Effectiveness of short-term administration of tibolone plus gonadotropin-releasing hormone analogue on the surgical outcome of laparoscopic myomectomy.
OBJECTIVE
To evaluate whether administration of tibolone changes the effectiveness of GnRH analogue administered before laparoscopic myomectomy.


METHODS
Prospective, randomized, open, placebo-controlled clinical trial.


METHODS
Department of Gynecology and Obstetrics, University of Naples Federico II, Naples, Italy.


METHODS
66 women with symptomatic uterine leiomyomas.


METHODS
Treatment for 2 months with leuprolide acetate and iron tablets, plus tibolone (group A) or placebo tablets (group B); or with leuprolide acetate and iron tablets (group C).


METHODS
Laparoscopic myomectomy at the end of treatment. Operative time and blood loss during surgery were recorded. Uterine volume, volume and number of uterine leiomyomas, volume and echogenicity of the largest uterine leiomyomas, hematologic data, and myoma-related symptoms were evaluated at baseline and 1 week before and after surgery.


RESULTS
Uterine and leiomyomata volume and myoma-related symptoms were significantly reduced and hematologic variables improved significantly in groups A and B, compared with baseline values and with group C. Operative time and blood loss were significantly less in groups A and B than in group C. After surgery, hematologic variables were significantly worse in group C compared with groups A and B. During the study no significant difference was detected between groups A and B.


CONCLUSIONS
Administration of tibolone administration in patients treated with GnRH analogue before laparoscopic myomectomy does not change the effectiveness of the analogue administered alone.
Palomba
S
S
Department of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, University of Naples Federico II, Naples, Italy. stefano.palombal@tin.it
Pellicano
M
M
Affinito
P
P
Di Carlo
C
C
Zullo
F
F
Nappi
C
C
D000328:Adult; D003131:Combined Modality Therapy; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000031:analogs & derivatives*; D019584:Hot Flashes / Q000139:chemically induced / Q000517:prevention & control; D006801:Humans; D007501:Iron / Q000627:therapeutic use; D010535:Laparoscopy; D007889:Leiomyoma / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D016729:Leuprolide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D009652:Norpregnenes / Q000008:administration & dosage* / Q000627:therapeutic use; D010919:Placebos; D011446:Prospective Studies; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*
D009652:Norpregnenes; D010919:Placebos; D007987:Gonadotropin-Releasing Hormone; D007501:Iron; D016729:Leuprolide; C027385:tibolone