ObjectivesTo systematically review the efficacy and safety of traditional Chinese herbal medicine Kuntai in the treatment of premature ovarian insufficiency (POI).MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on Kuntai for treating premature ovarian insufficiency from inception to August, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsTwenty-one RCTs involving 1 777 patients were included, which were categorized as Kuntai vs. western medicine and Kuntai combined with western medicine vs. western medicine. The results of meta-analysis showed that: the efficacy of Kuntai was equivalent to western medicine; effective rate (RR=2.78, 95%CI 1.73 to 4.45, P<0.000 01), the change of Kupperman’s score (MD=?3.25, 95%CI ?3.75 to ?2.76, P<0.000 01), the change of serum FSH (MD=?6.99, 95%CI ?8.07 to ?5.90, P<0.000 01), E2 (MD=7.01, 95%CI 3.01 to 11.01, P=0.000 6) and LH (MD=?4.66, 95%CI ?6.45 to ?2.86, P<0.000 01) in Kuntai combined with hormone replacement therapy (HRT) group were higher than that in the HRT group.ConclusionsKuntai combined with HRT is superior to HRT alone in the effective rate, the change of Kupperman’s score, the change of serum FSH, E2 and LH for patients with premature ovarian insufficiency. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusion.
ObjectiveTo evaluate the effectiveness of hormone replacement therapy (HRT) combined with Kuntai capsule in the treatment of diminished ovarian reserve (DOR) in the clinical practice based on real world data (RWD). MethodsEmploying a target trial emulation framework, this study utilized electronic medical record data from the Tianjin Regional Healthcare Database. The outcome measures were the changes from baseline in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) levels within 3 months of treatment. Inverse probability weighting was used to balance baseline confounders, and the average treatment effect (ATE) was estimated based on weighted linear models. The primary analysis included patients with complete FSH data, and multiple sensitivity analyses were conducted to verify the robustness of the results. ResultsA total of 239 patients with DOR who had at least one sex hormone outcome were included. Among them, 198, 142, and 223 patients had complete data for FSH, LH, and E2, respectively. In the primary analysis population (n=198), 131 patients were in the Western medicine group (HRT alone) and 67 were in the combination group (HRT plus Kuntai capsule). Compared to the Western medicine group, the combination group showed a significantly greater reduction in FSH levels (ATE=?5.92IU/L, 95%CI ?10.73 to ?1.12). In the population with complete E2 data, the combination group demonstrated a significantly greater increase in E2 levels (ATE=61.03pg/mL, 95%CI 33.16 to 88.91). For LH, the difference was not statistically significant between two groups. ConclusionIn real world clinical practice, HRT combined with Kuntai capsule is superior to HRT alone in improving FSH and E2 levels in patients with DOR. These findings are consistent with previous clinical evidence and suggest that the target trial emulation framework holds significant methodological value for evaluating the efficacy of integrated Chinese and Western medicine therapies.