How do nocebo effects in placebo groups of randomized controlled trials provide a possible explicative framework for the COVID-19 pandemic?

References

• Chatterjee SS, Barikar CM, Mukherjee A. Impact of COVID-19 pandemic on pre-existing mental health problems. Asian J Psychiatr. 2020;51:102071.
   PubMed Web of Science ®Google Scholar
• Wong S, Zhang D, Sit R, et al. Impact of COVID-19 on loneliness, mental health, and health service utilisation: a prospective cohort study of older adults with multimorbidity in primary care. Br J Gen Pract. 2020;70(700):e817–e824. .
   PubMed Web of Science ®Google Scholar
• Gavazzi G, Krause KH. Ageing and infection. Lancet Infect Dis. 2002;2(11):659–666.
   PubMed Web of Science ®Google Scholar
• Sepúlveda-Loyola W, Rodríguez-Sánchez I, Pérez-Rodríguez P, et al. Impact of social isolation due to COVID-19 on health in older people: mental and physical effects and recommendations. J Nutr Health Aging. 2020;24(9):938–947. .
   PubMed Web of Science ®Google Scholar
• Goldfarb EV. Participant stress in the COVID-19 era and beyond. Nat Rev Neurosci. 2020;21(12):663–664.
   PubMed Web of Science ®Google Scholar
• Amanzio M, Howick J, Bartoli M, et al. How do nocebo phenomena provide a theoretical framework for the COVID-19 pandemic? Front Psychol. 2020;11:589884.
   PubMed Web of Science ®Google Scholar
• Slomski A. “Important conversations” are needed to explain the nocebo effect. JAMA. 2021 Feb 23;325(8):707–709.
   PubMed Web of Science ®Google Scholar
• Wood FA, Howard JP, Finegold JA, et al. N-of-1 trial of a statin, placebo, or no treatment to assess side effects. N Engl J Med. 2020;383(22):2182–2184. .
   PubMed Web of Science ®Google Scholar
• Amanzio M, Corazzini LL, Vase L, et al. A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain. 2009;146(3):261–269. .
   PubMed Web of Science ®Google Scholar
• Amanzio M, Palermo S, Skyt I, et al. Lessons learned from nocebo effects in clinical trials for pain conditions and neurodegenerative disorders. J Clin Psychopharmacol. 2016;36(5):475–482.
   PubMed Web of Science ®Google Scholar
• Benedetti F, Amanzio M, Vighetti S, et al. The biochemical and neuroendocrine bases of the hyperalgesic nocebo effect. J Neurosci. 2006;26(46):12014–12022. .
   PubMed Web of Science ®Google Scholar
• Planès S, Villier C, Mallaret M. The nocebo effect of drugs. Pharmacol Res Perspect. 2016;4(2):e00208.
   PubMed Web of Science ®Google Scholar
• Fine S, Johnston C. Drug and placebo side effects in methylphenidate-placebo trial for attention deficit hyperactivity disorder. Child Psychiatry Hum Dev. 1993;24(1):25–30.
   PubMed Web of Science ®Google Scholar
• Okaïs C, Gay C, Seon F, et al. Disease-specific adverse events following nonlive vaccines: a paradoxical placebo effect or a nocebo phenomenon? Vaccine. 2011;29(37):6321–6326.
   PubMed Web of Science ®Google Scholar
• Aslaksen PM, Zwarg ML, Eilertsen HH, et al. Opposite effects of the same drug: reversal of topical analgesia by nocebo information. Pain. 2015;156(1):39–46. .
   PubMed Web of Science ®Google Scholar
• Colloca L, Lopiano L, Lanotte M, et al. Overt versus covert treatment for pain, anxiety, and Parkinson’s disease. Lancet Neurol. 2004;3(11):679–684.
   PubMed Web of Science ®Google Scholar
• Crichton F, Petrie KJ. Accentuate the positive: counteracting psychogenic responses to media health messages in the age of the Internet. J Psychosom Res. 2015;79(3):185–189.
   PubMed Web of Science ®Google Scholar
• Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603–2615. .
   PubMed Web of Science ®Google Scholar
• Baden LR, El Sahly HM, Essink B, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021;384(5):403–416. Epub 2020.
   PubMed Web of Science ®Google Scholar
• Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397(10269):99–111.
   PubMed Web of Science ®Google Scholar
• Amanzio M. Nocebo effects and psychotropic drug action. Exp Rev Clin Pharmacol. 2015;8(2):159–161.
   PubMed Web of Science ®Google Scholar
• Amanzio M, Palermo S. Nocebo effects and psychotropic drug action - an update. Exp Rev Clin Pharmacol. 2020;13(2):75–77.
   PubMed Web of Science ®Google Scholar
• Barsky AJ, Saintfort R, Rogers MP, et al. Nonspecific medication side effects and the nocebo phenomenon. JAMA. 2002;287(5):622–627. PMID: 11829702.
   PubMed Web of Science ®Google Scholar
• Palermo S, Giovannelli F, Bartoli M, et al. Are patients with schizophrenia spectrum disorders more prone to manifest nocebo-like-effects? A meta-analysis of adverse events in placebo groups of double-blind antipsychotic trials. Front Pharmacol. 2019;10:502.
   PubMed Web of Science ®Google Scholar
• Kravvariti E, Kotsani M, Mitsikostas DD, et al. * Nocebo phenomena may be enhanced in aging: implications for clinical practice. Maturitas. 2021;143:10–16.
   PubMed Web of Science ®Google Scholar
• Kravvariti E, Kitas GD, Mitsikostas DD, et al. Nocebos in rheumatology: emerging concepts and their implications for clinical practice. Nat Rev Rheumatol. 2018;14(12):727–740. .
   PubMed Web of Science ®Google Scholar
• Heikkilä R, Mäntyselkä P, Hartikainen-Herranen K, et al. Customers’ and physicians’ opinions of and experiences with generic substitution during the first year in Finland. Health Policy. 2007;82(3):366–374. .
   PubMed Web of Science ®Google Scholar
• Häuser W, Hansen E, Enck P. Nocebo phenomena in medicine: their relevance in everyday clinical practice. Dtsch Arztebl Int. 2012;109(26):459–465.
   PubMed Web of Science ®Google Scholar
• Daniali H, Flaten MA. A qualitative systematic review of effects of provider characteristics and nonverbal behavior on pain, and placebo and nocebo effects. Front Psychiatry. 2019;10:242.
   PubMed Web of Science ®Google Scholar
• Fragoulis GE, Evangelatos G, Arida A. et al. Nocebo-prone behaviour in patients with autoimmune rheumatic diseases during the COVID-19 pandemic. Mediter J Rheum. 2020;31(Suppl 2):288–294.
   PubMedGoogle Scholar
• WHO: managing the COVID-19 infodemic: promoting healthy behaviours and mitigating the harm from misinformation and disinformation 2020 Sep 23. [cited 2021 Jan 15]. Available from: https://www.who.int/news/item/23-09-2020-managing-the-covid-19-infodemic-promoting-healthy-behaviours-and-mitigating-the-harm-from-misinformation-and-disinformation.
   Google Scholar
• Soiza RL, Scicluna C, Thomson EC. Efficacy and safety of COVID-19 vaccines in older people. Age Ageing. 2020;50(2), 279–283.
   Web of Science ®Google Scholar
• Olliaro P. What does 95% COVID-19 vaccine efficacy really mean? Lancet Infect. 2021;17:S1473-3099(21)00075.
   Google Scholar
• European Centre for Disease Prevention and Control, 2021: COVID-19 [Internet]. Solna (SE): ECDC; c2021. COVID-19; [cited 2021 Feb 24]. Available from https://www.ecdc.europa.eu/en/covid-19
   Google Scholar
• Dyer O. Covid-19: countries are learning what others paid for vaccines. BMJ. 2021 Jan;372:n281.
   PubMed Web of Science ®Google Scholar
• Shenoy P, Harugeri A. Elderly patients’ participation in clinical trials. Perspect Clin Res. 2015;6(4):184–189. PMID: 26623388; PMCID: PMC4640010.
   PubMedGoogle Scholar
• Lockett J, Sauma S, Radziszewska B, et al. Adequacy of inclusion of older adults in NIH-funded phase III clinical trials. J Am Geriatr Soc. 2019;67(2):218–222.
   PubMed Web of Science ®Google Scholar
• Bartley H, Faasse K, Horne R, et al. You can’t always get what you want: the influence of choice on nocebo and placebo responding. Ann Behav Med. 2016 Jun;50(3):445–451. PMID: 26779715.
   PubMed Web of Science ®Google Scholar
• Silvestri A, Galetta P, Cerquetani E, et al. Report of erectile dysfunction after therapy with beta-blockers is related to patient knowledge of side effects and is reversed by placebo. Eur Heart J. 2003;24(21):1928–1932.
   PubMed Web of Science ®Google Scholar
• Elsenbruch S, Schmid J, Bäsler M, et al. How positive and negative expectations shape the experience of visceral pain: an experimental pilot study in healthy women. Neurogastroenterol Motil. 2012;24(10):914–e460.
   PubMed Web of Science ®Google Scholar
• Nestoriuc Y, Orav EJ, Liang MH, et al. Prediction of nonspecific side effects in rheumatoid arthritis patients by beliefs about medicines. Arthritis Care Res (Hoboken). 2010;62(6):791–799.
   PubMed Web of Science ®Google Scholar
• Kern A, Kramm C, Witt CM, et al. The influence of personality traits on the placebo/nocebo response: a systematic review. J Psychosom Res. 2020;128:109866.
   PubMed Web of Science ®Google Scholar
• Locher C, Koechlin H, Gaab J, et al. The other side of the coin: nocebo effects and psychotherapy. Front Psychiatry. 2019;10:555.
   PubMed Web of Science ®Google Scholar
• 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 Nov;49(11):1271–1276. Erratum in: J Clin Epidemiol 1997 Jun;50(6):747-8. PMID: 8892495…
   PubMed Web of Science ®Google Scholar
• Hansen E, Zech N. Nocebo effects and negative suggestions in daily clinical practice - forms, impact and approaches to avoid them. Front Pharmacol. 2019;10:77.
   PubMed Web of Science ®Google Scholar
• Colloca L, Barsky AJ. Placebo and nocebo effects. N Engl J Med. 2020;382(6):554–561.
   PubMed Web of Science ®Google Scholar
• Zelen M. A new design for randomized clinical trials. N Engl J Med. 1979;300(22):1242–1245.
   PubMed Web of Science ®Google Scholar
• Enck P, Bingel U, Schedlowski M, et al. The placebo response in medicine: minimize, maximize or personalize? Nat Rev Drug Discov. 2013;12(3):191–204.
   PubMed Web of Science ®Google Scholar