Fluoxetine for the treatment of fatigue in primary biliary cirrhosis: A randomized, double-blind controlled trial

Jayant A. Talwalkar, Jessica J. Donlinger, Andrea A. Gossard, Jill C. Keach, Roberta A. Jorgensen, Janice C. Petz, Keith D. Lindor

Research output: Contribution to journalArticlepeer-review

41 Scopus citations


Fatigue is a common symptom in primary biliary cirrhosis (PBC). In animal models of cholestasis, abnormalities in serotonin neurotransmission are observed with fatigue. The role of selective serotonin reuptake inhibitors in fatigue-related PBC, however, is unknown. A double-blind, placebo-controlled study design was conducted to determine the safety and efficacy of fluoxetine for the treatment of fatigue in PBC. Patients were randomized to fluoxetine, 20 mg daily, or matched placebo for 8 weeks' duration. Fatigue was assessed by the Fisk Fatigue Impact Scale (FFIS). The primary study endpoint was a ≥50% reduction in overall FFIS score at the end of treatment. Health-related quality of life (HRQL) was assessed as a secondary endpoint. Among 220 consecutively screened patients, only 18 (9%) eligible individuals were randomized to fluoxetine (n=10) or placebo (n=8) for 8 weeks. Baseline variables including median FFIS scores (52 vs 42; P=0.21) were similar between treatment arms (P>0.05). After 8 weeks of therapy, no statistically significant change in median FFIS score was observed in the fluoxetine group. Median FFIS score in the placebo group was reduced (42 to 28), but not statistically significant. No difference in HRQL was observed between treatment arms after 8 weeks. Fourteen (78%) patients completed therapy, while four (22%) individuals withdrew from the trial. Three of the four patients had drug-related adverse events with fluoxetine. In this study, fluoxetine did not improve fatigue in PBC and was associated with adverse events.

Original languageEnglish (US)
Pages (from-to)1985-1991
Number of pages7
JournalDigestive Diseases and Sciences
Issue number11
StatePublished - Nov 1 2006
Externally publishedYes


  • Fatigue
  • Liver disease
  • Primary biliary cirrhosis
  • Treatment

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology


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