Double-blind comparison of alclofenac and phenylbutazone in the short-term treatment of rheumatoid arthritis

Summary

Alclofenac, a new anti-inflammatory agent, has been assessed comparatively with phenylbutazone in a double-blind cross-over study including 92 patients with rheumatoid arthritis, using alclofenac at a dose of 2 g. and phenylbutazone 600 mg. daily in divided doses. Both objective measurements and subjective criteria revealed that the patients improved equally on both drugs but that alclofenac was statistically superior to phenylbutazone in improving morning stiffness.

Adverse clinical reactions occurred in 18 patients on phenylbutazone and on 9 patients with alclofenac. It was necessary to discontinue phenylbutazone treatment in 5 patients and to discontinue alclofenac in 2 patients. No serious side-effects occurred with alclofenac.

A double-blind crossover trial has been conducted to compare the therapeutic efficacy of a new antirheumatic drug, alclofenac, with that of phenylbutazone in rheumatoid arthritis. One hundred and four patients were randomly allocated to 4 treatment groups: alclofenac followed by phenylbutazone, phenylbutazone by alclofenac, phenylbutazone by phenylbutazone, or alclofenac by alclofenac. Each drug period lasted 14 days and the daily oral dose levels of alclofenac and phenylbutazone were 2 g. and 600 mg. respectively, as tablets to be taken one 4 times each day.

Most subjective and objective clinical parameters improved equally with the two drugs after 14 and 28-days' treatment, but alclofenac was significantly superior to phenylbutazone in improving morning stiffness. The introduction of alclofenac is a valuable contribution to the treatment of rheumatoid arthritis; because of its excellent tolerance, it should be tested long term in this condition, particularly when adverse effects prohibit the use of other drugs.

Key words: :

• Arthritis
• rheumatoid
• alclofenac
• phenylbutazone