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Nitazoxanide in the treatment of viral gastroenteritis: a randomized double‐blind placebo‐controlled clinical trial
Author(s) -
ROSSIGNOL J.F.,
ELGOHARY Y. M.
Publication year - 2006
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2006.03128.x
Subject(s) - nitazoxanide , norovirus , medicine , rotavirus , placebo , diarrhea , adverse effect , gastroenterology , clinical endpoint , randomized controlled trial , placebo controlled study , clinical trial , immunology , double blind , virus , pathology , alternative medicine
Summary Background Enteric viruses including noroviruses and rotavirus are leading causes of diarrhoeal disease and gastroenteritis worldwide, and there is no effective treatment. Aim To evaluate nitazoxanide, a thiazolide anti‐infective agent, in treating viral gastroenteritis in adults and adolescents. Methods 50 out‐patients at least 12 years of age (mean 33.5 years) presenting with diarrhoea and stool‐positive by enzyme‐linked immunosorbent assay for norovirus, rotavirus or adenovirus were enrolled in a double‐blind, placebo‐controlled clinical trial. Patients were randomly assigned either nitazoxanide 500 mg or placebo twice daily for 3 days. The primary end point was time from first dose to resolution of symptoms. Analysis was modified intent‐to‐treat for 45 patients, excluding five patients with other identified enteropathogens at baseline. Results The median time from first dose to resolution of symptoms was 1.5 days (IQR: 0.5–2.5) for nitazoxanide‐treated patients and 2.5 days (IQR: 1.5–4.5) for the placebo group. Significant reductions in time to resolution of symptoms were observed for all patients analysed ( P < 0.0001) and for subsets of patients with rotavirus ( P = 0.0052) and norovirus ( P = 0.0295). The number of patients with adenovirus ( n = 5) was too small to draw any conclusion. No significant adverse events were reported. Conclusions Nitazoxanide may play an important role in managing viral gastroenteritis in adults.