Controlled clinical study of the efficacy and tolerability of methoxybutropate compared to nimesulide in gynecology

BACKGROUND: This study was conducted to evaluate the efficacy and tolerability of methoxibutropate, a non-steroidal antiinflammatory drug, in gynecology. Methoxibutropate has now been available for some years and has recently been prepared in a new formulation: oral granules. MATERIALS AND METHODS: This was a double-blind study and enrolled 60 patients of childbearing potential (age: 19 to 42 years), with acute or sub-acute inflammatory diseases involving the genital system. Thirty women were treated for 20 days with 1200 mg/day of oral methoxibutropate. Thirty more women were treated with nimesulide as a control drug. Oral granules of nimesulide were administered in daily dosage of 200 mg. Efficacy was evaluated by assessing symptoms and signs at day 8, 15, 21 and 30 after the start of treatment. Symptoms assessed were: pelvic pain, bloated abdomen, breast tenderness, dysmenorrhea, etc. Signs assessed were: volume and consistency of uterus and adnexa, type and volume of vaginal discharge, pelvic tenderness, vaginal tenderness, etc. RESULTS AND CONCLUSIONS: All the sixty patients enrolled completed the study, at the end of which the drugs were shown to be equally effective: between day 21 and day 30 after the beginning of treatment, resolution of the assessed signs and symptoms was almost complete, especially with methoxibutropate. Lastly, tolerability was remarkable: side effects were few and mild; also in this case methoxibutropate was slightly better.