Ibuprofen versus buffered phenylbutazone in the treatment of osteoarthritis: double-blind trial.

In a double-blind multiclinic trial, a new nonsteroidal anti-inflammatory agent (ibuprofen) was compared with an established therapeutic agent (phenylbutazone-alka) for the treatment of osteoarthritis. Of the 159 patients from the 17 contributing clinics, 144 completed the four weeks of therapy. More than 60 per cent of them reported improvement in exercise-related pain by week 4, and there was no significant difference between treatment groups. The patients' and the physicians' evaluations of the total state of disease, as well as range-of-motion and functional tests, demonstrated similar degrees of improvement in both treatment groups. The incidence of side effects was within acceptable limits, and the frequency distribution was similar in both groups. Of the 70 reported side effects, 29 were considered by the investigator (blind trial) to be drug-related-11 in association with ibuprofen and 18 with phenylbutazone-alka. Hematologic and blood chemical studies, as well as urine and stool examinations, yielded normal results with the exception of a reduced mean value for serum uric acid and a slightly elevated mean value for SGPT in the phenylbutazone-alka group.