Efficacy and safety of alginate formulations in patients with gastroesophageal reflux disease: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE Alginate formulations are increasingly being used for treating gastroesophageal reflux disease (GERD). However, the benefits of alginate versus control or proton pump inhibitors (PPIs) are somewhat unclear. We performed a systematic review and meta-analysis to summarize data from recent randomized controlled trials (RCTs) comparing the efficacy and safety of alginate-based formulation with PPIs or control for the treatment of GERD. MATERIALS AND METHODS PubMed, Embase, Scopus, BioMed Central, CENTRAL, and Google scholar databases were searched from 1st January 2000 to 15th June 2020. Primary outcome was a reduction of symptoms while secondary outcomes were adverse events and treatment withdrawals. Ten articles with 11 RCTs were included. RESULTS Qualitative analysis of four trials indicated better outcomes with alginates vs. placebo/antacids. Our pooled analysis, however, indicated no statistically significant difference between alginates and placebo/antacids for relief of heartburn, regurgitation, or dyspepsia. Similarly, no difference was seen between a combination of alginate and PPI vs. PPI alone for reduction of heartburn, regurgitation, or dyspepsia symptoms. The risk of adverse events and treatment withdrawal did not differ between the two groups in either comparison. Descriptive analysis of studies comparing alginate vs. PPI indicated no difference between the two drugs. CONCLUSIONS Our study indicates that alginates may have greater efficacy than placebo/antacids in improving outcomes of GERD. However, current evidence on the efficacy of alginate-based formulations vs. PPI or the role of added alginates with PPI is questionable, and suggests no difference between the two drugs. The risk of adverse events with alginates is no greater than that of placebo or PPIs.