Research article

Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial [ISRCTN88246634]

Pieter CJ ter Borg¹ , Erik van Os² , Walter W van den Broek² , Bettina E Hansen³ and Henk R van Buuren¹

¹  Department of Gastroenterology and Hepatology, Erasmus MC, Dr. Molewaterplein 40, Rotterdam, The Netherlands

²  Department of Psychiatry, Erasmus MC, Dr. Molewaterplein 40, Rotterdam, The Netherlands

³  Department of Epidemiology and Biostatistics, Erasmus MC, Dr. Molewaterplein 40, Rotterdam, The Netherlands

author email corresponding author email

BMC Gastroenterology 2004, 4:13doi:10.1186/1471-230X-4-13

Published:	13 July 2004

Abstract

Background

Fatigue is a major clinical problem in many patients with primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). An effective treatment has not been defined. Recently, a large proportion of patients with these diseases was found to have symptoms of depression. Because fatigue is a frequent symptom of depression and there is some evidence that treatment with an antidepressant improves fatigue in patients with fibromyalgia, we hypothesised that the antidepressant fluvoxamine might improve fatigue related to PBC and PSC.

Methods

Fatigued patients were randomised to receive fluvoxamine (75 mg BID) or placebo for a six-week period. Fatigue and quality of life were quantified using a visual analogue scale, the Fisk Fatigue Severity Scale, the Multidimensional Fatigue Inventory and the SF-36.

Results

Seventeen and 16 patients were allocated to fluvoxamine and placebo, respectively. There was no statistically significant beneficial effect of fluvoxamine on fatigue or quality of life. The median VAS scores in the fluvoxamine and placebo groups were 7.40 and 7.45 at day 0, 6.9 and 7.15 at day 14, 7.45 and 7.65 at day 42 and 7.8 and 8.0 four weeks after treatment discontinuation.

Conclusion

We found no evidence for a beneficial effect of fluvoxamine on fatigue in these patients with cholestatic liver disease and severe chronic fatigue.