In a study led by Jeremy J. Theal, M.D. of the University of Toronto and published in the June 2005 issue of Hepatology, researchers examined the effects of ondansetron (an anti-nausea drug commonly used to treat nausea during chemotherapy) on fatigue associated with PBC, an inflammation of the bile ducts in the liver that leads to cirrhosis. Fatigue is often associated with depression, which may be caused by abnormalities in serotonin transmission; ondansetron helps regulate serotonin levels, which suggests its potential as a treatment for fatigue and depression.
Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD), published by John Wiley & Sons, Inc. is available online via Wiley InterScience at http://www.interscience.wiley.com/journal/hepatology.
A total of 54 patients from three Canadian centers (Toronto, Montreal, and Calgary) were included in a randomized, double blind placebo-controlled crossover trial, in which they received the drug in one four week period and a placebo in the other. The crossover design was chosen because fatigue is a subjective symptom and taking both the drug and the placebo in two separate blinded periods allowed patients to serve as their own controls. In addition to a diagnosis of PBC, patients had to score at least a 4 on the Fatigue Survey Score survey (FSS), a scoring system used to evaluate fatigue in patients with PBC. Patients received either a placebo in period 1 and ondansetron in period 2 or vice versa, but did not know which group they were in.