A randomized, controlled crossover trial of ondansetron in patients with primary biliary cirrhosis and fatigue

Hepatology

Volumn 41, Issue 6, 2005, Pages 1305-1312

  Theal, Jeremy J ^a   Toosi, Mohssen N ^a   Girlan, Larisa ^a   Heslegrave, Ronald J ^a   Huet, Pierre Michel ^b   Burak, Kelly W ^c   Swain, Mark ^c   Tomlinson, George A ^a   Heathcote, E Jenny ^a,d  

^a UNIVERSITY HEALTH NETWORK   (Canada)

^b UNIVERSITY OF MONTREAL   (Canada)

^c UNIVERSITY OF CALGARY   (Canada)

^d TORONTO WESTERN HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ONDANSETRON; PLACEBO; SEROTONIN 3 ANTAGONIST;

ADULT; AGED; AGITATION; ARTICLE; BILIARY CIRRHOSIS; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE SEVERITY; DIZZINESS; DROWSINESS; DRUG EFFICACY; FATIGUE; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUROTRANSMISSION; PATHOGENESIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROTONIN RELEASE; SIDE EFFECT; SYNCOPE; VALIDATION PROCESS;

CONSTIPATION; CROSS-OVER STUDIES; FATIGUE; HEADACHE; HUMANS; LIVER CIRRHOSIS, BILIARY; MIDDLE AGED; ONDANSETRON; PATIENT COMPLIANCE; SEROTONIN ANTAGONISTS; SEVERITY OF ILLNESS INDEX; TREATMENT FAILURE;

EID: 20044375206     PISSN: 02709139     EISSN: None     Source Type: Journal    
DOI: 10.1002/hep.20698     Document Type: Article

References (29)

1. Cauch-Dudek K, Abbey S, Stewart DE, Heathcote EJ. Fatigue in primary biliary cirrhosis. Gut 1998;43:705-710.
2. Huet P-M, Deslauriers J, Tran A, Faucher C, Charbonneau J. Impact of fatigue on the quality of life in patients with primary biliary cirrhosis. Am J Gastroenterol 2000;95:760-767.
3. Goldblatt J, Taylor PJ, Lipman T, Prince MI, Baragiotta A, Bassendine MF, et al. The true impact of fatigue in primary biliary cirrhosis: a population study. Gastroenterology 2002;122:1235-1241.
4. Witt-Sullivan H, Heathcote J, Cauch K, Blendis L, Ghent C, Katz A, et al. The demography of primary biliary cirrhosis in Ontario, Canada. HEPATOLOGY 1990;12:98-105.
5. Gluud C, Christensen E. Ursodeoxycholic acid for primary biliary cirrhosis: a meta-analysis. Cochrane Database Syst Rev 2002;CD000551.
6. Wiesner RH, Ludwig J, Lindor KD, Jorgensen RA, Baldus WP, Homburger HA, et al. A controlled trial of cyclosporine in the treatment of primary biliary cirrhosis. N Engl J Med 1990;322:1419-1424.
7. McCormick PA, Scott F, Epstein O, Burroughs AK, Scheuer PJ, McIntyre N. Thalidomide for primary biliary cirrhosis: a double-blind placebo-controlled pilot study. J Hepatol 1994:21:496-499.
8. Prince MI, Mitchison HC, Ashley D, Burke DA, Edwards N, Bramble MG, et al. Oral antioxidant supplementation for fatigue associated with primary biliary cirrhosis: results of a multicentre, randomized, placebo-controlled, cross-over trial. Aliment Pharmacol Ther 2003;17:137-143.
9. Jalan R, Gibson H, Lombard MG. Patients with PBC have central but not peripheral fatigue [Abstract]. HEPATOLOGY 1996;24(Suppl 1):A162.
10. Swain MG, Patchev V, Vergalla J, Chrousos G, Jones EA. Suppression of hypothalamic-pituitary-adrenal axis responsiveness to stress in rat model of acute cholestasis. J Clin Invest 1993;91:1903-1908.
11. Swain MG, Maric M. Improvement in cholestasis-associated fatigue with serotonin receptor agonist using a novel rat model of fatigue assessment. HEPATOLOGY 1997;25:291-294.
12. Swain MG, Mogiakou MA, Bergasa NV, Chrousos GP. Facilitation of ACTH and cortisol responses to corticotropin-releasing hormone (CRH) in patients with primary biliary cirrhosis (PBC) [Abstract]. HEPATOLOGY 1994;20(Suppl 1):146A.
13. Wilson WM, Maughan RJ. Evidence for a possible role of 5-HT in the genesis of fatigue in men: administration of paroxetine, a 5-HT re-uptake inhibitor, reduce the capacity to perform prolonged exercise. Exp Physiol 1992;77:921-924.
14. Bonhomme N, Esposito E. Involvement of serotonin and dopamine in the mechanism of action of novel antidepressant drugs: a review. J Clin Psychopharmacol 1998;18:447-454.
15. Blier P, De Montigny C. Serotonin and drug-induced therapeutic responses in major depression, obsessive-compulsive and panic disorders. Neuropsychopharmacology 1999;21(Suppl):91S-98S.
16. Bakheit AMO, Behan PO, Dianan TG, Gary CE, O'Keane V. Possible upregulation of hypothalamic 5-hydroxytryptamine receptors in patients with postural fatigue syndrome. BMJ 1992;304:1010-1012.
17. Jones EA. Relief from profound fatigue associated with chronic liver disease by long-term ondansetron therapy. Lancet 1999;354:397.
18. Schwartz JE, Jandorf L, Krupp LB. The measurement of fatigue: a new instrument. J Psychosom Res 1993;37:753-762.
19. Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the Fatigue Impact Scale. Clin Infect Dis 1994;18(Suppl):S79-S83.
20. Prince MI, James OF, Holland NP, Jones DE. Validation of a fatigue impact score in primary biliary cirrhosis: towards a standard for clinical and trial use. J Hepatol 2000;32:368-373.
21. Thorne DR, Genser SG, Sing HC, Hegge FW. The Walter Reed Performance Assessment Battery. Neurobehav Toxicol Teratol 1985;7:415-418.
22. Heslegrave RJ, Angus RG. The effects of task duration and work-session location on performance degradation induced by sleep loss and sustained cognitive work. Behav Res Methods Instrum Comput 1985;17:592-603.
23. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56-62.
24. Buysse DJ, Reynolds CF III, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res 1989;28:193-213.
25. Olver I, Paska W, Depierre A, Seitz JF, Stewart DJ, Goedhals L, et al. A muticentre, double-blind study comparing placebo, ondansetron and ondansetron plus dexamethasone for the control of cisplatin-induced delayed emesis. Ann Oncol 1996;7:945-952.
26. Katz R, Deveaugh-Geiss J. The issue of side effects and the 'blind ability' of clinical drug trials. Am J Psychiatry 1993;150:1759-1760.
27. White K, Kando J, Park T, Waternaux C, Brown WA. Side effects and the 'blindability' of clinical drug trials. Am J Psychiatry 1992; 149: 1730-1731.
28. Spilker B. Guide to Clinical Trials. New York: Lippincott-Raven, 1996.
29. Altman DG. Practical Statistics for Medical Research. London: Chapman & Hall, 1991.