OBJECTIVE: The aim of this manuscript is to determine and to compare the efficacy of real acupuncture with sham acupuncture on fibromyalgia (FM) treatment. METHODS: 50 women with FM were randomized into 2 groups to receive either true acupuncture or sham acupuncture. Subjects were evaluated with VAS (at night, at rest, during activity), SF-36, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression scale (BDI), Fatigue Severity Scale (FSS) at baseline, 1 month and 2 months after the 1st session. Patients in both groups received 3 sessions in the 1st week, 2 sessions/week during 2 weeks and 1 session/week in the following 5 weeks (totally 12 sessions). RESULTS: 25 subjects with a mean age of 47.28 +/- 7.86 years were enrolled in true acupuncture group and 25 subjects with a mean age of 43.60 +/- 8.18 years were enrolled in sham acupuncture group. Both groups improved significantly in all parameters 1 month after the 1st session and this improvement persisted 2 months after the 1st session (p < 0.05). However, real acupuncture group had better scores than sham acupuncture score in terms of all VAS scores, BDI and FIQ scores either 1 or 2 months after the 1st session (all p < 0.05). CONCLUSION: Acupuncture significantly improved pain and symptoms of FM. Although sham effect was important, real acupuncture treatment seems to be effective in treatment of FM.

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