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