[Effect of the Helicobacter pylori eradication in patients with functional dyspepsia: randomised placebo-controlled trial].
OBJECTIVE
The Helicobacter pylori eradication in patients with functional dyspepsia has been the subject of controversy because trials come to contradictory conclusions. The objective of this trial was to evaluate the effect, compared with placebo, of the eradication treatment in patients with functional dyspepsia.


METHODS
Randomized double blind placebo controlled trial. We included 158 patients attended by family physicians (Area 10 Primary Care, Health Institute of Madrid) with functional dyspepsia and Helicobacter pylori infection detected by the ureasa test in endoscopy. An OCA (ameprazole clarithromycin and amoxicillin group (n = 79) and a placebo group (n = 79) were randomized. During 7 days, patients at the OCA group received omeprazole (20 mg bid), clarithromycin (500 mg bid) and amoxicillin (1000 mg bid) daily, and patients at the control group received the placebo agent twice daily. Dyspepsia improvement according to a Likert scale (5 steps), and eradication of H. pylori by 13C-urea breath test were evaluated during one year.


RESULTS
Both groups were homogeneous in relation to age, sex and dyspepsia degree. The average age (standard deviation) of studied patients was 41.99 (13.93) years. At one year of follow up, H. pylori was eradicated in 81.01% (64/79) of the OCA group and 5.06% (4/79) of the placebo group. The difference of dyspepsia improvement (22.78%; 95% confidence interval [CI], 7.62-37.79) between the OCA group (41.77%; 95% CI, 30.77-53.41), and the placebo group (18.99%; 95% CI 11.03-29.38) was significant (p = 0.0018).


CONCLUSIONS
Eradication of Helicobacter pylori in patients with functional dyspepsia is more effective improving symptoms than placebo.
Ruiz García
Antonio
A
Area 10 Atención Primaria, IMSALUD, Getafe, Madrid, Spain. aruiz.gapm10@salud.madrid.org
Gordillo López
Francisco Javier
FJ
Hermosa Hernán
Juan Carlos
JC
Arranz Martínez
Ezequiel
E
Villares Rodríguez
José Enrique
JE
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D017291:Clarithromycin / Q000008:administration & dosage; D016001:Confidence Intervals; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D016017:Odds Ratio; D009853:Omeprazole / Q000008:administration & dosage; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole