According to research published in the Archives of Internal Medicine, Helicobacter pylori (H pylori) eradication for patients with functional dyspepsia may improve their symptoms.
The authors note that dyspepsia affects up to 40% of adults in the Western world and accounts for around 8.3% of visits to primary care physicians. The majority of patients have functional (non-ulcer) dyspepsia (i.e. there are no apparent structural or biochemical abnormalities to explain their symptoms); the underlying pathophysiology of this is complex.
Previous studies looking at the effects of H pylori eradication in patients with functional dyspepsia have yielded conflicting results; consensus statements also give conflicting recommendations. Due to this uncertainty, the authors conducted the HEROES (Helicobacter Eradication Relief of Dyspeptic Symptoms) study, a single-centre, randomised, double-blind assessment of the effects of H pylori eradication on the symptomatic responses and quality of life (QOL) of community and primary care patients with functional dyspepsia.
This single centre study, conducted in Brazil, included 404 adults with a diagnosis of H pylori infection and functional dyspepsia, who were recruited through advertising and/or invitation in primary care clinics. They were randomised to receive either: 1) omeprazole (20mg BD), amoxicillin trihydrate (1000mg BD), and clarithromycin (500mg BD) for 10 days (antibiotic group; n=201); or 2) omeprazole (20mg BD) plus placebo antibiotics for 10 days (control group; n=203). Randomisation was stratified by the presence of erosions and/or use of NSAIDs or aspirin. The dyspeptic symptoms score was evaluated at all visits using the Porto Alegre Dyspeptic Symptoms Questionnaire (PADYQ; score ranges from 0 [no symptoms] to 44 [severe symptoms]). The primary endpoint was the proportion of patients with ≥50% decrease in the dyspeptic symptoms score at 12 months compared with baseline. Endoscopy and H pylori tests were performed at screening and at 12 months.
A total of 389 patients (96.3%) completed the study. The main findings were as follows:
• The primary outcome was achieved in 49.0% of the antibiotics group and 36.5% of the control group (absolute difference of 12.5%; 95% CI 2.1%-22.7%; P=0.01; number needed to treat, 8). The authors note that the between-group difference remained significant (p=0.03) even if all those lost to follow-up were considered as non-responders)
• A total of 78.1% in the antibiotics group and 67.5% in the control group reported improvement in the patient global assessment of symptoms and the mean decrease in symptom scores were –10.47 and –7.76 (P=0.008), respectively.
• The antibiotics group had a larger increase in their mean (SD) Medical Outcomes Study 36-Item Short Form Health Survey physical component summary scores than the control group did (4.15 [8.5] vs. 2.2 [8.1]; P=0.02). There was however no difference between the groups for the mental component summary.
• Antibiotic group (odds ratio [OR], 1.63; P=0.01) and recent dyspepsia (OR, 1.51; P=0.048) were found to be predictors of symptomatic improvement. Pre-specified subgroup analysis showed that neither the presence of erosive gastritis nor NSAIDs/acetylsalicylic acid use affected patients' response to H pylori eradication.
The authors note that to their knowledge, this is the first large clinical trial on this topic that has focused on primary care patients. Most of the previous studies have included secondary and tertiary care patients who were likely to have more resistant symptoms, and who were not representative of the majority of patients with functional dyspepsia. They acknowledge its limitations, including its conduct in a single centre (which may limit external validity), and that a minimum symptomatic score could have been used.
They conclude that their findings support the concept of H pylori eradication in primary care patients with functional dyspepsia, and suggest their data should be considered by investigators performing cost-utility studies in this area.