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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
William Breitbart, MD;
Barry Rosenfeld, PhD;
Monique Kaim, PhD;
Julie Funesti-Esch, RN
Arch Intern Med. 2001;161:411-420.
Background Fatigue is a commonly encountered symptom of human immunodeficiency
virus (HIV) disease, associated with significant psychological and functional
morbidity and poor quality of life. Preliminary studies on the treatment of
fatigue from the cancer and multiple sclerosis literature suggest that psychostimulants
may be effective in reducing fatigue.
Objective To compare the efficacy of 2 psychostimulant medications, methylphenidate
hydrochloride (Ritalin) and pemoline (Cylert), with a placebo intervention
for the treatment of fatigue in patients with HIV disease.
Methods In this double-blind trial, 144 ambulatory patients with HIV disease
and persistent and severe fatigue were randomized to treatment with methylphenidate,
pemoline, or placebo. Medications were titrated up to a maximum dose of 60
mg of methlyphenidate hydrochloride, 150 mg of pemoline, or 8 capsules of
placebo daily. Fatigue was measured using 2 self-reported rating scales, the
Piper Fatigue Scale (PFS) and the Visual Analogue Scale for Fatigue (VAS-F).
We also used the timed isometric unilateral straight leg-raising task, a measure
of muscular endurance. Quality-of-life and psychological well-being measures
included the Beck Depression Inventory, the Brief Symptom Inventory, and the
36-Item Short-Form Medical Outcomes Study Health Status Survey. Side effects
were monitored using the Systematic Assessment for Treatment Emergent Events
and the Extra-pyramidal Symptom Rating Scale. All measures were rated weekly.
Results One hundred nine subjects completed the 6-week trial; 15 patients (41%)
receiving methylphenidate and 12 patients (36%) receiving pemoline demonstrated
clinically significant improvement compared with 6 patients (15%) receiving
placebo. Patients receiving methylphenidate or pemoline demonstrated significantly
more improvement in fatigue on several self-reported rating scales (PFS total
score, P= .04; affective subscale, P= .008; sensory
subscale, P= .04; and VAS-F energy subscale, P=
.02). Analysis of the regression slopes by means of hierarchical linear modeling
demonstrated a significantly greater rate of improvement in PFS total scores
among patients receiving psychostimulants compared with the placebo group
(P= .02). There were no significant differences in the efficacy
between methlyphenidate and pemoline on any outcome measure studied. Improvement
in fatigue was also significantly correlated with improvement in measures
of depression, psychological distress, and overall quality of life. Severe
side effects were relatively uncommon among this sample, and only hyperactivity
or jitteriness occurred significantly more often among subjects receiving
active medication.
Conclusions Many patients with HIV- and acquired immunodeficiency syndrome–unrelated
fatigue respond favorably to treatment with methylphenidate or pemoline. Both
psychostimulants appear to be equally effective and significantly superior
to placebo in decreasing fatigue severity with minimal side effects. Moreover,
improvement of fatigue was significantly associated with improved quality
of life and decreased levels of depression and psychological distress.
From the Department of Psychiatry and Behavioral Sciences, Memorial
Sloan-Kettering Cancer Center, New York, NY (Drs Breitbart and Kaim and Ms
Funesti-Esch); and the Department of Psychology, Fordham University, Bronx,
NY (Dr Rosenfeld).
Corresponding author and reprints: William Breitbart, MD, Psychiatry
Service and Pain and Palliative Care Service, Memorial Sloan-Kettering Cancer
Center, 1275 York Ave, Box 421, New York, NY 10021 (e-mail: breitbaw{at}mskcc.org).
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