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 Complement Altern Med. 2010 Apr 30;10:17. doi: 10.1186/1472-6882-10-17.
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.
ClinicalTrial.gov NCT00872430.
一种含有茴芹、茴香、黑接骨木和决明子的植物药复方在巴西被广泛用于治疗便秘。然而，该复方的通便疗效从未在随机临床试验中得到过验证。本研究旨在评估该产品的疗效和安全性。
本随机、交叉、安慰剂对照、单盲试验纳入了 20 名符合美国胃肠病学会标准的慢性便秘患者。治疗顺序在受试者之间进行了平衡：一半受试者接受植物药复方治疗 5 天，另一半受试者接受安慰剂治疗相同时间。两种治疗期之间有 9 天的洗脱期，然后进行相反的治疗 5 天。主要终点是通过放射学测量的结肠传输时间（CTT）。次要终点包括每天排便次数、肠道功能感知、不良反应和生活质量。
X 射线评估的平均 CTT 在活性治疗期为 15.7 小时（95%CI 11.1-20.2），在安慰剂治疗期为 42.3 小时（95%CI 33.5-51.1）（p<0.001）。在使用活性茶期间，每天排便次数增加；从治疗的第二天开始就观察到显著差异（p<0.001）。患者对肠道功能的感知得到改善（p<0.01），但在研究期间生活质量没有显示出显著差异。除了在活性治疗期间血清钾水平略有下降外，整个研究期间在不良反应方面没有观察到显著差异。
这项随机对照试验的结果表明，所评估的植物药复方具有通便疗效，是治疗便秘的一种安全替代选择。
ClinicalTrials.gov NCT00872430。
