Group of Toxicopharmacological Studies and Research, School of Pharmacy, Federal University of Goias, Avenida Universitária, Q. 62, Setor Universitário, 74605-220 Goiânia, GO, Brazil ; Hospital of Alternative Medicine, State Health Secretary of Goiás, Unified Health System, Rodovia BR-153, Km 8, Bairro Santo Antônio, 74853-040 Goiânia, GO, Brazil.
Group of Toxicopharmacological Studies and Research, School of Pharmacy, Federal University of Goias, Avenida Universitária, Q. 62, Setor Universitário, 74605-220 Goiânia, GO, Brazil ; Romulo Rocha Center of Clinical Analysis, School of Pharmacy, UFG, Avenida Universitária c/1a Avenida, Q. 62, Setor Universitário,74605-220 Goiânia, GO, Brazil.
Evid Based Complement Alternat Med. 2014;2014:760683. doi: 10.1155/2014/760683. Epub 2014 Mar 4.
In this double-blind, randomized clinical trial, 36 healthy male volunteers were randomly distributed into three groups (n = 12) that underwent a three-step treatment. For four consecutive days, we alternately administered a standardized dried extract of Equisetum arvense (EADE, 900 mg/day), placebo (corn starch, 900 mg/day), or hydrochlorothiazide (25 mg/day), separated by a 10-day washout period. Each volunteer served as his own control, and the groups' results were compared. We repeated the same evaluation after each stage of treatment to evaluate the safety of the drug. The diuretic effect of EADE was assessed by monitoring the volunteers' water balance over a 24 h period. The E. arvense extract produced a diuretic effect that was stronger than that of the negative control and was equivalent to that of hydrochlorothiazide without causing significant changes in the elimination of electrolytes. There was no significant increase in the urinary elimination of catabolites. Rare minor adverse events were reported. The clinical examinations and laboratory tests showed no changes before or after the experiment, suggesting that the drug is safe for acute use. Further research is needed to better clarify the mechanism of diuretic action and the other possible pharmacological actions of this phytomedicine.
在这项双盲、随机临床试验中,36 名健康男性志愿者被随机分为三组(每组 12 人),接受三步治疗。连续四天,我们交替给予标准化的木贼草干浸膏(EADE,900mg/天)、安慰剂(玉米淀粉,900mg/天)或氢氯噻嗪(25mg/天),每次给药间隔 10 天洗脱期。每位志愿者均作为自身对照,并比较了各组的结果。我们在每个治疗阶段后重复相同的评估,以评估药物的安全性。通过监测志愿者 24 小时内的水平衡来评估 EADE 的利尿作用。木贼草提取物产生的利尿作用强于阴性对照,与氢氯噻嗪相当,而不会导致电解质排泄明显变化。尿中代谢产物的排泄没有明显增加。报告了罕见的轻微不良事件。临床检查和实验室测试显示实验前后均无变化,提示该药物可安全用于急性使用。需要进一步研究以更好地阐明这种植物药的利尿作用机制和其他可能的药理学作用。