Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of sarcoidosis-associated fatigue.
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.


BACKGROUND
Clinicaltrials.gov Identifier: NCT00361387.
Lower
Elyse E
EE
Department of Medicine, University of Cincinnati Medical Center, Cincinnati, OH, USA. elower@ohcmail.com
Harman
Stacy
S
Baughman
Robert P
RP
D000328:Adult; D000368:Aged; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D018592:Cross-Over Studies; D064699:Dexmethylphenidate Hydrochloride; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005080:Exercise Test / Q000379:methods; D005221:Fatigue / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D008875:Middle Aged; D012129:Respiratory Function Tests; D012189:Retrospective Studies; D017565:Sarcoidosis, Pulmonary / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D016138:Walking
D000697:Central Nervous System Stimulants; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D064699:Dexmethylphenidate Hydrochloride; D008774:Methylphenidate