The efficacy and safety of fentiazac and diclofenac sodium in peri-arthritis of the shoulder: a multi-centre, double-blind comparison.

In a double-blind parallel group comparison of efficacy and safety, 19 patients with peri-arthritis of the shoulder received 200 mg fentiazac twice daily and 19 received 50 mg diclofenae sodium twice daily, with both drugs given orally for 3 weeks. In both groups, observers' verbal rating scales of pain severity at rest and on movement showed decreases that were significant by week 1. Both groups also had sig­ nificant improvement in abduction, external rotation, retroversion and anteversion. At week I, the patients reported improvement, on a verbal rating scale, of global effectiveness, but there were no subse­ quent changes. There were no statistically significant differences between the treatments in any ofthese variables. Five (26%) fentiazac­ treated patients and four (21%) diclofenac sodium-treated patients reported adverse effects, mostly gastro-intestinal. One case of rash in each group and one case of pruritus in a diclofenac sodium-treated patient were severe enough for the patients to be withdrawn from therapy. There were no clinically significant changes in laboratory values. It was concluded that fentiazac (400 mg/day) and diclofenac sodium (100 mg/day) were equally effective within 1 week in decreas­ ing pain severity and improving shoulder mobility.