| OBJEKTIVE:Clinical study 1 preliminarily investigated the correlation between TCM evidence patterns of patients with polycystic ovary syndrome and their lifestyle and emotional factors such as diet,sleep,and exercise,so as to provide more information for guiding lifestyle modification treatment in PCOS patients.Clinical study 2 was conducted to investigate the efficacy mechanism of the method to improve IR and chronic inflammation in obese patients with PCOS through the clinical study on the treatment of insulin resistance and chronic inflammation with the method to Yishen Jianpi Yangxue Tongli,thus providing a new research idea for the treatment of obese patients with PCOS with IR.METHODS:Clinical study 1:A questionnaire survey was conducted to collect relevant information,including general information,diet,sleep,exercise,and psychological status,from 234 patients who had been diagnosed with polycystic ovary syndrome and met the nadir criteria of this study,and were classified into 4 types according to the evidence and tongue and pulse identification:spleen deficiency,phlegm-dampness type,kidney deficiency,liver depression type The patients were classified into 4 types according to the symptoms and tongue and pulse:spleen deficiency,kidney deficiency,blood stasis,and phlegm-stasis.Statistical methods were used to analyze the similarities and differences of patients’ basic conditions,diet,sleep,exercise,emotion and other lifestyle,and to compare their relationship with the TCM evidence types.Clinical study 2:A prospective,randomized,controlled study was conducted using 42 patients with obese PCOS-IR who attended the outpatient clinic of the Department of Gynecology,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University from March 01,2022 to March 31,2023,and were screened by inclusion and exclusion criteria.In the control group,the patients were given lifestyle guidance such as diet and exercise,and in the treatment group,the patients were given lifestyle guidance combined with the formula of Yishen Jianpi Yangxue Tongli,and the changes of insulin resistance index(fasting glucose,fasting insulin,insulin resistance index),inflammatory factors(CRP,IL-6,TNF-α),obesity-related indexes(weight,BMI,waist circumference,hip circumference,WHR),sex hormone levels(LH,LH/FSH,T),and Chinese medicine evidence score were recorded before and after 3 months of treatment,Changes in TCM evidence scores.SPSS 20.0 was used to statistically analyze the above data.RESULTS:Clinical Study 1:There were statistically significant differences in BMI,dietary preferences,five taste preferences,whether they had exercise habits,exercise frequency,exercise time,exercise mode,exercise intensity,time from bed to sleep,sleep time,whether they were emotionally calm,whether they were anxious,and whether they were anxious and irritable compared among patients with polycystic ovary syndrome(P<0.05);the distribution of TCM evidence patterns in patients with polycystic ovary syndrome was related to age,education,occupation,family history,history of weight loss,general diet,sleep quality,time to sleep,frequency of staying up late,depression,compulsion,forgetfulness,fatigue,and self-conscious work-study stress were not significantly correlated(P>0.05).Clinical study 2:1.1.Insulin resistance index:intra-group comparison before and after treatment:fasting blood glucose,fasting insulin and insulin resistance index of patients in the treatment group decreased after treatment compared with the average value before treatment(P>0.05),and the difference was not statistically significant,while fasting blood glucose,fasting insulin and insulin resistance index of patients in the control group increased after treatment compared with the average value before treatment(P<0.05),and the difference was not statistically significant.Comparison between groups before and after treatment:the rate of change of insulin resistance index in the treatment group was(-0.0040±0.1031)%,and the rate of change of insulin resistance index in the control group was(0.1021±0.0842)%,and the difference of fasting insulin,insulin resistance index and insulin resistance index between the two groups before and after treatment was statistically significant(P<0.05),suggesting that the two groups of patients treated The difference of efficacy in the improvement of insulin resistance index before and after treatment was statistically significant(P<0.05),and the treatment group was superior.2.Inflammatory factors:intra-group comparison before and after treatment:the mean values of CRP,IL-6 and TNF-α decreased after treatment compared with those before treatment in patients of the treatment group(P>0.05),and the difference was not statistically significant;the mean values of TNF-α decreased after treatment compared with those before treatment in patients of the control group(P>0.05),and the difference was not statistically significant;the mean values of CRP and IL-6 increased after treatment compared with those before treatment in patients of the control group(P>0.05),the difference was not statistically significant.Comparison between groups before and after treatment:The difference in IL-6 between the two groups before and after treatment was statistically significant(P<0.05),suggesting that the difference in efficacy between the two groups before and after treatment in terms of improvement of IL-6 was statistically significant(P<0.05),and the treatment group was superior.3.Obesity-related indexes:intra-group comparison before and after treatment:the mean values of weight,BMI and waist circumference of the patients in the treatment group decreased after treatment compared with those before treatment(P<0.05),and the difference was statistically significant;the mean values of hip circumference and WHR decreased after treatment compared with those before treatment(P>0.05),and the difference was not statistically significant.In the control group,the mean values of weight and BMI decreased after treatment compared with those before treatment(P<0.05),and the differences were statistically significant,and the mean values of waist circumference,hip circumference and WHR decreased after treatment compared with those before treatment(P>0.05),and the differences were not statistically significant.Comparison between groups before and after treatment:The differences in weight,BMI,waist circumference,hip circumference and waist-hip ratio between the two groups before and after treatment were not statistically significant(P>0.05),suggesting that the differences in efficacy between the two groups before and after treatment were not statistically significant in terms of improvement of obesity-related indexes(P>0.05).4.Sex hormone levels:intra-group comparison before and after treatment:the mean value of T in the treatment group decreased after treatment compared with that before treatment(P<0.05),and the difference was statistically significant,while the mean value of LH and LH/FSH decreased after treatment compared with that before treatment(P>0.05),and the difference was not statistically significant.In the control group,the mean values of LH and LH/FSH decreased after treatment compared with those before treatment(P>0.05),and the difference was not statistically significant,and the mean values of LH increased after treatment compared with those before treatment(P>0.05),and the difference was not statistically significant.Comparison between groups before and after treatment:the difference in T between the two groups before and after treatment was statistically significant(P<0.05),suggesting that the difference in efficacy between the two groups before and after treatment in terms of improvement of T was statistically significant(P<0.05),and the treatment group was superior.5.TCM symptom scores:intra-group comparison before and after treatment:the mean values of TCM symptom scores of patients in both groups decreased after treatment compared with those before treatment(P<0.05),and the difference was statistically significant.Comparison between groups before and after treatment:the differences in the TCM symptom scores and the change rate of TCM symptom scores between the two groups before and after treatment were statistically significant(P<0.05),suggesting that the differences in efficacy between the two groups before and after treatment in terms of improvement of TCM symptoms were statistically significant(P<0.05),and the treatment group was superior.CONCLUSIONS:Clinical Study 1:Healthy lifestyle is of great practical significance for the prevention and treatment of PCOS.By investigating the association between patients’ TCM syndromes and diet,sleep,exercise,and psychological status,and clarifying the correlation between the above factors and each TCM syndromes,it can make the physicians’ guidance on lifestyle adjustment for patients with different TCM syndromes of PCOS more targeted and have positive significance for the targeted diagnosis and treatment of patients with different syndromes of PCOS.Clinical study 2:Yishen Jianpi Yangxue Tongli Formula can improve insulin resistance and chronic inflammation in obese PCOS to some extent. |
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