Generic placeholder image

Endocrine, Metabolic & Immune Disorders - Drug Targets

Editor-in-Chief

ISSN (Print): 1871-5303
ISSN (Online): 2212-3873

Clinical Trial

Effects of a Novel Barley-Based Formulation on Allergic Rhinitis: A Randomized Controlled Trial

Author(s): Alireza Derakhshan, Mahmood Khodadoost, Mostafa Ghanei*, Latif Gachkar, Homa Hajimahdipour, Ali Taghipour, Jaleh Yousefi, Maryam Khoshkhui and Farahzad J. Azad

Volume 19, Issue 8, 2019

Page: [1224 - 1231] Pages: 8

DOI: 10.2174/1871530319666190306100611

Price: $65

Abstract

Objective: Current treatment options for Allergic Rhinitis (AR) may have their own limitations and side effects. This study aimed to investigate the effects of Ma-al-Shaeer (MS), a novel natural formulation based on Hordeum vulgare, in the treatment of AR compared with Fexofenadine (FX).

Methods: A total of 77 patients with AR were divided into two groups: MS group (n=38) and FX group (n=39). The first group received 15 g of dried MS powder, and the second group received 60 mg of FX twice daily for 14 days. At baseline (week zero) and after the 14-day treatment period (week two), both groups were evaluated for sneezing, rhinorrhea, nasal congestion, nasal itching, post nasal drip, eye, throat, or ear symptoms, headache, cough, mental function, quality of life scores, blood eosinophil count and total IgE levels. Rhinitis control assessment tests were conducted at week zero and again at one week after cessation of treatment (week three) in both groups.

Results: All symptoms of AR except cough were significantly reduced in both groups; for nasal congestion, post nasal drip, and headache, the MS treatment was found to be superior. Rhinitis control was significantly increased after treatment in both groups (p value < 0.001). Both drugs significantly reduced total IgE levels. There was no significant change in eosinophil count in either group.

Conclusion: MS formulation based on H. vulgare may be an effective treatment for AR. Further studies are needed to confirm the effect of MS as an alternative treatment in AR.

Keywords: Allergic rhinitis, complementary therapies, Persian medicine, Hordeum vulgare, fexofenadine, randomized controlled trial.

Graphical Abstract
[1]
Wang, Y. Genetic predisposition for atopy and allergic rhinitis in the Singapore Chinese population. Asia Pac. Allergy, 2011, 1(3), 152-156.
[http://dx.doi.org/10.5415/apallergy.2011.1.3.152] [PMID: 22053312]
[2]
Lagos, J.A.; Marshall, G.D. Montelukast in the management of allergic rhinitis. Ther. Clin. Risk Manag., 2007, 3(2), 327-332.
[http://dx.doi.org/10.2147/tcrm.2007.3.2.327] [PMID: 18360641]
[3]
Feng, C.H.; Miller, M.D.; Simon, R.A. The united allergic airway: connections between allergic rhinitis, asthma, and chronic sinusitis. Am. J. Rhinol. Allergy, 2012, 26(3), 187-190.
[http://dx.doi.org/10.2500/ajra.2012.26.3762] [PMID: 22643942]
[4]
Cingi, C.; Gevaert, P.; Mösges, R.; Rondon, C.; Hox, V.; Rudenko, M.; Muluk, N.B.; Scadding, G.; Manole, F.; Hupin, C.; Fokkens, W.J.; Akdis, C.; Bachert, C.; Demoly, P.; Mullol, J.; Muraro, A.; Papadopoulos, N.; Pawankar, R.; Rombaux, P.; Toskala, E.; Kalogjera, L.; Prokopakis, E.; Hellings, P.W.; Bousquet, J. Multi-morbidities of allergic rhinitis in adults: European Academy of Allergy and Clinical Immunology Task Force Report. Clin. Transl. Allergy, 2017, 7, 17.
[http://dx.doi.org/10.1186/s13601-017-0153-z] [PMID: 28572918]
[5]
Blaiss, M.S. Allergic rhinitis: Direct and indirect costs. Allergy Asthma Proc., 2010, 31(5), 375-380.
[http://dx.doi.org/10.2500/aap.2010.31.3329] [PMID: 20929603]
[6]
Kim, H.I.; Hong, S.H.; Ku, J.M.; Kang, S.; Kim, T.Y.; Shin, Y.C.; Ko, S.G. Tonggyu-tang, a traditional Korean medicine, suppresses pro-inflammatory cytokine production through inhibition of MAPK and NF-κB activation in human mast cells and keratinocytes. BMC Complement. Altern. Med., 2017, 17(1), 186.
[http://dx.doi.org/10.1186/s12906-017-1704-5] [PMID: 28359265]
[7]
Man, L.X. Complementary and alternative medicine for allergic rhinitis. Curr. Opin. Otolaryngol. Head Neck Surg., 2009, 17(3), 226-231.
[http://dx.doi.org/10.1097/MOO.0b013e3283295791] [PMID: 19262383]
[8]
Barnes, P.M.; Bloom, B.; Nahin, R.L. Complementary and alternative medicine use among adults and children: United States, 2007. Natl. Health Stat. Rep., 2008, (12), 1-23.
[PMID: 19361005]
[9]
Bielory, L. complementary and alternative therapies for allergic rhinitis and conjunctivitis https://www.uptodate.com/contents/complementary-and-alternative-therapies-for-allergic-rhinitis-andconjunctivitis
[10]
Derakhshan, A.R. Natural Treatments for Fissure in Ano Used by Traditional Persian Scholars, Razi (Rhazes) and Ibn Sina (Avicenna). J. Evid. Based Complementary Altern. Med., 2017, 22(2), 324-333.
[http://dx.doi.org/10.1177/2156587216650302] [PMID: 27279645]
[11]
Aghili, S.M.H. Gharabadin Kabir; Tehran: Iran University of Medical Sciences, Institute of history of Medicine studies and Islamic medicine: Tehran, Iran,, 2009, 1, p. 1191.
[12]
Momen Tonekaboni, M. Shaeer. In Tohfe Momenin, Noore Vahy: Qom, Iran, 2011, Vol. 1, pp. 539-540.
[13]
Cooper, R. Re-discovering ancient wheat varieties as functional foods. J. Tradit. Complement. Med., 2015, 5(3), 138-143.
[http://dx.doi.org/10.1016/j.jtcme.2015.02.004] [PMID: 26151025]
[14]
Gul, S.; Ahmed, S.; Kifli, N.; Uddin, Q.T.; Batool Tahir, N.; Hussain, A.; Jaafar, H.Z.; Moga, M.; Zia-Ul-Haq, M. Multiple pathways are responsible for anti-inflammatory and cardiovascular activities of Hordeum vulgare L. J. Transl. Med., 2014, 12, 316.
[http://dx.doi.org/10.1186/s12967-014-0316-9] [PMID: 25428431]
[15]
Idehen, E.; Tang, Y.; Sang, S. Bioactive phytochemicals in barley. Yao Wu Shi Pin Fen Xi, 2017, 25(1), 148-161.
[http://dx.doi.org/10.1016/j.jfda.2016.08.002] [PMID: 28911532]
[16]
Arzani, M.A. In Teb Akbari. Jalaleddin: Qom, 2008, 1, 13.
[17]
Sadeghpour, O.; Esfahani, M.M.; Yousefi, M. Comparison of Ma-al-Shaeer and non-alchoholic beer formulations and labratory parameters: A lab study and text review. Tebvatazkiye (in Persian),, 2012, 21(2), 50-55.
[18]
Wallace, D.V.; Dykewicz, M.S.; Bernstein, D.I.; Blessing-Moore, J.; Cox, L.; Khan, D.A.; Lang, D.M.; Nicklas, R.A.; Oppenheimer, J.; Portnoy, J.M.; Randolph, C.C.; Schuller, D.; Spector, S.L.; Tilles, S.A. The diagnosis and management of rhinitis: an updated practice parameter. J. Allergy Clin. Immunol., 2008, 122(2)(Suppl.), S1-S84.
[http://dx.doi.org/10.1016/j.jaci.2008.06.003] [PMID: 18662584]
[19]
Meltzer, E.O.; Schatz, M.; Nathan, R.; Garris, C.; Stanford, R.H.; Kosinski, M. Reliability, validity, and responsiveness of the Rhinitis Control Assessment Test in patients with rhinitis. J. Allergy Clin. Immunol., 2013, 131(2), 379-386.
[http://dx.doi.org/10.1016/j.jaci.2012.10.022] [PMID: 23219170]
[20]
Iguchi, T.; Kawata, A.; Watanabe, T.; Mazumder, T.K.; Tanabe, S. Fermented barley extract suppresses the development of atopic dermatitis-like skin lesions in NC/Nga mice, probably by inhibiting inflammatory cytokines. Biosci. Biotechnol. Biochem., 2009, 73(3), 489-493.
[http://dx.doi.org/10.1271/bbb.80436] [PMID: 19270394]
[21]
Iguchi, T.; Kawata, A.; Arimitsu, H.; Watanabe, T.; Ma-zumder, T.K.; Nagai, S.; Muto, N. Effects of fermented bar-ley extract on allergic rhinitis in OVA-sensitized mice. Nippon Shokuhin Kagaku Kogaku Kaishi, 2007, 54(2), 61-66.
[http://dx.doi.org/10.3136/nskkk.54.61]
[22]
Belobrajdic, D.P.; Bird, A.R. The potential role of phytochemicals in wholegrain cereals for the prevention of type-2 diabetes. Nutr. J., 2013, 12, 62-62.
[http://dx.doi.org/10.1186/1475-2891-12-62] [PMID: 23679924]
[23]
Magrone, T.; Jirillo, E. Influence of polyphenols on allergic immune reactions: mechanisms of action. Proc. Nutr. Soc., 2012, 71(2), 316-321.
[http://dx.doi.org/10.1017/S0029665112000109] [PMID: 22369886]
[24]
Chirumbolo, S. Dietary assumption of plant polyphenols and prevention of allergy. Curr. Pharm. Des., 2014, 20(6), 811-839.
[http://dx.doi.org/10.2174/13816128113199990042] [PMID: 23701556]
[25]
Enomoto, T.; Nagasako-Akazome, Y.; Kanda, T.; Ikeda, M.; Dake, Y. Clinical effects of apple polyphenols on persistent allergic rhinitis: A randomized double-blind placebo-controlled parallel arm study. J. Investig. Allergol. Clin. Immunol., 2006, 16(5), 283-289.
[PMID: 17039666]
[26]
Bartłomiej, S.; Justyna, R.K.; Ewa, N. Bioactive compounds in cereal grains - occurrence, structure, technological significance and nutritional benefits - a review. Food Sci. Technol. Int., 2012, 18(6), 559-568.
[http://dx.doi.org/10.1177/1082013211433079] [PMID: 23064524]
[27]
Elenius, V.; Palomares, O.; Waris, M.; Turunen, R.; Puhakka, T.; Rückert, B.; Vuorinen, T.; Allander, T.; Vahlberg, T.; Akdis, M.; Camargo, C.A., Jr; Akdis, C.A.; Jartti, T. The relationship of serum vitamins A, D, E and LL-37 levels with allergic status, tonsillar virus detection and immune response. PLoS One, 2017, 12(2)e0172350
[http://dx.doi.org/10.1371/journal.pone.0172350] [PMID: 28235040]
[28]
Shahar, E.; Hassoun, G.; Pollack, S. Effect of vitamin E supplementation on the regular treatment of seasonal allergic rhinitis. Ann. Allergy Asthma Immunol., 2004, 92(6), 654-658.
[http://dx.doi.org/10.1016/S1081-1206(10)61432-9] [PMID: 15237767]
[29]
Montano Velazquez, B.B.; Jauregui-Renaud, K.; Banuelos Arias Adel, C.; Ayala, J.C.; Martinez, M.D. Campillo Navar-rete, R.; Rosalia, I. S.; Salazar Mdel, R.; Serrano, H. A.; Mondragon, A. O.; Perez, R. L. Vitamin E effects on nasal symptoms and serum specific IgE levels in patients with per-ennial allergic rhinitis. Ann. Allergy Asthma Immunol., 2006, 96(1), 45-50.
[http://dx.doi.org/10.1016/S1081-1206(10)61039-3] [PMID: 16440532]
[30]
Matsui, E.C.; Matsui, W. Higher serum folate levels are associated with a lower risk of atopy and wheeze. J. Allergy Clin. Immunol., 2009, 123(6), 1253-9.e2.
[http://dx.doi.org/10.1016/j.jaci.2009.03.007] [PMID: 19409604]
[31]
Thompson, I.J.; Oyston, P.C.; Williamson, D.E. Potential of the beta-glucans to enhance innate resistance to biological agents. Expert Rev. Anti Infect. Ther., 2010, 8(3), 339-352.
[http://dx.doi.org/10.1586/eri.10.10] [PMID: 20192687]
[32]
Kim, M-H.; Ko, Y.; Ahn, J-H.; Yun, Y.; Yun, M-N.; Ko, S-G.; Choi, I. Efficacy and safety of So-Cheong-Ryong-Tang in treatment of perennial allergic rhinitis: study protocol for a double-blind, randomised, parallel-group, multicentre trial. BMJ Open, 2017, 7(9)e016556
[http://dx.doi.org/10.1136/bmjopen-2017-016556] [PMID: 28963290]
[33]
Simpson, K.; Jarvis, B. Fexofenadine: a review of its use in the management of seasonal allergic rhinitis and chronic idiopathic urticaria. Drugs, 2000, 59(2), 301-321.
[http://dx.doi.org/10.2165/00003495-200059020-00020] [PMID: 10730552]
[34]
Van Cauwenberge, P.; Juniper, E.F. Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin. Exp. Allergy, 2000, 30(6), 891-899.
[http://dx.doi.org/10.1046/j.1365-2222.2000.00914.x] [PMID: 10848909]
[35]
Hampel, F.; Ratner, P.; Mansfield, L.; Meeves, S.; Liao, Y.; Georges, G. Fexofenadine hydrochloride, 180 mg, exhibits equivalent efficacy to cetirizine, 10 mg, with less drowsiness in patients with moderate-to-severe seasonal allergic rhinitis. Ann. Allergy Asthma Immunol., 2003, 91(4), 354-361.
[http://dx.doi.org/10.1016/S1081-1206(10)61682-1] [PMID: 14582814]
[36]
Laccourreye, O.; Werner, A.; Laccourreye, L.; Bonfils, P. Benefits, pitfalls and risks of phytotherapy in clinical practice in otorhinolaryngology. Eur. Ann. Otorhinolaryngol. Head Neck Dis., 2017, 134(2), 95-99.
[http://dx.doi.org/10.1016/j.anorl.2016.11.001] [PMID: 27914909]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy