| Objective1. To assess the clinical Efficacy and Safety of acupuncture in the treatment of PCOS by a systematic review.2. Aim to evaluate the clinical effect differences of acupuncture and Clomiphene Citrate for the ovulation obstacle of PCOS through the randomized controlled trial. Observe the effective in improving of PCOS patient mental anxiety and the correlation between the mental anxiety severity and PCOS ovulation obstacle. Provide a new idea for the clinical treatment of PCOS.Methods1. Systematic review of literatureAnalysised and evaluated the randomized controlled trials about acupuncture in the treatment of PCOS from1966January to2014January published in formal academic journals. Evaluated the curative effect, the current research deficiencies and the research improvement direction of acupuncture f PCOS. Determined’ polycystic ovary syndrome’or’PCOS’and ’acupuncture’for the key words. Searched Chinese Biomedical Literature database (CBM), China Academic Journal (CNKI), VIP database, Articals on the Chinese Medical Association, Cochrane Central Register of controlled trials database, PubMed database, Embase medical database. The risk of bias was evaluated by Cochrane reviews handbook5.2.0and the statistics was analyzed by Review Manage5.2software or separate descriptive analysis.2. Clinical StudyThe subjects were recruited from the PCOS outpatients of gynecology department and traditional therapy center of Guangdong Provincial Hospital of TCM. According to the proportion of1:1:1,90PCOS patients who met the inclusion criteria were randomly divided into3groups:acupuncture combined with medication group (group A), acupuncture group (group B) and medication group (group C). There were30patients in each group.Acupuncture combined with medication group (group A):Disposable sterile stainless steel needle was used for the acupuncture appliance (0.30×25mm or0.30×40mm). Select the needle length according to the obesity degree of the patient. Acupuncture prescription:Ganshu(BL18), Shenshu(BL23), Zhongwan (CV12), Guanyuan (CV4), Shuifen (CV9), Zhongji (CV3), needled the back visceral acupoints left and right turn; lateral position was selected for acupuncture; inserted needle with fast rotation, hand-manipulated needle with mild reinforcing and reducing method, retained the needle for30min. The amenorrhea patients needed to use progesterone withdrawal bleeding before acupuncture treatment. They were given the acupuncture treatment3times a week. The treatment was stopped immediately if the urine pregnancy test or blood HCG was positive. Medication taking methods:50mg clomiphene citrate (1tablet/day) was distributed in the first menstrual cycle5～9days. If the subjects ovulated, the medication dose remained unchanged. If the subjects didn’t ovulate, the medication dose was increased to100mg (2tablets/day) in the next menstrual cycle. If the subjects still had no ovulation, the clomiphene citrate would be increased to a maximum dose of150mg (3tablets/day) in the next course. If the subjects had ovulation, the dose would be maintained in the next cycle. The patient was not given clomiphene citrate in the fourth menstrual cycle.Acupuncture group (group B):the acupuncture manipulation method was the same as the group A. The clomiphene citrate wouldn’t be given.Medication group (group C):medication taking method was the same as group A. Didn’t do acupuncture for them.All patients received treatment for3months and follow-up for1month. All physical examinations were performed before and after treatment (hirsutism, body mass index), endocrine levels(testosterone, LH/FSH), mental anxiety score of SAS, tongue tassel line score. Observed the changes of the indicators before and after treatment. Did the blood testing of progesterone index to observe the ovulation effect during the period of treatment. All data were statistically analyzed with SPSS16.0.Results1. Systematic review of literature According to the search strategy and literature screening methods, a total of317papers published in formal academic journals were found. There were248papers written in Chinese and69papers written in English. After reading the title, abstract, text and doing bias risk assessment,6papers of high quality randomized clinical literature were screened out.2reports on side-effect were described in6articles. Totally6articles involving587cases were included. Acupuncture was safe in the treatment of PCOS. The total effective rate of acupuncture group was better than controlled group,OR=2.71,95%CI[1.45,5.07], Z=3.13(P<0.01). Because of the small quantity of included studies literature, funnel plot couldn’t be used to analysis the publication bias.2. Clinical StudyAfter3months of therapy,3cases fell off totally in the three groups of patients (1case in group A,0case in group B and2cases in group C). Finally,29cases in group A,30cases in group B and28cases in group C were analyzed statistically.(1)Before treatment, in order to determine the comparability of the three groups, did the data analysis of age, disease course, pregnant preparation time, BMI, hirsutism score, SAS score, tongue tassel line score, T level, LH/FSH ratio respectively. There were no significant differences (P>0.05).(2) Ovulation rateThe ovulation efficiency of the three groups in the treatment course and the follow-up period was calculated. There were significant differences among the three groups (P<0.05). The difference between group A and group B, C was statistically significant respectively (P<0.05). There was no significant difference between group B and group C (P>0.05). The data showed that all of the three groups could induce ovulation. Group A was better than group B and group C. The ovulation induction effect of group B and C was similar.(3) Correlation between anxiety state and ovulation, tongue tassel line scoreThrough analysis of the data, the severity of anxiety was associated with ovulation (P<0.05). The correlation of them was negative (r<0). The severity of anxiety was associated with ovulation (P<0.05). The correlation of them was positive(r>0).(4) SAS In relieving mental anxiety, the difference between before and after treatment of group A, B was statistically significant respectively (P<0.05). There was no significant difference between before and after treatment of group C (P>0.05). After treatment, SAS of group A, B compared with group C respectively, the difference was statistically significant (P<0.01). There was no statistical difference between group A and B(P>0.05). The data showed that group A and B was better than group C in relieving mental anxiety and group C had no obvious improvement.(5) Tongue tassel line scoreIn reducing the tongue tassel line score, the difference between before and after treatment of group A, B was statistically significant (P<0.01). There was no significant difference between before and after treatment of group C(P>0.05). There were significant differences among the three groups (P<0.01) after the treatment. There was no statistical difference between group A and B (P>0.05). Group A, B compared with group C respectively, the difference was statistically significant (P<0.05). The data showed that both of group A and B could reduce the tongue tassel line score remarkably. Group C had no obvious improvement in tongue tassel line score.(6) Testosterone levelThe differences between before and after treatment of group A, B and C respectively were statistically significant in reducing the testosterone leve(P<0.05). There were significant differences among the three groups (P <0.01) after the treatment. Group A compared with group B, C respectively, the difference was statistically significant(P<0.05). There was no statistical difference between group B and C (P>0.05). The data showed that all the three groups could reduce the testosterone leve. Group A was better than group B and C. The curative effects of group B, C in reduciing the testosterone leve were similar.(7) LH/FSH ratioIn reducing the LH/FSH ratio, the difference between before and after treatment of group A was statistically significant (P<0.01). There was no significant difference between before and after treatment of group B, C respectively (P>0.05). There were significant differences among the three groups (P<0.01) after the treatment. There was no statistical difference between group B and C (P>0.05). Group A compared with group B, C respectively, the difference was statistically significant (P<0.01). The data showed that group A was better than group B, C in reducing the the LH/FSH ratio and group B, C had no obvious improvement.(8) BMIIn reducing the BMI, the difference between before and after treatment of group A, B was statistically significant (P<0.01). There was no significant difference between before and after treatment of group C(P>0.05). Group A, B compared with group C respectively, the difference was statistically significant (P<0.01). There were significant differences among the three groups (P<0.01) after the treatment. There was no statistical difference between group A and B (P>0.05). The data showed that both of group A and B could reduce the BMI remarkably. Group C had no obvious improvement in obesity. In redcing weight, the curative effect of group A and C was similar.(9) FG scoreThe differences between before and after treatment of all the three groups were statistically significant (P<0.01) in the improvement of hirsutism. To compare the hirsutism score after treatment, there was no significant difference among group A, B and C(P>0.05). The data showed that all the three groups could improve hirsutism and their curative effects were similar.(10) Safety index and adverse reactionBlood, liver and kidney function damage were not found in all of the three groups. Although there was no statistically significant difference among group A, B and C (P>0.05), the data showed that group C had more adverse reaction than group A and B.Conclusion1. The literature review shows that acupuncture is effective in the treatment of PCOS, but it is not definite due to relatively low level of evidence. More high-quality evidences are needed.2. The acupuncture method can improve the ovulation disorders obviously. Its effect mechanism is related to the improvement of anxiety status, serum T, LH/FSH and obesity. The clinical therapeutic effect of acupuncture and simple oral clomiphene citrate is similar. Acupuncture or acupuncture combined with clomiphene can improve the mental anxiety and the quality of life. Both of them can be helpful in ovulation by improving the mental anxiety status of PCOS patient. Acupuncture has less adverse reaction and it has a good application prospect and popularization value in further research. |
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