Avants S K, Margolin A, Chang P, Kosten T R, Birch S
Yale University School of Medicine, CMHC/Substance Abuse Center, New Haven, CT 06519, USA.
J Subst Abuse Treat. 1995 May-Jun;12(3):195-205. doi: 10.1016/0740-5472(95)00014-v.
We conducted a 6-week, single-blind study of acupuncture for cocaine dependence in methadone-maintained patients (N = 40) for the purpose of identifying an appropriate needle puncture control for use in future large-scale clinical trials. Patients were randomly assigned to receive daily acupuncture in three auricular sites plus one body site (LI-4), or in control sites within 2-3 mm of the four active sites. Overall, there was a positive response to treatment on a variety of drug-related and psychosocial measures. Cocaine use decreased significantly for patients in both needle puncture groups. The only statistically significant difference between the two types of needle puncture was on ratings of craving. Subjects rated each type of needle puncture as equally credible and perceived no significant differences on the acute effects of the two types of needle insertions. Power calculations based on these findings suggest that very large sample sizes would be required to detect treatment differences between this control condition and active acupuncture. Alternative controls are suggested, and the challenges inherent in implementing controlled clinical trials of acupuncture are discussed.
我们针对美沙酮维持治疗的可卡因依赖患者(N = 40)开展了一项为期6周的针刺治疗单盲研究,目的是确定一种适用于未来大规模临床试验的针刺对照。患者被随机分配至在三个耳部穴位加一个身体穴位(LI-4)接受每日针刺治疗,或在四个有效穴位周围2 - 3毫米范围内的对照穴位接受针刺治疗。总体而言,在各种与药物相关及社会心理指标上,治疗均呈现出积极反应。两个针刺组患者的可卡因使用量均显著下降。两种针刺类型之间唯一具有统计学显著差异的是渴求评分。受试者认为每种针刺类型的可信度相同,且未察觉到两种针刺方式的急性效应存在显著差异。基于这些发现进行的效能计算表明,需要非常大的样本量才能检测出该对照条件与有效针刺治疗之间的差异。文中提出了替代对照,并讨论了实施针刺对照临床试验所固有的挑战。