合理設置針刺安慰對照方法的思考_《中國循證醫學雜志》

作者：

王揚 ,  劉志順

中國中醫科學院廣安門醫院針灸科（北京?100053）;

關鍵詞：

針刺臨床試驗安慰對照

DOI：

10.7507/1672-2531.20110223

視頻：

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針刺安慰對照設置是針刺臨床試驗的難點，尋找理想、標準化的針刺對照方法一直是國內外研究者關注的話題和熱點。本文討論了針刺對照設置的常見問題和困難，介紹了假針刺、非穴點針刺、穴位淺刺和非病癥相關穴位針刺4種常用的針刺對照方法。其中，穴位淺刺蒙蔽性較好，但在很多疾病的使用中受到限制。非病癥相關穴位對照、假針刺和非穴點針刺蒙蔽性稍遜，尤其對有針灸經驗的患者，往往會對治療持懷疑態度。選擇頭、頸、軀干后側作為對照針刺部位可在蒙蔽性、生理效應和可行性因素間達到最佳平衡，故本文提出針刺安慰對照的設置應當在遵循傳統針灸理論的前提下，采用在特殊部位取穴的理想對照模式，供今后的針刺臨床試驗參考。

引用本文： 王揚,劉志順. 合理設置針刺安慰對照方法的思考. 中國循證醫學雜志, 2011, 11(11): 1335-1338. doi: 10.7507/1672-2531.20110223 復制

1.	2 Howard H. Moffet M.P.H. Sham Acupuncture May Be as Efficacious as True Acupuncture: A Systematic Review of Clinical Trials. The Journal of Alternative and Complementary Medicine , 2009, 3(15): 213-216.
2.	3 Mayhew E, Ernst E. Acupuncture for fibromyalgia—a systematic review of randomized clinical trials. Rheumatology (Oxford) , 2007, 46(5): 801-804.
3.	4 Anna E, Mats H, Gunnar S, et al . Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle?. Complementary Therapies in Medicine , 2008, 16(5): 288-294.
4.	6 Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. The Lancet , 1998, 352(9125): 364-365.
5.	7 Tan CW, Christie L, St-Georges V, et al . Discrimination of Real and Sham Acupuncture Needles Using the Park Sham Device: A Preliminary Study. Arch Phys Med Rehabil , 2009, 90(12): 2141-2145.
6.	8 White P, Lewith G, Hopwood V, et al . The placebo needle, is it a valid and convincing placebofor use in acupuncture trials? A randomised, single-blind, cross-over pilot trial. Pain , 2003, 106(3): 401-409.
7.	9 Cummings M. Commentary: controls for acupuncture-can we finally see the light? BMJ , 2001, 322(7302): 1578.
8.	10 Karst M, Reinhard M, Thum P, et al . Needle acupuncture in tension-type headache: a randomized placebo-controlled study. Blackwell Science Ltd Cephalalgia , 2001, 21(6): 637-642.
9.	11 Karst M, Rollnik JD, Fink M, et al . Pressure pain threshold and needle acupuncture in chronic tension-type headache-a double-blind placebo-controlled study. Pain , 2000, 88(2): 199-203.
10.	12 Tsukayama H, Yamashita H, Kimura T, et al . Factors That Influence the Applicability of Sham Needle in Acupuncture Trials Two Randomized, Single-Blind, Crossover Trials With Acupuncture-Experienced Subjects. Clin J Pain , 2006, 22(4): 346-349.
11.	13 David J, Townsend S, Sathanathan R, et al . The effect of acupuncture on patients with rheumatoid arthritis: a randomized, placebo-controlled cross-over study. Rheumatology , 1999, 38(9): 864-869.
12.	14 White AR, Resch KL, Chan JC, et al . Acupuncture for episodic tension-type headache : a multicentre randomized controlled trial. Cephalalgia , 2000, 20(7): 632-637.
13.	15 Godfrey CM, Morgan P. A controlled trial of the theory of acupuncture in musculoskeletal pain. J Rheumatol , 1978, 5(2): 121-124.
14.	17 Lewth GT, Madun D. On the evaluation of the clinical effects of acupuncture. Pain , 1983,16(2): 111-127.
15.	20 Ceccherelli F, Rigoni MT, Gagliardi G. Comparison of Superficial and Deep Acupuncture in the Treatment of Lumbar Myofascial Pain: A Double-Blind Randomized Controlled Study. The Clinical Journal of Pain , 2002, 18(3): 149-153.
16.	26 Dincer F, Linde K. Sham interventions in randomized clinical trials of acupuncture—a review. Complementary Therapies in Medicine , 2003, 11(4): 235-242.
17.	管紅珍, 彭智聰, 傅鷹. 循證醫學中文獻證據等級標準的系統性綜述. 藥物流行病學雜志, 2002, 11(3): 145-148.
18.	黃梅芳, 俞昌德. 安慰對照針灸方法的可行性測試. 中國針灸, 2004, 24(7): 507-509.
19.	劉京, 王俊英, 劉俊嶺, 等. 安慰針刺對照設計的研究進展與相關問題探討. 針刺研究, 2007, 32(6): 389-424.
20.	張維, 劉志順, 李珺. 深刺天樞穴治療結腸慢轉運性便秘30例. 臨床研究, 2005, 124(10): 26-27.
21.	萬興, 顧一煌, 林容枝. 深刺天樞治療功能性便秘遠期療效觀察. 遼寧中醫藥大學學報, 2010, 12(4): 198-199.
22.	范郁山, 況彥德. 《針灸甲乙經》有關淺刺針法理論的研究探析. 亞太傳統醫藥, 2010, 6(1): 10-11.
23.	羅慶道. 揚皮部理論倡淺刺療法. 安徽中醫臨床雜志, 2003, 15(3): 173-174.
24.	黃梅芳, 俞昌德. 介紹國外針灸臨床研究中幾種安慰對照方法. 中國針灸, 2003, 23(10): 589-591.
25.	石學敏. 針灸學. 北京: 中國中醫藥出版社, 2002: 18.
26.	劉慧琳, 張琰, 李敬道, 等. 針灸臨床研究針刺安慰對照方法的設計與實踐. 中國循證醫學雜志, 2008, 8(12): 1133-1135.

1. 2 Howard H. Moffet M.P.H. Sham Acupuncture May Be as Efficacious as True Acupuncture: A Systematic Review of Clinical Trials. The Journal of Alternative and Complementary Medicine , 2009, 3(15): 213-216.
2. 3 Mayhew E, Ernst E. Acupuncture for fibromyalgia—a systematic review of randomized clinical trials. Rheumatology (Oxford) , 2007, 46(5): 801-804.
3. 4 Anna E, Mats H, Gunnar S, et al . Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle?. Complementary Therapies in Medicine , 2008, 16(5): 288-294.
4. 6 Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. The Lancet , 1998, 352(9125): 364-365.
5. 7 Tan CW, Christie L, St-Georges V, et al . Discrimination of Real and Sham Acupuncture Needles Using the Park Sham Device: A Preliminary Study. Arch Phys Med Rehabil , 2009, 90(12): 2141-2145.
6. 8 White P, Lewith G, Hopwood V, et al . The placebo needle, is it a valid and convincing placebofor use in acupuncture trials? A randomised, single-blind, cross-over pilot trial. Pain , 2003, 106(3): 401-409.
7. 9 Cummings M. Commentary: controls for acupuncture-can we finally see the light? BMJ , 2001, 322(7302): 1578.
8. 10 Karst M, Reinhard M, Thum P, et al . Needle acupuncture in tension-type headache: a randomized placebo-controlled study. Blackwell Science Ltd Cephalalgia , 2001, 21(6): 637-642.
9. 11 Karst M, Rollnik JD, Fink M, et al . Pressure pain threshold and needle acupuncture in chronic tension-type headache-a double-blind placebo-controlled study. Pain , 2000, 88(2): 199-203.
10. 12 Tsukayama H, Yamashita H, Kimura T, et al . Factors That Influence the Applicability of Sham Needle in Acupuncture Trials Two Randomized, Single-Blind, Crossover Trials With Acupuncture-Experienced Subjects. Clin J Pain , 2006, 22(4): 346-349.
11. 13 David J, Townsend S, Sathanathan R, et al . The effect of acupuncture on patients with rheumatoid arthritis: a randomized, placebo-controlled cross-over study. Rheumatology , 1999, 38(9): 864-869.
12. 14 White AR, Resch KL, Chan JC, et al . Acupuncture for episodic tension-type headache : a multicentre randomized controlled trial. Cephalalgia , 2000, 20(7): 632-637.
13. 15 Godfrey CM, Morgan P. A controlled trial of the theory of acupuncture in musculoskeletal pain. J Rheumatol , 1978, 5(2): 121-124.
14. 17 Lewth GT, Madun D. On the evaluation of the clinical effects of acupuncture. Pain , 1983,16(2): 111-127.
15. 20 Ceccherelli F, Rigoni MT, Gagliardi G. Comparison of Superficial and Deep Acupuncture in the Treatment of Lumbar Myofascial Pain: A Double-Blind Randomized Controlled Study. The Clinical Journal of Pain , 2002, 18(3): 149-153.
16. 26 Dincer F, Linde K. Sham interventions in randomized clinical trials of acupuncture—a review. Complementary Therapies in Medicine , 2003, 11(4): 235-242.
17. 管紅珍, 彭智聰, 傅鷹. 循證醫學中文獻證據等級標準的系統性綜述. 藥物流行病學雜志, 2002, 11(3): 145-148.
18. 黃梅芳, 俞昌德. 安慰對照針灸方法的可行性測試. 中國針灸, 2004, 24(7): 507-509.
19. 劉京, 王俊英, 劉俊嶺, 等. 安慰針刺對照設計的研究進展與相關問題探討. 針刺研究, 2007, 32(6): 389-424.
20. 張維, 劉志順, 李珺. 深刺天樞穴治療結腸慢轉運性便秘30例. 臨床研究, 2005, 124(10): 26-27.
21. 萬興, 顧一煌, 林容枝. 深刺天樞治療功能性便秘遠期療效觀察. 遼寧中醫藥大學學報, 2010, 12(4): 198-199.
22. 范郁山, 況彥德. 《針灸甲乙經》有關淺刺針法理論的研究探析. 亞太傳統醫藥, 2010, 6(1): 10-11.
23. 羅慶道. 揚皮部理論倡淺刺療法. 安徽中醫臨床雜志, 2003, 15(3): 173-174.
24. 黃梅芳, 俞昌德. 介紹國外針灸臨床研究中幾種安慰對照方法. 中國針灸, 2003, 23(10): 589-591.
25. 石學敏. 針灸學. 北京: 中國中醫藥出版社, 2002: 18.
26. 劉慧琳, 張琰, 李敬道, 等. 針灸臨床研究針刺安慰對照方法的設計與實踐. 中國循證醫學雜志, 2008, 8(12): 1133-1135.

《中國循證醫學雜志》

合理設置針刺安慰對照方法的思考

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《中國循證醫學雜志》

合理設置針刺安慰對照方法的思考

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