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First published online on February 8, 2008
Chest, doi:10.1378/chest.07-2952
A more recent version of this article appeared on May 1, 2008
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Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of Sarcoidosis Associated Fatigue

Elyse E Lower, MD1; Stacy Harman and Robert P. Baughman, MD1

1Department of Medicine, University of Cincinnati Medical Center, Cincinnati, OH

elower{at}ohcmail.com

Abstract

BackgroundFatigue is a common complaint in sarcoidosis. We studied the effectiveness of dexmethylphenidate hydrochloride (d-MPH) in treating sarcoidosis associated fatigue.

MethodsThis was a double blind, randomized placebo controlled crossover trial of d-MPH. Patients were seen weekly and completed Functional Assessment of Chronic Illness Therapy-Fatigue(FACIT-F) and Fatigue Assessment Score (FAS) instruments. After a 1 week washin, patients received either d-MPH or placebo. After 8 weeks, the medications were stopped. Following a 2 week wash-out period, patients were crossed over to 8 weeks of the other treatment. Forced vital capacity (FVC) and six minute walk distance (6MWD) were determined initially and after each treatment arm.

ResultsTen sarcoidosis patients were enrolled: 8 females and five African Americans. All were receiving systemic sarcoidosis therapy. Significant improvement in fatigue was reported by patients when receiving d-MPH (FACIT-F p<0.001, FAS p<0.02. The FVC was higher at the end of 8 weeks of d-MPH compared to the baseline values (Baseline: 2.38 l (1.17-4.53) (Median (Range)); Placebo: 2.41 l (1.50-4.65); d-MPH (2.56 l (1.50-4.96), (p<0.01)) There was no significant difference in the 6MWD (Baseline: 330 m (60-460); Placebo: 350 m (180-460); d-MPH: 390 m (200-460)). The d-MPH was well tolerated.

ConclusionsTreatment with d-MPH was associated with a significant improvement in sarcoidosis associated fatigue.

Study registered at ClinicalTrials.gov: NCT00361387







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