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

Perimenopausal symptoms affect most women and often substantially impair their quality of life, whereas conventional estrogen therapy alone does not fully address clinical needs. Baoqing granules (BQG), derived from Zuo Gui Wan in Jingyue's Complete Works, 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.