針刺臨床試驗治療失眠症的經驗分享

Clinical Acupuncture Trial on Insomnia Patients--A Taiwan Experience

目的：1.針刺療法與西藥Stilnox（俗名-Zolpidem）治療失眠症的療效比較。2. 針刺療法與西藥Stilnox合併使用治療失眠症是否更具療效。方法：自2007年8月至2008年5月，以隨機對照試驗 （Randomized Controlled Trial, RCT）方式收案，在臺北市立聯合醫院中興院區進行臨床試驗。參加者被隨機分為A組 （每天睡前服用5毫克Stilnox）、B組 （每天睡前服用5毫克Stilnox，並每週接受針刺治療3次） 及C組 （未服藥，僅每週接受針刺治療3次） 三組。治療期間為4週，並於治療後4週，接受隨訪（follow up）。受試者治療前及每週治療後均接受匹茲堡睡眠品質量表（PSQI）的療效評估。結果：總共有48位參加臨床試驗，其中未完成療程即退出者有28人，完成療程及追訪之受試者共20人，包括A組2人，B組10人，C組8人。治療結果顯示，B組或C組受試者在接受針刺治療三週及四週後的PSQI分數，與治療前的PQSI分數作比較，在統計學上均具有顯著的差異存在（P<0.05），且在治療後四週追訪時，其療效然存在。而B組與C組兩組間，則無統計上顯著差異（P=0.73）。結論：本研究受限於樣本數太小及高退出率，單獨採用針刺療法或合併使用Stilnox治療失眠症的療效仍不確定，但初步資料顯示，利用針刺治療失眠症，可能有其潛在的效益存在。Objective: The aims of this study were to examine whether acupuncture is better than/same as Stilnox (Generic name-Zolpidem) and whether combination of acupuncture with Stilnox is better than/same as acupuncture alone or Stinox alone. Methods: A randomized controlled trial was conducted from August 2007 to May 2008 in Zhong-Xing Branch , Taipei City Hospital, Taiwan. The participants were randomly assigned into one of the three groups for a 4-week intervention and a 4-week follow-up after treatments. Treatment of the participants was given on a weekly basis. Group A took Stilnox 5mg/day at bedtime. Group B took Stilnox 5mg/day at bedtime and received acupuncture 3 times a week. Group C took no medication but received acupuncture 3 times a week. The effectiveness of treatments of the three groups was all evaluated weekly by the Pittsburgh sleep quality index (PSQI). Results: A total of 48 participants were initially enrolled. Among them, 28 withdrew during the study. The remaining 20 participants, including 2 of Group A, 10 of Group B and 8 of Group C, completed the entire treatment course and were evaluated. The result showed that the PSQI value decreased significantly (p < 0.05) compared with baseline after 3-week intervention and 4-week intervention in both Group B (n＝10) and Group C (n＝8). The effects of treatments were still maintained at the 4-week follow-up after treatments. There was no significant difference(p = 0.73) in terms of effectiveness of treatment between Group B and Group C. Conclusions: The effectiveness of acupuncture alone or in combination with Stilnox remains uncertain, because of the small sample size and high drop-out rate, especially in the medication-only group. The initial data may reveal potential beneficial effects of acupuncture in treating insomnia.