Report of a pilot, double-blind, placebo-controlled study of megestrol acetate in elderly dialysis patients with cachexia.
J Ren Nutr
; 20(1): 52-62, 2010 Jan.
Article
em En
| MEDLINE
| ID: mdl-19819724
ABSTRACT
OBJECTIVE:
We examined the effects of megestrol acetate versus placebo and progressive resistance physical exercise on weight, lean muscle mass, quality of life, ability to exercise, proinflammatory cytokines, and anti-inflammatory cytokines, and their correlations with one another.DESIGN:
We organized a prospective 20-week, randomized, double-blind, placebo-controlled pilot trial of hemodialysis patients.SETTING:
This study took place at the Outpatient Unit of the Northport Veteran Affairs Medical Center.SUBJECTS:
We studied nine male hemodialysis patients who had two or more of the following albumin level <4.0 g/dL, total cholesterol <150 mg/dL, protein catabolic rate <0.8 g/kg/day, and predialysis serum urea nitrogen <60 mg/dL. Their ages were 50 to 83 years. Two were diabetic, and seven were nondiabetic.INTERVENTIONS:
Interventions included megestrol acetate (MA) or placebo 800 mg oral daily for 20 weeks, along with weight resistance physical therapy with weights twice a week before dialysis. Patients were followed prospectively for an additional 4 weeks. MAIN OUTCOME MEASUREMENTS Weight, body composition, activities of daily living, ability to exercise, and plasma cytokine levels were measured.RESULTS:
At 24 weeks, the MA group had a statistically significant weight gain (11.1-pound increase vs. 1.5-pound decrease for the placebo group, P = .018), body fat gain (6.2-pound increase vs. a 0.4-pound decrease for the placebo group, P = .044) and fat-free mass gain (5-pound increase vs. a 1.2-pound decrease in the placebo group). The MA group also had a greater tendency toward increased appetite and sense of well-being. The MA group showed a greater improvement in ability to exercise (mean change in rate of perceived exertion (RPE), 4.7) vs. the placebo group (mean change in RPE vs. 0.5, P = .02). Elevated cytokine levels were evident at baseline in both groups. In all patients, increases in weight, fat-free mass, sense of well-being, appetite, and ability to exercise were negatively correlated with tumor necrosis factor receptor subunit p75 (P < .05). There was a trend toward all of these parameters to be negatively correlated with tumor necrosis factor receptor subunit p55, although only sense of well-being was statistically significant (P < .05).CONCLUSION:
In a pilot trial in dialysis patients, MA showed significant benefits in improving weight and ability to exercise. Cytokine changes were correlated with weight gains and increases in fat-free mass.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Caquexia
/
Diálise Renal
/
Acetato de Megestrol
/
Estimulantes do Apetite
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
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Observational_studies
Limite:
Aged
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Aged80
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2010
Tipo de documento:
Article