Effect of Modified Cangfu Daotantang on Metabolism and Pregnancy in Patients with Polycystic Ovary Syndrome / 中国实验方剂学杂志

Objective:To observe the effect of modified Cangfu Daotantang on metabolism and pregnancy in patients with spleen deficiency and phlegm-dampness type polycystic ovary syndrome （PCOS）. Method:One hundred and twelve patients were randomly divided into control group and observation group according to the random number table. Both groups took non-pharmacological interventions， oral metformin hydrochloride， 500mg/time， 3 times/day； oral ethinyl estradiol and cyproterone tablets， 1 tablet/time， 1 time/day， starting from the third to fifth day of menstruation and lasting for twenty-one days， for a total of 3 menstrual cycles. Patients in control group additionally took Erchen pills orally， 10 g/time， 2 times/day， while patients in observation group additionally took modified Cangfu Daotantang orally， 1 dose/day. The course of treatment was six menstrual cycles in both groups （or termination after conception）. The waist-to-hip ratio （WHR）， body mass index （BMI）， insulin resistance index （HOMA-IR）， pancreatic <italic>β</italic>-cell function （HOMA-<italic>β</italic>）， triglycerides （TG）， low-density lipoprotein （LDL） and non-high-density lipoprotein （nHDL） elevation after treatment were compared. The number of ovulation cycles monitored by B-ultrasound （6 menstrual cycles）， ovulation rate， human chorionic gonadotropin （HCG） day endometrial thickness， follicle diameter， cervical mucus score>8 points and endometrial morphology type A rate were measured and recorded. The recovery of menstruation， pregnancy and early miscarriage were recorded. Luteinizing hormone （LH）， estradiol （E₂）， follicle stimulating hormone （FSH）， dehydroepiandrosterone sulfate （DHEAS）， testosterone （T）， anti-Müllerian hormone （AMH） levels， and insulin before and after treatment -Like growth factor-1 （IGF-1）， leptin （LP）， adiponectin （APN）， growth differentiation factor-9 （GDF-9） and tumor necrosis factor-<italic>α</italic> （TNF-<italic>α</italic>） levels were detected. Result:WHR， BMI and HOMA-IR levels of the observation group were lower than those of the control group （<italic>P</italic><0.05， <italic>P</italic><0.01）. HOMA-<italic>β</italic> level was higher than that in the control group （<italic>P</italic><0.01）. The increase rates of LDL， TG， and nHDL in the observation group were 19.61%（10/51），25.49%（13/51），23.53%（12/51）， respectively， lower than 41.18%（21/51），47.06%（24/51），45.10%（23/51）respectively in the control group （<italic>χ</italic>²=5.607， <italic>χ</italic>²=5.131， <italic>χ</italic>²=5.263， <italic>P</italic><0.05）. The menstrual recovery rate in the observation group was 90.20% （46/51）， higher than 72.55% （37/51） in the control group （<italic>χ</italic>²=5.239，<italic>P</italic><0.05）. The observation group had more ovulation cycles than the control group （<italic>P</italic><0.01）. The pregnancy rate in the observation group was 50.98% （26/51）， higher than 31.37% （16/51） in the control group （<italic>χ</italic>²=4.047，<italic>P</italic><0.05）. On HCG day after treatment， the endometrial thickness and follicle diameter in the observation group were better than those in the control group （<italic>P</italic><0.01）. The proportion of patients with cervical mucus score> 8 points was 78.43% （40/51） in the observation group， higher than 56.86% （29/51） in the control group （<italic>χ</italic>²=5.420，<italic>P</italic><0.05）. The intimal morphology type A rate in the observation group was 52.94% （27/51）， higher than 31.37% （16/51） in the control group （<italic>χ</italic>²=4.864，<italic>P</italic><0.05）. The levels of AMH， E₂， DHEAS， LH， T ， IGF-1， LP and TNF-<italic>α</italic> in the observation group were lower than those in the control group （<italic>P</italic><0.01）， while the APN and GDF-9 levels were superior to those in the control group （<italic>P</italic><0.01）. Conclusion:On the basis of conventional western medicine intervention， modified Cangfu Daotantang can regulate abnormal metabolism and reproductive endocrine in patients with PCOS， improve conception， and regulate the expression of IGF-1， GDF-9， adipocytokines and inflammatory factors， improve ovulation and improve pregnancy rate.