OBJECTIVE: To obtain information on the efficacy of repeated short cycles of GNRH agonist treatment in order to avoid hysterectomy in near-menopausal women with symptomatic fibroids. STUDY DESIGN: 72 pre-menopausal women (mean age 50 years) with one or more uterine fibroids >10 cm in diameter, symptomatic menorrhagia lasting three months or more and haemoglobin=9 g/dl entered the study. The patients were randomized with ratio of approximately 1:4 to: (a) immediate surgery; or (b) treatment with goserelin acetate. Patients randomized to goserelin acetate received a first cycle of 3.6 mg depot once every 28 days for four months. They were followed-up for three years. If menorrhagia was observed during the follow-up the woman was given goserelin acetate 3.6 mg depot for another three months. In case of further menorrhagia, a third cycle of goserelin acetate 3.6 mg depot for three months was given. After the third cycle of therapy if there was still menorrhagia, the patient underwent hysterectomy plus bilateral oophorectomy. RESULTS:A total of 13 women were assigned to the immediate surgery group and 59 to goserelin. Three years after trial entry a total of 23 women allocated togoserelin acetate treatment had undergone hysterectomy. CONCLUSION: This study suggests that GNRH agonists are efficacious for avoiding hysterectomy in women near menopause with uterine fibroids.
RCT Entities:
OBJECTIVE: To obtain information on the efficacy of repeated short cycles of GNRH agonist treatment in order to avoid hysterectomy in near-menopausal women with symptomatic fibroids. STUDY DESIGN: 72 pre-menopausal women (mean age 50 years) with one or more uterine fibroids >10 cm in diameter, symptomatic menorrhagia lasting three months or more and haemoglobin=9 g/dl entered the study. The patients were randomized with ratio of approximately 1:4 to: (a) immediate surgery; or (b) treatment with goserelin acetate. Patients randomized to goserelin acetate received a first cycle of 3.6 mg depot once every 28 days for four months. They were followed-up for three years. If menorrhagia was observed during the follow-up the woman was given goserelin acetate 3.6 mg depot for another three months. In case of further menorrhagia, a third cycle of goserelin acetate 3.6 mg depot for three months was given. After the third cycle of therapy if there was still menorrhagia, the patient underwent hysterectomy plus bilateral oophorectomy. RESULTS: A total of 13 women were assigned to the immediate surgery group and 59 to goserelin. Three years after trial entry a total of 23 women allocated to goserelin acetate treatment had undergone hysterectomy. CONCLUSION: This study suggests that GNRH agonists are efficacious for avoiding hysterectomy in women near menopause with uterine fibroids.