| BackgroundPolycystic ovary syndrome (Polycystic ovary syndrome, PCOS) is the clnical symptom of excessive secretion of androgen formation, menstrual irregularities, persistent anovulation, hyperandrogenism symptoms and polycystic ovarian changes cauesd by the increase of benign ovarian thecal cells.such Clinical manifestations are menstrual disorders, amenorrhea, Infertility, hirsutism, obesity, and polycystic ovaries increased, belongs to the concepts of Chinese medicine such as "medical infertility", "amenorrhea", "Zhengjia". How to cure the clinical symptoms of PCOS and improve pregnancy rates, reduce side effects caused by treatment, still are a matter of concern. Western treatment of infertility caused by PCOS is ovulation. Classical ovulation induction has methods auch as clomiphene citrate (CC) and human chorionic gonadotropin (HCG), have anti-androgen and anti-insulin treatment, urinary gonadotropin (HMG), FSH preparation, GnRH, ovarian wedge resection, intraperitoneal endoscopic ovarian drilling technique, in vitro fertilization-embryo transplantation therapy. However, Western medicine has some side effect and some operation risks, its indications and safety still have to be further confirmed. Chinese medicine treatment of PCOS has some advantages in these aspects:the adjustment of reproductive functions and areas of Endocrinology and Metabolism. Chinese medicine has integration of the overall regulation in patients with endocrine and metabolic disorders environmental and overcomes the disadvantages of Western treatment.Clinicians need to find evidence in support of TCM in the treatment of PCOS from the literature. However, There are some problems in the clinical research of TCM. how to collect the most convincing evidence from a broad array of literature is still a primary problem for clinicians to solve.evaluating Chinese medicine treatment for PCOS by evidence-based medicine can provide a comprehensive, systematic understanding of TCM for PCOS in the research design, implementation and efficacy assessment of the status in order to further improve the clinical research level and the application of clinical drugs. This subject search more information about TCM treatment for PCOS in clinical studies, and randomized controlled trials(RCT) are main research objects. According to the criteria manual work of Cochrane, we read each paper. Two reviewers focuse on the evaluation of RCT. We evaluate the quality of the literature according to Jadad rating score, then we use Kappa test to test the consistency of these results. Enrolled and excluded criteria, criteria for assessment of therapeutic effects, methods of randomization, assessment of sample content, comparability of baseline, methods of blinding, therapeutic methods, statistical methods, following-up, drop-out, conclusions derivation etc. in clinical studies are also evaluated. We use SPSS 13.0 to do the descriptive analysis. Also, we use RevMan4.2 to do Meta-analysis. From these analysis, we can find the advantages and disadvantages of TCM treatment for PCOS and have a more objective understanding of TCM for PCOS in order to carry out high-quality randomized controlled study in this area in furture.Research PurposeThe purpose of this systematic review is to evaluate the clinical efficacy and safety of TCM for PCOS by the analysis method of evidence-based medicine.Research Methodology1. Study object and inclusion criteriaalThe research object is the clinical research literature published in the medical journal of Chinese medicine treatment. Inclusion criteria:(1) randomized controlled design:article in a "randomized" words, or article using random number table, computer code, dice, flip a coin, drawing lots or other methods. (2) diagnostic criteria:Western diagnostic criteria based on authoritative international or national professional organizations such as the European Association of Human Reproduction and American Society for Reproductive Medicine in 2003, Chinese gynecology, the theory and practice standards of obstetrics and gynecology and so on. Chinese Medicine diagnostic criterias consistent with the "Infertility" "amenorrhea" and other diagnostic criteria such as "guiding principles of clinical research in Chinese medicine" and so on. (3)Subjects for the PCOS patient selection:patients hospitalized for observation. (4) The experimental group used therapeutic measures for Chinese medicine treatment:oral decoction (or Chinese fried-free particle), oral proprietary Chinese medicine, traditional Chinese medicine preparation intravenously, acupuncture, electroacupuncture, ear pressure, massage, acupuncture point injection, Chinese smoked wash or others.persons wtih one or more of these therapeutic measures are included. (5) interventions: comparison of medicine with other drugs (including Chinese and Western medicines), placebo or control treatment of PCOS in clinical research.2. Search strategiesThe databases include:Chinese Biomedical Literature Database (CBMWeb), Tsinghua Tongfang series database (CNKI) of the China Academic Journal, a VIP Chinese Science and Technology Periodical Database, PubMed, Cochrane Database of Systematic Reviews (DSR) and Cochrane Central Register of Controlled Trials (CCRC). In addition, we read references to track access to relevant literature. The word "ovary" is uesd as a key word or subject, The phrase "Chinese medicine", "Chinese medicine", "Chinese medicine" or "control" is used in any fields. According to the characteristics of each database, we make differernt search strategies.3. Evaluation of methodologyAccording to the design, measurement and evaluation in Clinical Research (DME) and the principles of evidence-based medicine, two received training evaluators read the full text and fill in the questionnaire independently. We discuss if we have different views in order to obtain consensus. The quality assessment uses Jadad rating scale combining with clinical epidemiology. Two reviewers give the score according to Cochrane systematic review manual in 3 respects such as randomization, blinding, follow up. Each part has the score of 0-2, and the total points is 0-5. If two reviewers have differences, they should have the discussion with the third party. Meanwhile, Enrolled and excluded criteria, criteria for assessment of therapeutic effects, methods of randomization, assessment of sample content, comparability of baseline, methods of blinding, therapeutic methods, statistical methods, following-up, drop-out, conclusions derivation etc. in clinical studies are also evaluated.4. Statistical analysisTo establish a database by using Excel 2003 for data input and management. Quality assessment is mainly in the expression of descriptive analysis. We will do meta-analysis by the software of Revman4.3.ResultsWe have retrieved a total of 591 potentially relevant documents. By reading the summary, removing the original that does not exist and the duplicate. There are 26 literatures may meet the included standards. RCT basic literature showed an increasing trend. There are no multi-center study. There are 3 researches having A fund supporter (11.54%). The score of Kappa is 0.70, P<0.01, the evaluation shows good agreement. There are 26 RCT, There are 3 researches having a Jadad score of 0,20 researches having a Jadad score of 1,3 researches having a Jadad score of 2.There are 20 (76.92%) documents referring only to "random" character, not describing specific methods of random allocation and hidden. There are No document referred to double-blind method or single blind method. There are no literature referring the number of lost, No ITT analysis. Inclusion and exclusion criteria are mentioned in only eight (30.77%) researches. There are 14 (53.85%) researches determining the efficacy of treatment. There are 6(23.08%) researches having sample<60 cases and 20 researches (76.92%) having sample≥60 cases. Above literature shows no basis for estimation of sample size. There are 8 (30.77%) researches that does not mention specific statistical methods, so it is impossible to evaluate the correctness of the statistical method. There are only 3 researches(11.54%) that referring the adverse drug reactions.The subject analysis 26 reports of TCM for PCOS. Meta-analysis showes that: Chinese medicine is efficient, the pregnancy rate of TCM group is significantly higher than that of western medicine group. The control group were divided into clomiphene citrate (CC) group, CC+HCG group, metformin group, thinylestradiol and Cyproterone Acetate Tablets group, spironolactone group.wo analysis the group treated with Chinese herbal compound group, Meta-analysis showes as follows:There are no significant difference (P=0.30) in the clinical effect between TCM group and Chinese herbal compound group. Funnel plot is in asymmetry distribution, so there may be some publication bias.ConclusionTCM is the effective treatment for PCOS. However, there is low methodological quality and potential publication biasin in RCT. The clinical efficacy and safety of RCT need to be confirmed and re-evaluation by multi-center randomized controlled trials in the future. |
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