Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy for fatigue in patients with advanced cancer.

Cancer
Maxine de la CruzEduardo Bruera

Abstract

A significant response to placebo in randomized controlled trials of treatments for cancer-related fatigue (CRF) had been reported. A retrospective study was conducted to determine the frequency and predictors of response to placebo effect and nocebo effects in patients with CRF treated in those trials. The records of 105 patients who received placebo in 2 previous randomized clinical trials conducted by this group were reviewed. The proportion of patients who demonstrated clinical response to fatigue, defined as an increase in Functional Assessment of Chronic Illness Therapy-Fatigue score of > or = 7 from baseline to Day 8, and the proportion of patients with a nocebo effect, defined as those reporting >2 side effects, were determined. Baseline patient characteristics and symptoms recorded using the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. Fifty-nine (56%) patients had a placebo response. Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate) were significantly associated with placebo response. Commonly reported side effects were insomnia (79%), anorexia (53%), nausea (38%), and restlessness (34%). Multivariat...Continue Reading

References

Nov 1, 1975·Journal of Psychiatric Research·M F FolsteinP R McHugh
May 25, 1994·JAMA : the Journal of the American Medical Association·J A TurnerW E Fordyce
Aug 1, 1993·Psychological Medicine·M Shepherd
Jan 7, 1998·Scientific American·W A Brown
Apr 20, 1999·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·S A Montgomery
May 17, 2000·Cancer·V T ChangM Feuerman
May 24, 2001·The New England Journal of Medicine·A Hróbjartsson, P C Gøtzsche
Jul 17, 2001·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·D CellaUNKNOWN Fatigue Coalition
Sep 15, 2001·Clinical Pharmacology and Therapeutics·M Averbuch, M Katzper
Feb 7, 2002·JAMA : the Journal of the American Medical Association·Arthur J BarskyJonathan F Borus
Dec 24, 1955·Journal of the American Medical Association·H K BEECHER
Jul 21, 2004·Journal of the National Cancer Institute. Monographs·Donald P LawrenceJoseph Lau
Apr 20, 2005·Headache·Donald W LewisWarren Wasiewski
Nov 11, 2005·The Journal of Neuroscience : the Official Journal of the Society for Neuroscience·Fabrizio BenedettiJon-Kar Zubieta
Apr 1, 2006·Alimentary Pharmacology & Therapeutics·N J TalleyD L Earnest
May 2, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eduardo BrueraJ Lynn Palmer
May 17, 2006·Pain·Luana Colloca, Fabrizio Benedetti
Feb 28, 2007·Journal of Psychosomatic Research·Michael E HylandAdam W A Geraghty
Aug 10, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eduardo BrueraJ Lynn Palmer
Mar 29, 2008·Pain·L CollocaF Benedetti
Apr 2, 2008·Contemporary Clinical Trials·Ted J KaptchukMichael E Wechsler
Apr 29, 2008·Journal of Psychosomatic Research·Ben WhalleyIrving Kirsch

❮ Previous
Next ❯

Citations

Aug 4, 2011·Journal of Neurology·Dimitrios Papadopoulos, Dimos Dimitrios Mitsikostas
Dec 24, 2011·Current Neurology and Neuroscience Reports·Dimos D Mitsikostas
Jun 12, 2012·Journal of Acupuncture and Meridian Studies·Fabrizio Benedetti
Mar 2, 2013·Nature Reviews. Drug Discovery·Paul EnckWinfried Rief
Mar 16, 2012·The American Journal of Bioethics : AJOB·Rebecca Erwin Wells, Ted J Kaptchuk
Aug 25, 2011·Psychosomatic Medicine·Luana Colloca, Franklin G Miller
Jul 14, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Amanda R MoraskaCharles L Loprinzi
Apr 5, 2014·BioMed Research International·Natalie SampsonChristoph Zenzmaier
Jul 25, 2013·Pharmacology & Therapeutics·Danielle Murray, A Jon Stoessl
May 14, 2014·Journal of Pain and Symptom Management·David Hui, Eduardo Bruera
Dec 17, 2014·Expert Review of Clinical Pharmacology·Martina Amanzio
Mar 26, 2013·Journal of Pain and Symptom Management·Christine SandersonDavid C Currow
Jun 12, 2012·The Journal of Supportive Oncology·Glenn J LesserUNKNOWN Wake Forest University Community Clinical Oncology Program Research Base
May 31, 2011·Patient Education and Counseling·Fabrizio Benedetti, Martina Amanzio
Sep 24, 2015·Journal of Crohn's & Colitis·J E KreijneC J van der Woude
Jan 22, 2011·Depression and Anxiety·Shawn D YoungstedtJames W Hardin
Apr 18, 2012·Cancer·Ann M BergerDeborah K Mayer
Apr 29, 2015·The Journal of Alternative and Complementary Medicine : Research on Paradigm, Practice, and Policy·Yichen XuXin Shelley Wang
Jun 16, 2012·Journal of Pain and Symptom Management·Sriram YennurajalingamEduardo Bruera
Dec 3, 2014·Gynecologic Oncology·Xin Shelley Wang, Jeanie F Woodruff
May 2, 2014·Pain·Gitte Laue PetersenLene Vase
Jun 30, 2016·Journal of Palliative Medicine·Timothy H M ToDavid C Currow
Apr 16, 2015·Integrative Cancer Therapies·Sriram YennurajalingamEduardo Bruera
Sep 1, 2016·Journal of Clinical Psychopharmacology·Martina AmanzioLene Vase
Oct 25, 2012·The Australian and New Zealand Journal of Psychiatry·João Data-Franco, Michael Berk
Feb 28, 2013·Palliative Medicine·Eduardo Bruera, David Hui
Sep 12, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Janet HardyDavid C Currow
May 22, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eduardo BrueraMarlene Z Cohen
Jun 21, 2017·Current Opinion in Psychiatry·Antje D ArltWinfried Rief
Feb 7, 2018·British Journal of Health Psychology·Rebecca K WebsterG James Rubin
Aug 18, 2018·Expert Review of Clinical Immunology·Lieven PouillonLaurent Peyrin-Biroulet
Jun 25, 2018·Journal of Medical Ethics·Phoebe Friesen, Charlotte Blease
Jan 30, 2020·Expert Review of Clinical Pharmacology·Martina Amanzio, Sara Palermo
Nov 22, 2012·Clinical Trials : Journal of the Society for Clinical Trials·Jarred YoungerSean Mackey
Dec 19, 2019·Frontiers in Pharmacology·Luana CollocaT Kevin Murphy

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