Objective: To investigate the effect of hormone treatment on psychosocial distress of women during the menopausal transition (aged 40-52 years, still menstruating and with minor symptoms), in a study carefully designed to reduce bias and placebo effect.
Methods: The study was randomized, controlled by placebo, blinded to the subject, investigators and biostatistician, crossed-over after 6 months, and evaluated by a 77-item questionnaire every month for 12 months. The medication tested was continuous conjugated estrogens (Premarin) and cyclic medroxyprogesterone acetate (Provera).
Results: Of an eligible 105 apparently healthy women, recruited by advertisement, 83 completed the questionnaires for the study. Randomization was successful. While there was a substantial variation over time in the change of scores for all the psychosocial outcomes, there was no significant difference between active and placebo treatment when order of treatment allocation was ignored. However, a strong and consistent effect of the order of treatment allocation for many of the scores was found; in particular, the effect of active treatment was substantially stronger when it was administered second. Positive effects of active treatment were found for the score for the overall symptom rating test (p < 0.009) and its components of depression and feeling of inadequacy (p = 0.011; p = 0.001, respectively).
Conclusions: The use of hormones, given as a continuous estrogen and cyclic progestogen formulation after a formal calibration/run-in period, may have a beneficial effect on psychosocial distress experienced by women towards the end of their reproductive function.