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Rofecoxib, 25 mg/day, was more effective than rofecoxib, 12.5 mg/day, celecoxib, or acetaminophen in osteoarthritis of the knee

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 QUESTION: In patients with symptomatic osteoarthritis (OA) of the knee, are rofecoxib, celecoxib, and acetaminophen effective and safe?

Design

Randomised {allocation concealed*}, blinded {clinicians, patients, data collectors and analysts, and outcome assessors},* controlled trial with 6 weeks of follow up.

Setting

29 clinical centres in the USA.

Patients

382 patients ≥ 40 years of age (mean age 63 y, 68% women) who had symptomatic OA of the knee for ≥ 6 months (American College of Rheumatology criteria and functional class rating of I, II, or III), used non-steroidal anti-inflammatory drugs (NSAIDs) or high dose acetaminophen for ≥ 30 days before study entry, and met relevant entry criteria based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (a visual analogue scale [VAS] ranging from 0 [best] to 100 …

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