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Am J Ther. 2017 Mar/Apr;24(2):e167-e176. doi: 10.1097/MJT.0000000000000387.

A Randomized, Placebo-Controlled Clinical Trial of Efficacy and Safety: Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis.

Author information

1
1Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, MN; 2Division of Gastroenterology and Hepatology, Case Western Reserve University, Louis Stokes Cleveland VA Medical Center and Case Medical Center, Cleveland, OH; 3Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix, AZ; and 4College of Health Solutions, Arizona State University, Phoenix, AZ.

Abstract

BACKGROUND AND AIMS:

Fatigue is a common symptom of primary biliary cirrhosis (PBC), and is associated with an impaired quality of life.

STUDY QUESTION:

No studies have assessed the use of modafinil in fatigue related to PBC in a controlled manner.

STUDY DESIGN, MEASURES, AND OUTCOMES:

A randomized, double-blind, placebo-controlled study was conducted to determine the safety and efficacy of modafinil for the treatment of fatigue in PBC. Forty patients were randomized to modafinil (n = 20) or placebo (n = 20) for 12 weeks. A verbal report of fatigue for at least 6 months was required for enrollment. Modafinil was administered at 100 mg by mouth once daily; a change by 50 mg every 2 weeks (maximum: 200 mg once daily) was allowed, depending on the subject's response to treatment. The primary outcome was defined as a ≥50% improvement in fatigue severity [quantified by the Fisk Fatigue Impact Scale (FFIS)] after 12 weeks of treatment, compared with baseline values.

RESULTS:

Thirty-three PBC patients completed the study. After 12 weeks of therapy, only 5 patients had a ≥50% reduction in FFIS scores: 3 patients (17.6%) in the modafinil arm and 2 (12.5%) in the placebo arm (P = 1.00). Change in median FFIS score was not statistically different between patients in the 2 treatment groups (P = 0.36). Modafinil was associated with minimal adverse events (headaches, diarrhea, and rash).

CONCLUSIONS:

In patients with PBC who have fatigue, treatment with modafinil for 12 weeks was safe and fairly well tolerated; however, it did not result in beneficial effects on fatigue compared with patients treated with placebo (CONSORT Table 1). ClinicalTrials.gov identifier NCT00943176.

PMID:
27148676
DOI:
10.1097/MJT.0000000000000387
[Indexed for MEDLINE]

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