A microcomputer-assisted study of nabumetone and slow release diclofenac in osteoarthritis.

20 UK general-practice centres entered 243 patients into a 6-week double-blind, double-dummy, randomised, parallel-group trial designed to compare nabumetone 1 g at night with slow release diclofenac 100mg at night in the treatment of osteoarthritis. Seven efficacy parameters were measured, adverse events were recorded and laboratory monitoring was performed. The study monitor entered trial data into a portable laptop microcomputer at the participating centres. Both treatment groups showed highly significant clinical improvements at the end of the 6-week study period and there were no significant inter-group differences. Overall, the incidence of adverse events was similar in the 2 groups, but significantly fewer patients in the nabumetone group (n = 21) than in the diclofenac group (n = 35) complained of gastrointestinal adverse events (p = 0.03). On-site use of the microcomputer contributed to increased monitoring efficiency and trialist motivation, resulting in rapid recruitment of patients, collection of high quality data and speedy analysis at the end of the study.