Comparison of Standard Triple Therapy and Non-Bismuth Concomitant Quadruple Therapy for Helicobacter pylori Eradication in Non-Ulcer Dyspepsia

Abstract

Background: Helicobacter pylori is one of the most common bacterial infections worldwide, affecting up to 75% of the population, and is a major cause of upper gastrointestinal diseases, including gastric cancer. Effective eradication is crucial to prevent disease progression and complications. In India, rising clarithromycin resistance has reduced the success of standard triple therapy, often yielding eradication rates below 80%. Evidence comparing standard triple therapy with non-bismuth concomitant quadruple therapy in patients with non-ulcer dyspepsia—where the benefit of eradication is still debated—remains limited. This study provides region-specific, real-world data to evaluate therapeutic efficacy, inform first-line treatment choices, and guide local and national management strategies in resource-limited, high-resistance settings. Aim: This study aims to determine the prevalence of Helicobacter pylori (H. pylori) in patients with non-ulcer dyspepsia (NUD) and evaluate the comparative efficacy and tolerability of triple-based therapy versus non-bismuth-based quadruple therapy for eradication. Methods: A prospective, randomized, controlled study was conducted over three years at a tertiary care hospital in Meerut, India. A total of 200 adult patients diagnosed with H. pylori-positive NUD were randomized into two treatment groups. Group A received standard triple therapy consisting of Pantoprazole (40 mg), Clarithromycin (500 mg), and Amoxicillin (1 g) twice daily for 14 days. Group B received non-bismuth-based quadruple therapy, which included Metronidazole (500 mg) in addition to the triple regimen. Eradication rates were assessed via follow-up testing, and adverse events were recorded. Results: The eradication rate was significantly higher in the quadruple therapy group (89%) compared to the triple therapy group (73%) (p = 0.004). Common endoscopic findings included gastritis in both groups, with no significant intergroup differences in additional findings such as esophagitis (p = 0.72). Adverse events, including diarrhea (32% in Group B vs. 13% in Group A), metallic taste (24% vs. 9%), and nausea (16% vs. 7%), were more frequent in the quadruple therapy group but did not substantially affect compliance. Conclusion: Non-bismuth-based quadruple therapy demonstrated superior eradication rates compared to standard triple therapy in H. pylori-positive NUD patients. However, the increased incidence of adverse effects necessitates careful patient selection, counseling, and adherence monitoring. These findings highlight the need for tailored treatment strategies, particularly in regions with high clarithromycin resistance.