Reflections on therapeutic trials in primary biliary cirrhosis: A quality of life oriented counter-view

Jones, David; Bhala, Neeraj; Newton, Julia L.

doi:10.1002/hep.21104

Cited by 8 publications

(1 citation statement)

References 6 publications

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“…In view of the very slowly progressive course of PBC in most instances, as also previously shown in a study analysing the transition from PBC stages I and II to stages III and IV (27), difficulties arise for any prognostic study to await the hard endpoints of the disease as mortality or liver transplantation and to obtain a sufficient number of patients, allowing clear‐cut answers in this matter. Furthermore, the striking variability of the clinical course, probably being an indicator of the heterogeneous nature of PBC, also explains why long‐term mortality oriented trials are still missing and obviously difficult to conduct (28, 29).…”

Section: Discussionmentioning

confidence: 99%

Demonstration of PDC‐E1 subunits as major antigens in the complement‐fixing fraction M4 and re‐evaluation of PDC‐E1‐specific antibodies in PBC patients

Berg¹,

Stein²,

Klein

et al. 2006

Liver International

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Section: Discussionmentioning

confidence: 99%

Demonstration of PDC‐E1 subunits as major antigens in the complement‐fixing fraction M4 and re‐evaluation of PDC‐E1‐specific antibodies in PBC patients

Berg¹,

Stein²,

Klein

et al. 2006

Liver International

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Methotrexate for primary biliary cirrhosis

Giljača

Poropat

Stimac

et al. 2010

Cochrane Database of Systematic Reviews

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Pharmacological interventions for primary biliary cholangitis

Saffioti

Gurusamy

Eusebi

et al. 2017

Cochrane Database of Systematic Reviews

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Based on very low quality evidence, there is currently no evidence that any intervention is beneficial for primary biliary cholangitis. However, the follow-up periods in the trials were short and there is significant uncertainty in this issue. Further well-designed randomised clinical trials are necessary. Future randomised clinical trials ought to be adequately powered; performed in people who are generally seen in the clinic rather than in highly selected participants; employ blinding; avoid post-randomisation dropouts or planned cross-overs; should have sufficient follow-up period (e.g. five or 10 years or more); and use clinically important outcomes such as mortality, health-related quality of life, cirrhosis, decompensated cirrhosis, and liver transplantation. Alternatively, very large groups of participants should be randomised to facilitate shorter trial duration.

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Reflections on therapeutic trials in primary biliary cirrhosis: A quality of life oriented counter-view

Cited by 8 publications

References 6 publications

Demonstration of PDC‐E1 subunits as major antigens in the complement‐fixing fraction M4 and re‐evaluation of PDC‐E1‐specific antibodies in PBC patients

Demonstration of PDC‐E1 subunits as major antigens in the complement‐fixing fraction M4 and re‐evaluation of PDC‐E1‐specific antibodies in PBC patients

Methotrexate for primary biliary cirrhosis

Pharmacological interventions for primary biliary cholangitis

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