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

Picon PD, Picon RV, Costa AF, Sander GB, Amaral KM, Aboy AL, Henriques AT - BMC Complement Altern Med (2010)

Bottom Line: Secondary endpoints included number of evacuations per day, perception of bowel function, adverse effects, and quality of life.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: 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

ABSTRACT

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.

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Proportion of one or more evacuations/day according to treatment period (active tea vs. placebo).
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Figure 2: Proportion of one or more evacuations/day according to treatment period (active tea vs. placebo).

Mentions: As to the subjective analysis, particularly of note was the question "How many times have you evacuated in the last 24 hours?": during the placebo treatment, 42% of the patients answered "none," whereas during the active treatment, only 14% gave the same answer (Fisher's exact test, p < 0.001). A comparison of the number of evacuations per day during the study period as informed in the questionnaire revealed significant differences among groups as of the second day of treatment (Wilcoxon signed-rank test) (Figure 2).


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

Picon PD, Picon RV, Costa AF, Sander GB, Amaral KM, Aboy AL, Henriques AT - BMC Complement Altern Med (2010)

Proportion of one or more evacuations/day according to treatment period (active tea vs. placebo).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2874511&req=5

Figure 2: Proportion of one or more evacuations/day according to treatment period (active tea vs. placebo).
Mentions: As to the subjective analysis, particularly of note was the question "How many times have you evacuated in the last 24 hours?": during the placebo treatment, 42% of the patients answered "none," whereas during the active treatment, only 14% gave the same answer (Fisher's exact test, p < 0.001). A comparison of the number of evacuations per day during the study period as informed in the questionnaire revealed significant differences among groups as of the second day of treatment (Wilcoxon signed-rank test) (Figure 2).

Bottom Line: Secondary endpoints included number of evacuations per day, perception of bowel function, adverse effects, and quality of life.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: 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

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus