Fenbufen compared with indomethacin in osteoarthrosis.

A double-blind, crossover clinical trial was carried out with a new propionic acid derivative, fenbufen, versus indomethacin and placebo in 20 patients with osteoarthrosis. Active drug dosages of 75 mg indomethacin daily and 600 mg fenbufen daily were used. Fenbufen scored significantly better than placebo with respect to two and indomethacin better than placebo with respect to five of the assessment indices used. Indomethacin was significantly better than fenbufen with respect to two indices and, overall, appeared more effective in the dosages tested. Biochemical abnormalities of liver function (serum alkaline phosphatase and/or SGOT) were noted in 5 patients after fenbufen therapy (in 3 patients after 4-weeks' treatment and in 2 after 6 weeks) but in none after indomethacin therapy. The significance of these findings is discussed. It is concluded that fenbufen should be withdrawn from further clinical use until the true incidence and significance of hepatotoxicity has been evaluated.