Effect of rofecoxib therapy on measures of health-related quality of life in patients with osteoarthritis

Background: Bodily pain and physical disability can negatively impact healt h-related quality of life (HRQL) in patients with osteoarthritis (OA). Objective: To assess the effects of treatment with a new agent, rofecoxib, on HRQL in patients with OA. Study Design: Randomized, double-blind, 6-week clinical trial comparing tre atment with rofecoxib, 5 to 50 mg, with placebo in 672 patients with OA of the hip or knee. Main Outcome Measure: Patient HRQL was assessed at baseline and at the end of treatment using the Medical Outcomes'Study 36-Item Short-Form Health Sur vey (SF-36). Results: At 6 weeks, mean change from baseline in all SF36 mental and physi cal health domain scores demonstrated significant improvement with rofecoxi b use (P < .05 for all doses for all SF-36 domains), with evidence of a dos e-response relation. Improvements in mental and physical HRQL domains with rofecoxib treatment were significantly greater than those with placebo trea tment (P < .05 for each dose of rofecoxib vs placebo for all domains except general health) and highly correlated with improvements observed using dis ease-specific OA outcome measures such as the Western Ontario and McMaster Universities Osteoarthritis Index-visual Analog 3.0 OA index pain and physi cal function subscales. The effect of rofecoxib vs placebo treatment on men tal health largely disappeared after adjustment for improvement in OA disea se-specific measures. Conclusions: Rofecoxib treatment increased physical and mental HRQL domain scores on the SF-36. Improvements in mental health with rofecoxib use prima rily resulted from effective treatment of OA (ie, reduction in pain and imp rovement in physical function).