TY - JOUR
T1 - Effectiveness of combined GnRH analogue plus raloxifene administration in the treatment of uterine leiomyomas
T2 - A prospective, randomized, single-blind, placebo-controlled clinical trial
AU - Palomba, Stefano
AU - Russo, Tiziana
AU - Orio, Francesco
AU - Tauchmanovà, Libuse
AU - Zupi, Errico
AU - Panici, Pier Luigi Benedetti
AU - Nappi, Carmine
AU - Colao, Annamaria
AU - Lombardi, Gaetano
AU - Zullo, Fulvio
PY - 2002/12/1
Y1 - 2002/12/1
N2 - 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 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.
AB - 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 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.
KW - Add-back therapy
KW - Fibroids
KW - GnRH analogue
KW - Leiomyomas
KW - Raloxifene
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M3 - Article
C2 - 12456626
AN - SCOPUS:0036904277
VL - 17
SP - 3213
EP - 3219
JO - Human Reproduction
JF - Human Reproduction
SN - 0268-1161
IS - 12
ER -