Efficacy of tibolone as "add-back therapy" in conjunction with a gonadotropin-releasing hormone analogue in the treatment of uterine fibroids.
OBJECTIVE
To assess the efficacy of tibolone add-back therapy with Goserelin treatment of uterine fibroids.


METHODS
Randomized placebo-controlled study.


METHODS
Gynecology department of an inner-city teaching hospital.


METHODS
Seventy-five women of reproductive age with uterine fibroids.


METHODS
All women were given monthly SC implants of 3.6 mg goserelin and were randomized to take 3 months of placebo followed by 3 months of tibolone 2.5 mg daily (delayed administration), tibolone 2.5 mg daily for 6 months, or placebo for 6 months.


METHODS
Changes in bone mineral density (BMD) at the hip and spine, fibroid and uterine size, and patient symptomatology.


RESULTS
In the tibolone group, 2% loss of BMD at the spine was observed compared with 5.5% loss in the placebo group. For total hip, tibolone led to a 0.7% gain in BMD compared with a loss of 1.7% in the placebo group. Tibolone did not affect GnRH analogue-induced fibroid shrinkage. Vasomotor symptom scores in women taking tibolone were 2.2 and were significantly lower than those taking placebo or in the delayed administration groups (mean scores 2.9 and 2.7, respectively).


CONCLUSIONS
Tibolone appears to be a safe and effective add-back therapy which can be given from the commencement of GnRH analogue treatment for fibroids.
Morris
Edward Patrick
EP
Menopause Research Unit, Department of Obstetrics and Gynaecology, Norfolk & Norwich University Hospital, Colney Lane, Norwich, UK. edward.morris@nnuh.nhs.uk
Rymer
Janice
J
Robinson
Jill
J
Fogelman
Ignac
I
D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects; D001842:Bone and Bones / Q000378:metabolism; D017024:Chemotherapy, Adjuvant; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000031:analogs & derivatives*; D017273:Goserelin / Q000627:therapeutic use*; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy*; D008875:Middle Aged; D009652:Norpregnenes / Q000009:adverse effects / Q000627:therapeutic use*; D010349:Patient Compliance; D010919:Placebos; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000139:chemically induced; D014594:Uterine Neoplasms / Q000188:drug therapy*
D018931:Antineoplastic Agents, Hormonal; D009652:Norpregnenes; D010919:Placebos; D017273:Goserelin; D007987:Gonadotropin-Releasing Hormone; C027385:tibolone