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A
Randomized, Double-blind, Placebo-Controlled Trial of Psychostimulants
for the Treatment of Fatigue in Ambulatory Patients with Human Immunodeficiency
Virus Disease [Breitbart W, et al. Arch Intern Med 2001;161:411]:
This is a
comparative trial of HIV-infected patients with persistent fatigue
for at least two weeks that was rated 5 or greater on a numerical
rating scale of 0 - 10. There were 109 patients who were randomized
to receive methylphenidate (Ritalin) or pemoline (Cylert) or placebo.
Doses were titrated to maximum tolerated doses with a maximum of
60 mg/d for Ritalin and 150 mg/d for Cylert. The trial was for six
weeks, and analysis at that time showed a 41% response rate to Ritalin,
36% response rate to Cylert, and a 15% response rate to placebo.
These results were based on patient assessment of fatigue using
several self-reported rating scales. Statistical analysis showed
no difference between the two drugs, but both were significantly
better than placebo according to the Piper Fatigue Scale, affective
subscale, sensory subscale, and the VAS-F energy subscale. The authors
concluded that these drugs are associated with a significant improvement
in fatigue and quality of life, and in decreased rates of depression.
Comment: The authors claim this is the first double-blind,
placebo controlled trial of psychostimulants for fatigue in patients
with HIV. The average maximum tolerated dose for Ritalin, with hyperactivity
as the limitation, was 35 mg/day, and for Cylert it was 70 mg/day,
with jitteriness as the limitation.
posted
2/22/2001
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