Appendix DEvidence Tables

Publication Details

Appendix Table D1. Characteristics of children in randomized controlled clinical trials about migraine prevention (MS Word, 36K)

Appendix Table D2. Reporting of characteristics of children in randomized controlled clinical trials about migraine prevention (MS Word, 37K)

Appendix Table D3. Subject flow in randomized controlled clinical trials about migraine prevention in children (MS Word, 42K)

Appendix Table D4. Risk of bias in randomized controlled clinical trials about migraine prevention* (MS Word, 36K)

Appendix Table D5. Risk of bias by journal of publication and funding of randomized controlled clinical trials about migraine prevention (MS Word, 37K)

Appendix Table D6. Randomized controlled clinical trials that examined efficacy of preventive drugs in children with migraine (MS Word, 41K)

Appendix Table D7. Ethical approval, funding, and conflict of interest in randomized controlled clinical trials that examined efficacy of preventive drugs in children with migraine (MS Word, 37K)

Appendix Table D8. Risk of bias in randomized controlled clinical trials that examined efficacy of preventive drugs in children with migraine (MS Word, 37K)

Appendix Table D9. Strength of evidence of reduction of baseline migraine frequency by >50%with antiepileptic topiramate in children (results from randomized controlled clinical trials) (MS Word, 36K)

Appendix Table D10. Reduction in frequency of migraine attack by at least 50% from baseline with topiramate vs. placebo in children (pooled with random effects results from randomized controlled clinical trials) (MS Word, 37K)

Appendix Table D11. Efficacy of topiramate on migraine prevention (results from a single RCT with medium risk of bias) (MS Word, 36K)

Appendix Table D12. Reduction in migraine days with topiramate vs. placebo in children (pooled with random effects results from randomized controlled clinical trials) (MS Word, 37K)

Appendix Table D13. Strength of evidence of migraine prevention with antiepileptic divalproex sodium in children (results from a single randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D14. Reduction in frequency of migraine attack by at least 50% from baseline with divalproex sodium vs. placebo in children (results from randomized controlled clinical trial with low risk of bias) (MS Word, 36K)

Appendix Table D15. Reduction in migraine days with divalproex sodium vs. placebo in children (results from low risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D16. Percentage of migraine headaches treated with symptomatic medications with divalproex sodium vs. placebo in children (individual low risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D17. Strength of evidence of migraine prevention with propranolol in children (results from randomized controlled clinical trials) (MS Word, 36K)

Appendix Table D18. Reduction in frequency of migraine attack with propranolol vs. placebo in children (individual low risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D19. Mean number of headaches per 3 month study period with propranolol vs. placebo in children (individual unclear risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D20. Reduction in migraine days and duration with antidepressant trazodone vs. placebo (results from low risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D21. Reduction in migraine days and duration with selective calcium channel blocker nimodipine vs. placebo (results from low risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D22. Strength of evidence of migraine prevention with clonidine, 25-50μg/day in children (MS Word, 36K)

Appendix Table D23. Reduction in frequency of migraine and severity with clonidine vs. placebo in children (results from individual double blind low risk of bias randomized controlled clinical trial) (MS Word, 37K)

Appendix Table D24. Randomized controlled clinical trials that examined comparative effectiveness of drugs for migraine prevention in children (MS Word, 37K)

Appendix Table D25. Funding and conflict of interest in randomized controlled clinical trials that examined comparative effectiveness of drugs for migraine prevention in children (MS Word, 36K)

Appendix Table D26. Risk of bias in randomized controlled clinical trials that examined comparative effectiveness of drugs for migraine prevention in children (MS Word, 36K)

Appendix Table D27. Comparative effectiveness of sodium valproate vs. propranolol in preventing migraine in children (pooled with random effects models results from randomized controlled clinical trials) (MS Word, 37K)

Appendix Table D28. Comparative effectiveness of sodium valproate vs. propranolol in preventing migraine in children (results from individual randomized controlled clinical trials) (MS Word, 37K)

Appendix Table D29. Comparative effectiveness of topiramate vs. sodium valproate in preventing migraine in children (results from a randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D30. Randomized controlled clinical trials that examined comparative effectiveness of drugs vs. active nonpharmacologic treatments for migraine prevention in children (MS Word, 36K)

Appendix Table D31. Funding and conflict of interest in randomized controlled clinical trials that examined comparative effectiveness of drugs vs. active nonpharmacologic treatments for migraine prevention in children (MS Word, 35K)

Appendix Table D32. Risk of bias in randomized controlled clinical trials that examined comparative effectiveness of drugs vs. active nonpharmacologic treatments for migraine prevention in children (MS Word, 36K)

Appendix Table D33. Comparative effectiveness of metoprolol and nonpharmacologic treatments in unclear risk of bias randomized controlled clinical trial (MS Word, 36K)

Appendix Table D34. Comparative effectiveness of metoprolol and nonpharmacologic treatments in unclear risk of bias randomized controlled clinical trial, mean differences (MS Word, 37K)

Appendix Table D35. Comparative effectiveness of propranolol and self-hypnosis in unclear risk of bias randomized controlled clinical trial (MS Word, 36K)

Appendix Table D36. Randomized controlled clinical trials that examined dose response effectiveness of drugs for migraine prevention in children (MS Word, 37K)

Appendix Table D37. Funding and conflict of interest in randomized controlled clinical trials that examined dose response effectiveness of drugs for migraine prevention in children (MS Word, 40K)

Appendix Table D38. Risk of bias in randomized controlled clinical trials that examined dose response effectiveness of drugs for migraine prevention in children (MS Word, 36K)

Appendix Table D39. Dose response effects with topiramate in preventing migraine in children (results from randomized controlled clinical trials) (MS Word, 37K)

Appendix Table D40. Dose response reduction in migraine intermediate outcomes with topiramate in children, results from randomized controlled clinical trials (MS Word, 37K)

Appendix Table D41. Dose response effects with divalproex sodium in preventing migraine in children (results from low risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D42. Dose response reduction in migraine intermediate outcomes with divalproex sodium in children (results from randomized controlled clinical trial) (MS Word, 39K)

Appendix Table D43. Randomized controlled clinical trial that examined Internet-based self management for migraine prevention in childhood and adolescence (unclear risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D44. Migraine prevention with Internet-based self management in childhood and adolescence (unclear risk of bias randomized controlled clinical trial) (MS Word, 40K)

Appendix Table D45. Migraine frequency with Internet-based self management for migraine prevention in childhood and adolescence (unclear risk of bias randomized controlled clinical trial) (MS Word, 37K)

Appendix Table D46. Quality of life with Internet-based self management for migraine prevention in childhood and adolescence (unclear risk of bias randomized controlled clinical trial) (MS Word, 40K)

Appendix Table D47. Randomized controlled clinical trials that examined adverse effects of preventive drugs in children with migraine (MS Word, 41K)

Appendix Table D48. Adverse effects with migraine preventive drugs in children (results from nonrandomized studies) (MS Word, 45K)

Appendix Table D49. Treatment discontinuation due to adverse effects with topiramate for migraine prevention in children (pooled with random effects model results from randomized controlled clinical trials) (MS Word, 42K)

Appendix Table D50. Strength of evidence about treatment discontinuation due to adverse effects with antiepileptic drugs for migraine prevention in children (MS Word, 37K)

Appendix Table D51. Adverse effects with topiramate vs. placebo in children (results from randomized controlled clinical trials) (MS Word, 44K)

Appendix Table D52. Adverse effects with topiramate vs. placebo in children (pooled with random effects results from randomized controlled clinical trials) (MS Word, 88K)

Appendix Table D53. Dose response effect on adverse effects with topiramate in children (results from randomized controlled clinical trials) (MS Word, 51K)

Appendix Table D54. Strength of evidence that divalproex sodium resulted in treatment discontinuation due to lack of efficacy (results from randomized controlled clinical trial) (MS Word, 37K)

Appendix Table D55. Adverse effects with divalproex sodium vs. placebo in children (results from randomized controlled clinical trial reviewed by the FDA and published as a journal article) (MS Word, 40K)

Appendix Table D56. Adverse effects with divalproex sodium vs. placebo in children (results from low risk of bias randomized controlled clinical trial) (MS Word, 42K)

Appendix Table D57. Dose response in adverse effects with divalproex sodium in children (results from randomized controlled clinical trial) (MS Word, 47K)

Appendix Table D58. Adverse effects with propranolol, 80mg/day, vs. placebo in children (results from medium risk of bias randomized controlled clinical trial) (MS Word, 37K)

Appendix Table D59. Treatment discontinuation with antidepressant trazodone vs. placebo in children (results from low risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D60. Adverse effects with clonidine, 25-50μg/day, vs. placebo in children (results from low risk of bias randomized controlled clinical trial) (MS Word, 36K)

Appendix Table D61. Adverse effects with magnesium, 9mg/kg/day, vs. placebo in children (results from medium risk of bias randomized controlled clinical trials) (MS Word, 36K)

Appendix Table D62. Comparative safety of topiramate vs. sodium valproate in preventing migraine in children (results from a randomized controlled clinical trial with unclear risk of bias) (MS Word, 36K)

References for Appendix D

1.
Ludvigsson J. Propranolol used in prophylaxis of migraine in children. Acta neurologica Scandinavica. 1974:109–15. [PubMed: 4839065]
2.
Sillanpää M. Clonidine prophylaxis of childhood migraine and other vascular headache. A double blind study of 57 children. Headache. 1977:28–31. [PubMed: 321395]
3.
Battistella PA, Ruffilli R, Moro R, et al. A placebo-controlled crossover trial of nimodipine in pediatric migraine. Headache. 1990 Apr;30(5):264–8. [PubMed: 2191938]
4.
Battistella PA, Ruffilli R, Cernetti R, et al. A placebo-controlled crossover trial using trazodone in pediatric migraine. Headache. 1993 Jan;33(1):36–9. [PubMed: 8436497]
5.
Apostol G, Cady RK, Laforet GA, et al. Divalproex extended-release in adolescent migraine prophylaxis: results of a randomized, double-blind, placebo-controlled study. Headache. 2008 Jul;48(7):1012–25. [PubMed: 18705027]
6.
U.S. Food and Drug Administration. Clinical Review of Divalproex Sodium. 2008.
7.
Lewis D, Winner P, Saper J, et al. Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate for migraine prevention in pediatric subjects 12 to 17 years of age. Pediatrics. 2009 Mar;123(3):924–34. [PubMed: 19255022]
8.
Winner P, Pearlman EM, Linder SL, et al. Topiramate for migraine prevention in children: a randomized, double-blind, placebo-controlled trial. Headache. 2005 Nov-Dec;45(10):1304–12. [PubMed: 16324162]
9.
Olness K, MacDonald JT, Uden DL. Comparison of self-hypnosis and propranolol in the treatment of juvenile classic migraine. Pediatrics. 1987 Apr;79(4):593–7. [PubMed: 3822681]
10.
Sorge F, Marano E. Flunarizine v. placebo in childhood migraine. A double-blind study. Cephalalgia. 1985 May;5 Suppl 2:145–8. [PubMed: 2861907]
11.
Ashrafi MR, Shabanian R, Zamani GR, et al. Sodium Valproate versus Propranolol in paediatric migraine prophylaxis. Eur J Paediatr Neurol. 2005;9(5):333–8. [PubMed: 16120482]
12.
Bidabadi E, Mashouf M. A randomized trial of propranolol versus sodium valproate for the prophylaxis of migraine in pediatric patients. Paediatric Drugs. 2010 Aug 1;12(4):269–75. [PubMed: 20593910]
13.
Unalp A, Uran N, Ozturk A. Comparison of the effectiveness of topiramate and sodium valproate in pediatric migraine. J Child Neurol. 2008 Dec;23(12):1377–81. [PubMed: 19073842]
14.
Sartory G, Muller B, Metsch J, et al. A comparison of psychological and pharmacological treatment of pediatric migraine. Behav Res Ther. 1998 Dec;36(12):1155–70. [PubMed: 9745800]
15.
Winner P, Gendolla A, Stayer C, et al. Topiramate for migraine prevention in adolescents: a pooled analysis of efficacy and safety. Headache. 2006 Nov-Dec;46(10):1503–10. [PubMed: 17115983]
16.
Lewis D, Paradiso E. A double-blind, dose comparison study of topiramate for prophylaxis of basilar-type migraine in children: a pilot study. Headache. 2007 Nov-Dec;47(10):1409–17. [PubMed: 18052950]
17.
Pandina GJ, Ness S, Polverejan E, et al. Cognitive effects of topiramate in migraine patients aged 12 through 17 years. Pediatr Neurol. 2010 Mar;42(3):187–95. [PubMed: 20159428]
18.
Trautmann E, Kroner-Herwig B. A randomized controlled trial of Internet-based self-help training for recurrent headache in childhood and adolescence. Behav Res Ther. 2010 Jan;48(1):28–37. [PubMed: 19782343]
19.
Wang F, Van DenEeden SK, Ackerson LM, et al. Oral magnesium oxide prophylaxis of frequent migrainous headache in children: a randomized, double-blind, placebo-controlled trial. Headache. 2003 Jun;43(6):601–10. [PubMed: 12786918]
20.
Forsythe WI, Gillies D, Sills MA. Propanolol (‘Inderal’) in the treatment of childhood migraine. Developmental medicine and child neurology. 1984:737–41. [PubMed: 6519358]
21.
Lewis DW, Diamond S, Scott D, et al. Prophylactic treatment of pediatric migraine. Headache. 2004 Mar;44(3):230–7. [PubMed: 15012660]
22.
Apostol G, Lewis DW, Laforet GA, et al. Divalproex sodium extended-release for the prophylaxis of migraine headache in adolescents: results of a stand-alone, long-term open-label safety study. Headache. 2009 Jan;49(1):45–53. [PubMed: 19040679]
23.
Pakalnis A, Greenberg G, Drake ME Jr., et al. Pediatric migraine prophylaxis with divalproex. Journal of Child Neurology. 2001 Oct;16(10):731–4. [PubMed: 11669346]
24.
Pakalnis A, Kring D, Meier L. Levetiracetam prophylaxis in pediatric migraine--an open-label study. Headache. 2007 Mar;47(3):427–30. [PubMed: 17371359]
25.
Miller GS. Efficacy and safety of levetiracetam in pediatric migraine. Headache. 2004 Mar;44(3):238–43. [PubMed: 15012661]
26.
Cruz MJ, Valencia I, Legido A, et al. Efficacy and tolerability of topiramate in pediatric migraine. Pediatric Neurology. 2009 Sep;41(3):167–70. [PubMed: 19664530]
27.
Jurgens TP, Ihle K, Stork JH, et al. “Alice in Wonderland syndrome” associated with topiramate for migraine prevention. J Neurol Neurosurg Psychiatry. 2011 Feb;82(2):228–9. [PubMed: 20571045]
28.
Taylor LM, Farzam F, Cook AM, et al. Clinical utility of a continuous intravenous infusion of valproic acid in pediatric patients. Pharmacotherapy. 2007 Apr;27(4):519–25. [PubMed: 17381378]
29.
Chan VW, McCabe EJ, MacGregor DL. Botox treatment for migraine and chronic daily headache in adolescents. Journal of Neuroscience Nursing. 2009 Oct;41(5):235–43. [PubMed: 19835236]