دورية أكاديمية
Evaluation of Safety and Efficacy of Add-on Alpha-Lipoic Acid on Migraine Prophylaxis in an Adolescent Population: A Randomized Controlled Trial.
| العنوان: | Evaluation of Safety and Efficacy of Add-on Alpha-Lipoic Acid on Migraine Prophylaxis in an Adolescent Population: A Randomized Controlled Trial. |
|---|---|
| المؤلفون: | Puliappadamb HM; Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India., Satpathy AK; Department of Paediatrics, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India., Mishra BR; Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India., Maiti R; Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India., Jena M; Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India. |
| المصدر: | Journal of clinical pharmacology [J Clin Pharmacol] 2023 Dec; Vol. 63 (12), pp. 1398-1407. Date of Electronic Publication: 2023 Aug 24. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2013- : Oxford : Wiley Original Publication: Stamford, Conn., Hall Associates. |
| مواضيع طبية MeSH: | Thioctic Acid*/adverse effects , Migraine Disorders*/drug therapy , Migraine Disorders*/prevention & control, Humans ; Adolescent ; Child ; Flunarizine/therapeutic use ; Calcitonin Gene-Related Peptide ; Analgesics/therapeutic use ; Sulfhydryl Compounds ; Treatment Outcome ; Double-Blind Method |
| مستخلص: | Nutraceuticals like alpha-lipoic acid (ALA) may have potential benefits as prophylactic agents for adolescent migraine, with fewer adverse events than existing medications. The present study was conducted to evaluate the safety and efficacy of add-on ALA for prophylaxis in adolescent migraine. A randomized, open-label, add-on clinical trial was conducted with 60 adolescent migraineurs, who were randomized to receive flunarizine or flunarizine with an add-on ALA. A clinical evaluation of the frequency and severity of migraine, responder rate, Pediatric Migraine Disability Assessment (PedMIDAS) scoring, serum thiol, and serum calcitonin gene-related peptide (CGRP) was performed both at baseline and following 12 weeks of treatment. The frequency of acute attacks of migraine decreased significantly (P = .001) in the test group compared with the control group. The responder rate was found to be significantly higher (80%) in the test group than in the control group (33.3%) (P = .001). The mean monthly migraine headache days in the test group showed a significant reduction (-7.7 days, 95%CI -9.1 to -6.3 days; P = .010). The severity of acute migraine attacks (mild, moderate, severe) also showed a significant reduction in the test group (P = .001). PedMIDAS scores showed significant improvement in the test group (P = .021), in comparison with the control group. Serum thiol levels were significantly increased in the test group (18 mmol/L, 95%CI 13.5 to 36.1 mmol/L; P = .001). Serum CGRP levels showed a significant reduction with adjunctive ALA therapy (-122.4 pg/mL, 95%CI -142.3 to -89.0 pg/mL; P = .006). Add-on ALA with flunarizine as a prophylactic agent for migraine in adolescents can improve clinical outcomes by improving clinical and biochemical parameters. (© 2023, The American College of Clinical Pharmacology.) |
| References: | Karsan N, Prabhakar P, Goadsby PJ. Premonitory symptoms of migraine in childhood and adolescence. Curr Pain Headache Rep. 2017;21(7):34. Eiland LS, Jenkins LS, Durham SH. Pediatric migraine: pharmacologic agents for prophylaxis. Ann Pharmacother. 2007;41(7):1181-1190. Hershey AD, Powers SW, Vockell AL, LeCates S, Kabbouche M. Effectiveness of topiramate in the prevention of childhood headaches. Headache. 2002;42(8):810-818. O'Brien HL, Kabbouche MA, Hershey AD. Treating pediatric migraine: an expert opinion. Expert Opin Pharmacother. 2012;13(7):959-966. Reiter PD, Nickisch J, Merritt G. Efficacy and tolerability of intravenous valproic acid in acute adolescent migraine. Headache. 2005;45(7):899-903. El-Chammas K, Keyes J, Thompson N, Vijayakumar J, Becher D, Jackson JL. Pharmacologic treatment of pediatric headaches: a meta-analysis. JAMA Pediatr. 2013;167(3):250-258. Pringsheim T, Davenport WJ, Becker WJ. Prophylaxis of migraine headache. CMAJ. 2010;182(7):E269-E276. D'Onofrio F, Raimo S, Spitaleri D, Casucci G, Bussone G. Usefulness of nutraceuticals in migraine prophylaxis. Neurol Sci. 2017;38(suppl 1):117-120. Borkum JM. Migraine triggers and oxidative stress: a narrative review and synthesis. Headache. 2016;56(1):12-35. Rozen TD, Oshinsky ML, Gebeline CA, et al. Open label trial of coenzyme Q10 as a migraine preventive. Cephalalgia. 2002;22(2):137-141. Gross EC, Putananickal N, Orsini AL, et al. Mitochondrial function and oxidative stress markers in higher-frequency episodic migraine. Sci Rep. 2021;11(1):4543. Wang J, Tang J, Zhou X, Xia Q. Physicochemical characterization, identification and improved photo-stability of alpha-lipoic acid-loaded nanostructured lipid carrier. Drug Dev Ind Pharm. 2014;40(2):201-210. Cavestro C, Bedogni G, Molinari F, Mandrino S, Rota E, Frigeri MC. Alpha-lipoic acid shows promise to improve migraine in patients with insulin resistance: a 6-month exploratory study. J Med Food. 2018;21(3):269-273. Eren Y, Dirik E, Neselioglu S, Erel O. Oxidative stress and decreased thiol level in patients with migraine: cross-sectional study. Acta Neurol Belg. 2015;115(4):643-649. Magis D, Ambrosini A, Sandor P, Jacquy J, Laloux P, Schoenen J. A randomized double-blind placebo-controlled trial of thioctic acid in migraine prophylaxis. Headache. 2007;47(1):52-57. Ali AM, Awad TG, Al-Adl NM. Efficacy of combined topiramate/thioctic acid therapy in migraine prophylaxis. Saudi Pharm J. 2010;18(4):239-243. Akbari M, Ostadmohammadi V, Tabrizi R, et al. The effects of alpha-lipoic acid supplementation on inflammatory markers among patients with metabolic syndrome and related disorders: a systematic review and meta-analysis of randomized controlled trials. Nutr Metab (Lond). 2018;15:39. Mendoza-Nunez VM, Garcia-Martinez BI, Rosado-Perez J, Santiago-Osorio E, Pedraza-Chaverri J, Hernandez-Abad VJ. The effect of 600 mg alpha-lipoic acid supplementation on oxidative stress, inflammation, and RAGE in older adults with type 2 diabetes mellitus. Oxid Med Cell Longev. 2019;2019:3276958. Durham PL. Calcitonin gene-related peptide (CGRP) and migraine. Headache. 2006;46(suppl 1):S3-S8. Edvinsson L. CGRP and migraine: from bench to bedside. Rev Neurol (Paris). 2021;177(7):785-790. Lai KL, Niddam DM, Fuh JL, et al. Flunarizine versus topiramate for chronic migraine prophylaxis: a randomized trial. Acta Neurol Scand. 2017;135(4):476-483. Victor S, Ryan SW. Drugs for preventing migraine headaches in children. Cochrane Database Syst Rev. 2003;(4):CD002761. Sorge F, De Simone R, Marano E, Nolano M, Orefice G, Carrieri P. Flunarizine in prophylaxis of childhood migraine. A double-blind, placebo-controlled, crossover study. Cephalalgia. 1988;8(1):1-6. Locher C, Kossowsky J, Koechlin H, et al. Efficacy, safety, and acceptability of pharmacologic treatments for pediatric migraine prophylaxis: a systematic review and network meta-analysis. JAMA Pediatr. 2020;174(4):341-349. World Health Organization. Adolescent Health. Accessed December 20, 2021. https://www.who.int/health-topics/adolescent-health#tab=tab_1. Headache Classification Committee of the International Headache S. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629-808. Bruijn J, Duivenvoorden H, Passchier J, Locher H, Dijkstra N, Arts WF. Medium-dose riboflavin as a prophylactic agent in children with migraine: a preliminary placebo-controlled, randomised, double-blind, cross-over trial. Cephalalgia. 2010;30(12):1426-1434. Fuh JL, Wang SJ, Lu SR, Liao YC, Chen SP, Yang CY. Headache disability among adolescents: a student population-based study. Headache. 2010;50(2):210-218. Lewis D, Paradiso E. A double-blind, dose comparison study of topiramate for prophylaxis of basilar-type migraine in children: a pilot study. Headache. 2007;47(10):1409-1417. Fan PC, Kuo PH, Lee MT, Chang SH, Chiou LC. Plasma calcitonin gene-related peptide: a potential biomarker for diagnosis and therapeutic responses in pediatric migraine. Front Neurol. 2019;10:10. Ciancarelli I, Tozzi-Ciancarelli MG, Di Massimo C, Marini C, Carolei A. Flunarizine effects on oxidative stress in migraine patients. Cephalalgia. 2004;24(7):528-532. Kubo K, Yoshitake I, Kumada Y, Shuto K, Nakamizo N. Radical scavenging action of flunarizine in rat brain in vitro. Arch Int Pharmacodyn Ther. 1984;272(2):283-295. de Sousa CNS, da Silva Leite CMG, da Silva Medeiros I, et al. Alpha-lipoic acid in the treatment of psychiatric and neurological disorders: a systematic review. Metab Brain Dis. 2019;34(1):39-52. Fernandes R, Ferreira JJ, Sampaio C. The placebo response in studies of acute migraine. J Pediatr. 2008;152(4):527-33, 533.e1. |
| فهرسة مساهمة: | Keywords: CGRP; PedMIDAS; adolescent migraine; alpha-lipoic acid; flunarizine; thiol |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04064814 |
| المشرفين على المادة: | R7PLA2DM0J (Flunarizine) 73Y7P0K73Y (Thioctic Acid) JHB2QIZ69Z (Calcitonin Gene-Related Peptide) 0 (Analgesics) 0 (Sulfhydryl Compounds) |
| تواريخ الأحداث: | Date Created: 20230811 Date Completed: 20231110 Latest Revision: 20231121 |
| رمز التحديث: | 20231122 |
| DOI: | 10.1002/jcph.2331 |
| PMID: | 37563914 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1552-4604 |
|---|---|
| DOI: | 10.1002/jcph.2331 |