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Sacolene in cholera: a double blind randomized controlled trial.
F C Patra1, R N Majumder, R Eeckels
1International Centre for Diarrhoeal Disease Research, Department of Clinical Science, Dhaka, Bangladesh.
Scandinavian Journal of Infectious Diseases
|August 14, 1999
Summary
Methylated casein (Sacolene) did not reduce purging rate or diarrhea duration in severe cholera patients. However, Sacolene therapy reduced the need for repeat intravenous therapy, suggesting potential benefits.
Area of Science:
- Gastroenterology
- Infectious Diseases
- Pharmacology
Background:
- Methylated casein (Sacolene) is a European diarrhea remedy with demonstrated antisecretory effects.
- Previous studies suggest Sacolene may benefit human diarrhea and reduce cholera-induced secretion in animals.
Purpose of the Study:
- To evaluate the efficacy of Sacolene in treating severe cholera in adult males.
- To assess Sacolene's impact on purging rate, diarrhea duration, and need for intravenous rehydration.
Main Methods:
- A placebo-controlled trial involving 78 adult males with severe cholera.
- Participants received initial intravenous therapy followed by Sacolene or placebo, alongside oral rehydration therapy.
- Dosage: 4g Sacolene/placebo initially, then 2g every 4 hours until diarrhea cessation.
Main Results:
- No significant differences were observed in purging rate or diarrhea duration between Sacolene and placebo groups.
- The proportion of patients requiring repeat intravenous therapy was significantly lower in the Sacolene group (46%) compared to the placebo group (69%, p=0.04).
Conclusions:
- Sacolene therapy did not reduce the severity or duration of cholera purging.
- Sacolene may reduce the need for repeat intravenous therapy in severe cholera patients, warranting further investigation.