What is the evidence for the 6 month sobriety rule in order to be added to a liver transplant waiting list?

calendarMost liver transplant centers impose a rule of  6 months demonstrated sobriety before they will add a potential transplant candidate to their waiting list. Since alcoholic cirrhosis is one of the most common indications for liver transplants in Western countries, it makes sense that there would be concern that transplants might not be successful due to alcoholic recidivism. On the other hand, many patients  simply cannot wait 6 months just to be added to the waiting list and there is increasing evidence that this 6 month sobriety criteria is somewhat arbitrary and not  necessarily a proven indicator.

Recent research of PubMed ( the major database of medical literature) reveals these  11 articles on this topic in recent years (abstracts provided when available).If you would like to obtain the full text of these articles or find out how I can help you use this information or find other transplant specific information for you, please use the contact form below.

1. J Med Ethics. 2006 May;32(5):263-5.

When alcohol abstinence criteria create ethical dilemmas for the liver transplant team.

Bramstedt KA, Jabbour N.

Department of Bioethics, Cleveland Clinic Foundation, Cleveland Clinic Lerner College of Medicine, 9500 Euclid Ave, JJ-60, Cleveland, OH 44195, USA. txbioethics@yahoo.com

PMCID: PMC2579412 PMID: 16648275  [PubMed – indexed for MEDLINE]

2. Ann Hepatol. 2012 Mar-Apr;11(2):213-21.

Predictive factors of abstinence in patients undergoing liver transplantation for alcoholic liver disease.

Altamirano J, Bataller R, Cardenas A, Michelena J, Freixa N, Monrás M, Ríos J, Liccioni A, Caballería J, Gual A, Lligoña A.

Liver Unit, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi i Sunyer, CIBER de Enfermedades Hepáticas y Digestivas, Barcelona, Spain.

INTRODUCTION: Alcoholic cirrhosis is one of the most common indications for liver transplantation (LT) in western countries. A major concern about transplant patients due to alcoholic liver disease (ALD) is alcoholic recidivism. Data concerning psycho-social characteristics of patients with 6 months of abstinence at initial evaluation for LT is scarce. Objectives. The aims of this study were 1) To evaluate the psycho-social profile of a cohort of patients with alcoholic cirrhosis being evaluated for LT. 2) Determine factors associated with abstinence from alcohol at initial psycho-social evaluation for LT and 3) To evaluate the potential impact of alcohol-free beer consumption on 6-month abstinence. MATERIAL AND METHODS: Ninety patients referred to the Alcohol Unit of the Hospital Clínic of Barcelona (January 1995-December 1996) were included. Univariate and multivariate logistic regression analyses were used to identify the factors associated with cessation in alcohol consumption and with 6-month abstinence. RESULTS: Factors associated with cessation in alcohol consumption were awareness of alcohol toxicity (OR = 5.84, CI 1.31-26.11, p = 0.02) and family recognition (OR = 3.81, CI 1.27-11.41, p = 0.01). Cessation of alcohol consumption at knowledge of ALD (OR = 5.50, CI 1.52-19.81, p = 0.009), awareness of alcohol toxicity (OR = 2.99, CI 1.02-9.22, p = 0.05) and family recognition (OR = 5.21, CI 1.12-24.15, p = 0.03) were the independent factors associated with 6-month abstinence previous to psycho-social evaluation for LT. CONCLUSION: In conclusion awareness of alcohol toxicity and family recognition are the independent factors that influence cessation in alcohol consumption and 6-month abstinence in patients evaluated for LT. The use of alcohol-free beer was associated with a higher rate of abstinence in patients without alcohol cessation.

PMID: 22345338  [PubMed – indexed for MEDLINE]

3. Curr Opin Organ Transplant. 2013 Jun;18(3):259-64. doi: 10.1097/MOT.0b013e32835fb94b.

Should length of sobriety be a major determinant in liver transplant selection?

Rice JP, Lucey MR.

Department of Medicine, Division of Gastroenterology and Hepatology, University of Wisconsin Hospital and Clinics, Madison, Wisconsin 53705-2281, USA.

PURPOSE OF REVIEW: For patients with alcoholic liver disease, most liver transplant programs enforce a mandatory period of sustained abstinence prior to considering transplant. The ‘6-month’ rule may eliminate potentially acceptable transplant candidates from a lifesaving procedure. This review focuses on the use of sobriety length as a determinant of transplant candidacy and as a predictor of future alcohol use. We will also review the use of liver transplant in patients with severe alcoholic hepatitis, and the impact of alcohol use on posttransplant outcomes. RECENT FINDINGS: Patients with alcoholic hepatitis that underwent transplantation had an increased survival when compared with controls. Alcohol relapse after transplantation was infrequent. Similarly, a United Network for Organ Sharing database review revealed similar survival in patients transplanted for alcoholic hepatitis versus alcoholic cirrhosis. Allograft loss due to alcohol use was not seen. However, alcohol usage after transplantation has been associated with a lower long-term survival in both alcoholic and nonalcoholic recipients. SUMMARY: The 6-month rule is insufficient in predicting relapse risk. Liver transplantation may be lifesaving in cases of alcoholic hepatitis and inflexible sobriety rules may eliminate patients from transplant consideration at a low risk of relapse. An ongoing alcohol use assessment, both pre- and posttransplant, are critical to achieving good long-term outcomes.

PMID: 23492643  [PubMed – indexed for MEDLINE]

4. N Engl J Med. 2012 Feb 2;366(5):478-9; author reply 479. doi: 10.1056/NEJMc1114241#SA3.

Early liver transplantation for severe alcoholic hepatitis.

Di Martino V, Sheppard F, Vanlemmens C.

Erratum in     N Engl J Med. 2012 Apr 5;366(14):1356.

Comment on     N Engl J Med. 2011 Nov 10;365(19):1790-800.

PMID: 22296091  [PubMed – indexed for MEDLINE]

5. N Engl J Med. 2012 Feb 2;366(5):478; author reply 479. doi: 10.1056/NEJMc1114241#SA2.

Early liver transplantation for severe alcoholic hepatitis.

John S, Chung RT.

Comment on     N Engl J Med. 2011 Nov 10;365(19):1790-800.

PMID: 22296090  [PubMed – indexed for MEDLINE]

6. N Engl J Med. 2012 Feb 2;366(5):477-8; author reply 479. doi: 10.1056/NEJMc1114241#SA1.

Early liver transplantation for severe alcoholic hepatitis.

Tamura S, Sugawara Y, Kukudo N.

Comment on     N Engl J Med. 2011 Nov 10;365(19):1790-800.

PMID: 22296089  [PubMed – indexed for MEDLINE]

7. N Engl J Med. 2011 Nov 10;365(19):1836-8. doi: 10.1056/NEJMe1110864.

Transplantation for alcoholic hepatitis–time to rethink the 6-month “rule”.

Brown RS Jr.

Comment on     N Engl J Med. 2011 Nov 10;365(19):1790-800.

PMID: 22070481  [PubMed – indexed for MEDLINE]

8. N Engl J Med. 2011 Nov 10;365(19):1790-800. doi: 10.1056/NEJMoa1105703.

Early liver transplantation for severe alcoholic hepatitis.

Mathurin P, Moreno C, Samuel D, Dumortier J, Salleron J, Durand F, Castel H, Duhamel A, Pageaux GP, Leroy V, Dharancy S, Louvet A, Boleslawski E, Lucidi V, Gustot T, Francoz C, Letoublon C, Castaing D, Belghiti J, Donckier V, Pruvot FR, Duclos-Vallée JC.

Hôpital Claude Huriez, Services Maladies de l’Appareil Digestif and INSERM Unité 995, Centre Hospitalier Universitaire, de Lille and Université Nord de France, Lille.

Comment in     Z Gastroenterol. 2012 Jul;50(7):699-701.     N Engl J Med. 2011 Nov 10;365(19):1836-8.     N Engl J Med. 2012 Feb 2;366(5):478; author reply 479.     N Engl J Med. 2012 Feb 2;366(5):477-8; author reply 479.     N Engl J Med. 2012 Feb 2;366(5):478-9; author reply 479.     Gastroenterology. 2012 Apr;142(4):1037-8.     Evid Based Med. 2013 Feb;18(1):21-2.     Gastroenterol Hepatol. 2012 Aug-Sep;35(7):457-9.     J Hepatol. 2012 Aug;57(2):451-2.

BACKGROUND: A 6-month abstinence from alcohol is usually required before patients with severe alcoholic hepatitis are considered for liver transplantation. Patients whose hepatitis is not responding to medical therapy have a 6-month survival rate of approximately 30%. Since most alcoholic hepatitis deaths occur within 2 months, early liver transplantation is attractive but controversial. METHODS: We selected patients from seven centers for early liver transplantation. The patients had no prior episodes of alcoholic hepatitis and had scores of 0.45 or higher according to the Lille model (which calculates scores ranging from 0 to 1, with a score ≥ 0.45 indicating nonresponse to medical therapy and an increased risk of death in the absence of transplantation) or rapid worsening of liver function despite medical therapy. Selected patients also had supportive family members, no severe coexisting conditions, and a commitment to alcohol abstinence. Survival was compared between patients who underwent early liver transplantation and matched patients who did not. RESULTS: In all, 26 patients with severe alcoholic hepatitis at high risk of death (median Lille score, 0.88) were selected and placed on the list for a liver transplant within a median of 13 days after nonresponse to medical therapy. Fewer than 2% of patients admitted for an episode of severe alcoholic hepatitis were selected. The centers used 2.9% of available grafts for this indication. The cumulative 6-month survival rate (±SE) was higher among patients who received early transplantation than among those who did not (77 ± 8% vs. 23 ± 8%, P<0.001). This benefit of early transplantation was maintained through 2 years of follow-up (hazard ratio, 6.08; P = 0.004). Three patients resumed drinking alcohol: one at 720 days, one at 740 days, and one at 1140 days after transplantation. CONCLUSIONS: Early liver transplantation can improve survival in patients with a first episode of severe alcoholic hepatitis not responding to medical therapy. (Funded by Société Nationale Française de Gastroentérologie.).

PMID: 22070476  [PubMed – indexed for MEDLINE]

9. Hepatogastroenterology. 2012 Mar-Apr;59(114):4 p preceding 311. doi: 10.5754/hge11691.

Alcoholic hepatitis and liver transplantation:is an abstinence of six months necessary?

Testino G, Borro P.

PMID: 22510448  [PubMed – indexed for MEDLINE]

10. Clin Liver Dis. 2012 Nov;16(4):851-63. doi: 10.1016/j.cld.2012.08.012.

Evaluation and selection of the patient with alcoholic liver disease for liver transplant.

Leong J, Im GY.

Recanati/Miller Transplantation Institute, Mount Sinai School of Medicine, One Gustave Levy Place, New York, NY 10029, USA. Jennifer.leong@mountsinai.org

Alcoholic liver cirrhosis is the second most common indication for liver transplantation in the United States. Studies have shown that these patients do as well as those transplanted for nonalcoholic liver disease. Recently, transplantation of patients with alcoholic liver disease has come under closer scrutiny following an article in the New England Journal of Medicine demonstrating comparable outcomes and survival in patients transplanted for acute alcoholic hepatitis. This article reviews the literature and data on the evaluation and selection of patients with alcoholic cirrhosis for liver transplant, and discusses the most recent indication (once a contraindication), acute alcoholic hepatitis.

Copyright © 2012 Elsevier Inc. All rights reserved.

PMID: 23101986  [PubMed – indexed for MEDLINE]

11. Evid Based Med. 2013 Feb;18(1):21-2. doi: 10.1136/ebmed-2012-100541. Epub 2012 Jun 26.

In patients with a first episode of severe alcoholic hepatitis non-responsive to medical therapy, early liver transplant increases 6-month survival.

Lucey MR.

Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin-Madison, Madison, Wisconsin 53705, USA. mrl@medicine.wisc.edu

Comment on     N Engl J Med. 2011 Nov 10;365(19):1790-800.

PMID: 22736660  [PubMed]

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