Women with multiple sclerosis (MS) who took a hormonal therapy containing bazedoxifene and conjugated estrogen reported fewer hot flashes, better satisfaction, and fewer missed doses than women taking a placebo, according to a phase 1b/2a double-blind, randomized controlled trial published in Multiple Sclerosis and Related Disorders.
“This product is composed of conjugated estrogens (such as those used in Premarin) combined with a selective estrogen receptor modulator (bazedoxifene),” the authors explained. “It may offer some advantages over conventional [hormone therapy] that are favorable to women with MS, including benefits on breast health and bone health.”
Most women are diagnosed with MS prior to menopause. Therefore, the question of whether improvements in vasomotor symptoms using proven medications during the menopausal transition could potentially improve their MS-related symptoms and quality of life is an important and under-investigated area.
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One hurdle to such investigations is the perceived risk of safety issues with hormonal therapy, which makes recruitment into trials a challenge. Due to concerns about the risks of hormone therapy, enrollment for this small study required 34 months.
However, the high level of retention (87%) and the encouraging treatment satisfaction results support the development of a larger powered trial of longer duration to assess whether bazedoxifene + conjugated estrogen could improve function in women with MS.
To facilitate such a trial and its enrollment, the authors suggest educating women with MS and their physicians about the updated risks and benefits of hormone therapy, which have been summarized in recent position statements by the North American Menopause Society and regional societies around the US. The future trial could include specific MS-related outcomes including sleep quality, symptoms as measured by a specific scale such as SymtoMS, and quality of life.
Bove R, Anderson A, Rowles W, et al. A hormonal therapy for menopausal women with MS: a phase Ib/IIa randomized controlled trial. Mult Scler Relat Disord. Published online March 19, 2022. doi:10.1016/j.msard.2022.103747