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

Chest. 2008 May;133(5):1189-95. doi: 10.1378/chest.07-2952. Epub 2008 Feb 8.


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: Identifier: NCT00361387.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Central Nervous System Stimulants / therapeutic use*
  • Cross-Over Studies
  • Dexmethylphenidate Hydrochloride*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Exercise Test / methods
  • Fatigue / diagnosis
  • Fatigue / drug therapy*
  • Fatigue / etiology
  • Female
  • Follow-Up Studies
  • Glucocorticoids / therapeutic use
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Male
  • Methylphenidate / therapeutic use*
  • Middle Aged
  • Respiratory Function Tests
  • Retrospective Studies
  • Sarcoidosis, Pulmonary / complications*
  • Sarcoidosis, Pulmonary / diagnosis
  • Sarcoidosis, Pulmonary / drug therapy
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Treatment Outcome
  • Walking


  • Central Nervous System Stimulants
  • Glucocorticoids
  • Immunosuppressive Agents
  • Dexmethylphenidate Hydrochloride
  • Methylphenidate

Associated data