PURPOSE: Fatigue is a major complaint of sarcoidosis patients. Dexmethylphenidate hydrochloride (d-MPH, Focalin) has been shown to be effective for chemotherapy associated fatigue. We studied the effectiveness of d-MPH in treating sarcoidosis associated fatigue.
METHODS: We performed a double blind randomized placebo controlled crossover trial of d-MPH in patients with sarcoidosis. Patients were seen weekly throughout the trial. After one week wash in period, patients were started on one tablet twice a day of either 5 mg d-MPH or placebo. At each weekly visit, patients completed instruments to assess fatigue: the non disease specific Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Fatigue Assessment Score (FAS), specific for sarcoidosis. For FACIT-F, the higher the score, the less the fatigue and the maximum score is 52. For FAS, the higher the score, the more the fatigue and the maximum score is 50. The number of pills (5 mg tablets of d-MPH or placebo) was adjusted at each visit based on toxicity, with a maximal potential dose of d-MPH of 10 mg twice a day. After 8 weeks, the medications were stopped. After a 2 week wash-out period, patients were then crossed over to 8 weeks of the other treatment (d-MPH or placebo).
RESULTS: Ten sarcoidosis patients were enrolled in this study: 8 females and five African Americans. All patients were receiving systemic therapy for their sarcoidosis. The results of the FAS and FACIT-F scores were compared for the last 4 weeks of d-MPH versus placebo. Patients experienced less fatigue while on d-MPH, with the FACIT-F score being significantly higher (d-MPH= 28.5 (7-52) (Median (range); Placebo= 25 (4-46), (p<0.002) and the FAS score significantly lower (d-MPH= 28 (8-43); Placebo=34 (9-45), (p<0.005). The major complaint was insomnia, which responded to lower afternoon drug doses.
CONCLUSION: Treatment with d-MPH was associated with a significant improvement in sarcoidosis associated fatigue.
CLINICAL IMPLICATIONS: In patients with sarcoidosis associated fatigue, therapy with d-MPH or similar agents may improve clinical symptoms and improve the patient's quality of life.
DISCLOSURE: Robert Baughman, No Financial Disclosure Information; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. d-MPH is not approved for fatigue in sarcoidosis