A double-blind comparison of oral ketoprofen 'controlled release' and indomethacin suppository in the treatment of rheumatoid arthritis with special regard to morning stiffness and pain on awakening.

A double-blind, double-dummy, crossover study was carried out in 8 centres to compare the efficacy and tolerability of 'controlled-release' ketoprofen tablets (200 mg) with that of indomethacin suppositories (100 mg) in out-patients with definite or classical rheumatoid arthritis. Patients were allocated at random to receive a daily bedtime dose of either 1 ketoprofen tablet or 1 indomethacin suppository plus the dummy of the other formulation for a period of 3 weeks. They were then crossed over to the alternative treatment for a further 3 weeks. Daily diary records were kept by patients of the number of night-time awakenings due to pain, pain severity at awakening in the morning and the duration of early morning stiffness. Treatment efficacy was also assessed at the end of each trial period by means of an articular index and by physician's and patient's overall evaluation of response. Adverse effects spontaneously mentioned by the patients or elicited by direct questioning using a symptom check-list were recorded. Statistical analysis of the results from 83 evaluable patients showed that the 'controlled-release' tablet formulation of 200 mg ketoprofen was equally as effective as the 100 mg indomethacin suppository in the treatment of rheumatoid arthritis, especially with regard to pain at awakening and morning stiffness. Side-effects in both groups were those commonly seen with non-steroidal anti-inflammatory drugs and, as expected, gastro-intestinal and CNS disturbances predominated. Overall, side-effects were fewer with ketoprofen than with indomethacin.

RCT Entities:   Population Interventions Outcomes