Key result
High-dose cyclic estrogen replacement therapy with progesterone resulted in no statistically significant difference in thrombophlebitis, myocardial infarction, or uterine cancer compared to placebo.
Why the study?
Does high-dose estrogen replacement therapy with progesterone affect the incidence of cardiovascular events and carcinoma in postmenopausal women?
RCT (n=168)
Double-blind
Randomly chosen matched pairs
Does high-dose estrogen replacement therapy with progesterone affect the incidence of cardiovascular events and carcinoma in postmenopausal women?
In a small 10-year prospective study, estrogen replacement therapy did not significantly increase cardiovascular events or uterine cancer, but was associated with an increased risk of cholelithiasis.
Answers are grounded in this paper and cite their sources.
Challenges prior safety concerns for high-dose estrogen-progesterone; reinforces RCT evidence on CV and uterine cancer endpoints but leaves open larger confirmatory trials.
A 10-year double-blind prospective study was undertaken to evaluate the effects of estrogen replacement therapy (ERT). The sample population consisted of 84 pairs of randomly chosen postmenopausal in-patients, matched for age and diagnosis. The treatment group received high-dose conjugated estrogens, cyclically with progesterone. The controls recieved placebos. Results revealed no statistically significant difference in that incidence of thrombophlebitis, myocardial infarction (MI), or uterine cancer. There was a lower incidence of breast cancer in the treated group. Estrogen-treated patients showed a higher incidence of cholelithiasis. Those in the treated group who began the study with elevated beta/alpha lipoprotein ratios showed a reduction in that ratio over the course of the study, while the controls either maintained or increased their ratios. The low number of cases precludes drawing any real significance from the data on diseases of low frequency. The study excludes only a high incidence of complications from estrogens.
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Nachtigall et al. (1979) conducted an RCT in Postmenopausal (n=168). Conjugated estrogens with progesterone vs. Placebo was evaluated on Incidence of thrombophlebitis, myocardial infarction, or uterine cancer. High-dose cyclic estrogen replacement therapy with progesterone resulted in no statistically significant difference in thrombophlebitis, myocardial infarction, or uterine cancer compared to placebo.
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