Screening Data Of The Subjects Based On The Clinical Trial Of "The Effects Of Acupuncture And Clomiphene Citrate For Live Birth In Polycystic Ovary Syndrome"

Objective:By screening of the subjects who are likely to enter clinical trials of“Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome”in outpatient,we can understand the overall status of patients with PCOS and their awareness to PCOS and clinical trial of traditional Chinese medicine,to dig the important role of screening in popularization related knowledge and early detection and treatment of disease.The reasons that patients cannot enter into the treatment group the study can provide theoretical support and objective basis for development of the clinical trial protocol and its applications in clinic.Methods:“The National Twelfth Five-Year”chronic disease project of gynecology——Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome:study design of a randomized controlled trial.This paper sets screening patients as the object of study.The sub-center research assistant who a unified training first carry the preliminary screening for outpatients from the gynaecological clinic of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine,and then choose PCOS women(characterized by oligomenorrhea or amenorrhea)of aged between 20 to 40 years old and have fertility requirement in Mainland China as screening subject,all 133 patients enter into the study.The research assistant explains and registers the project to them.At last,according to the patients and their family members’ will and the examination results,the assistant fill in print PCOSAct Screening Form-Per subject(appendix 2)to record screening result.The principal investigator hope that screening patients complete the PCOS outpatient medical records table,traditional Chinese medicine syndrome quantization table(appendix 3)and keep their copies of results after the trial.Save data,then dawn conclusions.Results:1.The majority of the patients do not know PCOS completely(63.91%),even 93.98%patients do not understand the clinical trials of traditional Chinese medicine.2.The reasons why patients can’t into the treatment group mainly concentrate on the following respects.Firstly,Distance too far and transportation an issue are the largest,comprising 30%;Secondly,subject not interested is about 17.27%,do not want random selection,accounting for 8.18%,time commitment too much has a weight of 5.45%;Finally,partner’s semen analysis not meet criteria showed 7.27%.3.Distribution of four syndromes in 97 patients with PCOS of screening:spleen deficiency and dampness-heat syndrome(43.30%),phlegm-stasis syndrome(30.93%),renal deficiency and hepatic stagnation syndrome(17.52%),renal deficiency and blood stasis syndrome(8.25%).4.Screening analysis:(1)Most of them are from Heilongjiang province in screening patients,especially in Harbin,individual patients come from other provinces.(2)Menstrual history:72.04%of the patients had troubled irregular menstruation since menarche,27.96%of the patients maintained regular menstrual cycles several years,later changed,and oligomenorrhea and amenorrhoea are the main,while dysfunctional uterine bleeding.(3)Dietary mode:Over half of the patients like to eat snacks,sweet or fried foods;18.06%of the patients have regular exercise habits,81.94%of them hardly ever exercise.(4)Family history:57.90%of the screening patients have family history,42.10%no。(5)Physical examination:32.47%of the patients have troubled hairy,acne is 35.07%,acanthosis nigricans is 41.56%.57.61%of the patients are obese by BMI>25kg/m2,WHR>0.85,with this standard,68.00%of the patients are central obesity.(6)PCOS with metabolic disorder:63 people among 84 patients suffer from different levels of metabolic abnormalities,including nonalcoholic fatty liver disease,insulin resistance,dyslipidemia,impaired glucose tolerance,diabetes.(7)Hormone level:All 84 patients,33 patients’(39.29%)LH/FSH are abnormal,58 patients(69.05%)have got hyperandrogenism.Conclusions:1.The patients’ awareness to PCOS and clinical trial of traditional Chinese medicine is low.2.Women with PCOS show higher willingness for screening and treatment into the group,but some reasons lead to fail to enter into the group.Such as the distance too far,traffic inconvenience,all violative laboratory results,and their incorrect attitudes toward clinical trial participation.3.Distribution of traditional Chinese medicine syndrome in these patients:spleen deficiency and dampness-heat syndrome is most,followed by phlegm-stasis syndrome,renal deficiency and hepatic stagnation syndrome,renal deficiency and blood stasis syndrome is least.4.Through the analysis of the screening,PCOS is characterized by hyperandrogenism,the patients with PCOS usually have suffered from irregular menstruation since adolescence;Poor eating habits and a lack of exercise;They often have family history of hypertensive,diabetes,oligomenorrhea or even infertility;The incidence of obesity is higher in PCOS,and accompanied by more severe endocrine and metabolic disorder.5.Screening is an effective way to spread knowledge of PCOS,it can improve the rates of early diagnosis and early treatment of PCOS and its complication.Analyze the causes screening for failure may be useful for development of the clinical trial protocol and its applications in clinic.