Category: Other -

Monitor: 16

16 - TESTOSTERONE SUPPLEMENTATION IN CIRRHOSIS: A SYSTEMATIC REVIEW OF RANDOMIZED CLINICAL TRIALS

Saturday, Apr 27
10:00 AM – 10:30 AM

Objective :

Patients with cirrhosis have lower levels of testosterone compared to non-cirrhotic counterparts. Observational studies suggest that low levels of serum testosterone are associated with higher morbidty and mortaltiy in patients with cirrhosis. It is unclear if testosterone supplementation improves clinical outcomes in cirrhosis. We aimed to review outcomes of randomized clinical trials that used testosterone supplementation in patients with cirrhosis.


Methods :

Two reviewers independently searched PUBMED and EMBASE without language restriction for randomized controlled trials of testosterone use in patients with cirrhosis, published from inception to July 2018. Our search included a combination of the terms “liver cirrhosis,” “liver graft,” “cirrhosis,” “liver transplant,” “testosterone,” and “androgen”. Our main outcomes were biochemical, liver-related and anthropometric. Disagreements were resolved by a third reviewer. Risk of bias was assessed in each study using the Cochrane risk of bias tool. Data extraction was compliant with PRISMA guidelines and Cochrane Handbook for Systematic Reviews of Interventions.


Results :

1,620 abstracts (1,260 PubMed and 360 EMBASE) were reviewed. Three randomized clinical trials met our inclusion criteria (303 patients:186 in the intervention group, 117 in the placebo). Most participants had decompensated cirrhosis as defined by Child-Pugh-Turcotte B or C. In the intervention arms patients were given testosterone over a period of 1 to 36 months via tablet, injection, or gel. Biochemical outcomes: studies reported increase in testosterone levels but mixed effect on hemoglobin, albumin levels; no significant change in INR or bilirubin.  Liver-related outcomes: no meaningful differences in disease severity scores or liver related complications or mortality.  Anthropometric outcomes: one study reported improvement of appendicular lean mass, total body lean mass, bone mass, and femoral T score in the testosterone group.


Discussion : In patients with decompensated cirrhosis, testosterone supplementation improved serum testosterone, total body lean mass, and bone mass. There were no significant effects on liver disease severity and/or liver related complications. There were no significant side effects associated with testosterone use. Of the three studies, two had low risk of bias, whereas risk of bias could not be determined in one.


Conclusion : Testosterone supplementation may be considered as a part of pre-habilitation in patients with decompensated cirrhosis. Whether testosterone use improves other clinical outcomes (readmission, wait-list mortality and death) remains to be determined.

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Aleem Kanji

Fellow
Baylor College of Medicine

Endocrinology Fellow at Baylor College of Medicine

Niharika Mallepally

Internal Medicine Resident
Baylor College of Medicine

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Fasiha Kanwal

Professor
Baylor College of Medicine

Professor and Section Chief of Gastroenterology and Hepatology at Baylor College of Medicine

Maya Balakrishnan

Assistant professor
Baylor College of Medicine

I am an academic gastroenterologist/Hepatologist interested in metabolic disease and the liver.

Marco Marcelli

Acting Chief Section Endocrinology
Baylor College of Medicine, Hoston VA Medical Center
Houston, Texas

During my training I participated in the molecular cloning the Androgen receptor, and maintained and interest on androgen physiopathology ever since. This work represents a continuation of my interest in this field.

Ruben Hernaez

Clinical Assistant Professor
Baylor College of Medicine

Ruben Hernaez is a Spanish physician initially trained as endocrinologist at the Clinic Hospital in Barcelona, Spain. He moved later on to the United States to receive training in Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health (Delta Omega Alpha'06 and Phi Beta Kappa '10). He completed his internal medicine residency at the Washington Hospital Center in Washington, D.C. and is finished double certification in Gastroenterology and Transplant Hepatology Fellowship at the Johns Hopkins Hospital. Starting in August 2016, Dr. Hernaez will join the Section of Gastroenterology and Hepatology at BCM and st the VA in Houston. Since 2013, Dr. Hernaez is also an Associate Editor, Statistics for Gut, the second most influential gastrointestinal journal in the World.
Dr. Hernaez main clinical interest is hepatology; in addition, he is particularly interested in the improvement of epidemiological methods and statistics in gastrointestinal research.

Aleem Kanji

Fellow
Baylor College of Medicine