Do we need a new procedure for the assessment of adverse events in anti-migraine clinical trials?

Recent Patents on CNS Drug Discovery

Volumn 6, Issue 1, 2011, Pages 41-47

  Amanzio, Martina ^a  

^a UNIVERSITY OF TURIN   (Italy)

Author keywords

Adverse events; Almotriptan; Anticonvulsants (topiramate; Diclofenac; Elitriptan; Frovatriptan; Gabapentin; Ibuprofen; Indobufen); Ketoprofen; Migraine; Naratriptan); Nocebo; Nsaids (rofecoxib; Placebo; Randomized clinical trials; Rizatriptan; Triptans (sumatriptan; Valdecoxib; Valproate); Zolmitriptan

Indexed keywords

ANTICONVULSIVE AGENT; ANTIMIGRAINE AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; TOPIRAMATE; TRIPTAN DERIVATIVE;

ABDOMINAL PAIN; ANOREXIA; ANXIETY; CLINICAL ASSESSMENT; CLINICAL TRIAL; DIARRHEA; DIZZINESS; DRUG INDUCED DISEASE; DRUG WITHDRAWAL; DYSPEPSIA; FATIGUE; HUMAN; INJECTION SITE BURNING; INJECTION SITE REACTION; MEMORY DISORDER; MIGRAINE; NAUSEA; NAUSEA AND VOMITING; PARESTHESIA; PRIORITY JOURNAL; REVIEW; SOMNOLENCE; THORAX PAIN; UPPER RESPIRATORY TRACT INFECTION; XEROSTOMIA;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTICONVULSANTS; HUMANS; MIGRAINE DISORDERS; PLACEBO EFFECT; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TRYPTAMINES;

EID: 78650945171     PISSN: 15748898     EISSN: None     Source Type: Journal    
DOI: 10.2174/157488911794079109     Document Type: Review

References (32)

1. Burke A, Smyth EM, Fitzgerald GA. Analgesic-antipyretic andantiinflammatory agents, pharmacotherapy of gout. In: Brunton LL, Lazo JS, Parker K, Eds. Goodman & Gilman's. The Pharmacological Basis of Therapeutics. New York: Mc Graw-Hill 2006; 671-716.
2. Nappi G, Sandrini G, Sances G. Tolerability of the triptans:Clinical implications. Drug Saf 2003; 26: 93-107.
3. McNamara JO. Pharmacotherapy of the Epilepsies. In: Brunton LL,Lazo JS, Parker K, Eds. Goodman & Gilman's. The Pharmacological Basis of Therapeutics. New York: Mc Graw-Hill 2006; 501-526.
4. Peroutka SJ. Drugs effective in the therapy of migraine. In:Hardman JG, Limbird LE, Eds. Goodman & Gilman's. The Pharmacological Basis of Therapeutics. New York: Mc Graw-Hill1996; 487-502.
5. Robbins L. Frequent triptan use: Observations on safety issues. Headache 2004; 44: 178-82.
6. Gallagher RM, Kunkel R. Migraine medication attributes importantfor patient compliance: Concerns about side effects may delaytreatment. Headache 2003; 43: 36-43.
7. Barsky AJ, Saintfort R, Rogers MP, Borus JF. Nonspecificmedication side effects and the nocebo phenomenon. JAMA 2002; 287: 622-7.
8. Amanzio M, Corazzini LL, Vase L, Benedetti F. A systematicreview of adverse events in placebo groups of anti-migraineclinical trials. Pain 2009; 146: 261-9.
9. Rief W, Nestoriuc Y, von Lilienfeld-Toal A, Dogan I, Schreiber F, Hofmann SG, et al. Differences in adverse effect reporting inplacebo groups in SSRI and tricyclic antidepressant trials: Asystematic review and meta-analysis. Drug Saf 2009; 32: 1041-56.
10. Speciali JP, Peres M, Bigal ME. Migraine treatment and placeboeffect. Expert Rev Neurother 2010, 10: 413-9.
11. Láinez MJ, Freitag FG, Pfeil J, Ascher S, Olson WH, Schwalen S. Time course of adverse events most commonly associated with topiramate for migraine prevention. Eur J Neurol 2007; 14: 900-6.
12. Luykx J, Mason M, Ferrari MD, Carpay J. Are migraneurs atincrease risk of adverse drug responses? A meta-analyticcomparison of topiramate-related adverse drug reactions inepilepsy and migraine. Clin Pharmacol Ther 2009; 85: 283-8.
13. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds JM,Gavaghan DJ, et al. Assessing the quality of reports of randomizedclinical trials: Is blinding necessary? Control Clin Trials 1996; 17:1-12.
14. Benedetti F, Amanzio M. The neurobiology of placebo analgesia: From endogenous opioids to cholecystokinin. Prog Neurobiol 1997; 52: 109-125.
15. Kennedy WP. The nocebo reaction. Med World 1961; 95: 203-5.
16. Kissel P, Barrucand D. Placebos et Effect-Placebo en Medecine.Paris: Masson 1974.
17. Macedo A, Baños JE, Farré M. Placebo response in the prophylaxisof migraine: A meta-analysis. Eur J Pain 2008; 12: 68-75.
18. Levine ME, Stern RM, Koch KL. The effects of manipulatingexpectations through placebo and nocebo administration on gastrictachyarrhythmia and motion-induced nausea. Psychosom Med2006; 68: 478-86.
19. Liccardi G, Senna G, Russo M, Bonadonna P, Crivellaro M, Dama, A., et al. Evaluation of the nocebo effect during oral challenge inpatients with adverse drug reactions. J Investig Allergol ClinImmunol 2004; 14: 104-7.
20. Flaten MA, Simonsen T, Olsen H. Drug-related informationgenerates placebo and nocebo responses that modify the drugresponse. Psychosom Med 1999; 61: 250-5.
21. Colloca L, Sigaudo M. Benedetti F. The role of learning in noceboand placebo effects. Pain 2008; 136: 211-8.
22. Amanzio M, Benedetti F. Neuropharmacological dissection ofplacebo analgesia: Expectation-activated opioid systems versusconditioning-activated specific sub-systems. J Neurosci 1999; 19:484-94.
23. Wolf S, Pinsky RM. Effects of placebo administration andoccurence of toxic reactions. JAMA 1954; 155: 339-41.
24. Andrykowski M, Redd W. Longitudinal analysis of thedevelopment of anticipatory nausea. J Consult Clin Psychol 1987; 55: 36-41.
25. Ferguson JM, Alprazolam XR. Patient acceptability, safety, andtolerability. Psychiatr Ann 1993; 23: 20-6.
26. Davis C, Ralevski E, Kennedy SH, Neitzert CS. The role ofpersonality factors in the reporting of side effect complaints tomoclobemide and placebo. J Clin Psychopharmacol 1995; 15: 347-52.
27. Uhlenhuth EH, Alexander PE, Dempsey GM, Jones W, Coleman B.S., Swiontek, A.M. Medication side effects in anxious patients: Negative placebo responses? J Affect Disord 1998; 47: 183-90.
28. Benedetti F, Amanzio M, Vighetti S, Asteggiano G. The biochemical and neuroendocrine bases of the hyperalgesic noceboeffect. J Neurosci 2006; 26: 12014-22.
29. Rainero I, Amanzio M, Vighetti S, Bergamasco B, Pinessi L, Benedetti F. Quantitative EEG responses to ischaemic arm stress inmigraine. Cephalalgia 2001; 21: 224-9.
30. Sheftell FD, Feleppa M, Tepper SJ, Rapoport AM, Ciannella L, Bigal ME. Assessment of adverse events associated with triptans. Methods of assessment influence the results. Headache 2004; 44:978-82.
31. 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: 766-74.
32. Fava, M., Schoenfeld, D. System and method for reducing the placebo effect in controlled clinical trials. US7647235 (2010).