El ibuprofeno, el paracetamol y el placebo en la osteoartritis de la rodilla: Un niño de seis días de duración, doble ciego estudio

The objective was to evaluate and compare the analgesic efficacy and safety of five-day dosing with ibuprofen 1,200 mg/day, acetaminophen 4,000 mg/day and placebo in patients with osteoarthritis of the knee with at least moderate pain at baseline. Twenty doses of study medication were given to 693 patients with moderate osteoarthritis of the knee in a randomized, double-blind, multiple-dose, multi-center, parallel group, placebo-controlled six-day study. Evaluations at baseline and on days 4 and 6 included Knee Pain on Walking (primary efficacy variable), Knee Pain on Weight Bearing, modified WOMAC Index, Limitation of Activity, an Overall Efficacy Evaluation, and a Daily Knee Pain Evaluation on days 1 to 5. The primary analysis was performed on 548 evaluable subjects. Ibuprofen was numerically better than acetaminophen and both were significantly (p < 0.05) better than placebo for reducing Knee Pain on Walking on days 4 and 6. Similar results were observed for all secondary variables on days 4 and 6. In subjects with moderately severe or severe baseline knee pain, ibuprofen was significantly (p < 0.05) better than acetaminophen for Knee Pain on Walking and for Overall Efficacy on days 4 and 6. Adverse experiences were uncommon, with fewer gastrointestinal events in the ibuprofen group than with acetaminophen. The short-term use of a non-prescription dose of ibuprofen was at least as effective as acetaminophen in the treatment of pain from osteoarthritis of the knee. In subjects with moderately severe or severe baseline pain, ibuprofen was superior to acetaminophen and placebo. Both treatments were well-tolerated, with a lower incidence of gastrointestinal adverse experiences in the ibuprofen group.