clinicaltrials.gov Identifier: NCT00404534.

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.

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.

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

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BackgroundSeveral countries have used pegylation technology to improve the pharmacokinetic properties of essential drugs. Recently, a novel interferon alfa-2b protein conjugated to four-branched 12 kDa polyethylene glycol molecules was developed jointly between Cuba and Brazil. The aim of this study was to compare the pharmacokinetic properties of BIP48 (pegylated interferon alfa-2b from Bio-Manguinhos/Fiocruz, Brazil) to those of PEGASYS® (commercially available pegylated interferon alfa-2a from Roche Pharmaceutical).MethodsThis phase I, single-centre, randomized, double-blind crossover trial enrolled 31 healthy male volunteers aged 19 to 35 who were allocated to two stages, either side of a 5-week wash-out period, with each arm lasting 14 consecutive days after subcutaneous administration of 180 μg of one formulation or the other (study or comparator). The main outcome variable was serum pegylated interferon concentrations in 15 samples collected during the course of the study and tested using an enzyme immunoassay.ResultsThere were no differences between formulations in terms of magnitude or absorption parameters. Analysis of time parameters revealed that BIP48 remained in the body significantly longer than PEGASYS® (Tmax: 73 vs. 54 h [p = 0.0010]; MRT: 133 vs. 115 h [p = 0.0324]; ke: 0.011 vs. 0.013 h(−1) [p = 0.0153]; t1/2: 192 vs. 108 h [p = 0.0218]).ConclusionBIP48 showed the expected pharmacokinetic profile for a pegylated product with a branched molecular structure. Compared to PEGASYS®, the magnitude absorption was similar, but time parameters were consistent with slower elimination. Further studies should be conducted to evaluate the clinical implications of these findings. A phase II-III repeated-dose clinical trial is ongoing to study these findings in patients with chronic hepatitis C virus infection.Trial registrationThis study is registered on the ClinicalTrials.gov platform (accession number NCT01889849). This trial was retrospectively registered in June 2013.

SUMMARYBackground: The protective role of Helicobacter pylori in gastro-oesophageal reflux disease has been widely discussed. Aim: To assess the risk of reflux oesophagitis in patients with functional dyspepsia after treatment for H. pylori infection. Methods: A randomized, placebo-controlled, investigator-blinded trial was carried out on 157 functional dyspeptic patients. Patients were randomized to receive lansoprazole, amoxicillin and clarithromycin (antibiotic group) or lansoprazole and identical antibiotic placebos (control group). Upper gastrointestinal endoscopy was performed at baseline, 3 and 12 months after randomization. The primary aim was to detect the presence of reflux oesophagitis. Analyses were performed on an intention-to-treat basis. Results: A total of 147 patients (94%) and 133 (85%) completed 3 months and 12 months follow-up, respectively. The eradication rate of H. pylori was 90% in the antibiotic group (74 of 82) and 1% (one of 75) in the control group. At 3 months, reflux oesophagitis was diagnosed in 3.7% (three of 82) in the antibiotic group and 4% (three of 75) in the control group (P > 0.2). At 12 months, diagnosis was established in five new cases within the first group and in four within the second (P > 0.2). No difference was found in heartburn symptoms. Conclusions: H. pylori eradication does not cause reflux oesophagitis in this western population of functional dyspeptic patients.

The Rome III Diagnostic Questionnaire for Functional Dyspepsia is ready to be used in clinical researches in lusophone countries, as it has been successfully validated in Portuguese.