Lack of benefit of treating Helicobacter pylori infection in patients with functional dyspepsia. Randomized one-year follow-up study.
OBJECTIVE
To assess whether H. pylori therapy is significantly better than control therapy in patients with functional dyspepsia, and to assess whether curing the infection relieves symptoms of dyspepsia.


METHODS
We prospectively included consecutive H. pylori-positive patients in whom a gastroscopy was carried out and who were diagnosed of functional dyspepsia. At endoscopy, biopsies were obtained (histology and rapid urease test), and a 13C-urea breath test was carried out. Patients were randomly assigned to 10 days of treatment with either eradication therapy (omeprazole, amoxicillin and clarithromycin) or with ranitidine. No antisecretory therapy was prescribed thereafter. Breath test was repeated four weeks after completing eradication treatment. A validated five-point Likert scale was used to measure severity of symptoms, both at the beginning of the study and 6 and 12 months after treatment.


RESULTS
Fifty patients were included in the study. Sixteen patients were randomized to ranitidine and 34 to eradication treatment. The two groups were well balanced for base-line characteristics. One patient in each treatment arm was lost to follow-up at 12 months. Differences between ranitidine and eradication groups were not demonstrated in any of the symptom comparisons, either initially or at 12 months. The rates of treatment success for each symptom were similar in both groups. H. pylori was eradicated in 76% of the patients receiving antibiotics. Differences between groups of patients with eradication success and failure were not demonstrated in any of the symptom comparisons, either initially or at 12 months. Among the groups given eradication regimen, the rates of treatment success for each symptom were similar in the group with H. pylori eradication success and failure.


CONCLUSIONS
H. pylori eradication is not likely to play a major role in the treatment of symptoms in patients with functional dyspepsia.
Gisbert
Javier P
JP
Department of Gastroenterology, University Hospital of La Princesa, Madrid, Spain. gisbert@meditex.es
Cruzado
Ana Isabel
AI
Garcia-Gravalos
Rafael
R
Pajares
Jose Maria
JM
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology*; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D011446:Prospective Studies; D011899:Ranitidine / Q000627:therapeutic use*; D017211:Treatment Failure
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D000658:Amoxicillin; D011899:Ranitidine; D017291:Clarithromycin; D009853:Omeprazole