Carlos F. Francesconi

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.

Clinical outcomes of eradication of Helicobacter pylori in nonulcer dyspepsia in a population with a high prevalence of infection : results of a 12-month randomized, double blind, placebo-controlled study

Ninety-one Helicobacter pylori-positive patients with nonulcer dyspepsia were randomized to receive either lansoprazole, amoxicillin, and clarithromycin or lansoprazole and placebo. A validated questionnaire assessed dyspeptic symptoms at baseline and at 3, 6, and 12 months. Endoscopies and biopsies were performed at baseline and at 3 and 12 months. There was an overall trend, although not statistically significant, for a benefit of H. pylori eradication. Of the patients in the antibiotics group, 16 of 46 (35%) had symptomatic improvement, versus 9 of 43 (21%) in the control group (P = 0.164). In a secondary analysis, it was found that of the patients without endoscopic gastric erosions, 15 of 34 (44%) in the antibiotics group and 5 of 33 (15%) of controls had symptomatic improvement (P = 0.015). Helicobacter pylori eradication did not prove to be clinically beneficial, although a tendency to symptomatic benefit was detected. Further studies are necessary to confirm the implications of endoscopic gastric erosions in these patients.

Development and validation of a cross-cultural questionnaire to evaluate nonulcer dyspepsia: the Porto Alegre Dyspeptic Symptoms Questionnaire (PADYQ).

Despite its high prevalence, nonulcer dyspepsia is still difficult to study, due to the lack of adequate tools to measure significant outcomes. The objective of this study was to develop and validate a symptom-focused, disease-specific questionnaire to evaluate patients with nonulcer dyspepsia. For that, the questionnaire was carefully written following widely accepted terminology, so as to facilitate translation and validation in other languages and cultures. The questionnaire was developed using Rome I terminology for symptoms, which were evaluated according to their intensity, duration, and frequency when applicable. Thirty-one patients with nonulcer dyspepsia, as well as 31 sex-and age-matched volunteers without digestive problems were used to assess the internal consistency, reproducibility, responsiveness, content validity, and discriminant validity of the questionnaire. Another 31 functional dyspeptic patients were enrolled for assessment of criterion validity. Cronbach’s α coefficient was 0.82. The intraclass correlation coefficient for the scores obtained 7 days apart was 0.86. The mean score obtained after 3 months of treatment was 16.4, vs. 23.03 at baseline (P=0.001). Two blinded gastroenterologists agreed that the questionnaire adequately evaluated nonulcer dyspepsia. The median symptoms score for controls was 0, vs. 22.5 for dyspeptic patients (P=0.001). An inverse correlation was observed between quality of life and dyspeptic symptoms (R = −0.28, P = 0.026). The proposed questionnaire has high degrees of both reproducibility and responsiveness. As this questionnaire was based on Rome I International Consensus terminology, it is expected that it will be easy to translate and validate.

Helicobacter pylori eradication does not cause reflux oesophagitis in functional dyspeptic patients: a randomized, investigator-blinded, placebo-controlled trial

Background : The protective role of Helicobacter pylori in gastro‐oesophageal reflux disease has been widely discussed.

Randomized clinical trial comparing sodium picosulfate with mannitol on the preparation FOR colonoscopy in hospitalized patients

BACKGROUND The cleansing of the colon for a colonoscopy exam must be complete so as to allow the visualization and inspection of the intestinal lumen. The ideal cleansing agent should be easily administered, have a low cost, and minimum collateral effects. Sodium picosulfate together with the magnesium citrate is a cathartic stimulant and mannitol is an osmotic laxative, both usually used for this purpose. AIMS Assess the colon cleanliness comparing the use of mannitol and sodium picosulfate as well as evaluate the level of patient satisfaction, the presence of foam, pain, and abdominal distension in hospitalized patients undergoing colonoscopy. METHODS A prospective, randomized, single-blind study with 80 patients that compared two groups: mannitol (40) and sodium picosulfate (40). Both groups received the same dietary orientation. The study was approved by the hospitals Ethics and Research Committee. The endoscopist was blind to the type of preparation. Outcomes evaluated: level of the colons cleanliness, patients satisfaction, the presence of foam, abdominal pain and distension, and the duration of the exam. The data was analyzed by means of the chi-squared test for proportions and Mann-Whitney for independent samples. RESULTS There were no statistically significant differences between the groups in relation to the level of the colons cleanliness, patients satisfaction, the presence of foam, abdominal pain, and the duration of the exam. Fifteen percent of the exams of the mannitol group were interrupted while from the sodium picosulfate group it was 5%. The presence of foam was similar for both groups. The average duration for carrying out the exam was 28.44 minutes for the mannitol group and 35.59 minutes for the sodium picosulfate group. Abdominal distension was more frequent in the mannitol group. If they would have to do the same exam, the answer was that 80% said yes from the mannitol group and 92.5% from the sodium picosulfate group. CONCLUSION The quality of the colon preparation, foam formation, exam duration, and the collateral effects (nauseas, vomiting, and abdominal pain) were similar in both kinds of preparations. Abdominal distension was greater in the mannitol group. Both methods of preparation were well accepted by the hospitalized patients.

O uso de nutrição enteral precoce pós-transplante hepático adulto

BACKGROUND: Orthotopic liver transplantation is the treatment of choice for end-stage liver disease. Malnutrition is common in this population. Early enteral nutrition is not routine in the transplant groups. AIM: To report our experience with the use of early enteral nutrition in patients undergoing orthotopic liver transplantation and also evaluate its safety. PATIENTS/METHODS: We studied 41 adults submitted to orthotopic liver transplantation. Pre- orthotopic liver transplantation nutritional assessment was accomplished by the subjective global assessment and grip strength. Enteral nutrition was begun in 12 hours. Oral feeding was initiate gradually as soon as possible. RESULTS: We studied 35 individuals, with an average of age of 45.5 years (8.93). The prevalence of malnutrition in orthotopic liver transplantation was of 77.1% determined by subjective global assessment, and 100% by grip strength. Early enteral nutrition was begun in all of the individuals in up to 12 hours, mode 10.9 hours, and maintained exclusively by medium period of 2.6 days (2.2). Oral feeding was obtained in the medium period of 9.5 days (9.7). Early enteral nutrition provided total caloric intake in 97% of the cases. Intolerance to the enteral feeding occurred in five individuals (14.2%), and in four of them it was resumed successfully after 12 hours. The prevalence of respiratory infection was of 28.6%. In only two patients (5.7%) there was aspirative bronchopneumonia. CONCLUSIONS: Early enteral nutrition is an effective method in the provision of calories and safe in application to patients undergoing orthotopic liver transplantation.

Mass eradication of Helicobacter pylori: feasible and advisable?

In The Lancet, E Robert Greenberg and colleagues present an Article about the effi cacy of three diff erent therapeutic regimens for the eradication of Helicobacter pylori in several Latin American countries. A large sample of adults with symptomatic and asymptomatic disease was studied. Besides aiming to identify the best therapeutic regimen, the study also served as a preliminary step to support future programmes of gastric cancer prevention in the Latin American population. Gastric cancer is the fi fth most common cause of cancer in this region (fi gure) and is the leading cause of cancer mortality among males in many Latin American countries. The study showed that the 14-day standard therapy with lansoprazole, amoxicillin, and clarithromycin was superior to both the 5-day concomitant and sequential four-drug regimens (lansoprazole, amoxicillin, clarithromycin, and metronidazole). Generic (off -patent) preparations of the study drugs were used in this trial. The use of low-cost generic drugs is an important factor for public health strategies in Latin America. These preparations were validated in the USA and the results from the study done by Greenberg and colleagues show that good quality generic drugs were used. However, if these drugs are used in large populations for H pylori eradication, quality control of grafts; choice of biological or genetic markers for subsets of patients most likely to benefi t; assessments of outcome through new validated activity scores; defi nitions of drugfree remission; required durations of follow-up to assess risk of relapse; and defi nition of cure for an autoimmune disease such as systemic sclerosis for which the term cure is not defi ned. Although randomised trials are key, other types of studies are appropriate, and capture of data from all trials including non-randomised studies is important as promoted by the European Group for Blood and Marrow Transplantation (EBMT). Multicentre collaboration is crucial to establish the best therapeutic approach, with analysis of shared registry data and biological material obtained with adequate technical platforms. In this context, the European Orphan Disease Plan, which includes national and regional centres of reference and networks for HSCT in autoimmune diseases, might help to extend the important fi ndings of ASSIST.

Quantitative assessment of CD30+ lymphocytes and eosinophils for the histopathological differential diagnosis of inflammatory bowel disease

BACKGROUND AND AIMS The histopathological discrimination of Crohns disease [CD] and ulcerative colitis [UC] can be challenging. The aim of this study was to evaluate if quantification of CD30(+) lymphocytes and eosinophils in histopathological material improves the accuracy of diagnosis of inflammatory bowel disease. METHODS A total of 156 patients were diagnosed with IBD by a gastroenterologist and corroborated by 5 years of follow-up. Patients were treatment naïve at the time of biopsy. Samples were taken from diseased areas of the colon and examined by a gastrointestinal pathologist. RESULTS The median number of eosinophils in biopsies from affected segments was 42/high power field [hpf] [25.5-63.5] in CD and 98/hpf [67-123] in UC [p < 0.001]. Biopsies containing ≥ 70 eosinophils/hpf field had a sensitivity of 78.3% and a specificity of 71% for the diagnosis of UC ({area under the receiver operating characteristic (ROC) curve 0.767 (95% confidence interval [CI] 0.696-0.838)}. There was a median of three CD30(+) cells/hpf [range 2-6] in diseased CD biopsies and 33 cells/hpf [24-52] in diseased UC biopsies [p < 0.001]. The cut-off determined by the ROC curve was 15 (sensitivity 97.4%, specificity 97.4%, positive likelihood ratio (PLR) 17.1, Negative likelihood ratio (NLR) 0.03, area under the curve [AUC]: 0.978; 95% CI 0.95310.999). CONCLUSIONS Routine histopathological assessment with quantification of CD30+ cells is highly accurate at discriminating CD and UC. All the measured parameters are easy to perform, low-cost, and available in most pathological laboratories.

S1279 Brazilian Prevalence of Irritable Bowel Syndrome: A Population-Based Study

BACKGROUND: The prevalence of irritable bowel syndrome (IBS) in the developed world is estimated to be 10% to 20%. To our knowledge, there is no studies evaluating the nation wide prevalence of IBS in South America. AIMSM mean age of the sample: 37.6y (SD13.8y). Prevalence of IBS in the entire sample: 24.7 %. Prevalence by sex: males 15.7%, females 30.2%. Logistic regression did show that sex (female), age (younger) and level of education (less education) were associated with higher prevalence of IBS in our population while social class and geographical regions of Brazil had no impact. CONCLUSIONS: This first large population-based survey conducted in South America estimates the prevalence and the sex distribution of IBS in Brazil to be comparable to the observed in the Western developed countries. Our data suggest that the prevalence is higher in females, younger and less educated persons. Regarding IBS sub-types there was a higher prevalence of females with IBS-C, IBS-U and IBS-M. Prevalence of the different IBS subtypes

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.