Nocebo in clinical trials for depression: A meta-analysis

Psychiatry Research

Volumn 215, Issue 1, 2014, Pages 82-86

  Mitsikostas, Dimos D ^a   Mantonakis, Leonidas ^b   Chalarakis, Nikolaos ^b  

^a ATHENS NAVAL HOSPITAL   (Greece)

^b NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

Author keywords

Adverse events; Clinical trials; Depression; Meta analysis; Nocebo

Indexed keywords

AMFEBUTAMONE; DULOXETINE; ESCITALOPRAM; FLUOXETINE; GEPIRONE; PAROXETINE; PLACEBO; QUETIAPINE; VENLAFAXINE;

ADVERSE DRUG REACTION; ARTICLE; CLINICAL PRACTICE; CORRELATION ANALYSIS; DATA EXTRACTION; DEPRESSION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; FIBROMYALGIA; HUMAN; INFORMATION RETRIEVAL; MEDLINE; META ANALYSIS; MIGRAINE; MULTIPLE SCLEROSIS; NEUROPATHIC PAIN; NOCEBO; PARKINSON DISEASE; PATIENT COMPLIANCE; PATIENT DROPOUTS; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); TENSION HEADACHE; TREATMENT WITHDRAWAL;

ADVERSE EVENTS; CLINICAL TRIALS; DEPRESSION; META-ANALYSIS; NOCEBO;

ANTIDEPRESSIVE AGENTS; DEPRESSION; DEPRESSIVE DISORDER; HUMANS; NOCEBO EFFECT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84892863680     PISSN: 01651781     EISSN: 18727123     Source Type: Journal    
DOI: 10.1016/j.psychres.2013.10.019     Document Type: Article

References (31)

1. Aggarwal V.R., McBeth J., Zakrzewska J.M., Lunt M., Macfarlane G.J. The epidemiology of chronic syndromes that are frequently unexplained: do they have common associated factors?. International Journal of Epidemiology 2006, 35:468-476.
2. Antonaci F., Chimento P., Diener H.C., Sances G., Bono G. Lessons from placebo effects in migraine treatment. Journal of Headache and Pain 2007, 8:63-66.
3. Barsky A.J., Saintfort R., Barsky A.J., Saintfort R., Rogers M.P., Borus J.F. Nonspecific medication side effects and the nocebo phenomenon. JAMA. The Journal of the American Medical Association 2002, 287:622-627.
4. Benedetti F., Lanotte M., Lopiano L., Colloca L. When words are painful: unraveling the mechanisms of the nocebo effect. Neuroscience 2007, 147:260-271.
5. Cochran W.G. The combination of estimates from different experiments. Biometrics 1954, 10:100-129.
6. Cepeda M.S., Lobanov V., Berlin J.A. Use of ClinicalTrials.gov to estimate condition-specific nocebo effects and other factors affecting outcomes of analgesic trials. Journal of Pain 2013, 14:405-411.
7. Colloca L., Miller F.G. The nocebo effect and its relevance for clinical practice. Psychosomatic Medicine 2011, 73:598-603.
8. Egger M., Smith G.D., Schneider M., Minder C. Bias in meta-analysis detected by a simple, graphical test. British Medical Journal 1997, 315:629-634.
9. Elsenbruch S., Schmid J., Bäsler M., Cesko E., Schedlowski M., Benson S. How positive and negative expectations shape the experience of visceral pain: an experimental pilot study in healthy women. Neurogastroenterology and Motility 2012, 24. (914-e460).
10. Enck P., Benedetti F., Schedlowski M. New insights into the placebo and nocebo responses. Neuron 2008, 59:195-206.
11. Fayed N., Andres E., Rojas G., Moreno S., Serrano-Blanco A., Roca M., Garcia-Campayo J. Brain dysfunction in fibromyalgia and somatization disorder using proton magnetic resonance spectroscopy: a controlled study. Acta Psychiatrica Scandinavica 2012, 126:115-125.
12. Higgins J.P., Thompson S.G. Quantifying heterogeneity in a meta-analysis. Statistics in Medicine 2002, 21:1539-1558.
13. Ioannidis J.P. Interpretation of tests of heterogeneity and bias in meta-analysis. Journal of Evaluation in Clinical Practice 2008, 14:951-957.
14. Jadad A.R., Moore R.A., Carroll D., Jenkinson C., Reynolds D.J., Gavaghan D.J., McQuay H.J. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled Clinical Trials 1996, 17:1-12.
15. Kennedy W.P. The nocebo reaction. Medical World 1961, 9:203-205.
16. Kong J., Gollub R.L., Polich G., Kirsch I., Laviolette P., Vangel M., Rosen B., Kaptchuk T.J. A functional magnetic resonance imaging study on the neural mechanisms of hyperalgesic nocebo effect. Journal of Neuroscience 2008, 28:13354-13362.
17. Manchikanti L., Giordano J., Fellows B., Hirsch J.A. Placebo and nocebo in interventional pain management: a friend or a foe-or simply foes?. Pain Physician 2011, 14:E157-E175.
18. Mitsikostas D.D. Nocebo in headaches: implications for clinical practice and trial design. Current Neurology and Neuroscience Reports 2012, 12:132-137.
19. Mitsikostas D.D., Chalarakis N.G., Mantonakis L.I., Delicha E.M., Sfikakis P.P. Nocebo in fibromyalgia: meta-analysis of placebo-controlled clinical trials and implications for practice. European Journal of Neurology 2012, 19:672-680.
20. Mitsikostas D.D., Mantonakis L.I., Chalarakis N.G. Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment in headaches. Cephalalgia 2011, 31:550-561.
21. Moher D., Liberati A., Tetzlaff J., Altman D.G., the PRISMA Group Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Annals of Internal Medicine 2009, 151:264-269.
22. Mora M.S., Nestoriuc Y., Rief W. Lessons learned from placebo groups in antidepressant trials. Philos. Trans. R. Soc. Lond. Ser B Biol. Sci. 2011, 366:1879-1888.
23. Olivo S.A., Macedo L.G., Gadotti I.C., Fuentes J., Stanton T., Magee D.J. Scales to assess the quality of randomized controlled trials: a systematic review. Physical Therapy 2008, 88:156-175.
24. Papadopoulos D., Mitsikostas D.D. Nocebo effects in multiple sclerosis trials: a meta-analysis. Multiple Sclerosis Journal 2010, 16:816-828.
25. Papadopoulos D., Mitsikostas D.D. A meta-analytic approach to estimating nocebo effects in neuropathic pain trials. Journal of Neurology 2012, 259:436-447.
26. Scott D.J., Stohler C.S., Egnatuk C.M., Wang H., Koeppe R.A., Zubieta J.K. Placebo and nocebo effects are defined by opposite opioid and dopaminergic responses. Archives of General Psychiatry 2008, 65:220-231.
27. Stathis P., Smpiliris M., Konitsiotis S., Mitsikostas D.D. Nocebo as a potential confounding factor in clinical trials for Parkinson's disease treatment: a meta-analysis. European Journal of Neurology 2013, 20:527-533.
28. Sutton A.J., Abrams K.R., Jones D.R., Sheldon T.A., Song F. Systematic reviews of trials and other studies. Health Technology Assessment 1998, 2:1-276.
29. Tracey I. Getting the pain you expect: mechanisms of placebo, nocebo and reappraisal effects in humans. Nature Medicine 2010, 16:1277-1283.
30. Viechtbauer W. Conducting meta-analyses in R with the metafor package. Journal of Statistical Software 2010, 36:1-48.
31. Wells R.E., Kaptchuck T.J. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. American Journal of Bioethics 2012, 12:22-29.