Randomized clinical trial of a phytotherapic compound containing Pimpinella anisum, Foeniculum vulgare, Sambucus nigra, and Cassia augustifolia for chronic constipation. BMC Complement Altern Med 10:17

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: 2.02). 04/2010; 10(1):17. DOI: 10.1186/1472-6882-10-17
Source: PubMed


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.

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Available from: Rafael V. Picon, Oct 06, 2015
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    • "When used in patients with gastrointestinal disorders, due to the potential for gastrointestinal distress or upset, diarrhea, nausea, vomiting, abdominal cramps, and dyspepsia (Anonymous, 1984; Grbic et al., 2011; Kunitz et al., 1984; Tsui, Dennehy, & Tsourounis, 2001). When used in patients with hypokalemia, due to the potential for decreased potassium, according to human research (Picon et al., 2010). When used in patients with migraines , due to the potential for headache, according to human research (Grbic et al., 2011). "
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    ABSTRACT: ABSTRACT An evidence-based systematic review of elderberry and elderflower (Sambucus nigra) by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.
    Journal of Dietary Supplements 01/2014; 11(1). DOI:10.3109/19390211.2013.859852
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    • "This effect was demonstrated by a decrease in colonic transit time as well as an increase in the number of daily evacuations. Although quality of life did not show significant differences among the study periods and no significant differences were observed in terms of adverse effects throughout the study period, so this compound can be a safe alternative option for the treatment of constipation [43]. "
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    ABSTRACT: Pimpinella anisum (anise) , belonging to Umbelliferae family, is an aromatic plant which has been used In Iranian traditional medicine (especially its fruits) as carminative, aromatic, disinfectant, and galactagogue. Because the wide traditional usage of Pimpinella anisum for treatment of diseases, in this review published scientific reports about the composition and pharmacological properties of this plant were collected with electronic literature search of GoogleScholar, PubMed, Sciencedirect, Scopus, and SID from 1970 to 2011. So far, different studies were performed on aniseeds and various properties such as antimicrobial, antifungal, antiviral, antioxidant, muscle relaxant, analgesic and anticonvulsant activity as well as different effects on gastrointestinal system have been reported of aniseeds. It can also reduce morphine dependence and has beneficial effects on dysmenorrhea and menopausal hot flashes in women. In diabetic patients, aniseeds showed hypoglycemic and hypolipidemic effect and reduce lipid peroxidation. The most important compounds of aniseeds essential oil were trans-anetole, estragole, γ -hymachalen, para-anisaldehyde and methyl cavicol. Due to broad spectrum of pharmacological effects, and very few clinical studies of Pimpinella anisum , more clinical trials are recommended to evaluate the beneficial effects of this plant in human models and synthesis of new drugs from the active ingredients of this plant in future.
    07/2012; 2012(3):510795. DOI:10.5402/2012/510795
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    • "They comprised almost 50 to 70% trans-anethole, 20% fenchona, and 9% estragole. Other compounds are present in concentrations that are usually less than 1% (limonene, camphor, and α-pinene) (Picon et al., 2010). Sollievo Bio is intended to be taken to maintain, support and optimize the gastrointestinal physiological transit function within the limits of its homeostatic condition. "
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    ABSTRACT: Chronic constipation (CC) is one of the most common functional gastrointestinal disorders and despite it is a rarely life-threatening condition, its effects can lead to discomfort and diminish the quality of life. Laxatives are commonly prescribed in CC patients including herbal products in standardized forms. The aim of the present study was to evaluate a commercially available herbal formulation (Sollievo Bio, Aboca, Sansepolcro, Italy), for potential cytotoxicity, genotoxicity and antigenotoxicity on a human colorectal adenocarcinoma cell line (HT-29). The cytokinesis-block micronucleus test was used for genotoxicity and antigenotoxicity testing, three concentrations of Sollievo Bio (0.2, 0.4 and 0.8 mg/ml) were assayed and mitomycin C (MMC: 3 µg/ml) was used as an inductor of micronuclei. Sollievo Bio did not induce any significant variation in spontaneous micronucleus (MN) frequency and, interestedly, reduced the MN frequency induced by MMC in a dose-dependent manner. In conclusion, our findings confirmed the safety of Sollievo Bio and suggested that Sollievo Bio may possess strong antigenotoxic and protective effects on MMC in vitro.
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