Growth hormone, glutamine, and an optimal diet reduces parenteral nutrition in patients with short bowel syndrome: a prospective, randomized, placebo-controlled, double-blind clinical trial.
OBJECTIVE
To determine if growth hormone (GH) and glutamine (Gln) might allow for a reduction in parenteral nutrition (PN) in individuals with short bowel syndrome.


BACKGROUND
Following massive intestinal resection, patients frequently sustain severe nutrient malabsorption and are dependent on PN for life. GH treatment with or without Gln might allow for a reduction in PN.


METHODS
A prospective, double-blind, randomized, placebo-controlled clinical trial performed in 41 adults dependent on PN. Following screening, patients were admitted to an in-house facility for 6 weeks. After 2 weeks of stabilization and dietary optimization, patients were randomized to one of 3 treatment arms (1:2:2 ratio): oral Gln (30 g/day) + GH placebo (control group, n = 9), Gln placebo + GH (0.1 mg/kg per day, n = 16), or Gln + GH (n = 16). Standard criteria based on clinical and laboratory measurements were followed to determine PN volume and content. After 4 weeks of treatment, patients were discharged and monitored; GH and GH placebo were discontinued, but the diet with Gln or Gln placebo was continued for 3 months.


RESULTS
Patients receiving GH + Gln placebo + diet showed greater reductions in PN volume (5.9 +/- 3.8 L/wk, mean +/- SD), PN calories (4338 +/- 1858 calories/wk), and PN infusions (3 +/- 2 infusions/wk) than corresponding reductions in the Gln + diet group (3.8 +/- 2.4 L/wk; 2633 +/- 1341 calories/wk; 2 +/- 1 infusions/wk, P < 0.05). Patients who received GH + Gln + diet showed the greatest reductions (7.7 +/- 3.2 L/wk; 5751 +/- 2082 calories/wk; 4 +/- 1 infusions/wk, P < 0.001 versus Gln + diet). At the 3-month follow-up, only patients who had received GH + Gln + diet maintained significant reductions in PN (P < 0.005) compared with the Gln + diet.


CONCLUSIONS
Treatment with GH + diet or GH + Gln + diet initially permitted significantly more weaning from PN than Gln + diet. Only subjects receiving GH + Gln + diet maintained this effect for at least 3 months.
Byrne
Theresa A
TA
Laboratory for Surgical Metabolism and Nutrition, Department of Surgery, Brigham and Woman's Hospital, Harvard Medical School, Boston, MA, USA.
Wilmore
Douglas W
DW
Iyer
Kishore
K
Dibaise
John
J
Clancy
Kerri
K
Robinson
Malcolm K
MK
Chang
Peter
P
Gertner
Joseph M
JM
Lautz
David
D
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D003131:Combined Modality Therapy; D004032:Diet; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005973:Glutamine / Q000008:administration & dosage*; D019382:Human Growth Hormone / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009751:Nutritional Requirements; D009752:Nutritional Status; D010288:Parenteral Nutrition / Q000706:statistics & numerical data*; D011336:Probability; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D012778:Short Bowel Syndrome / Q000175:diagnosis / Q000628:therapy*; D016896:Treatment Outcome
D005973:Glutamine; D019382:Human Growth Hormone