CONTEXT: Fatigue has been identified in more than one-half of patients with sarcoidosis. Although fatigue is not synonymous with impaired quality of life, most studies of sarcoidosis identify fatigue as a major cause of impaired quality of life. OBJECTIVES: To test the hypothesis that stimulants may have a role in the treatment of fatigued sarcoidosis patients, even without objective evidence of daytime sleepiness. METHODS: This was a double-blind, placebo-controlled, crossover study of sarcoidosis patients followed up in one sarcoidosis clinic Sarcoidosis patients with fatigue received eitherarmodafinil or placebo with eight weeks of therapy for each arm and a two week washout period before crossover to the other treatment. Initial armodafinil dose was 150mg and increased to 250mg after four weeks. Patients underwent polysomnography and multiple sleep latency testing (MSLT) the following day. Patients with an apnea/hypopnea index <6/hour received eitherarmodafinil or placebo. Polysomnography with MSLT was repeated after each treatment arm. RESULTS:Fifteen patients received the study drug. Fatigue was assessed using the Fatigue Assessment Scale (the lower the score, the less the fatigue) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (the higher the score, the less the fatigue). After eight weeks of therapy, there was a significant improvement in the Fatigue Assessment Scale during armodafinil treatment (median -4.5, range -20, 5) compared with placebo treatment (median 3.5, range -9, 14, P<0.05) and for the FACIT-F (armodafinil: median 9, range -12, 26 vs. placebo: median -5, range -17, 11, P<0.005). This improvement in fatigue was seen for both those with and without shortened sleep onset latency time during the MSLT. CONCLUSION:Armodafinil treatment led to a significant reduction in fatigue in sarcoidosis patients. This effect was seen even in patients who did not have excessive daytime somnolence.
RCT Entities:
CONTEXT: Fatigue has been identified in more than one-half of patients with sarcoidosis. Although fatigue is not synonymous with impaired quality of life, most studies of sarcoidosis identify fatigue as a major cause of impaired quality of life. OBJECTIVES: To test the hypothesis that stimulants may have a role in the treatment of fatigued sarcoidosispatients, even without objective evidence of daytime sleepiness. METHODS: This was a double-blind, placebo-controlled, crossover study of sarcoidosispatients followed up in one sarcoidosis clinic Sarcoidosispatients with fatigue received either armodafinil or placebo with eight weeks of therapy for each arm and a two week washout period before crossover to the other treatment. Initial armodafinil dose was 150mg and increased to 250mg after four weeks. Patients underwent polysomnography and multiple sleep latency testing (MSLT) the following day. Patients with an apnea/hypopnea index <6/hour received either armodafinil or placebo. Polysomnography with MSLT was repeated after each treatment arm. RESULTS: Fifteen patients received the study drug. Fatigue was assessed using the Fatigue Assessment Scale (the lower the score, the less the fatigue) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (the higher the score, the less the fatigue). After eight weeks of therapy, there was a significant improvement in the Fatigue Assessment Scale during armodafinil treatment (median -4.5, range -20, 5) compared with placebo treatment (median 3.5, range -9, 14, P<0.05) and for the FACIT-F (armodafinil: median 9, range -12, 26 vs. placebo: median -5, range -17, 11, P<0.005). This improvement in fatigue was seen for both those with and without shortened sleep onset latency time during the MSLT. CONCLUSION:Armodafinil treatment led to a significant reduction in fatigue in sarcoidosispatients. This effect was seen even in patients who did not have excessive daytime somnolence.
Authors: K W Rammohan; J H Rosenberg; D J Lynn; A M Blumenfeld; C P Pollak; H N Nagaraja Journal: J Neurol Neurosurg Psychiatry Date: 2002-02 Impact factor: 10.154
Authors: G W Hunninghake; U Costabel; M Ando; R Baughman; J F Cordier; R du Bois; A Eklund; M Kitaichi; J Lynch; G Rizzato; C Rose; O Selroos; G Semenzato; O P Sharma Journal: Sarcoidosis Vasc Diffuse Lung Dis Date: 1999-09 Impact factor: 0.670
Authors: Johan Verbraecken; Elske Hoitsma; Chris P M van der Grinten; Nicolle A M Cobben; Emiel F M Wouters; Marjolein Drent Journal: Sarcoidosis Vasc Diffuse Lung Dis Date: 2004-06 Impact factor: 0.670
Authors: David Cella; Martin J Zagari; Christina Vandoros; Dennis D Gagnon; Hans-Jürgen Hurtz; Johan W R Nortier Journal: J Clin Oncol Date: 2003-01-15 Impact factor: 44.544
Authors: Charles DeBattista; Karl Doghramji; Matthew A Menza; Murray H Rosenthal; Ronald R Fieve Journal: J Clin Psychiatry Date: 2003-09 Impact factor: 4.384
Authors: Michael J Fisch; Fengmin Zhao; Ann M O'Mara; Xin Shelley Wang; David Cella; Charles S Cleeland Journal: Cancer Date: 2013-10-21 Impact factor: 6.860
Authors: Robert P Baughman; Nadera Sweiss; Ruth Keijsers; Surinder S Birring; Ralph Shipley; Lesley Ann Saketkoo; Elyse E Lower Journal: Lung Date: 2017-03-28 Impact factor: 2.584
Authors: Christopher Atkins; Richard Fordham; Allan B Clark; Andrea Stockl; Andrew P Jones; Andrew M Wilson Journal: BMJ Open Date: 2017-12-04 Impact factor: 2.692