Glucocorticoid with cyclophosphamide for oral paraquat poisoning

Luying Ryan Li; Bhuwan Chaudhary; Chao You; Jane A Dennis; Helen Wakeford

doi:10.1002/14651858.CD008084.pub5

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Figure 1

Study flow diagram for 2021 update

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Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies

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Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study

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Figure 4

Forest plot of comparison: 1 All‐cause mortality, outcome: 1.1 All‐cause mortality

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Figure 5

Forest plot of comparison: 1.2 Sensitivity analysis: all‐cause mortality at final follow‐up: including fulminant (and excluding Afzali 2008 due to risk of selection bias)

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Figure 6

Forest plot of comparison: 1 All‐cause mortality, outcome: 1.3 Sensitivity analysis: all‐cause mortality: excluding studies without plasma paraquat assessment at baseline

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Analysis 1.1

Comparison 1: All‐cause mortality, Outcome 1: All‐cause mortality

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Analysis 1.2

Comparison 1: All‐cause mortality, Outcome 2: Sensitivity analysis: all‐cause mortality re‐including fulminant participants

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Analysis 1.3

Comparison 1: All‐cause mortality, Outcome 3: Sensitivity analysis: all‐cause mortality: excluding studies without plasma paraquat assessment at baseline

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Summary of findings 1. Glucocorticoid with cyclophosphamide plus usual care compared to usual care (with or without placebo) for oral paraquat poisoning

Outcomes	№ of participants (studies)	Certainty of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
Glucocorticoid with cyclophosphamide plus usual care compared to usual care, with or without placebo, for oral paraquat poisoning
Patient or population: people with moderate to severe oral paraquat poisoning Setting: hospital Intervention: glucocorticoid(s) with cyclophosphamide plus usual care Comparison: usual care (with or without placebo)
Outcomes	№ of participants (studies)	Certainty of the evidence (GRADE)	Relative effect (95% CI)	Risk with standard care	Risk with glucocorticoid plus cyclophosphamide
Mortality at 30 days following the ingestion of paraquat	No included studies reported this outcome.
All‐cause mortality at final follow‐up: at hospital discharge	322 (2 RCTs)	⊕⊕⊝⊝ LOW ¹	(RR 0.82, 95% CI 0.68 to 0.99) (results of a sensitivity analysis)	63 per 100	52 per 100 (43 to 62)
All‐cause mortality at final follow‐up: 3 months	293 (1 RCT)	⊕⊕⊝⊝ LOW ^2,3	RR 0.98 (0.85 to 1.13)	72 per 100	71 per 100 (61 to 81)
New infection within 1 week after initiation of treatment Assessed through clinical diagnosis	0 (0 RCTs)	⊕⊝⊝⊝ VERY LOW ⁴	No clinical infections were diagnosed within 1 week after initiation of methylprednisolone and cyclophosphamide in the included studies. Lin 1999 reported the related outcome of leukopenia in 8 of 22 participants (36.4%) in the intervention arm. These participants spontaneously recovered 1 week later, with no mortality. Lin 2006 reported leukopenia in 6 of 16 participants (37.4%) in the intervention arm, all of whom recovered within 1 to 2 weeks. Neither Gawarammana 2017, the largest included study, nor Afzali 2008, measured infection or leukopenia.
*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; RCT: randomised controlled trial; RR: risk 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.
¹The sample size fell short of the required information size (439 participants required in each arm of the study), therefore we downgraded one level for imprecision, and a further level because of the high heterogeneity (I² = 77%). ²We downgraded one level for imprecision, as the sample fell short of the required information size (as above). ³We downgraded once for indirectness: we consider that the reasons for participant mortality whilst being treated after self‐poisoning in hospital may differ substantially from the reasons for participant mortality at longer‐term follow‐up, in the absence of any other information on cause of death. ⁴The largest RCT, Gawarammana 2017, did not assess infection as an outcome, therefore this outcome was assessed by only two small trials. We therefore downgraded twice for serious imprecision, and once for indirectness (i.e. the outcome of leukopenia is a precursor of, but not identical to, infection).

Summary of findings 1. Glucocorticoid with cyclophosphamide plus usual care compared to usual care (with or without placebo) for oral paraquat poisoning

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Comparison 1. All‐cause mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 All‐cause mortality Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1.1 Mortality at hospital discharge	4	392	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.61, 0.88]
1.1.2 Mortality at 3 months	1	293	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.85, 1.13]
1.2 Sensitivity analysis: all‐cause mortality re‐including fulminant participants Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.2.1 Mortality at hospital discharge	4	463	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.69, 0.93]
1.3 Sensitivity analysis: all‐cause mortality: excluding studies without plasma paraquat assessment at baseline Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.3.1 Mortality at hospital discharge	2	322	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.68, 0.99]

Comparison 1. All‐cause mortality

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