Long-term growth hormone (GH) therapy is safe in patients with decompensated cirrhosis (DC) and is associated with improved nutritional status, although it has no effect on survival at 12 months, according to a study in the American Journal of Gastroenterology.
The open-label, randomized controlled trial (ClinicalTrials.gov Identifier: NCT03420144) was conducted at a tertiary center and included adult patients aged younger than 80 years with decompensated cirrhosis of any etiology.
The study participants were randomly assigned 1:1 to receive GH therapy with standard medical therapy (SMT; group A) or SMT alone (group B).
Researchers followed up with patients monthly for 12 months to evaluate the safety of the treatment. The primary outcome was improvement in skeletal muscle index (SMI) score. Secondary outcomes included improvement in body mass index (BMI), mid-arm muscle circumference (MAMC), hand grip strength (HGS), liver frailty index (LFI), clinical scores, and quality of life (QOL).
Group A had 38 participants (mean [SD] age, 52.5[9.78] years; men, 84%), and group B had 38 participants (mean age, 51.58[11.23] years; men, 74%).
For the primary outcome, the predicted least squares (LS) mean difference in SMI from baseline to 12 months was significantly greater for group A (-6.122; 95% CI, -9.460 to -2.785 cm2/m2; P = .0002), but not in group B (-0.3706; 95% CI, -3.815 to 3.074 cm2/m2; P = .9621). Improvement in SMI at 12 months was significantly increased in group A (5.87; 95% CI, 2.51-8.57 cm2/m2) vs group B (-0.34; 95% CI, -6.35 to 6.01 cm2/m2; P = .005). GH therapy was associated with improved SMI independent of age, sex, baseline MELD, and BMI (P = .004) in multivariate analysis.
Group A also had a statistically significant predicted LS mean difference at 12 months from baseline in BMI (-2.078; 95% CI, -3.584 to -0.5718 kg/m2; P = .005), MAMC (-1.960; 95% CI, -2.928 to -0.9908 cm; P <.0001), HGS (-5.595; 95% CI, -7.159 to -4.031 kg; P = .0056), albumin (-0.3967; 95% CI, -0.6876 to -0.1057 g/dL; P = .0056), and LFI (0.3328; 95% CI, 0.07786-0.5878; P = .0090). These differences were not statistically significant in group B. MAMC and HGS were significantly increased in group A compared with group B at 12 months, although no difference was found for the other nutritional parameters or frailty.
The predicted LS mean difference in QOL scores (physical component score, -12.55; 95% CI, -15.65 to -9.443; P <.0001; and mental component score, -19.81; 95% CI, -24.71 to -14.91; P <.0001) at 12 months was significantly greater in group A, and no such improvement was observed in group B.
Group A had no significant difference in survival (P = .35) compared with group B (mortality at 12 months: 13.16 % [5/38] in group A and 21.05 % [13/38] in group B).
Limitations include the single-center, open-label design and potential for respondent bias. Another limitation is the use of Western cutoffs for defining sarcopenia, and the impact of exercise on nutrition was not evaluated.
“We demonstrated for the first time that long-term GH supplementation helps to improve nutritional status as demonstrated by improvement in anthropometric measures, measures of muscle mass, and muscle strength,” the study authors noted. “A multicentric, double blind, randomized, placebo-controlled trial should be planned to confirm our encouraging results.”
Kumari S, De A, Kalra N, Singh V. Growth hormone therapy in decompensated cirrhosis: an open-label, randomized control trial. Am J Gastroenterol. Published online May 15, 2023. doi:10.14309/ajg.0000000000002300