Ding Ning, Yue Rensong, Wang Lizhen, Yang Hongjing
Hospital of Chengdu University of Traditional Chinese Medicine.
Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Medicine (Baltimore). 2020 Dec 4;99(49):e22982. doi: 10.1097/MD.0000000000022982.
Known as an endocrine disorder, Polycystic ovary syndrome (PCOS) has posed an influence on 6% to 20% reproductive females worldwide. The commonly used pharmaceutical agents currently are Oral Contraceptives (OCs) and insulin-sensitizing agents. However, OCs is not appropriate for females pursuing pregnancy. Furthermore, some of insulin-sensitizing agents are found to be related to a high incidence of gastrointestinal adverse effects. In this regard, the effectiveness of Chinese herbal medicine in handling reproductive and metabolic defects simultaneously has been proved by extensive evidence. In this research, the effectiveness and safety of Chinese herbal medicine for obese females with PCOS were examined.
In the systematic review, we searched databases of AMED, Science Online, EMbase, WorldSciNet, the Cochrane Library, PubMed, Nature, MEDLINE, China National Knowledge Infrastructure, the Wanfang Databse and China Biology Medicine Disc and the Chongqing VIP Chinese Science and Technology Periodical Database, to find out the papers published in Chinese or English by September 25, 2020 in this field. In addition, potential reference lists, relevant conference proceedings, qualified studies, related system reviews and other resources were also considered. Two researchers were responsible for independently selecting the research papers, collecting data, and evaluating research quality. Moreover, the data were synthesized with the combination of a fixed-effects or random-effects model with the heterogeneity test. According to the objective and self-reported assessment, the primary outcomes will be Nausea and vomiting were primary outcomes. RevMan 5 software was used to analyze the collected data, the evidence level of which was evaluated by GRADE. The selection between the fixed-effects and random-effects models was determined by the heterogeneity level. In addition to the 95% Confidence Interval (CI), odds ratio (OR), or risk ratio (RR) was applied to the 2 categories. Moreover, 95% CI and standardized mean difference (SMD) or the weighted mean difference (WMD) were taken as the continuous variables. When existing meaningful heterogeneity could not be explained by any assessment such as subgroup analysis, we would not conduct a meta-analysis. During the subgroup analysis, each subgroup in specific cases should be comprehensively considered.
The evaluation of rights or personal information of patients was not involved in the systematic review. Hence, we need not gain approval from ethical institutions. This paper will be present at related conferences for communication and published in journals.
Open Science Framework (OSF) Preregistration: osf.io/yp86h.
多囊卵巢综合征（PCOS）作为一种内分泌紊乱疾病，对全球6%至20%的育龄女性产生了影响。目前常用的药物有口服避孕药（OCs）和胰岛素增敏剂。然而，口服避孕药不适用于有怀孕需求的女性。此外，一些胰岛素增敏剂被发现与胃肠道不良反应的高发生率有关。在这方面，大量证据证明了中药在同时处理生殖和代谢缺陷方面的有效性。在本研究中，对中药治疗肥胖型PCOS女性的有效性和安全性进行了研究。
在系统评价中，我们检索了AMED、Science Online、EMbase、WorldSciNet、Cochrane图书馆、PubMed、Nature、MEDLINE、中国知网、万方数据库、中国生物医学文献数据库和重庆维普中文科技期刊数据库，以查找2020年9月25日前该领域发表的中英文论文。此外，还考虑了潜在的参考文献列表、相关会议论文集、合格研究、相关系统评价和其他资源。两名研究人员负责独立选择研究论文、收集数据和评估研究质量。此外，采用固定效应或随机效应模型结合异质性检验对数据进行综合分析。根据客观和自我报告评估，主要结局将是恶心和呕吐。使用RevMan 5软件对收集的数据进行分析，其证据水平由GRADE评估。固定效应模型和随机效应模型的选择由异质性水平决定。除95%置信区间（CI）外，比值比（OR）或风险比（RR）应用于两类数据。此外，95%CI和标准化均数差（SMD）或加权均数差（WMD）作为连续变量。当现有有意义的异质性无法通过亚组分析等任何评估来解释时，我们将不进行荟萃分析。在亚组分析中，应综合考虑特定情况下的每个亚组。
系统评价未涉及对患者权利或个人信息的评估。因此，我们无需获得伦理机构的批准。本文将在相关会议上发表以进行交流，并在期刊上发表。
开放科学框架（OSF）预注册：osf.io/yp86h。
