Clinical-liver, pancreas, and biliary tractNutritional supplementation with branched-chain amino acids in advanced cirrhosis: a double-blind, randomized trial☆
Section snippets
Study design
The study, planned in 1996 by a steering committee, was a multicenter, randomized, controlled study involving 15 centers with a specific interest in patients with liver disease. Each center was to recruit 12 patients with advanced liver cirrhosis of any etiology in a 6-month period. Inclusion criteria were (1) a diagnosis of liver cirrhosis documented by histology and confirmed by laboratory data, (2) Child-Pugh score21 ≥7 (class B or C), and (3) sonographic and endoscopic evidence of portal
Clinical course
In individual patients, the study period lasted from 1 to 15.5 months; only one of the 174 patients was lost to follow-up after withdrawal from the study for adverse effects at 1 month (see following text). A total of 1809 patient-months (657 on BCAA, 551 on L-ALB, and 601 on M-DXT) was available for analysis. Forty-three events were recorded (Table 2). Twenty-five patients died during the study period (5 in the BCAA group, 11 in the L-ALB group, and 9 in the M-DXT group). In 4 cases, death
Discussion
After 2 decades of debate, the potential benefits of nutritional supplementation with BCAA are still an unsettled issue. This is particularly true for oral supplementation, for which a meta-analysis on the 9 available trials (a total of 165 patients) was not possible17 because of conflicting results as well as differences in study design, duration of treatment, and type of nutritional supplementation. Most studies were also exceedingly short; even considering the crossover design of a few
References (40)
- et al.
Body composition in nonalcoholic cirrhosisthe effect of disease etiology and severity on nutritional compartments
Gastroenterology
(1994) - et al.
ESPEN guidelines for nutrition in liver disease and transplantation
Clin Nutr
(1997) - et al.
Response of phenylalanine and leucine kinetics to branched chain-enriched amino acids and insulin in patients with cirrhosis
Gastroenterology
(1996) - et al.
Factors associated with poor health-related quality of life of patients with cirrhosis
Gastroenterology
(2001) New norms of upper limb fat and muscle areas for assessment of nutritional status
Am J Clin Nutr
(1981)- et al.
Long-term oral branched-chain amino acid treatment in chronic hepatic encephalopathy. A randomized double-blind casein-controlled trial
J Hepatol
(1990) - et al.
Long-term treatment of latent portosystemic encephalopathy with branched-chain amino acids. A double-blind placebo-controlled cross-over study
J Hepatol
(1993) - et al.
Malnutrition and immuno-incompetence in patients with liver disease
Lancet
(1980) - et al.
Nutrition and survival in patients with liver cirrhosis
Nutrition
(2001) - et al.
Nutritional support in children with end-stage liver diseasea randomized crossover trial of a branched-chain amino acid supplement
Am J Clin Nutr
(1992)
Forms of malnutrition in patients with liver cirrhosis
Clin Invest
Nutritional assessment and adequacy of dietary intake in hospitalized patients with alcoholic cirrhosis
Br J Nutr
Nutritional status in cirrhosis
J Hepatol
Early detection of protein depletion in alcoholic cirrhosisrole of body composition analysis
Gastroenterology
Elevated protein requirements in cirrhosis of the liver investigated by whole body protein turnover studies
Clin Sci
Disordered energy and protein metabolism in liver disease
Semin Liver Dis
Leucine metabolism in stable cirrhosis
Hepatology
Nature and quantity of fuels consumed in patients with alcoholic cirrhosis
J Clin Invest
Nutrition, hormones, metabolism and liver regeneration
Semin Liver Dis
Plasma tryptophan levels and anorexia in liver cirrhosis
Int J Eat Disord
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Supported by Divisione Medica Europa, Bracco Imaging spa, Milano, Italy. Data collection and statistical analyses were performed by 2 principal investigators (G.M. and G.B.) at the University of Bologna independently of the sponsor.
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Participating centers and investigators: Cattedra di Gastroenterologia, Università di Bari (F. Guglielmi, C. Panella, and L. Pietrini); Dipartimento di Medicina Interna, Cardioangiologia, Epatologia, and Cattedra di Malattie del Ricambio, Università di Bologna (M. Bertelli, G. Bianchi, S. Loffreda, G. Marchesini, B. Rossi, and G. Zoli); Dipartimento di Medicina Interna e Gastroenterologia, Università di Bologna (G. Danesi, R. Mimmo, C. Morelli, and C. Sama); Divisione di Gastroenterologia, Azienda Ospedaliera S. Orsola-Malpighi, Bologna (P. Leo and R. Muratori); Divisione di Gastroenterologia, Azienda AUSL Città di Bologna, Bologna (F. Sarti); Divisione Medica Europa, Bracco Imaging spa, Milano (R. Abbiati and E. Grossi); Divisione di Epatologia e Gastroenterologia “Crespi,” Ospedale Ca’ Granda - Niguarda, Milano (C. Vai); Cattedra di Gastroenterologia, II Università di Napoli (A. Federico and C. Loguercio); Dipartimento di Medicina Clinica e Sperimentale - Clinica Medica II, Università di Padova (P. Amodio and G. Campo); II Cattedra di Gastroenterologia, Università “La Sapienza,” Roma (M. Merli and O. Riggio); Cattedra di Medicina Interna, Università Cattolica, Roma (G. L. Rapaccini and L. Puglisi); Dipartimento di Medicina Clinica, Università “La Sapienza,” Roma (C. Cangiano, A. Laviano, and F. Rossi-Fanelli); Cattedra di Gastroenterologia, Università di Torino (B. Lavezzo and A. Ottobrelli); Dipartimento di Medicina III, Ospedale S. Bortolo - USL 6, Vicenza (E. Ambrosini and M. Salvagnini).