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

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Abstract
SummaryA 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-li...