Table 2. Summary of outcomes and certainty of evidence (GRADE).
| Outcomes | № of participants | Certainty of the evidence (GRADE)* | Relative effect (95% CI) | Anticipated absolute effects | |
|---|---|---|---|---|---|
| Risk with Placebo or not treatment | Risk difference with Benznidazole | ||||
| SEROLOGICAL RESPONSE TO THERAPY | |||||
| RCT in children. | 217 (2 CT) [38,41] |
⨁⨁⨁◯ MODERATE** |
OR 38.35 (10.73 to 137.03) |
28 per 1000 |
493 more per 1000 (205 more to 767 more) |
| OBS in children | 61 (1 OBS) [45] |
⨁⨁◯◯ LOW |
OR 34.95 (1.96 to 624.09) |
--a | --a |
| OBS in adults | 1454 (4 OBS) [18,44,47,48] |
⨁◯◯◯ VERY LOW |
OR 17.11 (2.27 to 129.14) |
12 per 1000 |
157 more per 1000 (14 more to 593 more) |
| CLINICAL PROGRESSION | |||||
| RCT in adults | 2854 (1 CT) [21] |
⨁⨁⨁◯ MODERATE |
OR 0.93 (0.79 to 1.09) |
99 per 1000 |
6 fewer per 1000 (19 fewer to 8 more) |
| OBS in adults | 1331 (4 OBS) [18,42,47,48] |
⨁◯◯◯ VERY LOW |
OR 0.49 (0.19 to 1.25) |
64 per 1000 |
32 fewer per 1000 (51 fewer to 15 more) |
| PARASITOLOGICAL SECONDARY ENDPOINT | |||||
| RCT in children | 196 (2 CT) [38,41] |
⨁◯◯◯ VERY LOW |
OR 6.77 (0.90 to 51.09) |
417 per 1000 |
412 more per 1000 (25 fewer to 557 more) |
| RCT in adults | 1828 (6 CT) [21,29,30,40,50,51] |
⨁⨁◯◯ LOW |
OR 41.56 (7.25 to 238.15) |
313 per 1000 |
637 more per 1000 (455 more to 678 more) |
| OBS in adults | 187 (3 OBS) [43,46,47] |
⨁◯◯◯ VERY LOW |
OR 165.12 (4.56 to 5972.95) |
86 per 1000 |
853 more per 1000 (215 more to 912 more) |
*GRADE Working Group grades of evidence: High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
**In the Sosa-Estani 1998 study, there is no information regarding the generation of the randomisation sequence, allocation concealment or blinding of outcome assesment, so we consider that there may be a risk of selection and performance bias. Regarding Andrade 1996, there are no considerable biases to downgrade the quality if the evidence.
Abbreviations: RCT: Randomized controlled trials, OBS: Observational studies
a. RR can not be calculated because the number of events with placebo or not treatment is cero.
Patient or population: Patients with chronic Chagas disease
Intervention: Benznidazole. Comparison: Placebo or not treatment