Validation of a sham acupuncture procedure in a randomised, controlled clinical trial of chronic pelvic pain treatment
Validation of a sham acupuncture procedure in a randomised, controlled clinical trial of chronic pelvic pain treatment
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DOI：
10.1136/aim.2010.003137
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发表时间：
2011-03-01
影响因子：
2.5
通讯作者：
Krieger, John N.
中科院分区：
文献类型：
--
作者：
Lee, Shaun Wen Huey;Liong, Men Long;Krieger, John N.
针灸是治疗慢性前列腺炎/慢性骨盆疼痛综合征（CP/CPPS）的一种有吸引力的治疗选择，已被证明是传统药物治疗的难治性。不幸的是，很难确定针灸的好处，因为很少有研究采用对照或生理结果measures. ObjectiveTo确定的可行性假，或微创，针灸作为对照研究评估针灸治疗慢性盆腔疼痛的疗效。一项比较针刺与假手术治疗CP/CPPS患者的随机盲法试验。针刺或假手术进行了10周的时间。假针灸包括在距离真实穴位（CV1，CV 4，SP 6和SP 9）0.5 cm的位置放置短针。要求参与者在治疗结束时确定他们的手术分配。共有35名参与者也同意有血液分析皮质醇，β-内啡肽和亮氨酸脑啡肽。结果三十五（78%）的45名参与者随机分配到假治疗认为他们已经接受了针灸相比，27（61%）的44名参与者随机针灸（P=0.11）。生化数据显示治疗后各组间无差异。44名针灸参与者中有32名（73%）符合预定义的临床反应标准，而45名假针灸参与者中有21名（47%）符合预定义的临床反应标准（p=0.017，相对风险1.81，95%CI 1.3至3.1）。研究结束时，针刺组的β-内啡肽和亮氨酸脑啡肽水平均高于对照组（P <0.05）。
Background Acupuncture is an attractive treatment option for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) that has proved refractory to conventional medical treatments. Unfortunately, it is difficult to determine the benefit of acupuncture because few studies have employed controls or had physiological outcome measures.Objective To determine the feasibility of a sham, or minimally invasive, acupuncture as a control for studies evaluating the efficacy of acupuncture treatment for chronic pelvic pain.Methods Participants were recruited from a double-blind randomised trial comparing acupuncture with a sham procedure for patients with CP/CPPS. Acupuncture or sham procedures were performed over a 10-week period. Sham acupuncture involved placement of short needles at sites 0.5 cm away from true acupuncture points (CV1, CV4, SP6 and SP9). Participants were asked to determine their procedure allocation at the end of treatment. A total of 35 participants also agreed to have blood analyses for cortisol, beta-endorphin and leucine-enkephalin.Results Thirty-five (78%) of the 45 participants randomised to the sham treatment thought they had received acupuncture compared with 27 (61%) of the 44 participants randomised to acupuncture (p=0.11). Biochemical data showed no differences between the groups immediately after treatment. Thirty-two (73%) of 44 acupuncture participants met the predefined clinical response criterion compared with 21 (47%) of 45 sham acupuncture participants (p=0.017, relative risk 1.81, 95% CI 1.3 to 3.1). At the end of the study, beta-endorphin and leucine-enkephalin levels were both higher in the acupuncture group (p