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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

Byrne, Theresa A. DSc; Wilmore, Douglas W. MD*; Iyer, Kishore MD; Dibaise, John MD; Clancy, Kerri RN; Robinson, Malcolm K. MD*; Chang, Peter PhD§; Gertner, Joseph M. MB, BChir§; Lautz, David MD

doi: 10.1097/01.sla.0000186479.53295.14
Randomized Controlled Trials

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 Data: 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.

In patients (n = 41) dependent on parenteral nutrition (PN), treatment with growth hormone (GH) ± glutamine (Gln) and an optimized oral diet allowed for significantly more weaning from PN than Gln + diet. Only those receiving GH + Gln maintained reductions at 3 months.

From the *Laboratories for Surgical Metabolism and Nutrition, Department of Surgery, Brigham and Woman's Hospital, Harvard Medical School, Boston, MA; †Nutritional Restart Center, Hopkinton, MA; ‡Nebraska Medical Center, Omaha, NE; and §Serono, Inc., Rockland, MA.

Supported by Serono, Inc., Rockland, MA, and Nutritional Restart Pharmaceutical, LP, Durham, NC.

Reprints: Douglas W. Wilmore, MD, P.O. Box 1245, Kilauea, HI 96754. E-mail: dwilmore@partners.org.

© 2005 Lippincott Williams & Wilkins, Inc.