A Randomized clinical trial of acupuncture compared with sham acupuncture in Fibromyalgia
A Randomized clinical trial of acupuncture compared with sham acupuncture in Fibromyalgia
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DOI：
10.7326/0003-4819-143-1-200507050-00005
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发表时间：
2005-07-05
影响因子：
39.2
通讯作者：
Buchwald, D
中科院分区：
文献类型：
--
作者：
Assefi, NP;Sherman, KJ;Buchwald, D
背景资料：Fibromyalgia是一种常见的慢性疼痛的条件，患者经常使用acupuncture.Objective：To determine whether acupuncture relies pain in fibromyalgia.Design：Randomized，sham-controlled trial in which participants，data collection staff，and data analysts were blinded to treatment group.Setting：Private acupuncture offices in greater西雅图，华盛顿，metropolitan area.患者：100名患有纤维肌痛的成人。干预措施：每周两次治疗12周，采用专门设计用于治疗纤维肌痛的针灸方案，或3种假针灸治疗中的1种：针对不相关疾病的针灸，在非穴位位置插入针，或非插入模拟acupunctures.Measurements：主要结局是主观疼痛，通过10 cm视觉模拟量表测量，范围从0（无疼痛）到10（最严重的疼痛）。在基线、治疗第1、4、8和12周以及治疗完成后3和6个月进行测量。通过自我报告确定受试者的盲法和不良反应。合并3个假对照组，并将其与接受针灸治疗纤维肌痛的患者进行比较，以评估主要结局。结果：接受针灸治疗纤维肌痛的患者的平均主观疼痛评分与合并的假针灸组无差异（平均组间差异，0.5 cm [95%CI，-0.3 cm至1.2 cm]）。在整个试验中，参与者的盲法是足够的，没有严重的不良反应被noted.Limitations：针灸处方在固定点可能不同于针灸管理在临床环境中，治疗是个性化的，往往结合草药补充和其他预防措施。结论：针刺在缓解纤维肌痛疼痛方面并不比假针刺好。
Background: Fibromyalgia is a common chronic pain condition for which patients frequently use acupuncture.Objective: To determine whether acupuncture relieves pain in fibromyalgia.Design: Randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group.Setting: Private acupuncture offices in the greater Seattle, Washington, metropolitan area. Patients: 100 adults with fibromyalgia. Intervention: Twice-weekly treatment for 12 weeks with an acupuncture program that was specifically designed to treat fibromyalgia, or 1 of 3 sham acupuncture treatments: acupuncture for an unrelated condition, needle insertion at nonacupoint locations, or noninsertive simulated acupuncture.Measurements: The primary outcome was subjective pain as measured by a 10-cm visual analogue scale ranging from 0 (no pain) to 10 (worst pain ever). Measurements were obtained at baseline; 1, 4, 8, and 12 weeks of treatment; and 3 and 6 months after completion of treatment. Participant blinding and adverse effects were ascertained by self-report. The primary outcomes were evaluated by pooling the 3 sham-control groups and comparing them with the group that received acupuncture to treat fibromyalgia.Results: The mean subjective pain rating among patients who received acupuncture for fibromyalgia did not differ from that in the pooled sham acupuncture group (mean between-group difference, 0.5 cm [95% CI, -0.3 cm to 1.2 cm]). Participant blinding was adequate throughout the trial, and no serious adverse effects were noted.Limitations: A prescription of acupuncture at fixed points may differ from acupuncture administered in clinical settings, in which therapy is individualized and often combined with herbal supplementation and other adjunctive measures. A usual-care comparison group was not studied.Conclusion: Acupuncture was no better than sham acupuncture at relieving pain in fibromyalgia.