Long-term, double-blind randomized parallel group studies comparing fenbufen and indomethacin in patients with osteoarthritis.

A controlled trial was designed to compare both the long-term efficacy and the safety of fenbufen and indomethacin in patients with osteoarthritis. One hundred and ten patients of both sexes (aged 33 to 79 years) who had both subjective and objective (including radiological) evidence of osteoarthritis, and who met the minimal entry criteria, were enrolled into the studies. Patients were randomly assigned to receive either fenbufen capsules b.i.d. (600-1000 mg/day) or identical appearing indomethacin capsules b.i.d. (750-125 mg/day). Thirty-seven fenbufen and 26 indomethacin patients completed twelve months of treatment. Both fenbufen and indomethacin provided statistically nd clinically significant improvement at months 1, 3, 6, 9 and 12. There were no significant differences in improvement between the two treatment groups. Fenbufen-treated patients, however, reported fewer occurrences (4) of severe drug-related adverse experiences than indomethacin-treated patients (20). Significantly fewer headaches were reported with fenbufen and the number of patients terminating treatment because of adverse experiences was significantly greater with indomethacin. Fenbufen, in this patient population, provided a superior ratio of benefits to risk for the long-term treatment of osteoarthritis.U