SYMPTOM RELIEF AND SIDE-EFFECTS OF POSTMENOPAUSAL HORMONES - RESULTS FROM THE POSTMENOPAUSAL ESTROGEN PROGESTIN INTERVENTIONS TRIAL/

Objective: To assess pair-wise differences between placebo, estrogen, and each of three estrogen-progestin regimens on selected symptoms. Me thods: This was a 3-year, multicenter, double-blind, placebo-controlle d trial in 875 postmenopausal women aged 45-64 years at baseline. Part icipants were assigned randomly to one of five groups: 1) placebo, 2) daily conjugated equine estrogens, 3) conjugated equine estrogens plus cyclical medroxyprogesterone acetate, 4) conjugated equine estrogens plus daily medroxyprogesterone acetate, and 5) conjugated equine estro gens plus cyclical micronized progesterone. Symptoms were self-reporte d using a checklist at 1 and 3 years. Factor analysis reduced 52 sympt oms to a set of six symptom groups. Results: In intention-to-treat ana lyses at 1 year, each active treatment demonstrated a marked, statisti cally significant, protective effect against vasomotor symptoms compar ed with placebo (odds ratios [ORs] 0.17-0.28); there was no additional benefit of estrogen-progestin over estrogen alone. Only progestin-con taining regimens were significantly associated with higher levels of b reast discomfort (OR 1.92-2.27). Compared with placebo, women randomiz ed to conjugated equine estrogens reported no increase in perceived we ight. Those randomized to medroxyprogesterone acetate reported less pe rceived weight gain (OR 0.61-0.69) than placebo. Anxiety, cognitive, a nd affective symptoms did not differ by treatment assignment. Analyses restricted to adherent women were not materially different than those using intention-to-treat, except that women adherent to medroxyproges terone acetate and micronized progesterone regimens reported fewer mus culoskeletal symptoms (OR 0.62-0.68). Conclusion: These results confir m the usefulness of postmenopausal hormone therapy for hot flashes, sh ow convincingly that estrogen plus progestin causes breast discomfort, and demonstrate little influence of postmenopausal hormones on anxiet y, cognition, or affect. (Obstet Gynecol 1998;92:982-8. (C) 1998 by Th e American College of Obstetricians and Gynecologists.).