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.


BACKGROUND
ClinicalTrial.gov NCT00872430.
Picon
Paulo D
PD
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. paulopicon@gmail.com
Picon
Rafael V
RV
Costa
Andry F
AF
Sander
Guilherme B
GB
Amaral
Karine M
KM
Aboy
Ana L
AL
Henriques
Amélia T
AT
D000328:Adult; D002366:Cassia; D003106:Colon / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000502:physiology; D003248:Constipation / Q000097:blood / Q000188:drug therapy*; D003672:Defecation / Q000187:drug effects; D005260:Female; D030001:Foeniculum; D005772:Gastrointestinal Transit / Q000187:drug effects*; D006801:Humans; D054368:Laxatives / Q000494:pharmacology / Q000627:therapeutic use*; D019684:Magnoliopsida; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D008517:Phytotherapy; D028042:Pimpinella; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D011188:Potassium / Q000097:blood; D011788:Quality of Life; D011859:Radiography; D027923:Sambucus; D016037:Single-Blind Method; D014965:X-Rays
D054368:Laxatives; D010936:Plant Extracts; D011188:Potassium