Chest
Volume 133, Issue 5, May 2008, Pages 1189-1195
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Original Research: Sarcoidosis
Double-Blind, Randomized Trial of Dexmethylphenidate Hydrochloride for the Treatment of Sarcoidosis-Associated Fatigue

https://doi.org/10.1378/chest.07-2952Get rights and content

Background

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

Methods

This 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 wash-in period, 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. FVC and 6-min walk distance (6MWD) were determined initially and after each treatment arm.

Results

Ten patients with sarcoidosis were enrolled: 8 women and 5 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). FVC was higher at the end of 8 weeks of d-MPH compared to the baseline values (baseline median, 2.38 L; range, 1.17 to 4.53 L; placebo median, 2.41 L; range, 1.50 to 4.65 L; d-MPH median, 2.56 L; range, 1.50 to 4.96 L; p < 0.01). There was no significant difference in the 6MWD (baseline median, 330 m; range, 60 to 460 m; placebo median, 350 m; range, 180 to 460 m; d-MPH median, 390 m; range, 200 to 460 m). d-MPH was well tolerated.

Conclusions

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

Trial registration

Clinicaltrials gov Identifier: NCT00361387.

Section snippets

Materials and Methods

All study participants had biopsy-confirmed sarcoidosis with consistent clinical features for > 2 years1 and complained of chronic fatigue with no other identified causes. Patients were excluded from the study if they had uncontrolled hypertension or cardiac arrhythmias. Maintenance systemic therapy without significant change was administered throughout the study. Patients provided written informed consent of a protocol approved by the University of Cincinnati Institutional Review Board.

Results

The study was performed between June 2006 and January 2007. Forty-four sarcoidosis patients were screened for the study (Fig 2). The two major reasons for not participating were exclusion criteria (not receiving stable therapy or clinically significant cardiac arrythmias) or not available for the 20 weekly visits required by the study. Ten patients were enrolled, and all completed all aspects of the study. The enrolled patients had a median age of 52 years (range, 39 to 74 years). Eight of the

Discussion

Fatigue is a common complaint expressed by many patients with chronic diseases. In one study3 of unselected sarcoidosis patients, fatigue was noted in > 70% of patients, compared to only 20% of a control population. This high frequency has been reported in other sarcoidosis populations.216 As in other chronic diseases, including cancer, the cause of the fatigue can be multifactorial. Fatigue is not associated with most other clinical markers of disease activity in sarcoidosis.3 However,

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    The authors have no conflicts of interest to disclose.

    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

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