Acupuncture Treatment For Affective Symptoms And Health-Related Quality Of Life In Women With Polycystic Ovary Syndrome And Insulin Resistance

Background and ObjectivePolycystic ovary syndrome(PCOS)is one of the most common endocrine and metabolic disorder in reproductive age women,which is associated with hyperinsulinemia and insulin resistance(IR).PCOS adversely affects health-related quality of life and increase risk of depression and anxiety.Besides,IR may increased the odds of mood disturbances in women with PCOS.Acupuncture is an integral part of traditional Chinese medicine with a long history,having effects on improving anxiety and depression scores,as well as health-related quality of life scores in women with PCOS.However,no studies have investigated whether acupuncture to be effective for the treatment of anxiety and depression and for the improvement of the quality of life in patients with PCOS and IR.Therefore,the objectives of this trial include the following three points:(1)Explore the prevalence of anxiety and depression in patients with PCOS and IR;(2)Find the correlations of anxiety,depression and quality of life with the clinical and biochemical features of women with PCOS and IR;(3)Compare the efficacies of acupuncture plus metformin placebo(group A),sham acupuncture plus metformin(group B)and sham acupuncture plus metformin placebo(group C)on anxiety and depression disorders and quality of life in women with PCOS and IR.MethodA randomised controlled trial of women with PCOS and IR was conducted from November 2015 to March 2018 in the the First Affiliated Hospital of Guangzhou Medical University,Xuzhou Maternity and Child Health Care Hospital,Hexian Memorial Affiliated Hospital of Southern Medical University and Guangdong Maternal and Child Health Hospital.A total of 291 women with PCOS and IR between the ages of 18-38 years who completed scales and questionnaires were included.Recruited Participants were randomly allocated into the following three groups: acupuncture plus metformin placebo group(group A),sham acupuncture plus metformin group(group B)and sham acupuncture plus metformin placebo group(group C).All treatments were started 2 days after the baseline visit.They received active or sham acupuncture treatment three times a week with a maximum of 48 treatment sessions over 16 weeks.Besides,one pill of metformin or metformin placebo(500 mg per tablets)were given three times a day for 16 weeks.All subjects will be asked to use a barrier method for contraception.Following measurements were collected:(1)Body composition: height,weight,waist circumference,hip circumference,acne scores and Ferriman-Gallway scores,body mass index(BMI)calculated by height and weight,waist-to-hip ratio(WHR)calculated by waist circumference and hip circumference;(2)Metabolic and endocrine measures: fasting glucose,fasting insulin,glycated hemoglobin(Hb A1C),follicle stimulating hormone(FSH),luteinizing hormone(LH),prolactin,total testosterone(T),sex hormone binding globulin(SHBG),homeostasis model assessment-insulin resistance(HOMA-IR)calculated by fasting glucose and fasting insulin,free androgen index(FAI)calculated by T and SHBG,and LH to FSH ratio calculated by LH and FSH;(3)Scales and questionnaires: Self-Rating Anxiety Scale(SAS),Self-Rating Depression Scale(SDS),Polycystic Ovary Syndrome Questionnaire(PCOSQ)and Chinese Quality of Life Scale(Ch QOL).Results1.There were no significant baseline differences between the groups regarding age,weight,BMI,WHR,acne scores,Ferriman-Gallway scores,HOMA-IR,Hb A1 C,FSH,LH,LH to FSH ratio,T,and FAI;and SAS scores,SDS scores,PCOSQ scores,and Ch QOL scores.Overall 34.4% subjects had anxiety,while 26.67%had depression.2.Correlation analysis of baseline psychosocial function: A high HOMA-IR correlated with a higher SAS scores(r=0.141,P=0.021);A high HOMA-IR,Hb A1 C,weight,BMI and WHR correlated with higher SDS scores(HOMA-IR:r=0.132,P=0.030;Hb A1C: r=0.125,P=0.040;weight: r=0.135,P=0.026;BMI:r=0.126,P=0.038;WHR: r=0.130,P=0.032);A high HOMA-IR,weight,BMI,WHR,Ferriman-Gallway scores,Hb A1 C and FAI,as well as SAS scores and SDS scores correlated with lower PCOSQ scores(HOMA-IR: r=-0.133,P=0.029;weight: r=-0.166,P=0.006;BMI: r=-0.180,P=0.003;WHR: r=-0.205,P=0.001;Ferriman-Gallway score: r=-0.126,P=0.039;Hb A1C: r=-0.142,P=0.020;SAS scores: r=-0.429,P=0.000;SDS score: r=-0.352,P=0.000);A high SAS score and SDS score correlated with a lower Ch QOL scores(SAS score: r=-0.683,P=0.000;SDS score: r=-0.644,P=0.000).3.Anxiety and depression: There were no significant differences in SAS and SDS scores among group A,group B and group C after 16 weeks of treatment.By contrast,a significant differences in SAS scores ware noted when comparing pre-treatment and post-treatment measurements in group A,group B and group C(P<0.001,P<0.01 and P<0.01,respectively).Nevertheless,no significant reductions in SDS scores over time were found in all three groups after the intervention.4.Health related quality of life: PCOSQ: Subjects showed significant improvements in PCOSQ overall scores in all three groups(P<0.001,P<0.001 and P<0.01,respectively),as well as in most domains of the PCOSQ after 16 weeks treatment.Group A and group B showed significant improvements in all 5 domains that include emotion domain,body hair domain,weight domain,infertility domain and menstrual problems domain(group A: P<0.001,P<0.05,P<0.001,P<0.001 and P<0.05,respectively;group B: P<0.01,P<0.05,P<0.001,P<0.001 and P<0.05,respectively),while group C did not show improvements in hair domain compared to baseline scores(P<0.001,P<0.01,P<0.01 and P<0.01,respectively).On comparing PCOSQ overall scores and body hair domain scores after 16 weeks intervention between groups,group A showed significant improvement when compared to group C(P<0.05 and P<0.05,respectively).Ch QOL: The scores of physical form domain,complexion facets,stamina facets,appetite & digestion facets,adaptation to climate facets,thinking facets and spirit of the eyes facets had a great increase after treatments in group A(P<0.001,P<0.05,P<0.05,P<0.001,P<0.01,P<0.05 and P<0.05,respectively);while the scores of group B in Ch QOL overall scores,physical form domain,emotion domain,complexion facets,stamina facets and depressed mood facets after intervention were higher than the those scores in basseline(P<0.05,P<0.05,P<0.01,P<0.05,P<0.05 and P<0.01,respectively);the scores of group C in sleep facets,stamina facets and anger facets were significant increase after treatments(P<0.05,P<0.05,and P<0.01,respectively).On comparing the scores of appetite & digestion facets and adaptation to climate facets after 16 weeks intervention between groups,group A showed significant improvement when compared to group B in appetite &digestion facets while group A showed significant difference when compared to group C in adaptation to climate facets(P <0.01 and P <0.05,respectively).5.Clinical efficacy: After 16 weeks of treatments,there were no differences in HOMA-IR,weight,BMI and WHR among group A,group B and group C.HOMA-IR,weight,BMI and WHR decreased significantly in group A(P<0.05,P<0.001,P<0.001,and P<0.05,respectively);HOMA-IR,weight and BMI decreased significantly in group B(P<0.001;P<0.001 and P<0.001,respectively);meanwhile,weight and BMI decreased significantly in group C(P<0.001 and P<0.001,respectively).Conclusion1.In women with PCOS and IR,higher level of HOMA-IR appears to play a role in anxiety and depression,as well as in quality of life.Weight,BMI,WHR and Hb A1 c has a positive correlation with depression and quality of life.Furthermore,Ferriman-Gallway scors seems to influence quality of life in women with PCOS and IR.2.There was a great improvement in anxiety scores in women treated with acupuncture.Acupuncture exert a substantial reduction in the incidence of anxiety in patients with PCOS and IR,though there is no significant difference compared to metformin and sham acupuncture.In addition,all interventions make no effect on depression.3.This research witnessed improved PCOSQ scores after acupuncture treatments,indicating that acupuncture can improve the quality of life in women PCOS and IR.Acupuncture treatments result in better quality of life than sham acupuncture treatment.4.Acupuncture can ameliorate IR and obesity in patients with PCOS and IR,which may be related to the improvement of quality of life.