Clinical Question: Which patients with normal upper endoscopy and negative Helicobacter pylori study results are likely to benefit from a proton pump inhibitor?

Bottom Line: Among dyspeptic patients who are negative for Helicobacter pylori (HP) and have a normal endoscopy, approximately half of those who are overweight or obese and one fifth of those who are normal weight will respond to a proton pump inhibitor (PPI). (Level of Evidence: 1b)

Reference: Fletcher J, Derakhshan MH, Jones GR, Wirz AA, McColl KE. BMI is superior to symptoms in predicting response to proton pump inhibitor: randomised trial in patients with upper gastrointestinal symptoms and normal endoscopy. Gut 2011;60(4):442-448.

Study Design: Randomized controlled trial (nonblinded)

Funding Source: Industry

Allocation: Concealed

Setting: Outpatient (specialty)

Synopsis: You've referred your patient with dyspepsia for endoscopy and the result is normal. Her HP results were normal, as well. Will a PPI help? This study identified 105 similar patients and randomized them in a 2:1 ratio to receive lansoprazole 30 mg per day or placebo. The primary outcome was the Glasgow Dyspepsia Severity Score, measured 2 weeks later. Patients and outcome assessors were masked, allocation was concealed, and analysis was by intention to treat. Most patients had a chief complaint of retrosternal pain or regurgitation (43%), epigastric pain (42%), or nausea and vomiting (9%). Not terribly surprisingly, patients receiving the PPI were more likely to experience a clinically meaningful 50% reduction in their symptom score (36% vs 6%; P < .001; number needed to treat [NNT] = 3). More interesting, the only noninvasive predictor of response to PPI was increasing body mass index (BMI). Patients with a BMI of at least 25 kg/m2 had a 53% response rate, compared with only 23% of those with a BMI below that cutoff (NNT = 3). In general, symptoms were found to be of little value in predicting response to a PPI in this group of patients.