RANDOMIZED COMPARISON OF ESTROGEN VERSUS ESTROGEN PLUS PROGESTOGEN HORMONE REPLACEMENT THERAPY IN WOMEN WITH HYSTERECTOMY

Objective-To compare the acceptability and symptomatic and metabolic e ffects of two regimens of hormone replacement therapy in women with hy sterectomy. Design-Randomised, double blind comparison. Setting-Seven group practices in the Medical Research Council's general practice res earch framework. Subjects-321 women with hysterectomy aged 35-59. Inte rventions-Hormone replacement therapy with (a) conjugated equine oestr ogen 625 mu g daily alone or (b) conjugated equine oestrogen 625 mu g daily plus the progestogen norgestrel 150 mu g daily for the last It d ays of the ''cycle.'' Main outcome measures-Changes in blood pressure, weight, symptoms, and haemostatic and lipid values. Results-After two years 36% (57/158) of women randomly allocated to take oestrogen alon e had discontinued treatment as compared with 30% (49/163) of women al located to take oestrogen plus progestogen. Smokers were more likely t o withdraw than non-smokers. There were no clear differences between t he two groups in symptoms often attributed to hormone replacement ther apy or in blood pressure or weight. At one year low density lipoprotei n cholesterol concentrations had fallen substantially in both groups. High density lipoprotein cholesterol concentrations rose to significan tly higher values in oestrogen alone compared with oestrogen plus prog estogen, though triglyceride concentrations and factor VII activity we re also significantly higher in this group. Fibrinogen concentration t ended to fall, though not significantly, in both groups, possibly more in women taking oestrogen alone. Conclusions-Oestrogen plus progestog en was no less well tolerated than oestrogen alone. There was a fairly even balance between possibly beneficial and adverse effects of the t wo regimens on lipid concentrations and coagulability. Concern that th e combined regimen may not have the cardioprotective effects ascribed to oestrogen alone can to some extent be allayed, with reassurance for the growing numbers of women with intact uteri using the combined reg imen. Misgivings about the combined regimen in women with hysterectomy on the grounds of its acceptability and its effects on lipid values m ay also be unfounded.