Supplementary Material for: Effects of Sulfate-Rich Mineral Water on Functional Constipation: A Double-Blind, Randomized, Placebo-Controlled Study
Naumann J.
Sadaghiani C.
Alt F.
Huber R.
10.6084/m9.figshare.4004946.v1
https://karger.figshare.com/articles/dataset/Supplementary_Material_for_Effects_of_Sulfate-Rich_Mineral_Water_on_Functional_Constipation_A_Double-Blind_Randomized_Placebo-Controlled_Study/4004946
Background: Magnesium sulfate has a long tradition as a laxative.
It osmotically prevents water absorption in the large
bowel and thus leads to an acceleration of the intestinal transit
and better stool consistency. We wanted to investigate the
efficacy of a carbonated calcium/magnesium sulfate-rich natural
mineral water in subjects with functional constipation
(FC). Patients and Methods: In this double-blind, randomized,
placebo-controlled study, subjects with FC (Rome III criteria)
received 1 l/day (4 × 250 ml) of mineral water (Ensinger Schiller
Quelle) or carbonated tap water (placebo) for 6 weeks.
The primary endpoint was the change in the frequency of
bowel movements per week between baseline and visit 4
(after 6 weeks). The prespecified main secondary endpoint
was the change in the frequency of bowel movements per
week between baseline and visit 3 (after 3 weeks). Results:
Efficacy was analyzed in 100 subjects (intention-to-treat).
After 6 weeks of treatment there was no statistical difference
between the groups (p = 0.163). However, statistical significance
was reached after 3 weeks, with an increase in the frequency
of bowel movements per week of 2.02 ± 2.22 for the
mineral water group compared to 0.88 ± 1.67 for the placebo
group (p = 0.005). Conclusions: A 3-week treatment with 1 l/
day of the sulfate-rich mineral water improved the frequency
of bowel movements in subjects with FC compared with tap
water; however, the difference was no longer significant after
6 weeks. Further evaluation in rigorously designed clinical
studies will be necessary to validate the impact of sulfate-rich
natural mineral water on FC.
2016-10-11 13:36:47
Functional constipation
Bowel movements
Mineral water
Sulfate
Magnesium