针刺治疗原发性纤维肌痛：一项随机对照试验的研究方案。

Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial.

机构信息

Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

Department of Rheumatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.

出版信息

Trials. 2020 Jun 17;21(1):538. doi: 10.1186/s13063-020-04317-y.

DOI:10.1186/s13063-020-04317-y

PMID:32552731

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7301472/

Abstract

BACKGROUND

Acupuncture is well recognized for its unique therapeutic effect for many diseases as a nonpharmacological therapy in traditional Chinese medicine (TCM). However, whether acupuncture can effectively treat fibromyalgia is currently unclear. Therefore, we aim to design a study protocol of a randomized controlled clinical trial and assess the effectiveness of acupuncture for patients with fibromyalgia, which may lead to alleviation of clinical symptoms and improvement of patients' quality of life.

METHODS

The study is designed as a randomized, blinded, placebo-controlled trial of two cohorts conducted at Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Shenzhen Traditional Chinese Medicine Hospital, respectively. A total of 68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria, are randomly allocated with a 1:1 ratio to acupuncture or sham acupuncture groups. All subjects will receive acupuncture intervention for 8 weeks with follow-up assessments every 4 weeks for 16 weeks. The primary outcome will be evaluated using the visual analogue scale (VAS) and revised fibromyalgia impact questionnaire (FIQR) for pain intensity. The secondary outcome measures will include: Multidimensional Assessment of Fatigue scale (MAF), Short Form-36 (SF-36), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), Chinese perceived stress scales (pss-14), changes in the number of 18 tender points, patient satisfaction for the treatment and adverse events. The mentioned outcome measurements will be assessed every 4 weeks for 6 months.

DISCUSSION

This clinical trial will use advanced research methods to evaluate the efficacy and safety of acupuncture on fibromyalgia. The results of this trial may provide clinical evidence on the beneficial effects of acupuncture in treating fibromyalgia.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR1800016826: AMCTR-IOR-18000184. Registered 27 June 2018, http://www.acmctr.org/listbycreater.aspx.

摘要

背景

针灸作为中医的一种非药物疗法，以其独特的疗效被广泛认可，可用于治疗多种疾病。然而，针灸是否能有效治疗纤维肌痛症目前尚不清楚。因此，我们旨在设计一项随机对照临床试验研究方案，评估针灸治疗纤维肌痛症患者的疗效，这可能会减轻患者的临床症状，提高患者的生活质量。

方法

本研究设计为在中国中医科学院广安门医院和深圳市中医院分别进行的两队列随机、双盲、安慰剂对照试验。共纳入 68 例符合美国风湿病学会标准的原发性纤维肌痛症患者，按 1:1 比例随机分配至针灸组或假针灸组。所有受试者均接受 8 周的针灸干预，每 4 周进行一次随访，共随访 16 周。主要结局评估采用视觉模拟评分（VAS）和修订后的纤维肌痛影响问卷（FIQR）评估疼痛强度。次要结局指标包括：多维疲劳评估量表（MAF）、简明健康状况量表 36 项（SF-36）、贝克抑郁量表（BDI）、匹兹堡睡眠质量指数（PSQI）、中国感知压力量表（pss-14）、18 个压痛点数量的变化、患者对治疗的满意度和不良反应。上述结局测量将在 6 个月内每 4 周评估一次。