AcuTrials

Treatment of fibromyalgia with acupuncture: a randomized placebo controlled trial of 16 weeks duration

Item

Title

Treatment of fibromyalgia with acupuncture: a randomized placebo controlled trial of 16 weeks duration

Author(s)

Date

2001

volume

44(9)

Research Type

RCT

Keywords

Nervous System Diseases
Acu + Usual Care Versus > 1 Control
Usual Care Control, Pharmaceutical

Abstract

Fibromyalgia is a chronic pain syndrome of unknown origin. Control of signs and symptoms is difficult and usually requires a multidimensional approach. With pain being a major concern, and with the high incidence of side effects with the current pharmacologic drugs used to treat these patients, alternative pain control therapies should be studied. Acupuncture is already widely used for pain management in many different musculoskeletal conditions, even when proper evidence is still lacking. Therefore, the aim of this study was to evaluate the usefulness of acupuncture in the treatment of patients with fibromyalgia. Sixty patients who fulfilled the ACR-90 criteria were randomly assigned to either one of three groups: group A, 20 patients, underwent a once a week acupuncture session for 16 weeks; group B, 20 patients, underwent sham acupuncture sessions, once a week for 16 weeks; group C, 20 patients, received only amitryptiline 25 mg. at bedtime, for 16 weeks. Patients in groups A and B also received amitryptiline in the same dose. All 3 groups were similar in baseline and demographic characteristics. Patients were evaluated at baseline, and then at weeks 4, 8, 12, and 16 by a blinded investigator to treatment groups. Evaluation consisted of a VAS scale for pain (0 to 10), the Short form questionnaire (SF-36) and the Beck inventory for depression. All individuals that completed the first 4 weeks enter the statistical analysis, with an intention to treat with last observation carried forward design. Data were analysed by repetitive measure ANOVA. Patients treated with acupuncture were the only ones to show a statistical significant improvement on all outcome measures, from week 4 up to week 16. Patients in the other 2 groups failed to improve significantly over time. When the three groups were compared, the acupuncture group was significantly better than the other two in the VAS scale for pain and the Becks depression score. In conclusion, acupuncture is a valuable method to increase pain control in these patients, and this effect does not seem to be due to a placebo effect.

Frequency of Treatment

1/WK

Time in Treatment

16 Weeks

has health condition studied

Nervous System Diseases

has study population number

60

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