Thirty patients with definite or classical
rheumatoid arthritis were enrolled in a six-month, prospective, double-blind study. Fifteen patients received 750 mg/day of
naproxen and 15 patients received 900 mg/day of
fenbufen. The
fenbufen-treated group showed significant improvement in four parameters:
pain at rest,
pain on movement, duration of
pain, and number of swollen joints.
Naproxen produced significant improvement in three parameters:
pain at rest, duration of morning stiffness, and number of swollen joints. There were no significant differences between treatments in any of the parameters at any assessment except for duration of morning stiffness at one observation point. Marked differences were noted in the number of patients with side effects and in the number of side effects reported. In the
naproxen-treated group, 11 patients reported a total of 20 adverse reactions, while in the
fenbufen-treated group, five patients reported a total of eight adverse reactions. Throughout the period of assessment, no consistent changes in laboratory values were observed. One patient in the
naproxen-treated group showed an abnormal WBC at the third and fourth assessment, but this was not considered
drug related. These results suggest that
fenbufen is at least as effective as and better tolerated than
naproxen in the treatment of patients with
rheumatoid arthritis.