Anabolic effects of nandrolone decanoate in patients receiving dialysis: a randomized controlled trial.
BACKGROUND
Patients receiving dialysis commonly experience malnutrition, reduced muscle mass (sarcopenia), and fatigue for which no effective treatment has been identified. Anabolic steroids are known to increase muscle mass and strength in healthy individuals, but their effect on the sarcopenia and fatigue associated with long-term dialysis has not been evaluated.


OBJECTIVE
To assess the effects of an anabolic steroid, nandrolone decanoate, on lean body mass (LBM), functional status, and quality of life in dialysis patients.


METHODS
Randomized, double-blind, placebo-controlled trial conducted between April 1996 and July 1997.


METHODS
Hospital-based outpatient dialysis unit.


METHODS
Twenty-nine patients undergoing dialysis for at least 3 months.


METHODS
Nandrolone decanoate, 100 mg (n = 14), or placebo (n = 15) by intramuscular injection once a week for 6 months.


METHODS
Weight, LBM, fatigue, grip strength, walking and stair-climbing times, and treadmill performance after 3 and 6 months of treatment.


RESULTS
Lean body mass increased significantly in patients given nandrolone compared with patients given placebo (mean change [SD], +4.5 [2.3] kg; P<.001 compared with baseline). This effect was significantly greater than the change in LBM in the placebo group (mean change [SD], +1.9 [1.6] kg; P = .003 compared with baseline; P = .005 compared with nandrolone group). Serum creatinine levels increased in the nandrolone group (+168 [203] mmol/L [1.9 [2.3] mg/dL]; P = .02) but not in the placebo group (-4.0 [177] mmol/L [0.04 [2.0] mg/dL]; P = .95), suggesting an increase in muscle mass. Time to complete the walking and stair-climbing test decreased from 36.5 to 32.7 seconds in the nandrolone group, while those in the placebo group increased from 38.7 to 42.1 seconds (P = .05). Peak oxygen consumption increased in the individuals in the nandrolone group who performed treadmill tests, but not to a statistically significant degree. Grip strength did not change in either group.


CONCLUSIONS
Treatment with nandrolone for 6 months resulted in a significant increase in LBM associated with functional improvement in patients undergoing dialysis.
Johansen
K L
KL
Department of Medicine, San Francisco General Hospital, University of California, USA. johanse@itsa.ucsf.edu
Mulligan
K
K
Schambelan
M
M
D015502:Absorptiometry, Photon; D000328:Adult; D045930:Anabolic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001774:Blood Chemical Analysis; D001823:Body Composition / Q000187:drug effects; D004311:Double-Blind Method; D005080:Exercise Test; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D007676:Kidney Failure, Chronic / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009142:Musculoskeletal Physiological Phenomena / Q000187:drug effects; D009277:Nandrolone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077603:Nandrolone Decanoate; D015596:Nutrition Assessment; D011788:Quality of Life; D012044:Regression Analysis; D006435:Renal Dialysis
D045930:Anabolic Agents; D009277:Nandrolone; D000077603:Nandrolone Decanoate