TL;DR
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A retrospective study of more than 109,000 women using systemic menopause hormone therapy found a slightly higher incidence of a combined autoimmune disease outcome among those taking estrogen alone than among those taking estrogen with a progestogen. The study cannot show that either regimen causes autoimmune disease or whether hormone therapy changes risk compared with no treatment.
A retrospective study of 109,384 women using systemic menopause hormone therapy found a slightly higher incidence of a combined autoimmune disease outcome among those taking estrogen-only therapy than among those taking estrogen with a progestogen. The findings, presented at the Menopause Society annual meeting, show an association—not proof that one treatment causes autoimmune disease or that either regimen changes risk compared with no hormone therapy.
Researchers Hadia Saroya and Xuezhi (Daniel) Jiang of Drexel University College of Medicine used records from the TriNetX U.S. Collaborative Network to compare women ages 45 to 70 taking systemic estrogen-only or estrogen-progestogen therapy. After matching for demographic and medical characteristics, including hysterectomy and surgical menopause, each group included 54,692 women. The primary outcome was a composite of autoimmune diseases assessed at least 180 days after therapy began.
The composite outcome occurred in 4.9% of estrogen-only users and 4.5% of combined-therapy users. The reported hazard ratio was 1.076 (95% CI 1.015-1.141; P=0.022). The authors also reported statistically significant differences for five of 20 individual conditions: systemic lupus erythematosus, psoriasis, psoriatic arthritis, multiple sclerosis and lichen sclerosis. Rates were low; for example, multiple sclerosis was recorded in 0.2% versus 0.1% of the groups.
The authors said the absolute differences were small and may not be clinically meaningful. Jiang told MedPage Today the results support informed discussions and individualized care, not immediate treatment changes. He also said the study cannot establish whether either regimen raises or lowers risk compared with women who do not use hormone therapy.
A Small Difference, Not a Treatment Verdict
The report adds evidence about whether the type of menopause hormone therapy may matter when researchers study autoimmune outcomes. Much prior research has treated hormone therapy as a single exposure, while this study compared estrogen-only and estrogen-progestogen regimens. That distinction is relevant because the regimens are used in different clinical circumstances: combined therapy is generally used when endometrial protection is needed, while estrogen alone is commonly used after hysterectomy.
For patients and clinicians, the results are a reason to interpret the evidence carefully, not to assume a personal risk or change a prescription based on this study alone. The observed difference in the composite outcome was 0.4 percentage points, and the analysis cannot determine cause and effect. Researchers say prospective studies are needed to test whether the association holds and whether it has practical importance.
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How the Study Compared Therapy Types
The research team excluded women with a prior autoimmune disease, chemotherapy or immunotherapy exposure, premature ovarian insufficiency, organ transplantation, HIV, or vaginal estrogen use. The analysis focused on systemic hormone therapy and compared diagnoses recorded after treatment initiation. Matching was used to balance measured characteristics between the two groups, but it cannot account for every possible difference.
Earlier evidence has not produced a simple picture. JoAnn E. Manson of Harvard Medical School, a past Menopause Society president and an investigator in the Women’s Health Initiative, told MedPage Today that the findings were “provocative but need replication” in large randomized trials. She noted that WHI data did not show a significant difference in rheumatoid arthritis risk or severity between women assigned postmenopausal hormone therapy and placebo. A separate randomized trial in women with lupus found no increased risk of 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
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Limits of the Available Evidence
Because this was a retrospective observational study, it can identify an association but cannot establish that estrogen-only therapy caused the differences. The authors noted possible residual confounding and misclassification in electronic medical records. The database also lacked details on hormone therapy route, dose, and specific estrogen or progestogen formulations.
The findings do not compare either treatment with no hormone therapy, and the reported results do not show whether the association varies by age, timing of treatment, type of menopause, or underlying autoimmune susceptibility. Although five individual conditions had statistically significant results, their recorded rates were low; the clinical importance of those differences remains uncertain.
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Prospective Studies Needed to Test Findings
The researchers described this analysis as a starting point for prospective research. Future studies could compare hormone therapy users with non-users and examine whether results differ by treatment formulation, including natural micronized progesterone versus synthetic progestins. Researchers also called for analysis by age, timing of therapy initiation, surgical versus natural menopause, and baseline autoimmune susceptibility.
For now, the report does not establish a basis for changing treatment. Jiang’s stated message is to discuss individual care with a clinician; the next major evidence step is replication in stronger study designs, including large-scale randomized trials where feasible.
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Key Questions
What did the study find?
In this retrospective comparison, the composite autoimmune disease outcome occurred in 4.9% of estrogen-only users and 4.5% of estrogen-progestogen users. The study reported a small association, not proof of cause and effect.
Did the study show hormone therapy causes autoimmune disease?
No. The researchers examined health records retrospectively, so the results cannot establish that either treatment caused autoimmune disease. They also did not compare the treatment groups with women who used no hormone therapy.
Which conditions had higher reported rates?
The researchers reported statistically significant differences for systemic lupus erythematosus, psoriasis, psoriatic arthritis, multiple sclerosis and lichen sclerosis. The rates were low, and the authors said the absolute differences may not be clinically meaningful.
Should someone change their menopause hormone therapy because of this report?
The study authors said the findings support informed, individualized discussions rather than immediate treatment changes. Anyone considering a change should discuss their circumstances with a qualified healthcare professional.
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