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Published in: Trials 1/2019

Open Access 01-12-2019 | Acupuncture | Study protocol

Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial

Authors: Chan-Yung Jung, Min-Jin Cho, Ha-Ra Kang, Seung-Ug Hong, Won-Suk Sung, Eun-Jung Kim

Published in: Trials | Issue 1/2019

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Abstract

Background

Allergic rhinitis (AR) is an IgE-mediated disease that adversely affects quality of life. Many studies report that moxibustion is an effective treatment for perennial allergic rhinitis (PAR). However, it is difficult to perform moxibustion on the face because of possible burning of the skin and the noxious effects of smoke. Electric heating moxibustion does not have these limitations. The purpose of this clinical trial is to assess the possibility of treating PAR with electric heating moxibustion and to assess the feasibility of conducting a clinical test on a larger scale.

Methods

This is a randomized, open-label, assessor-blind, parallel-design pilot clinical study. We will recruit 40 eligible participants and randomly allocate them into an electric heating moxibustion group or an acupuncture group at a 1:1 ratio. Patients in both groups will receive eight treatments over 4 weeks, and the final follow-up will be 4 weeks after the last treatment. Eleven acupuncture points will be used for patients in both groups (EX-HN3 and bilateral EX-HN-8, LI20, LI4, GB20, and ST36). The primary outcome measure is change in the Total Nasal Symptom Score, and the secondary outcome measures are changes in the Rhinoconjunctivitis Quality of Life Questionnaire, nasal endoscopy index for pattern identification, pattern identification questionnaire for AR, total IgE, eosinophil count, and adverse effects.

Discussion

This clinical trial will examine the effect of electric heating moxibustion on PAR.

Trial registration

ClinicalTrials.gov, NCT03342105. Registered on 14 November 2017.
Appendix
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Literature
1.
go back to reference Van Cauwenberge P, Bachert C, Passalacqua G, Bousquet J, Canonica GW, Durham SR, et al. Consensus statement on the treatment of allergic rhinitis. Allergy. 2000;55(2):116–34.PubMedCrossRef Van Cauwenberge P, Bachert C, Passalacqua G, Bousquet J, Canonica GW, Durham SR, et al. Consensus statement on the treatment of allergic rhinitis. Allergy. 2000;55(2):116–34.PubMedCrossRef
2.
go back to reference Skoner DP. Allergic rhinitis: definition, epidemiology, pathophysiology, detection, and diagnosis. J Allergy Clin Immunol. 2001;108(1 Suppl):S2–8.PubMedCrossRef Skoner DP. Allergic rhinitis: definition, epidemiology, pathophysiology, detection, and diagnosis. J Allergy Clin Immunol. 2001;108(1 Suppl):S2–8.PubMedCrossRef
3.
go back to reference Hong S, Son DK, Lim WR, Kim SH, Kim H, Yum HY, et al. The prevalence of atopic dermatitis, asthma, and allergic rhinitis and the comorbidity of allergic diseases in children. Environ Health Toxicol. 2012;27:e2012006.PubMedPubMedCentralCrossRef Hong S, Son DK, Lim WR, Kim SH, Kim H, Yum HY, et al. The prevalence of atopic dermatitis, asthma, and allergic rhinitis and the comorbidity of allergic diseases in children. Environ Health Toxicol. 2012;27:e2012006.PubMedPubMedCentralCrossRef
4.
go back to reference Nathan RA, Meltzer EO, Seiner JC, Storms W. Prevalence of allergic rhinitis in the United States. J Allergy Clin Immunol. 1997;99(6):S808–14.CrossRef Nathan RA, Meltzer EO, Seiner JC, Storms W. Prevalence of allergic rhinitis in the United States. J Allergy Clin Immunol. 1997;99(6):S808–14.CrossRef
5.
go back to reference Bauchau V, Durham SR. Prevalence and rate of diagnosis of allergic rhinitis in Europe. Eur Respir J. 2004;24(5):758–64.PubMedCrossRef Bauchau V, Durham SR. Prevalence and rate of diagnosis of allergic rhinitis in Europe. Eur Respir J. 2004;24(5):758–64.PubMedCrossRef
6.
go back to reference Zheng M, Lin C, Zheng L, He F. Effects of acupuncture-moxibustion on monocyte Th1/Th2 cytokine in peripheral blood of patients with perennial allergic rhinitis. J Acupunct Tuina Sci. 2010;8(2):85–8.CrossRef Zheng M, Lin C, Zheng L, He F. Effects of acupuncture-moxibustion on monocyte Th1/Th2 cytokine in peripheral blood of patients with perennial allergic rhinitis. J Acupunct Tuina Sci. 2010;8(2):85–8.CrossRef
7.
go back to reference Bousquet J, Van Cauwenberge P, Khaltaev N, Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001;108(5 Suppl):S147–334.PubMedCrossRef Bousquet J, Van Cauwenberge P, Khaltaev N, Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001;108(5 Suppl):S147–334.PubMedCrossRef
8.
go back to reference Seidman MD, Gurgel RK, Lin SY, Schwartz SR, Baroody FM, Bonner JR, et al. Clinical practice guideline: allergic rhinitis. Otolaryngol Head Neck Surg. 2015;152(1S):S1–43.PubMedCrossRef Seidman MD, Gurgel RK, Lin SY, Schwartz SR, Baroody FM, Bonner JR, et al. Clinical practice guideline: allergic rhinitis. Otolaryngol Head Neck Surg. 2015;152(1S):S1–43.PubMedCrossRef
9.
go back to reference Shiue HS, Lee YS, Tsai CN, Hsueh YM, Sheu JR, Chang HH. DNA microarray analysis of the effect on inflammation in patients treated with acupuncture for allergic rhinitis. JAltern Complement Med. 2008;14(6):689–98.CrossRef Shiue HS, Lee YS, Tsai CN, Hsueh YM, Sheu JR, Chang HH. DNA microarray analysis of the effect on inflammation in patients treated with acupuncture for allergic rhinitis. JAltern Complement Med. 2008;14(6):689–98.CrossRef
10.
go back to reference Swartzman LC, Harshman RA, Burkell J, Lundy ME. What accounts for the appeal of complementary/alternative medicine, and what makes complementary/alternative medicine “alternative”? Med Decis Mak. 2002;22(5):431–50.CrossRef Swartzman LC, Harshman RA, Burkell J, Lundy ME. What accounts for the appeal of complementary/alternative medicine, and what makes complementary/alternative medicine “alternative”? Med Decis Mak. 2002;22(5):431–50.CrossRef
12.
go back to reference Min C, Peng C, Wei G, Huang X, Fu T, Du Y, et al. Moxibustion with Chinese herbal has good effect on allergic rhinitis. Int J Clin Exp Med. 2015;8(9):16480–7.PubMedPubMedCentral Min C, Peng C, Wei G, Huang X, Fu T, Du Y, et al. Moxibustion with Chinese herbal has good effect on allergic rhinitis. Int J Clin Exp Med. 2015;8(9):16480–7.PubMedPubMedCentral
13.
go back to reference Ko E, Rho S, Cho C, Choi H, Ko S, Lee Y, et al. So-Cheong-Ryong-Tang, tradititional Korean medicine, suppresses Th2 lineage development. Biol Pharm Bull. 2004;27(5):739–43.PubMedCrossRef Ko E, Rho S, Cho C, Choi H, Ko S, Lee Y, et al. So-Cheong-Ryong-Tang, tradititional Korean medicine, suppresses Th2 lineage development. Biol Pharm Bull. 2004;27(5):739–43.PubMedCrossRef
14.
go back to reference Zijlstra FJ, van den Berg-de Lange I, Huygen FJ, Klein J. Anti-inflammatory actions of acupuncture. Mediat Inflamm. 2003;12(2):59–69.CrossRef Zijlstra FJ, van den Berg-de Lange I, Huygen FJ, Klein J. Anti-inflammatory actions of acupuncture. Mediat Inflamm. 2003;12(2):59–69.CrossRef
15.
go back to reference Petti FB, Liguori A, Ippoliti F. Study on cytokines IL-2, IL-6, IL-10 in patients of chronic allergic rhinitis treated with acupuncture. J Tradit Chin Med. 2002;22(2):104–11.PubMed Petti FB, Liguori A, Ippoliti F. Study on cytokines IL-2, IL-6, IL-10 in patients of chronic allergic rhinitis treated with acupuncture. J Tradit Chin Med. 2002;22(2):104–11.PubMed
16.
go back to reference Rao YQ, Han NY. Therapeutic effect of acupuncture on allergic rhinitis and its effects on immunologic function. Zhongguo Zhen Jiu. 2006;26(8):557–60.PubMed Rao YQ, Han NY. Therapeutic effect of acupuncture on allergic rhinitis and its effects on immunologic function. Zhongguo Zhen Jiu. 2006;26(8):557–60.PubMed
18.
go back to reference Choi TY, Lee MS, Kim JI, Zaslawski C. Moxibustion for the treatment of osteoarthritis: an updated systematic review and meta-analysis. Maturitas. 2017;100:33–48.PubMedCrossRef Choi TY, Lee MS, Kim JI, Zaslawski C. Moxibustion for the treatment of osteoarthritis: an updated systematic review and meta-analysis. Maturitas. 2017;100:33–48.PubMedCrossRef
19.
go back to reference Kim HG, Yoo SR, Park HJ, Son CG. Indirect moxibustion (CV4 and CV8) ameliorates chronic fatigue: a randomized, double-blind, controlled study. J Altern Complement Med. 2013;19(2):134–40.PubMedPubMedCentralCrossRef Kim HG, Yoo SR, Park HJ, Son CG. Indirect moxibustion (CV4 and CV8) ameliorates chronic fatigue: a randomized, double-blind, controlled study. J Altern Complement Med. 2013;19(2):134–40.PubMedPubMedCentralCrossRef
20.
go back to reference Yang SR, Chen H, Xie Q. Observation on therapeutic effect of moxibustion at "heat sensitive points" on perennial allergic rhinitis. Zhongguo Zhen Jiu. 2008;28(2):114–6.PubMed Yang SR, Chen H, Xie Q. Observation on therapeutic effect of moxibustion at "heat sensitive points" on perennial allergic rhinitis. Zhongguo Zhen Jiu. 2008;28(2):114–6.PubMed
21.
go back to reference Xu S, Wang L, Cooper E, Zhang M, Manheimer E, Berman B, et al. Adverse events of acupuncture: a systematic review of case reports. Evid Based Complement Alternat Med. 2013;2013:581203.PubMedPubMedCentral Xu S, Wang L, Cooper E, Zhang M, Manheimer E, Berman B, et al. Adverse events of acupuncture: a systematic review of case reports. Evid Based Complement Alternat Med. 2013;2013:581203.PubMedPubMedCentral
22.
go back to reference Huang J, Lim MY, Zhao B, Shao L. PM10 mass concentration and oxidative capacity of moxa smoke. QJM. 2015;108(9):705–10.PubMedCrossRef Huang J, Lim MY, Zhao B, Shao L. PM10 mass concentration and oxidative capacity of moxa smoke. QJM. 2015;108(9):705–10.PubMedCrossRef
23.
go back to reference Xu J, Deng H, Shen X. Safety of moxibustion: a systematic review of case reports. Evid Based Complement Alternat Med. 2014;2014:783704.PubMedPubMedCentral Xu J, Deng H, Shen X. Safety of moxibustion: a systematic review of case reports. Evid Based Complement Alternat Med. 2014;2014:783704.PubMedPubMedCentral
24.
go back to reference Jang BH, Choi IH, Kim KS, Kim HT, Kim KJ, Kim MH, et al. Current status of allergic rhinitis patients in Korean Medicine hospitals-exploratory study based on electronic medical records of 3 hospitals. J Korean Med Ophthalmol Otolaryngol Dermatol. 2014;27(1):117–29.CrossRef Jang BH, Choi IH, Kim KS, Kim HT, Kim KJ, Kim MH, et al. Current status of allergic rhinitis patients in Korean Medicine hospitals-exploratory study based on electronic medical records of 3 hospitals. J Korean Med Ophthalmol Otolaryngol Dermatol. 2014;27(1):117–29.CrossRef
25.
go back to reference Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008;63:8–160.PubMedCrossRef Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008;63:8–160.PubMedCrossRef
26.
go back to reference Xiao L, Li B, Du YH, Xiong J, Gao X. Systematic evaluation of the randomized controlled trials about acupuncture and moxibustion treatment of allergic rhinitis. Zhongguo Zhen Jiu. 2009;29(6):512–6.PubMed Xiao L, Li B, Du YH, Xiong J, Gao X. Systematic evaluation of the randomized controlled trials about acupuncture and moxibustion treatment of allergic rhinitis. Zhongguo Zhen Jiu. 2009;29(6):512–6.PubMed
27.
go back to reference Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat J Appl Stat Pharm Ind. 2005;4(4):287–91. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat J Appl Stat Pharm Ind. 2005;4(4):287–91.
28.
go back to reference Chen ZX. Clinical observation on acupuncture for treatment of allergic rhinitis. Zhongguo Zhen Jiu. 2007;27(8):578–80.PubMed Chen ZX. Clinical observation on acupuncture for treatment of allergic rhinitis. Zhongguo Zhen Jiu. 2007;27(8):578–80.PubMed
29.
go back to reference Chen Q, Zhang Q, Jiang L, Li X, Liu Y, Xie Y, et al. Effectiveness of strengthened stimulation during acupuncture for the treatment of allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2014;15:301.PubMedPubMedCentralCrossRef Chen Q, Zhang Q, Jiang L, Li X, Liu Y, Xie Y, et al. Effectiveness of strengthened stimulation during acupuncture for the treatment of allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2014;15:301.PubMedPubMedCentralCrossRef
30.
go back to reference Ellis AK, Soliman M, Steacy L, Boulay MÈ, Boulet LP, Keith PK, et al. The Allergic Rhinitis - Clinical Investigator Collaborative (AR-CIC): nasal allergen challenge protocol optimization for studying AR pathophysiology and evaluating novel therapies. Allergy Asthma Clin Immunol. 2015;11(1):16.PubMedPubMedCentralCrossRef Ellis AK, Soliman M, Steacy L, Boulay MÈ, Boulet LP, Keith PK, et al. The Allergic Rhinitis - Clinical Investigator Collaborative (AR-CIC): nasal allergen challenge protocol optimization for studying AR pathophysiology and evaluating novel therapies. Allergy Asthma Clin Immunol. 2015;11(1):16.PubMedPubMedCentralCrossRef
31.
go back to reference Juniper EF, Thompson AK, Ferrie PJ, Roberts JN. Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire. J Allergy Clin Immunol. 1999;104(2 Pt 1):364–9.PubMedCrossRef Juniper EF, Thompson AK, Ferrie PJ, Roberts JN. Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire. J Allergy Clin Immunol. 1999;104(2 Pt 1):364–9.PubMedCrossRef
32.
go back to reference Kim KS, Yun YH, Nam HJ, Choi IH, Ko SG. Inter- and intra-rater reliability of a nasal endoscopy index for pattern identification in patients with allergic rhinitis. Orient Pharm Exp Med. 2015;15(3):167–71.CrossRef Kim KS, Yun YH, Nam HJ, Choi IH, Ko SG. Inter- and intra-rater reliability of a nasal endoscopy index for pattern identification in patients with allergic rhinitis. Orient Pharm Exp Med. 2015;15(3):167–71.CrossRef
33.
go back to reference Kim MH, Ko Y, Ahn JH, Yun Y, Yun MN, et al. 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.PubMedPubMedCentralCrossRef Kim MH, Ko Y, Ahn JH, Yun Y, Yun MN, et al. 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.PubMedPubMedCentralCrossRef
34.
go back to reference Park JE, Lee SS, Lee MS, Choi SM, Ernst E. Adverse events of moxibustion: a systematic review. Complement Ther Med. 2010;18(5):215–23.PubMedCrossRef Park JE, Lee SS, Lee MS, Choi SM, Ernst E. Adverse events of moxibustion: a systematic review. Complement Ther Med. 2010;18(5):215–23.PubMedCrossRef
35.
go back to reference Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC. A survey of the burden of allergic rhinitis in Europe. Allergy. 2007;85(62Suppl):17–25.CrossRef Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC. A survey of the burden of allergic rhinitis in Europe. Allergy. 2007;85(62Suppl):17–25.CrossRef
36.
go back to reference Gelfand EW. Inflammatory mediators in allergic rhinitis. J Allergy Clin Immunol. 2004;114(5 Suppl):S135–8.PubMedCrossRef Gelfand EW. Inflammatory mediators in allergic rhinitis. J Allergy Clin Immunol. 2004;114(5 Suppl):S135–8.PubMedCrossRef
37.
go back to reference Choi S, Park JE, Li SS, Jung H, Zi M, Kim TH, et al. A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis. Allergy. 2013;68(3):365–74.PubMedCrossRef Choi S, Park JE, Li SS, Jung H, Zi M, Kim TH, et al. A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis. Allergy. 2013;68(3):365–74.PubMedCrossRef
38.
go back to reference Liangyue D, Yijun G, Shuhui H, Xiaoping J, Yang L, Rufen W. Chinese acupuncture and moxibustion. In: World Health Organization. Traditional Medicine in Asia. New Delhi: WHO Regional Publications; 2002. p. 76. Liangyue D, Yijun G, Shuhui H, Xiaoping J, Yang L, Rufen W. Chinese acupuncture and moxibustion. In: World Health Organization. Traditional Medicine in Asia. New Delhi: WHO Regional Publications; 2002. p. 76.
39.
go back to reference Kim SY, Chae Y, Lee SM, Lee H, Park HJ. The effectiveness of moxibustion: an overview during 10 years. Evid Based Complement Alternat Med. 2011;2011:306515.PubMedPubMedCentral Kim SY, Chae Y, Lee SM, Lee H, Park HJ. The effectiveness of moxibustion: an overview during 10 years. Evid Based Complement Alternat Med. 2011;2011:306515.PubMedPubMedCentral
40.
go back to reference Sun Y, Zhao H, Ye Y, Nie W, Bai W, Liu J, et al. Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2016;17(1):305.PubMedPubMedCentralCrossRef Sun Y, Zhao H, Ye Y, Nie W, Bai W, Liu J, et al. Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2016;17(1):305.PubMedPubMedCentralCrossRef
41.
go back to reference Li CW, Chen DHDH, Zhong JT, Lin ZB, Peng H, Lu HG, et al. Epidemiological characterization and risk factors of allergic rhinitis in the general population in Guangzhou City in China. PLOSOne. 2014;9(12):e114950.CrossRef Li CW, Chen DHDH, Zhong JT, Lin ZB, Peng H, Lu HG, et al. Epidemiological characterization and risk factors of allergic rhinitis in the general population in Guangzhou City in China. PLOSOne. 2014;9(12):e114950.CrossRef
42.
go back to reference Chen S, Guo S, Wang J, Ha E, Marmori F, Wang Y, et al. Effectiveness of moxibustion for allergic rhinitis: protocol for a systematic review. BMJ Open. 2015;5(5):e006570.PubMedPubMedCentralCrossRef Chen S, Guo S, Wang J, Ha E, Marmori F, Wang Y, et al. Effectiveness of moxibustion for allergic rhinitis: protocol for a systematic review. BMJ Open. 2015;5(5):e006570.PubMedPubMedCentralCrossRef
43.
go back to reference Zhang W, Chen MR, Xiong J. Effects of different quantity of moxibustion at "Dazhui" (GV 14) on cellular immunity in asthma rats. Zhen Ci Yan Jiu. 2012;37(3):202–5 217.PubMed Zhang W, Chen MR, Xiong J. Effects of different quantity of moxibustion at "Dazhui" (GV 14) on cellular immunity in asthma rats. Zhen Ci Yan Jiu. 2012;37(3):202–5 217.PubMed
44.
go back to reference Kim TG, Lee YM, Park YP, Cheon MW. Development of the electronic moxibustion device for realizing the heating effect of the moxa cautery. Trans Electr Electron Mater. 2014;15(1):28–31.CrossRef Kim TG, Lee YM, Park YP, Cheon MW. Development of the electronic moxibustion device for realizing the heating effect of the moxa cautery. Trans Electr Electron Mater. 2014;15(1):28–31.CrossRef
Metadata
Title
Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial
Authors
Chan-Yung Jung
Min-Jin Cho
Ha-Ra Kang
Seung-Ug Hong
Won-Suk Sung
Eun-Jung Kim
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3550-x

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