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Sirs, The recent study by Imam MH et al.[1] reviewed patients previously enrolled in a study that evaluated high ursodeoxycholic acid (UDCA) dose (28–30 mg/kg) in primary sclerosing cholangitis (PSC). UDCA given in earlier histological stages and/or with higher bilirubin values was associated with worse outcomes. The issue of giving UDCA and outcomes in early histological stages is very interesting, and needs attention, as we have discussed in our recent meta-analysis.[2]

However, the conclusions of the effects of high-dose UDCA[1] should be interpreted with caution. Firstly the study is retrospective, secondly no second biopsies were performed, so data regarding histological progression are not available, and lastly serum IgG4 concentrations were not evaluated. In addition, certain important groups of patients were excluded; those with previous intraductal stones, or interventions on the biliary tree (excluding cholecystectomy), such as biliary drainage preceding the diagnosis of PSC, or recurrent cholangitis requiring hospitalisation occurring more than twice per year.

The mechanism or associated factors that could explain why high UDCA doses (28–30 mg/kg) were harmful in early stages is not known. Unfortunately our meta-analysis[2] did not allow confirmatory evidence to be established, as randomised trials that evaluated standard UDCA doses, did not give specific data, according to baseline histological stage of PSC.

Taking into consideration that a long duration of lower dose UDCA trial in PSC has found no adverse events,[3] and that recent data suggest a possible protective role of lower UDCA doses against colorectal carcinoma[4] in PSC, there may still be a role for UDCA, but a large multicentre trial from different geographical regions is needed.[2] Lastly, as many PSC patients worldwide have taken high-dose UDCA, we suggest that a register be set up to establish if unfavourable outcomes are confirmed. Although this would be retrospective, survival analysis would be robust. Such a register may be the only way to provide data to validate the findings by Imam et al.[1]

Acknowledgements

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  2. Acknowledgements
  3. References

Declaration of personal interests: Dr CK Triantos has served as a speaker for Gilead. Declaration of funding interests: None.

References

  1. Top of page
  2. Acknowledgements
  3. References