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H. pylori eradication decreases functional dyspepsia symptoms (HEROES)

Clinical Question:
Is Helicobacter pylori eradication in H. pylori-positive patients more effective than placebo to decrease symptoms of functional dyspepsia?

Bottom Line:
It might make sense to test more patients with functional dyspepsia for H. pylori and give antibiotic therapy to those with positive results. These authors enrolled primary care patients with functional dyspepsia symptoms who were positive for H. pylori (as is half the adult population), and they found better symptom improvement with eradication therapy than with placebo, though the benefit is not nearly as significant as with peptic ulcer disease. For every 8 patients treated with eradication therapy instead of placebo, one additional patient will have a 50% improvement in symptoms 1 year later. However, the range of this estimate is quite large (4.6 - 38.8). (LOE = 1b-)

Mazzoleni LE, Sander GB, Francesconi CF, et al. Helicobacter pylori eradication in functional dyspepsia. HEROES trial. Arch Intern Med 2011;171(21):1929-1936  [PMID:22123802]

Study Design:
Randomized controlled trial (double-blinded)



Outpatient (any)

The Brazilian investigators conducting this study recruited patients from primary care clinics as well via media advertisements. This is the first major study that enrolled patients from primary care practices rather than specialty clinics. The 404 patients in this study (79% women) were positive for H. pylori and were had functional dyspepsia, defined as postprandial fullness, early satiety, and epigastric pain or burning for at least 6 months without evidence of structural disease established via endoscopy before enrollment. The authors excluded patients with heartburn or symptoms of other illnesses and those who had previous treatment for H. pylori or recent acid suppression therapy. The patients were randomized, using concealed allocation, to receive omeprazole combined either with placebo or with H. pylori eradication therapy consisting of amoxicillin and clarithromycin for 10 days. The primary outcome was a 50% decrease in symptoms at 12 months, which was reported by 49.0% of treated patients as compared with 36.5% of placebo-treated patients (P = .01). This difference translates into a number needed to treat of 8 (95% CI, 4.6 - 38.8). Using a global assessment, 78.1% of treated patients reported being symptomatically better as compared with 67.5% of untreated patients (P = .02).


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