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Blue Cross and Blue Shield of Montana (BCBSMT) considers an inpatient program of intestinal rehabilitation, consisting of metabolic evaluation, patient counseling and education, nutritional counseling, physical therapy, and treatment with growth hormone and glutamine experimental, investigational and unproven in patients with short bowel syndrome who are dependent on total parenteral nutrition.
The published data are almost exclusively derived from researchers working at the Nutritional Restart Center near Boston. Most reports consist of small case series, many with presumably overlapping patients. One case series consists of 45 patients with short bowel syndrome maintained on long-term parenteral nutrition. These patients were treated with growth hormone, glutamine, and a modified diet for four weeks and then followed up for an average of 1.8 years. After four weeks of therapy, 58% no longer required TPN. At follow-up, the percentage of patients not receiving TPN fell to 40%. A review article published in the same year included 67 adults receiving TPN, and presumably includes overlapping patients. At completion of the four-week program, the TPN requirement for each patient was noted as discontinued (52%), reduced (38%), or no change (10%). Over an unspecified follow-up period, there was some attrition of the treatment effect.
The relative contributions of the pharmacologic, dietary and counseling/education aspects of the overall program cannot be determined. Specifically, some researchers have questioned whether the treatment effect was primarily due to meticulous dietary counseling as opposed to any effect from glutamine or growth hormone. For example, Scolapio conducted a randomized six-week double-blind, placebo-controlled trial of eight patients who alternatively received growth hormone, glutamine supplementation, and a high carbohydrate, low-fat diet which alternated with a placebo treatment. Active treatment was associated with an increased body weight and lean body mass, decreased percent of body fat without increase in fluid, or macronutrient absorption. All patients receiving active treatment developed peripheral edema, suggesting that an increase in extra cellular fluid may have been responsible for the positive findings. In addition, after discontinuation of growth hormone, the weight returned to baseline. In another blinded crossover study of eight patients, Szkudlarek and colleagues examined the effect of growth hormone and glutamine supplementation on intestinal function. Unlike the above study, the patients did not receive a high carbohydrate, low-fat diet. Growth hormone with glutamine was not associated with improved intestinal absorption of energy, carbohydrate, sodium, potassium, calcium, or magnesium.
An additional research question is the contribution of an intensive inpatient program, compared to similar elements of the program offered in an outpatient setting. This issue has not been addressed in the published literature.
An updated search of the medical literature found that there is no consistent definition or components of intestinal rehabilitation nor is there long-term health outcomes measured for intestinal rehabilitation. Studies continued to assess the relative contributions of growth hormone, glutamine, glucagon-like peptide-two, and diet but did not assess the optimal treatment settings or components of intestinal rehabilitation according to patient characteristics.
One study involved twelve adults with short bowel syndrome who were dependent on a home-based, high carbohydrate parenteral nutrition diet. Patients were randomized in a double-blind placebo-controlled crossover study. Patients received daily low-dose growth hormone and placebo for a two- to three-week period, separated by a one-week washout period. Treatment with growth hormone increased intestinal absorption of energy, nitrogen, carbohydrates, and fats. The increased food absorption represented 37% +/- 16% of total parenteral energy delivery. Body weight, lean mass, and D-xylose absorption increased. However, the study did not assess long-term health outcomes beyond the immediate study period.
One study assigned 59 patients with life-threatening complications of intestinal failure to three treatment options. Sixty-eight percent of patients were considered appropriate candidates for intestinal transplants, 10% were managed with rehabilitation, and 17% were maintained on optimized parenteral nutrition. All patients managed with rehabilitation were weaned from parenteral nutrition within six months.
Wu and colleagues assessed bowel rehabilitation combined with nutritional therapy and found that 33 of 38 patients maintained body weight and serum albumin concentrations after an average follow-up of 5.9+/-4.3 years for the 33 survival patients. Nutrient absorption in eight patients treated with growth hormone and glutamine seemed to increase, but the effects occurred only during the treatment period and were not sustained.
The Federal Drug Administration (FDA) label for Zorbtive indicates growth hormone has been shown in human clinical trials to enhance the Tran mucosal transport of water, electrolytes, and nutrients. The FDA approval for Zorbtive was based on the results of a randomized, controlled, Phase III clinical trial in which patients dependent on intravenous parenteral nutrition who received Zorbtive (either with or without glutamine) over a four-week period had significantly greater reductions in the weekly total volume of intravenous parenteral nutrition required for nutritional support. However, the effects beyond four weeks were not evaluated nor were the treatment locations (inpatient vs. outpatient) identified.
The FDA has noted growth hormone for patients with short bowel syndrome should be limited to patients receiving specialized nutritional support in conjunction with optimal management of short bowel syndrome. Specialized nutritional support may consist of a high-carbohydrate, low-fat diet adjusted for individual patient requirements. Optimal management may include dietary adjustments, enteral feedings, parenteral nutrition, fluid and micronutrient supplements. Zorbtive is administered daily at 0.1mg/kg subcutaneously up to eight mg/day. Administration of Zorbtive for longer than four weeks has not been adequately studied per the FDA indications.
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