Efficacy and safety of a magnesium sulfate-rich natural mineral water for patients with functional constipation.
BACKGROUND & AIMS
Little is known about the effects of natural mineral water on constipation in adults. We assessed the effect of a magnesium sulfate-rich natural mineral water (Hépar; Nestlé Waters, Issy-les-Moulineaux, France) on gastrointestinal transit in constipated women.


METHODS
We performed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Hépar in outpatients with functional constipation (based on the Rome III criteria). The study included 244 female patients, age 18 to 60 years, identified by 62 general practitioners throughout France. After a washout period, subjects drank 1.5 L natural low-mineral water daily (control, n = 77), 0.5 L Hépar and 1 L natural low-mineral water daily (Hépar 0.5 group, n = 85), or 1 L Hépar and 0.5 L natural low-mineral water daily (Hépar 1 group, n = 82) for 4 weeks. We collected information on the number and types of stools, abdominal pain, rescue medications, adverse events, and volume of water consumed.


RESULTS
We observed no significant effect at week 1. At week 2, constipation was reduced in 21.1% of patients in the control group, in 30.9% in the Hépar 0.5 group (P = .099 vs controls), and in 37.5% in the Hépar 1 group (P = .013 vs controls). The Hépar 1 group also had a decreased number of hard or lumpy stools (Bristol scale, P = .030 vs baseline) and a substantial decrease in the use of rescue medication (P = .034 vs controls). Patient responses correlated with magnesium sulfate concentrations. Safety was very good; there were no serious adverse events among patients who drank Hépar.


CONCLUSIONS
In a controlled trial, daily consumption of 1 L Hépar reduced constipation and hard or lumpy stools in a greater percentage of women with functional constipation than natural low-mineral water, as early as the second week of treatment.