Comparative Efficacy and Safety of Nitazoxanide-based Triple Therapy Versus Standard Triple Therapy in Treating Helicobacter Pylori Infections: An Updated Systematic Review and Meta-analysis of Randomized Controlled Trials

Abstract

Helicobacter pylori infections are the major cause of gastrointestinal disease, mainly chronic gastritis, peptic ulcer, and gastric carcinomas, affecting half of the population globally. Due to the emergence of antibiotic resistance, the efficacy of current standard therapies, particularly clarithromycin and metronidazole, has been reduced. Nitazoxanide (NTZ), a broad-spectrum antimicrobial drug, has shown promising efficacy against H. pylori infections. This study aims to assess the comparative efficacy and safety of NTZ-based regimens versus standard triple therapy in H. pylori infections. A comprehensive literature search was conducted across 4 databases. Eight randomized controlled trials, comprising 1286 participants, comparing NTZ-based regimens with standard triple therapy, were included. A random-effects model was used to estimate pooled risk ratios (RRs) with 95% confidence intervals (CIs). NTZ-based therapy showed significant improvement in primary outcome, which includes H. pylori eradication rate compared to standard triple therapy. In per-protocol (PP) and intention-to-treat patients, durational analysis showed significant improvement in H. pylori eradication rates (RR=1.40; 95% CI: 1.19-1.56; P <0.0001) and (RR=1.36; 95% CI: 1.19-1.56; P <0.0001), respectively. In addition, post follow-up assessment also shows significant effects in both patients per-protocol (RR= 1.40; 95% CI: 1.21-1.62; P <0.0001) and intention-to-treat (RR=1.36; 95% CI: 1.19-1.56; P <0.0001). In secondary outcomes, NTZ-based therapy showed non-significant reduction in abdominal pain (RR=0.50) and nausea (RR=0.78). Risk of bias was reported as low to high, although certainty of evidence was consistently high. Egger's test shows non-significant publication bias ( P =0.161). Future research should focus on NTZ's optimal duration, resistance pattern, safety, and symptom relief.

Keywords: eradication rate; helicobacter pylori; nitazoxanide; randomized controlled trials; triple therapy.