Does initial endoscopy improve outcomes in patients with gastroesophageal reflux disease and no alarm symptoms?

Early endoscopy for patients with gastroesophageal reflux disease (GERD) without alarm symptoms does not improve symptoms or quality of life, but increases costs. (LOE = 1b)

Giannini EG, Zentilin P, Dulbecco P, Vigneri S, Scarlata P, Savarino V. Management strategy for patients with gastroesophageal reflux disease: a comparison between empirical treatment with esomeprazole and endoscopy-oriented treatment. Am J Gastroenterol 2008;103:267-275.  [PMID:18289194]

Randomized controlled trial (nonblinded)

Industry

Uncertain

Outpatient (specialty)

These Italian researchers enrolled adults referred to a gastroenterologist with at least 3 months of typical GERD symptoms and no alarm symptoms or major comorbidities. Those who had significant heartburn and regurgitation during a 7-day untreated run-in period were randomized to receive either empiric esomeprazole (Nexium) 40 mg per day for 4 weeks or initial endoscopy. Those who underwent endoscopy received esomeprazole 40 mg once daily if they had evidence of esophagitis or 20 mg once daily if they did not. After 4 weeks, all patients free of symptoms at 4 weeks received a maintanence dose of esomeprazole 20 mg once daily for 20 additional weeks. A total of 612 patients were randomized; 57% were men and the mean age was 44 years. The primary outcome was treatment response using 4-point scales for heartburn and regurgitation; a responder was a patient with 1 or fewer points (of a total of 8) on each of the 7 days prior to the assessment visit. In the intention-to-treat analysis, there was no difference between groups at 4 weeks or 24 weeks. The cost of treatment was higher for the endoscopy group (127 vs 88 euros per patient). The authors estimated a cost of 57 euros for endoscopy without biopsy (approximately $110.00). In the United States, where the procedure is much more expensive, the cost would be even higher for the endoscopy group. There was no difference between groups in standardized quality of life scores at any point in the study.