Clinical Exploratory Research On The Treatment Of Obese PCOS With Chinese Medicine Fasting Therapy

Objective:Observe the clinical efficacy,safety,and possible mechanism of intermittent traditional Chinese medicine fasting therapy for obese polycystic ovary syndrome（PCOS）.Methods:Recruit obese PCOS subjects as research subjects,and those who meet the inclusion criteria will start this study after signing the informed consent form for traditional Chinese medicine special treatment under completely voluntary conditions.The subjects were treated with intermittent traditional Chinese medicine fasting therapy under the guidance of a professional physician,with a duration of 3 months.The single fasting therapy period includes a 7-day fasting period,a 3-day liquid diet period,and a 5-7 day low salt solid diet period.The subjects completed four fasting periods within two and a half months.Before fasting therapy,on the 8th and 90th days,collect fasting blood from patients,isolate serum,and store it in a refrigerator at-80℃.At the same time,record data such as Menstrual condition,Traditional Chinese Medicine symptom points,body mass,and blood pressure.Unified testing of serum after the end of the experiment,test indicators include,fasting blood glucose（FPG）,fasting insulin（FINS）,triglyceride（TG）,total cholesterol（TC）,high density lipoprotein（HDL-C）,low density lipoprotein（LDL-C）,apolipoprotein A-1（APOA1）,apolipoprotein B（APOB）,testosterone（T）,follicle-stimulating hormone（FSH）,luteinizing hormone（LH）,liver function,kidney function,etc.Analyzethe overall efficacy of fasting therapy on obese PCOS,as well as its effects on menstrual regulation,body mass,blood pressure,Traditional Chinese Medicine symptom points,and sexual hormones,insulin resistance index（HOMA-IR）,FPG,and blood lipids.The mixed effects model was used for repeated measurement analysis in statistical analysis,and the P values compared to before fasting therapy on the 8th and 90th days were corrected using the Dunnett method.The difference before fasting therapy was the mean±standard error adjusted by the Dunnett Hsu method.The statistical results were statistically significant at P<0.05,and the data analysis was conducted on the SAS9.4 platform.Result:1.Clinical efficacy:（1）Menstrual regulation efficacy:On the 90th day of menstrual regulation efficacy,5 people showed significant effect,4people showed effective effect,and the effective rate was 55.56%,with a total effective rate of 100%.（2）Body mass efficacy:The body mass before fasting therapy was（92.9±11.6）kg,on the 8th day（87.28±11.23）kg,and on the 90th day（77.43±10.4）kg,The weight was significantly reduced compared to before fasting therapy,and the difference was statistically significant（P<0.05）.（3）Traditional Chinese Medicine symptom score curative effect:The totalscore of traditional Chinese medicine symptoms before and on the 90th day of fasting therapy respectively were（11.33±3.00）and（1.98±1.17）;On the 90th day,the total score of traditional Chinese medicine symptoms decreased compared to before fasting therapy,and thedifference was statistically significant（P<0.05）.（4）Hypertension efficacy:6 subjects had hypertension before fasting therapy,3 showed significant improvement on the 8th day of fasting therapy,and 4 showed total improvement;On the 90th day,5 cases showed significant improvement,and6 cases had a total effective.（5）The impact on waist circumference and abdominal circumference:Before fasting therapy,the waist circumference was（103.33±7.71）cm,and the abdominal circumference was（112.83±11.01）cm.On the 90th day,the waist circumference was（89.72±9.68）cm,and the abdominal circumference was（96.39±10.6）cm,all of which were significantly lower than before fasting therapy（P<0.05）.2.Effects on metabolic indicators:TG,FPG,FINS,HOMA-IR,LDL-C,APOA,and APOB before fasting therapy,respectively were（1.71±1.01）mmol·L^-1,（5.81±1.05）mmol·L^-1,（38.12±17.94）μU·ml^-1,（10.22±5.64）,（3.16±0.82）mmol·L^-1,（1.19±0.13）g·L^-1,（0.92±0.20）g·L^-1;On the 8th day of fasting therapy,respectively were（1.14±0.23）mmol·L^-1,（4.23±0.58）mmol·L^-1,（10±4.01）μU·ml^-1,（1.92±0.92）,（4.16±1.32）mmol·L^-1,（1.03±0.18）g·L^-1,（1.25±0.30）g·L^-1;On the 90th day of fasting therapy,respectively were（1.23±0.46）mmol·L^-1,（5.09±0.54）mmol·L^-1,（14.82±5.00）μU·ml^-1,（3.42±1.33）,（3.66±0.49）mmol·L^-1,（1.27±0.18）g·L^-1,（0.95±0.15）g·L^-1;On the 8th day,TG,FPG,FINS,HOMA-IR,and APOA significantly decreased compared to before fasting therapy,while LDL-C and APOB increased compared to before fasting therapy（P<0.05）;On the 90th day,TG,FINS,and HOMA-IR were significantly reduced compared to before fasting therapy（P<0.05）;On the 90th day,there was no statistically significant difference in FPG,LDL-C,APOA,and APOB compared to before fasting therapy.3.Effect on sex hormones:The serum level of testosterone（T）before fasting therapy was（0.55±0.18）ng·ml^-1,and the serum level of T on the90th day was（0.34±0.17）ng·ml^-1,which was significantly reduced compared to before fasting therapy（P<0.05）,and the difference was statistically significant.4.Safety indicators:（1）In terms of blood pressure:diastolic blood pressure（DBP）before fasting therapy（91.67±14.49）mm Hg,systolic blood pressure（SBP）（124.89±10.41）mm Hg;On the 8th day,DBP（85.78±14.11）mm Hg,SBP（115.11±14.3）mm Hg;On the 90th day,DBP（77.78±8.71）mm Hg,SBP（114.22±9.46）mm Hg.There were no incidents of hypotension during the fasting therapy.（2）In terms of liver and kidney function:On the 8th day,Indirect bilirubin（IBIL）,Direct bilirubin（DBIL）,total bilirubin（TBIL）,Serum albumin（ALB）,Creatinine（Cr）,UA significantly increased compared to before fasting therapy（P<0.05）;BUN and BUN/Cr both significantly decreased compared to before fasting therapy（P<0.05）;On the90th day,TP,ALB,γ-Glutamyl transaminase（γ-GGT）significantly decreased compared to before rest（P<0.05）;On the 90th day,there was no statistically significant difference in IBIL,DBIL,TBIL,Cr,BUN,BUN/Cr,Uric-Acid（UA）compared to before fasting therapy.Transaminase did not show obvious abnormality during fasting therapy.Conclusion:Intermittent traditional Chinese medicine fasting therapy has a certain improvement effect on the menstrual cycle,T levels,and Traditional Chinese Medicine symptoms of obese PCOS patients.It can significantly reduce the body mass,body mass index（BMI）,waist and abdominal circumference,HOMA-IR as well as the levels of TG,UA,and FINS in PCOS patients.It can effectively reduce DBP and SBP in patients with concomitant hypertension.No serious safety incidents were observed during the fasting therapy.The mechanism of fasting therapy in treating obese PCOS may be related to the significant reduction of body mass,improvement of Insulin Resistance（IR）,and reduction of T and TG levels,but its exact mechanism of action still needs to be further explored.