Amitriptyline and intraoral devices for migraine prevention: a randomized comparative trial

ABSTRACT

Objectives: Nonpharmacological treatments, such as the Nociceptive Trigeminal Inhibition Tension Suppression System (NTI-tss), are approved for migraine prophylaxis. We aimed at evaluating the effectiveness of the NTI-tss and to compare its efficacy with amitriptyline and with a sham intraoral device in the preventive treatment of migraine.

Methods: Consecutive patients with migraine were randomized to receive 25 mg of amitriptyline/day (n = 34), NTI-tss (n = 33) and a non-occlusal splint (n = 30). The headache frequency was evaluated at six and 12 weeks.

Results: The amitriptyline group showed, respectively, 60% and 64% reduction in attack frequency at six and 12 weeks (P = 0.000). In the NTI-tss and non-occlusal splint groups, reduction was 39% and 30%, respectively, at six weeks and 48% for both groups at 12 weeks.

Conclusions: Amitriptyline proved superior to the NTI-tss and the non-occlusal splint. Despite its approval by the United States Food and Drug Administration, the NTI-tss was not superior to a sham device.

RESUMO

Objetivo: Tratamentos não farmacológicos como o Nociceptive Trigeminal Inhibition Tension Suppression System (NTI-tss), são aprovados para a prevenção da migrânea. Avaliamos a eficácia do NTI-tss no tratamento preventivo da migrânea e comparamos sua eficácia com a de um medicamento tradicional (amitriptilina) e com um dispositivo intraoral que não interfere com a oclusão (placa palatina).

Métodos: Pacientes consecutivos com migrânea foram randomizados e receberam 25mg de amitriptilina/dia (n = 34), NTI-tss (n = 33) ou placa palatina não oclusal (n = 30). A frequência da cefaleia foi comparada após seis e 12 semanas.

Resultados: No grupo da amitriptilina houve redução de 60% em seis semanas e de 64% em 12 semanas (P = 0.000). Nos grupos do NTI-tss e da placa não oclusal a redução foi respectivamente de 39% e 30% após seis semanas, e de 48% para ambos em 12 semanas.

Conclusões: Amitriptilina foi superior ao NTI-tss e à placa palatina no tratamento da migrânea sem aura. O NTI-tss obteve resultados similares aos da placa não oclusal.

Keywords:

migraine disorders - amitriptyline - preventive medicine

Palavras-chave:

transtornos da enxaqueca - amitriptilina - medicina preventiva

• References

• 1 World Health Organization. Atlas of headache disorders and resources in the world. Geneva: WHO; 2011.
• 2 Stovner L, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. https://doi.org/10.1111/j.1468-2982.2007.01288.x
• 3 Spierings EL. Mechanism of migraine and action of antimigraine medications. Med Clin North Am. 2001 Jul;85(4):943-58. https://doi.org/10.1016/S0025-7125(05)70352-7
• 4 Krymchantowski AV. Combining therapies for the treatment of migraine: is there a role? Expert Rev Neurother. 2005 Mar;5(2):145-7. https://doi.org/10.1586/14737175.5.2.145
• 5 Gomersall JD, Stuart A. Amitriptyline in migraine prophylaxis. Changes in pattern of attacks during a controlled clinical trial. J Neurol Neurosurg Psychiatry. 1973 Aug;36(4):684-90. https://doi.org/10.1136/jnnp.36.4.684
• 6 Couch JR, Ziegler DK, Hassanein R. Amitriptyline in the prophylaxis of migraine. Effectiveness and relationship of antimigraine and antidepressant effects. Neurology. 1976 Feb;26(2):121-7. https://doi.org/10.1212/WNL.26.2.121
• 7 Okeson J. Management of temporomandibular disorders and occlusion. 7th ed. St. Louis: Elsevier; 2013.
• 8 Shankland WE 2nd. Migraine and tension-type headache reduction through pericranial muscular suppression: a preliminary report. Cranio. 2001 Oct;19(4):269-78. https://doi.org/10.1080/08869634.2001.11746178
• 9 Shankland WE. Nociceptive trigeminal inhibition: tension suppression system: a method of preventing migraine and tension headaches. Compend Contin Educ Dent. 2002 Feb;23(2):105-8.
• 10 Ekberg E, Vallon D, Nilner M. Treatment outcome of headache after occlusal appliance therapy in a randomized controlled trial among patients with TMDs of mainly arthrogenous origen. Swed Dent J. 2002;26(3):115-24.
• 11 Jokstad A, Mo A, Krogstad BS. Clinical comparison between two different splint designs for temporomandibular disorder therapy. Acta Odontol Scand. 2005 Aug;63(4):218-26. https://doi.org/10.1080/00016350510019982
• 12 Stapelmann H, Türp JC. The NTI-tss device for the therapy of bruxism, temporomandibular disorders, and headache: where do we stand? A qualitative systematic review of the literature. BMC Oral Health. 2008 Jul;8(1):22. https://doi.org/10.1186/1472-6831-8-22
• 13 Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992;6(4):301-55.
• 14 The International Classification of Headache Disorders: 2nd edition. Cephalalgia 2004;24 Suppl 1:9-160.
• 15 Burch R, Wells R. Pathophysiology of migraine. Headache. 2013 Feb;53(2):420-2. https://doi.org/10.1111/head.12027
• 16 Bigal ME, Lipton RB. Migraine chronification. Curr Neurol Neurosci Rep. 2011 Apr;11(2):139-48. https://doi.org/10.1007/s11910-010-0175-6
• 17 Puledda F, Messina R, Goadsby PJ. An update on migraine: current understanding and future directions. J Neurol. 2017 Sep;264(9):2031-9. https://doi.org/10.1007/s00415-017-8434-y
• 18 Drummond PD, Lance JW. Extracranial vascular changes and the source of pain in migraine headache. Ann Neurol. 1983 Jan;13(1):32-7. https://doi.org/10.1002/ana.410130108
• 19 Wright EF, Jundt JS. The NTI appliance for TMD and headache therapy. Tex Dent J. 2006 Dec;123(12):1118-24.
• 20 May BM, Garabadian C. Reducing condylar compression in clenching patients. Crit Rev Biomed Eng. 2000;28(3-4):389-94. https://doi.org/10.1615/CritRevBiomedEng.v28.i34.70
• 21 Becker I, Tarantola G, Zambrano J, Spitzer S, Oquendo D. Effect of a prefabricated anterior bite stop on electromyographic activity of masticatory muscles. J Prosthet Dent. 1999 Jul;82(1):22-6. https://doi.org/10.1016/S0022-3913(99)70127-7
• 22 Baad-Hansen L, Jadidi F, Castrillon E, Thomsen PB, Svensson P. Effect of a nociceptive trigeminal inhibitory splint on electromyographic activity in jaw closing muscles during sleep. J Oral Rehabil. 2007 Feb;34(2):105-11. https://doi.org/10.1111/j.1365-2842.2006.01717.x
• 23 Ciancaglini R, Radaelli G. The relationship between headache and symptoms of temporomandibular disorder in the general population. J Dent. 2001 Feb;29(2):93-8. https://doi.org/10.1016/S0300-5712(00)00042-7
• 24 Ballegaard V, Thede-Schmidt-Hansen P, Svensson P, Jensen R. Are headache and temporomandibular disorders related? A blinded study. Cephalalgia. 2008 Aug;28(8):832-41. https://doi.org/10.1111/j.1468-2982.2008.01597.x
• 25 Gonçalves DA, Speciali JG, Jales LC, Camparis CM, Bigal ME. Temporomandibular symptoms, migraine, and chronic daily headaches in the population. Neurology. 2009 Aug;73(8):645-6. https://doi.org/10.1212/WNL.0b013e3181b389c2
• 26 Franco AL, Gonçalves DA, Castanharo SM, Speciali JG, Bigal ME, Camparis CM. Migraine is the most prevalent primary headache in individuals with temporomandibular disorders. J Orofac Pain. 2010;24(3):287-92.
• 27 Klasser GD, Greene CS. Oral appliances in the management of temporomandibular disorders. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Feb;107(2):212-23. https://doi.org/10.1016/j.tripleo.2008.10.007
• 28 Wright EF. Manual of temporomandibular disorders. 2nd ed. Amis: Wiley-Blackwell, 2010.
• 29 Stohler CS. Interocclusal appliances: do they offer a biologic advantage? In: McNeill C, editor. Science and practice of occlusion. Chicago: Quintessence; 1997. p. 381-93.
• 30 Tfelt-Hansen PC, Hougaard A. Migraine: differential effects of placebos in migraine clinical trials. Nat Rev Neurol. 2014 Jan;10(1):10-1. https://doi.org/10.1038/nrneurol.2013.255