| BackgroundPolycystic Ovary Syndrome (PCOS) is a common endocrine dysfunction in gynecological disease, which often causes infertility and long-term complication such as endometrial cancer, breast tumor and diabetes. The clinical manifestations are so multiple that they severely impact the emotional well-being and quality-of-life of PCOS patients. In the modern medicine system, the cause and the mechanism of PCOS are still unclear, and symptomatic treatment is still the main therapeutic way for PCOS. Meanwhile, it has been reported that TCM treatment has obvious curative effects on it, which can reduce some side effects.The Ling-zhu granule and Shen-qi capsule prescribed by Professor Li Liyun also display their positive effects on PCOS, reported in prior research and utilized extensively. On the other hand, with the transition of modern medical mode, the concentration of medical research has been placed on the health-related quality-of-life(HRQoL)rather than the clinical index. Especially in the assessment of chronic disease, the measurement of quality-of-life has an important role. The principal of measurement of HRQol resembles with of TCM system in the respect of the entirety of health status.Considering the features of PCOS constellation, prior research has been taken to evaluate the HRQol of PCOS patients and suggested that PCOS and its associated symptom profile have a negative effect on HRQoL. Thus far, little attention has been paid to treatment status in studies on the psychological issues in PCOS, and little is known with regard to the sensitivity of HRQoL variables to treatment.Now we hope to assess the effect of the Ling-zhu granule and Shen-qi capsule treatment in the HRQoL respect, and try to explore the correlation between the curative effect and improvement of HRQoL. ObjectiveIn a prospective observational study, we analysed the effects of the Ling-zhu granule and Shen-qi capsule treatment on HRQoL as the proof of clinical application. We assessed and identified the probable influential factors to explore the way to prevent or reduce the impact PCOS on HRQoL. What's more,we expected to lead the measurement of HRQoL into the assessment of TCM therapeutic effect to construct a bridge between modern medicine and TCM.MethodNon-randomized controlled trial was used,66 out-patients with PCOS were observed in department of Gynecology in Guangdong Provincial TCM Hospital from January 2009 to January 2010. Patients were divided into two groups,53 in the trial group treated by Ling-zhu granule and Shen-qi capsule,and 13 in the control group treated be the metformin. Before and after 3 months of treatment,changes in clinical and endocrine parameters,and index of HRQoL were assessed using validated questionnaires(SF-36,SCL-90).The correlation of them was calculated to identify the possible association.Result1.In the curative effect facet,testosterone level,ratio of LH/FSH, insulin sensitivity index(ISI),body mass index (BMI)and the menses status in both groups were significantly improved(P<0.01 or P<0.05),while no significant statistical differences were found in the terminal index(P >0.05).Besides, waist-to-hip ratio(WHR)and acne were improved significantly(P<0.01),while no significant statistical differences were found in other aspects(P>0.05).There is no distinct difference between the total effective rate of both groups(P>0.05).2. In the HRQoL facet, during the treatment, HRQoL, particularly the psychosocial aspects(indicated by significant decrease of most SCL-90 scales and increase of SF-36 scales such as General Health, Vitality,Mental Health, Psychological Sum scale and total sum scale) improved in trial group (P<0.01 or P<0.05).While in control group, just the SCL-90 scale Depression, total sum scale and Positive Symptom Number, and SF-36 scale Social Functioning and total sun scale improved significantly(P<0.01 or P<0.05).3. Before the treatment, the request of procreation, obesity, insuline resistance, acne, hirsutism and differentiation of TCM had conceivable association with HRQoL of PCOS patients.During the treatment of Ling-zhu granule and Shen-qi capsule, improvement in HRQoL was correlated with the curative effects in some extent.(0.3≤r≤0.5, P<0.01 or P<0.05).Conelusion1.Treatment of Ling-zhu granule and Shen-qi capsule can improve the clinical and endocrine parameters of PCOS patients,while no significant differences were found in the terminal index of both TCM and metformin groups.2.Treatment of both groups can improve the HRQoL of PCOS patients, and the treatment of Ling-zhu granule and Shen-qi capsule has obvious advantage compared with control group.3.The symptom constellation of PCOS has impact on the HRQoL before and after treatment of Ling-zhu granule and Shen-qi capsule,which may interact with each other. However it is exceedingly difficult to discern the role of pretreatment symptom constellation and treatment-induced changes in the improvement of HRQoL. As a result,we should pay more attention to a general healing pattern composed of drug treatment, lifestyle improved and psychological guidance from the respect of entirety of health. Obviously TCM based on the entirety of health has shown its advantage.4.As a result of the common base of the entirety of health, with the advantage of TCM treatment in HRQoL, we can try to lead the assessment of HRQoL to the TCM systems to link up with modern medicine system.
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