Orrego 1979.

Methods	Randomised clinical trial.
Participants	A total of 143 patients (69 in the PTU and 74 in placebo group) were included in the trial. Inclusion criteria: excessive drinking, and well‐documented history of spree‐drinking. The criteria for diagnosing liver disease required one or more of the following clinical findings: hepatomegaly, tender liver, jaundice, ascites, collateral circulation, spider nevi, and splenomegaly. Further, at least two of the following abnormal laboratory tests were required: s‐aspartate aminotransferase, s‐alanine aminotransferase, s‐gamma glutamyltranspeptidase, s‐alkaline phosphatase, s‐total bilirubin. In 79 patients in whom the prothrombin time permitted, liver biopsies were performed at 7.6 ± 0.1 day after admission. All biopsy specimens were classified in: fatty liver, alcoholic hepatitis, and cirrhosis without hepatitis. The three histologically diagnosed groups were analysed separately. Exclusion criteria: hypothyroidism; diabetes; other therapies that contraindicated the use of PTU; congestive heart failure. The indications for being withdrawn from the study were massive gastrointestinal bleeding, incapacity to ingest drug, leukopenia, or adverse reactions.
Interventions	Experimental group: PTU 300 mg orally every day. Control group: placebo. Maximum period of treatment and of follow‐up: 46 days. Patients could be discharged before this period if clinical improvement made further stay in the hospital unnecessary.
Outcomes	All‐cause mortality. Biochemistry. Liver histology. Adverse events. Thyroid function. A Composite Clinical and Laboratory Index was developed for assessing efficacy. The scoring system was based on the concept that the severity of the disease was proportional to the number of abnormal clinical and laboratory findings. The index included signs and symptoms (hepatomegaly, splenomegaly, ascites, encephalopathy, bleeding tendency, spider naevi, palmar erythema, collateral circulation, peripheral edema, anorexia, and weakness) and laboratory tests (s‐bilirubin, prothrombin time, s‐albumin, s‐gamma glutamyltranspeptidase, s‐glutamic oxalacetic transaminase) and depending on the finding, a score (0 to 27) was added for each patient. See also Orrego et al (Orrego 1987b).
Notes	Sent letter in 2001. No reply.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: generation of allocation sequence by computer.
Allocation concealment (selection bias)	Low risk	Comment: allocation concealment involved an independent pharmacist
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.