Credibility of a newly designed placebo needle for clinical trials in acupuncture research
Credibility of a newly designed placebo needle for clinical trials in acupuncture research
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DOI：
10.1159/000057254
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发表时间：
2001-12-01
期刊：
影响因子：
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通讯作者：
Karst, M
中科院分区：
文献类型：
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作者：
Fink, M;Gutenbrunner, C;Karst, M
目的：检验一种新设计的安慰针在针灸研究中的可信度。设计图：一项随机、安慰剂对照、患者和评价者盲态临床试验中真实干预和安慰剂干预的可信度数据分析。患者和设置：这项研究是在大学物理医学和康复系进行的。68例符合国际头痛协会紧张型头痛标准的患者（年龄48.1 ± 14.1岁，平均值± SD）入组研究。干预措施：第1组（治疗组）被分配到传统的针放置和操作，而在第2组（对照组）中，使用新的安慰剂装置。结果参数：在第一次治疗后，与真实的或安慰剂针灸，患者被要求填写一份问卷的可信度。此外，治疗3或4次后，询问患者的进针感觉和得气情况。结果：真实的针刺与安慰剂针刺治疗的可信度无差异（p > 0.05）。真实的针灸组的所有患者和安慰剂组除4名患者外的所有患者都识别出了针头插入（p < 0.05）。真实的针灸组中84%的患者和安慰剂组中34%的患者报告了得气（p < 0.001）。结论：用这里描述的安慰针装置进行针灸具有很高的可信度，与真实的针灸治疗没有区别。然而，为了在两种治疗条件下获得可比的刺痛感，需要仔细训练安慰剂针头。此外，从这些结果中产生了关于安慰剂针的安慰剂反应的新问题。需要进行进一步研究，以检测安慰剂针头是否为活性对照。
Objective: To test the credibility of a newly designed placebo needle for acupuncture research. Design: Analysis of data on credibility of true and placebo interventions of a randomised, placebo-controlled, patient- and evaluator-blind clinical trial. Patients and Setting: The study was carried out at a university department for physical medicine and rehabilitation. 68 patients (age 48.1 +/- 14.1 years, mean +/- SD) fulfilling the criteria of the International Headache Society for tension-type headache were enrolled into the study. Interventions: Group 1 (treatment) was assigned to traditional needle placement and manipulation, whereas in group 2 (control) a new placebo device was used. Outcome Parameters: After the first treatment with real or placebo acupuncture, patients were asked to fill in a questionnaire on credibility. In addition, after 3 or 4 treatments, patients were asked for the feeling of needle insertion and deqi. Results: No difference between real and placebo acupuncture was detected with respect to the credibility of the treatment (p > 0.05). Needle insertion was recognised in all patients in the real acupuncture group and in all but 4 patients of the placebo group (p < 0.05). deqi was reported by 84% of patients in the real acupuncture group and by 34% of patients in the placebo group (p < 0.001). Conclusion: Acupuncture with the placebo needle device described here is of high credibility, and does not differ from that of real acupuncture treatment. However, to achieve comparable prick sensations in both treatment conditions, careful training with the placebo needle is needed. Furthermore, from these results arise new questions with respect to the placebo response of placebo needles. Further investigations are warranted to test if placebo needles are active controls.