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Cranberry versus placebo in the prevention of urinary infections in multiple
sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial.
Gallien P, Amarenco G, Benoit N, Bonniaud V, Donzé C, Kerdraon J, de Seze M,
Denys P, Renault A, Naudet F, Reymann JM.
Author information:
Physical Medicine and Rehabilitation Center, Saint Hélier Clinic, Rennes, France.
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.
sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial.
Gallien P, Amarenco G, Benoit N, Bonniaud V, Donzé C, Kerdraon J, de Seze M,
Denys P, Renault A, Naudet F, Reymann JM.
Author information:
Physical Medicine and Rehabilitation Center, Saint Hélier Clinic, Rennes, France.
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.
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