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Efficacy and Tolerability of Melatonin Versus Topiramate in Migraine Prevention

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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 y 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 pro- phylaxis. 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 www.revistaavft.com - 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 - - Table 2. Comparison of headache characteristics before and after - Topiramate Melatonin Before after Before after Group data P P treatment treatment treatment treatment value* value* (mean±SD) (mean±SD) (mean±SD) (mean±SD) monthly headache 7.07 ± 2.56 3.82±1.97 0.000* 6.77±2.57 3.71±1.88 0.000* frequency Severity of 3.80 ± 1.63 2.57±1.54 0.000* 4.03±1.67 2.49±1.47 0.000* headache Headache duration in 10.38±11.68 6.71 ± 7.47 0.017* 9.92 ± 11.04 6.27 ± 6.68 0.008* hours Headache disability: 13.68±7.75 10.16±7.67 0.003* 14.28 ± 7.63 10.00±7.41 0.000* MIDAS - 40, número 1, 2021 Volumen Table 3. Comparison of clinical response in both groups Archivos Venezolanos de Farmacología y Terapéutica Archivos Venezolanos Table 1. Comparison of characteristics of patients in groups Before treatment After treatment Group data Total Topiramate Melatonin P value* Topiramate Melatonin Topiramate Melatonin Group data (n=100) (n=100) P (n=76) (n=84) P AVFT N. 200 100 100 value* value* Age in years (mean±SD) (mean±SD) (mean±SD) (mean±SD) 31.36±9.53 31.77± 9.48 30.95 ± 9.61 0.544 (mean ± SD) monthly 29 Onset age of headache 7.07±2.56 6.77±2.57 0.409 3.82±1.97 3.71±1.88 0.718 migraine (mean 24.92±8.68 25.67± 8.63 24.17± 8.70 0.222 frequency ± SD) Severity of 3.80±1.63 4.03±1.67 0. 325 2.42±1.48 2.38±1.43 0.737 Monthly headache headache 6.92±2.56 7.07 ± 2.56 6.77 ± 2.57 0.409 frequency Headache (mean ±SD) duration in 10.38±11.68 9.92±11.04 0. 775 6.71±7.47 6.27±6.68 0.694 hours Severity of headache 3.92±1.65 3.80 ± 1.63 4.03 ± 1.67 0.325 Headache (mean ±SD) disability: 13.68±7.75 14.28±7.63 0.581 10.16±7.67 10.00±7.41 0.893 Headache MIDAS duration in 10.15±11.34 10.38 ± 11.68 9.92 ± 11.04 0.775 hours (mean ±SD) Headache disability: 13.98±7.68 13.68 ± 7.75 14.28 ± 7.63 0.581 MIDAS (mean ±SD) Sex M 64 34 30 0.54 F 136 66 70 www.revistaavft.com - - - 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 - - - al, 200416 Topiramate as in Freitage, 200317 13- - 21,22 6,10 2,6 - 9- 23. - - tonin in treating migraine patients. Conclusion 2017918. - 40, número 1, 2021 Volumen including socioeconomic matters. de Farmacología y Terapéutica Archivos Venezolanos - AVFT 1. Statement on Integrating New Migraine Treatments into Clinical 31 - 2. - 3. - - 4. 19, 20 . - 6. . Neto J, Peres MF. Randomised clinical trial comparing melatonin 7. - www.revistaavft.com 8. 16. - 17. - 9.
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