| BackgroundPolycystic ovarian syndrome(PCOS) is a persistent anovulation, hyperandrogenism or insulin resistance syndrome is characterized by endocrine disorders, the incidence rate as high as5%-10%. In recent years, a large number of studies have shown that PCOS, whether obese or not, there are varying degrees of insulin resistance (insulin resistance, IR), an incidence of up to70%, and that the IR may be the initiating factor and the central link of the PCOS condition. Western medicine treatment of PCOS with IR preferred metformin, but metformin single medication to restore menstruation and ovulation efficacy poor, prone to gastrointestinal side effects, and embryonic security is not yet clear, clinical application is subject to certain restrictions.The famous professor Li LiYun of GuangDong Province Hospital of Traditional Chinese Medicine, created Ling-Zhu granule, early experimental and clinical studies confirmed that is very effective to treat the patient of PCOS and insulin resistance. Studies show that acupoint catgut embedding can improve the clinical symptoms of patients with polycystic ovary syndrome by reducing the body mass index. Hence, in order to explore and find an effective treatment method for PCOS and IR with fewer side effects, in this study, joint Ling-Zhu granule with acupoint catgut embedding for treatment of polycystic ovary syndrome and insulin resistance, in order to evaluate the efficacy and safety, hoping to disease-oriented treatment to provide a new approach and new ideas.Objectives Through comparing the clinical healing effect difference for PCOS between the Ling-Zhu granule from Professor Li Liyun, acupoint catgut embedding, the most common medicine metformin for curing PCOS with IR in Western Medicine and the Ling-Zhu granule 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 Ling-Zhu granule 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 prospective clinical controlled trial, chooses175PCOS and IR patients who went to Guangdong TCM Hospital to see gynecologic doctors during the time from December2009to December2011and are conforming to the diagnosis and adopting standard and divides them into four groups, Ling-Zhu granule group, acupoint catgut embedding group, metformin group and Ling-Zhu granule and acupoint catgut embedding combined group. Ling-Zhu granule group has44patients and they are treated with the experienced prescription Ling-Zhu granule group (domestic preparation, batch number:08102305). acupoint catgut embedding group has43patients and they are treated with acupoint catgut embedding therapy. Metformin group has44patients and they are treated with metformin (made in Shanghai). Ling-Zhu granule and acupoint catgut embedding combined group has44patients and they are treated with Ling-Zhu granule and acupoint catgut embedding combined 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.Results1. Four groups of patients with body mass index, waist-hip ratio have improved. After treatment, the body weight, BMI, and waist-hip ratio levels than before treatment was significantly decreased, the differences were statistically significant(P<0.05); Ling-Zhu granule and acupoint catgut embedding combined group was better than Ling-Zhu granule group, acupoint catgut embedding group and metformin group in decreasing body mass index, the differences were statistically significant(P<0.05).2. Four groups of patients with IR have improved. After treatment, the INS and HOMA-IR levels have improved than before treatment. Ling-Zhu granule and acupoint catgut embedding combined group was better than Ling-Zhu granule group and acupoint catgut embedding group in improveing HOMA-IR, the differences were statistically significant(P<0.05); The difference between Ling-Zhu granule and acupoint catgut embedding combined group and metformin group was not statistically significant (P>0.05), We believe that the efficacy is similar between Ling-Zhu granule and acupoint catgut embedding combined group and metformin group in improving HOMA-IR.3. Results of this study confirmed:Ling-Zhu granule and acupoint catgut embedding combined treatment is an effective treatment method for curing PCOS and IR. Ling-Zhu granule and acupoint catgut embedding combined solved the problem of gastrointestinal discomfort and unsafely in using metformin, we believe that Ling-Zhu granule and acupoint catgut embedding combined is the preferred treatment method for fertility patients.4. The treatment of all of the four groups can improve the quantitative scores of TCM symptoms of PCOS patients. Ling-Zhu granule and acupoint catgut embedding combined group improve the quantitative scores of TCM symptoms better than the other three groups.5. Blood lipids status can be improved in Ling-Zhu granule and acupoint catgut embedding combined group. Its effect is better than the other three groups.6. 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.ConclusionLing-Zhu granule and acupoint catgut embedding combined treatment of PCOS with IR is effective. IR had improved maybe by reducing body mass index and waist-hip ratio. The efficacy of Ling-Zhu granule and acupoint catgut embedding combined treatment was equivalent to metformin, and it was better than Ling-Zhu granule or acupoint catgut embedding. But Ling-Zhu granule and acupoint catgut embedding combined treatment has no side effects, its security is clear, so it is suitable for the patients who has fertility requirements or can not tolerate metformin side effects.
|
PDF Full Text Request