Esomeprazole, amoxicillin, clarithromycin, and berberine hydrochloride,
does it really help with First-line Helicobacter pylori eradication?
research showsGrade C with 50 points. A 612-person open-label noninferiority trial reported ITT eradication of 266/308 (86.4%) with bismuth and 274/304 (90.1%) with berberine. However, allocation labels conflict with the flow and per-protocol denominators, requiring a warning about exact arm attribution.
ads claimDo not claim that berberine alone eradicates infection or replaces antibiotics.
Useful facts when choosing a product
- This verdict applies only to the displayed formulation, route, dose, duration, population, endpoint, and comparator.
- Berberine hydrochloride, botanical extracts, combination formulas, dihydroberberine, other derivatives, and topical products are not interchangeable.
- Warning. This antibiotic regimen includes clarithromycin, amoxicillin, and a PPI; allergy, diarrhea, resistance, and multidrug interactions require guideline-based clinical management.
Chamgap Semantic Classification Code
Permanent code issued
S.berberine-quadruple.oral-combination.helicobacter-pylori-eradication.improve.bismuth-quadrupleSupplements and nutraceuticals > Berberine-containing antibiotic quadruple therapy > Oral combination > H. pylori eradication > Improvement claim > Bismuth quadruple therapy
Bound to the full 14-day quadruple regimen and ¹³C-UBT 28 days later; this is not monotherapy, and the paper's arm-label/denominator conflict is retained. The code identifies the intervention and claim; it never contains the evidence grade, score, or safety result.
Exact Claim Classification
These independent facets prevent evidence from different forms, routes, populations, effects, and comparators from being mixed.
| Intervention class | S · Supplement or nutraceutical |
|---|---|
| Canonical ingredient or intervention | Berberine-containing antibiotic quadruple therapy |
| Source or part used | Purified berberine hydrochloride; source plant unverified |
| Formulation or processing | PPI, amoxicillin, clarithromycin, and berberine quadruple regimen |
| Route | Oral combination therapy |
| Dose | Berberine hydrochloride 500 mg twice daily plus three standard medicines |
| Duration | 14 days; ¹³C-UBT 28 days after treatment |
| Population | Treatment-naive adults with H. pylori infection |
| Effect or condition | Confirmed eradication rate |
| Primary endpoint | Negative ¹³C urea breath test 28 days after treatment |
| Comparator | The same antibiotic quadruple regimen containing bismuth tartrate instead |
| Duplicate-detection key | Berberine-containing antibiotic quadruple therapy|PPI, amoxicillin, clarithromycin, and berberine quadruple regimen|Oral combination therapy|Treatment-naive adults with H. pylori infection|Confirmed eradication rate|14 days; ¹³C-UBT 28 days after treatment |
What the research actually shows
The NCT02296021 paper, PMC tables, and abstract were cross-checked and the ITT/PP denominator conflicts retained.
Why this is classified as C (50)
Axes are H/R1/I1/E~/B2/CX. H is one strength, but noninferiority, active-only comparison, under-12-week follow-up, and arm-attribution conflict yield C/50.
Counterpoint. Eradication rates were favorable, but single-center open-label conduct, internal reporting conflict, and regional resistance patterns limit generalization.
Rejudgment record. Independent Codex cross-check — One formulation, route, population, claim, principal endpoint, and comparator
| Endpoint | H | Hard endpoint - actual events such as death |
| Replication | R1 | Single confirmatory trial |
| Independence | I1 | Mixed funding sources |
| Effect size | E~ | Statistically positive but below the threshold |
| Precision | CX | No pooled confidence interval could be confirmed |
The scoring table and the verdict agree (C).
Cross-check — AI research and Codex final gate
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial | Design, allocation, masking, endpoint hierarchy, and analysis set were independently checked. | 304 | Funding, product support, employee authorship, and conflicts were assessed separately. | The principal endpoint contract is preserved; other outcomes remain separate. | Verified estimates are preserved; missing confidence intervals were not invented. | Evidence weight reflects directness, formulation match, hierarchy, and reporting limitations. |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-09-08).
Final verification and publication gate: Codex · Verification cutoff: 2026-09-08 · Corrections: none
Cite this verdict
[Chamgap] Berberine-Containing Quadruple Therapy for H. pylori—Noninferior to Bismuth Quadruple Therapy, but Arm Denominators Conflict Within the Paper — Evidence Grade C·50. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/gut/berberine-antibiotic-quadruple-h-pylori-eradication/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.