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Vol 274 No 7347 p512
30 April 2005

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Modafinil fails to improve fatigue

Modafinil, a drug used to treat daytime sleepiness, does not appear to improve fatigue in patients with multiple sclerosis, a trial has revealed. Aspirin, on the other hand, may reduce the severity of this symptom.

French researchers examined the effects of modafinil in 115 patients with relapsing remitting or progressive MS who were also suffering from chronic fatigue. They found that the drug was no better than placebo at relieving self-reported fatigue symptoms. After 35 days of treatment, both had improved mean scores on a modified fatigue impact scale (63.1±9.3 to 52.3±18.5 for modafinil vs 63.3±10 to 49.2±16.6 for placebo).

Although the researchers conclude that no benefit was detected for modafinil, they say that an unpublished post hoc analysis did reveal an effect related to sleepiness. “Among patients with excessive daytime sleepiness, modafinil tended to provide more benefit than placebo on the physical component of fatigue,” they say (Neurology 2005;64:1139).

In a second study (ibid, p1267), researchers observed an improvement in patient scores during treatment with aspirin (1,300mg daily) compared with placebo (P=0.043). Patients were treated with both aspirin and placebo in the cross-over trial. Among the 26 patients who completed both phases, 10 (38.5 per cent) preferred aspirin whereas only one (3.9 per cent) preferred placebo (P=0.012).

An accompanying editorial warns that the apparent benefit of aspirin and the lack of benefit of modafinil may be related to their effects on other MS symptoms. “It is not clear that patients adequately distinguish effects of fatigue from motor impairment, cognitive impairment and other symptoms,” the authors argue (ibid, p1111).

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