Dopaminergic agonists for hepatic encephalopathy

Bodil Als‐Nielsen; Lise Lotte Gluud; Christian Gluud

doi:10.1002/14651858.CD003047.pub2

Dopaminergic agonists for hepatic encephalopathy

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Referencias

References to studies included in this review

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estudios excluidos
otras referencias

Koshy A, Pratap B, Datta DV. Prospective randomised controlled trial of L‐dopa and hydrocortisone in fulminant hepatitis. The Journal of the Association of Physicians of India 1982;30(9):613‐4. [MEDLINE: 7184928]

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References to studies excluded from this review

Ir a:

estudios incluidos
otras referencias

Burroughs AK, Morgan MY, Sherlock S. Double‐blind controlled trial of bromocriptine, chlordiazepoxide and chlormethiazole for alcohol withdrawal symptoms. Alcohol & Alcoholism 1985;20:263‐71. [MEDLINE: PMID: 3902038]

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Lunzer M, James IM, Weinman J, Sherlock S. Treatment of chronic hepatic encephalopathy with levodopa. Gut 1974;15(7):555‐61. [MEDLINE: 4430473]

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Additional references

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estudios incluidos
estudios excluidos

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Kjaergard LL, Villumsen J, Gluud C. Reported methodological quality and discrepancies between small and large randomized trials in meta‐analyses. Ann Intern Med 2001;135(11):982‐989.

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Koshy 1982

Methods	Parallel group trial. Generation of the allocation sequence: unclear. Allocation concealment: unclear. Blinding: not performed. Follow‐up: unclear. Intention to treat analyses: unclear. Sample size estimation: no.
Participants	40 patients with fulminant hepatic failure were randomised. Mean age: not reported. Aetiology of fulminant hepatic failure: viral hepatitis 100%. Proportion of men: not reported.
Interventions	Experimental: levodopa 4 gram/day + standard HE regime. Control: standard HE regime (including neomycin). Treatment duration: not reported.
Outcomes	Mortality.
Notes	Number of dropouts: uncertain. Health economics: not assessed.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Michel 1980

Methods	Parallel group trial. Generation of the allocation sequence: unclear. Allocation concealment: unclear. Blinding: adequate, double blinded using placebo. Follow‐up: unclear. Intention to treat analyses: unclear. Sample size estimation: no.
Participants	75 patients with cirrhosis and acute hepatic encephalopathy were randomised. Mean age: 57 years. Aetiology of cirrhosis: alcohol 80%, viral hepatitis 15%, cryptogenic 5%. Proportion of men: 80%
Interventions	Experimental 1: levodopa (2 gram on day 1, 4 gram/day the next 6 days). Experimental 2: levodopa (as above) + dopa‐decarboxylase inhibitor (0.2 gram on day 1, 0.4 gram the next 6 days). Control: placebo. Additional therapy: all patients received enemas and magnesium sulfate. Treatment duration: 7 days.
Outcomes	Clinical improvement. Mortality. Electroencephalogram.
Notes	Number of dropouts: uncertain. Health economics: not assessed.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Morgan 1980

Methods	Crossover trial. Generation of the allocation sequence: adequate using a computer‐generated random sequence. Allocation concealment: adequate, controlled by hospital pharmacy. Blinding: adequate, double blinded using placebo. Follow‐up: adequate. Intention to treat analyses: adequate. Sample size estimation: no.
Participants	Five patients with cirrhosis and chronic hepatic encephalopathy were randomised. Mean age: 51 years. Aetiology of cirrhosis: alcohol 60%, cryptogenic 40%. Proportion of men: 100%
Interventions	Experimental: bromocriptine 15 mg/day. Control: placebo (lactose). Additional therapy: all patients received 40 ml lactulose/day. Treatment duration: 8 weeks in each period with no washout period.
Outcomes	Clinical improvement. Adverse events.
Notes	Number of dropouts: 0. Health economics: not assessed.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Uribe 1979

Methods	Crossover trial. Generation of the allocation sequence: adequate using a random numbers table. Allocation concealment: unclear. Blinding: adequate, double blinded using placebo + statistician was blinded. Follow‐up: adequate. Intention to treat analyses: inadequate. Sample size estimation: no.
Participants	Eight patients with cirrhosis and chronic hepatic encephalopathy were randomised. Age: ranged from 45‐78 years. Aetiology of cirrhosis: alcohol 63%, viral hepatitis 37%. Proportion of men: 63%
Interventions	Experimental: bromocriptine 15 mg/day. Control: placebo (glucose). Additional therapy: none. Treatment duration: 2 weeks in each period, 10 days washout period before trial start and between the two periods.
Outcomes	Clinical improvement. Number connection test. Asterixis. Arterial ammonia. Adverse events.
Notes	Number of dropouts: 1 patient died in the first treatment period while receiving placebo. Health economics: not assessed.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Vij 1979

Methods	Parallel group trial. Generation of the allocation sequence: unclear. Allocation concealment: unclear. Blinding: not performed. Follow‐up: unclear. Intention to treat analyses: unclear. Sample size estimation: no.
Participants	16 patients with fulminant hepatic failure were randomised. Mean age: 32 years. Aetiology of fulminant hepatic failure: viral hepatitis 100%. Proportion of men: not reported.
Interventions	Experimental: levodopa 3‐4 gram/day + supportive therapy. Control: supportive therapy (included 6 gram ampicillin, 2 bowel washes, vitamins, lactobacilli acidophilus, infusion of electrolytes). Treatment duration: not reported.
Outcomes	Mortality.
Notes	Number of dropouts: uncertain. Health economics: not assessed.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos

Study	Reason for exclusion
Burroughs 1985	Randomised trial assessing the effect of bromocriptine for alcohol withdrawal symptoms. Excluded because patients did not have hepatic encephalopathy at entry and this was not assessed as an outcome.
Catalano 1982	Controlled crossover study including five patients with chronic hepatic encephalopathy comparing bromocriptine + lactulose, levodopabenserazide + lactulose, and lactulose during five treatment periods. Excluded because the study does not appear to be randomised. We have contacted the authors, but have not obtained a response yet. We urge anyone with knowledge about the design of this study to contact us with information on the design.
Datta 1976	Observational study on four patients with fulminant hepatic failure given L‐dopa. Excluded due to lack of randomisation.
Jorge 1973	Observational study on three patients with hepatic encephalopathy given levodopa. Excluded due to lack of randomisation.
Lunzer 1974	Controlled crossover study including three patients with chronic hepatic encephalopathy comparing levodopa with placebo. Excluded because the study does not appear to be randomised. We have contacted the authors, but have not obtained a response yet. We urge anyone with knowledge about the design of this study to contact us with information on the design.
Messner 1982	Randomised crossover trial including 11 patients with chronic hepatic encephalopathy comparing bromocriptine with lactulose. Excluded because the control group received lactulose.
Pascual 1979	Controlled crossover study including seven patients with chronic hepatic encephalopathy comparing bromocriptine with placebo. Excluded because the study does not appear to be randomised. We have contacted the authors, but have not obtained a response yet. We urge anyone with knowledge about the design of this study to contact us with information on the design.
Trovato 1982	Controlled crossover study including ten patients with chronic hepatic encephalopathy comparing amantadine + lactulose, levodopabenserazide + lactulose, and lactulose during six treatment periods. Excluded because the study does not appear to be randomised. We have contacted the authors, but have not obtained a response yet. We urge anyone with knowledge about the design of this study to contact us with information on the design.
Ubiria 1980	Controlled crossover study including six patients with chronic hepatic encephalopathy comparing bromocriptine with placebo during four treatment periods. Excluded due to lack of randomisation.
Uribe 1982	Randomised trial assessing the effect of metoclopramide, a dopamine‐antagonist, in four patients with cirrhosis and hepatic encephalopathy. Excluded because the experimental group did not receive a dopamine agonist.
Uribe 1983	Randomised crossover trial including four patients with chronic hepatic encephalopathy comparing bromocriptine with neomycin. Excluded because the control group received antibiotics.
Uribe 1984	Narrative review.

Data and analyses

Open in table viewer

Comparison 1. Dopaminergic agonists versus placebo for hepatic encephalopathy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of patients without improvement ‐ including data from 1. treatment period in crossover trials Show forest plot	2	80	Odds Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 11.25]
Open in figure viewer Analysis 1.1 Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 1 Number of patients without improvement ‐ including data from 1. treatment period in crossover trials.
1.1 Levodopa for acute hepatic encephalopathy ‐ parallel trial	1	75	Odds Ratio (M‐H, Random, 95% CI)	1.22 [0.47, 3.15]
1.2 Bromocriptine for chronic hepatic encephalopathy ‐ first treatment period result	1	5	Odds Ratio (M‐H, Random, 95% CI)	0.03 [0.00, 1.99]
2 Number of patients without improvement ‐ including paired data from crossover trials Show forest plot	3		OR (Random, 95% CI)	0.68 [0.17, 2.67]
Open in figure viewer Analysis 1.2 Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 2 Number of patients without improvement ‐ including paired data from crossover trials.
2.1 Levodopa for acute hepatic encephalopathy ‐ parallel trial	1		OR (Random, 95% CI)	1.07 [0.77, 1.49]
2.2 Bromocriptine for chronic hepatic encephalopathy ‐ result from paired data	2		OR (Random, 95% CI)	0.15 [0.00, 6.44]
3 Mortality Show forest plot	4	139	Odds Ratio (M‐H, Random, 95% CI)	1.11 [0.35, 3.54]
Open in figure viewer Analysis 1.3 Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 3 Mortality.
3.1 Levodopa for acute hepatic encephalopathy	1	75	Odds Ratio (M‐H, Random, 95% CI)	1.45 [0.58, 3.63]
3.2 Bromocriptine for chronic hepatic encephalopathy	1	8	Odds Ratio (M‐H, Random, 95% CI)	0.26 [0.01, 8.52]
3.3 Levodopa for fulminant hepatic failure	2	56	Odds Ratio (M‐H, Random, 95% CI)	1.04 [0.05, 22.17]
4 Adverse events Show forest plot	2		OR (Random, 95% CI)	8.33 [0.37, 187.74]
Open in figure viewer Analysis 1.4 Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 4 Adverse events.
5 Sensitivity analysis ‐ methodological quality, number of patients without improvement Show forest plot	3		OR (Random, 95% CI)	0.68 [0.17, 2.67]
Open in figure viewer Analysis 1.5 Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 5 Sensitivity analysis ‐ methodological quality, number of patients without improvement.
5.1 High quality	1		OR (Random, 95% CI)	0.01 [0.00, 2.11]
5.2 Low quality	2		OR (Random, 95% CI)	1.05 [0.76, 1.46]

Figure 1

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Analysis 1.1

Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 1 Number of patients without improvement ‐ including data from 1. treatment period in crossover trials.

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Analysis 1.2

Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 2 Number of patients without improvement ‐ including paired data from crossover trials.

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Analysis 1.3

Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 3 Mortality.

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Analysis 1.4

Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 4 Adverse events.

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Analysis 1.5

Comparison 1 Dopaminergic agonists versus placebo for hepatic encephalopathy, Outcome 5 Sensitivity analysis ‐ methodological quality, number of patients without improvement.

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Comparison 1. Dopaminergic agonists versus placebo for hepatic encephalopathy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of patients without improvement ‐ including data from 1. treatment period in crossover trials Show forest plot	2	80	Odds Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 11.25]

1.1 Levodopa for acute hepatic encephalopathy ‐ parallel trial	1	75	Odds Ratio (M‐H, Random, 95% CI)	1.22 [0.47, 3.15]
1.2 Bromocriptine for chronic hepatic encephalopathy ‐ first treatment period result	1	5	Odds Ratio (M‐H, Random, 95% CI)	0.03 [0.00, 1.99]
2 Number of patients without improvement ‐ including paired data from crossover trials Show forest plot	3		OR (Random, 95% CI)	0.68 [0.17, 2.67]

2.1 Levodopa for acute hepatic encephalopathy ‐ parallel trial	1		OR (Random, 95% CI)	1.07 [0.77, 1.49]
2.2 Bromocriptine for chronic hepatic encephalopathy ‐ result from paired data	2		OR (Random, 95% CI)	0.15 [0.00, 6.44]
3 Mortality Show forest plot	4	139	Odds Ratio (M‐H, Random, 95% CI)	1.11 [0.35, 3.54]

3.1 Levodopa for acute hepatic encephalopathy	1	75	Odds Ratio (M‐H, Random, 95% CI)	1.45 [0.58, 3.63]
3.2 Bromocriptine for chronic hepatic encephalopathy	1	8	Odds Ratio (M‐H, Random, 95% CI)	0.26 [0.01, 8.52]
3.3 Levodopa for fulminant hepatic failure	2	56	Odds Ratio (M‐H, Random, 95% CI)	1.04 [0.05, 22.17]
4 Adverse events Show forest plot	2		OR (Random, 95% CI)	8.33 [0.37, 187.74]

5 Sensitivity analysis ‐ methodological quality, number of patients without improvement Show forest plot	3		OR (Random, 95% CI)	0.68 [0.17, 2.67]

5.1 High quality	1		OR (Random, 95% CI)	0.01 [0.00, 2.11]
5.2 Low quality	2		OR (Random, 95% CI)	1.05 [0.76, 1.46]

Comparison 1. Dopaminergic agonists versus placebo for hepatic encephalopathy

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Referencias

References to studies included in this review

Koshy 1982 {published data only}

Michel 1980 {published data only}

Morgan 1980 {published data only}

Uribe 1979 {published data only}

Vij 1979 {published data only}

References to studies excluded from this review

Burroughs 1985 {published data only}

Catalano 1982 {published data only}

Datta 1976 {published data only}

Jorge 1973 {published data only}

Lunzer 1974 {published data only}

Messner 1982 {published data only}

Pascual 1979 {published data only}

Trovato 1982 {published data only}

Ubiria 1980 {published data only}

Uribe 1982 {published data only}

Uribe 1983 {published data only}

Uribe 1984 {published data only}

Additional references

Als‐Nielsen 2001

Als‐Nielsen 2003

Als‐Nielsen 2004a

Als‐Nielsen 2004b

Als‐Nielsen 2004c

Altman 2003

Basile 1991

Becker 1993

Bernuau 1999

Blei 1999

Conn 1977

Conn 1979

Cordoba 2001

DerSimonian 1986

Elbourne 2002

Ferenci 2002

Fischer 1971

Fischer 1984

Gitlin 1996

Gluud 2004

Haussinger 2000

Higgins 2003

Hollis 1999

ICH‐GCP 1997

Ioannidis 2003

Jadad 1996

Jover 2003

Kjaergard 2001

Lizardi‐Cervera 2003

Miyasaki 2002

Moher 1998

Parkes 1970

Rose 1999

Schulz 1995

Spahr 2000

Streiner 1995

Wood 2003

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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