Guilherme Becker Sander

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.

Randomized clinical trial of a phytotherapic compound containing Pimpinella anisum, Foeniculum vulgare, Sambucus nigra, and Cassia augustifolia for chronic constipation.

BackgroundA phytotherapic compound containing Pimpinella anisum L., Foeniculum vulgare Miller, Sambucus nigra L., and Cassia augustifolia is largely used in Brazil for the treatment of constipation. However, the laxative efficacy of the compound has never been tested in a randomized clinical trial. The aim of this study was to evaluate the efficacy and safety of the product.MethodsThis randomized, crossover, placebo-controlled, single-blinded trial included 20 patients presenting with chronic constipation according to the criteria of the American Association of Gastroenterology. The order of treatments was counterbalanced across subjects: half of the subjects received the phytotherapic compound for a 5-day period, whereas the other half received placebo for the same period. Both treatment periods were separated by a 9-day washout period followed by the reverse treatment for another 5-day period. The primary endpoint was colonic transit time (CTT), measured radiologically. Secondary endpoints included number of evacuations per day, perception of bowel function, adverse effects, and quality of life.ResultsMean CTT assessed by X ray was 15.7 hours (95%CI 11.1-20.2) in the active treatment period and 42.3 hours (95%CI 33.5-51.1) during the placebo treatment (p < 0.001). Number of evacuations per day increased during the use of active tea; significant differences were observed as of the second day of treatment (p < 0.001). Patient perception of bowel function was improved (p < 0.01), but quality of life did not show significant differences among the study periods. Except for a small reduction in serum potassium levels during the active treatment, no significant differences were observed in terms of adverse effects throughout the study period.ConclusionsThe findings of this randomized controlled trial allow to conclude that the phytotherapic compound assessed has laxative efficacy and is a safe alternative option for the treatment of constipation.Trial registrationClinicalTrial.gov NCT00872430

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.

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.

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.

Effectiveness of alpha interferon (+ ribavirin) in the treatment of chronic viral hepatitis C genotypes 2 and 3 in a brazilian sample

CONTEXT Pharmacovigilance studies aim to detect, assess, understand and prevent risks of adverse effects of medications or any other possible drug related problem. Alpha interferon is being produced by Bio-Manguinhos/Fiocruz, Rio de Janeiro, RJ, Brazil and used in the treatment of chronic hepatitis C at Brazilian National Health System. OBJECTIVE To study the safety profile and effectiveness of alpha interferon in a sample of Brazilian patients with chronic hepatitis C genotypes 2 and 3, in Porto Alegre, RS, Brazil. METHOD We followed a cohort of chronic hepatitis C genotypes 2 and 3 patients treated with alpha interferon plus ribavirin in a specialized outpatient clinic in southern Brazil. Adverse events were collected and classified according to severity in monthly structured interviews. To measure effectiveness, hepatitis C viral load was evaluated before, at the end and 24 weeks after the treatment. RESULTS We followed 141 patients during the study period, of which 52.5% were female with mean age of 52 years. The most frequent adverse events were fatigue (84%), headache (79%) and myalgia (75%). There were 13 treatment interruptions due to adverse events, 9 of those considered serious adverse events. Virological response at end of treatment was 54.6% and after 24 weeks 39.7%, considering all patients who started treatment. CONCLUSION The product produced by Bio-Manguinhos has similar efficacy and adverse event and sustained virological response profiles comparable to those found in the literature. This is the first study of pharmacovigilance performed with the Brazilian product. These data will be useful for planning and management of this disease in Brazil.

Short-Term Therapy with Enoxaparin or Unfractionated Heparin for Venous Thromboembolism in Hospitalized Patients: Utilization Study and Cost-Minimization Analysis

OBJECTIVES To evaluate the direct costs of venous thromboembolism (VTE) treatment with unfractionated heparin (UFH) and low-molecular weight heparin, from the institutional perspective. METHODS This is a real-world cohort study that included inpatients treated with UFH or enoxaparin for deep venous thromboembolism or pulmonary embolism in a tertiary public hospital. To estimate medical costs we computed the acquisition costs of drugs, supplies for administration, laboratory tests, and hospitalization cost according to the patient ward. RESULTS One hundred sixty-seven patients aged 18 to 92 years were studied (50 treated with UFH and 117 with enoxaparin). The median of days in use of heparin was the same in both groups. Activated partial thromboplastin time was monitored in 98% of patients using UFH and 56.4% using enoxaparin. Nonstatistically significant differences were observed between groups in the number of bleeding events (10.0% and 9.4%; P = 1.00); blood transfusion (2.0% and 2.6%; P = 1.00); death (8.0% and 3.4%; P = 0.24); and recurrent VTE, bleeding, or death (20.0% and 14.5%; P = 0.38). Daily mean cost per patient was US

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

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