| ObjectiveTo explore the mechanisms of acupuncture and traditional Chinese medicine(TCM)artificial cycle therapy improving insulin resistance and regulating the expressions of related genes in insulin signaling pathway of polycystic ovary syndrome(PCOS)with phlegm dampness and to provide scientific basis for the further optimization of traditional Chinese medicine in the treatment of insulin resistance in PCOS with phlegm dampness.MethodsThis study used a prospective randomized controlled clinical trial.62 PCOS outpatients with phlegm dampness who matched the diagnostic criteria and inclusion criteria were enrolled from the department of TCM of Fujian Provincial Maternity and Children Health Hospital from December 2014 to October 2016.According to the inclusion criteria,the patients were randomly divided into two groups:treatment group(acupuncture and TCM artificial cycle group)and control group(metformin group).The treatment group was treated with acupuncture,traditional Chinese medicine and metformin,while the control group was treated with metformin.The two groups were treated for a period of 12 weeks and followed up for a period of 4 weeks.The main outcome measures including TCM symptom score,menstruation,ovulation rate,pregnancy rate,BMI,waist circumference,sex hormone levels(FSH,LH,PRL,E2,T),blood lipids(TG,CHOL,HDL,LDL),insulin resistance index[FPG,FINS,Ln(HOMA-IR)],expression levels of miRNA(miR-143,miR29,let-7)and related target genes(INSR,IRS,PI3K,AKT,ERK1,ERK2),expression levels and phosphorylation levels of insulin signaling pathway related proteins(INSR,IRS,PI3K,AKT,ERK1,ERK2);safety indexes including routine test of blood,urine and stool,liver function,renal function and electrocardiogram(ECG).The observation point were at the beginning of treatment and the twelfth week after treatment,all the curative effect and safety index were evaluated,and the follicular development and endometrium were evaluated at the end of the fourth week and the eighth week.The follow-up time was fourth weeks after the end of treatment.The data were analyzed by SPSS17.0 statistics.Results1 Safety analysisThe incidence rate of adverse reactions in the control group was 43.3%,the treatment group was 25%.Before and after treatment,two groups of patients were examined with safety indicators such as routine test of blood,urine and stool,liver function,renal function,ECG.All the results showed that the safety indices of the two groups were not significantly abnormal.Being unable to tolerate the adverse reactions of metformin,the dropout rate was 10%in the control group and 3.1%in the treatment group.It is suggested that the acupuncture and TCM artificial cycle therapy is safe.2 Curative effect analysis(1)Analysis of TCM symptom scoreThe comparison within groups showed that TCM symptom scores of the treatment group and control group were both significantly decreased after treatment,and that acupuncture and TCM artificial cycle therapy and metformin could both obviously improve the clinical symptoms and the menstruation.The differences within groups were statistically significant analyzed by the paired rank sum test(P<0.05).The comparison between groups showed that the difference of TCM symptom score of treatment group was significantly higher than that of control group,and that the treatment group could better improve the clinical symptoms and the menstruation.The difference was statistically significant analyzed by the independent sample rank sum test(P<0.05).(2)Analysis of menstruationThe comparison within groups showed that menstrual cycle of the treatment group and control group were both significantly decreased after treatment,and that acupuncture and TCM artificial cycle therapy and metformin could both obviously improve the menstruation.The differences within groups were statistically significant analyzed by the paired rank sum test(P<0.05).The comparison between groups showed that the difference of menstrual cycle of treatment group was significantly higher than that of control group,and that the treatment group could better improve the menstruation.The difference was statistically significant analyzed by the independent sample rank sum test(P<0.05).(3)Analysis of ovulation rate and pregnancy rateThe ovulation rate(88%)and pregnancy rate(58.6%)in the treatment group were significantly higher than ovulation rate(73.3%)and pregnancy rate(26.1%)in the control group.The difference was statistically significant analyzed by chi square test(P<0.05).(4)Analysis of obesityThe comparison within groups showed that body weight,BMI,waist circumference of the treatment group and control group were all significantly decended after treatment,and that acupuncture and TCM artificial cycle therapy and metformin could both significantly improve obesity signs of patients.The differences within groups were statistically significant analyzed by paired t test(P<0.05).The comparison between groups showed that the differences of body weight,BMI,waist circumference of treatment group were significantly higher than those of control group,and that the treatment group could better improve the obesity signs.The difference was statistically significant analyzed by the independent sample rank sum test(P<0.05).(5)Analysis of sex hormone levelsThe comparison within groups showed that LH,LH/FSH and T levels of the treatment group and control group were all significantly decended after treatment,and that acupuncture and TCM artificial cycle therapy and metformin could both effectively regulate the reproductive endocrine disorders.The differences within groups were statistically significant analyzed by paired t test(P<0.05).The comparison between groups showed that the differences of LH,LH/FSH,T of treatment group were significantly higher than those of control group,and that the treatment group could better regulate the reproductive endocrine disorders.The difference was statistically significant analyzed by the independent sample rank sum test(P<0.05).(6)Analysis of blood lipid levelThe comparison within groups showed that TG,CHOL and LDL levels of the treatment group and control group were all significantly decreased,HDL levels were significantly increased after treatment,and that acupuncture and TCM artificial cycle therapy and metformin could both effectively improve lipid metabolism.The differences within groups were statistically significant analyzed by paired t test(P<0.05).The comparison between groups showed that the differences of TG,CHOL,HDL,LDL of treatment group were significantly higher than those of control group,and that the treatment group could better improve lipid metabolism.The difference was statistically significant analyzed by the independent sample rank sum test(P<0.05).(7)Analysis of insulin resistance indexThe comparison within groups showed that FPG,FINS,Ln(HOMA-IR)levels of the treatment group and control group were all significantly decended after treatment,and that acupuncture and TCM artificial cycle therapy and metformin could both effectively improve insulin resistance in patients.The differences within groups were statistically significant analyzed by paired t test(P<0.05).The comparison between groups showed that the differences of FINS and Ln(HOMA-IR)of treatment group were significantly higher than those of control group,and that the treatment group could better improve insulin resistance.The difference was statistically significant analyzed by the independent sample rank sum test(P<0.05).(8)Analysis of expression levels of miRNA and related target geneThe comparison within groups showed that miR-143 and AKTmRNA levels of the treatment group and control group were all significantly increased after treatment,and that acupuncture and TCM artificial cycle therapy and metformin could both effectively regulate miRNA and related target gene transcription.The differences within groups were statistically significant analyzed by paired t test(P<0.05).The comparison between groups showed that the differences of miR-143,AKTmRNA of treatment group were significantly higher than those of control group,and that the treatment group could better regulate miRNA and related target gene transcription.The difference was statistically significant analyzed by the independent sample rank sum test(P<0.05).(9)Analysis of expression and phosphorylation levels of insulin signaling pathway related proteinThe comparison within groups showed that expression level of AKT protein of the treatment group and control group were both significantly increased,P-AKT,AKT,P-ERK1 and ERK1 phosphorylation ratio were significantly decreased after treatment,and that acupuncture and TCM artificial cycle therapy and metformin could both effectively regulate the expression and phosphorylation levels of insulin signaling pathway related protein.The differences within groups were statistically significant analyzed by paired t test(P<0.05).The comparison between groups showed that the differences of AKT,P-ERK1 and P-ERK1 phosphorylation ratio of treatment group were significantly higher than those of control group,and that the treatment group could better regulate the expression and phosphorylation levels of insulin signaling pathway related protein.The difference was statistically significant analyzed by the independent sample rank sum test(P<0.05).Conclusion1 Acupuncture and TCM artificial cycle therapy can effectively improve the patient’s menstrual conditions,phlegm symptoms and obesity signs and increase ovulation rate and pregnancy rate.2 Acupuncture and TCM artificial cycle therapy can effectively regulate the reproductive endocrine disorders.3 Acupuncture and TCM artificial cycle therapy can effectively improve the insulin resistance of patients,the mechanism may be through the regulation of miR-143 and PI3K/AKT and MAPK/ERK insulin signaling pathways.4 Acupuncture and TCM artificial cycle therapy not only cause no obvious abnormality in the safety index but also can reduce the adverse reaction caused by metformin and the incidence rate of loss,indicating good safety.5 Acupuncture and TCM artificial cycle therapy is worthy of popularization and application because of good effect and high safety for obese insulin resistant PCOS patients. |
PDF Full Text Request