Chinese Herbal Medicine Improves Pregnancy Outcome and Decreases Recurrence Rate after Surgery for Endometriosis-Associated Infertility: A Retrospective Study.

Abstract

Objective: To evaluate the long-term efficacy of Chinese herbal medicine (CHM) in enhancing reproductive outcomes and reducing recurrence rates among endometriosis-associated infertility women infertile women.

Methods: This study is a retrospective analysis of a randomized, double-blind, placebo-controlled clinical trial implemented from May 2014 to April 2018. The study included patients with endometriosis-associated infertility who had undergone standardized laparoscopic surgery. After surgery, the participants were randomly assigned to 2 groups: the intervention group received a CHM treatment regimen, while the control group was given placebo therapy. Both groups were subjected to the same blinding procedures and received treatment for a period of 6 months. Five years after surgery, the researchers conducted follow-up with the participants and analysed the data on pregnancy outcomes and recurrence of endometriosis.

Results: In this trial, a total of 202 patients with endometriosis-associated infertility (101 per group) were followed up at 5 years post-surgery for clinical pregnancy, live birth, and recurrence outcomes (101 patients per group). According to our data, pregnancies occurred in 83 (82.18%) participants in the CHM group, with a pregnancy rate of 69.02 person-years, and 70 (69.31%) participants in the placebo group, with a pregnancy rate of 42.86 person-years during pregnancy-related median follow-up of 0.75 years [interquartile range (IQR) 0.25-1.71, hazard ratio (HR) 1.451, 95% confidence interval (CI) 1.055-1.997; P=0.017]. Clinical pregnancies occurred in 80 (79.21%) participants in the CHM group, with a clinical pregnancy rate of 64.91 person-years, and in 67 (66.34%) participants in the placebo group, with a clinical pregnancy rate of 39.14 person-years over the course of a median clinical pregnancy-related follow-up of 0.83 years (IQR 0.33-1.83, HR 1.495, 95% CI 1.079-2.072; P=0.012). Live births occurred in 78 (77.23%) participants in the CHM group at a rate of 36.72 person-years and in 60 (59.41%) participants in the placebo group at a rate of 23.94 person-years during the live birth-related median follow-up of 1.79 years (IQR 1.06-3, HR 1.542, 95% CI 1.097-2.165; P=0.010). Recurrence occurred in 12 (11.88%) participants in the CHM group, with a recurrence rate of 2.95 person-years, and in 24 (23.76%) participants in the placebo group, with a recurrence rate of 7.09 person-years (HR 0.458, 95% CI 0.229-0.916; P=0.022) during the recurrence-related median follow-up of 5 years (IQR 1.0-5.0). When assessed within subgroups, the HRs of the intervention on pregnancy and recurrence were similar in participants in different layers (P interaction>0.05).

Conclusion: CHM can improve postoperative pregnancy outcomes, shorten the time to conception, and reduce the risk of long-term recurrence in infertile patients with endometriosis after laparoscopic surgery. (Registration Number. ChiCTR2300070138).