Yanghe Xiaonang Decoction （阳和消囊汤） for the Treatment of Polycystic Ovary Syndrome-Related Infertility with Healthy Qi Deficiency and Phlegm Stasis Syndrome：A Randomized Controlled Trial
10.13288/j.11-2166/r.2026.18.014
- VernacularTitle:阳和消囊汤治疗正虚痰瘀型多囊卵巢综合征性不孕症的随机对照试验
- Author:
Pengxuan YAN
1
;
Jia FU
1
;
Kun LI
1
;
Jingchun ZHANG
2
;
Yukun ZHAO
3
;
Nanxing XIAN
1
;
Wentong ZHU
1
Author Information
1. China Academy of Chinese Medical Sciences，Beijing，100700
2. Xiyuan Hospital，China Academy of Chinese Medical Sciences
3. Institute of Traditional Chinese Medicine Basic Theory，China Academy of Chinese Medical Sciences
- Publication Type:Journal Article
- Keywords:
polycystic ovary syndrome;
infertility;
healthy qi deficiency and phlegm stasis syndrome;
Yanghe Xiaonang Decoction （阳和消囊汤）;
randomized controlled trials
- From:
Journal of Traditional Chinese Medicine
2026;67(18):1995-2002
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical efficacy and safety of Yanghe Xiaonang Decoction （阳和消囊汤， YXD） in the treatment of polycystic ovarian syndrome （PCOS）-related infertility with healthy qi deficiency and phlegm stasis syndrome. MethodsA total of 120 PCOS-related infertility participants with healthy qi deficiency and phlegm stasis syndrome were randomly divided into a treatment group and a control group in a 1∶1 ratio， with 60 cases in each group. The treatment group started taking YXD on the first day of the menstrual cycle， one dose daily， until the day of sexual intercourse when follicles matured and were released. Those without mature follicles or ovulation could take it until the 14th to 28th day. The control group was given oral letrozole at 2.5 mg daily starting on the 5th day of the menstrual cycle for 5 consecutive days. If the basal body temperature curve remained monophasic on the 28th day of the menstrual cycle， and no dominant follicle was detected by color Doppler ultrasound， estrogen plus progesterone or progesterone alone was administered for withdrawal bleeding， followed by a new treatment cycle. The treatment lasted for three consecutive menstrual cycles. Patients were followed up for 3 months upon confirmed pregnancy or after the completion of the 3rd treatment cycle. The clinical pregnancy rate， total effective rate， pregnancy rate， biochemical pregnancy rate， embryonic arrest rate， and ectopic pregnancy rate between the two groups were compared. Transvaginal color Doppler ultrasound was used for monitoring endometrial thickness， cyclic ovulation status， number of follicles between 2-9 mm， and the difference in transverse and longitudinal diameters of dominant follicles. The levels of endocrine hormone indicators including serum testosterone （T）， prolactin （PRL）， luteinizing hormone （LH）， follicle-stimulating hormone （FSH）， progesterone （P）， estradiol （E2）， free testosterone （F-T）， androstenedione （ASD）， inhibin B （INH-B）， and anti-Müllerian hormone （AMH）， as well as the total traditional Chinese medicine （TCM） symptom scores before and after treatment were compared between the two groups. ResultsA total of 58 patients in each group were included in the statistical analysis. The clinical pregnancy rate in the treatment group was 39.66% （23/58）， higher than 22.41% （13/58） in the control group （P＜0.05）. The total effective rate in the treatment group was 96.55% （56/58）， higher than 79.31% （46/58） in the control group （P＜0.05）. The biochemical pregnancy rate and embryonic arrest rate in the treatment group were lower than those in the control group （P＜0.05）. The treatment group was superior to the control group in increasing endometrial thickness and reducing the number of 2-9 mm follicles at the 2nd and 3rd cycles， as well as in improving the cyclic ovulation status and the difference in transverse and longitudinal diameters of dominant follicles at the 3rd cycle （P＜0.05）. After treatment， the treatment group exhibited significant reductions in serum T， LH， F-T， ASD， INH-B， and AMH levels （P＜0.05）. The control group also showed significant decreases in LH， F-T， INH-B， and AMH levels （P＜0.05）. The levels of F-T， INH-B， and AMH in the treatment group after treatment were lower than those in the control group （P＜0.05）. The improvement of the total TCM symptom score in the treatment group was superior to that in the control group （P＜0.05）. ConclusionYXD can significantly improve the clinical pregnancy rate， reduce the rates of biochemical pregnancy and embryonic arrest， alleviate clinical symptoms， increase endometrial thickness， enhance dominant follicles， and improve endocrine hormone levels in PCOS-related infertility with healthy qi deficiency and phlegm stasis syndrome， showing good safety.
