The Placebo Response in Studies of Acute Migraine

Journal of Pediatrics

Volumn 152, Issue 4, 2008, Pages

  Fernandes, Ricardo ^a   Ferreira, Joaquim J ^b   Sampaio, Cristina ^b  

^a HOSPITAL DE SANTA MARIA   (Portugal)

^b INSTITUTO DE MEDICINA MOLECULAR JOÃO LOBO ANTUNES   (Portugal)

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; ANTIEMETIC AGENT; IBUPROFEN; PARACETAMOL; PLACEBO; SUMATRIPTAN; TRIPTAN DERIVATIVE;

ANALGESIA; ARTICLE; ATTRIBUTABLE RISK; CALCULATION; CLINICAL TRIAL; HEADACHE; HUMAN; MEDLINE; MIGRAINE; NORTH AMERICA; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PEDIATRICS; PLACEBO EFFECT; PRIORITY JOURNAL; STATISTICAL SIGNIFICANCE; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

EID: 40749135778     PISSN: 00223476     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpeds.2007.09.024     Document Type: Article

References (46)

1. Abu-Arefeh I., and Russell G. Prevalence of headache and migraine in schoolchildren. BMJ 309 (1994) 765-769
2. Headache Classification Committee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 8 (1988) 1-96
3. Headache Classification Subcomittee of the International Headache Society. The International Classification of Headache Disorders, 2nd edition. Cephalalgia 24 (2004) 9-160
4. Raieli V., Raimondo D., Gangitano M., D'Amelio M., Cammalleri R., and Camarda R. The IHS classification criteria for migraine headaches in adolescents need minor modifications. Headache 36 (1996) 362-366
5. Hershey A.D., Winner P., Kabbouche M.A., Gladstein J., Yonker M., Lewis D., et al. Use of the ICHD-II criteria in the diagnosis of pediatric migraine. Headache 45 (2005) 1288-1297
6. Lewis D., Ashwal S., Hershey A., Hirtz D., Yonker M., and Silberstein S. Practice parameter: pharmacological treatment of migraine headache in children and adolescents: report of the American Academy of Neurology Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society. Neurology 63 (2004) 2215-2224
7. Damen L., Bruijn J.K., Verhagen A.P., Berger M.Y., Passchier J., and Koes B.W. Symptomatic treatment of migraine in children: a systematic review of medication trials. Pediatrics 116 (2005) e295-e302
8. European Medicines Agency. Assessment of pediatric needs: migraine. http://www.emea.europa.eu/pdfs/human/peg/22451506en.pdf Accessed February 2007
9. Rothner A.D., Wasiewski W., Winner P., Lewis D., and Stankowski J. Zolmitriptan oral tablet in migraine treatment: high placebo responses in adolescents. Headache 46 (2006) 101-109
10. Lewis D.W., Winner P., and Wasiewski W. The placebo responder rate in children and adolescents. Headache 45 (2005) 232-239
11. Loder E., Goldstein R., and Biondi D. Placebo effects in oral triptan trials: the scientific and ethical rationale for continued use of placebo controls. Cephalalgia 25 (2005) 124-131
12. World Medical Association. Policy Statement. Declaration of Helsinki: Ethical Principals For Research Involving Human Subjects (2004), World Medical Association, Ferney-Voltaire, France
13. Caldwell P.H., Butow P.N., and Craig J.C. Pediatricians' attitudes toward randomized controlled trials involving children. J Pediatr 141 (2002) 798-803
14. Caldwell P.H., Butow P.N., and Craig J.C. Parents' attitudes to children's participation in randomized controlled trials. J Pediatr 142 (2003) 554-559
15. Caldwell P.H., Murphy S.B., Butow P.N., and Craig J.C. Clinical trials in children. Lancet 364 (2004) 803-811
16. Macedo A., Farre M., and Banos J.E. A meta-analysis of the placebo response in acute migraine and how this response may be influenced by some of the characteristics of clinical trials. Eur J Clin Pharmacol 62 (2006) 161-172
17. Hrobjartsson A., and Gotzsche P.C. Is the placebo powerless?. An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 344 (2001) 1594-1602
18. de la Fuente-Fernandez R., Schulzer M., and Stoessl A.J. The placebo effect in neurological disorders. Lancet Neurol 1 (2002) 85-91
19. Robinson K.A., and Dickersin K. Development of a highly sensitive search strategy for the retrieval of reports of controlled trials using PubMed. Int J Epidemiol 31 (2002) 150-153
20. Jadad A.R., Moore R.A., Carroll D., Jenkinson C., Reynolds D.J., Gavaghan D.J., et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 17 (1996) 1-12
21. Higgins J.P.T., Thompson S.G., Deeks J.J., and Altman D.G. Measuring inconsistency in meta-analysis. BMJ 327 (2003) 557-560
22. Winner P., Prensky A., Linder S., DeBussey S., and Asgharnejad M. Adolescent migraine: efficacy and safety of sumatriptan tablets. J Neurol Sci 150 (1997) S17-S22
23. Rothner A.D., Edwards K., Kerr L., DeBussey S., and Asgharnejad M. Efficacy and safety of naratriptan tablets in adolescent migraine. J Neurol Sci 150 (1997) S106
24. Kellstein D.E., Lipton R.B., Geetha R., Koronkiewicz K., Evans F.T., Stewart W.F., et al. Evaluation of a novel solubilized formulation of ibuprofen in the treatment of migraine headache: a randomized, double-blind, placebo-controlled, dose-ranging study. Cephalalgia 20 (2000) 233-243
25. Hamalainen M.L., Hoppu K., Valkeila E., and Santavuori P. Ibuprofen or acetaminophen for the acute treatment of migraine in children: a double-blind, randomized, placebo-controlled, crossover study. Neurology 48 (1997) 103-107
26. Hamalainen M.L., Hoppu K., and Santavuori P.R. Oral dihydroergotamine for therapy-resistant migraine attacks in children. Pediatr Neurol 16 (1997) 114-117
27. Hamalainen M.L., Hoppu K., and Santavuori P. Sumatriptan for migraine attacks in children: a randomized placebo-controlled study. Do children with migraine respond to oral sumatriptan differently from adults?. Neurology 48 (1997) 1100-1103
28. Ueberall M.A., and Wenzel D. Intranasal sumatriptan for the acute treatment of migraine in children. Neurology 52 (1999) 1507-1510
29. Winner P., Rothner A.D., Saper J., Nett R., Asgharnejad M., Laurenza A., et al. A randomized, double-blind, placebo-controlled study of sumatriptan nasal spray in the treatment of acute migraine in adolescents. Pediatrics 106 (2000) 989-997
30. Winner P., Lewis D., Visser W.H., Jiang K., Ahrens S., and Evans J.K. Rizatriptan 5 mg for the acute treatment of migraine in adolescents: a randomized, double-blind, placebo-controlled study. Headache 42 (2002) 49-55
31. Lewis D.W., Kellstein D., Dahl G., Burke B., Frank L.M., Toor S., et al. Children's ibuprofen suspension for the acute treatment of pediatric migraine. Headache 2 (2002) 780-786
32. Visser W.H., Winner P., Strohmaier K., Klipfel M., Peng Y., McCarroll K., et al. Rizatriptan 5 mg for the acute treatment of migraine in adolescents: results from a double-blind, single-attack study and two open-label, multiple-attack studies. Headache 44 (2004) 891-899
33. Ahonen K., Hamalainen M.L., Rantala H., and Hoppu K. Nasal sumatriptan is effective in treatment of migraine attacks in children: a randomized trial. Neurology 62 (2004) 883-887
34. Moerman D.E. Cultural variations in the placebo effect: ulcers, anxiety, and blood pressure. Med Anthropol Q 14 (2000) 51-72
35. Winner P., Rothner A.D., Wooten J.D., Webster C., and Ames M. Sumatriptan nasal spray in adolescent migraineurs: a randomized, double-blind, placebo-controlled, acute study. Headache 46 (2006) 212-222
36. Evers S., Rahmann A., Kraemer C., Kurlemann G., Debus O., Husstedt I.W., et al. Treatment of childhood migraine attacks with oral zolmitriptan and ibuprofen. Neurology 67 (2006) 497-499
37. Ahonen K., Hamalainen M.L., Eerola M., and Hoppu K. A randomized trial of rizatriptan in migraine attacks in children. Neurology 67 (2006) 1135-1140
38. Emanuel E.J., and Miller F.G. The ethics of placebo-controlled trials: a middle ground. N Engl J Med 345 (2001) 915-919
39. Berlin J.A., Santanna J., Schmid C.H., Szczech L.A., and Feldman H.I. Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head. Stat Med 21 (2002) 371-387
40. Freedman B., Glass K.C., and Weijer C. Placebo orthodoxy in clinical research. II: ethical, legal, and regulatory myths. J Law Med Ethics 24 (1996) 252-259
41. Ellenberg S.S., and Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern Med 133 (2000) 464-470
42. Lewis J.A., Jonsson B., Kreutz G., Sampaio C., and van Zwieten-Boot B. Placebo-controlled trials and the Declaration of Helsinki. Lancet 359 (2002) 1337-1340
43. Miller F.G., Wendler D., and Wilfond B. When do the federal regulations allow placebo-controlled trials in children?. J Pediatr 142 (2003) 102-107
44. de Craen A.J., Tijssen J.G., de Gans J., and Kleijnen J. Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos. J Neurol 247 (2000) 183-188
45. Macedo A., and Sampaio C. Influence of placebo effect on planning and analysis of clinical trials. Rev Port Cardiol 20 (2001) 313-319 [in Portuguese]
46. Turner J.A., Deyo R.A., Loeser J.D., Von Korff M., and Fordyce W.E. The importance of placebo effects in pain treatment and research. JAMA 271 (1994) 1609-1614