Program in Clinical Drug Development of Herbal Medicine, Taipei Medical University, Taipei, Taiwan.
Department of Pharmacy, Taipei Medical University Hospital, Taipei, Taiwan.
Complement Med Res. 2023;30(6):481-491. doi: 10.1159/000534590. Epub 2023 Nov 1.
In Taiwan, Chinese herbal medicine (CHM) is used to treat female infertility. Evidence indicates that the absence of monotherapy efficacy assessment and comparison with mainstream interventions may lead to the improper use of CHM for female infertility.
A retrospective cohort study enrolled female patients at a hospital undergoing CHM intervention to treat infertility from 2012 to 2020 in order to determine the outcomes of CHM monotherapy for female infertility. Kaplan-Meier analysis under strict assumptions was used to estimate the cumulative probability of pregnancy and live births after CHM. Cox hazard regression analysis was used to estimate the hazard ratios of prognostic variables, namely, the woman's age and diagnostic category.
694 women met the inclusion criteria and accounted for 2,145 cycles. A total of 190 pregnancies resulted in 125 live births, all of which were singleton births of babies with 16 perinatal complications requiring hospitalization. The real cumulative pregnancy rate and cumulative live birth rate (CLBR) for the total population after 10 cycles were between 27.4% and 35.2% and between 18% and 22.1%, respectively. Compared with the live birth rate corresponding to patients aged under 35 years, that of older patients, particularly those aged 38-39 years, was significantly lower (hazard ratio: 0.19, 95% confidence interval: 0.11-0.33). Women with other diagnoses, namely, uterine problems or endometriosis, had a greater probability of a live birth than did women with tubal pathology (hazard ratio: 6.31, 95% confidence interval: 1.99-20.07).
To the best of our knowledge, this is the first retrospective study to employ life table analysis to determine the CHM treatment outcomes in terms of female infertility. The study established a basis to compare in vitro fertilization (IVF) with CHM and identified the advantages and disadvantages of CHM for treating female infertility. Although the CLBR of present study is lower than those reported in IVF studies, CHM in treating female infertility can still be beneficial to women aged younger than 38 years or with diagnoses other than tubal pathology and worth recommendation by reproductive specialists according to the promising results gained from the strict criteria. However, in order to determine the optimal timing, possible mechanism, corresponding side effects, and the efficacy of CHM combined with IVF for treating female infertility, rigorous research is required.
在台湾,中草药(CHM)被用于治疗女性不孕症。有证据表明,缺乏对单一疗法疗效的评估以及与主流干预措施的比较,可能导致 CHM 对女性不孕症的不当使用。
本回顾性队列研究纳入了 2012 年至 2020 年期间在医院接受 CHM 干预以治疗不孕症的女性患者,以确定 CHM 单一疗法治疗女性不孕症的结果。严格假设下的 Kaplan-Meier 分析用于估计 CHM 后妊娠和活产的累积概率。Cox 危害回归分析用于估计预后变量(即女性年龄和诊断类别)的危害比。
694 名女性符合纳入标准,共涉及 2145 个周期。共有 190 次妊娠导致 125 次活产,所有活产均为单胎,16 例新生儿围产期并发症需要住院治疗。总人群在 10 个周期后的真实累积妊娠率和累积活产率(CLBR)分别在 27.4%至 35.2%和 18%至 22.1%之间。与年龄在 35 岁以下的患者的活产率相比,年龄较大的患者(尤其是 38-39 岁的患者)的活产率显著降低(危害比:0.19,95%置信区间:0.11-0.33)。患有子宫问题或子宫内膜异位症等其他诊断的女性的活产概率高于患有输卵管病变的女性(危害比:6.31,95%置信区间:1.99-20.07)。
据我们所知,这是第一项使用寿命表分析来确定 CHM 治疗女性不孕症结果的回顾性研究。该研究为比较体外受精(IVF)与 CHM 奠定了基础,并确定了 CHM 治疗女性不孕症的优缺点。尽管本研究的 CLBR 低于 IVF 研究报告的水平,但 CHM 治疗女性不孕症对年龄在 38 岁以下或患有非输卵管病变等其他诊断的女性仍可能有益,并值得生殖专家根据严格标准获得的有希望的结果推荐。然而,为了确定 CHM 治疗女性不孕症的最佳时机、可能的机制、相应的副作用以及 CHM 联合 IVF 的疗效,需要进行严格的研究。