Efficacy and Safety of Esomeprazole for the Treatment of Reflux Symptoms in Patients with Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis

Abstract

Background: We investigated the efficacy of esomeprazole for the treatment of gastroesophageal reflux disease (GERD) in a meta-analysis of clinical trials results.

Methods: Medline, Embase, PubMed and Web of Science databases were systematically searched for suitable studies, and double-blind, randomized controlled trials (RCTs) were involved. A meta-analysis of RCTs was performed to analyze the efficacy of esomeprazole on clinical outcomes that associated with the severity of GERD.

Results: A total of 8 clinical trials were selected in our meta-analysis (N=4495, patients with GERD). Esomeprazole treatment yielded a significant improvement in clinical signs and symptoms of GERD compared to placebo group. Funnel plot and Egger test showed there was no significant bias in the publication. Cochrane collaboration tool and Jadad scale were used to indicate that all 8 RCTs were of high quality. The results of Galbraith radial plot showed that no study was the major source of heterogeneity. Esomeprazole treatment significantly decreased the relapse rates more than that of placebo group (RR = 0.729; 95% CI: 0.670 to 0.794; P<0.001). It seems to be lower rates of heartburn (RR = 0.747; 95%CI: 0.665-0.839; P <0.001) and epigastric pain (RR = 0.795; 95%CI: 0.679-0.932; P =0.005) in esomeprazole-treated group compared with the placebo group. Moreover, serious adverse events was less likely to happen after esomeprazole therapy (RR = 1.406, 95% CI: 1.030-1.918; P =0.032).

Conclusion: Compared with the control group, esomeprazole is a promising therapeutic agent that improves the management of patients with GERD.

Keywords: Clinical efficacy; Esomeprazole; Gastroesophageal reflux disease; Meta-analysis; Safety.

Fig. 1:

Flow diagram of study selection. A total of 791 potentially relevant studies were collected, of which 8 RCTs were included in the meta-analysis

Fig. 2:

Risk of publication bias for each trial. Both the funnel plot and Egger test showed no significant evidence of bias in the publication

Fig. 3:

Risk of bias assessment. The qualities of the included studies were evaluated using Cochrane collaboration tool, indicating that there is no significant risk of bias in the included trials of this meta-analysis

Fig. 4:

Forest plot of the 8 RCT studies. (A)relapse rates; (B)heartburn; (C)acid regurgitation; (D)epigastric pain. Black dots represent the standardized mean difference (SMD), and Horizontal lines represent 95%Cls of the SMD estimates. Diamonds stand for summary effect estimate of the meta-analysis

Fig. 5:

Forest plot of the adverse events and serious adverse events of esomeprazole. (A) adverse events; (B) serious adverse events. Black dots represent the standardized mean difference (SMD), and Horizontal lines represent 95%Cls of the SMD estimates. Diamonds stand for summary effect estimate of the meta-analysis

Fig. 6:

Galbraith radial plot. The figures show the contribution of results from the different studies to the heterogeneity. No study was shown to be the main source of the heterogeneity