Comparative double-blind study of droxicam (new NSAID) versus indomethacin in rheumatoid arthritis.

This randomized, controlled and double-blind clinical trial compares the efficacy of droxicam (20mg/day) with that of indomethacin (75mg/day) in 40 RA patients (11 male, 29 female) aged (+/- SD) 53 +/- 12.5 years. After a 7-day single-blind run-in placebo period, patients were divided into two groups and treated for 9 weeks. Assessments were done at baseline and at the end of the 1st, 2nd, 4th, 6th and 9th weeks. Both drugs improved significantly the articular pain, the duration of morning stiffness, the articular index, the functional status and the degree of fatigue. Patient's and doctor's opinions were in accordance with the above-mentioned results. The effect of both drugs was more noticeable in the first 2 weeks of treatment. Droxicam was found to be statistically more active than indomethacin in alleviating morning stiffness and improving the functional status. The improvement of the variables induced by droxicam increased progressively throughout the study whereas that induced by indomethacin remained unchanged after the 2nd or 4th week of treatment. One patient treated with indomethacin withdrew from the study due to staggering and dizziness and several patients reported dyspepsia. Droxicam seems to be as effective as indomethacin (75mg/day) in the symptomatic relief of RA patients. The possibility of the use of droxicam for the relief of morning stiffness is of particular interest.