Growth Hormone Therapy in Decompensated Cirrhosis: An Open-Label, Randomized Control Trial

• Published in: The American journal of gastroenterology Vol. 119; no. 1; pp. 116 - 126
• Main Authors: Kumari, Sunita, De, Arka, Kalra, Naveen, Singh, Virendra
• Format: Journal Article
• Language: English
• Published: United States Wolters Kluwer 01-01-2024; Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
• Subjects: Body mass index; Creatinine; End Stage Liver Disease - drug therapy; Growth Hormone - therapeutic use; Growth hormones; Hand Strength; Hematology; Human Growth Hormone - therapeutic use; Humans; Insulin-like growth factors; Liver cirrhosis; Liver Cirrhosis - drug therapy; Liver diseases; Liver transplants; Malnutrition; Malnutrition - drug therapy; Malnutrition - etiology; Medical prognosis; Musculoskeletal system; Nitrogen; Nutritional status; Protein synthesis; Proteins; Quality of Life; Sarcopenia; Severity of Illness Index; Software; Statistical analysis
• ISSN: 0002-9270; 1572-0241; 1572-0241
• DOI: 10.14309/ajg.0000000000002300

Effect of long-term growth-hormone (GH) therapy in decompensated cirrhosis (DC) is unknown. We studied the safety and efficacy of GH therapy on malnutrition, nitrogen metabolism, and hormonal changes in patients with DC.
Patients with DC were randomized to standard medical therapy plus GH (group A; n = 38) or standard medical therapy alone (group B; n = 38). Body mass index, midarm muscle circumference (MAMC), hand grip strength (HGS), liver frailty index (LFI), skeletal muscle index (SMI), nitrogen balance, Child-Turcotte-Pugh, model for end-stage liver disease, quality of life (QOL), serum albumin, GH, insulin like growth factor-1, and acid labile subunit (ALS) were assessed at baseline and at 12 months.
The mean difference between baseline and 12-months in SMI (-6.122 [-9.460 to -2.785] cm 2 /m 2 ), body mass index (-2.078 [-3.584 to -0.5718] kg/m 2 ), MAMC (-1.960 [-2.928 to -0.9908] cm), HGS (-5.595 [-7.159 to -4.031] kg), albumin (-0.3967 [-0.6876 to -0.1057] g/dL), LFI (0.3328 [0.07786-0.5878]), Child-Turcotte-Pugh (0.9624 [0.1435-1.781]), model for end-stage liver disease (1.401 [0.04698-2.75]), insulin-like growth factor-1 (-6.295 [-11.09 to -1.495] ng/dL), and ALS (-8.728 [-14.12 to -3.341] pg/mL) were statistically significantly better ( P < 0.05) in group A. There was no improvement in nutritional parameters, clinical scores, QOL scores, or nitrogen balance in group B. The mean difference between group A and B in SMI, HGS, MAMC, LFI, ALS, physical component summary, and mental component summary at 12 months was also statistically significant. Survival at 12 months was similar in both groups ( P = 0.35). No serious adverse events were observed.
Long-term use of GH is safe in DC and leads to improvement in malnutrition and possibly QOL. However, there is no improvement in 12-month survival (NCT03420144).