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. |
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| 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. |
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| 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 Seventy‐one patients were randomised, but two patients refused participation and two patients were withdrawn as s‐bilirubin was 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. |
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| 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. |