Adverse reactions to benznidazole in the treatment of Chagas’ Disease: a systematic review of randomized and controlled trials

Abstract

Background

In Brazil, the only drug available for the treatment of Trypanosoma cruzi, which causes Chagas' Disease (CD), is the Benznidazole (BZN) whose the adverse reactions might lead to treatment dropout.

Objective

The objective of this study is to quantify the proportion of occurrence of adverse effects, to describe them and to identify the risk factors associated with this occurrence.

Method

This is a systematic review conducted through the standards established by the Preferred Reporting Items in Systematic Reviews and Metanalyses (PRISMA). Only randomized controlled trials were included.

Results

Five of 134 studies were included. The sample size ranged from 77 to 2854 people, and the age range of the participants ranged from zero to 75 years old. All included studies reported adverse reactions to BZN use. The frequency of adverse reaction was 38% and the most common reaction was the skin rash. The treatment dropout caused by the adverse reactions was cited in three studies and was ranging from 6.4% to 13.4%.

Conclusion

The adverse reactions caused by the use of BZN varied with the age of patients and the therapeutic scheme of dose and time adopted. Therefore, medical knowledge is imperative for the safe use of BZN and adherence to treatment.

Keywords:
Chagas disease; trypanosomicides; side effects and adverse drug reactions; systematic review; clinical trial