Effectiveness of combined GnRH analogue plus raloxifene administration in the treatment of uterine leiomyomas: a prospective, randomized, single-blind, placebo-controlled clinical trial.
BACKGROUND
Raloxifene hydrochloride is a synthetic non-steroidal drug used for the prevention and treatment of post-menopausal osteoporosis. Pre-clinical and clinical data have shown that raloxifene may have a beneficial effect on leiomyomas. The aim of this prospective single-blind, randomized, placebo-controlled clinical trial was to evaluate the effectiveness of the addition of raloxifene to GnRH analogues on uterine, leiomyoma, and non-leiomyoma sizes, and on the occurrence of leiomyoma-related symptoms.


METHODS
After randomization using a computer-generated list, 100 pre-menopausal women with symptomatic uterine leiomyomas received either leuprolide acetate depot plus raloxifene 60 mg daily (group A) or leuprolide plus placebo tablet (group B) for six cycles of 28 days. At baseline and after treatment, uterine, leiomyoma and non-leiomyoma sizes, and leiomyoma-related symptoms were evaluated for each woman. Analysis was by intention-to-treat method.


RESULTS
After six cycles of treatment, a significant decrease in uterine, leiomyoma, and non-leiomyoma sizes was detected in both groups in comparison with baseline. At the same time, no significant difference in uterine and non-leiomyoma sizes was observed between the groups. Leiomyoma sizes were significantly (P < 0.05) lower in group A than in group B. No difference was observed in leiomyoma-related symptoms between groups throughout the study period.


CONCLUSIONS
In women treated with GnRH analogue, the raloxifene administration induces a higher reduction of leiomyoma sizes.
Palomba
Stefano
S
Department of Obstetrics Gynecology, University 'Magna Graecia' of Catanzaro, Catanzaro. stefanopalomba@tin.it
Russo
Tiziana
T
Orio
Francesco
F
Tauchmanovà
Libuse
L
Zupi
Errico
E
Panici
Pier Luigi Benedetti
PL
Nappi
Carmine
C
Colao
Annamaria
A
Lombardi
Gaetano
G
Zullo
Fulvio
F
D003692:Delayed-Action Preparations; D005260:Female; D019584:Hot Flashes; D006801:Humans; D007889:Leiomyoma / Q000000981:diagnostic imaging / Q000188:drug therapy*; D016729:Leuprolide / Q000008:administration & dosage* / Q000009:adverse effects; D008595:Menorrhagia; D010146:Pain; D010352:Patient Dropouts; D010919:Placebos; D017697:Premenopause; D011446:Prospective Studies; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage* / Q000009:adverse effects; D014463:Ultrasonography; D014594:Uterine Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy*
D003692:Delayed-Action Preparations; D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride; D016729:Leuprolide