目的:探討中醫藥治療失眠的療效與安全性。
材料與方法:從PubMed，Google Scholar， VIP and CINTCM檢索出2000至2007年間臨床病例 (包含隨機對照或雙盲試驗)，但排除動物實驗，病例報告。
結果:收錄了22篇隨機對照試驗，其中的篇以針灸為主要治療，剩下7篇以中醫藥為主要治療O以針灸為主要治療的文獻中顯示治療組療效率對比對照組療效率分別是( 90.8-96.87% ) : ( 45-90% ) ;以中醫藥為主要治療的文獻中顯示治療組療效率對此對照組療效率分別是(89.5-100% ) : ( 63.2-85.53% )。綜合而論，這些文章仍有缺陷，如沒有完整描述隨機對照、缺乏雙盲試驗、甚少報導副作用及安全性等。
結論:與對照組或與西藥治療比較，中醫藥可以有效治療失眠.

Objectives: To review clinical trials on the efficacy and safety of Traditional Chinese Medicine (TCM) for Insomma.The interventions included acupuncture， herbal formula， Tuina massage and other modalities of TCM.
Methods: PubMed， Ooogle Scholar， VIP and CINTCM were searched for randomized controlled trials (RCTs) that tested TCM for Insomnia and reported between 2000 and 2007. All of them were reviewed for their safety and adverse event reports as well. They could be placebo controlled or non-placebo controlled blinded or non-blinded clinical trials. Literature published in Chinese language was also included. Case reports， case series， uncontrolled clinical trials， and animal studies were excluded.
Results: Twenty two RCTs that qualified our criteria were included in this review; of which fifteen were on acupuncture and the remaining seven were on Chinese herbal medicine (CHM). Both acupuncture and CHM were tested either as an adjuvant to conventional medicine/ tuina massage or as an independent treatment modality. The control groups (COs) received either conventional care alone or sometimes a placebo. Results of all acupuncture trials reported an improvement (90.8-96.87%) in the symptoms of Insomnia over CO (45-90%). Similar positive outcomes were reported by CHM trials as well (Percentage of improvement 89.5-100% in the treatment group (TO)vs. 63.2% -85.53% in the CO). Despite no differences in the outcomes when acupuncture was tested alone or when it was tested as an adjuvant in the above trials， most of the Twenty two RCTs we reviewed， reported promising results. However， there were many limitations in these trials， which included lack of blinding， use of nonstandardized outcome measures， insufficient treatment details， and no clear details of randomization. Additionally， adverse events were rarely reported.
Conclusion: TCM can be a useful treatment for insomnia compared to conventional medicine or placebo. However， the poor quality of the trials suggest further rigorous trials to substantiate the results.