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.
Keywords: Fundoplication; Gastroesophageal reflux; Meta-analysis; Proton pump inhibitors; Systematic review.