Comparison of tenoxicam and bromazepan in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial.

Abstract Fibromyalgia is a painful syndrome of non-articular origin, predominantly involving muscles, and the commonest cause of chronic widespread musculoskeletal pain. The diversity of therapeutic programs for patients with fibromyalgia reflects both the lack of a known pathophysiology for this disorder and the low efficacy of the current therapies. We studied the efficacy of tenoxicam and bromazepan in the treatment of patients with fibromyalgia. One hundred and sixty-four patients from our Rheumatology Outpatient Clinic fulfilling the American College of Rheumatology criteria for the classification of fibromyalgia, with widespread pain at study entry. Each of the 164 patients was randomly assigned to 1 of 4 treatment groups: double placebo (P), tenoxicam (20 mg) + placebo (T), bromazepan (3 mg) + placebo (B), or tenoxicam (20 mg) + bromazepan 3 mg (TB). Patient global assessment of disease, pain, sleep quality, morning stiffness, and number of tender points were evaluated at baseline and 8 weeks afterwards. At the end of the trial, 17%, 10%, 12%, and 29% of the P, T, B, and TB patients, respectively, had clinical improvement. A statistically significant difference was found only between the T and TB groups. Our data indicate that treatment with tenoxicam + bromazepan can be effective for some patients with fibromyalgia, but the differences with the placebo group were neither clinically nor statistically significant.