The efficacy and safety of Femoston combined with Baoqing granules for kidney Yin deficiency in perimenopausal women: a randomized, double-blind, placebo-controlled trial

Background: , were modified to target kidney Yin deficiency and have shown promising clinical efficacy, although robust randomized evidence remains limited. Methods: The trial was registered with the Chinese Clinical Trial Registry (ChiCTR2300073338; http://www.chictr.org.cn). In this randomized, double-blind, placebo-controlled clinical trial, eligible perimenopausal women received either Femoston plus placebo or Femoston plus BQG for four weeks, followed by a four-week follow-up. The primary outcomes were the Modified Kupperman Menopausal Index (Modified KMI) and traditional Chinese medicine (TCM) syndrome scores. Secondary outcomes included the Menopause-Specific Quality of Life Questionnaire (MENQOL), Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and serum levels of sex hormones and lipids. Safety was evaluated through hepatic and renal function tests and adverse-event monitoring. Results: Both groups showed significant improvements from baseline; however, participants in the BQG group experienced greater short-term improvements that persisted at week 8 in Modified KMI, TCM syndrome scores, MENQOL, and PSQI, while differences in SAS and SDS became significant only at follow-up. Hormone and lipid profiles showed no overall between-group differences, although exploratory subgroup analyses suggested higher estradiol and lower follicle-stimulating hormone levels in postmenopausal women receiving BQG. Liver and kidney functions remained within normal ranges, and only one mild adverse event was reported. Conclusion: In this 8-week study, BQG as an adjunct to Femoston was associated with additional short-term improvements in multidimensional perimenopausal symptoms, with acceptable tolerability. These findings support the potential role of BQG as a complementary therapy; however, longer-term studies are needed to confirm the durability of benefit and long-term safety. Clinical Trial Registration: http://www.chictr.org.cn, identifier ChiCTR2300073338.