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.

Leuprolide acetate treatment with and without coadministration of tibolone in premenopausal women with menstrual cycle-related irritable bowel syndrome.

PALOMBA, STEFANO;ORIO, FRANCESCO;MANGUSO, FRANCESCO;RUSSO, TOMMASO;LOMBARDI, GAETANO;
2005

Abstract

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.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/342072
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