Methods |
Randomised trial comparing parenteral nutrition to no parenteral nutrition in hospitalized patients with alcoholic hepatitis. Geographical location: Jackson, Mississippi, USA. Paper published 1987. |
Participants |
Inclusion criteria: alcoholic hepatitis. Exclusion criteria: none cited. 40 hospitalized patients randomised, but demographics only available for the 28 who completed trial (23 male/5 female, mean age 46/51 in treatment/control groups). |
Interventions |
Intervention group received parenteral nutrition (21.25 g amino acids, 430 kcal/liter, 2 liters/day) + conventional diet; Controls received conventional diet (2675 kcal, 100 gm protein, 119 gm fat, 295 gm carbohydrates with salt restriction as needed). Duration therapy at least 21 days. |
Outcomes |
Mortality, appearance/resolution ascites, appearance/resolution hepatic encephalopathy, serum bilirubin (estimated from Figure 1A). One patient in parenteral nutrition group noted to have thrombophlebitis, but data regarding adverse events did not appear to have been systematically obtained. |
Category of study |
Parenteral nutrition/Medical. |
Sample size calculation |
Not reported if done. |
Full paper or abstract only |
Full paper. |
Notes |
Patients in parenteral nutrition group also given 10 mg cortisol/1000 IU heparin/d for thrombophlebitis prophylaxis; it was decided that these agents were not likely to impact on the clinical course. Request for further information sent to Dr Achord via US mail on September 12, 2011. (Address = James L Achord, MD, Emeritus Professor at University of Mississippi, University of Mississippi, P.O. Box 1848, University, MS 38677), but the letter returned as undeliverable. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Blind drawing of coded cards at time of assignment. |
Allocation concealment (selection bias) |
Low risk |
Blind drawing of coded cards at time of assignment. |
Blinding (performance bias and detection bias) All outcomes |
High risk |
Not blinded. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
7 dropouts in treatment group and 5 dropouts in control group all accounted for. |
Selective reporting (reporting bias) |
Low risk |
Mortality and morbidity outcomes reported. |
Other bias |
Unclear risk |
Funder of trial not reported. |
Intent to treat analysis |
High risk |
Could not be done. |
Baseline imbalance? |
Low risk |
No imbalance identified. |
Early stopping? |
Unclear risk |
No sample size calculation and unknown why stopped. |