Dopamine agents for hepatic encephalopathy

Anders Ellekær Junker; Bodil Als‐Nielsen; Christian Gluud; Lise Lotte Gluud

doi:10.1002/14651858.CD003047.pub3

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Figure 1

Figure 1. Study flow diagram.

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Figure 2

Figure 2. Risk of bias graph: review authors' judgements about all risk of bias items presented as percentages across all included studies.

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Figure 3

Trial sequential analysis of dopamine agents versus placebo or no intervention in participants with hepatic encephalopathy.

The outcome measure is mortality. The analysis was performed with an event rate of 54% (Pc) in the control group, a risk ratio (RR) reduction of 20%, alpha 5%, beta 20%, and diversity 0%. The cumulative Z‐curve does not cross the naive 5% statistical boundaries (dotted horizontal lines) or the trial sequential boundaries for benefits or harms (inward sloping etched lines). The results show that the diversity‐adjusted required information size was 673 participants, corresponding to 21% of the total sample size in the included trials. The programme did not even draw futility boundaries. Accordingly, the meta‐analysis does not recommend or refute an intervention effect; data are simply too few.

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Analysis 1.1

Comparison 1 Dopamine agonists versus placebo or no intervention, Outcome 1 Mortality.

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Analysis 1.2

Comparison 1 Dopamine agonists versus placebo or no intervention, Outcome 2 Mortality stratified by type of hepatic encephalopathy.

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Analysis 1.3

Comparison 1 Dopamine agonists versus placebo or no intervention, Outcome 3 Mortality stratified by liver disease.

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Analysis 1.4

Comparison 1 Dopamine agonists versus placebo or no intervention, Outcome 4 Mortality stratified by intervention.

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Analysis 1.5

Comparison 1 Dopamine agonists versus placebo or no intervention, Outcome 5 Mortality stratified by bias risk.

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Analysis 1.6

Comparison 1 Dopamine agonists versus placebo or no intervention, Outcome 6 Mortality stratified by trial design.

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Analysis 1.7

Comparison 1 Dopamine agonists versus placebo or no intervention, Outcome 7 Hepatic encephalopathy.

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Analysis 1.8

Comparison 1 Dopamine agonists versus placebo or no intervention, Outcome 8 Hepatic encephalopathy paired data.

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Analysis 1.9

Comparison 1 Dopamine agonists versus placebo or no intervention, Outcome 9 Adverse events paired data.

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Summary of findings for the main comparison. Dopamine agonists for hepatic encephalopathy

Dopamine agonists versus placebo or no intervention for hepatic encephalopathy
Patient or population: patients with hepatic encephalopathy. Settings: hospitalised patients. Intervention: dopamine agonists versus placebo or no intervention.
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control (placebo or no intervention)	Dopamine agonists
Mortality Follow‐up: mean one month	Study population		OR 1.11 (0.35 to 3.54)	144 (five studies)	⊕⊕⊝⊝ low^1,2,3
	535 per 1000	561 per 1000 (287 to 803)
	Moderate
	395 per 1000	420 per 1000 (186 to 698)
Hepatic encephalopathy Follow‐up: mean one month	Study population		OR 2.99 (0.09 to 100.55)	80 (two studies)	⊕⊕⊝⊝ low^1,2,3
	350 per 1000	617 per 1000 (46 to 982)
	Moderate
	184 per 1000	403 per 1000 (20 to 958)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; OR: Odds ratio.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹The randomisation methods were classed as adequate in two trials, and three trials were double‐blind. ²The sample size was small, and the statistical power of included trials was weak. ³Because of the small number of trials, tests for publication bias were of limited value.

Summary of findings for the main comparison. Dopamine agonists for hepatic encephalopathy

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Comparison 1. Dopamine agonists versus placebo or no intervention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	5	144	Odds Ratio (M‐H, Random, 95% CI)	1.11 [0.35, 3.54]

2 Mortality stratified by type of hepatic encephalopathy Show forest plot	5	144	Odds Ratio (M‐H, Random, 95% CI)	1.11 [0.35, 3.54]

2.1 Acute episode of hepatic encephalopathy	3	131	Odds Ratio (M‐H, Random, 95% CI)	1.28 [0.34, 4.83]
2.2 Chronic hepatic encephalopathy	2	13	Odds Ratio (M‐H, Random, 95% CI)	0.26 [0.01, 8.52]
3 Mortality stratified by liver disease Show forest plot	5	144	Odds Ratio (M‐H, Random, 95% CI)	1.11 [0.35, 3.54]

3.1 Fulminant liver failure	2	56	Odds Ratio (M‐H, Random, 95% CI)	1.04 [0.05, 22.17]
3.2 Cirrhosis	3	88	Odds Ratio (M‐H, Random, 95% CI)	1.30 [0.54, 3.15]
4 Mortality stratified by intervention Show forest plot	5	144	Odds Ratio (M‐H, Random, 95% CI)	1.11 [0.35, 3.54]

4.1 Levodopa	3	131	Odds Ratio (M‐H, Random, 95% CI)	1.28 [0.34, 4.83]
4.2 Bromocriptine	2	13	Odds Ratio (M‐H, Random, 95% CI)	0.26 [0.01, 8.52]
5 Mortality stratified by bias risk Show forest plot	5	144	Odds Ratio (M‐H, Fixed, 95% CI)	1.24 [0.59, 2.59]

5.1 Low bias risk	2	13	Odds Ratio (M‐H, Fixed, 95% CI)	0.26 [0.01, 8.52]
5.2 Unclear bias risk	3	131	Odds Ratio (M‐H, Fixed, 95% CI)	1.36 [0.63, 2.91]
6 Mortality stratified by trial design Show forest plot	5	144	Odds Ratio (M‐H, Random, 95% CI)	1.11 [0.35, 3.54]

6.1 Parallel group	3	131	Odds Ratio (M‐H, Random, 95% CI)	1.28 [0.34, 4.83]
6.2 Cross‐over	2	13	Odds Ratio (M‐H, Random, 95% CI)	0.26 [0.01, 8.52]
7 Hepatic encephalopathy Show forest plot	2	80	Odds Ratio (M‐H, Random, 95% CI)	2.99 [0.09, 100.55]

8 Hepatic encephalopathy paired data Show forest plot	3		Odds Ratio (Random, 95% CI)	0.68 [0.17, 2.67]

9 Adverse events paired data Show forest plot	2		OR (Random, 95% CI)	2.12 [‐0.99, 5.24]

Comparison 1. Dopamine agonists versus placebo or no intervention

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