R Garry1, A Khair, P Mooney, M Stuart. 1. Women's Endoscopic Laser Foundation, South Cleveland Hospital, Middlesbrough, UK.
Abstract
OBJECTIVE: To compare the effectiveness of goserelin and danazol prior to endometrial laser ablation and assess different dosage regimens. DESIGN: A prospective open randomised trial. SETTING:Specialist unit in minimal access gynaecological surgery in a district general hospital. PARTICIPANTS: One hundred and sixty premenopausal women with dysfunctional uterine bleeding. INTERVENTIONS: Randomisation into four groups receiving either one or two injections of goserelin acetate (3.6 mg subcutaneously) or 28 or 56 days of danazol (four 200 mg tablets daily), followed by endometrial laser ablation. MAIN OUTCOME MEASURES: Endometrial thickness pretreatment and, immediately prior to endometrial laser ablation, assessed by vaginal ultrasound and full thickness endometrial biopsy; appearance of the endometrium at surgery; duration of the operation; the amount of fluid absorbed during surgery; and the clinical outcome at 24 weeks after surgery. RESULTS: The two drugs were equally effective in thinning the endometrium. Compared with danazol, goserelin was better tolerated and resulted in a more satisfactory endometrial appearance at hysteroscopy, a greater reduction in cavity length (0.5 cm compared with 0.3 cm, P = 0.002), a shorter operation (16.4 min compared with 21.6 min, P < 0.001), less fluid absorption (0 ml compared with 200 ml, P = 0.001), and a higher rate of amenorrhoea or oligoamenorrhoea (77% compared with 54%, P < 0.001) at the six month check. The administration of goserelin for 8 weeks compared with 4 weeks produced greater thinning of the endometrium on ultrasound and on histological examination, a greater reduction in cavity length on ultrasound and an increase in reported vasomotor symptoms. In both treatment regimens, 95% of women reported a satisfactory reduction in menstrual flow at the six month check. CONCLUSIONS:Goserelin appears to be more effective and better tolerated than danazol for treatment prior to endometrial laser ablation. Eight weeks treatment with goserelin resulted in better operating conditions and more vasomotor side effect, compared with four weeks treatment, although there was no difference in clinical outcome.
RCT Entities:
OBJECTIVE: To compare the effectiveness of goserelin and danazol prior to endometrial laser ablation and assess different dosage regimens. DESIGN: A prospective open randomised trial. SETTING: Specialist unit in minimal access gynaecological surgery in a district general hospital. PARTICIPANTS: One hundred and sixty premenopausal women with dysfunctional uterine bleeding. INTERVENTIONS: Randomisation into four groups receiving either one or two injections of goserelin acetate (3.6 mg subcutaneously) or 28 or 56 days of danazol (four 200 mg tablets daily), followed by endometrial laser ablation. MAIN OUTCOME MEASURES: Endometrial thickness pretreatment and, immediately prior to endometrial laser ablation, assessed by vaginal ultrasound and full thickness endometrial biopsy; appearance of the endometrium at surgery; duration of the operation; the amount of fluid absorbed during surgery; and the clinical outcome at 24 weeks after surgery. RESULTS: The two drugs were equally effective in thinning the endometrium. Compared with danazol, goserelin was better tolerated and resulted in a more satisfactory endometrial appearance at hysteroscopy, a greater reduction in cavity length (0.5 cm compared with 0.3 cm, P = 0.002), a shorter operation (16.4 min compared with 21.6 min, P < 0.001), less fluid absorption (0 ml compared with 200 ml, P = 0.001), and a higher rate of amenorrhoea or oligoamenorrhoea (77% compared with 54%, P < 0.001) at the six month check. The administration of goserelin for 8 weeks compared with 4 weeks produced greater thinning of the endometrium on ultrasound and on histological examination, a greater reduction in cavity length on ultrasound and an increase in reported vasomotor symptoms. In both treatment regimens, 95% of women reported a satisfactory reduction in menstrual flow at the six month check. CONCLUSIONS: Goserelin appears to be more effective and better tolerated than danazol for treatment prior to endometrial laser ablation. Eight weeks treatment with goserelin resulted in better operating conditions and more vasomotor side effect, compared with four weeks treatment, although there was no difference in clinical outcome.