Philippe Gallien1, Gérard Amarenco2, Nicolas Benoit3, Véronique Bonniaud4, Cécile Donzé5, Jacques Kerdraon6, Marianne de Seze7, Pierre Denys8, Alain Renault9, Florian Naudet10, Jean Michel Reymann11. 1. Physical Medicine and Rehabilitation Center, Saint Hélier Clinic, Rennes, France Department of Physical Medicine and Rehabilitation, Pontchaillou Hospital, Rennes University Hospital and University of Rennes 1, Rennes, France. 2. Department of Neuro-Urology, Tenon Hospital, and Pierre and Marie Curie University, Paris, France. 3. Physical Medicine and Rehabilitation Center, Saint Hélier Clinic, Rennes, France. 4. Multidisciplinary Pelviperineology and Rehabilitation Unit, Dijon University Hospital, Dijon, France. 5. Department of Physical Medicine and Rehabilitation, Saint Philibert Hospital, Lille Catholic Institute Hospital Group, Lomme, France. 6. Kerpape Functional Rehabilitation Center, Ploemeur, France. 7. Neuro-Urology, Pelviperineology and Urodynamic Clinical Center, Clinique Saint Augustin, Bordeaux, France. 8. Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France. 9. Clinical Investigation Center, Pontchaillou Hospital, Rennes University Hospital and University of Rennes 1, Rennes, France. 10. Clinical Investigation Center, Pontchaillou Hospital, Rennes University Hospital and University of Rennes 1, Rennes, France Experimental and Clinical Pharmacology Laboratory, Faculty of Medicine, Rennes, France floriannaudet@gmail.com. 11. Clinical Investigation Center, Pontchaillou Hospital, Rennes University Hospital and University of Rennes 1, Rennes, France Experimental and Clinical Pharmacology Laboratory, Faculty of Medicine, Rennes, France.
Abstract
OBJECTIVE: Our aim was to assess the usefulness of cranberry extract in multiple sclerosis (MS) patients suffering from urinary disorders. METHODS: In total, 171 adult MS outpatients with urinary disorders presenting at eight centers were randomized (stratification according to center and use of clean intermittent self-catheterization) to cranberry versus placebo in a 1-year, prospective, double-blind study that was analyzed using a sequential method on an intent-to-treat basis. An independent monitoring board analyzed the results of the analyses each time 40 patients were assessed on the main endpoint. Cranberry extract (36 mg proanthocyanidins per day) or a matching placebo was taken by participants twice daily for 1 year. The primary endpoint was the time to first symptomatic urinary tract infection (UTI), subject to validation by a validation committee. RESULTS: The second sequential analyses allowed us to accept the null hypothesis (no difference between cranberry and placebo). There was no difference in time to first symptomatic UTI distribution across 1 year, with an estimated hazard ratio of 0.99, 95% CI [0.61, 1.60] (p = 0.97). Secondary endpoints and tolerance did not differ between groups. CONCLUSION:Taking cranberry extract versus placebo twice a day did not prevent UTI occurrence in MS patients with urinary disorders. Trial Registration NCT00280592.
RCT Entities:
OBJECTIVE: Our aim was to assess the usefulness of cranberry extract in multiple sclerosis (MS) patients suffering from urinary disorders. METHODS: In total, 171 adult MS outpatients with urinary disorders presenting at eight centers were randomized (stratification according to center and use of clean intermittent self-catheterization) to cranberry versus placebo in a 1-year, prospective, double-blind study that was analyzed using a sequential method on an intent-to-treat basis. An independent monitoring board analyzed the results of the analyses each time 40 patients were assessed on the main endpoint. Cranberry extract (36 mg proanthocyanidins per day) or a matching placebo was taken by participants twice daily for 1 year. The primary endpoint was the time to first symptomatic urinary tract infection (UTI), subject to validation by a validation committee. RESULTS: The second sequential analyses allowed us to accept the null hypothesis (no difference between cranberry and placebo). There was no difference in time to first symptomatic UTI distribution across 1 year, with an estimated hazard ratio of 0.99, 95% CI [0.61, 1.60] (p = 0.97). Secondary endpoints and tolerance did not differ between groups. CONCLUSION: Taking cranberry extract versus placebo twice a day did not prevent UTI occurrence in MSpatients with urinary disorders. Trial Registration NCT00280592.
Authors: Holly Fisher; Yemi Oluboyede; Thomas Chadwick; Mohamed Abdel-Fattah; Catherine Brennand; Mandy Fader; Simon Harrison; Paul Hilton; James Larcombe; Paul Little; Doreen McClurg; Elaine McColl; James N'Dow; Laura Ternent; Nikesh Thiruchelvam; Anthony Timoney; Luke Vale; Katherine Walton; Alexander von Wilamowitz-Moellendorff; Jennifer Wilkinson; Ruth Wood; Robert Pickard Journal: Lancet Infect Dis Date: 2018-06-28 Impact factor: 25.071