Table 159Summary included studies

StudyIntervention/ComparisonPopulationOutcomesComments
Cochrane systematic reviews

Cochrane systematic review
Comparison: UDCA vs placebo
(, , )
People with CF diagnosed by sweat test and clinical symptoms.
  • Lack of normalisation of liver enzymes (ALT, AST and GGT)
Primary studies included in the SR

(Italy)
RCT
UDCA
  • 6 months
  • at a daily dose of 1 to 3 300 mg capsules
Placebo
N=55 children, young people and adults with CF and chronic liver disease with persistent alterations of serum liver enzymes. Median age (range): 13.8 years (4 to 22 years)
  • Percentage change in hepatocellular enzymes: ALT, AST and GGT.
  • Liver failure
  • Liver transplantation

(Italy)
Cross-over trial
UDCA
  • dose of 12 mg/kg per day
Placebo
N=51 children, young people and adults with CF.
Median age (range): 14 years (8 to 32)
Participants with CFRLD and no CFRLD included.
  • Change in hepatocellular enzymes (AST, ALT, GGT)
  • No development of liver disease

(Ireland)
RCT
UDCA
  • 20 mg/kg per day
No treatment
N=12 children, young people and adults with CF and liver disease based on hepatomegaly and/or splenomegaly.
Median age (range): 17 (12 to 20) in the intervention group; 17.5 (14 to 25 in the control group)
  • Change in hepatocellular enzymes (AST, ALT, GGT)
  • Final bilirubin value

ALT: alanine aminotransferase; AST: aspartate aminotransferase; CF: cystic fibrosis; GGT, gammaglutamyl transferase; mg/kg: milligrams per kilogram; OR: odds ratio; SR: systematic review; UDCA: ursodeoxycholic acid

From: 10, Other monitoring, assessment and management

Cover of Cystic Fibrosis
Cystic Fibrosis: Diagnosis and management.
NICE Guideline, No. 78.
National Guideline Alliance (UK).
Copyright © NICE 2017.

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