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

BMC Complementary and Alternative Medicine

Research Article

Karine M Amaral¹  Guilherme B Sander¹  Andry F Costa¹  Rafael V Picon¹  Paulo D Picon²  Ana L Aboy³  Amélia T Henriques³ 

[1] Clinical Research Unit, Hospital de Clínicas, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil;Department of Internal Medicine and Chief of the Clinical Research Unit at Hospital de Clínicas, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil;Faculty of Pharmacy, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil;

关键词: Irritable Bowel Syndrome;    Rutin;    Bowel Function;    Chronic Constipation;    Colonic Transit Time;   

DOI  :  10.1186/1472-6882-10-17

 received in 2009-09-15, accepted in 2010-04-30,  发布年份 2010

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY   
© Picon et al; licensee BioMed Central Ltd. 2010