OBJECTIVE: To evaluate the effectiveness of gonadotropin-releasing hormone agonists (GnRH-a) with or without coadministration of tibolone in women with menstrual cycle-related irritable bowel syndrome (IBS). DESIGN: Prospective, randomized, placebo-controlled clinical trial. SETTING: Universities of Catanzaro and Naples. PATIENT(S): One hundred twenty young premenopausal women with menstrual cycle-related IBS (Rome II criteria). INTERVENTION(S): Administration of leuprolide acetate depot (LAD, 11.25 mg IM/3 months) plus tibolone (group A), LAD plus placebo tablets (group B), and injection of a placebo solution plus placebo tablets (group C). MAIN OUTCOME MEASURE(S): Severity of bowel symptoms or signs of IBS and quality of life (QoL), at baseline and after 6 months of treatment. RESULT(S): In all groups, the mean scores for each symptom or sign of IBS and for QoL were significantly improved after treatment. A significant difference was observed between group C and groups A and B. No difference between these last groups was detected in symptoms or signs of IBS. The QoL scores were significantly higher in group A than in group B. CONCLUSION(S): Gondotropin-releasing hormone agonist administration is effective in women with menstrual cycle-related IBS. The addition of tibolone does not reduce effectiveness compared with agonist alone and increases QoL.
RCT Entities:
OBJECTIVE: To evaluate the effectiveness of gonadotropin-releasing hormone agonists (GnRH-a) with or without coadministration of tibolone in women with menstrual cycle-related irritable bowel syndrome (IBS). DESIGN: Prospective, randomized, placebo-controlled clinical trial. SETTING: Universities of Catanzaro and Naples. PATIENT(S): One hundred twenty young premenopausal women with menstrual cycle-related IBS (Rome II criteria). INTERVENTION(S): Administration of leuprolide acetate depot (LAD, 11.25 mg IM/3 months) plus tibolone (group A), LAD plus placebo tablets (group B), and injection of a placebo solution plus placebo tablets (group C). MAIN OUTCOME MEASURE(S): Severity of bowel symptoms or signs of IBS and quality of life (QoL), at baseline and after 6 months of treatment. RESULT(S): In all groups, the mean scores for each symptom or sign of IBS and for QoL were significantly improved after treatment. A significant difference was observed between group C and groups A and B. No difference between these last groups was detected in symptoms or signs of IBS. The QoL scores were significantly higher in group A than in group B. CONCLUSION(S): Gondotropin-releasing hormone agonist administration is effective in women with menstrual cycle-related IBS. The addition of tibolone does not reduce effectiveness compared with agonist alone and increases QoL.