A Randomized Controlled Trial of Low-Dose Recombinant Human Growth Hormone in the Treatment of Malnourished Elderly Medical Patients1
High-dose recombinant human GH (rhGH) has been shown to improve the nutritional status of malnourished older adults. It is uncertain whether low-dose rhGH is effective and whether its effect on nutritional status will lead to any improvement in physical function. There is also no data on the outcome...
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Published in | The journal of clinical endocrinology and metabolism Vol. 86; no. 5; pp. 1913 - 1920 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Endocrine Society
01.05.2001
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Online Access | Get full text |
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Summary: | High-dose recombinant human GH (rhGH) has been shown to improve
the nutritional status of malnourished older adults. It is uncertain
whether low-dose rhGH is effective and whether its effect on
nutritional status will lead to any improvement in physical function.
There is also no data on the outcome after a short course of rhGH
treatment. The objectives of this study were to determine the efficacy
of low-dose rhGH treatment for 4 weeks in malnourished elderly
patients, its effect on physical functions, and the intermediate term
outcome after a 4-week rhGH treatment. The study design was a
randomized, placebo-controlled, double-blind trial conducted in a
university teaching hospital. The patients were 19 medically stable
malnourished elderly subjects. Intervention in the rhGH group was as
follows: rhGH (Saizen, Serono, Switzerland) 0.09 IU/kg body weight (BW)
3 times weekly were given together with appropriate dietary
intervention as prescribed by the dietitian. In the placebo group,
equal volumes of normal saline per kilogram BW were given 3 times
weekly together with the dietary intervention.
The baseline demographic, anthropometric, nutritional, and
hematological variables, measures of physical function, and
insulin-like growth factor I levels in both groups were comparable.
Compared with the placebo group, the GH-treated group showed a more
rapid gain in BW (after 3 weeks, +1.27 ± 0.36 vs.−
0.28 ± 0.37 kg; P = 0.008), total lean body
mass (change after 3 weeks by bio-impedance analysis, +1.45 ±
0.36 vs. −0.37 ± 0.48 kg; P =
0.009) and a faster improvement in 5-m walking time (decrease after 4
weeks, 23.79 ± 9.41 vs. 0.45 ± 4.62 sec;
P = 0.047). The hemoglobin level rose more in the
rhGH than the placebo groups (change at 8 weeks, +0.84 ± 0.34
vs. −0.42 ± 0.29 g/dL; P =
0.012). Serum albumin level also showed a greater delayed increase in
the rhGH group than in the placebo group (change at 8 weeks, +5.1±
0.8 vs. 1.6 ± 1.2 g/dL; P =
0.023). There was no statistically significant difference for other
nutritional variables. There was a greater rise in the mean serum
insulin-like growth factor I level at 4 weeks in the GH than in the
placebo groups (197 ± 58 vs. 54 ± 26 U/L;
P = 0.034). The improvement in the rhGH group
gradually diminished on follow-up and became statistically
insignificant 8 weeks after stopping rhGH treatment. There were no
GH-related adverse effects.
Low-dose rhGH was an effective and safe adjuvant to dietary
augmentation for stable malnourished elderly subjects. It led to a
faster gain in total lean body mass, which was associated with greater
improvement in walking speed when compared with dietary intervention
alone. There were no apparent side effects. |
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ISSN: | 0021-972X 1945-7197 |
DOI: | 10.1210/jcem.86.5.7457 |