A PROSPECTIVE OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF TOPIRAMATE ALONE VERSUS TOPIRAMATE WITH VITAMIN D IN PROPHYLACTIC TREATMENT OF PATIENTS WITH MIGRAINE

Authors

  • ALOK DIXIT Department of Pharmacology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah. UP-206130, India
  • MANIK BRAHEMI Department of Pharmacology, GMC, Budaun-243601, Uttar Pradesh, India
  • NASREEN FATMA KHAN Department of Pharmacology, GSVM MC, Kanpur. UP-208002, India https://orcid.org/0009-0001-2073-2212
  • RAMAKANT YADAV Department of Neurology, University of Medical Sciences, Saifai, Etawah-206130, Uttar Pradesh, India https://orcid.org/0000-0002-7787-0771
  • C. V. SINGH Department of Pharmacology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah. UP-206130, India https://orcid.org/0000-0003-3248-7610

DOI:

https://doi.org/10.22159/ijpps.2025v17i3.53449

Keywords:

Pain severity, Migraine disability assessment score

Abstract

Objective: Migraine affects 10% of the global population, especially women aged 25-55, causing severe headaches with light and sound sensitivity. While acute treatments are common, preventive therapies are underutilized. Recent studies suggest combining vitamin D with Topiramate, an anticonvulsant, could enhance prevention, reducing both attack frequency and duration. Therefore, the present study compares the safety and efficacy of Topiramate alone versus topiramate with Vitamin D.

Methods: A study was conducted on 100 migraine patients to compare the effect of topiramate alone versus topiramate with vitamin D. Pain severity and disability were measured using a Visual Analog Scale (VAS), Migraine Disability Assessment Score (MIDAS), and Migraine Severity (MIGSEV) scores over 12 w, excluding patients with other medical conditions.

Results: Both the Topiramate and Topiramate with Vitamin D groups showed significant reduction in VAS, MIDAS, and MIGSEV scores after 12 weeks. Migraine without aura was more common in both groups. The Topiramate with Vitamin D group also experienced increased serum calcium and Vitamin D levels. Both groups showed significant improvements in pain and disability, with the Topiramate with Vitamin D group showing better results.

Conclusion: Combining topiramate with vitamin D effectively reduces migraine frequency and disability.

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References

Ommurugan B, Priya A, Bairy LK. A complete review of migraine. Asian J Pharm Clin Res. 2017 Oct;10(10):57-62. doi: 10.22159/ajpcr.2017.v10i10.19207.

Pietrobon D. Insights into migraine mechanisms and CaV2.1 calcium channel function from mouse models of familial hemiplegic migraine. J Physiol. 2010;588(11):1871-8. doi: 10.1113/jphysiol.2010.188003, PMID 20194127.

Nattagh Eshtivani E, Sani MA, Dahri M, Ghalichi F, Ghavami A, Arjang P. The role of nutrients in the pathogenesis and treatment of migraine headaches: review. Biomed Pharmacother. 2018 Jun;102:317-25. doi: 10.1016/j.biopha.2018.03.059, PMID 29571016.

Mulder EJ, Van Baal C, Gaist D, Kallela M, Kaprio J, Svensson DA. Genetic and environmental influences on migraine: a twin study across six countries. Twin Res. 2003;6(5):422-31. doi: 10.1375/136905203770326420, PMID 14624726.

Sangermani R, Boncimino A. The use of nutraceutics in childrens and adolescents headache. Neurol Sci. 2017;38 Suppl 1:121-4. doi: 10.1007/s10072-017-2896-7, PMID 28527085.

Evers S. Treatment of migraine with prophylactic drugs. Expert Opin Pharmacother. 2008;9(15):2565-73. doi: 10.1517/14656566.9.15.2565, PMID 18803445.

Silberstein SD. Migraine. Lancet. 2004;363(9406):381-91. doi: 10.1016/S0140-6736(04)15440-8, PMID 15070571.

Lukacs M, Tajti J, Fulop F, Toldi J, Edvinsson L, Vecsei L. Migraine neurogenic inflammation drug development pharmacochemical aspects. Curr Med Chem. 2017;24(33):3649-65. doi: 10.2174/0929867324666170712163437, PMID 28707585.

Eyles DW, Burne TH, MC Grath JJ. Vitamin D effects on brain development adult brain function and the links between low levels of vitamin D and neuropsychiatric disease. Front Neuroendocrinol. 2013;34(1):47-64. doi: 10.1016/j.yfrne.2012.07.001, PMID 22796576.

WU Z, Malihi Z, Stewart AW, Lawes CM, Scragg R. The association between vitamin D concentration and pain: a systematic review and meta-analysis. Public Health Nutr. 2018;21(11):2022-37. doi: 10.1017/S1368980018000551, PMID 29559013.

Nagata E, Fujii N, Hosomichi K, Mitsunaga S, Suzuki Y, Mashimo Y. Possible association between dysfunction of vitamin D binding protein (GC globulin) and migraine attacks. Plos One. 2014;9(8):e105319. doi: 10.1371/journal.pone.0105319, PMID 25147936.

Holick MF, Binkley NC, Bischoff Ferrari HA, Gordon CM, Hanley DA, Heaney RP. Evaluation treatment and prevention of vitamin D deficiency: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(7):1911-30. doi: 10.1210/jc.2011-0385, PMID 21646368.

Autier P, Boniol M, Pizot C, Mullie P. Vitamin D status and ill health: a systematic review. Lancet Diabetes Endocrinol. 2014;2(1):76-89. doi: 10.1016/S2213-8587(13)70165-7, PMID 24622671.

Prakash S, Kumar M, Belani P, Susvirkar A, Ahuja S. Interrelationships between chronic tension-type headache musculoskeletal pain and vitamin D deficiency: is osteomalacia responsible for both headache and musculoskeletal pain? Ann Indian Acad Neurol. 2013;16(4):650-8. doi: 10.4103/0972-2327.120487, PMID 24339599.

Garcion E, Sindji L, Nataf S, Brachet P, Darcy F, Montero Menei CN. Treatment of experimental autoimmune encephalomyelitis in rat by 1,25-dihydroxyvitamin D3 leads to early effects within the central nervous system. Acta Neuropathol. 2003;105(5):438-48. doi: 10.1007/s00401-002-0663-0, PMID 12677443.

Messlinger K, Lennerz JK, Eberhardt M, Fischer MJ. CGRP and NO in the trigeminal system: mechanisms and role in headache generation. Headache. 2012;52(9):1411-27. doi: 10.1111/j.1526-4610.2012.02212.x, PMID 22788114.

Minton GC, Miller AD, Bookstaver PB, Love BL. Topiramate: safety and efficacy of its use in the prevention and treatment of migraine. J Cent Nerv Syst Dis. 2011;3:155-68. doi: 10.4137/JCNSD.S4365, PMID 23861645.

Theeler BJ, Kenney K, Prokhorenko OA, Fideli US, Campbell W, Erickson JC. Headache triggers in the US military. Headache. 2010;50(5):790-4. doi: 10.1111/j.1526-4610.2009.01571.x, PMID 19925623.

Somerville BW. The role of estradiol withdrawal in the etiology of menstrual migraine. Neurology. 1972;22(4):355-65. doi: 10.1212/wnl.22.4.355, PMID 5062827.

Victor TW, HU X, Campbell J, White RE, Buse DC, Lipton RB. Association between migraine anxiety and depression. Cephalalgia. 2010;30(5):567-75. doi: 10.1111/j.1468-2982.2009.01944.x, PMID 19614684.

GBD 2016 Headache Collaborators. Global regional and national burden of migraine and tension-type headache 1990-2016: a systematic analysis for the global burden of disease study 2016. Lancet Neurol. 2018;17(11):954-76. doi: 10.1016/S1474-4422(18)30322-3, PMID 30353868.

Russell MB, Rasmussen BK, Fenger K, Olesen J. Migraine without aura and migraine with aura are distinct clinical entities: a study of four hundred and eighty-four male and female migraineurs from the general population. Cephalalgia. 1996;16(4):239-45. doi: 10.1046/j.1468-2982.1996.1604239.x, PMID 8792035.

Stang PE, Carson AP, Rose KM, MO J, Ephross SA, Shahar E. Headache cerebrovascular symptoms and stroke: the atherosclerosis risk in communities study. Neurology. 2005;64(9):1573-7. doi: 10.1212/01.WNL.0000158326.31368.04, PMID 15883318.

Silberstein SD, Hulihan J, Karim MR, WU SC, Jordan D, Karvois D. 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(7):1002-11. doi: 10.1016/j.clinthera.2006.07.003, PMID 16990078.

Moras K, Nischal H. Impact of amitryptiline on migraine disability assessment score. J Clin Diagn Res. 2014;8(9):KC01-2. doi: 10.7860/JCDR/2014/7546.4854, PMID 25386467.

Dwajani S, Ugargol AP. Assessment of quality of life in patients with migraine receiving topiramate. Indian J Pharm Pharmacol. 2014;1(1):30-4.

Laghari MJ, Qazi N, Jamali S, Mustafa G. Role of topiramate in improving quality of life in migraine sufferers versus gold standard propranolol. JLUMHS. 2012;11(1):11-4.

El Hasnaoui A, Vray M, Richard A, Nachit Ouinekh F, Boureau F, MIGSEV Group. Assessing the severity of migraine: development of the MIGSEV scale. Headache. 2003;43(6):628-35. doi: 10.1046/j.1526-4610.2003.03105.x, PMID 12786922.

Published

01-03-2025

How to Cite

DIXIT, ALOK, et al. “A PROSPECTIVE OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF TOPIRAMATE ALONE VERSUS TOPIRAMATE WITH VITAMIN D IN PROPHYLACTIC TREATMENT OF PATIENTS WITH MIGRAINE”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 17, no. 3, Mar. 2025, pp. 32-35, doi:10.22159/ijpps.2025v17i3.53449.

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