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

European Journal of Clinical Pharmacology

Volumn 62, Issue 3, 2006, Pages 161-172

  Macedo, Ana ^a   Farré, Magí ^a,b   Baños, Josep E ^c  

^a UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^b INST MUNIC D INVESTIGACIO MEDICA   (Spain)

^c UNIVERSITAT POMPEU FABRA   (Spain)

Author keywords

Clinical trials; Meta analysis; Methodology; Migraine; Placebo

Indexed keywords

NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; TRIPTAN DERIVATIVE;

ANALGESIA; ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; HUMAN; MEDLINE; META ANALYSIS; MIGRAINE; NORTH AMERICA; PRIORITY JOURNAL; RECURRENT DISEASE; SIDE EFFECT; SYSTEMATIC REVIEW; VASCULAR HEADACHE;

ACUTE DISEASE; ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; EUROPE; FEMALE; HUMANS; HYPERACUSIS; MALE; MIGRAINE DISORDERS; NAUSEA; NORTH AMERICA; OUTCOME ASSESSMENT (HEALTH CARE); PAIN MEASUREMENT; PHOTOPHOBIA; PLACEBO EFFECT; RANDOMIZED CONTROLLED TRIALS; RECURRENCE; TRYPTAMINES;

EID: 33644818564     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-005-0088-5     Document Type: Article

References (40)

1. Carli GF, Fabbri L, Cavazzuti L, Roncolato M, Agnello V, Recchia G (1998) The epidemiology of migraine: a retrospective study in Italian emergency departments. Headache 38:697-704
2. Henry P, Auray JP, Gaudin AF, Dartigues JF, Duru G, Lanteri-Minet M, Lucas C, Pradalier A, Chazot G, El Hasnaoui A (2002) Prevalence and clinical characteristics of migraine in France. Neurology 23:232-237
3. Snow V, Weiss K, Wall EM, Mottur-Pilson C (2002) Pharmacologie management of acute attacks of migraine and prevention of migraine headache. Ann Intern Med 137:840-849
4. Aukerman G, Knutson D, Miser WF (2002) Management of the acute migraine headache. Am Fam Physician 66:2123-2130
5. Gladstone JP, Dodick DW (2004) Revised 2004 International Classification of Headache Disorders: new headache types. Can J Neurol Sci 31:3004-3014
6. Goadsby PJ, Lipton RB, Ferrari MD (2002) Migraine - current understanding and treatment. N Engl J Med 346:257-270
7. Hughes EG (2003) Randomized clinical trials: the meeting place of medical practice and clinical research. Semin Reprod Med 21:55-64
8. Macedo A, Farré M, Baños JE (2003) Placebo effect and placebos: what are we talking about? Some conceptual and historical considerations. Eur J Clin Pharmacol 59:337-342
9. González de Dios J (2001) De la medicina basada en la evidencia a la evidencia basada en la medicina. Ann Esp Pediatr 55:429-439
10. Calvo CB, Rubinstein A (2002) Influence of new evidence on prescription patterns. J Am Board Fam Pract 15:457-462
11. Fairhurst K, Huby G (1998) From trial data to practical knowledge: qualitative study of how general practitioners have accessed and used evidence about statin drugs in their management of hypercholesterolaemia. BMJ 317:1130-1134
12. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B (2003) Evidence-b(i)ased medicine - selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 326:1171-1173
13. Macedo A, Sampaio C (2001) Influence of placebo effect on planning and analysis of clinical trials. Rev Port Cardiol 20:313-319
14. Burdett S, Stewart LA, Tierney JF (2003) Publication bias and meta-analyses: a practical example. Int J Technol Assess Health Care 19:129-134
15. Ernst E, Resch KL (1995) Concept of true and perceived placebo effects. BMJ 311:551-553
16. Buckalew LW, Coffield KE (1982) An investigation of drug expectancy as a function of capsule color and size and preparation form. J Clin Psychopharmacol 2:245-248
17. de Craen AJ, Tijssen JG, de Gans J, Kleijnen J (2000) Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos. J Neurol 247:183-188
18. Schwartz NA, Turturro MA, Istvan DJ, Larkin GL (2000) Patients' perceptions of route of nonsteroidal anti-inflammatory drug administration and its effect on analgesia. Acad Emerg Med 7:857-861
19. Flaten, M A, Simonses T, Olsen H (1999) Drug-related information generates placebo and nocebo responses that modify the drug response. Psychosom Med 61:250-255
20. Averbuch M, Katzper M (2001) Gender and the placebo analgesic effect in acute pain. Clin Pharmacol Ther 70:287-291
21. McQuay H, Carroll D, Moore A (1995) Variation in the placebo effect in randomised controlled trials of analgesics: all is as blind as it seems. Pain 64:331-335
22. Jones SF, McQuay HJ, Moore RA, Hand CW (1998) Morphine and ibuprofen compared using the cold pressor test. Pain 34:117-122
23. Kilo S, Forster C, Geisslinger G, Brune K, Handwerker HO (1995) Inflammatory models of cutaneous hyperalgesia are sensitive to effects of ibuprofen in man. Pain 62:187-193
24. Petersen KL, Jones B, Segredo V, Dahl JB, Rowbotham MC (2001) Effect of remifentanil on pain and secondary hyperalgesia associated with the heat-capsaicin sensitization model in healthy volunteers. Anesthesiology 94:15-20
25. Steen KH, Reeh PW, Kreysel HW (1995) Topical acetylsalicylic, salicylic acid and indomethacin suppress pain from experimental tissue acidosis in human skin. Pain 62:339-347
26. Telekes A, Holland RL, Peck AW (1997) Indomethacin: effects on cold-induced pain and the nervous system in healthy volunteers. Pain 30:321-328
27. Voudouris NJ, Peck CL, Coleman G (1989) Conditioned response models of placebo phenomena: further support. Pain 38:109-116
28. Bigal ME, Bigal JO, Bordini CA, Speciali JG (2001) Evaluation of placebo use in migraine without aura, migraine with aura and episodic tension-type headache acute attacks. Arq Neuropsiquiatr 59:552-558
29. Chvetzoff G, Tannock IF (2003) Placebo effects in oncology. J Natl Cancer Inst 95:19-29
30. Polio A, Vighetti S, Rainero I, Benedetti F (2003) Placebo analgesia and the heart. Pain 102:125-133
31. Hrobjartsson A, Gotzsche PC (2001) Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 344:1594-1602
32. Hrobjartsson A, Gotzsche PC (2003) Placebo treatment versus no treatment. Cochrane Database Syst Rev 2003;1:CD003974
33. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF (for the QUOROM Group) (1999) Improving the quality of reports of meta-analyses of randomised controlled trials: the QUORUM statement. Lancet 354:1896-1900
34. Headache Classification Committee of the IHS (1988) Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 8:1-96
35. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 17:1-12
36. Diversity and heterogeneity - http://www.cochrane-net.org/openlearning/ HTML/mod13-4.htm (consulted November 18, 2003)
37. Ferrari MD, Roon KI, Lipton RB, Goadsby PJ (2001) Oral triptans (serotonin 5-HT(1B/1D) agonists) in acute migraine treatment: a meta-analysis of 53 trials. Lancet 358:1668-1675
38. Ferrari MD, Goadsby PJ, Roon KI, Lipton RB (2002) Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia 22:633-658
39. Oldman AD, Smith LA, McQuay HJ, Moore RA (2002) Pharmacological treatments for acute migraine: quantitative systematic review. Pain 97:247-257
40. Olson CM, Rennie D, Cook D, Dickersin K, Flanagin A, Hogan JW, Zhu Q, Reiling J, Pace B (2002) Publication bias in editorial decision making. JAMA 287:2825-2828