title: Tibolone reverses the cognitive effects caused by leuprolide acetate administration, improving mood and quality of life in patients with symptomatic uterine leiomyomas.
abstract: 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.
authors.affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Catanzaro, Italy. stefanopalomba@tin.it <stefanopalomba@tin.it>
authors.forename: Stefano
authors.initials: S
authors.lastname: Palomba
authors.forename: Francesco
authors.initials: F
authors.lastname: Orio
authors.forename: Angela
authors.initials: A
authors.lastname: Falbo
authors.forename: Rosamaria
authors.initials: R
authors.lastname: Oppedisano
authors.forename: Achille
authors.initials: A
authors.lastname: Tolino
authors.forename: Fulvio
authors.initials: F
authors.lastname: Zullo
mesh_terms: 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
chemical_list: D018931:Antineoplastic Agents, Hormonal; D002491:Central Nervous System Agents; D003692:Delayed-Action Preparations; D009652:Norpregnenes; D016729:Leuprolide; C027385:tibolone