Department of Evidence-Based Medicine, Centro Universitário Lusíada, R. Oswaldo Cruz, 179, Santos, São Paulo, 11045-101, Brazil.
Department of Evidence-Based Medicine, Universidade de São Paulo, São Paulo, São Paulo, Brazil.
Esophagus. 2021 Apr;18(2):173-180. doi: 10.1007/s10388-020-00806-w. Epub 2021 Feb 2.
Gastroesophageal reflux disease (GERD) is a widely studied and highly prevalent condition. However, few are reported about the exact efficacy and safety of fundoplication (FPT) compared to oral intake proton-pump inhibitors (PPI). This systematic review and meta-analysis of randomized clinical trials (RCT) aims to compare PPI and FPT in relation to the efficacy, as well as the adverse events associated with these therapies. Search carried out in June 2020 was conducted on Medline, Cochrane, EMBASE and LILACS. Selection was restricted to RCT comparing PPI and FPT (open or laparoscopic) in GERD patients. Certainty of evidence and risk of bias were assessed with GRADE Pro and with Review Manager Version 5.4 bias assessment tool. Ten RCT were included. Meta-analysis showed that heartburn (RD = - 0.19; 95% CI = - 0.29, - 0.09) was less frequently reported by patients that underwent FPT. Furthermore, patients undergoing surgery had greater pressure on the lower esophageal sphincter than those who used PPI (MD = 7.81; 95% CI 4.79, 10.83). Finally, FPT did not increase significantly the risk for adverse events such as postoperative dysphagia and impaired belching. FPT is a more effective therapy than PPI treatment for GERD, without significantly increasing the risk for adverse events. However, before indicating a possible surgical approach, it is extremely important to correctly assess and select the patients who would benefit from FPT to ensure better results.
胃食管反流病(GERD)是一种广泛研究且高度流行的疾病。然而,与口服质子泵抑制剂(PPI)相比,关于胃底折叠术(FPT)的确切疗效和安全性的报道却很少。本系统评价和随机临床试验(RCT)的荟萃分析旨在比较 PPI 和 FPT 治疗 GERD 的疗效以及与这些治疗相关的不良事件。2020 年 6 月进行的检索在 Medline、Cochrane、EMBASE 和 LILACS 上进行。选择限制为比较 PPI 和 FPT(开放或腹腔镜)治疗 GERD 患者的 RCT。使用 GRADE Pro 和 Review Manager Version 5.4 偏倚评估工具评估证据确定性和偏倚风险。纳入了 10 项 RCT。荟萃分析显示,接受 FPT 的患者较少报告烧心(RD=-0.19;95%CI=-0.29,-0.09)。此外,与使用 PPI 的患者相比,接受手术的患者食管下括约肌压力更高(MD=7.81;95%CI=4.79,10.83)。最后,FPT 并没有显著增加术后吞咽困难和嗳气障碍等不良事件的风险。FPT 是治疗 GERD 的一种比 PPI 更有效的治疗方法,不会显著增加不良事件的风险。然而,在考虑可能的手术方法之前,正确评估和选择可能从 FPT 中获益的患者极为重要,以确保更好的治疗效果。