{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T22:53:21Z","timestamp":1779317601453,"version":"3.51.4"},"reference-count":34,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2006,12,20]],"date-time":"2006-12-20T00:00:00Z","timestamp":1166572800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2007,2]]},"abstract":"<jats:sec><jats:title>Summary<\/jats:title><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Fatigue is a debilitating symptom which frequently impairs the quality of life of patients with primary biliary cirrhosis (PBC). Although the mechanisms underpinning fatigue in PBC remain unclear, there is an emerging consensus that CNS mechanisms play a key role. It has recently been shown that there is a strong association between abnormalities in sleep regulation, in particular excessive daytime somnolence, and fatigue severity in PBC. The CNS\u2010acting drug modafinil has an established role in the treatment of excessive daytime somnolence in non\u2010liver disease states.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To explore, in an open label study, the responses of PBC patients suffering from significant daytime somnolence and associated fatigue to modafinil therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>All patients in the series (<jats:italic>n<\/jats:italic>\u2003=\u200321) underwent daytime somnolence assessment using the Epworth Sleepiness Scale and PBC symptom assessment using the PBC\u201040, a multi\u2010domain, disease specific, psychometrically robust quality of life measure. Modafinil was started at a dose of 100\u2003mg\/day and was titrated according to tolerability and response. Patients underwent repeat Epworth Sleepiness Scale and PBC\u201040 assessment after 2\u2003months of treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Significant improvement was seen in Epworth Sleepiness Scale scores with modafinil therapy [15\u2003\u00b1\u20033 vs. 8\u2003\u00b1\u20036, <jats:italic>P<\/jats:italic>\u2003&lt;\u20030.0005 (intention\u2010to\u2010treat analysis)]. An equally significant improvement in fatigue severity was also seen [PBC\u201040 fatigue domain score (46\u2003\u00b1\u20036 vs. 34\u2003\u00b1\u200312, <jats:italic>P<\/jats:italic>\u2003&lt; 0.0001) (intention\u2010to\u2010treat analysis)].<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Open label modafinil therapy was associated, where tolerated by patients, with improvement in excessive daytime somnolence and associated fatigue in PBC. Further study in placebo\u2010controlled trials is warranted.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1365-2036.2006.03223.x","type":"journal-article","created":{"date-parts":[[2010,7,23]],"date-time":"2010-07-23T12:45:37Z","timestamp":1279889137000},"page":"471-476","source":"Crossref","is-referenced-by-count":98,"title":["An open study of modafinil for the treatment of daytime somnolence and fatigue in primary biliary cirrhosis"],"prefix":"10.1111","volume":"25","author":[{"given":"D. E. J.","family":"JONES","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. 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