Abstract
BackgroundThe efficacy of Kuntai capsule combined with letrozole (LE) in improving ovarian function of polycystic ovary syndrome (PCOS) has been evaluated before, but there is still a lack of evidence-based support for the regulation of sex hormone levels. In recent years, new randomized clinical trials (RCTs) have been reported on the effect of combined therapy on regulating sex hormone levels.ObjectiveWe aimed to systematically evaluate the efficacy of Kuntai capsule combined with LE in the treatment of PCOS.MethodsA search across the China Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang database, PubMed, Web of Science, The Cochrane Library, and Embase was conducted on Kuntai capsule combined with LE in the treatment of PCOS. The time of the self-built database was up to April 30, 2021. RCTs of LE in the control group and LE combined with Kuntai capsule in the experimental group were selected. RevMan5.3 software was used for data analysis.ResultsA total of 17 studies were gathered, which included 1,684 patients. The meta-analysis results showed that the total effective rate of the combined group was 93.36% and that of the LE group was 78.15%. The improvement in the ovulation rate, pregnancy rate, number of mature follicles, endometrial thickness, cervical mucus score, and serum follicle stimulating hormone (FSH), luteinizing hormone (LH), and prolactin (PRL) in the combined group was consistent with the results of a previous meta-analysis and was better than that in the LE group (p < 0.05). In addition, the combination group was better than the LE group in regulating the levels of estradiol (E2) and testosterone (T) (p < 0.05). There were no adverse drug reactions in the two groups during treatment.ConclusionAs a type of pure traditional Chinese medicine preparation, Kuntai capsule combined with LE had a better effect than LE alone in the treatment of PCOS, with advantages mainly reflected in enhancing ovarian function and regulating the levels of sex hormones in vivo, among others, but the value of combined therapy still needs to be verified by more high-quality RCTs.
Highlights
Kuntai capsule is the first Chinese patent medicine approved for the treatment of ovarian function decline [1]
Kuntai capsule can improve the ovarian function in polycystic ovary syndrome (PCOS), and its efficacy is mainly manifested in improving the ovulation rate, pregnancy rate, number of mature follicles, endometrial thickness, cervical mucus score, etc
In this paper, randomized clinical trials related to the combined intervention of two drugs on PCOS were screened from multiple databases, aiming to evaluate the clinical value of Kuntai capsule combined with LE in the intervention of PCOS and to provide new evidence for further research on the synergistic and antagonistic effects of Kuntai capsule combined with LE in clinical applications
Summary
Kuntai capsule is the first Chinese patent medicine approved for the treatment of ovarian function decline [1]. By looking for evidence-based medical proof and combining expert clinical drug use experience, expert consensus can be reached, and guidelines will be formed and issued for clinical frontline doctors in the use of Kuntai capsule combined with LE. This is of great significance for reducing clinical risks and improving clinical efficacy. The efficacy of Kuntai capsule combined with letrozole (LE) in improving ovarian function of polycystic ovary syndrome (PCOS) has been evaluated before, but there is still a lack of evidence-based support for the regulation of sex hormone levels. New randomized clinical trials (RCTs) have been reported on the effect of combined therapy on regulating sex hormone levels
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