Sucralfate
| Evidence Level: L2 | Predicted Indications: 2 |
Table of Contents
- Sucralfate
- Pharmacist Assessment Report
- Sucralfate: From Duodenal Ulcer to Duodenogastric Reflux
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Note on the Second Predicted Indication
- Disclaimer
Sucralfate: From Duodenal Ulcer to Duodenogastric Reflux
One-Sentence Summary
Sucralfate is a mucosal protectant originally used to treat duodenal ulcer. The TxGNN model predicts it may be effective for duodenogastric reflux (bile reflux gastritis), with no registered clinical trials but 11 publications, including 2 randomized trials, supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Duodenal ulcer |
| Predicted New Indication | Duodenogastric reflux |
| TxGNN Prediction Score | 0.9937 |
| Evidence Level | L2 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on general pharmacological knowledge, sucralfate forms a protective, adherent barrier over damaged gastric mucosa and binds bile acids and pepsin. This mechanism underlies its established use in duodenal ulcer.
Duodenogastric reflux injures the stomach lining through bile and other duodenal contents flowing backward. Binding bile acids and shielding the mucosa could plausibly counter that injury. The literature includes randomized trials in symptomatic alkaline reflux gastritis, including post-cholecystectomy gastritis, and a case series of 50 patients with post-surgical biliary reflux gastritis.
This mechanistic link rests on general knowledge of sucralfate, not on mechanism data supplied for this report.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 3839973 | 1985 | RCT | Am J Med | Double-blind trial of sucralfate (6 g/day) vs placebo in 23 patients with alkaline reflux gastritis symptoms after gastric surgery; 6 weeks of blinded treatment followed by 6 weeks of open-label sucralfate |
| 12923369 | 2003 | RCT | Eur J Gastroenterol Hepatol | Sucralfate vs rabeprazole vs no treatment for dyspeptic symptoms and endoscopic/histological signs in post-cholecystectomy alkaline reactive gastritis |
| 1391144 | 1992 | Clinical study | Minerva Gastroenterol Dietol | 18 patients with duodenogastric reflux gastritis given cisapride 30 mg/day or sucralfate 4 g/day for 2 months |
| 3616071 | 1987 | Case series | Rev Esp Enferm Apar Dig | 50 cases of gastritis from post-surgical biliary reflux treated with sucralfate |
| 3475771 | 1987 | Review | Scand J Gastroenterol Suppl | Half-year randomized sucralfate vs placebo trial in gastritis, comparing gastroesophageal with duodenogastric reflux |
| 14723838 | 2004 | Review | Curr Treat Options Gastroenterol | Treatment of duodenogastric reflux-induced (alkaline) esophagitis; proton-pump inhibitors are described as the best medical treatment |
| 6372664 | 1984 | Review | Annu Rev Med | Overview of alkaline reflux gastritis and esophagitis: causes, diagnosis and pathophysiology |
| 3838414 | 1985 | Committee statement | Am J Gastroenterol | Sucralfate’s non-ulcer uses (gastritis, esophagitis, stomatitis) are promising but not clearly established |
| 12836018 | 2003 | Clinical study | Eur J Pediatr | Six children and adolescents with primary duodenogastric reflux unresponsive to antacids; not specific to sucralfate |
The retrieved literature also includes a general peptic ulcer review and a surgical series (duodenal switch operation) that do not test sucralfate for this indication. They are omitted here.
India Market Information
Sucralfate is marketed in India with 20 valid single-ingredient registrations. Approved indication text is not available in the data compiled for this report.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 209716 | Scrat O Syrup | Syrup, 100 ml bottle | Positive Medicare Pvt Ltd |
| 204345 | Sucrarol Syrup | Syrup, 100 ml bottle | Royal Labs |
| 66566 | Damcid OX Oral Suspension | Oral suspension, 100 ml bottle | Damsa Pharma |
| 200549 | Sucral Tablet | Tablet, strip of 10 | Strassenburg Pharmaceuticals Ltd |
| 207402 | Sufrate PZ Powder | Powder, 105 g box | Eskag Pharma Pvt Ltd |
Available forms are mainly oral suspensions and syrups, with one tablet and one powder product.
Safety Considerations
- Contraindications (from the TxGNN model (deep learning), not label text; may reflect similarities the model learned between related diseases, not biological evidence): hyperglycemia, chronic kidney disease, chronic renal failure syndrome, end-stage renal failure.
- Drug Interactions: 413 interactions were identified. Major interactions:
- Dolutegravir
- Bictegravir
Moderate interactions include:
- Doxycycline and tetracycline
- Bisphosphonates (alendronic acid, risedronic acid, ibandronate)
- Antidiabetic drugs (acarbose, alogliptin, pioglitazone, albiglutide)
- Allopurinol
- Ascorbic acid
- Calcifediol
- Baloxavir marboxil
Minor interactions include several beta-blockers (acebutolol, atenolol, betaxolol, bisoprolol) and anagrelide.
Package insert warnings and contraindications from the India label are not available. Please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Two randomized trials and a case series support sucralfate in alkaline reflux gastritis, and the proposed mechanism is consistent with its known cytoprotective action. However, the trials are small and old, no registered clinical trials exist, and the label safety information is missing. This supports further study rather than a full “Go.”
To proceed, the following is needed:
- India package insert warnings and contraindications (blocking for safety screening)
- Detailed mechanism of action data
- Full-text review of the two randomized trials to confirm efficacy outcomes
- A safety plan for patients with renal impairment or diabetes, and a dosing-separation plan for interacting drugs (antiretroviral integrase inhibitors, tetracyclines, bisphosphonates)
Note on the Second Predicted Indication
The second predicted indication, duodenal obstruction (TxGNN score 0.9930), has no credible mechanistic link or supporting studies. Sucralfate is a mucosal protectant and does not relieve mechanical obstruction. The score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. The evidence level is L5 and the recommendation is Hold.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.