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 cen tres to compare the efficacy and tolerability of 'controlled-release' ketoprofen tablets (200 mg) with that of indomethacin suppositories (1 00 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 dum my of the other formulation for a period of 3 weeks. They were then cr ossed over to the alternative treatment for a further 3 weeks. Daily d iary records were kept by patients of the number of night-time awakeni ngs due to pain, pain severity at awakening in the morning and the dur ation. of early morning stiffness. Treatment efficacy was also assesse d at the end of each trial period by means of an articular index and b y physician's and patient's overall evaluation of response. Adverse ef fects spontaneously mentioned by the patients or elicited by direct qu estioning using a symptom check-list were recorded Statistical analysi s of the results from 83 evaluable patients showed that the 'controlle d-release' tablet formulation of 200 mg ketoprofen was equally as effe ctive as the 100 mg indomethacin suppository in the treatment of rheum atoid arthritis, especially with regard to pain at awakening and morni ng stiffness. Side-effects in both groups were those commonly seen wit h non-steroidal anti-inflammatory drugs and, as expected, gastro-intes tinal and CNS disturbances predominated Overall, side-effects were few er with ketoprofen than with indomethacin.