Orrego 1987.

Methods	Randomised clinical trial.
Participants	A total of 360 patients were included in the study, 182 in PTU group (152 males and 30 females, mean age (standard error of the mean (SEM)) 49.2 ± 0.8 y and 178 in the placebo group (139 males and 39 females), mean age (SEM) 49.6 ± 0.8 y. Inclusion criteria: a) alcoholism, defined as excessive drinking or spree drinking consisting of repeated prolonged inebriations or a well documented history of > 80 g of ethanol per day; and b) a clinical and laboratory evidence of liver disease. The severity of disease in each patient were determined with use of the clinical and laboratory index. Exclusion criteria: hepatoma, presence of the hepatitis B surface antigen, contraindications to PTU therapy, and a history of hypothyroidism.
Interventions	Experimental group: PTU 150 mg every 12 h orally every day. Because of the risk of severe hypothyroidism, patients in the PTU group were automatically switched every three months by the pharmacy to the placebo for one month, after which they were again given PTU. Control group: placebo. Additional treatment: 15 mg of riboflavin, a fluorescent compound that was used as a marker of compliance. Most of the urine samples contained the riboflavin marker (93.2 ± 0.8 percent in the placebo group, while 93.1 ± 0.7 percent in the PTU group). Maximum period of treatment: 24 months.
Outcomes	All‐cause mortality. Biochemistry. Liver histology. Adverse events. Alcohol consumption. Thyroid function. This trial also evaluated efficacy with the Combined Clinical and Laboratory Index similar to that of Orrego 1979, but not identical to it (score range 0 to 25).
Notes	Sent letter in 2001. No reply. Only 310 compliant patients form the basis of the reports of the trial.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: generation of allocation sequence by computer.
Blinding (performance bias and detection bias) All outcomes	Unclear 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.