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

Abstract

INTRODUCTION: 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. METHODS: 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. RESULTS: The mean difference between baseline and 12-months in SMI (−6.122 [−9.460 to −2.785] cm2/m2), body mass index (−2.078 [−3.584 to −0.5718] kg/m2), 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. DISCUSSION: 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).