• Nutrition · Sep 2019

    Randomized Controlled Trial Multicenter Study

    Time to treatment response of a magnesium- and sulphate-rich natural mineral water in functional constipation.

    • Christophe Dupont, Florence Constant, Aurélie Imbert, Guillaume Hébert, Othar Zourabichvili, and Nathalie Kapel.
    • Service d'Explorations Fonctionnelles Digestives Pédiatriques, AP-HP, Hôpital Necker Enfant Malade, Université Paris Descartes, Paris, France. Electronic address: Christophe.dupont@nck.aphp.fr.
    • Nutrition. 2019 Sep 1; 65: 167-172.

    ObjectivesFirst-line recommendations for the management of functional constipation include nutritional-hygienic measures. We previously showed that a natural mineral water rich in sulphates and magnesium (Hépar) is efficient in the treatment of functional constipation. The aim of this study was to consolidate those first results and determine a precise time to respond to Hépar.MethodsThis multicenter, randomized, double-blind, controlled study of the effect of Hépar on stool consistency and frequency in functional constipation included 226 outpatients. After washout, patients used 1.5 L of water daily, including 1 L of Hépar or of low-mineral water, during 14 d. In addition to a daily reporting of stool consistency by the patient, an expert investigator blindly analyzed stool consistency (Bristol stool scale) based on photographs taken by the patient.ResultsThe primary endpoint was met. Treatment response was more frequent in the Hépar arm than in the control group at day 14 (50% versus 29%, respectively; P = 0.001). Mean time to treatment response was shorter in the Hépar group (6.4 d) than in the control arm (7.3 d; P = 0.013). Concomitant stool scoring was available for 60% of the patients. Scores given to 79% of the stools were similar between the patient and the expert (differences ≤1). Safety analyses showed excellent results.ConclusionThis study confirms the efficacy and safety of Hépar in the treatment of functional constipation and shows that it is associated with a response within 7 d. Hépar could be a safe response to the current absence of first-line medication in the treatment of functional constipation.Copyright © 2019. Published by Elsevier Inc.

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