[Methods and statistics of multicentral double-blind "cross-over" examination of naproxen compared to indomethacin]

The methodology of documenting clinical findings and statistical analysis of the results of a multicentre double-blind cross-over study, in which the efficacy of d-2-(6'-methoxy-2'-naphthyl)-propionic acid (naproxen) and indometacin in the treatment of rheumatic diseases was compared, is presented. Eight investigators from four clinics conducted this clinical trial according to an identical protocol in a total of 100 patients. 46 patients (5 male and 31 female) with rheumatoid arthritis received either of the two drugs over a period of 26 days. 35 patients (32 male and 3 female) with ankylosing spondylitis and 19 patients (8 male and 11 female) with osteoarthrosis were treated with either of the drugs for 15 days. The following parameters were investigated and documented: pain and its localization, inhibition of joint function, symptoms of inflammation, and the "quasi" irreversible joint changes. These various parameters were for statistical purposes combined as indices for pain, function, and inflammation. This permitted a quantitative evaluation of the analgesic and antiinflammatory efficacy as well as of the improvement of joint function of the two compounds tested. The overall results of the clinical parameters revealed no significant difference in efficacy for the two drugs. When differentiating the patients as to their sex, both drugs showed higher efficacy in male patients, and only slight efficacy in female patients.