Efficacy and Tolerability of Melatonin Versus Topiramate in Migraine Prevention

Efficacy and tolerability of melatonin versus topiramate in migraine prevention

Eficacia y tolerabilidad de la melatonina frente al topiramato en la prevención de la migraña

Waseem H. Alkhaffaf1, Akram M. Al.mahdawi2 1lecturer (Board Certificate in Neuromedicine) / Dept. of Medicine / college of medicine/ Ninevah University/ Mosul, Iraq; email: [email protected] 2Consultant Neurologist, Baghdad teaching hospital/ Medical City Chairman of Iraqi Neurology Council, Chairman of Iraqi neurology society. email: [email protected] Corresponding author: Waseem H. Alkhaffaf, lecturer (Board Certificate in Neuromedicine)/ Dept. of Medicine / college of medicine/Ninevah University/ Mosul, Iraq. Mobile: 009647702010315. Postal Code: 41001. email: [email protected] Received/Recibido: 12/28/2020 Accepted/Aceptado: 01/15/2021 Published/Publicado: 02/10/2021 DOI: http://doi.org/10.5281/zenodo.4660433

Terapéutica

Abstract Resumen

2021 Background: Migraine is one of the common neurological Antecedentes: la migraña es una de las enfermedades

diseases. the aims of this study are to compare the effective- neurológicas más frecuentes. los objetivos de este estudio Farmacología

ness and tolerability of Topiramate and Melatonin drugs as son comparar la eficacia y la tolerabilidad de los fármacos de

número 1, número monotherapy in the prophylaxis of migraine and to support topiramato y melatonina como monoterapia en la profilaxis

40, the use of Melatonin as a preventive therapy. de la migraña y apoyar el uso de melatonina como terapia preventiva. Materials and Methods: a prospective, comparative study,

Venezolanos

in which 200 Patients diagnosed with migraine were enrolled. Materiales y métodos: estudio prospectivo, comparativo, en Volumen Monthly headache frequency, headache severity, mean at- el que se inscribieron 200 pacientes diagnosticados de mi- tack duration in hours, and disability, were assessed at the graña. La frecuencia mensual de los dolores de cabeza, la

Archivos baseline and at the end of 3rd month of follow up. Tolerability gravedad del dolor de cabeza, la duración media del ataque measures including the incidence of adverse events were re- en horas y la discapacidad se evaluaron al inicio y al final corded also. del tercer mes de seguimiento. También se registraron las medidas de tolerabilidad, incluida la incidencia de eventos AVFT Results: Forty patients withdrew from the study, the anal- adversos. ysis was performed for the remaining cases, 160 patients, 27 (76 in topiramate group and 84 in melatonin group). There Resultados: Cuarenta pacientes se retiraron del estudio, el was a significant improvement in the clinical response after 3 análisis se realizó para los casos restantes, 160 pacientes, months of treatment in all parameters, and without significant (76 en el grupo de topiramato y 84 en el grupo de melato- differences between both groups. nina). Hubo una mejora significativa en la respuesta clínica a los 3 meses de tratamiento en todos los parámetros, y sin Conclusion: this study showed that the Melatonin is effective diferencias significativas entre ambos grupos. as, if not superior to, Topiramate for episodic migraine prophylaxis. Moreover, it is more tolerated and has less adverse Conclusión: este estudio mostró que la melatonina es efi- events than Topiramate. caz, si no superior, al topiramato para la profilaxis de la mi- graña episódica. Además, es más tolerado y tiene menos Key words: Migraine, Topiramate, Melatonin. efectos adversos que el topiramato.

Palabras clave: migraña, topiramato, melatonina.

Introdution

Migraine is one of the common neurological diseases and it is Effective treatment of migraine starts with making a correct characterized by throbbing unilateral headache attacks, that diagnosis, excluding the alternate causes, addressing the are associated with phonophobia, photophobia, nausea, and impact on the patient’s life and educating the patient regard- vomiting, and it is exacerbated by physical activity1. ing therapeutic options, treatment duration, adverse effects

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- Exclusion Criteria agement2. - - - ity, or duration3 - patient. 2. 4. Any Pregnant and lactating woman. - - - - - - patic, or respiratory diseases. - 1 . dergoing treatment.

- 2 . Topiramate 4 in adults . - s - - . 28 7 - - - 8.

Materials and Methods - - st ten - - Disorders, experiencing test, paired and unpaired-t-test were used. Demographic data (mean ±SD) Age inyears N. Group data Table 1.Comparisonofcharacteristicspatientsingroups Sex ±SD) MIDAS (mean disability: Headache ±SD) hours (mean duration in Headache (mean ±SD) headache Severity of (mean ±SD) frequency headache Monthly ± SD) migraine (mean Onset ageof M F 10.15±11.34 13.98±7.68 24.92±8.68 31.36±9.53 3.92±1.65 6.92±2.56 Total 200 136 64 10.38 ±11.68 13.68 ±7.75 Topiramate 25.67± 8.63 31.77± 9.48 3.80 ±1.63 7.07 ±2.56 100 66 34 30.95 ±9.61 14.28 ±7.63 9.92 ±11.04 24.17± 8.70 6.77 ±2.57 4.03 ±1.67 Melatonin 100 70 30 P value 0.581 0.775 0.325 0.409 0.222 0.544 0.54 * - - Group data Group data Severity of duration in Headache Headache headache headache frequency Table 3.Comparisonofclinicalresponseinbothgroups Table 2. Comparison of headache characteristics before and after Severity of duration in disability: Headache Headache headache headache frequency disability: monthly MIDAS monthly MIDAS hours hours

10.38±11.68 (mean±SD) 13.68±7.75 3.80 ±1.63 7.07 ±2.56 10.38±11.68 Topiramate (mean±SD) treatment 13.68±7.75 3.80±1.63 7.07±2.56 Before (n=100) Before treatment Topiramate

(mean±SD) 14.28±7.63 9.92±11.04 Melatonin 4.03±1.67 6.77±2.57 (mean±SD) 10.16±7.67 6.71 ±7.47 treatment 2.57±1.54 3.82±1.97 (n=100) after

0. 775 0. 325 value 0.581 0.409

0.017 0.000 0.000 0.003 value P P * * * * * * Topiramate (mean±SD) 10.16±7.67 6.71±7.47 2.42±1.48 3.82±1.97 14.28 ±7.63 9.92 ±11.04 (mean±SD) treatment 4.03±1.67 6.77±2.57 (n=76) www.revistaavft.com Before After treatment Melatonin

(mean±SD) 10.00±7.41 Melatonin 6.27±6.68 2.38±1.43 3.71±1.88 (mean±SD) 10.00±7.41 6.27 ±6.68 treatment 2.49±1.47 3.71±1.88 (n=84) after

value 0.893 0.694 0.737 0.718 0.000 0.008 0.000 0.000 value P P * * * * * * - -

29 AVFT Archivos Venezolanos de Farmacología y Terapéutica Volumen 40, número 1, 2021 - -

- Discussion - .

and melatonin groups - Topiramate Melatonin - The responder rate (%) (%) 84 76 (100%) (100%)

- 0.57 - 0.52 - 11 . : - tions as well as treating clinicians, most clinicians accept ev- - - - 12. - - - 30

Topiramate Melatonin Side effects (N=76)(%) (N=84)(%) 13,14 Sleepiness 15(19.7) 15(17.8) 0.760 , Dizziness 7(9.2) 10(11.9) 0.580 - Paresthesia 30(39.4) ------0.000* Anorexia 13(17.1) ------0.000* Fatigability 7(9.2) 5(5.9) 0.434 Dry mouth 2(2.6) ------0.134 Diarrhea 3(3.9) ------0.066 - Worsening headache 3(3.9) 1(1.1) 0.264 Constipation ------1(1.1) 0.340 concentration/attention 10(13.1) 3(3.5) 0.026* - Tremor 3(3.9) ------0.066 (Long R et al,2018; Gonçalves AL et al, 2016; Peres M et - - including socioeconomicmatters. 2017 2003 Freitage, in as Topiramate 2004 al, 9 16 6,10 19 ,

18 . 17 20 . . 13 9 ------ Conclusion tonin intreatingmigrainepatients. 7. 6. 4. 3. 2. 1. melatonin comparing trial clinical Randomised MF. Peres J, Neto Clinical into Treatments Migraine New Integrating on Statement 21,22 www.revistaavft.com 2,6 23 . ------

31 AVFT Archivos Venezolanos de Farmacología y Terapéutica Volumen 40, número 1, 2021 8. 16. - 17. - 9. - 18. 10. - 19. - 11. - 20. - 12. - 21. 13. 22. 14. - - 23. neur.61.4.490 - CAPSS-277 Investigator Group. Topiramate versus amitriptyline in -