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

BACKGROUND: A 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. METHODS: This 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. RESULTS: Mean 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. CONCLUSIONS: The 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 REGISTRATION: ClinicalTrial.gov NCT00872430.

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.

Efficiency of short and long term antimicrobial therapy in transrectal ultrasound-guided prostate biopsies.

OBJECTIVE: Prostate biopsy is a frequent diagnostic measure to detect prostatic conditions, including primarily prostate cancer. Its performance does not follow a pattern, mainly regarding preparation for the examination through antimicrobial prophylaxis. The aim of this study is to compare the efficiency of short and long term antimicrobial prophylaxis in transrectal ultrasound-guided prostate biopsies. MATERIALS AND METHODS: A clinical study was conducted with a total of 140 patients submitted to prostate biopsy with transrectal ultrasonographic control. Patients were randomly separated in two groups: Group 1 receiving norfloxacin 400mg single dose before the procedure and Group 2 receiving norfloxacin 400mg initiating before the procedure and then bid up to 6 doses. Efficiency control was determined by the incidence of urinary tract infection (UTI) and complications in both groups after statistical analysis. RESULTS: The incidence of minor complications in our study was 75%, consistent with data found in the literature. Among the patients with diagnosis of simple UTI, 23% belonged to Group 1 and 8% to Group 2 (p=0.08). Among the patients with complicated UTI, 37% belonged to Group 1 and none belonged to Group 2 (p=0.44). CONCLUSIONS: Several advances made transrectal ultrasound-guided prostate biopsies a useful and safe diagnostic tool in the workup of urologic patients. There is no optimal prophylactic preparation to the performance of this procedure. Long term antimicrobial prophylaxis presents a trend toward lower incidence of infectious complications.