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ALCOHOLIC LIVER DISEASE BENEFITS FROM PTU

Clinical Bottom Line:
  1. Propylthiouracil(PTU)appears to be effective in reducing the longterm mortality of alcoholic liver disease by 50%. The group with prolonged prothrombin time and significant anemia achieves the greatest benefit.
  2. In patients with severe acute alcoholic hepatitis, PTU shows no benefit in short-term (6 week) mortality.
  3. PTU administered in low doses of 300 mg daily is well tolerated over a 2 year period.
Appraised by: ME Farkouh, March 11th 1993

The Study:

  1. RCT of 310 patients with a variety of alcoholic liver disease. Subjects received either PTU 300 mg daily or placebo for a maximum of 2 years.
  2. RCT: PTU 300 mg/day versus placebo in patients with alcoholic liver disease treated for a max. 46 d.
  3. 6 week RCT of PTU 300 mg daily versus placebo in patients with severe alcoholic hepatitis.

* 13 studies with 659 patients * therapeutic effect weighted by sample size * effect seen only in small trials, not in large trials * poorer prognosis with encephalopathy and high bilirubin

The Evidence:
Outcomes: for long-term therapy (2 years)
Group Studied & Endpt.PTU DeathsPlacebo DeathsARRRRRNNT
Combined ALD (1)0.130.250.120.488.3
ALD (1) -PT>3s, Hb <900.280.620.340.552.9
AH (1)0.0780.190.110.588.9
Outcomes for short-term therapy (6 weeks)
Group StudiedPTU DeathsPlacebo DeathsARRRRRNNT
Combined ALD (2)0.063
(4/63)		0.086
(6/70)		0.023
NS		0.02743
Severe AH (3)0.23
(7/31)		0.62
(7/36)		-0.04
NS		-0.21-25

Abbreviations: ALD= Alcoholic Liver Disease, AH= Alcoholic Hepatitis

Comments:

  1. Longterm therapy with PTU in alcoholic liver disease needs further evaluation in a large trial.
  2. No role for PTU in severe acute alcoholic hepatitis is well established.
  3. There was a significant drop-out rate in both arms - 14%(25/182) in the treatment group and 14%(25/178) in the placebo group. The outcomes in these patients are important in drawing any definitive conclusions as to the use of PTU in this population.

References:

  1. Orrego H, Blake JE, Blendis LM, et al. Long-term treatment of alcoholic liver disease with propylthiouracil. N Engl J Med 1987;317:1421-7.
  2. Orrego H, Kalant H, Israel Y, et al. Effect of short-term therapy with propylthiouracil in patients with alcoholic liver disease. Gastroenterology 1979;76:105-15.
  3. Orrego H, Kalant H, Israel Y, et al. Effect of short-term therapy with propylthiouracil in patients with alcoholic liver disease. Gastroenterology 1979;76:105-15.

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