Oral Chinese herbal formulas have shown potential for improving hormone levels in patients with premature ovarian insufficiency, but their safety and overall efficacy remains unclear.
A systematic review of randomized controlled trials was conducted by searching through eight bibliographic databases, clinical trial registry platforms, and the Chinese Clinical Trial Registry until May 30, 2026. The aim was to compare hormone replacement therapy (HRT)-based regimens with pure oral Chinese herbal formulas within three specific categories of therapeutic principles. Emphasis was placed on evaluating menstrual return and levels of follicle-stimulating hormone and anti-Müllerian hormone, designated as primary surrogate biomarkers indicative of ovarian function. 41 HRT-controlled trials fitting the specified criteria were incorporated into the study.
The review found no distinctive differences in menstrual return between participants using HRT and those using herbal formulas. However, hormone level analysis showed a preference towards herbal formulas for improving levels of follicle-stimulating hormone and anti-Müllerian hormone. Concurrently, these results were associated with high uncertainty due to their surrogate nature. Furthermore, the study also noted that fewer adverse events were reported among participants taking herbal formulas. Nevertheless, safety imperatives associated with herbal formulas could not be established due to incomplete reporting. Additionally, the study could not establish any comparative superiority among the specific categories of herbal formulas based on kidney-tonifying principles.
