The Effects of Combination Herbal Medicine Tablet on Migraine Headache: A Randomized, Double-blind, Placebo, Controlled Study
,
Abstract
Background: Migraine is the second most common cause of headache, various methods have been mentioned for the treatment of migraine, including herbal medicine. Iaraj Fiqra is a combination of Aloe, saffron, cinnamon, mustalci, balsam incense and asaroon and claim to be effective in migraine. The present study aims to compare the effect of Iaraj Fiqra and placebo tablets on migraine headache.
Methods: In this randomized, controlled trial, patients with migraine (based on the International Headache Society definition) received Iaraj Fiqra (500mg/daily) or placebo tablets for two months. Headache characteristics were measured using the Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6).
Results: Iaraj Fiqra reduced significantly the frequency (P=0.007), the severity (P=0.000) and the duration (P=0.000) of attacks compared to placebo. MIDAS and HIT-6 scores were significantly reduced in the drug group other than the placebo group (P=0.014 and P=0.000 respectively). Analgesic use also reduced. No significant difference was observed between the two groups in term of side effects (P=0.23).
Conclusion: This study showed that Iaraj Fiqra had significant effects on reducing headache characteristics and analgesic use and given its limited side effects, it is recommended for the treatment of migraine.
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18. Maan AA, Nazir A, Khan MKI, et al. The therapeutic properties and applications of Aloe vera: A review. J Herb Med. 2018;12:1-10.
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21. Khorvash F, Askari G, Zarei A. The effect of cinnamon on migraine treatment and blood levels of CGRP and IL-6: A double-blinded randomized controlled clinical trial. J Neurol Sci. 2019;405:106-7.
22. Zareie A, Sahebkar A, Khorvash F, Bagherniya M, Hasanzadeh A, Askari G. Effect of cinnamon on migraine attacks and inflammatory markers: A randomized double‐blind placebo‐ controlled trial. Phytother Res. 2020;34(11):2945-52.
23. Javadi B, Sahebkar A, Emami SA. A survey on saffron in major Islamic traditional medicine books. Iran J Basic Med Sci. 2013;16(1):1-11.
24. Landau S, Muklada H, Markovics A, Azaizeh H. Traditional uses of Pistacia lentiscus in veterinary and human medicine. Medicinal and aromatic plants of the middle-east: Springer; 2014. p. 163-80.
25. Abbas FA, Al-Massarany SM, Khan S, Al-Howiriny TA, Mossa JS, Abourashed EA. Phytochemical and biological studies on Saudi Commiphora opobalsamum L. Nat Prod Res. 2007;21(5):383-91.
26. Asawavichienjinda T, Imruetaijaroenchoke W, Phanthumchinda K. Thai-version Migraine Disability Assessment (MIDAS) Questionnaire: concurrent validity, test–retest reliability, internal consistency, and factors predictive for migraine related disability. Asian Biomed (Res Rev News). 2020;14(4):139-50.
27. Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(suppl 1):S20-S8.
28. Kosinski M, Bayliss M, Bjorner J, et al. A six-item short- form survey for measuring headache impact: The HIT-6™. Qual Life Res. 2003;12(8):963-74.
29. Zandifar A, Asgari F, Haghdoost F, et al. Reliability and validity of the migraine disability assessment scale among migraine and tension type headache in Iranian patients. Biomed Res Int. 2014;2014:978064.
30. Zandifar A, Banihashemi M, Haghdoost F, et al. Reliability and validity of the Persian HIT‐6 questionnaire in migraine and tension‐type headache. Pain Pract. 2014;14(7):625-31.
31. Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016;13(1):67-75.
32. Zeinali M, Zirak MR, Rezaee SA, Karimi G, Hosseinzadeh H. Immunoregulatory and anti inflammatory properties of Crocus sativus (Saffron) and its main active constituents: A review. Iran J Basic Med Sci. . 2019;22(4):334.
33. Nassiri-Asl M, Hosseinzadeh H. Neuropharmacology effects of saffron (Crocus sativus) and its active constituents. Bioactive nutraceuticals and dietary supplements in neurological and brain disease: Elsevier; 2015. p. 29-39.
34. Siddiqui SA, Ali Redha A, Snoeck ER, et al. Anti Depressant Properties of Crocin Molecules in Saffron. Molecules. 2022;27(7):2076.
35. Sadeghi F, Fazljou SMB, Sepehri B, Khodaie L, Monirifar H. Effects of Pistacia lentiscus and Coriander Triphala on adult gastroesophageal reflux disease: a randomized double-blinded clinical trial. Iranian Red Crescent Medical Journal. 2020;22(6).
36. Pachi VK, Mikropoulou EV, Gkiouvetidis Pet al. Traditional uses, phytochemistry and pharmacology of Chios mastic gum (Pistacia lentiscus var. Chia Anacardiaceae): A review. J Ethnopharmacol. 2020;254:112485.
37. Levin M. Herbal treatment of headache. Headache. 2012;52:76-80
2. Olesen J. International classification of headache disorders. Lancet Neurol. 2018;17(5):396-7.
3. Diener H-C, Tassorelli C, Dodick DW, et al. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults. Cephalalgia. 2019;39(6):687-710.
4. Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine:measuring disability in headache disorders with WHO’s Classification of Functioning, Disability and Health (ICF). J Headache Pain. 2005;6(6):429-40.
5. Song TJ, Cho SJ, Kim WJ, Yang KI, Yun CH, Chu MK. Sex Differences in Prevalence, Symptoms, Impact, and Psychiatric Comorbidities in Migraine and Probable Migraine: A Population‐Based Study. Headache. 2019;59(2):215-23.
6. Farhadi Z, Alidoost S, Behzadifar M, et al. The prevalence of migraine in Iran: a systematic review and meta-analysis. Iran Red Crescent Med J. 2016;18(10):e40061.
7. Olla D, Sawyer J, Sommer N, Moore JB. Migraine treatment. Clin Plast Surg. 2020;47(2):295-303.
8. Ha H, Gonzalez A. Migraine headache prophylaxis. Am Fam Physician. 2019;99(1):17-24.
9. Starkweather A. Migraine Management—Standard Therapies and New Strategies. Topics in Pain Management. 2019;34(9):1-7.
10. Chen Y, Wang S, Wang Y. Role of herbal medicine for prevention and treatment of migraine. Phytother Res. 2022;36(2):730-60.
11. Gorji A. Pharmacological treatment of headache using traditional Persian medicine. Trends Pharmacol Sci. 2003;24(7):331-4.
12. Rezaei M, Afshari D, Fakhri N. The effect of sodae herbal capsule on migraine headaches. Journal of Medicinal Plants. 2020;19(73):143-51.
13. di Giacomo V, Ferrante C, Ronci M, et al. Multiple pharmacological and toxicological investigations on Tanacetum parthenium and Salix alba extracts: Focus on potential application as anti-migraine agents. Food Chem Toxicol. 2019;133:110783.
14. Mohammad Taheri F, Tavakol K, Gheysari R, Moradi Y, Akhlaghdoost M. the effect of oral peppermint extract on migraine. journal of anesthesiology and pain (persian)[internet]. 2017;7(2):1-12. 15. Nikbakht A, Kafi M, editors. The history of traditional medicine and herbal plants in Iran. VIII International People-Plant Symposium on Exploring Therapeutic Powers of Flowers, Greenery and Nature 790; 2004.
16. Dilmurod o’g’li BQ, Tohir o’g’li P, Lutfullo og XJ. Abu Ali ibn Sina and Medicine. Texas Journal of Medical Science. 2021;3:44-7.
17. Sánchez M, González-Burgos E, Iglesias I, Gómez Serranillos MP. Pharmacological update properties of Aloe vera and its major active constituents. Molecules. 2020;25(6):1324.
18. Maan AA, Nazir A, Khan MKI, et al. The therapeutic properties and applications of Aloe vera: A review. J Herb Med. 2018;12:1-10.
19.Hajimonfarednejad M, Ostovar M, Raee MJ, Hashempur MH, Mayer JG, Heydari M. Cinnamon: A systematic review of adverse events. Clin Nutr. 2019;38(2):594-602.
20.Ahmadi A, Naziri M, Fallahpour F, et al. Therapeutic potential of cinnamon for neurological disorders: A mini-review. Neurol Asia. 2022;27(1).
21. Khorvash F, Askari G, Zarei A. The effect of cinnamon on migraine treatment and blood levels of CGRP and IL-6: A double-blinded randomized controlled clinical trial. J Neurol Sci. 2019;405:106-7.
22. Zareie A, Sahebkar A, Khorvash F, Bagherniya M, Hasanzadeh A, Askari G. Effect of cinnamon on migraine attacks and inflammatory markers: A randomized double‐blind placebo‐ controlled trial. Phytother Res. 2020;34(11):2945-52.
23. Javadi B, Sahebkar A, Emami SA. A survey on saffron in major Islamic traditional medicine books. Iran J Basic Med Sci. 2013;16(1):1-11.
24. Landau S, Muklada H, Markovics A, Azaizeh H. Traditional uses of Pistacia lentiscus in veterinary and human medicine. Medicinal and aromatic plants of the middle-east: Springer; 2014. p. 163-80.
25. Abbas FA, Al-Massarany SM, Khan S, Al-Howiriny TA, Mossa JS, Abourashed EA. Phytochemical and biological studies on Saudi Commiphora opobalsamum L. Nat Prod Res. 2007;21(5):383-91.
26. Asawavichienjinda T, Imruetaijaroenchoke W, Phanthumchinda K. Thai-version Migraine Disability Assessment (MIDAS) Questionnaire: concurrent validity, test–retest reliability, internal consistency, and factors predictive for migraine related disability. Asian Biomed (Res Rev News). 2020;14(4):139-50.
27. Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(suppl 1):S20-S8.
28. Kosinski M, Bayliss M, Bjorner J, et al. A six-item short- form survey for measuring headache impact: The HIT-6™. Qual Life Res. 2003;12(8):963-74.
29. Zandifar A, Asgari F, Haghdoost F, et al. Reliability and validity of the migraine disability assessment scale among migraine and tension type headache in Iranian patients. Biomed Res Int. 2014;2014:978064.
30. Zandifar A, Banihashemi M, Haghdoost F, et al. Reliability and validity of the Persian HIT‐6 questionnaire in migraine and tension‐type headache. Pain Pract. 2014;14(7):625-31.
31. Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016;13(1):67-75.
32. Zeinali M, Zirak MR, Rezaee SA, Karimi G, Hosseinzadeh H. Immunoregulatory and anti inflammatory properties of Crocus sativus (Saffron) and its main active constituents: A review. Iran J Basic Med Sci. . 2019;22(4):334.
33. Nassiri-Asl M, Hosseinzadeh H. Neuropharmacology effects of saffron (Crocus sativus) and its active constituents. Bioactive nutraceuticals and dietary supplements in neurological and brain disease: Elsevier; 2015. p. 29-39.
34. Siddiqui SA, Ali Redha A, Snoeck ER, et al. Anti Depressant Properties of Crocin Molecules in Saffron. Molecules. 2022;27(7):2076.
35. Sadeghi F, Fazljou SMB, Sepehri B, Khodaie L, Monirifar H. Effects of Pistacia lentiscus and Coriander Triphala on adult gastroesophageal reflux disease: a randomized double-blinded clinical trial. Iranian Red Crescent Medical Journal. 2020;22(6).
36. Pachi VK, Mikropoulou EV, Gkiouvetidis Pet al. Traditional uses, phytochemistry and pharmacology of Chios mastic gum (Pistacia lentiscus var. Chia Anacardiaceae): A review. J Ethnopharmacol. 2020;254:112485.
37. Levin M. Herbal treatment of headache. Headache. 2012;52:76-80
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| Issue | Vol 12, No 1 (Winter 2024) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/jpc.v12i1.16028 | |
| Keywords | ||
| Migraine Herbal Medicine Iaraj Fiqra | ||
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How to Cite
1.
Mousavi S, Zare Bidaki M, Yazdi N, Tafazoli V, Sadeghi Dinani M. The Effects of Combination Herbal Medicine Tablet on Migraine Headache: A Randomized, Double-blind, Placebo, Controlled Study. J Pharm Care. 2024;12(1):32-39.
