Short-term administration of tibolone plus GnRH analog before laparoscopic myomectomy.
OBJECTIVE
To evaluate whether tibolone modifies the effectiveness of gonadotropin-releasing hormone (GnRH) analog administered before laparoscopic myomectomy.


METHODS
Prospective, randomized, open, placebo-controlled clinical trial (Canadian Task Force classification I).


METHODS
University-affiliated hospital.


METHODS
Sixty-six women with symptomatic leiomyomas.


METHODS
Patients received 2 months of treatment with GnRH analog and iron plus tibolone (group A) or placebo (group B); group C received only iron. Laparoscopic myomectomy was performed after medical treatment.


RESULTS
Uterine volume, number and volume of leiomyomas, echogenicity and volume of the largest leiomyomas, hematologic values, and myoma-related symptoms were evaluated at baseline, 1 week before, and 1 week after surgery. We observed significant (p <0.05) reductions in uterine and leiomyomata volume, myoma-related symptoms, and improvement in hematologic values before surgery in groups A and B, without significant difference between groups compared with baseline values and group C. Operating time and blood loss were significantly (p <0.05) lower in groups A and B, without significant difference compared with group C. After surgery, significant numbers of women in group C had worsening of hematologic values (p <0.05).


CONCLUSIONS
Adding tibolone to the GnRH analog regimen before laparoscopic myomectomy does not modify the effectiveness of GnRH analog administered alone.
Palomba
Stefano
S
Department of Obsterics and Gynecology, University of Messina, Italy.
Morelli
Michele
M
Noia
Roberto
R
Santagata
Marco
M
Oliverio
Anna
A
Sena
Teresa
T
Zullo
Fulvio
F
Mastrantonio
Pasquale
P
D000328:Adult; D020847:Estrogen Receptor Modulators / Q000008:administration & dosage*; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000031:analogs & derivatives*; D006801:Humans; D010535:Laparoscopy; D007889:Leiomyoma / Q000601:surgery*; D008875:Middle Aged; D009652:Norpregnenes / Q000008:administration & dosage*; D011300:Preoperative Care; D011446:Prospective Studies; D014594:Uterine Neoplasms / Q000601:surgery*
D020847:Estrogen Receptor Modulators; D009652:Norpregnenes; D007987:Gonadotropin-Releasing Hormone; C027385:tibolone