Mastic gum as an adjunct therapy to standard bismuth quadruple therapy for Helicobacter pylori eradication: A randomized single-blind pilot study.

Abstract

Background and objectives: Helicobacter pylori infection is highly prevalent globally. Standard bismuth quadruple therapy is commonly used in India, but there are growing concerns regarding the emergence of anti-microbial resistance and treatment failure, necessitating the search for newer modalities. This study evaluated the efficacy and safety of adding mastic gum to standard bismuth quadruple therapy (BQTs) for H. pylori eradication.

Methods: In this single-blind, randomized pilot trial, adults with Helicobacter pylori infection were assigned to receive two weeks' course of either standard bismuth quadruple therapy combined with mastic gum (Group A, n = 32) or bismuth quadruple therapy alone (Group B, n = 32). The primary endpoint was the eradication rate of Helicobacter pylori assessed by urea breath test at six weeks after therapy. Secondary endpoints included symptom improvement, measured by Dyspepsia Symptom Severity Index (DSSI), adverse events and compliance.

Results: Urea breath test demonstrated higher eradication rates in Group A vs. Group B (85% vs. 67%, absolute risk reduction = 0.18, number needed to treat ≈ six). However, it failed to reach statistical significance (p = 0.19). Both groups showed significant reductions in DSSI scores, with greater mean improvement in Group A (0.941 vs. 0.766, p = 0.001). Both treatment regimens were well-tolerated and treatment compliance was notably high in both groups, with 84.4% in each group reporting 100% compliance.

Conclusions: In this pilot study, the addition of mastic gum to standard bismuth quadruple therapy resulted in an observed increase in the proportion of eradicated cases; however, it did not meet the primary endpoint due to a lack of statistical significance. Nevertheless, the adjunct therapy was associated with significantly greater dyspepsia symptom relief and was well-tolerated without increasing adverse effects.