Liver transplantation has become a widely accepted form of treatment for numerous end-stage liver diseases.
Bile acids may decrease the degree of allograft rejection after liver transplantation.
This may occur by changing the expression of major histocompatibility complex class molecules in bile duct epithelium and central vein endothelium.
Dr Chen Gluud and colleagues assessed the beneficial and harmful effects of bile acids for liver-transplanted patients.
The research team performed searches of the Cochrane Hepato-Biliary Group Trials Register, CENTRAL, MEDLINE, and EMBASE to 2003.
The team also searched The Chinese Biomedical Database to 2002.
The researchers included all randomized clinical trials comparing any dose of bile acids or duration of treatment in liver-transplanted patients versus placebo.
Randomized clinical trials that compared bile treatment but had no intervention, or another intervention were also included.
The team included randomized clinical trials irrespective of blinding, language, and publication status.
|6 out of 7 randomized trials identified evaluated ursodeoxycholic acid vs placebo|
|The Cochrane Database of Systematic Reviews|
The researchers independently extracted and validated the data.
The methodological quality of the trials was evaluated from the method for generation of the allocation sequence, and allocation concealment.
The team also considered double blinding, and follow-up as part of the methodological quality assessment.
The team used intention-to-treat principle to perform meta-analyses.
The outcomes were presented as relative risk or weighted mean difference, both with 95% confidence intervals.
The research team identified 7 randomised trials, of which 6 evaluated ursodeoxycholic acid versus placebo or no intervention.
A further 1 of these trials evaluated tauro-ursodeoxycholic acid versus no intervention with a total of 335 liver-transplanted patients.
The team noted that the administration of bile acids began 1 day or more after liver transplantation.
All patients received the standard triple-drug immunosuppressive regimen of steroids, azathioprine, and cyclosporine or tacrolimus.
The triple-drug regimen was used to suppress the allograft rejection response after liver transplantation.
The team found that bile acids did not significantly reduce all-cause mortality, or mortality related to allograft rejection.
In addition, the team found that bile acids did not reduce retransplantation, acute cellular rejection, or number of patients with steroid-resistant rejection.
Bile acids significantly reduced the number of patients who had chronic rejection in a fixed-effect model but not in a random-effects model.
The researchers noted that bile acids were safe and well tolerated by liver-transplanted patients.
Dr Gluud's team concludes, “Bile acids do not seem to have significant beneficial effects in liver-transplanted patients.”