Abstract
PurposeThe present placebo-controlled, double-blind, randomized trial aimed to investigate whether a natural mineral water rich in magnesium sulphate and sodium sulphate (Donat Mg) may help to improve bowel function.MethodsA total of 106 otherwise healthy subjects with functional constipation were randomly assigned to consume 300 or 500 mL of a natural mineral water as compared to placebo water, over a course of 6 weeks. The 300-mL arms were terminated due to the results of a planned interim analysis. Subjects documented the complete spontaneous bowel movements, spontaneous and overall bowel movements/week, stool consistency, gastrointestinal symptoms and general well-being in a diary. Change in the number of complete spontaneous bowel movements was defined as the primary outcome.ResultsFor the 75 subjects in the 500-mL arms, the change in the number of complete spontaneous bowel movements per week tended to be higher in the active group when compared to placebo after 6 weeks (T2 = 1.8; pvalue = 0.036; one-sided). The mean number of spontaneous bowel movements significantly increased over the course of the study, with significant differences between study arms considering the whole study time (F test = 4.743; ptime × group = 0.010, 2-sided). Stool consistency of spontaneous bowel movements (p < 0.001) and the subjectively perceived symptoms concerning constipation (p = 0.005) improved significantly with the natural mineral water as compared to placebo.ConclusionsThe daily consumption of a natural mineral water rich in magnesium sulphate and sodium sulphate improved bowel movement frequency and stool consistency in subjects with functional constipation. Moreover, the subjects’ health-related quality of life improved.Clinical Trial RegistrationEudraCT No 2012-005130-11.
Highlights
Constipation is one of the leading bowel conditions affecting health-related quality of life and comprising other complaints resulting in substantial healthcare costs [1,2,3]
Out of the 132 subjects assessed for eligibility, 106 were randomized (Fig. 1); 30 subjects thereof were allocated to the 300-mL arms, which were terminated after the interim analysis
Of the 76 subjects allocated to the 500-mL arms, 75 were included in the full analysis set (FAS) population
Summary
Constipation is one of the leading bowel conditions affecting health-related quality of life and comprising other complaints resulting in substantial healthcare costs [1,2,3]. Functional constipation is a functional gastrointestinal disorder characterized by straining during defecation, lumpy or hard stool, sensation of incomplete evacuation and infrequent bowel movements without evident organic or structural diseases [4]. An integrative review of eleven studies conducted in Asian, South American and European countries revealed a prevalence of constipation ranging from 2.6 to 26.9 % in the general adult population [5]. The spectrum of stool types in the general healthy population is wide including hard, fragmented lumps to sausage-like or snake-like forms up to mushy material, which correlates with transit time and faecal bulk [7]. Stool consistency is frequently related to bowel movement, which differs
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