| BackgroundPolycystic ovary syndrome(PCOS) is a common endocrine syndrome of childbearing age women.Its incidence rate is as high as 5%to 10%,50%of which is caused by fatness,and 50%to 70%of them is caused by insulin resistance,which is a majority part in patients.Too much insulin acting on the corresponding receptor in the ovary will cause obstacles in follicular development and maturity and there won't any advanced follicles.This will thus lead to anovulation and infertility.In that case,the symptoms,such as rare menstruation,amenorrhea,acne,hirsutism,obesity,infertility and so on will emerge.At present,it is considered that insulin resistance and hyperinsulinemia play a key role in the pathogenesis of polycystic ovary syndrome.Insulin resistance is also a high risk factor for many clinical diseases.It may increase the incidence ratio of diabetes,cardiovascular disease and endometrial cancer and has long future harm.Hence,it is very important to explore and find an effective treatment method for PCOS and IR with fewer side effects,which is also effectively preventive to future complications.Based on the existing treatises from former researchers and the long time clinical experiences accumulated by herself,TCM professor of our hospital Li Liyun,who is a provincial veteran,put forward the conclusion that the pathogenesis of polycystic ovary syndrome is basically in kidney deficiency and apparently in blood stasis and sputum obstacle.It is a deficiency-excess complication.So the method is tonifying the kidney,smoothing the sputum and invigorating the blood circulation to cure PCOS.She has established an experienced prescription and made the preparations,Necromancy Particle and Shenshi Capsule.Previous research has proved that these medicines do have healing effect onto the treatment of PCOS.Acupoint catgut embedding is a green acupuncture treatment rising in recent years,which is characterized by simplicity and cheapness.This treatment has a certain achievement on the treatment and research for obese patients.It is rare to find some reports on the clinical healing effect,action principle of TCM combined with acupoint catgut embedding therapy for curing PCOS,and the intervening effect of this treatment to the risk factor IR, obesity and blood fat related to PCOS long future complication.The evaluation standard o the healing effect is also different with each other.There is an obvious lack of systematic and normative research.So according to the present TCM research status of PCOS and the limitation of Western Medicine,we are planning to establish a TCM and acupoint catgut embedding combined method to see whether this combined treatment method can play an important role on intervening and curing PCOS and the high risk factors of its long future complication with the benefit of the good treatment effect of acupoint catgut embedding for obesity and the experienced prescription of Necromancy Particle from professor Li Liyun for curing PCOS.ObjectivesThrough comparing the clinical healing effect difference for PCOS between the Necromancy Particle from Professor Li Liyun,the most common medicine metformin for curing PCOS and IR in Western Medicine and the Necromancy Particle and acupoint catgut embedding combined treatment as well as observing improvement of menstruation,ovulation,body mass,reproductive endocrinology, insulin resistance,lipids,etc,this study is aiming at making objective evaluation to the clinical healing effects of Necromancy Particle and Necromancy Particle and acupoint catgut embedding combined treatment for PCOS and exploring the possible action mechanism in order to lay the foundation for the treatment method which has high efficiency and less side for curing PCOS and can also excellently prevent its long future complication.MethodThis study adopts forward looking clinical experiment research,chooses 77 PCOS and IR patients who went to Guangdong TCM Hospital to see gynecologic doctors during the time from February 2008 to February 2009 and are conforming to the diagnosis and adopting standard and divides them into three groups, TCM treatment group,Western Medicine treatment group and injection and medicine combined group.TCM treatment group has 28 patients and they are treated with the experienced prescription Necromancy Particle(domestic preparation,batch number:08102305).Western Medicine treatment group has 21 patients and they are treated with metformin(made in Shanghai).Injection and Medicine combined group has 28 patients and they are treated with Necromancy Particle and acupoint catgut embedding therapy,three months for each treatment period.This study evaluates the improvement situation of clinical symptoms and signs before and after the treatment,as well as the improvement situation of weight,BMI,waistline,hipline,WHR,hirsutism,acne scores,BBT,sex hormones before and after treatment,GLU,INS,HOMA-IR,TG, Tc,HDL-C,LDL-C,ApoA,ApoB and other indicators to determine efficacy, examines the general safety items before and after the treatment and records the occurrence of adverse reactions.Conclusion1.The treatment of all of the three groups can improve the endocrine status of PCOS patients.There is no significant difference with T level lowering between the three groups.The Western Medicine treatment group and injection and medicine combined group can also lower LH/FSH.2.The treatment of all of the three groups can improve the weight index, waistline and hipline of PCOS patients.The weight,waistline and hipline loss is the most significant in injection and medicine combined group after the treatment.That of the Western Medicine treatment group and TCM treatment group is almost the same.3.The treatment of all of the three groups can improve the IR of PCOS patients. The treatment of injection and medicine combined group and Western Medicine group has a better effect on HOMA-IR improvement than that of the TCM treatment group.There is no statistic importance to compare the HOMA-IR improvement effect of the Western Medicine group with that of the injection and medicine combined group.4.Blood fat status can be improved in injection and medicine combined group. Its effect is better than that of the TCM group and Western Medicine group. 5.The treatment of all of the three groups can improve the quantitative scores of TCM symptoms of PCOS patients.The TCM group and injection and medicine combined group have a better effect than the Western Medicine group.6.According to the results of this study,we suppose that the action principle of Necromancy Particle which is used to tonify the kidney,strengthen the spleen,smooth the sputum and remove obstacle,and Necromancy Particle and acupoint catgut embedding combined therapy for PCOS is to regulate the endocrine by lowering T level,improving insulin resistance and lowering the weight of patients.It has the function of regulating hypothalamus-pituitary -ovarian axis with multiple targets and overall aspect so as to achieve the promotion of follicular development and ovulation,Lowering the body mass may play a key role for that.7.Based on above objective results,we think the Necromancy Particle and acupoint catgut embedding combined treatment is an effective treatment method for curing PCOS and IR.It can significantly lower weight,waistline,hipline, and T level,regulate menstruation,restore ovulation,make some patients with infertility become pregnant,cure hyperprolanemia by lowering T,improve acne, and improve insulin resistance and vicarious hyperinsulinemia caused by insulin resistance by lowering FINS and HOMA-IR.injection and medicine combined treatment can also improve the blood fat metabolism status.According to the curative effect differences between the groups,we think the Necromancy Particle and acupoint catgut embedding combined treatment has a synergy effect in the treatment of PCOS and IR patients.It is better than single TCM treatment or Western Medicine treatment.8.According to the objective findings,we believe that the Necromancy Particle and acupoint catgut embedding combined treatment,through lowering the body mass,improving the insulin resistance and improving the blood fat metabolism status,can lower in a way the risk of PCOS long future complications,such as diabetes,high blood cholesterol,angiocardiopathy and so on.
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