Recent trial shows popular ICP drug is ineffective

A UK based randomised and controlled trial which tested the drug ursodeoxycholic acid (urso) against a placebo treatment for pregnant women suffering from ICP, has published it’s results, showing that the commonly prescribed urso is actually ineffective in treating the condition in most cases.

What is ICP?

Intrahepatic cholestasis of pregnancy (ICP), also known as obstetric cholestasis (OC) is the most common pregnancy-specific liver disease in the UK, affecting around 5,500 women a year. Although ICP is not generally harmful for the mother-to-be it is associated with fetal distress in labour, premature labour (spontaneous and induced) and stillbirth. The most common symptom of ICP is itching. Many women do itch in pregnancy, but the itch in ICP is typically noticed on the hands, feet, arms and legs, although it can also be generalised.

Other symptoms of the condition can include:

-Dark urine
-Pale stools
-Jaundice (although this is not common)

What were the conclusions from the trial?

This trial is five times larger than the largest previous trial and nearly three times larger than all previous trials combined. Women were managed in a high-income health-care setting, with free access to care and regular surveillance (including repeated bile acid measurements), such that the trial is likely to represent current management of this condition.

Treatment with ursodeoxycholic acid does not reduce adverse perinatal outcomes in women with ICP, although there is still some speculation by researchers that it may help some women who have very severe ICP (bile acids >100 µmol/L). Further research on this is needed. With this in mind, urso’s routine use for this condition should be reconsidered and research into more effective treatments is needed.

Although ursodeoxycholic acid appeared to be safe, it had no clinically meaningful effect on maternal itch symptoms. It did not reduce maternal bile acid concentrations, and the reduction in alanine transaminase was of uncertain clinical significance, given that alanine transaminase is not known to be associated with the risk of stillbirth or preterm labour in ICP.

Jenny, the Founder and CEO of ICP Support says:

“It’s disappointing news but we needed to have these answers so that women with ICP aren’t being falsely reassured by taking urso. It also means that as a charity, we can now use our energies in supporting researchers to find a new drug that will reduce or eliminate the itch in ICP, and that will also better protect those unborn babies whose mothers have very severe ICP” 

Where can I find more information?

There is more information about ICP and other pregnancy conditions on the MAMA website, where you can also purchase a Wellbeing Wallet to remind yourself of important symptoms to look out for during pregnancy and when you should contact your health provider or midwife immediately. With many thanks to our friends from ICP Support, our website has been fully updated to reflect the new research. We highly recommend that you get in touch with them if you have been affected by / are worried about ICP. Click here to see the full research paper.