OBJECTIVE: To assess health-related quality of life (HRQOL) in patients with moderate-to-severe fibromyalgia pain compared with the general population, and to assess the relationship between pain severity and HRQOL before and after treatment with an analgesic.

METHODS: Data were obtained from a randomized, double-blind study of patients with moderate-to-severe fibromyalgia pain. Patients received either tramadol/acetaminophen or placebo 4 times/day as needed for 91days. HRQOL was measured with the Short Form 36 Health Survey 9SF-36) and the Fibromyalgia Impact Questionnaire (FIQ). Baseline HRQOL sores were compared with HRQOL due to congestive heart failure. Patients with fibromyalgia were divided into tertiles by change in pain severity, and SF-e6 scores were compared across the tertiles. Mean changes in SF-36 and FIQ scores were compared between treatment groups.

RESULTS: Patients with fibromyalgia scored lower than the US norm on all SF-36 scales (P< 0.0001) and lower than patients with congestive heart failure on most scales. More severe pain was associated with greater impairment of HRQOL compared with less severe pain (P< 0.0001). Patients in the highest tertile for improved pain severity had greater improvement in HRQOL scores than patients in the lower tertiles. Compared with patients who received placebo (n=157), patients treated with tramadol/acetaminophen (n=156) showed greater improvement on SF-36 Physical functioning, role physical, bodily pain, and physical summary scales, as well as FIQ scales for ability to do job, pain, and stiffness (P< 0.01).

CONCLUSION: Moderate-to-severe fibromyalgia pain significantly impairs HRQOL, and effective pain relief in these patients significantly increases HRQOL.

Arth & Rheum (Arthritis Care and Research), Vol. 53, No.4 Aug 15, 2005, pp 519-527