Favoured Liver Disease Treatment Not Necessarily Better Than Placebo
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Favoured Liver Disease Treatment Not Necessarily Better Than Placebo

LONDON, UK -- September 24, 1999 -- Ursodeoxycholic acid (UDCA) is the only approved treatment for primary biliary cirrhosis (a liver disease), but its effect on disease progression and survival is uncertain. In the week’s The Lancet, Dr. John Goulis and colleagues from the Royal Free Hospital, UK, report on the efficacy of UDCA in primary biliary cirrhosis.

A systematic review was done for all the trials that compared UDCA with a placebo drug. Trial data were gathered from the two major databases of medical literature, Medline and Embase. Manual searches found review articles and abstracts published for major international medical meetings. The researchers identified 17 relevant articles. UDCA had a favourable effect on liver biochemistry in most of the studies but not on symptoms of primary biliary cirrhosis or progression of the disease; two studies did not assess survival, liver transplantation or complications of liver disease.

Although a meta-analysis cannot replace the value of a large-scale, randomised, controlled trial to establish evidence for therapeutic efficacy, these analyses are nonetheless useful when individual studies may be limited by small sample sizes.

John Goulis and colleagues found that the published randomised, controlled trials do not show evidence of therapeutic benefit of UDCA in primary biliary cirrhosis and they suggest that its use as a standard therapy needs to be re-examined. The researchers add: "UDCA is not a gold standard-though it may be a useful placebo, because it does no harm. We still need a sufficiently large multicentre or multinational, randomised, placebo-controlled study to assess the effect of UDCA on clinically meaningful endpoints in primary biliary cirrhosis."

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