Felipe Mazzoleni

Helicobacter pylori eradication in functional dyspepsia: HEROES trial.

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). CONCLUSION Helicobacter pylori eradication provided significant benefits to primary care patients with functional dyspepsia. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00404534.

Influence of Organic and Functional Dyspepsia on Work Productivity: The HEROES-DIP Study

OBJECTIVES Dyspepsia is defined as persistent or recurrent abdominal pain or discomfort centered in the upper abdomen. Dyspepsia represents up to 8.3% of all primary care physician visits and causes huge economic costs to patients and to the economy as a whole. The aim of this study was to measure the influence of dyspepsia on work productivity of people within the Brazilian workforce. METHODS Adult patients were enrolled if they met the Roma III criteria for uninvestigated dyspepsia. All patients answered a demographic questionnaire. Productivity impairment was measured by the Work Productivity and Activity Impairment questionnaire. Subjects underwent upper gastrointestinal endoscopy and were classified as having functional or organic dyspepsia. The study protocol was approved by the Ethics Committee of Hospital de Clínicas de Porto Alegre, Brazil. RESULTS Eight hundred fifty patients with dyspepsia were evaluated: 628 were women (73.9%); mean age was 46.4 ± 12.9 years; 387 (45.5%) were active workers. Among active workers, 32.2% mentioned that dyspepsia had caused absenteeism from work during the preceding week and 78% reported a reduction of the work productivity (presenteeism). The lost work productivity score was 35.7% among all employed patients. The affect on work productivity was similar between patients with functional or organic dyspepsia. CONCLUSIONS Our study showed an important influence of dyspepsia on work productivity. We did not find any statistically significant difference on the influence on work between patients with organic dyspepsia and functional dyspepsia. The social impact of these findings is underscored by taking into account the prevalence (up to 40%) of this condition in Brazil.

Influence of CYP2C19 on Helicobacter pylori eradication in Brazilian patients with functional dyspepsia

The aim of this study was to examine the effect of polymorphisms in the cytochrome P450 (CYP) 2C19 gene (CYP2C19) on the Helicobacter pylori eradication rate in Brazilian patients with functional dyspepsia. Adults diagnosed with functional dyspepsia based on the ROME III criteria and infected with H. pylori were recruited to this study. The patients were subjected to gastrointestinal endoscopy and the H. pylori status was defined when both urease test and histopathology results were negative or positive. The patients were treated with proton pump inhibitor-based triple therapy (omeprazole, amoxicillin, and clarithromycin). CYP2C19*2 and CYP2C19*3 were genotyped by polymerase chain reaction-restriction fragment length polymorphism. One hundred and forty-eight patients (81.8% women) with a mean (± SD) age of 46.1 (12.2) years were included in this study. Based on the CYP2C19 genotypes, the patients were classified as homozygous extensive metabolizer (HomEM; 67.6%), heterozygous extensive metabolizer (HetEM; 26.3%), or poor metabolizer (PM; 6.1%). The H. pylori eradication rates in patients with HomEM, HetEM, and PM were 85.0, 89.7, and 100.0% (P = 0.376), respectively. The included study population comprised a high frequency of patients carrying the HomEM genotype. Although the genotypes of CYP2C19 variants were not statistically significant, the results of this study suggest a possible effect of the PM genotype on the efficacy of H. pylori eradication.

Helicobacter pylori eradication: influence of interleukin-1beta –31 C/T polymorphism

AIM To analyze the influence of the -31 C/T polymorphism of the interleukin-1β gene on Helicobacter pylori eradication therapy success in patients with functional dyspepsia. METHODS Functional dyspepsia was diagnosed according to the Rome III criteria. All patients underwent upper gastrointestinal endoscopy, and gastric biopsies were obtained at screening and 12 months after randomization (last follow-up visit). Urease test and histological examination were performed to define the H. pylori status. Patients received twice-daily amoxicillin, clarithromycin and omeprazole for 10 days. Genotyping of the interleukin-1beta -31 C/T polymorphism (rs1143627) was performed using polymerase chain reaction-restriction fragment length polymorphism. RESULTS One hundred forty-nine patients received treatment with triple therapy for H. pylori eradication. Only one patient was lost to follow-up, and adherence to study medication was 94.6%. A total of 148 patients (mean age 46.08 ± 12.24 years; 81.8% women) were evaluated for the influence of the interleukin-1beta -31 C/T polymorphism on the outcome of H. pylori eradication therapy. After treatment, bacteria were eradicated in 87% of patients (129/148). Genotype frequencies of the polymorphism were as follows: CC, 38/148 (25.7%); CT, 71/148 (47.9%); and TT, 39/148 (26.4%). Successful eradication rate was 78.9%, 94.4% and 82.1% for the CC, CT and TT genotypes, respectively. The CT genotype was significantly associated with successful H. pylori eradication (p = 0.039). CONCLUSION This study suggests that the CT genotype of the interleukin-1beta -31 C/T polymorphism plays a role in the successful eradication of H. pylori among patients with functional dyspepsia.

Tu1203 Duodenal Eosinophilia and Functional Dyspepsia: A Case-Control Study in an Area With High Helicobacter Pylori Infection Prevalence

Figure. Main results of the study{BR}(A) Proportion of responders during 4 weeks.{BR}† Proportion of responders: proportion of patients who showed adequate relief of overall epigastric pain or discomfort more than four times out of eight during 4 weeks of therapeutic period. *** P < 0.001 vs. waitlist control group analyzed by Fishers exact test.{BR}(B) Total score of NDI questionnaire.{BR}NDI-K: Nepean dyspepsia index Korean version, * P < 0.05 vs. waitlist control group analyzed by Mann-Whitney U test, *** P < 0.001 vs. baseline analyzed by Wilcoxon signed rank test.{BR}(C) The scores of FDQoL.{BR}FD-QOL: Functional dyspepsia quality of life, *** P < 0.001 vs. baseline analyzed by Wilcoxon signed rank test.