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Review

The influence of the nocebo effect in clinical trials

Pages 61-68 | Published online: 05 Nov 2012

References

  • Kennedy WP. The nocebo reaction. Med World. 1961;95:203–205.
  • Kissel P, Barrucand D. Placebos et Effet Placebo en Medecine. [Placebos and placebo effects in medicine]. Paris: Masson; 1964. French.
  • Rief W, Buhlmann U, Wilhelm S, Borkenhagen A, Brahler E. The prevalence of body dysmorphic disorder: a population-based survey. Psychol Med. 2006;36(6):877–885.
  • Barsky AJ, Saintfort R, Rogers MP, Borus JF. Nonspecific medication side effects and the nocebo phenomenon. JAMA. 2002;287(5): 622–627.
  • Colloca L, Benedetti F. Nocebo hyperalgesia: how anxiety is turned into pain. Curr Opin Anaesthesiol. 2007;20(5):435–439.
  • Colloca L, Miller FG. The nocebo effect and its relevance for clinical practice. Psychosom Med. 2011;73(7):598–603.
  • Benedetti F, Lanotte M, Lopiano L, Colloca L. When words are painful: unraveling the mechanisms of the nocebo effect. Neuroscience. 2007; 147(2):260–271.
  • Schweiger A, Parducci A. Nocebo: the psychologic induction of pain. Pavlov J Biol Sci. 1981;16(3):140–143.
  • Oftedal G, Straume A, Johnsson A, Stovner LJ. Mobile phone headache: a double blind, sham-controlled provocation study. Cephalalgia. 2007;27(5):447–455.
  • Stovner LJ, Oftedal G, Straume A, Johnsson A. Nocebo as headache trigger: evidence from a sham-controlled provocation study with RF fields. Acta Neurol Scand Suppl. 2008;188:67–71.
  • Colloca L, Sigaudo M, Benedetti F. The role of learning in nocebo and placebo effects. Pain. 2008;136(1–2):211–218.
  • Rief W, Henningsen P, Hiller W. Classification of somatoform disorders. Am J Psychiatry. 2006;163(4):746–847; author reply 747–748.
  • Klosterhalfen S, Kellermann S, Braun S, et al. Gender and the nocebo response following conditioning and expectancy. J Psychosom Res. 2009;66(4):323–328.
  • Mazzoni G, Foan L, Hyland ME, Kirsch I. The effects of observation and gender on psychogenic symptoms. Health Psychol. 2010;29(2):181–185.
  • Hahn RA. The nocebo phenomenon: concept, evidence, and implications for public health. Prev Med. 1997;26(5 Pt 1):607–611.
  • Koyama T, McHaffie JG, Laurienti PJ, Coghill RC. The subjective experience of pain: where expectations become reality. Proc Natl Acad Sci USA. 2005;102(36):12950–12955.
  • Keltner JR, Furst A, Fan C, Redfern R, Inglis B, Fields HL. Isolating the modulatory effect of expectation on pain transmission: a functional magnetic resonance imaging study. J Neurosci. 2006;26(16):4437–4443.
  • Scott DJ, Stohler CS, Egnatuk CM, Wang H, Koeppe RA, Zubieta JK. Placebo and nocebo effects are defined by opposite opioid and dopaminergic responses. Arch Gen Psychiatry. 2008;65(2):220–231.
  • Bingel U, Wanigasekera V, Wiech K, Ni Mhuircheartaigh R, Lee MC, Ploner M, Tracey I. The effect of treatment expectation on drug efficacy: imaging the analgesic benefit of the opioid remifentanil. Sci Transl Med. 2011 Feb 16;3(70):70ra14.
  • Luparello TJ, Leist N, Lourie CH, Sweet P. The interaction of psychologic stimuli and pharmacologic agents on airway reactivity in asthmatic subjects. Psychosom Med. 1970;32(5):509–513.
  • Flaten MA, Simonsen T, Olsen H. Drug-related information generates placebo and nocebo responses that modify the drug response. Psychosom Med. 1999;61(2):250–255.
  • Benedetti F, Pollo A, Lopiano L, Lanotte M, Vighetti S, Rainero I. Conscious expectation and unconscious conditioning in analgesic, motor, and hormonal placebo/nocebo responses. J Neurosci. 2003;23(10):4315–4323.
  • Benedetti F, Amanzio M, Casadio C, Oliaro A, Maggi G. Blockade of nocebo hyperalgesia by the cholecystokinin antagonist proglumide. Pain. 1997;71(2):135–140.
  • Benedetti F, Amanzio M, Vighetti S, Asteggiano G. The biochemical and neuroendocrine bases of the hyperalgesic nocebo effect. J Neurosci. 2006;26(46):12014–12022.
  • Andre J, Zeau B, Pohl M, Cesselin F, Benoliel JJ, Becker C. Involvement of cholecystokininergic systems in anxiety-induced hyperalgesia in male rats: behavioral and biochemical studies. J Neurosci. 2005;25(35):7896–7904.
  • Rief W, Barsky AJ, Glombiewski JA, Nestoriuc Y, Glaesmer H, Braehler E. Assessing general side effects in clinical trials: reference data from the general population. Pharmacoepidemiol Drug Saf. 2011;20(4):405–415.
  • Kasdan ML, Lewis K, Bruner A, Johnson AL. The nocebo effect: do no harm. J South Orthop Assoc. 1999;8(2):108–113.
  • Rief W, Avorn J, Barsky AJ. Medication-attributed adverse effects in placebo groups: implications for assessment of adverse effects. Arch Intern Med. 2006;166(2):155–160.
  • Rosenzweig P, Brohier S, Zipfel A. The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Clin Pharmacol Ther. 1993;54(5): 578–583.
  • Reuter U, Sanchez del Rio M, Carpay JA, Boes CJ, Silberstein SD; for GSK Headache Masters Program. Placebo adverse events in headache trials: headache as an adverse event of placebo. Cephalalgia. 2003;23(7):496–503.
  • Mitsikostas DD, Mantonakis LI, Chalarakis NG. Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment in headaches. Cephalalgia. 2011;31(5):550–561.
  • Amanzio M, Corazzini LL, Vase L, Benedetti F. A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain. 2009;146(3):261–269.
  • de la Cruz M, Hui D, Parsons HA, Bruera E. Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy for fatigue in patients with advanced cancer. Cancer. 2010;116(3):766–774.
  • Stockhorst U, Wiener JA, Klosterhalfen S, Klosterhalfen W, Aul C, Steingruber HJ. Effects of overshadowing on conditioned nausea in cancer patients: an experimental study. Physiol Behav. 1998;64(5): 743–753.
  • Colagiuri B, Zachariae R. Patient expectancy and post-chemotherapy nausea: a meta-analysis. Ann Behav Med. 2010;40(1):3–14.
  • Myers MG, Cairns JA, Singer J. The consent form as a possible cause of side effects. Clin Pharmacol Ther. 1987;42(3):250–253.
  • Cairns JA, Gent M, Singer J, et al. Aspirin, sulfinpyrazone, or both in unstable angina. Results of a Canadian multicenter trial. N Engl J Med. 1985;313(22): 1369–1375.
  • Andre-Obadia N, Magnin M, Garcia-Larrea L. On the importance of placebo timing in rTMS studies for pain relief. Pain. 2011;152(6): 1233–1237.
  • Colloca L. Learned placebo analgesia in sequential trials: what are the Pros and Cons? Pain. 2011;152(6):1215–1216.
  • O’Donoghue DP, Dawson AM, Powell-Tuck J, Bown RL, Lennard-Jones JE. Double-blind withdrawal trial of azathioprine as maintenance treatment for Crohn’s disease. Lancet. 1978;2(8097):955–957.
  • Lombardi C, Gargioni S, Canonica GW, Passalacqua G. The nocebo effect during oral challenge in subjects with adverse drug reactions. Eur Ann Allergy Clin Immunol. 2008;40(4):138–141.
  • Liccardi G, Senna G, Russo M, et al. Evaluation of the nocebo effect during oral challenge in patients with adverse drug reactions. J Investig Allergol Clin Immunol. 2004;14(2):104–107.
  • Benedetti F, Carlino E, Pollo A. Hidden administration of drugs. Clin Pharmacol Ther. 2011;90(5):651–661.
  • Colloca L, Lopiano L, Lanotte M, Benedetti F. Overt versus covert treatment for pain, anxiety, and Parkinson’s disease. Lancet Neurol. 2004;3(11):679–684.
  • Mondaini N, Gontero P, Giubilei G, et al. Finasteride 5 mg and sexual side effects: how many of these are related to a nocebo phenomenon? J Sex Med. 2007;4(6):1708–1712.
  • Varelmann D, Pancaro C, Cappiello EC, Camann WR. Nocebo-induced hyperalgesia during local anesthetic injection. Anesth Analg. 2010;110(3):868–870.
  • Brody H, Colloca L, Miller FG. The placebo phenomenon: implications for the ethics of shared decision-making. J Gen Intern Med. 2012;27(6):739–742.
  • Colloca L, Finniss D. Nocebo effects, patient-clinician communication, and therapeutic outcomes. JAMA. 2012;307(6):567–568.
  • Martin A, Rief W, Klaiberg A, Braehler E. Validity of the Brief Patient Health Questionnaire Mood Scale (PHQ-9) in the general population. Gen Hosp Psychiatry. 2006;28(1):71–77.
  • Peters E, Hart PS, Fraenkel L. Informing patients: the influence of numeracy, framing, and format of side effect information on risk perceptions. Med Decis Making. 2011;31(3):432–436.
  • Woloshin S, Schwartz LM. Communicating data about the benefits and harms of treatment: a randomized trial. Ann Intern Med. 2011;155(2):87–96.
  • O’Connor AM, Pennie RA, Dales RE. Framing effects on expectations, decisions, and side effects experienced: the case of influenza immunization. J Clin Epidemiol. 1996;49(11):1271–1276.
  • Edwards A, Elwyn G, Covey J, Matthews E, Pill R. Presenting risk information – a review of the effects of “framing” and other manipulations on patient outcomes. J Health Commun. 2001;6(1):61–82.