Abstract
A randomized, placebo-controlled, double-blind trial Objective. The present randomized placebo-controlled double-blind trial was conducted to examine whether natural mineral water with a high content of magnesium sulfate and sodium sulfate (Donat Mg) contributes to improvement of the bowel function. Methods. A total of 106 healthy subjects with functional constipations were randomized in groups to receive 500 ml natural mineral water for the 6-week course and a comparison group who took placebo water. Trial participants recorded in a diary each complete spontaneous bowel movement, the number of spontaneous bowel movements per week overall, consistency of stool, gastrointestinal symptoms and general wellbeing. The change in the number of complete spontaneous bowel movements was defined as the primary outcome of the trial. Results. In 75 trial participants in groups that took 500 ml the change in the number of complete spontaneous bowel movements per week after 6 weeks., as a rule, was higher in the active treatment group compared with the placebo group (T2 = 1.8; P-value= 0.036; one-sided criterion). The average number of complete spontaneous bowel movements significantly increased during the trial, with significant differences between trial groups, taking into account the duration of the trial in general (F-criterion = 4,743; R time × group = 0,010, a two-sided criterion). Intake of mineral water, compared with placebo considerably improved the stool consistency at spontaneous bowel movements (p < 0.001), subjectively perceived signs of constipation significantly decreased (p = 0.005). Conclusion. Daily intake of natural mineral water, rich in magnesium sulfate and sodium sulfate, has increased frequency of bowel movements and improved stool consistency in people with functional constipations. In addition, assessment of the participants in the trial of quality of life associated with the condition improved. Clinical trial registration number in the EudraCT database: No. 2012-005130-11.
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