Trial reportBMC gastroenterology2004
Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial [ISRCTN88246634].
Trial report in BMC gastroenterology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 5 syntheses or guidelines pooled it, 63 citations in OpenAlex.
- Quality of life in primary sclerosing cholangitis: a systematic review.Health and quality of life outcomes · 2021Pooled it
- Guideline
- Treatment of Fatigue in Primary Biliary Cholangitis: A Systematic Review and Meta-Analysis.Digestive diseases and sciences · 2019Pooled it
- Patient-reported outcome measures used in patients with primary sclerosing cholangitis: a systematic review.Health and quality of life outcomes · 2018Pooled it
- Pharmacological interventions for primary biliary cholangitis: an attempted network meta-analysis.The Cochrane database of systematic reviews · 2017Pooled it
- Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary Sclerosing Cholangitis.American journal of therapeuticsTrial
- Understanding fatigue in primary biliary cholangitis: From pathophysiology to treatment perspectives.World journal of hepatology · 2022Review
- Review article: current and emerging therapies for the management of cirrhosis and its complications.Alimentary pharmacology & therapeutics · 2022Review
- Fatigue in chronic liver disease patients: prevalence, pathophysiology, and management.Przeglad gastroenterologiczny · 2022Review
- Magnetic resonance imaging evidence of hippocampal structural changes in patients with primary biliary cholangitis.Clinical and translational gastroenterology · 2018Article
- The impact of depression and antidepressant usage on primary biliary cholangitis clinical outcomes.PloS one · 2018Article
- Pharmacological interventions for primary sclerosing cholangitis: an attempted network meta-analysis.The Cochrane database of systematic reviews · 2017Review
- Managing Sleep Disturbances in Cirrhosis.Scientifica · 2016Review
- Primary Sclerosing Cholangitis: Therapeutic Options and Surveillance Management.Clinical medicine insights. Gastroenterology · 2016Review
- Fatigue in primary sclerosing cholangitis is associated with sympathetic over-activity and increased cardiac output.Liver international : official journal of the International Association for the Study of the Liver · 2015Article
- Primary Biliary Cirrhosis and Primary Sclerosing Cholangitis: a Review Featuring a Women's Health Perspective.Journal of clinical and translational hepatology · 2014Review
- Fatigue before, during and after antiviral therapy of chronic hepatitis C: results from the Virahep-C study.Journal of hepatology · 2012Article
- Fatigue in primary biliary cirrhosis.Nature reviews. Gastroenterology & hepatology · 2010Review
- Moexipril for treatment of primary biliary cirrhosis in patients with an incomplete response to ursodeoxycholic acid.Digestive diseases and sciences · 2010Article
- Modafinil in the treatment of debilitating fatigue in primary biliary cirrhosis: a clinical experience.Digestive diseases and sciences · 2009Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFatigue 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.
methodsFatigued 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.
resultsSeventeen 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.
conclusionWe found no evidence for a beneficial effect of fluvoxamine on fatigue in these patients with cholestatic liver disease and severe chronic fatigue.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.