A DOUBLE-BLIND EVALUATION OF TOPICAL PIROXICAM GEL WITH ORAL IBUPROFEN IN OSTEOARTHRITIS OF THE KNEE

Two hundred thirty-five patients with mild osteoarthritis of the knee participated in a double-blind, parallel-group, comparative trial of topical piroxicam and oral ibuprofen. The study was conducted by general practitioners at 23 centers. One gram of 0.5% piroxicam gel (equivalent to 5-mg piroxicam) was applied by 117 patients to one affected knee joint three times daily and an ibuprofen tablet (400 mg) was taken three times daily by 118 patients. Blinding was achieved using double-dummy placebos and treatment with study drugs lasted for four weeks. After four weeks of therapy, both groups showed a marked reduction of at least 30% in the intensity of pain both day and night, and a notable improvement in functional capacity as measured by the ability to stand up unaided, to walk, and to climb stairs. There were no statistically significant differences in the response to treatment measured by patient or by physician between the two drug groups. Neither was there a difference between treatments in the requirement for supplementary rescue analgesia. The type and incidence of adverse events were similar for both drug groups; the majority of complaints were gastrointestinal (all patients received either active or placebo oral treatment), there were few local effects attributed to treatment, and few patients withdrew because of adverse experiences. At the conclusion of the trial, overall efficacy was judged to be good or excellent by 64% of patients receiving piroxicam gel and 60% receiving ibuprofen. The study demonstrates that topical piroxicam gel and oral ibuprofen are equally effective and well tolerated in treating mild osteoarthritis of the knee. Piroxicam gel would appear to provide a useful alternative to oral nonsteroidal anti-inflammatory drugs in the management of superficial joint osteoarthritis.