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Title: Ondansetron May Reduce Fatigue in Patients with Primary Biliary Cirrhosis: Presented at AASLD

"Ondansetron May Reduce Fatigue in Patients with Primary Biliary Cirrhosis: Presented at AASLD"

By Charles Bankhead Special to DG News BOSTON, MA -- November 5, 2002 -- The serotonin type-3 receptor antagonist ondansetron could prove useful in relieving fatigue associated with primary biliary cirrhosis (PBC). The finding was presented here November 3 at the American Association for the Study of Liver Diseases. During treatment with ondansetron, significantly more patients had improvement in fatigue scores, as compared to the placebo phase of the study. The mean fatigue score also was significantly lower during ondansetron treatment. However, patients' ability to recognize ondansetron-associated constipation could have skewed the results, said Dr. Jeremy Theal, an internal medicine research resident at the University of Toronto, in Ontario, Canada. "Fatigued PBC patients taking ondansetron exhibited a statistically significant reduction in fatigue," said Dr. Theal. "However, constipation was common in patients taking ondansetron, and this might have produced an unblinding or sequence effect, although it was not statistically detectable." Potential limitations notwithstanding, ondansetron eliminated fatigue in more than twice as many patients, as compared to placebo, he added. Fatigue affects a majority of PBC patients, and the proportion ranges as high as 86 percent in some studies, said Dr. Theal. The pathogenesis of PBC-related fatigue is not well understood, but altered serotonin levels or activity is one theory. Anecdotal and case evidence suggests ondansetron might be useful in treating fatigue. The findings came from a randomised, blinded, crossover trial involving 60 PBC patients who had fatigue, as defined by Fisk Fatigue Severity Score (FFSS) greater than 4. The patients were randomised to treatment with placebo or to ondansetron 4 mg/day for 4 weeks, followed by a washout period, then crossover to the opposite therapy for an additional four weeks. Ondansetron therapy was associated with a statistically significant decline in FFSS, whereas the mean fatigue score did not change during placebo treatment. Two of three dimensions of the Fatigue Impact Score also declined significantly during ondansetron treatment (physical and social), and the third dimension (cognitive) showed a strong trend toward improvement. Overall, 33 percent of patients were not fatigued during ondansetron therapy (defined as an FFSS of less than 4), compared to 14 percent during the placebo phase. The impact of ondansetron on fatigue was most pronounced during the second phase of randomised therapy, as 44 percent of patients were not fatigued, compared to 13 percent in the placebo group. Ondansetron did not have a significant effect on fatigue during the first phase. The mean fatigue score was 4.33 with ondansetron and 5.29 during placebo treatment (p=.01). Patients were told in advance that constipation is a potential side effect of ondansetron, and three-fourths of the patients experienced constipation during ondansetron therapy. Although statistical analysis revealed no confounding variables, Dr. Theal and colleagues speculated that patients might have known when they were being treated with ondansetron, which could have explained the more pronounced treatment effect during the second phase of the study.

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