Lei Wenwen, Gao Yang, Hu Shiruo, Liu Dongying, Chen Qiu
Hospital of Chengdu University of Traditional Chinese Medicine, PR China.
Medicine (Baltimore). 2020 Jul 24;99(30):e20696. doi: 10.1097/MD.0000000000020696.
Polycystic ovary syndrome (PCOS), an intricate and multifactorial disease, has characteristics of diverse clinical, metabolic and endocrine disorder. It represents a primary cause of infertility in reproductive women, which seriously affects the physical and mental health of patients. Several small studies have indicated that inositol and alpha lipoic acid (ALA) supplementation can ameliorate the outcomes in terms of menstrual cyclicity, ovulation and hyperinsulinemia in PCOS women. However, there is a lack of sufficient evidence to affirm this practice. Consequently, we aim to objectively review and estimate the efficacy and safety of inositol plus ALA in adult women suffering from PCOS.
We will retrieve PubMed, EMBASE, The Web of Science, The Cochrane Library of Controlled Trials, Clinical Trials.gov, Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP database), Wan-Fang database with no specific limitations on language. Simultaneously we will manually retrieve reference lists and grey literature to acquire potential eligibility. We will restrict our search to randomized controlled trials (RCTs) of inositol in combination with ALA for PCOS. Researchers will separately identify studies, extract data and evaluate the quality of studies. We will conduct risk of bias estimates, data synthesis and analysis using Review Manager 5.3 software.
The study will comprehensively determine the effectiveness and safety of inositol conjunct with ALA therapy for PCOS. Meanwhile we intend to disseminate the final findings in a peer-reviewed journal to help patients, clinicians and health policymakers select treatment strategy of PCOS by providing high-quality evidence.
多囊卵巢综合征（PCOS）是一种复杂的多因素疾病，具有多种临床、代谢和内分泌紊乱特征。它是育龄女性不孕的主要原因之一，严重影响患者身心健康。几项小型研究表明，补充肌醇和α硫辛酸（ALA）可改善PCOS女性的月经周期、排卵和高胰岛素血症等情况。然而，目前缺乏足够证据证实这一做法。因此，我们旨在客观地综述和评估肌醇加ALA对成年PCOS女性的疗效和安全性。
我们将检索PubMed、EMBASE、科学引文索引数据库、Cochrane对照试验中心注册库、ClinicalTrials.gov、中国生物医学文献数据库（CBM）、中国知网（CNKI）、维普中文科技期刊数据库（VIP数据库）、万方数据库，对语言无特定限制。同时，我们将手动检索参考文献列表和灰色文献以获取潜在的合格研究。我们将搜索限制在肌醇联合ALA治疗PCOS的随机对照试验（RCT）。研究人员将分别识别研究、提取数据并评估研究质量。我们将使用Review Manager 5.3软件进行偏倚风险估计、数据合成和分析。
本研究将全面确定肌醇联合ALA治疗PCOS的有效性和安全性。同时，我们打算在同行评审期刊上发表最终研究结果，通过提供高质量证据，帮助患者、临床医生和卫生政策制定者选择PCOS的治疗策略。
