| Report of a pilot, double-blind, placebo-controlled study of megestrol acetate in elderly dialysis patients with cachexia. | |
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MedLine Citation:
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PMID: 19819724 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Shing-Shing Yeh; Mozhdeh Marandi; Henry C Thode; Daniel M Levine; Thomas Parker; Troy Dixon; Michael W Schuster |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-10-12 |
Journal Detail:
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Title: Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation Volume: 20 ISSN: 1532-8503 ISO Abbreviation: J Ren Nutr Publication Date: 2010 Jan |
Date Detail:
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Created Date: 2010-02-03 Completed Date: 2010-04-15 Revised Date: 2011-03-25 |
Medline Journal Info:
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Nlm Unique ID: 9112938 Medline TA: J Ren Nutr Country: United States |
Other Details:
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Languages: eng Pagination: 52-62 Citation Subset: IM |
Affiliation:
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Geriatric Division, Department of Medicine, Northport Veteran Affairs Medical Center, Northport, New York 11768, USA. shingshing.yeh@va.gov |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Activities of Daily Living Aged Aged, 80 and over Appetite Stimulants / administration & dosage* Blood Urea Nitrogen Body Composition Body Weight Cachexia / diagnosis, drug therapy*, therapy* Cholesterol / blood Cytokines / blood Double-Blind Method Exercise Humans Male Megestrol Acetate / administration & dosage* Middle Aged Pilot Projects Placebos Prospective Studies Protein Subunits / blood Receptors, Tumor Necrosis Factor / blood Renal Dialysis* Resistance Training Serum Albumin / analysis Weight Gain |
| Chemical | |
Reg. No./Substance:
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0/Appetite Stimulants; 0/Cytokines; 0/Placebos; 0/Protein Subunits; 0/Receptors, Tumor Necrosis Factor; 0/Serum Albumin; 51154-23-5/Megestrol Acetate; 57-88-5/Cholesterol |
| Comments/Corrections | |
Comment In:
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J Ren Nutr. 2011 Mar;21(2):200-2
[PMID:
21239187
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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