初级保健中针灸治疗纤维肌痛：一项随机对照试验。

Acupuncture for fibromyalgia in primary care: a randomised controlled trial.

作者信息

Vas Jorge, Santos-Rey Koldo, Navarro-Pablo Reyes, Modesto Manuela, Aguilar Inmaculada, Campos M Ángeles, Aguilar-Velasco José Francisco, Romero Milagrosa, Párraga Patricia, Hervás Vanesa, Santamaría Olalla, Márquez-Zurita Carmen, Rivas-Ruiz Francisco

机构信息

Pain Treatment Unit, Doña Mercedes Primary Health Centre, Dos Hermanas, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Andalucía, Spain.

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

出版信息

Acupunct Med. 2016 Aug;34(4):257-66. doi: 10.1136/acupmed-2015-010950. Epub 2016 Feb 15.

DOI:10.1136/acupmed-2015-010950

PMID:26879181

Abstract

OBJECTIVES

To evaluate the efficacy of an individualised acupuncture protocol for patients with fibromyalgia.

METHODS

Randomised controlled multicentre trial, blinded to participants and to data analysts. Conducted in three primary care centres in southern Spain. A total of 164 participants aged over 17 years and diagnosed with fibromyalgia were enrolled in this trial; 153 participants completed the study. Participants were randomly assigned to either the real intervention (individualised acupuncture, IA) or the sham intervention (sham acupuncture, SA). In both the IA and SA groups, one session per week (lasting 20 min) was provided, in addition to usual pharmacological treatment. The primary outcome was change in pain intensity at 10 weeks.

RESULTS

Intention-to-treat analysis revealed that the decrease in pain intensity at 10 weeks was greater (p=0.001) in the IA group (-41.0%, 95% CI -47.2% to -34.8%) than in the SA group (-27.1%, 95% CI -33.2% to -20.9%). During the follow-up period, significant differences (p<0.01) in favour of the IA group persisted at 12 months (IA: -19.9%, 95% CI -24.6% to -15.1%; vs SA: -6.2%, 95% CI -11.2% to -1.2%).

CONCLUSIONS

Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended.

TRIAL REGISTRATION NUMBER

ISRCTN60217348.

摘要

目的

评估个体化针灸方案对纤维肌痛患者的疗效。

方法

随机对照多中心试验，参与者和数据分析人员均为盲法。在西班牙南部的三个初级保健中心进行。共有164名年龄超过17岁且被诊断为纤维肌痛的参与者纳入本试验；153名参与者完成了研究。参与者被随机分配到真实干预组（个体化针灸，IA）或假干预组（假针灸，SA）。在IA组和SA组中，除常规药物治疗外，每周提供一次治疗（持续20分钟）。主要结局是10周时疼痛强度的变化。

结果

意向性分析显示，IA组在10周时疼痛强度的降低幅度（-41.0%，95%可信区间-47.2%至-34.8%）大于SA组（-27.1%，95%可信区间-33.2%至-20.9%）（p=0.001）。在随访期间，有利于IA组的显著差异（p<0.01）在12个月时仍然存在（IA组：-19.9%，95%可信区间-24.6%至-15.1%；SA组：-6.2%，95%可信区间-11.2%至-1.2%）。