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


CONCLUSIONS
We found no evidence for a beneficial effect of fluvoxamine on fatigue in these patients with cholestatic liver disease and severe chronic fatigue.
ter Borg
Pieter C J
PC
Department of Gastroenterology and Hepatology, Erasmus MC, Dr, Molewaterplein 40, Rotterdam, The Netherlands. pterborg@zonnet.nl
van Os
Erik
E
van den Broek
Walter W
WW
Hansen
Bettina E
BE
van Buuren
Henk R
HR
D015209:Cholangitis, Sclerosing / Q000150:complications*; D004244:Dizziness / Q000139:chemically induced; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology*; D005260:Female; D016666:Fluvoxamine / Q000009:adverse effects / Q000627:therapeutic use*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008105:Liver Cirrhosis, Biliary / Q000150:complications*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D016896:Treatment Outcome
D016666:Fluvoxamine