Hekun decoction versus Femoston for women with amnestic mild cognitive impairment in early menopause: a randomized, three-arm, double-blind clinical trial

Zhai Z, Lin G, Chen S, Liu H, Yuan R, Gao X, Ni X, Shen M, Fan H, Wang W, Zhao Y, Wu Y, Gu C, Cong C, Xiao S, Zhang Y, Zhao J, Xu J, Wang Y, Chen J, Chen Y, Zong Y, Tang Q, Li S, Zhang Z, Xu L · Frontiers in Neurology · 2025 September 12

DOI 10.3389/fneur.2025.1610562

Objective

To investigate the efficacy and safety of Hekun Decoction in women with amnestic mild cognitive impairment during early menopause.

Conclusions

Hekun Decoction demonstrated non-inferior efficacy to Femoston in improving cognitive function over 24 weeks in women with amnestic mild cognitive impairment during early menopause, with a favorable safety profile and fewer adverse events than Femoston.

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Insights

An herbal medicine improved cognition and menopausal symptoms as effectively as hormone therapy, while causing fewer adverse events in early-menopausal women with mild cognitive impairment.

This prospective, randomized, double-blind, three-group clinical trial enrolled women in early menopause who had amnestic mild cognitive impairment. Participants received either Hekun Decoction, hormone therapy with Femoston, or a placebo for twenty-four weeks. Researchers assessed changes in cognitive performance, menopausal symptoms, sleep disturbance, and adverse events. Both Hekun Decoction and hormone therapy improved cognitive function, menopausal symptoms, and insomnia more than placebo. The herbal treatment performed comparably to hormone therapy for cognitive improvement and showed a more favorable safety profile, with fewer adverse events and no reported abdominal discomfort, breast pain, or abnormal uterine bleeding.