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.

Treatment of hepatitis C with peginterferon and ribavirin in a public health program.

BACKGROUND/AIMS: In hepatitis C treatment, literature is limited with regard to independent studies developed outside the context of clinical assays. To evaluate the sustained virological response to the treatment of patients with chronic hepatitis C genotype 1 in a public program in the south of Brazil. METHODOLOGY: It is a mixed cohort, the data of all patients with chronic hepatitis C treated with peginterferon associated with ribavirin for 48 weeks were collected. If there was no early virological response on week 12 the treatment was discontinued. The significance level adopted in the statistical analysis was micro = 0.05. RESULTS: The cohort was comprised of 323 individuals. The treatment was completed in 215 (66.6%) patients. With the intention to treat analysis, the sustained virological response was obtained in 114 (35.3%) patients. The factors predictive of the response were lower age (below 40 years) and minor fibrosis (< F3 according METAVIR score), as well as viral load less than 600,000 IU/ml and the absence of hepatitis C virus viremia on 12th week of treatment. CONCLUSION: The sustained virological response in patients with chronic hepatitis C genotype 1 treated with peginterferon and ribavirin in a public health system did not reproduce the results obtained in the major clinical trials.