Walbaum Benjamin, Valda María Laura, Rada Gabriel
Department of Public Health, Faculty of Medicine, Pontificia Universidad Católica de Chile, Marcoleta 434, Santiago, Chile.
Emergency Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Lira 63, Santiago, Chile.
Syst Rev. 2016 May 10;5:78. doi: 10.1186/s13643-016-0250-4.
Avid renal sodium and water retention among other mechanisms produce ascites in patients with cirrhosis. The main guidelines recommend sodium intake reduction in order to counteract this complication. However, some randomized controlled trials have suggested a lack of benefit with a sodium-restricted over an unrestricted diet, and even an increase in ascites and renal complications has been reported. There are no systematic reviews addressing this question.
A systematic review protocol has been designed and will be reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). We will search for randomized controlled trials evaluating a salt-restricted versus unrestricted regime in patients with cirrhosis and ascites in EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials. We will also try to identify literature by reviewing reference list of included studies and relevant reviews, screening main conference proceedings, and searching for unpublished and ongoing trials in the World Health Organization (WHO) International Clinical Trials Registry Platform. Two researchers will independently undertake selection of studies, data extraction, and assessment of the quality of included studies. We will estimate pooled risk ratios for dichotomous data and the mean difference or standardized mean difference for continuous outcomes. A random effect model will be used for meta-analyses. Data synthesis and other analyses will be conducted using RevMan software.
no ethics approval is considered necessary. Results of this study will be disseminated via peer-reviewed publications and social networks
Sodium restriction is a widely accepted coadjuvant therapy for ascites; however, this indication is based primarily on expert recommendations. As far as we know, this will be the first systematic review assessing the effects of a sodium-restricted diet for ascites in cirrhotic patients. Our systematic review will aim to provide a high-quality synthesis of current evidence for patients and clinicians about this question. The main limitation might result from the reduced number and quality of primary studies available.
PROSPERO CRD42015022161.
肝硬化患者出现腹水的机制包括肾对钠和水的强烈潴留等。主要指南建议减少钠摄入以对抗这一并发症。然而，一些随机对照试验表明，与不限钠饮食相比，限钠饮食并无益处，甚至有报告称腹水和肾脏并发症会增加。目前尚无针对该问题的系统评价。
已设计了一项系统评价方案，并将按照系统评价与Meta分析方案的首选报告项目（PRISMA-P）进行报告。我们将在EMBASE、MEDLINE和Cochrane对照试验中央注册库中检索评估限盐与不限盐方案对肝硬化腹水患者影响的随机对照试验。我们还将通过查阅纳入研究的参考文献列表和相关综述、筛选主要会议论文集以及在世界卫生组织（WHO）国际临床试验注册平台上搜索未发表和正在进行的试验来识别文献。两名研究人员将独立进行研究选择、数据提取和纳入研究质量评估。我们将估计二分数据的合并风险比以及连续结果的平均差或标准化平均差。将使用随机效应模型进行Meta分析。数据合成和其他分析将使用RevMan软件进行。
无需伦理批准。本研究结果将通过同行评审出版物和社交网络进行传播。
限钠是一种广泛接受的腹水辅助治疗方法；然而，这一适应症主要基于专家建议。据我们所知，这将是第一项评估限钠饮食对肝硬化腹水患者影响的系统评价。我们的系统评价旨在为患者和临床医生提供关于这个问题的高质量当前证据综合。主要局限性可能源于现有原始研究数量减少和质量不高。
PROSPERO CRD42015022161
