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A study of more than 100,000 women found a slightly higher incidence of autoimmune disease among users of estrogen-only menopausal hormone therapy than among users of estrogen-progestogen therapy. The researchers said the observational findings do not establish that either treatment causes or prevents autoimmune disease, and the absolute difference was small.
A retrospective study of 109,384 women using systemic menopausal hormone therapy found a small difference in autoimmune disease incidence: 4.9% with estrogen-only therapy and 4.5% with estrogen-progestogen therapy. The results, presented at the Menopause Society annual meeting, show an association between treatment type and recorded diagnoses, but do not establish that either regimen causes or prevents autoimmune disease.
Researchers Hadia Saroya and Xuezhi (Daniel) Jiang of Drexel University College of Medicine used records from the TriNetX U.S. Collaborative Network. They compared two propensity score-matched groups of 54,692 women each, ages 45 to 70, who received systemic menopausal hormone therapy. The primary outcome was a composite of autoimmune diseases assessed at least 180 days after treatment began.
The composite outcome occurred in 4.9% of the estrogen-only group and 4.5% of the combined-therapy group. The study reported a hazard ratio of 1.076 (95% CI 1.015-1.141; P=0.022). Of 20 individual conditions assessed, five had statistically higher hazards in the estrogen-only group: systemic lupus erythematosus, psoriasis, psoriatic arthritis, multiple sclerosis and lichen sclerosis. The absolute percentages for those conditions were low, and some rounded percentages were similar between groups.
The authors said the differences were statistically significant but small and may not be clinically meaningful. The study excluded women with a prior autoimmune disease and several other conditions or exposures, including chemotherapy or immunotherapy, organ transplantation and HIV. It did not compare hormone users with women who took no hormone therapy.
Why the Small Difference Matters
The findings may help clinicians and patients discuss whether hormone therapy formulations could be associated with different health outcomes. Estrogen-only therapy is commonly used after hysterectomy, while estrogen-progestogen treatment is generally used when progestogen is needed to protect the uterine lining. The study does not show that switching regimens would reduce autoimmune disease risk, and its results are not a reason on their own to change treatment.
Jiang told MedPage Today that the clinical message is to support informed discussions and individualized care, rather than immediate treatment changes. The study also highlights a research gap: earlier work has often treated menopausal hormone therapy as one exposure, despite estrogen and progesterone having different effects on immune function.
The findings are relevant because autoimmune diseases are more common in women than men, but the observed overall difference was four-tenths of a percentage point in this study. Individual risk, treatment benefits and risks, and medical history still require discussion with a qualified healthcare professional.
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How Researchers Compared Therapies
The research was a retrospective cohort study, not a randomized trial. Investigators matched participants on demographic and medical characteristics, including hysterectomy and surgical menopause, and followed them for comparable periods. Matching can reduce differences between groups, but it cannot account for every factor that might affect both treatment choice and health outcomes.
Past evidence has not settled how menopausal hormone therapy relates to autoimmune disease. JoAnn E. Manson of Harvard Medical School told MedPage Today that the findings 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 taking postmenopausal hormone therapy and those taking placebo. A separate randomized trial in women with lupus found no increase in severe flares, though it reported a small risk of more mild-to-moderate flares.
“The clinical message is to encourage informed discussions and individualized care rather than immediate changes in treatment.”
— Xuezhi (Daniel) Jiang, study co-author, speaking to MedPage Today
Limits of the Risk Estimate
Because the analysis used existing medical records, it can identify an association but cannot establish cause and effect. Residual confounding may remain despite matching, and diagnoses in electronic records may be misclassified. The researchers also lacked information on treatment route, dose, and the specific estrogen or progestogen formulations used.
The study does not answer whether either regimen raises or lowers autoimmune disease risk compared with no hormone therapy. It also remains unclear whether results vary by age, when treatment starts, natural versus surgical menopause, underlying autoimmune susceptibility, or the use of micronized progesterone versus synthetic progestins. The reported percentages are group-level findings and do not predict an individual patient’s risk.
Further Studies Needed
The researchers described the analysis as a starting point for prospective research that can compare hormone therapy with no treatment and examine specific formulations. Future studies could test whether the associations differ by age, timing of initiation, type of menopause and underlying autoimmune risk.
For now, the findings are a conference-reported observational result. Clinicians and patients should base treatment decisions on individual circumstances and established medical guidance, not on this study alone. Replication and larger randomized trials would be needed to clarify whether the observed differences reflect treatment effects or other factors.
Key Questions
What did the study find?
Among systemic hormone therapy users, 4.9% of women using estrogen only and 4.5% using estrogen with progestogen had the study’s composite autoimmune disease outcome. The retrospective study found an association, not proof that treatment caused the difference.
Does this mean estrogen-only therapy causes autoimmune disease?
No. The researchers used existing health records, so the study cannot establish cause and effect. The authors also said they could not determine whether either regimen changes risk compared with taking no hormone therapy.
Which conditions had higher reported hazards?
The study reported statistically higher hazards in the estrogen-only group for lupus, psoriasis, psoriatic arthritis, multiple sclerosis and lichen sclerosis. The absolute percentages were low; the results need confirmation in further research.
Should patients change their hormone therapy?
The study authors advised informed, individualized discussions rather than immediate treatment changes. Patients should consult a qualified healthcare professional about decisions based on their own health history and needs.
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