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


METHODS
Prospective, randomized, placebo-controlled clinical trial.


METHODS
Universities of Catanzaro and Naples.


METHODS
One hundred twenty young premenopausal women with menstrual cycle-related IBS (Rome II criteria).


METHODS
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).


METHODS
Severity of bowel symptoms or signs of IBS and quality of life (QoL), at baseline and after 6 months of treatment.


RESULTS
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.


CONCLUSIONS
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.
Palomba
Stefano
S
Department of Obstetrics and Gynecology, University Magna Graecia of Catanzaro, Via Nicolardi 188, Naples 80131, Italy. stefanopalomba@tin.it
Orio
Francesco
F
Manguso
Francesco
F
Russo
Tiziana
T
Falbo
Angela
A
Lombardi
Gaetano
G
Doldo
Patrizia
P
Zullo
Fulvio
F
D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D016729:Leuprolide / Q000008:administration & dosage* / Q000009:adverse effects; D008597:Menstrual Cycle; D009652:Norpregnenes / Q000008:administration & dosage* / Q000009:adverse effects; D010352:Patient Dropouts; D017697:Premenopause; D011788:Quality of Life; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; D009652:Norpregnenes; D016729:Leuprolide; C027385:tibolone