Summary of findings 2. SDAC + hospital intervention versus hospital intervention alone for first aid in patients with acute oral poisoning.
| SDAC + hospital intervention versus hospital intervention alone for first aid in patients with acute oral poisoning | ||||||
| Patient or population: first aid in patients with acute oral poisoning (not specified, tricyclic antidepressants, combinations of different drugs or yellow oleander) Setting: hospital setting Intervention: single‐dose activated charcoal (SDAC) + hospital intervention Comparison: hospital intervention | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with hospital intervention | Risk with SDAC + hospital intervention | |||||
| Incidence of mortality | Study population | Peto OR 1.04 (0.79 to 1.37) | 3425 (2 RCTs) | ⊕⊕⊝⊝ Lowa,b | SDAC in addition to hospital treatments may make little or no difference on incidence of mortality. | |
| 62 per 1000 | 64 per 1000 (49 to 85) | |||||
| Incidence of adverse events | Incidence of vomiting: intervention group: 118/570 and control group: 163/1236 (RR 1.44, 95% CI 0.88 to 2.37; 1806 participants; 2 studies). Incidence of absent bowel sounds: intervention group: 7/1544 and control group: 17/1554 (RR 0.41, 95% CI 0.17 to 1.00, 1 study, 3098 participants). |
— | 4904 (3 RCTs) | ⊕⊝⊝⊝ Very lowa,c,d | Statistically significant heterogeneity was found, which may be explained partially by subgroup analyses per type of adverse event. We are uncertain about the effect of SDAC in addition to hospital treatments on incidence of adverse events. | |
| Incidence and severity of symptoms of poisoning: incidence of need for intubation | Patients that received gastric lavage prior to SDAC: intervention group: 80/1578 and control group: 87/1597 (RR 0.95, 95% CI 0.70 to 1.27, 2 studies, 3175 participants). Patients that did not receive gastric lavage prior to SDAC: intervention group: 24/194 and control group: 10/193 (RR 2.61, 95% CI 1.38 to 4.93, 1 study, 387 participants). |
— | 3562 (4 RCTs) | ⊕⊝⊝⊝ Very lowa,b,c | Statistically significant heterogeneity was found, which may be explained by subgroup analyses in patients receiving or not receiving gastric lavage. We are uncertain about the effect of SDAC on incidence of need for intubation. | |
| Duration of toxic symptoms: duration of intubation (h) |
Eddleston 2008: intervention group median (IQR): 112.0 (36.6 to 234.9) h and control group median (IQR): 88.5 (38.5 to 203.1) h (median difference: 23.5 h, P > 0.05). Merigian 2002: intervention group mean: 54.6 h and control group mean: 39.9 h (MD: 14.7 h, P = 0.70). |
— | (2 RCTs) | ⊕⊕⊝⊝ Lowa,e | Data were reported as median with IQR in one or means without measure of spread in another study, without information on participant numbers. SDAC in addition to hospital treatments may make little or no difference on the duration of intubation. |
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| Drug absorption: cardenolide: AUC (µg/L) × h Follow‐up: 1 days | The median (IQR) in intervention group was 17.7 (11.1 to 21.8) (µg/L) × h and in the control group 19.0 (13.7 to 24.3) (µg/L) × h (median difference: −1.3 h, P > 0.05) | — | 68 (1 RCT) | ⊕⊝⊝⊝ Very lowa,f,g | We are uncertain about the effect of SDAC in addition to hospital treatments on cardenolide absorption. | |
| Incidence of hospitalization | 125 per 1000 | 196 per 1000 (152 to 252) | RR 1.57 (1.22 to 2.02) | 1479 (1 RCT) | ⊕⊝⊝⊝ Very lowa,g,h | We are uncertain about the effect of SDAC in addition to hospital treatments on incidence of hospitalization. |
| Incidence of ICU admission | 30 per 1000 | 69 per 1000 (42 to 114) | RR 2.33 (1.42 to 3.82) | 1479 (1 RCT) | ⊕⊝⊝⊝ Very lowa,g,h | We are uncertain about the effect of SDAC in addition to hospital treatments on incidence of ICU admission. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; ICU: intensive care unit; IQR: interquartile range; RCT: randomized controlled trial; RR: risk ratio; SDAC: single‐dose activated charcoal; OR: odds ratio. | ||||||
| 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. | ||||||
aDowngraded one level for serious indirectness: study conducted in a hospital setting. bDowngraded one level for serious imprecision: low number of events and wide confidence intervals. cDowngraded one level for serious inconsistency: large and statistically significant heterogeneity present (I² > 60%, P < 0.10). dDowngraded one level for serious imprecision: wide confidence intervals. eDowngraded one level for serious imprecision: lack of data on the number of patients analysed. fDowngraded one level due to serious limitations in study design: high risk of other bias: it is not entirely clear what is measured with the assay used. The fact that both active cardenolides and (inactive) metabolites might be detected by the assay compromise the results of these analyses, as they might explain the wide variability observed. gDowngraded one level for serious imprecision: low number of events. hDowngraded one level for serious limitations in study design: high risk of selection bias.