 clinical articles, 20 are ROT （randomized controlled trails） composed of 1907 cases, including 4 high-quality trails and 16 lowerquality trails. Regarding the assessment of the therapeutic effect, measuring scales are often adopted in overseas studies, while in domestic researches, self-drawn standards are frequently used. In conclusion, there have had no high-quality clinical trails about acupuncture treatment of primary insomnia in China at the present, and the related evaluating methods could not definitely confirm the efficacy of acupuncture in relieving insomnia. Therefore, a strict and scientific clinical trail scheme being in line with evidencebased medicine is urgently needed in the coming studies on acupuncture treatment of primary insomnia.