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

Abstract

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

A Review of the Antiviral Properties of Black Elder (Sambucus nigraL.) Products

“…Further, it has been shown to promote insulin secretion and cellular glucose uptake and thus shows potential in treating diabetes mellitus (Gray et al, 2000;Christensen et al, 2009;Christensen et al, 2010;Bhattacharya et al, 2013). Less certain are its potential as a laxative (Picon et al, 2010) and in the inhibition of gingivitis (Grbic et al, 2011;Samuels et al, 2012a;Samuels et al, 2012b). It also has the potential to prevent endothelial dysfunction, atherosclerosis, and gout through XO inhibition of its constituent quercetin (Chang et al, 1993;Lü et al, 2010;Lin et al, 2008;Schröder et al, 2006).…”

Constipation and Laxative Herbs in Iranian Traditional Medicine

“…For some of these herbs, their pharmacological effects are explained in detail, such as Ficuscarica (15), Rosa damascenna (16), and Viola odorata (17); some have been used as a laxative in folklore medicine or other traditional medicine, such as those of the Greeks, Romans, and Egyptians, including Alhagi mannifera (18), Linnium usitatissimum (19), and Malva sylvestris (20). Some of these plants are mentioned as a laxative in different articles, such as Aloe species (21), Cassia angustifolia (22), Cassia fistula (23), Cordia myxa (24), Olea europaea (25), Plantago ovate (26), and Prunus domestica (27). Additionally, anthraquinone, which has a laxative effect, is considered to be a heating agent in plants with hot temperaments, such as Cassia fistula (23,28).…”

Spasmolytic Potential of Some Medicinal Plants Belonging to Family Umbelliferae: A Review

“…Antispasmodic and relaxant effects of three hydroalcoholic extracts of the aerial parts of Pimpinella anisum (ethanol: water; 40 : 60, 60 : 40, and 80 : 20) were investigated on rat anococcygeus smooth muscle 90 ( Figure 6). The laxative efficacy of a phytotherapeutic compound containing Pimpinella anisum L., Foeniculum vulgare Miller, Sambucus nigra L., and Cassia augustifolia was studied in a randomized clinical trial included 20 patients presenting with chronic constipation 91 . Essential oil of Pimpinella anisum showed significant analgesic effect similar to morphine and aspirin 92 .…”