TL;DR
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A retrospective study of 109,384 women found autoimmune disease incidence of 4.9% among those using systemic estrogen-only therapy and 4.5% among those using estrogen-progestogen therapy. Researchers said the association was small, does not show that either treatment changes risk compared with no hormone therapy, and should not prompt immediate treatment changes.
A retrospective study of more than 100,000 women using systemic menopause hormone therapy found a slightly higher incidence of autoimmune disease among those taking estrogen-only therapy than among those taking estrogen-progestogen therapy. The difference was small, and the researchers said the findings do not establish whether either regimen raises or lowers risk compared with no hormone therapy.
The matched study included 54,692 women in each treatment group, identified through the TriNetX U.S. Collaborative Network. Participants were ages 45 to 70, and researchers assessed new composite autoimmune disease diagnoses at least 180 days after therapy began. Incidence was 4.9% with estrogen-only therapy and 4.5% with combined therapy, a statistically significant association (hazard ratio 1.076; 95% confidence interval 1.015 to 1.141).
Among 20 individual autoimmune diseases assessed, the researchers reported significantly higher hazards in the estrogen-only group for systemic lupus erythematosus, psoriasis, psoriatic arthritis, multiple sclerosis and lichen sclerosus. The reported incidence figures were low for each condition; for example, multiple sclerosis was recorded in 0.2% of the estrogen-only group and 0.1% of the combined-therapy group. The authors cautioned that these absolute differences may not be clinically meaningful.
The results were presented in a poster at the Menopause Society annual meeting by medical student Hadia Saroya and Xuezhi (Daniel) Jiang, MD, PhD, of Drexel University College of Medicine. The study compared the two types of systemic treatment; it did not include a group of women who used no hormone therapy. Its findings show an association, not proof that the treatment type caused the diagnoses.
What the Small Difference Means
The results could inform conversations between patients and clinicians about hormone therapy, but they do not establish that a woman should switch treatments or avoid estrogen-only therapy. The observed difference in overall autoimmune disease incidence was 0.4 percentage points, and the authors said the absolute differences could lack clinical significance. Treatment decisions also depend on a patient’s health history and the reason hormone therapy is being used.
Estrogen-only therapy is commonly used after hysterectomy, while estrogen-progestogen therapy is generally used when progestogen is needed to protect the uterine lining. These are not necessarily interchangeable options for every patient. Jiang told MedPage Today that the clinical message is to support informed discussion and individualized care, rather than immediate changes in treatment.
The study may help shape future research because autoimmune diseases are more common in women than in men, according to Menopause Society medical director Stephanie Faubion. But the findings need confirmation before they can clarify how particular hormone regimens relate to autoimmune disease risk.
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How Researchers Compared Therapies
The researchers used electronic health records to identify women ages 45 to 70 who were taking systemic menopausal hormone therapy. They excluded people with a prior autoimmune disease and those with several other factors, including chemotherapy or immunotherapy exposure, premature ovarian insufficiency, organ transplantation, HIV or vaginal estrogen use. The groups were matched on demographic and medical characteristics, including hysterectomy and surgical menopause.
Prior research has often treated menopausal hormone therapy as a single exposure, Jiang explained to MedPage Today. This study instead compared estrogen-only therapy with estrogen-progestogen therapy, which have different uses and involve hormones that may affect immune function through different mechanisms. Earlier evidence has not been consistent: the Women’s Health Initiative did not find a significant difference in rheumatoid arthritis risk or severity between participants assigned hormone therapy or placebo. A separate trial in women with lupus found no increase in severe flares, though it reported a small risk of increased mild-to-moderate flares.
“The clinical message is to encourage informed discussions and individualized care rather than immediate changes in treatment.”
— Xuezhi (Daniel) Jiang, MD, PhD, co-author, speaking to MedPage Today
Limits of the Risk Estimate
Because the study was retrospective and observational, unmeasured differences between patients could help explain the results. The authors also noted possible errors in electronic-record diagnoses. TriNetX data did not specify the hormone therapy route, dose, or the particular estrogen and progestogen formulations, limiting the researchers’ ability to compare those details.
The study cannot show whether either regimen changes autoimmune disease risk compared with no treatment, nor can it establish that hormone therapy caused the conditions recorded. It is also unclear whether the associations vary by age, when therapy began, surgical versus natural menopause, or underlying autoimmune susceptibility. The authors said the small absolute differences may not be clinically meaningful.
Research Needed to Test the Findings
The researchers described the study as a starting point for prospective research that includes a comparison with women not using hormone therapy. Further work could also compare natural micronized progesterone with synthetic progestins and examine whether results differ by age, timing of treatment initiation, menopause type or baseline autoimmune susceptibility.
For now, the reported evidence supports discussion with a health professional rather than a blanket change in treatment. Large-scale randomized trials and independent replication would be needed to establish whether the association is consistent and whether it has practical consequences for patients.
Key Questions
What did the study find?
In a matched retrospective comparison, composite autoimmune disease incidence was 4.9% with estrogen-only therapy and 4.5% with estrogen-progestogen therapy. The study found an association, not proof that one regimen caused disease.
Which conditions had higher reported hazards with estrogen-only therapy?
The researchers reported higher hazards for systemic lupus erythematosus, psoriasis, psoriatic arthritis, multiple sclerosis and lichen sclerosus. The absolute incidence figures for these individual conditions were low.
Does this mean patients should change their hormone therapy?
No. The study authors said the findings should encourage informed, individualized discussions, not immediate treatment changes. Patients should discuss their treatment and health history with their clinician.
Can the study show that hormone therapy increases autoimmune disease risk?
No. It compared two hormone therapy groups and did not include women who used no hormone therapy. Its retrospective design also means it cannot establish cause and effect.
What research is needed next?
The authors called for prospective studies, including research comparing hormone therapy with no treatment. They also identified formulation, dose, age, treatment timing and menopause type as areas for further study.
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