This systematic review and meta-analysis evaluated the efficacy of nitazoxanide-based triple therapy versus standard triple therapy for H. pylori eradication. The analysis included 1286 participants across multiple studies. The primary outcome was H. pylori eradication rate, assessed both per-protocol and intention-to-treat, with post-follow-up assessments also reported.
Key findings showed a significant improvement in eradication rates with nitazoxanide-based therapy. Per-protocol analysis yielded a risk ratio of 1.40 (95% CI: 1.19-1.56; P<0.0001), and intention-to-treat analysis showed RR=1.36 (95% CI: 1.19-1.56; P<0.0001). Post-follow-up results were consistent. Secondary outcomes of abdominal pain and nausea showed non-significant reductions (RR=0.50 and RR=0.78, respectively), but p-values were not reported.
The authors noted that risk of bias ranged from low to high across included studies. Certainty of evidence was consistently high. Safety data, including adverse events and discontinuations, were not reported. The review did not provide absolute event rates.
Practice relevance is limited by the lack of safety data and variability in study quality. Future research should focus on optimal treatment duration, resistance patterns, safety, and symptom relief. Clinicians should interpret these results cautiously, considering the potential for bias and absence of harm data.
View Original 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.