[Study of the action of bromocriptine in hyperprolactinemic states. Results of a cooperative trial in 135 patients].

The therapeutic activity of bromocriptine mesilate (CB 154) was studied in a coooperative trial over a period of three months and using the same protocol in eleven different centres. 126 women and 9 men were studied. All had hyperprolactinaemia associated either with gonadal insufficiency-amenorrhoea/galactorrhoea syndrome (102 cases), isolated amenorrhoea (8 cases), impotence (6 cases), or to galactorrhoea with in certain men gynaecomastia. 32 patients had previously undergone removal of a pituitary adenoma, but had a normal response to the administration of LH-RH. Of the 106 untreated patients, only 36 had tumour-like deformities of the sella turcica. Under the effects of treatment, blood prolactin levels fell in all cases exception 4 and returned to normal in 66% of patients. The average value fell from 197 +/- 19 to 36.8 +/- 3.4 ng/ml (p less than 0.001). Spontaneous and provoked galactorrhoea regressed in 100% and 75% of cases respectively. Ovarian function reappeared in 89.4% of cases, with 32 pregnancies occurring during the 3 months period. Gynaecomastia and impotence responded in approximately half the men. The effectiveness of treatment was independent of the duration of the disorder (ranging from a few months to five years), the initial prolactin level and the radiological state of the sella turcica. Tolerance was satisfactory apart from transient problems (essentially digestive) occurring during the first days of treatment. In case of pregnancy, careful repeated studies of the sella turcica and visual fields are needed in order to detect possible growth of underlying pituitary adenomas or micro-adenomas.