Objective Based on the"preventive treatment of disease"theory and real-world data,this study aimed to evaluate the clinical efficacy of Yangyin Shugan Formula in patients with ovarian dysfunction characterized by the syndrome of kidney deficiency and liver depression at different stages and to provide evidence for optimizing the timing of traditional Chinese medicine(TCM)in premature ovarian insufficiency(POI)management.Methods Ovarian dysfunction patients under 40 years old characterized by syndrome of kidney deficiency and liver depression,registered in the outpatient electronic medical records of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2020 to December 2023,were stratified into three groups:subclinical POI,POI,and premature ovarian failure(POF)groups.The therapeutic outcomes of the three groups of patients were compared,including TCM syndrome total response rates,menstrual total response rates/normalization(cured)rates,base follicle-stimulating hormone(FSH)total response rate/normalization rates and anti-Müllerian hormone(AMH)levels.Results A total of 307 patients meeting the research criteria were included(97 cases in subclinical POI group,112 cases in POI group,and 98 cases in POF group).The TCM syndrome total response rates ranked as subclinical POI group(98.97%,96/97)>POI group(95.54%,107/112)>POF group(83.67%,82/98),with the POF group was lower than that of the subclinical POI and POI groups(P<0.017);while the difference of the subclinical POI group with the POI group was not significant.Menstrual total response rates ranked as subclinical POI group(97.22%,70/72)>POI group(72.32%,81/112)>POF group(51.02%,50/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017);normalization rates ranked as subclinical POI group(90.28%,65/72)>POI group(54.46%,61/112)>POF group(26.53%,26/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).FSH total response rates ranked as subclinical POI group(89.69%,87/97)>POI group(81.25%,91/112)>POF group(60.20%,59/98),while POF group was lower than that of the other two groups(P<0.017),and the difference of the subclinical POI group with the POI group was not significant.Normalization FSH rates ranked as subclinical POI group(71.13%,69/97)>POI group(53.57%,60/112)>POF group(16.33%,16/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).Compared with before treatment,the FSH levels in all three groups decreased after treatment(P<0.01).The reduction of FSH in the POF and POI groups were better than that in the subclinical P OI group(P<0.017).No significant difference was observed in the reduction of FSH between the POI and POF groups.Post-treatment AMH elevation observed in the subclinical POI and POI groups(P<0.01).Conclusion Yangyin Shugan Formula improves the menstrual conditions and TCM syndromes across all the stages.It also improves elevated FSH levels across all the stages and has a specific effect on normalizing FSH and menstruation.Yangyin Shugan Formula increases the AMH levels of patients with subclinical POI and POI,highlighting the applicability of TCM in staged preventive management.

Objective Based on the"preventive treatment of disease"theory and real-world data,this study aimed to evaluate the clinical efficacy of Yangyin Shugan Formula in patients with ovarian dysfunction characterized by the syndrome of kidney deficiency and liver depression at different stages and to provide evidence for optimizing the timing of traditional Chinese medicine(TCM)in premature ovarian insufficiency(POI)management.Methods Ovarian dysfunction patients under 40 years old characterized by syndrome of kidney deficiency and liver depression,registered in the outpatient electronic medical records of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2020 to December 2023,were stratified into three groups:subclinical POI,POI,and premature ovarian failure(POF)groups.The therapeutic outcomes of the three groups of patients were compared,including TCM syndrome total response rates,menstrual total response rates/normalization(cured)rates,base follicle-stimulating hormone(FSH)total response rate/normalization rates and anti-Müllerian hormone(AMH)levels.Results A total of 307 patients meeting the research criteria were included(97 cases in subclinical POI group,112 cases in POI group,and 98 cases in POF group).The TCM syndrome total response rates ranked as subclinical POI group(98.97%,96/97)>POI group(95.54%,107/112)>POF group(83.67%,82/98),with the POF group was lower than that of the subclinical POI and POI groups(P<0.017);while the difference of the subclinical POI group with the POI group was not significant.Menstrual total response rates ranked as subclinical POI group(97.22%,70/72)>POI group(72.32%,81/112)>POF group(51.02%,50/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017);normalization rates ranked as subclinical POI group(90.28%,65/72)>POI group(54.46%,61/112)>POF group(26.53%,26/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).FSH total response rates ranked as subclinical POI group(89.69%,87/97)>POI group(81.25%,91/112)>POF group(60.20%,59/98),while POF group was lower than that of the other two groups(P<0.017),and the difference of the subclinical POI group with the POI group was not significant.Normalization FSH rates ranked as subclinical POI group(71.13%,69/97)>POI group(53.57%,60/112)>POF group(16.33%,16/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).Compared with before treatment,the FSH levels in all three groups decreased after treatment(P<0.01).The reduction of FSH in the POF and POI groups were better than that in the subclinical P OI group(P<0.017).No significant difference was observed in the reduction of FSH between the POI and POF groups.Post-treatment AMH elevation observed in the subclinical POI and POI groups(P<0.01).Conclusion Yangyin Shugan Formula improves the menstrual conditions and TCM syndromes across all the stages.It also improves elevated FSH levels across all the stages and has a specific effect on normalizing FSH and menstruation.Yangyin Shugan Formula increases the AMH levels of patients with subclinical POI and POI,highlighting the applicability of TCM in staged preventive management.