title: Helicobacter pylori eradication in functional dyspepsia: HEROES trial.
abstract: BACKGROUND
  Eradication of Helicobacter pylori in patients with functional dyspepsia continues to be a matter of debate. We studied eradication effects on symptoms and quality of life of primary care patients.
  
  
  METHODS
  Helicobacter pylori -positive adult patients with functional dyspepsia meeting the Rome III International Consensus criteria were randomly assigned to receive omeprazole, amoxicillin trihydrate, and clarithromycin, or omeprazole plus placebo for 10 days. Endoscopy and H pylori tests were performed at screening and at 12 months. Outcome measures were at least 50% symptomatic improvement at 12 months using a validated disease-specific questionnaire (primary end point), patient global assessment of symptoms, and quality of life.
  
  
  RESULTS
  We randomly assigned 404 patients (78.7% were women; mean age, 46.1 years); 201 were assigned to be treated with antibiotics (antibiotics group) and 203 to a control group. A total of 389 patients (96.3%) completed the study. The proportion of patients who achieved the primary outcome was 49.0% (94 of 192) in the antibiotics group and 36.5% (72 of 197) in the control group (P = .01; number needed to treat, 8). In the patient global assessment of symptoms, 78.1% in the antibiotics group (157 of 201) answered that they were better symptomatically, and 67.5% in the control group (137 of 203) said that they were better (P = .02). The antibiotics group had a significantly 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 = .02).
  
  
  CONCLUSIONS
  Helicobacter pylori eradication provided significant benefits to primary care patients with functional dyspepsia.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00404534.
authors: School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. lemazzoleni@yahoo.com.br
authors: Luiz Edmundo
authors: LE
authors: Mazzoleni
authors: Guilherme Becker
authors: GB
authors: Sander
authors: Carlos Fernando de Magalhães
authors: CF
authors: Francesconi
authors: Felipe
authors: F
authors: Mazzoleni
authors: Diego Mendonça
authors: DM
authors: Uchoa
authors: Laura Renata
authors: LR
authors: De Bona
authors: Tobias Cancian
authors: TC
authors: Milbradt
authors: Pâmela Schitz
authors: PS
authors: Von Reisswitz
authors: Otavio
authors: O
authors: Berwanger
authors: Mathias
authors: M
authors: Bressel
authors: Maria Isabel
authors: MI
authors: Edelweiss
authors: Stela Scaglioni
authors: SS
authors: Marini
authors: Cynthia Goulart
authors: CG
authors: Molina
authors: Luciano
authors: L
authors: Folador
authors: Roberta Perin
authors: RP
authors: Lunkes
authors: Renata
authors: R
authors: Heck
authors: Oscar Augusto
authors: OA
authors: Birkhan
authors: Bianca Michel
authors: BM
authors: Spindler
authors: Natan
authors: N
authors: Katz
authors: Bruno da Silveira
authors: Bda S
authors: Colombo
authors: Pedro Proença
authors: PP
authors: Guerrieri
authors: Luiza Brusius
authors: LB
authors: Renck
authors: Elisa
authors: E
authors: Grando
authors: Bianca
authors: B
authors: Hocevar de Moura
authors: Franciele Darsie
authors: FD
authors: Dahmer
authors: Juliano
authors: J
authors: Rauber
authors: João Carlos
authors: JC
authors: Prolla
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000150:complications / Q000188:drug therapy*; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D011320:Primary Health Care / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009853:Omeprazole