TL;DR
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A retrospective study of more than 100,000 women using systemic menopausal hormone therapy found a slightly higher rate of diagnosed autoimmune diseases among estrogen-only users than among users of estrogen-progestogen therapy. The researchers cautioned that the absolute difference was small, the study cannot establish cause and effect, and it did not compare either treatment with no hormone therapy.
A retrospective study of 109,384 women using systemic menopausal hormone therapy found a slightly higher incidence of autoimmune disease among those taking estrogen-only therapy than among those taking estrogen with a progestogen. The researchers reported the finding at the Menopause Society annual meeting, but said the small difference does not show that one regimen causes autoimmune disease or that either is riskier than no hormone therapy.
Researchers Hadia Saroya and Xuezhi (Daniel) Jiang of Drexel University College of Medicine compared two groups of 54,692 women each, matched on demographic and medical characteristics. Participants were ages 45 to 70 and had received systemic menopausal hormone therapy. The primary outcome was a composite of autoimmune diseases identified at least 180 days after treatment began.
The composite outcome occurred in 4.9% of estrogen-only users and 4.5% of estrogen-progestogen users. The reported hazard ratio was 1.076, with a 95% confidence interval of 1.015 to 1.141. The researchers also assessed 20 individual diseases; five had statistically higher hazards in the estrogen-only group: systemic lupus erythematosus, psoriasis, psoriatic arthritis, multiple sclerosis and lichen sclerosus. The absolute percentages for those conditions were low, and some rounded rates were similar between groups.
The authors said the results were statistically significant but that the absolute differences were small and might not be clinically meaningful. The study was a poster presentation and used records from the TriNetX U.S. Collaborative Network. It excluded women with a prior autoimmune disease and several other conditions or exposures, including chemotherapy or immunotherapy, organ transplantation and HIV.
How the Treatment Groups Compared
The findings may matter to patients and clinicians discussing which type of hormone therapy is appropriate, but they do not establish that changing regimens would reduce autoimmune disease risk. Estrogen-only therapy is commonly used after hysterectomy, while combined estrogen-progestogen therapy is generally used when a patient needs endometrial protection. Those treatment choices are not interchangeable for everyone.
Jiang told MedPage Today that the clinical message is to support informed discussion and individualized care, rather than immediate treatment changes. The study compared one therapy type with another; it did not include a group of women taking no hormone therapy. Readers should not interpret the reported percentages as evidence that hormone therapy itself raises risk.
The results also add to research on how different sex hormones may relate to immune function. Because autoimmune diseases are more common in women than in men, researchers say the association merits further study. The current analysis, however, cannot determine a biological explanation or show that the observed differences would appear in other populations.
menopause hormone therapy patient guide estrogen progestogen
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Why Researchers Compared Regimens
Much prior research has treated menopausal hormone therapy as a single exposure, Jiang said. This study instead separated estrogen-only and estrogen-progestogen regimens, which have different clinical uses and may affect immune function through different mechanisms. The analysis matched participants on factors including hysterectomy and surgical menopause, then assessed outcomes after treatment initiation.
Earlier evidence has not provided a consistent answer. JoAnn E. Manson of Harvard Medical School, a past Menopause Society president, told MedPage Today that findings from this study need replication and testing in large randomized trials. She noted that the Women’s Health Initiative did not find a significant difference in rheumatoid arthritis risk or severity between women receiving postmenopausal hormone therapy and placebo. A separate randomized trial in women with lupus found no higher risk of severe flares with hormone replacement therapy, but reported a small risk of increased mild-to-moderate flares.
These studies examined different outcomes and populations, so they do not directly confirm or refute the new comparison. The current report is an observational analysis presented at a professional meeting, not a randomized trial.
“The clinical message is to encourage informed discussions and individualized care rather than immediate changes to treatment.”
— Xuezhi (Daniel) Jiang, Drexel University College of Medicine, speaking to MedPage Today
Limits of the Risk Estimate
Because the study was retrospective, it can identify an association but cannot establish that estrogen-only therapy caused the difference. The researchers acknowledged possible residual confounding and misclassification in electronic medical records. The database also lacked information on route of administration, dosage, and the specific estrogen or progestogen formulations used.
The report does not establish how the results compare with women who use no hormone therapy. It also remains unclear whether the associations vary by age, when treatment begins, surgical versus natural menopause, underlying autoimmune susceptibility, or the type of progestogen. The authors said the absolute differences may not be clinically meaningful; the study did not determine the impact on an individual patient’s health.
Research Needed to Test the Finding
The researchers described the analysis as a starting point for prospective studies that could better track treatment exposure and autoimmune outcomes. They said future work should compare hormone therapy with no treatment and examine whether natural micronized progesterone and synthetic progestins are associated with different results.
Further research could also test whether the pattern differs by age, timing of treatment, type of menopause and baseline autoimmune risk. Until those questions are studied, the meeting report does not support a blanket recommendation to start, stop or change hormone therapy. Patients with questions about their regimen should discuss their circumstances and treatment options with a qualified clinician.
Key Questions
What did the study find?
In a retrospective comparison of systemic hormone therapy users, composite autoimmune disease incidence was 4.9% with estrogen-only therapy and 4.5% with estrogen-progestogen therapy. The researchers described the absolute difference as small.
Does this prove estrogen-only therapy causes autoimmune disease?
No. The study was observational and cannot establish cause and effect. The authors also said it did not show whether either regimen increases or decreases risk compared with no hormone therapy.
Which conditions had higher reported hazards?
The study reported statistically higher hazards in the estrogen-only group for systemic lupus erythematosus, psoriasis, psoriatic arthritis, multiple sclerosis and lichen sclerosus. The absolute rates were low.
Should patients change their hormone therapy because of this report?
The researchers advised informed, individualized discussions rather than immediate changes based on this finding. Patients should consult a qualified clinician about treatment decisions.
What are the main limitations?
The retrospective design can leave confounding and record-classification errors. The database lacked details such as hormone dose, route and specific formulations, and the study did not include a no-hormone-therapy comparison group.
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