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

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.
BMC Complementary and Alternative Medicine (Impact Factor: 1.88). 04/2010; 10:17. DOI: 10.1186/1472-6882-10-17
Source: PubMed

ABSTRACT 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.
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.
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.
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. NCT00872430.


Available from: Rafael V. Picon, Jun 11, 2015
1 Follower
  • [Show abstract] [Hide abstract]
    ABSTRACT: In the past Alpine populations were isolated from comforts of industrial and technological development present in large cities and, therefore, they were obliged to find in nature a source of sustenance and care. Traditional use of plant is a wealth of local knowledge that is likely to be lost. This work, carried out during 2012, aims to collect, analyze and process information on the species used for medicinal, veterinary, cosmetic, domestic, ritual and religious purposes by the inhabitants of Valfurva, in the Province of Sondrio (Italy). Furthermore it is a means for the preservation of local traditions regarding such uses and increases the ethnobotanical data from Northern Italy, till now poorly documented.
    Journal of Ethnopharmacology 01/2015; 163. DOI:10.1016/j.jep.2014.12.054 · 2.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Pimpinella species have long been used traditionally in the treatment of various ailments by the people mainly living in Turkey, China, Korea, Iran, Egypt, Palestine, Lebanon, and European countries (United Kingdom and Italy). Plants belonging to this family have economic importance and they have long been used as condiments or vegetables in addition to their traditional therapeutic values. Members of Pimpinella, particularly Pimpinellaanisum, together with other Apiaceae species, have also been used in several industrial areas along the Mediterranean countries, particularly in beverage industry, to produce spirit drinks due to their characteristic flavors. This review is prepared to provide an overview to the knowledge of last 14 years (since 2000) and to make suggestions for filling the gaps available in the literature for this genus. Pimpinella species were found among the major sources of natural compounds having a broad spectrum of biological activities such as antimicrobial, antioxidant, enzyme inhibitory and/or stimulant, anti-inflammatory, anti-diabetic, anti-convulsing etc. In this review, toxic potential of Pimpinella species were also discussed. Although the majority of compounds tested were found as safe on various cell lines, some compounds that are highly toxic were particularly underlined here. Although the majority of compounds tested were found as not toxic on various cell lines, 4-methoxy-2-(1-propenyl)-phenyl angelate, (+)-4-methoxy-2-(3-methyloxiranyl)-phenyl tiglate, and estragole were described as a potent carcinogens. Plant based products containing estragole were discussed and some suggestion were presented for the producers. Additionally, since there are enormous amount of traditional experiences on the expectorant effects of Pimpinella species, it is suggested to evaluate the bronchodilator effect of these species scientifically together with the identification of active phytochemicals, as well as their possible side effects on pregnant women.
    Industrial Crops and Products 07/2015; 69. DOI:10.1016/j.indcrop.2015.01.069 · 3.21 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: We aimed to assess the effects of anise on quality of life (QOL) of patients with functional dyspepsia (FD) in a double-blind randomized clinical trial. Of 180 patients attending the gastroenterology clinic, 107 ones with the diagnosis of postprandial distress syndrome according to Rome III criteria were enrolled. They were randomized into two groups, anise and placebo. Anise group involved 47 patients and received anise powders, 3 g after each meal (3 times/day) for 4 weeks. Control group had 60 patients who received placebo powders (cornstarch), 3 g after each meal (3 times/day) for 4 weeks. The QOL was assessed by short-form (SF)-36 questionnaire. Mean scores of eight health domains of the two groups were compared at baseline and at the end of study. The age, sex, body mass index, smoking history, tea and coffee drinking patterns of the two groups were not significantly different. All domains of SF-36 were similar between the two groups at baseline but were significantly different at week 12. At baseline, mean score of physical component summary was 159 in placebo group and 167 in anise group (P = 0.1). At week 12, the score was 141 in placebo group and 251 in anise group (P = 0.0001). Mean baseline score of mental component summary was 172 and 165 in placebo and anise groups, respectively (P = 0.1). At week 12, the score was 135 in placebo group and 233 in anise group (P = 0.0001). The current study revealed the effectiveness of anise in improvement of QOL in patients with FD.