DECREASE IN SYMPTOMS, BLOOD-LOSS AND UTERINE SIZE WITH NAFARELIN ACETATE BEFORE ABDOMINAL HYSTERECTOMY - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY

To evaluate the efficacy and safety of nafarelin before hysterectomy i n a prospective placebo-controlled trial, we randomized 188 pre-menopa usal women with uterine fibroids (n = 111), menometrorrhagia (n = 58) or pelvic pain (n = 19) to receive either nafarelin (200 mu g twice da ily as a nasal spray) or a placebo for 3 months before abdominal hyste rectomy, The data analysis could be performed in 166 women, of whom 10 7 received nafarelin and 59 a placebo, Nafarelin led to a rise in bloo d haemoglobin (5.5 g/l) and to a decrease in uterine volume (23.7%), T his, however, gave no objective benefit during surgery (similar operat ive durations and blood losses), The uteri from patients treated with nafarelin (255.5 +/- 12.6 g, mean +/- SD) were significantly lighter ( P = 0.029) than those from patients treated with a placebo (346.2 +/- 35.7 g), Histological examination of the fibroids or uteri revealed ch anges typical for hypo-oestrogenism, but no specific histological patt ern could be established, The endometrium was proliferative in 56% and showed mild hyperplastic features in 10% of patients given nafarelin, whereas the respective figures for the placebo group were 41 and 0%, Hot hushes were the most common side-effects, being reported by 61% in the nafarelin group and 35% in the placebo group, Nafarelin can be us eful as a pre-surgical adjunct in a patient scheduled for abdominal hy sterectomy if there is a need to raise the haemoglobin concentration o r to reduce the size of the uterus.