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Equine gastric ulcer syndrome (treatment): omeprazole plus sucralfate vs omeprazole alone — MAYBE (weak evidence)

In horses with established gastric ulcers, does adding sucralfate to omeprazole improve endoscopic healing vs omeprazole alone?

Shelf #178 · gate-verified and approved by the developer

MAYBE (weak evidence): No carded — and no found — randomised trial directly compares omeprazole plus sucralfate against omeprazole alone for healing of established ulcers, so the draft premise cannot be confirmed from direct evidence. What the genuine records show is indirect and sobering: in a prospective clinical study of glandular disease with gastroscopy evaluators blinded to treatment, the combined omeprazole-sucralfate regimen healed only 20% of lesions (95% CI 7–41) and improved 65% (95% CI 43–83) at 28–35 days, and was significantly inferior to misoprostol (healing 72%; P <0.001). The closest randomised, blinded adjunct trial in the Sykes programme tested a different adjunct — trimethoprim-sulphadimidine added to omeprazole — and found no superiority over omeprazole alone for glandular healing (47% vs 23%; OR 1.8, 95% CI 0.32 to 10.0; P = 0.67), a null result for that adjunct, not for sucralfate. Omeprazole alone itself heals glandular ulcers incompletely and dose-dependently in the blinded randomised dose trial. This shelf is treatment/healing only and is distinct from the prevention topics #4/#67; a fasting/NSAID prophylaxis study (PMID: 34719063) was deliberately not carded here. Drafted Nov 10, 2026 (VetMed build, topic #178); all figures from abstracts fetched and verified at drafting.

Varley 2019: combined omeprazole-sucralfate healed 20% of glandular lesions at 28–35 days and was inferior to misoprostol (72% healed)

Prospective, clinical study (record's own study-design wording; gastroscopy evaluators blinded, allocation by centre — randomisation not stated)

Who: Horses: 63 sports horses with grade >1/4 glandular gastric disease identified by gastroscopy in a clinical (client-owned) setting, treated either with misoprostol 5 µg/kg orally twice daily 1 hour before feeding, or with combined enteric-coated omeprazole 4 mg/kg orally once daily plus sucralfate 12 mg/kg orally twice daily (sucralfate given 60 minutes after omeprazole, drugs 1 hour before feeding); allocation was dependent upon centre, and gastroscopy was repeated at 28–35 days with evaluators of the images blinded to treatment and reviewing independently.

Result: Misoprostol was superior to combined omeprazole-sucralfate both for healing (misoprostol 72% [95% CI 43–67 as printed in the record] and omeprazole-sucralfate 20% [95% CI 7–41]; P <0.001) and for improvement (misoprostol 98% [95% CI 90–100] and omeprazole-sucralfate 65% [95% CI 43–83]; P <0.001). Overall healing (P <0.001; OR = 11 [2.8–45]) and improvement (P = 0.006; OR = 11 [1.9–59]) of lesions were associated with resolution of clinical signs; the most common presenting sign in both groups was poor performance (overall 65.1%).

Watch out: There is no omeprazole-alone arm: this study benchmarks the combination against misoprostol, so it cannot show whether sucralfate added anything to omeprazole. Allocation was by centre, not randomised, and clients were not blinded (the record's own stated limitations); endoscopic image evaluators were blinded, as the record states. The misoprostol healing confidence interval is reproduced exactly as printed in the record.

Varley G, Bowen IM, Habershon-Butcher JL, Nicholls V, Hallowell GD. Misoprostol is superior to combined omeprazole-sucralfate for the treatment of equine gastric glandular disease. Equine veterinary journal. 2019;51(5):575-580. PMID: 30809869. Registry ID: none in the record. MeSH: Animals · Anti-Ulcer Agents/administration & dosage,therapeutic use · Drug Therapy, Combination · Female · Gastric Mucosa/pathology · Horse Diseases/drug therapy · Horses · Male · Misoprostol/therapeutic use · Odds Ratio · Omeprazole/administration & dosage,therapeutic use · Stomach Diseases/drug therapy,pathology,veterinary · Sucralfate/administration & dosage,therapeutic use

Sykes 2014 (adjunct trial): adding trimethoprim-sulphadimidine to omeprazole did not improve glandular healing vs omeprazole alone (47% vs 23%; P = 0.67)

Randomised, blinded, clinical study (record's own title wording; MeSH includes Single-Blind Method; publication types include Randomized Controlled Trial)

Who: Horses: 28 horses with naturally occurring equine glandular gastric ulceration in a clinical setting, randomised to omeprazole plus trimethoprim-sulphadimidine (TMPS group, n = 15) or omeprazole monotherapy (OMEP group, n = 13), with glandular mucosal healing and improvement assessed endoscopically.

Result: Combination therapy could not be demonstrated to be superior to omeprazole monotherapy. Healing of the glandular mucosa was observed in 7 of 15 (47%; 95% CI 24 to 71%) horses in the TMPS group and 3 of 13 (23%; 95% CI 7% to 50%) in the OMEP group (OR = 1.8; 95% CI 0.32 to 10.0; P = 0.67). Improvement was observed in 12 of 15 (80%; 95% CI 56 to 94%) and 9 of 13 (69%; 95% CI 42 to 89%) horses, respectively (OR = 2.9; 95% CI 0.6 to 15.0; P = 0.25). The authors concluded that the results do not support adding trimethoprim-sulphadimidine to therapeutic protocols for equine glandular ulceration.

Watch out: The adjunct tested here is an antimicrobial, NOT sucralfate — this card is carded as the only randomised blinded test of the 'add an adjunct to omeprazole' strategy in glandular disease, and its null result must not be transferred to sucralfate as if sucralfate itself had been trialled. The confidence intervals are wide (28 horses), so a moderate adjunct effect is not excluded even for TMPS.

Sykes BW, Sykes KM, Hallowell GD. Administration of trimethoprim-sulphadimidine does not improve healing of glandular gastric ulceration in horses receiving omeprazole: a randomised, blinded, clinical study. BMC veterinary research. 2014;10:180. PMID: 25927827. Registry ID: none in the record. MeSH: Animals · Anti-Ulcer Agents/administration & dosage,therapeutic use · Female · Horse Diseases/drug therapy · Horses · Male · Omeprazole/administration & dosage,therapeutic use · Single-Blind Method · Stomach Ulcer/drug therapy,veterinary · Treatment Outcome · Trimethoprim, Sulfamethoxazole Drug Combination/administration & dosage,therapeutic use

Sykes 2014 (dose trial): omeprazole alone showed a dose-response for ulcer healing, and glandular ulcers improved less completely than squamous ulcers

Blinded, randomised, dose-response clinical trial (record's own study-design wording; publication types include Randomized Controlled Trial)

Who: Horses: 20 Thoroughbred racehorses with grade ≥2/4 glandular ulceration on gastroscopy in a clinical setting (17 also had grade ≥2/4 squamous ulceration), randomly assigned to oral omeprazole once daily at a high dose (2.0 g; 4.0 mg/kg body weight) or a low dose (0.8 g; 1.6 mg/kg body weight), with gastroscopy repeated at 28–35 days.

Result: Time and dose significantly affected grades of squamous (P <0.0001 and P = 0.02, respectively) and glandular (P = 0.006 and P = 0.005) ulceration. The analysis did not support the hypothesis that the lower dose would be noninferior to the higher dose for ulcer healing and improvement. Improvement was more likely with the high dose for the squamous (P = 0.05) but not the glandular (P = 0.4) mucosa, and the percentage of glandular ulcers that improved was less than that of squamous ulcers (P = 0.02).

Watch out: No sucralfate arm — this card establishes the omeprazole-alone baseline against which any adjunct must be judged: even at 4.0 mg/kg, glandular healing is incomplete, which is the clinical gap sucralfate is added to fill, but a gap is not evidence that the adjunct fills it. Endoscopic scoring masking beyond the record's 'blinded' design wording is not further specified in the abstract and is not claimed here.

Sykes BW, Sykes KM, Hallowell GD. A comparison of two doses of omeprazole in the treatment of equine gastric ulcer syndrome: a blinded, randomised, clinical trial. Equine veterinary journal. 2014;46(4):416-21. PMID: 24102898. Registry ID: none in the record. MeSH: Animals · Anti-Ulcer Agents/administration & dosage,therapeutic use · Dose-Response Relationship, Drug · Female · Horse Diseases/drug therapy · Horses · Male · Omeprazole/administration & dosage,therapeutic use · Stomach Ulcer/drug therapy,veterinary

Synthesis: the added benefit of sucralfate on top of omeprazole is untested in a direct randomised trial — the combination's own healing record in glandular disease is poor (20%)

Synthesis

Who: Synthesis of the cards above: Varley 2019 (63 sports horses with glandular disease, prospective clinical study, blinded gastroscopy evaluators, allocation by centre), Sykes 2014 adjunct trial (28 horses with glandular ulceration, randomised blinded) and Sykes 2014 dose trial (20 Thoroughbred racehorses, blinded randomised) — all horses with established, naturally occurring ulcers in clinical settings.

Result: (1) No carded study randomises horses to omeprazole plus sucralfate versus omeprazole alone, so the shelf question has no direct answer. (2) The combination's absolute performance in glandular disease was weak: 20% healed at 28–35 days in the Varley study. (3) The one randomised blinded adjunct-to-omeprazole trial (a different adjunct, TMPS) was null. (4) Omeprazole alone is dose-responsive but heals glandular ulcers incompletely. Together these make 'sucralfate improves healing when added to omeprazole' a claim the current record does not support — MAYBE (weak evidence), resting on indirect evidence only.

Watch out: Squamous and glandular disease respond differently and are pooled differently across these studies; most carded healing data are glandular. Prevention/prophylaxis evidence (including the fasting/NSAID induction model) is a different question, housed at topics #4/#67, and was excluded here by design.

Synthesis of Varley G et al. PMID: 30809869; Sykes BW et al. PMID: 25927827; Sykes BW et al. PMID: 24102898. Registry IDs as on the individual cards.

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