Journal of General Internal Medicine

, Volume 28, Issue 9, pp 1225–1237

Preventive Pharmacologic Treatments for Episodic Migraine in Adults

  • Tatyana A. Shamliyan
  • Jae-Young Choi
  • Rema Ramakrishnan
  • Jennifer Biggs Miller
  • Shi-Yi Wang
  • Frederick R. Taylor
  • Robert L. Kane
Reviews

Abstract

OBJECTIVES

Systematic review of preventive pharmacologic treatments for community-dwelling adults with episodic migraine.

DATA SOURCES

Electronic databases through May 20, 2012.

ELIGIBILITY CRITERIA

English-language randomized controlled trials (RCTs) of preventive drugs compared to placebo or active treatments examining rates of ≥50 % reduction in monthly migraine frequency or improvement in quality of life.

STUDY APPRAISAL AND SYNTHESIS METHODS

We assessed risk of bias and strength of evidence and conducted random effects meta-analyses of absolute risk differences and Bayesian network meta-analysis.

RESULTS

Of 5,244 retrieved references, 215 publications of RCTs provided mostly low-strength evidence because of the risk of bias and imprecision. RCTs examined 59 drugs from 14 drug classes. All approved drugs, including topiramate (9 RCTs), divalproex (3 RCTs), timolol (3 RCTs), and propranolol (4 RCTs); off-label beta blockers metoprolol (4 RCTs), atenolol (1 RCT), nadolol (1 RCT), and acebutolol (1 RCT); angiotensin-converting enzyme inhibitors captopril (1 RCT) and lisinopril (1 RCT); and angiotensin II receptor blocker candesartan (1 RCT), outperformed placebo in reducing monthly migraine frequency by ≥50 % in 200–400 patients per 1,000 treated. Adverse effects leading to treatment discontinuation (68 RCTs) were greater with topiramate, off-label antiepileptics, and antidepressants than with placebo. Limited direct evidence as well as frequentist and exploratory network Bayesian meta-analysis showed no statistically significant differences in benefits between approved drugs. Off-label angiotensin-inhibiting drugs and beta-blockers were most effective and tolerable for episodic migraine prevention.

LIMITATIONS

We did not quantify reporting bias or contact principal investigators regarding unpublished trials.

CONCLUSIONS

Approved drugs prevented episodic migraine frequency by ≥50 % with no statistically significant difference between them. Exploratory network meta-analysis suggested that off-label angiotensin-inhibiting drugs and beta-blockers had favorable benefit-to-harm ratios. Evidence is lacking for long-term effects of drug treatments (i.e., trials of more than 3 months duration), especially for quality of life.

KEY WORDS

migraine evidence based medicine adverse drug effects 

Supplementary material

11606_2013_2433_MOESM1_ESM.doc (1.5 mb)
ESM 1(DOC 1534 kb)

REFERENCES

  1. 1.
    Goadsby PJ, Raskin NH. Chapter 15. Headache. In: Fauci AS, Braunwald E, Kasper DL, et al., eds. Harrison’s principles of internal medicine. 17th ed. New York: The McGraw-Hill Companies; 2008.Google Scholar
  2. 2.
    Silberstein SD. Preventive migraine treatment. Neurol Clin. 2009;27:429–43.PubMedCrossRefGoogle Scholar
  3. 3.
    Solomon GD, Santanello N. Impact of migraine and migraine therapy on productivity and quality of life. Neurology. 2000;55:S29–35.PubMedCrossRefGoogle Scholar
  4. 4.
    Diamond S, Bigal ME, Silberstein S, Loder E, Reed M, Lipton RB. Patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention study. Headache. 2007;47:355–63.PubMedGoogle Scholar
  5. 5.
    Lipton RB, Scher AI, Kolodner K, Liberman J, Steiner TJ, Stewart WF. Migraine in the United States: epidemiology and patterns of health care use. Neurology. 2002;58:885–94.PubMedCrossRefGoogle Scholar
  6. 6.
    Bigal ME, Lipton RB, Winner P, et al. Migraine in adolescents: association with socioeconomic status and family history. Neurology. 2007;69:16–25.PubMedCrossRefGoogle Scholar
  7. 7.
    Hernandez-Latorre MA, Roig M. Natural history of migraine in childhood. Cephalalgia. 2000;20:573–9.PubMedCrossRefGoogle Scholar
  8. 8.
    Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24(Suppl 1):9–160.Google Scholar
  9. 9.
    Olesen J, Bousser MG, Diener HC, et al. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006;26:742–6.PubMedCrossRefGoogle Scholar
  10. 10.
    Solomon S. New appendix criteria open for a broader concept of chronic migraine (Comment on: Cephalagia 2006 Jun:26(6):742–6). Cephalalgia. 2007;27:469. author reply −70.PubMedCrossRefGoogle Scholar
  11. 11.
    Stewart WF, Ricci JA, Chee E, Morganstein D. Lost productive work time costs from health conditions in the United States: results from the American Productivity Audit. J Occup Environ Med. 2003;45:1234–46.PubMedCrossRefGoogle Scholar
  12. 12.
    Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML. Burden of migraine in the United States: disability and economic costs. Arch Intern Med. 1999;159:813–8.PubMedCrossRefGoogle Scholar
  13. 13.
    Burton WN, Landy SH, Downs KE, Runken MC. The impact of migraine and the effect of migraine treatment on workplace productivity in the United States and suggestions for future research. Mayo Clin Proc. 2009;84:436–45.PubMedGoogle Scholar
  14. 14.
    Lipton RB, Scher AI, Steiner TJ, et al. Patterns of health care utilization for migraine in England and in the United States. Neurology. 2003;60:441–8.PubMedCrossRefGoogle Scholar
  15. 15.
    Lipton RB, Stewart WF. The epidemiology of migraine. Eur Neurol. 1994;34(Suppl 2):6–11.PubMedCrossRefGoogle Scholar
  16. 16.
    Rapoport AM. Acute and prophylactic treatments for migraine: present and future. Neurol Sci. 2008;29(Suppl 1):S110–22.PubMedCrossRefGoogle Scholar
  17. 17.
    Stafford RS. Regulating off-label drug use–rethinking the role of the FDA. N Engl J Med. 2008;358:1427–9.PubMedCrossRefGoogle Scholar
  18. 18.
    Silberstein S, Tfelt-Hansen P, Dodick DW, et al. Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults. Cephalalgia. 2008;28:484–95.PubMedCrossRefGoogle Scholar
  19. 19.
    Schroeder BM. AAFP/ACP-ASIM release guidelines on the management and prevention of migraines. Am Fam Physician. 2003;67(1392):5–7.Google Scholar
  20. 20.
    Morey SS. Guidelines on migraine: part 4. General principles of preventive therapy. Am Fam Physician. 2000;62:2359–60.PubMedGoogle Scholar
  21. 21.
    Lainez 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.PubMedCrossRefGoogle Scholar
  22. 22.
    Luykx J, Mason M, Ferrari MD, Carpay J. Are migraineurs at increased risk of adverse drug responses? A meta-analytic comparison of topiramate-related adverse drug reactions in epilepsy and migraine. Clin Pharmacol Ther. 2009;85:283–8.PubMedCrossRefGoogle Scholar
  23. 23.
    Geraud G, Lanteri-Minet M, Lucas C, Valade D. French guidelines for the diagnosis and management of migraine in adults and children. Clin Ther. 2004;26:1305–18.PubMedCrossRefGoogle Scholar
  24. 24.
    Evers S, Afra J, Frese A, et al. EFNS guideline on the drug treatment of migraine–revised report of an EFNS task force. Eur J Neurol. 2009;16:968–81.PubMedCrossRefGoogle Scholar
  25. 25.
    Dowson AJ, Lipscombe S, Sender J, Rees T, Watson D. New guidelines for the management of migraine in primary care. Curr Med Res Opin. 2002;18:414–39.PubMedCrossRefGoogle Scholar
  26. 26.
    Epstein RM, Alper BS, Quill TE. Communicating evidence for participatory decision making. JAMA. 2004;291:2359–66.PubMedCrossRefGoogle Scholar
  27. 27.
    Amanzio M, Corazzini LL, Vase L, Benedetti F. A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain. 2009;146:261–9.PubMedCrossRefGoogle Scholar
  28. 28.
    Whyte CA, Tepper SJ. Adverse effects of medications commonly used in the treatment of migraine. Expert Rev Neurother. 2009;9:1379–91.PubMedCrossRefGoogle Scholar
  29. 29.
    Sung NS, Crowley WF Jr, Genel M, et al. Central challenges facing the national clinical research enterprise. JAMA. 2003;289:1278–87.PubMedCrossRefGoogle Scholar
  30. 30.
    Institute of Medicine (US). Finding what works in health care: Standards for systematic reviews. Heidelberg: National Academies Press; 2011.Google Scholar
  31. 31.
    Institute of Medicine (US). Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Ethical and scientific issues in studying the safety of approved drugs. Washington: National Academies Press; 2012.Google Scholar
  32. 32.
    Slutsky J, Atkins D, Chang S, Collins Sharp BA. Comparing medical interventions: AHRQ and the Effective Health Care Program. Methods Guide for Effectiveness and Comparative Effectiveness Reviews AHRQ Publication No 10(11)-EHC063-EF. 2011/03/25 ed. Rockville, MD: Agency for Healthcare Research and Quality; 2008:1–4. Available at http://effectivehealthcare.ahrq.gov/ehc/products/118/324/MethodsGuide_Slutsky_Comparing%20Medical%20Interventions.pdf; accessed on February 19, 2013.
  33. 33.
    Helfand M, Balshem H. Principles in Developing and Applying Guidance. 2008.Google Scholar
  34. 34.
    Whitlock EP, Lopez SA, Chang S, Helfand M, Eder M, Floyd N. AHRQ series paper 3: identifying, selecting, and refining topics for comparative effectiveness systematic reviews: AHRQ and the effective health-care program. J Clin Epidemiol. 2010;63:491–501.PubMedCrossRefGoogle Scholar
  35. 35.
    Rothner AD. Complicated migraine and migraine variants. Curr Pain Headache Rep. 2002;6:233–9.PubMedCrossRefGoogle Scholar
  36. 36.
    Hansen JM, Thomsen LL, Olesen J, Ashina M. Calcitonin gene-related peptide does not cause the familial hemiplegic migraine phenotype. Neurology. 2008;71:841–7.PubMedCrossRefGoogle Scholar
  37. 37.
    Norris S, Atkins D, Bruening W, et al. Chapter 4. Selecting observational studies for comparing medical interventions. Methods Guide for Effectiveness and Comparative Reviews AHRQ Publication No 10(11)-EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2011:56–68. Available at: http://effectivehealthcare.ahrq.gov/ehc/products/196/454/MethodsGuideNorris_06042010.pdf; accessed on February 19, 2013.
  38. 38.
    Chou R, Aronson N, Atkins D, et al. AHRQ series paper 4: assessing harms when comparing medical interventions: AHRQ and the Effective Health-Care Program. J Clin Epidemiol. 2008;63:502–12.PubMedCrossRefGoogle Scholar
  39. 39.
    Higgins J, Green S, eds. Cochrane handbook for systematic reviews of interventions. Version 5.1.0. London: The Cochrane Collaboration; 2011.Google Scholar
  40. 40.
    Higgins JP, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.PubMedCrossRefGoogle Scholar
  41. 41.
    van der Velde G, van Tulder M, Cote P, et al. The sensitivity of review results to methods used to appraise and incorporate trial quality into data synthesis. Spine. 2007;32:796–806. Phila Pa 1976.PubMedCrossRefGoogle Scholar
  42. 42.
    Herbison P, Hay-Smith J, Gillespie WJ. Adjustment of meta-analyses on the basis of quality scores should be abandoned. J Clin Epidemiol. 2006;59:1249–56.PubMedCrossRefGoogle Scholar
  43. 43.
    Wallace BC, Schmid CH, Lau J, Trikalinos TA. Meta-Analyst: software for meta-analysis of binary, continuous and diagnostic data. BMC Med Res Methodol. 2009;9:80.PubMedCrossRefGoogle Scholar
  44. 44.
    Egger M, Smith GD, Altman DG. Systematic reviews in health care: meta-analysis in context. 2nd ed. London: BMJ Books; 2001.CrossRefGoogle Scholar
  45. 45.
    Treadwell JR, Uhl S, Tipton K, et al. Assessing equivalence and noninferiority. J Clin Epidemiol. 2012;65:1144–9.PubMedCrossRefGoogle Scholar
  46. 46.
    Lievre M, Cucherat M, Leizorovicz A. Pooling, meta-analysis, and the evaluation of drug safety. Current controlled trials in cardiovascular medicine. 2002;3:6.PubMedCrossRefGoogle Scholar
  47. 47.
    Fu R, Gartlehner G, Grant M, et al. Chapter 9. Conducting quantitative synthesis when comparing medical interventions. Methods Guide for Effectiveness and Comparative Effectiveness Reviews AHRQ Publication No 10(11)-EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2011:104–19. Available at: http://effectivehealthcare.ahrq.gov/ehc/products/243/554/MethodsGuide--ConductingQuantitativeSynthesis.pdf; accessed on February 20, 2013.
  48. 48.
    Rucker G, Schwarzer G, Carpenter J, Olkin I. Why add anything to nothing? The arcsine difference as a measure of treatment effect in meta-analysis with zero cells. Stat Med. 2009;28:721–38.PubMedCrossRefGoogle Scholar
  49. 49.
    Bradburn MJ, Deeks JJ, Berlin JA, Russell LA. Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events. Stat Med. 2007;26:53–77.PubMedCrossRefGoogle Scholar
  50. 50.
    Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Stat Med. 2004;23:1351–75.PubMedCrossRefGoogle Scholar
  51. 51.
    Stijnen T, Hamza TH, Ozdemir P. Random effects meta-analysis of event outcome in the framework of the generalized linear mixed model with applications in sparse data. Stat Med. 2010;29:3046–67.PubMedCrossRefGoogle Scholar
  52. 52.
    White IR. Multivariate random-effects meta-regression: Updates to mvmeta. The Stata Journal 2011;11.Google Scholar
  53. 53.
    Owens DK, Lohr KN, Atkins D, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions-Agency for Healthcare Research and Quality and the Effective Health-Care Program. J Clin Epidemiol. 2010;63:513–23.PubMedCrossRefGoogle Scholar
  54. 54.
    Viechtbauer W. Confidence intervals for the amount of heterogeneity in meta-analysis. Stat Med. 2007;26:37–52.PubMedCrossRefGoogle Scholar
  55. 55.
    Knapp G, Biggerstaff BJ, Hartung J. Assessing the amount of heterogeneity in random-effects meta-analysis. Biom J. 2006;48:271–85.PubMedCrossRefGoogle Scholar
  56. 56.
    DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177–88.PubMedCrossRefGoogle Scholar
  57. 57.
    Ad Hoc Committee on Classification of Headache. Classification of headache. JAMA. 1962;179:717–8.CrossRefGoogle Scholar
  58. 58.
    Ebrahim S. The use of numbers needed to treat derived from systematic reviews and meta-analysis. Caveats and pitfalls. Eval Health Prof. 2001;24:152–64.PubMedCrossRefGoogle Scholar
  59. 59.
    Altman DG. Confidence intervals for the number needed to treat. BMJ. 1998;317:1309–12.PubMedCrossRefGoogle Scholar
  60. 60.
    Coory M, Jordan S. Frequency of treatment-effect modification affecting indirect comparisons: a systematic review. Pharmcoeconomics. 2010;28:723–32.CrossRefGoogle Scholar
  61. 61.
    Wells G, Sultan S, Chen L, Khan M, Coyle D. Indirect evidence: Indirect treatment comparisons in meta-analysis. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2009.Google Scholar
  62. 62.
    Glenny AM, Altman DG, Song F, et al. Indirect comparisons of competing interventions. Health Technol Assess. 2005;9:1–134. iii-iv.PubMedGoogle Scholar
  63. 63.
    Song F, Loke YK, Walsh T, Glenny AM, Eastwood AJ, Altman DG. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ. 2009;338:b1147.PubMedCrossRefGoogle Scholar
  64. 64.
    Donegan S, Williamson P, Gamble C, Tudur-Smith C. Indirect comparisons: a review of reporting and methodological quality. PLoS One. 2010;5:e11054.PubMedCrossRefGoogle Scholar
  65. 65.
    Carlin BP, Louis TA. Bayesian methods for data analysis. Boca Raton: Chapman & Hall/CRC; 2009.Google Scholar
  66. 66.
    Higgins JPT, Jackson D, Barrett JK, Lu G, Ades AE, White IR. Consistency and inconsistency in network meta-analysis: concepts and models for multi-arm studies. Research Synthesis Methods. 2012;3:98–110.CrossRefGoogle Scholar
  67. 67.
    Aschengrau A, Seage GR. Essentials of epidemiology in public health. Sudbury: Jones and Bartlett; 2003.Google Scholar
  68. 68.
    Lunn D, Thomas A, Best N, Spiegelhalter D. WinBUGS- a Bayesian modelling framework: concepts, structure, and extensibility. Statistics and Computing. 2000;10:325–37.CrossRefGoogle Scholar
  69. 69.
    Berkman ND, Lohr KN, Morgan LC, et al. Reliability Testing of the AHRQ EPC Approach to Grading the Strength of Evidence in Comparative Effectiveness Reviews. Rockville (MD) 2012.Google Scholar
  70. 70.
    Guyatt G, Oxman AD, Kunz R, et al. GRADE guidelines 6. Rating the quality of evidence-imprecision. J Clin Epidemiol 2011.Google Scholar
  71. 71.
    Sterne JA, Sutton AJ, Ioannidis JP, et al. Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials. BMJ. 2011;343:d4002.PubMedCrossRefGoogle Scholar
  72. 72.
    Silberstein S. Efficacy and safety of topiramate in migraine prevention: a dose-ranging, placebo-controlled, double-blind, multicenter study. Advanced Studies in Medicine. 2003;3:S565–8.Google Scholar
  73. 73.
    Brandes JL, Saper JR, Diamond M, et al. Topiramate for migraine prevention: a randomized controlled trial. JAMA. 2004;291:965–73.PubMedCrossRefGoogle Scholar
  74. 74.
    Silberstein SD, Neto W, Schmitt J, Jacobs D. Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol. 2004;61:490–5.PubMedCrossRefGoogle Scholar
  75. 75.
    Diener HC, Agosti R, Allais G, et al. Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2007;6:1054–62.PubMedCrossRefGoogle Scholar
  76. 76.
    Brandes JL, Kudrow DB, Rothrock JF, Rupnow MF, Fairclough DL, Greenberg SJ. Assessing the ability of topiramate to improve the daily activities of patients with migraine. Mayo Clin Proc. 2006;81:1311–9.PubMedCrossRefGoogle Scholar
  77. 77.
    Diener HC, Bussone G, Van Oene JC, Lahaye M, Schwalen S, Goadsby PJ. Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study. Cephalalgia. 2007;27:814–23.PubMedCrossRefGoogle Scholar
  78. 78.
    Dahlof C, Loder E, Diamond M, Rupnow M, Papadopoulos G, Mao L. The impact of migraine prevention on daily activities: a longitudinal and responder analysis from three topiramate placebo-controlled clinical trials. Health Qual Life Outcomes. 2007;5:56.PubMedCrossRefGoogle Scholar
  79. 79.
    Klapper J. Divalproex sodium in migraine prophylaxis: a dose-controlled study. Cephalalgia. 1997;17:103–8.PubMedCrossRefGoogle Scholar
  80. 80.
    Mei D, Ferraro D, Zelano G, et al. Topiramate and triptans revert chronic migraine with medication overuse to episodic migraine. Clin Neuropharmacol. 2006;29:269–75.PubMedCrossRefGoogle Scholar
  81. 81.
    Lipton RB, Silberstein S, Dodick D, et al. Topiramate intervention to prevent transformation of episodic migraine: the topiramate INTREPID study. Cephalalgia. 2011;31:18–30.PubMedCrossRefGoogle Scholar
  82. 82.
    Bussone G, Diener HC, Pfeil J, Schwalen S. Topiramate 100 mg/day in migraine prevention: a pooled analysis of double-blind randomised controlled trials. Int J Clin Pract. 2005;59:961–8.PubMedCrossRefGoogle Scholar
  83. 83.
    Forssman B, Henriksson KG, Johannsson V, et al. Propranolol for migraine prophylaxis. Headache. 1976;16(5):238–45.PubMedCrossRefGoogle Scholar
  84. 84.
    Schoonman GG, Wiendels NJ, Ferrari MD. Gabapentin in migraine prophylaxis: is it effective and well tolerated? Headache. 2002;42:235.PubMedGoogle Scholar
  85. 85.
    Nanda RN, Johnson RH, Gray J, Keogh HJ, Melville ID. A double blind trial of acebutolol for migraine prophylaxis. Headache. 1978;18(1):20–2.PubMedCrossRefGoogle Scholar
  86. 86.
    Forssman B, Lindblad CJ, Zbornikova V. Atenolol for migraine prophylaxis. Headache. 1983;23(4):188–90.PubMedCrossRefGoogle Scholar
  87. 87.
    Freitag FG, Diamond S. Nadolol and placebo comparison study in the prophylactic treatment of migraine. The Journal of the American Osteopathic Association. 1984;84(4):343–7.PubMedGoogle Scholar
  88. 88.
    Minervini MG, Pinto K. Captopril relieves pain and improves mood depression in depressed patients with classical migraine. Cephalalgia. 1987;7(Suppl 6):485–6.Google Scholar
  89. 89.
    Schrader H, Stovner LJ, Helde G, Sand T, Bovim G. Prophylactic treatment of migraine with angiotensin converting enzyme inhibitor (lisinopril): randomised, placebo controlled, crossover study. BMJ. 2001;322:19–22.PubMedCrossRefGoogle Scholar
  90. 90.
    Tronvik E, Stovner LJ, Helde G, Sand T, Bovim G. Prophylactic treatment of migraine with an angiotensin II receptor blocker: a randomized controlled trial. JAMA. 2003;289:65–9.PubMedCrossRefGoogle Scholar
  91. 91.
    Diener HC, Gendolla A, Feuersenger A, et al. Telmisartan in migraine prophylaxis: a randomized, placebo-controlled trial. Cephalalgia. 2009;29:921–7.PubMedCrossRefGoogle Scholar
  92. 92.
    Adelman J, Freitag FG, Lainez M, et al. Analysis of safety and tolerability data obtained from over 1,500 patients receiving topiramate for migraine prevention in controlled trials. Pain Med. 2008;9:175–85.PubMedCrossRefGoogle Scholar
  93. 93.
    Couch JR, Hassanein RS. Amitriptyline in migraine prophylaxis. Arch Neurol. 1979;36:695–9.PubMedCrossRefGoogle Scholar
  94. 94.
    Lampl C, Huber G, Adl J, et al. Two different doses of amitriptyline ER in the prophylaxis of migraine: long-term results and predictive factors. Eur J Neurol. 2009;16:943–8.PubMedCrossRefGoogle Scholar
  95. 95.
    Silberstein SD, Hulihan J, Karim MR, et al. Efficacy and tolerability of topiramate 200 mg/d in the prevention of migraine with/without aura in adults: a randomized, placebo-controlled, double-blind, 12-week pilot study. Clin Ther. 2006;28:1002–11.PubMedCrossRefGoogle Scholar
  96. 96.
    Reuter U, Del Rio MS, Diener HC, et al. Migraines with and without aura and their response to preventive therapy with topiramate. Cephalalgia: an International Journal of Headache. 2010;30(5):543–51.Google Scholar
  97. 97.
    Barden J, Derry S, McQuay HJ, Moore RA. Bias from industry trial funding? A framework, a suggested approach, and a negative result. Pain. 2006;121:207–18.PubMedCrossRefGoogle Scholar
  98. 98.
    Fox AW. Disease modification in migraine: study design and sample size implications. Headache. 2008;48:1169–75.PubMedCrossRefGoogle Scholar
  99. 99.
    Hazard E, Munakata J, Bigal ME, Rupnow MFT, Lipton RB. The burden of migraine in the United States: current and emerging perspectives on disease management and economic analysis. Value in Health. 2009;12:55–64.PubMedCrossRefGoogle Scholar
  100. 100.
    Russell MB, Hilden J, Sorensen SA, Olesen J. Familial occurrence of migraine without aura and migraine with aura. Neurology. 1993;43:1369–73.PubMedCrossRefGoogle Scholar
  101. 101.
    Arends LR, Hoes AW, Lubsen J, Grobbee DE, Stijnen T. Baseline risk as predictor of treatment benefit: three clinical = meta-re-analyses. Stat Med. 2000;19:3497–518.PubMedCrossRefGoogle Scholar
  102. 102.
    Gentile G, Missori S, Borro M, Sebastianelli A, Simmaco M, Martelletti P. Frequencies of genetic polymorphisms related to triptans metabolism in chronic migraine. Journal of Headache & Pain. 2010;11:151–6.CrossRefGoogle Scholar
  103. 103.
    Schurks M, Zee RY, Buring JE, Kurth T. ACE D/I polymorphism, migraine, and cardiovascular disease in women. Neurology. 2009;72:650–6.PubMedCrossRefGoogle Scholar
  104. 104.
    Feldman HL. Pushing drugs: genomics and genetics, the pharmaceutical industry, and the law of negligence. Washburn Law J. 2003;42:575–99.PubMedGoogle Scholar
  105. 105.
    Tomson T, Battino D. Teratogenic effects of antiepileptic drugs. Lancet Neurol. 2012;11:803–13.PubMedCrossRefGoogle Scholar
  106. 106.
    Coebergh JA, Waldinger MD. Reversible anorgasmia with topiramate for migraine prophylaxis. The Journal of Neuropsychiatry and Clinical Neurosciences. 2012;24:E30–1.PubMedGoogle Scholar
  107. 107.
    Huang CY, Keller JJ, Sheu JJ, Lin HC. Migraine and erectile dysfunction: evidence from a population-based case–control study. Cephalalgia. 2012;32:366–72.PubMedCrossRefGoogle Scholar
  108. 108.
    Bingham MF, Johnson FR, Miller D. Modeling choice behavior for new pharmaceutical products. Value in Health. 2001;4:32–44.PubMedCrossRefGoogle Scholar
  109. 109.
    Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78:1337–45.PubMedCrossRefGoogle Scholar
  110. 110.
    Brouwers MC, Kho ME, Browman GP, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. J Clin Epidemiol. 2010;63:1308–11.PubMedCrossRefGoogle Scholar
  111. 111.
    Mullan RJ, Flynn DN, Carlberg B, et al. Systematic reviewers commonly contact study authors but do so with limited rigor. J Clin Epidemiol. 2009;62:138–42.PubMedCrossRefGoogle Scholar
  112. 112.
    Finding Evidence and Assessing for Reporting Biases when Comparing Medical Interventions: AHRQ and the Effective Health Care Program. In press 2012. The draft is available at: http://effectivehealthcare.ahrq.gov/ehc/products/486/1305/Reporting-Bias_DraftReport_20121023.pdf; accessed on February 19, 2013
  113. 113.
    Edwards IR. Off-label pharmacovigilance. Drug Saf. 2011;34:795–7.PubMedCrossRefGoogle Scholar
  114. 114.
    Layton D, Hazell L, Shakir SA. Modified prescription-event monitoring studies: a tool for pharmacovigilance and risk management. Drug Saf. 2011;34:e1–9.PubMedCrossRefGoogle Scholar
  115. 115.
    Mathew NT, Saper JR, Silberstein SD, et al. Migraine prophylaxis with divalproex. Arch Neurol. 1995;52:281–6.PubMedCrossRefGoogle Scholar
  116. 116.
    Freitag FG, Collins SD, Carlson HA, et al. A randomized trial of divalproex sodium extended-release tablets in migraine prophylaxis. Neurology. 2002;58:1652–9.PubMedCrossRefGoogle Scholar
  117. 117.
    Storey JR, Calder CS, Hart DE, Potter DL. Topiramate in migraine prevention: a double-blind, placebo-controlled study. Headache. 2001;41:968–75.PubMedCrossRefGoogle Scholar
  118. 118.
    Mei D, Capuano A, Vollono C, et al. Topiramate in migraine prophylaxis: a randomised double-blind versus placebo study. Neurol Sci. 2004;25:245–50.PubMedCrossRefGoogle Scholar
  119. 119.
    Silvestrini M, Bartolini M, Coccia M, Baruffaldi R, Taffi R, Provinciali L. Topiramate in the treatment of chronic migraine. Cephalalgia. 2003;23:820–4.PubMedCrossRefGoogle Scholar
  120. 120.
    Gupta P, Singh S, Goyal V, Shukla G, Behari M. Low-dose topiramate versus lamotrigine in migraine prophylaxis (the Lotolamp study). Headache. 2007;47:402–12.PubMedGoogle Scholar
  121. 121.
    Silberstein S, Lipton R, Dodick D, et al. Topiramate treatment of chronic migraine: a randomized, placebo-controlled trial of quality of life and other efficacy measures. Headache. 2009;49:1153–62.PubMedCrossRefGoogle Scholar
  122. 122.
    Tfelt-Hansen P, Standnes B, Kangasneimi P, Hakkarainen H, Olesen J. Timolol vs propranolol vs placebo in common migraine prophylaxis: a double-blind multicenter trial. Acta Neurol Scand. 1984;69:1–8.PubMedCrossRefGoogle Scholar
  123. 123.
    Diener HC, Tfelt-Hansen P, Dahlof C, et al. Topiramate in migraine prophylaxis–results from a placebo-controlled trial with propranolol as an active control. J Neurol. 2004;251:943–50.PubMedCrossRefGoogle Scholar
  124. 124.
    Diamond S, Medina JL. Double blind study of propranolol for migraine prophylaxis. Headache. 1976;16:24–7.PubMedCrossRefGoogle Scholar
  125. 125.
    Standnes B. The prophylactic effect of timolol versus propranolol and placebo in common migraine: beta-blockers in migraine. Cephalalgia. 1982;2:165–70.PubMedCrossRefGoogle Scholar
  126. 126.
    Stellar S, Ahrens SP, Meibohm AR, Reines SA. Migraine prevention with timolol. A double-blind crossover study. JAMA. 1984;252:2576–80.PubMedCrossRefGoogle Scholar
  127. 127.
    Wessely P, Baumgartner C, Klingler D, et al. Preliminary results of a double-blind study with the new migraine prophylactic drug Gabapentin. Cephalalgia. 1987;7:477–8.Google Scholar
  128. 128.
    Mathew NT, Rapoport A, Saper J, et al. Efficacy of gabapentin in migraine prophylaxis. Headache. 2001;41:119–28.PubMedCrossRefGoogle Scholar
  129. 129.
    NCT00742209. Prevention study in adult patients suffering from migraine headaches. 2010.Google Scholar
  130. 130.
    Havanka-Kanniainen H, Hokkanen E, Myllylä VV. Efficacy of nimodipine in the prophylaxis of migraine. Cephalalgia: an International Journal of Headache. 1985;5(1):39–43.CrossRefGoogle Scholar
  131. 131.
    Gelmers HJ. Nimodipine, a new calcium antagonist, in the prophylactic treatment of migraine. Headache. 1983;23(3):106–9.PubMedCrossRefGoogle Scholar
  132. 132.
    Kangasniemi P, Andersen AR, Andersson PG, et al. Classic migraine: effective prophylaxis with metoprolol. Cephalalgia. 1987;7:231–8.PubMedCrossRefGoogle Scholar
  133. 133.
    Andersson PG, Dahl S, Hansen JH, et al. Prophylactic treatment of classical and non-classical migraine with metoprolol–a comparison with placebo. Cephalalgia. 1983;3:207–12.PubMedCrossRefGoogle Scholar
  134. 134.
    Peikert A, Wilimzig C, Kohne-Volland R. Prophylaxis of migraine with oral magnesium: results from a prospective, multi-center, placebo-controlled and double-blind randomized study. Cephalalgia. 1996;16:257–63.PubMedCrossRefGoogle Scholar
  135. 135.
    Pfaffenrath V, Wessely P, Meyer C, et al. Magnesium in the prophylaxis of migraine–a double-blind placebo-controlled study. Cephalalgia. 1996;16:436–40.PubMedCrossRefGoogle Scholar
  136. 136.
    Silberstein SD, Lipton RB, Dodick DW, et al. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007;47:170–80.PubMedCrossRefGoogle Scholar
  137. 137.
    Edwards KR, Potter DL, Wu SC, Kamin M, Hulihan J. Topiramate in the preventive treatment of episodic migraine: a combined analysis from pilot, double-blind, placebo-controlled trials. CNS Spectr. 2003;8:428–32.PubMedGoogle Scholar
  138. 138.
    Pradalier A, Serratrice G, Collard M, et al. Long-acting propranolol in migraine prophylaxis: results of a double-blind, placebo-controlled study. Cephalalgia. 1989;9:247–53.PubMedGoogle Scholar
  139. 139.
    Boisen E, Deth S, Hübbe P, Jansen J, Klee A, Leunbach G. Clonidine in the prophylaxis of migraine. Acta Neurologica Scandinavica. 1978;58(5):288–95.PubMedCrossRefGoogle Scholar
  140. 140.
    Adam EI, Gore SM, Price WH. Double blind trial of clonidine in the treatment of migraine in a general practice. J R Coll Gen Pract. 1978;28:587–90.PubMedGoogle Scholar
  141. 141.
    Couch JR. Amitriptyline in the prophylactic treatment of migraine and chronic daily headache. Headache. 2011;51:33–51.PubMedCrossRefGoogle Scholar
  142. 142.
    Orholm M, Honore PF, Zeeberg I. A randomized general practice group-comparative study of femoxetine and placebo in the prophylaxis of migraine. Acta Neurol Scand. 1986;74:235–9.PubMedCrossRefGoogle Scholar
  143. 143.
    Orholm M, Le Fevre P. Prophylactic treatment of migraine with femoxetine—a randomized comparison with placebo. Cephalalgia 1985:516–7.Google Scholar
  144. 144.
    Steiner TJ, Findley LJ, Yuen AW. Lamotrigine versus placebo in the prophylaxis of migraine with and without aura. Cephalalgia. 1997;17:109–12.PubMedCrossRefGoogle Scholar
  145. 145.
    Hering R, Kuritzky A. Sodium valproate in the prophylactic treatment of migraine: a double-blind study versus placebo. Cephalalgia. 1992;12:81–4.PubMedCrossRefGoogle Scholar
  146. 146.
    Jensen R, Brinck T, Olesen J. Sodium valproate has a prophylactic effect in migraine without aura: a triple-blind, placebo-controlled crossover study. Neurology. 1994;44:647–51.PubMedCrossRefGoogle Scholar
  147. 147.
    Welch KMA, Ellis DJ, Keenan PA. Successful migraine prohpylaxis with naproxen sodium. Neurology1985.Google Scholar
  148. 148.
    Ziegler DK, Ellis DJ. Naproxen in prophylaxis of migraine. Archives of neurology. 1985;42(6):582–4.PubMedCrossRefGoogle Scholar
  149. 149.
    (MINES) M-NESG. European multicenter trial of nimodipine in the prophylaxis of classic migraine (migraine with aura). Headache. 1989;29:639–42.CrossRefGoogle Scholar
  150. 150.
    Dodick DW, Freitag F, Banks J, et al. Topiramate versus amitriptyline in migraine prevention: a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs. Clin Ther. 2009;31:542–59.PubMedCrossRefGoogle Scholar
  151. 151.
    Keskinbora K, Aydinli I. A double-blind randomized controlled trial of topiramate and amitriptyline either alone or in combination for the prevention of migraine. Clin Neurol Neurosurg. 2008;110:979–84.PubMedCrossRefGoogle Scholar

Copyright information

© Society of General Internal Medicine 2013

Authors and Affiliations

  • Tatyana A. Shamliyan
    • 1
    • 2
  • Jae-Young Choi
    • 3
  • Rema Ramakrishnan
    • 4
  • Jennifer Biggs Miller
    • 2
  • Shi-Yi Wang
    • 5
  • Frederick R. Taylor
    • 6
  • Robert L. Kane
    • 1
    • 2
  1. 1.Minnesota Evidence-based Practice CenterMinneapolisUSA
  2. 2.University of Minnesota School of Public HealthMinneapolisUSA
  3. 3.Division of BusinessHallym UniversityChuncheonSouth Korea
  4. 4.University of South Florida College of Public HealthTampaUSA
  5. 5.Yale School of Public HealthNew HavenUSA
  6. 6.University of Minnesota Medical SchoolMinnesotaUSA

Personalised recommendations