针刺治疗纤维肌痛症的疗效：一项多中心随机对照试验的研究方案。

Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial.

机构信息

Pain Treatment Unit, Doña Mercedes Primary Health Care Centre, Dos Hermanas, Spain.

出版信息

Trials. 2011 Feb 28;12:59. doi: 10.1186/1745-6215-12-59.

DOI:10.1186/1745-6215-12-59

PMID:21356075

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3055832/

Abstract

BACKGROUND

Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life.

METHODS/DESIGN: Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment.

DISCUSSION

This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression.

TRIAL REGISTRATION

ISRCTN trial number ISRCTN60217348 (19 October 2010).

摘要

背景

纤维肌痛是一种多维障碍，目前的治疗方法仍不尽如人意。尽管基于针灸的治疗方法在患者和医护人员中广泛接受，但针对这种综合征的疗效尚未产生足够的证据。本研究旨在评估个体化针灸治疗纤维肌痛患者的效果，以减轻其疼痛和残疾程度，并改善其生活质量。

方法/设计：这是一项随机对照多中心研究，纳入了 156 名年龄在 17 岁以上的门诊患者，根据美国风湿病学会的标准诊断为纤维肌痛，或根据《精神障碍诊断与统计手册》的标准伴有严重抑郁症。参与者将被随机分配接受“真针灸”或“假针灸”。他们将使用特定的测量系统进行评估，该系统由纤维肌痛影响问卷和汉密尔顿抑郁量表组成。还将考虑临床和主观疼痛强度、患者的家庭结构和关系、心理方面、生活质量、先前临时残疾的持续时间、抗抑郁药、镇痛药和抗炎药的消耗情况，以及被认为是预后不良的预测因素的潜在影响。所有这些方面都将通过问卷和其他适当验证的工具进行检查。将在治疗开始后 10 周、6 个月和 12 个月分析获得的结果。