Characteristics of included studies [ordered by study ID]
|
| Methods | Random allocation of patients to treatment groups.
Allocation to treatment groups was concealed from participants. |
|
| | Participants | 77 patients with chronic Chagas disease. |
|
| | Interventions | 26 in benznidazole group .
27 in nifurtimox group (both groups had the following scheme: 5m/kg/day every 12 hours, during 30 days).
24 in placebo group.
Placebo was identical to treatment. |
|
| | Outcomes | Parasitologic cure was found to be no different between treatment groups Serological reaction did not change over the follow-up and there were not clinical EKG or X ray changes one year after treatment.
The assessment of outcomes was made 1, 2, 3 and 12 months after treatment was finished. |
|
| | Notes | 17% Losses to follow-up |
|
| | Risk of bias |
| | Bias | Authors' judgement | Support for judgement |
| | Random sequence generation (selection bias) | Unclear risk | not reported |
| | Allocation concealment (selection bias) | Unclear risk | not reported |
| Blinding (performance bias and detection bias)
All outcomes | Unclear risk | patients and physicians |
| | Selective reporting (reporting bias) | Low risk | |
| | Other bias | Unclear risk | none |
|
|
Characteristics of excluded studies [ordered by study ID]
|
| Study | Reason for exclusion |
|---|
| | Braga 2000 | There was no randomization process. |
| | Cancado 2002 | The article reports the follow-up of patients with both, acute and chronic Chagas disease, treated with Benznidazole. There was no randomization process. |
| | Fabro 2000 | There was no randomization process. |
| | Lauria-Pires 2000 | There was no randomization process. |
| | Viotti 1994 | There was no randomization process. |
|
|
Characteristics of ongoing studies [ordered by study ID]
|
| Trial name or title | BENEFIT |
| | Methods | Multicenter, randomised, double-blind, placebo-controlled clinical trial. |
| | Participants | 3000 patients with Chagas' cardiomyopathy. |
| | Interventions | Benznidazole (5 mg/kg per day) or matched placebo, for 60 days. |
| | Outcomes | The primary outcome is the composite of death; resuscitated cardiac arrest; sustained ventricular tachycardia; insertion of pacemaker or cardiac defibrillator; cardiac transplantation; and development of new heart failure, stroke, or systemic or pulmonary thromboembolic events. The average follow-up time will be 5 years, and the trial has a 90% power to detect a 25% relative risk reduction. |
| | Starting date | November 2004 |
| | Contact information | |
| | Notes | The BENEFIT program also comprises a sub-study evaluating the effects of benznidazole on parasite clearance and an echo sub study exploring the impact of etiologic treatment on left ventricular function. |
|
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