title: Efficacy and safety of a magnesium sulfate-rich natural mineral water for patients with functional constipation.
abstract: OBJECTIVE
  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.
authors.affiliation: Service d'Explorations Fonctionnelles Digestives Pédiatriques, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfant Malade, Université Paris Descartes, Paris, France. Electronic address: christophe.dupont@nck.aphp.fr.
authors.forename: Christophe
authors.initials: C
authors.lastname: Dupont
authors.affiliation: General Practitioner, Tours, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Campagne
authors.affiliation: Nestlé Waters M.T., Issy-les-Moulineaux, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Constant
mesh_terms: D000293:Adolescent; D000328:Adult; D003248:Constipation / Q000628:therapy*; D005260:Female; D005602:France; D006801:Humans; D008278:Magnesium Sulfate / Q000008:administration & dosage* / Q000032:analysis*; D008875:Middle Aged; D008900:Mineral Waters / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D008900:Mineral Waters; D008278:Magnesium Sulfate
keywords: Bowel Movement; Clinical Trial; Mineral Water; Treatment