Randomised controlled trialindependent cross-checkabstract checked I-GUT-112 in-depth review
H. pylori treatments in Egypt cure about 70-79%
Vonoprazan-based therapy versus standard regimen for Helicobacter pylori infection management in Egypt: an open-label randomized controlled trial.
Overview
Shekeban YM et al.. Sci Rep 2025 · PMID 40341536 · DOI 10.1038/s41598-025-98606-8
In an Egyptian trial, standard triple therapy cleared H. pylori in 70% and vonoprazan-based regimens in 76-79% of those who completed treatment.
Does the study support the specific claim? Partly · Methodological quality: low
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Compare H. pylori regimens in Egypt.
- How was the study done?
Open-label RCT.
- How many people, animals or samples were studied?
Egyptian adults (n not in abstract).
- What was actually found?
Eradication 70%, 76%, 79%; no significant difference.
- How large was the observed effect?
70% vs 79%.
- What do the results mean in everyday life?
Standard treatment in Egypt fails in about 3 in 10 people who complete it.
- What are the study's limitations?
Small, open-label.
- What does it say about Elawady's specific claim?
Supports regimen criticism, not denial of H. pylori.
- Do the results apply to Germany and Europe?
Not European data.
- What can explicitly not be concluded from this study?
Cannot show ulcers are not caused by H. pylori.
Scientific in-depth review
1. Full reference
- Authors
- Shekeban YM et al.
- Journal
- Sci Rep
- Year
- 2025
- Identifier
- PMID 40341536 DOI 10.1038/s41598-025-98606-8
- Verification
- verified – PubMed efetch 2026-10-26 + Crossref 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Authors declare no competing interests
2. Research question
How effective are vonoprazan-based dual/triple therapy versus standard PPI triple therapy for H. pylori in Egypt?
3. Study design and population
- Study design
- Randomised controlled trial – Open-label randomised controlled trial, 3 arms, 14 days
- Population
H. pylori-infected adults, Alexandria, Egypt
- Country
Egypt
- Period
Registered 2022 (NCT05614934)
- Sample size
Not stated in abstract
- Inclusion and exclusion criteria
Not stated in abstract
4. Methods and endpoints
- Exposure / intervention
Vonoprazan + amoxicillin/clavulanate (+ clarithromycin)
- Comparator
Standard triple therapy (PPI + amoxicillin/clavulanate + clarithromycin)
- Endpoints
Eradication rate, safety, compliance
- Statistical methods
Per-protocol comparison
5. Actual results
- Results
Per-protocol eradication: standard triple therapy 70%, vonoprazan dual 76.2%, vonoprazan triple 79.2% (P=0.777); authors describe all as suboptimal.
- Absolute risks
Eradication 70-79%
- Authors' conclusion
Regimens need optimisation; new regimens with higher eradication rates are needed.
6. Strengths
- Egyptian RCT
- Recent
7. Weaknesses
- Open label
- Per-protocol only in abstract
- Sample size not in abstract
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Open label; per-protocol analysis.
9. Assessment of the statistical interpretation
Underpowered for differences between arms.
10. Relevance to the specific claim
Egyptian data showing standard triple therapy cures only about 70% (per protocol), i.e. the regimen criticism has a factual basis in Egypt.
11. Independent contrary findings
Eradication still succeeded in most patients.
12. Transferability to Germany and Europe
Egypt-specific resistance.
13. Overall methodological judgement
Regional context: triple therapy is suboptimal, but treating the infection is not wrong.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | low |
| Risk of bias | some concerns |
| Precision of results | low |
| Directness | direct |
| Reproducibility | unknown |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Best regimen in Egypt.