A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis: Results of a Department of Veterans Affairs cooperative study

Charles L. Mendenhall, Thomas E. Moritz, Gary A. Roselle, Timothy R. Morgan, Bernard A. Nemchausky, Carlo H. Tamburro, Eugene R Schiff, Craig J. Mcclain, Luis S. Marsano, John I. Allen, Arun Samanta, Robert E. Weesner, William Henderson, Peter Gartside, Thomas S. Chen, Samuel W. French, Antonio Chedid

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Abstract

A Veterans Affairs cooperative study involving 273 male patients was performed to evaluate efficacy of oxandrolone in combination with an enteral food supplement in severe alcoholic hepatitis. All patients had some degree of protein calorie malnutrition. On an intention-to-treat basis, only minimal changes in mortality were observed. However, in patients with moderate malnutrition mortality on active treatment at 1 mo was 9.4% compared with 20.9% in patients receiving placebo. This beneficial effect was maintained so that after 6 mo on active treatment 79.7% of patients were still alive, compared with 62.7% of placebo-treated patients (p = 0.037). Improvements in both the severity of the liver injury (p = 0.03) and malnutrition (p = 0.05) also occurred. No significant improvement was observed with severe malnutrition. To better determine the effect on therapeutic efficacy, we compared results with those from a nearly identical population (cooperative study 119) treated with oxandrolone but not given the food supplement. Patients were stratified according to their caloric intake (greater than 2,500 kcal/day was considered adequate to supply energy needs and promote anabolism). For patients with moderate malnutrition and adequate caloric intake, oxandrolone treatment reduced 6-mo mortality (4% active treatment vs. 28% placebo [p = 0.002]). For patients with moderate malnutrition and inadequate calorie intake, oxandrolone had no effect on mortality (30% active treatment vs. 33% placebo). In cases of severe malnutrition, oxandrolone had no effect on survival. However, adequate caloric intake was associated with 19% mortality, whereas patients with inadequate intake exhibited 51% mortality (p = 0.0001). These results indicate that nutritional status should be evaluated in patients with alcoholic hepatitis. When malnutrition is present, vigorous nutrition therapy should be provided, and in patients with moderate malnutrition oxandrolone should be added to the regimen.

Original languageEnglish
Pages (from-to)564-576
Number of pages13
JournalHepatology
Volume17
Issue number4
StatePublished - Apr 1 1993

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Oxandrolone
Alcoholic Hepatitis
Nutritional Support
Veterans
Malnutrition
Mortality
Energy Intake
Placebos
Dietary Supplements
Nutrition Therapy
Therapeutics
Protein-Energy Malnutrition
Therapeutic Uses
Nutritional Status

ASJC Scopus subject areas

  • Hepatology

Cite this

Mendenhall, C. L., Moritz, T. E., Roselle, G. A., Morgan, T. R., Nemchausky, B. A., Tamburro, C. H., ... Chedid, A. (1993). A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis: Results of a Department of Veterans Affairs cooperative study. Hepatology, 17(4), 564-576.

A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis : Results of a Department of Veterans Affairs cooperative study. / Mendenhall, Charles L.; Moritz, Thomas E.; Roselle, Gary A.; Morgan, Timothy R.; Nemchausky, Bernard A.; Tamburro, Carlo H.; Schiff, Eugene R; Mcclain, Craig J.; Marsano, Luis S.; Allen, John I.; Samanta, Arun; Weesner, Robert E.; Henderson, William; Gartside, Peter; Chen, Thomas S.; French, Samuel W.; Chedid, Antonio.

In: Hepatology, Vol. 17, No. 4, 01.04.1993, p. 564-576.

Research output: Contribution to journalArticle

Mendenhall, CL, Moritz, TE, Roselle, GA, Morgan, TR, Nemchausky, BA, Tamburro, CH, Schiff, ER, Mcclain, CJ, Marsano, LS, Allen, JI, Samanta, A, Weesner, RE, Henderson, W, Gartside, P, Chen, TS, French, SW & Chedid, A 1993, 'A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis: Results of a Department of Veterans Affairs cooperative study', Hepatology, vol. 17, no. 4, pp. 564-576.
Mendenhall, Charles L. ; Moritz, Thomas E. ; Roselle, Gary A. ; Morgan, Timothy R. ; Nemchausky, Bernard A. ; Tamburro, Carlo H. ; Schiff, Eugene R ; Mcclain, Craig J. ; Marsano, Luis S. ; Allen, John I. ; Samanta, Arun ; Weesner, Robert E. ; Henderson, William ; Gartside, Peter ; Chen, Thomas S. ; French, Samuel W. ; Chedid, Antonio. / A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis : Results of a Department of Veterans Affairs cooperative study. In: Hepatology. 1993 ; Vol. 17, No. 4. pp. 564-576.
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abstract = "A Veterans Affairs cooperative study involving 273 male patients was performed to evaluate efficacy of oxandrolone in combination with an enteral food supplement in severe alcoholic hepatitis. All patients had some degree of protein calorie malnutrition. On an intention-to-treat basis, only minimal changes in mortality were observed. However, in patients with moderate malnutrition mortality on active treatment at 1 mo was 9.4{\%} compared with 20.9{\%} in patients receiving placebo. This beneficial effect was maintained so that after 6 mo on active treatment 79.7{\%} of patients were still alive, compared with 62.7{\%} of placebo-treated patients (p = 0.037). Improvements in both the severity of the liver injury (p = 0.03) and malnutrition (p = 0.05) also occurred. No significant improvement was observed with severe malnutrition. To better determine the effect on therapeutic efficacy, we compared results with those from a nearly identical population (cooperative study 119) treated with oxandrolone but not given the food supplement. Patients were stratified according to their caloric intake (greater than 2,500 kcal/day was considered adequate to supply energy needs and promote anabolism). For patients with moderate malnutrition and adequate caloric intake, oxandrolone treatment reduced 6-mo mortality (4{\%} active treatment vs. 28{\%} placebo [p = 0.002]). For patients with moderate malnutrition and inadequate calorie intake, oxandrolone had no effect on mortality (30{\%} active treatment vs. 33{\%} placebo). In cases of severe malnutrition, oxandrolone had no effect on survival. However, adequate caloric intake was associated with 19{\%} mortality, whereas patients with inadequate intake exhibited 51{\%} mortality (p = 0.0001). These results indicate that nutritional status should be evaluated in patients with alcoholic hepatitis. When malnutrition is present, vigorous nutrition therapy should be provided, and in patients with moderate malnutrition oxandrolone should be added to the regimen.",
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