Christophe Dupont1, Florence Constant2, Aurélie Imbert2, Guillaume Hébert3, Othar Zourabichvili4, Nathalie Kapel5. 1. Service d'Explorations Fonctionnelles Digestives Pédiatriques, AP-HP, Hôpital Necker Enfant Malade, Université Paris Descartes, Paris, France. Electronic address: Christophe.dupont@nck.aphp.fr. 2. Nestlé Waters M.T., Issy-les-Moulineaux, France. 3. SC Partners, Paris, France. 4. Quanta Medical, Rueil-Malmaison, France. 5. Laboratoire de Coprologie Fonctionnelle, Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, APHP, Paris, France.
Abstract
OBJECTIVES: First-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. METHODS: This 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. RESULTS: The 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. CONCLUSION: This 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.
RCT Entities:
OBJECTIVES: First-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. METHODS: This 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. RESULTS: The 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. CONCLUSION: This 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.
Authors: Magdalena Dumitrescu; Madalina Gabriela Iliescu; Laura Mazilu; Sergiu Ioan Micu; Adrian Paul Suceveanu; Felix Voinea; Claudia Voinea; Anca Pantea Stoian; Andra-Iulia Suceveanu Journal: Exp Ther Med Date: 2021-12-07 Impact factor: 2.447
Authors: Pascual-Vicente Crespo; Fernando Campos; Manuel Leal; Francisco Maraver Journal: Int J Environ Res Public Health Date: 2021-03-22 Impact factor: 3.390