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. 2011 Jun 15;2011(6):CD002800. doi: 10.1002/14651858.CD002800.pub3

Hallé 1982.

Methods Randomised clinical trial.
Participants Sixty‐seven patients with severe alcoholic hepatitis. Thirty‐one patients (29 males and two females, mean age 40 ± 2 years (y)) received PTU, while 36 patients (32 males and four females, mean age 38.9 ± 1 y) received placebo.
Inclusion criteria: heavy ethanol ingestion and clinical diagnosis of ALD. All had serum bilirubin > 5 mg/dl and at least one of the following: hepatic tenderness, fever above 100 degrees Fahrenheit, or leukocytosis above 12,000 per mm3.
Exclusion criteria: serious bacterial infection, massive gastrointestinal bleeding, preexisting renal failure, and previous or current thyroid disease.
Interventions Experimental group: 
 PTU 75 mg orally every six hours.
Control group: 
 placebo.
Duration of the treatment: six weeks.
Duration of follow‐up: eight weeks.
Outcomes All‐cause mortality. 
 Complications. 
 Biochemistry. 
 Liver histology. 
 Adverse events.
Notes Sent letter in 2001. 
 Dr. Reynolds answered, but no additional data were obtained.
Seventy‐one patients were randomised, but two patients refused participation and two patients were withdrawn as s‐bilirubin was < 5 mg/dl at randomisation.
Risk of bias
Bias Authors' judgement Support for judgement
Blinding (performance bias and detection bias) 
 All outcomes Low risk Comment: double blind with placebo of identical presentation.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The post‐randomisation drop‐outs unlikely to result in a change in the effect estimate.
Selective reporting (reporting bias) Low risk All the important outcomes were reported.
Free of academic bias Low risk Comment: No previous trial of the same comparison by the same authors was identified.