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

• Main Authors: Amaral Karine M (Author), Sander Guilherme B (Author), Costa Andry F (Author), Picon Rafael V (Author), Picon Paulo D (Author), Aboy Ana L (Author), Henriques Amélia T (Author)
• Format: Book
• Published: BMC, 2010-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

<p>Abstract</p> <p>Background</p> <p>A phytotherapic compound containing <it>Pimpinella anisum </it>L., <it>Foeniculum vulgare </it>Miller, <it>Sambucus nigra </it>L., and Cassia <it>augustifolia </it>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p> <p>Trial registration</p> <p>ClinicalTrial.gov NCT00872430</p>

Item Description

10.1186/1472-6882-10-17
1472-6882