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Tibolone reverses the cognitive effects caused by leuprolide acetate administration, improving mood and quality of life in patients with symptomatic uterine leiomyomas
- Publication Year :
- 2008
- Publisher :
- ELSEVIER SCIENCE INC, 2008.
-
Abstract
- Objective To investigate the effects of tibolone co-administration with GnRH agonist treatment in terms of cognition, mood, and quality of life. Design Randomized, controlled, single-blind, clinical trial. Setting Department of gynecology and obstetrics at a university in Italy. Patient(s) One hundred ten premenopausal women with symptomatic uterine leiomyomas. Intervention(s) 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). Main Outcome Measure(s) At baseline and after 6 months of treatment, uterine and leiomyoma sizes, leiomyoma-related symptoms, climacteric-like symptoms, cognition, mood, and quality of life. Result(s) 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. Conclusion(s) 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.
- Subjects :
- cognition
Time Factors
Administration, Oral
Tibolone
Gastroenterology
Quality of life
Leuprorelin
Delayed-Action Preparation
Uterine Neoplasm
Single-Blind Method
Leiomyoma
Obstetrics and Gynecology
Middle Aged
Treatment Outcome
tibolone
Uterine Neoplasms
Corticosteroid
Female
Central Nervous System Agent
SNC
Human
medicine.drug
Adult
medicine.medical_specialty
Time Factor
Antineoplastic Agents, Hormonal
Norpregnenes
medicine.drug_class
mood
Placebo
GnRH-a
leuprolide acetate
Internal medicine
medicine
Humans
Gynecology
Norpregnene
business.industry
medicine.disease
Clinical trial
Affect
Mood
Reproductive Medicine
Delayed-Action Preparations
Quality of Life
Leuprolide
business
Central Nervous System Agents
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....55f3d2fafd3d5358f5d219a4b367f8e4