Systematic review: ulcer definition in NSAID ulcer prevention trials

Area of Science:

• Gastroenterology
• Clinical Trial Methodology
• Pharmacology

Background:

• Establishing a consistent definition for peptic ulcers in clinical trials is crucial for accurate prevention studies.
• Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly associated with peptic ulcer development, necessitating clear outcome measures.

Purpose of the Study:

• To systematically review and evaluate the various ulcer definitions employed in clinical trials focused on NSAID-induced ulcer prevention.
• To identify if a consensus or preferred definition for ulcers exists within this research area.

Main Methods:

• A comprehensive literature search was performed across PubMed, Medline, and EMBASE databases.
• Inclusion criteria focused on randomized, controlled NSAID trials of at least 8 weeks duration with endoscopic ulcer assessment as the primary endpoint.
• Studies published in English between June 1987 and June 2007 were considered.

Main Results:

• Forty-five publications met the study criteria.
• A majority of studies (25) defined an ulcer by a diameter of ≥3 mm, often including depth criteria.
• Variations in definitions included unspecified diameter with depth, excavated mucosal breaks >3 mm, or minimum sizes of ≥5 mm or >5 mm; five studies had unclear definitions.

Conclusions:

• For clinical trials on NSAID users, a preferred definition of a gastric or duodenal lesion is ≥3 mm in diameter with significant depth.
• Standardizing ulcer definitions is essential for improving the reliability and comparability of NSAID-related ulcer prevention research.