Abstract
PURPOSE: This study aims to evaluate the clinical efficacy of KunTai capsules combined with Femoston on bone mineral density (BMD) in women with premature ovarian insufficiency (POI). METHODS: This prospective, randomized, controlled clinical trial was conducted at the First and Second Hospitals of Hebei Medical University from September 2018 to July 2022. Participants were randomly assigned in a 1:1 ratio to the control (Femoston alone) or the observation group (Femoston + KunTai capsules). Treatment duration was 12 months. The primary endpoint was the change in lumbar spine BMD at 12 months. Secondary endpoints included bone turnover markers (P1NP, β-CTX), hormone levels (E(2), FSH, LH), and modified Kupperman scores. RESULTS: A total of 104 women were randomized, and 73 completed the 12-month follow-up. After 12 months of treatment, the observation group demonstrated significant increases in total lumbar spine and L1-L4 BMD compared with baseline (P < 0.05). In addition, BMD changes at total lumbar spine, L2, and L3 were significantly greater compared to the control group (P < 0.05). In terms of bone turnover markers (P1NP and β-CTX), no significant differences were observed either between the two groups or compared with baseline after treatment (P > 0.05). In the control group, E(2) levels were significantly increased at 3, 6, and 12 months compared with baseline (P < 0.05), while FSH levels were significantly decreased at 3 and 6 months (P < 0.05) but showed no significant difference at 12 months. In the observation group, compared with baseline, E(2) levels were significantly increased, whereas FSH and LH levels were significantly decreased at 3, 6, and 12 months (P < 0.05). After 12 months of treatment, improvements in modified Kupperman scores were significantly greater in the observation group than in the control group (P < 0.05). CONCLUSION: The combination of KunTai capsules and Femoston was associated with a greater increase in lumbar spine BMD at 12 months compared with Femoston monotherapy in women with POI. Improvements in menopausal symptoms were also observed; however, no significant between-group differences were found in bone turnover markers or hormone levels. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=26556, identifier (ChiCTR1800017774).