A PROSPECTIVE, CONTROLLED TRIAL OF SIX FORMS OF HORMONE REPLACEMENT THERAPY GIVEN TO POSTMENOPAUSAL WOMEN

This large prospective controlled study gleaned its patients from age/sex registers of 2 large general practices to study the effects of various forms of hormone replacement therapy (HRT) on postmenopausal women. Variables controlled were age duration of amenorrhea and general health; and was accomplished by each subject acting as her own control. In addition placebo effect was investigated by random allocation of placebo or 1 of 6 forms of HRT. The 7 therapy groups included: placebo; conjugated equine estrogens 1.25 mg; EO 1.25 mg plus norethisterone acetate (NA) 5 mg; piperazine estrone sulfate 1.5 mg; ES 1.5 mg plus NA 5 mg; estradiol valerate (E) 2 mg; and E 2 mg plus norgestrel (Ng) .5 mg. These broad conclusions were drawn: 1) hot flashes and sweating persist in some women despite high endogenous estrogen concentrations; 2) vaginal cytology is not a good indicator of endogenous estrogen status; 3) prolactin is unaffected by HRT and luteinizing hormone and follicle stimulating hormone though decreased do not approach premenopausal levels; 4) plasma cholesterol levels were reduced on HRT; 5) pulse rate declined; 6) systolic and diastolic blood pressures were reduced to a small extent; 7) no adverse effect on blood clotting occurred; and 8) most women experienced relief of symptoms on all forms of HRT as did some women taking placebos. Combined estrogen-progestin formulations produced vaginal bleeding in 80% of women. To avoid bleeding a low-dose estrogen preparation is recommended to be taken cyclically for 6-12 months.