Tibolone reverses the cognitive effects caused by leuprolide acetate administration, improving mood and quality of life in patients with symptomatic uterine leiomyomas.
OBJECTIVE
To investigate the effects of tibolone co-administration with GnRH agonist treatment in terms of cognition, mood, and quality of life.


METHODS
Randomized, controlled, single-blind, clinical trial.


METHODS
Department of gynecology and obstetrics at a university in Italy.


METHODS
One hundred ten premenopausal women with symptomatic uterine leiomyomas.


METHODS
Six months of treatment with leuprolide acetate depot (11.25 mg IM, every 3 mo) associated with either tibolone (2.5 mg/d orally; group A) or placebo (1 tablet per d; group B).


METHODS
At baseline and after 6 months of treatment, uterine and leiomyoma sizes, leiomyoma-related symptoms, climacteric-like symptoms, cognition, mood, and quality of life.


RESULTS
At study entry, no difference was detected between groups in any parameters assessed. After treatment, the leiomyoma-related symptoms were significantly reduced in both groups, without any statistically significant differences between them. The Kupperman Index was statistically significantly higher in group B in comparison with baseline and group A. The cognition scores were statistically significantly different in comparison with baseline in group B, whereas no change was observed in group A. After treatment, mood and quality of life were statistically significantly improved in both groups, even though the improvement was significantly higher in group A than in group B.


CONCLUSIONS
Tibolone administration reverses the deleterious effect on cognition that is caused by leuprolide acetate depot and improves mood and quality of life in patients who receive GnRH agonist for symptomatic uterine leiomyomas.
Palomba
Stefano
S
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy. stefanopalomba@tin.it <stefanopalomba@tin.it>
Orio
Francesco
F
Falbo
Angela
A
Oppedisano
Rosamaria
R
Tolino
Achille
A
Zullo
Fulvio
F
D000284:Administration, Oral; D000328:Adult; D000339:Affect / Q000187:drug effects*; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects*; D002491:Central Nervous System Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy* / Q000523:psychology; D016729:Leuprolide / Q000009:adverse effects*; D008875:Middle Aged; D009652:Norpregnenes / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000523:psychology
D018931:Antineoplastic Agents, Hormonal; D002491:Central Nervous System Agents; D003692:Delayed-Action Preparations; D009652:Norpregnenes; D016729:Leuprolide; C027385:tibolone