title: Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial.
abstract: Our aim was to assess the usefulness of cranberry extract in multiple sclerosis (MS) patients suffering from urinary disorders.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Taking cranberry extract versus placebo twice a day did not prevent UTI occurrence in MS patients with urinary disorders. Trial Registration NCT00280592.
authors.affiliation: 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.
authors.forename: Philippe
authors.initials: P
authors.lastname: Gallien
authors.affiliation: Department of Neuro-Urology, Tenon Hospital, and Pierre and Marie Curie University, Paris, France.
authors.forename: Gérard
authors.initials: G
authors.lastname: Amarenco
authors.affiliation: Physical Medicine and Rehabilitation Center, Saint Hélier Clinic, Rennes, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Benoit
authors.affiliation: Multidisciplinary Pelviperineology and Rehabilitation Unit, Dijon University Hospital, Dijon, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Bonniaud
authors.affiliation: Department of Physical Medicine and Rehabilitation, Saint Philibert Hospital, Lille Catholic Institute Hospital Group, Lomme, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Donzé
authors.affiliation: Kerpape Functional Rehabilitation Center, Ploemeur, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Kerdraon
authors.affiliation: Neuro-Urology, Pelviperineology and Urodynamic Clinical Center, Clinique Saint Augustin, Bordeaux, France.
authors.forename: Marianne
authors.initials: M
authors.lastname: de Seze
authors.affiliation: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Denys
authors.affiliation: Clinical Investigation Center, Pontchaillou Hospital, Rennes University Hospital and University of Rennes 1, Rennes, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Renault
authors.affiliation: 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.
authors.forename: Florian
authors.initials: F
authors.lastname: Naudet
authors.affiliation: 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.
authors.forename: Jean Michel
authors.initials: JM
authors.lastname: Reymann
mesh_terms: D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005602:France; D005638:Fruit; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D010946:Plants, Medicinal; D044945:Proanthocyanidins / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000175:diagnosis / Q000382:microbiology / Q000517:prevention & control*; D029799:Vaccinium macrocarpon
chemical_list: D000890:Anti-Infective Agents; D010936:Plant Extracts; D044945:Proanthocyanidins
keywords: Multiple sclerosis; cranberry (Vaccinium macrocarpon); neurogenic bladder; urinary tract infection