Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial

Lei-Miao Yin, Yu Wang, Lei Fan, Yu-Dong Xu, Wen-Qian Wang, Yan-Yan Liu, Jun-Tao Feng, Cheng-Ping Hu, Pei-Yu Wang, Tie-Feng Zhang, Su-Ju Shao, Yong-Qing Yang, Lei-Miao Yin, Yu Wang, Lei Fan, Yu-Dong Xu, Wen-Qian Wang, Yan-Yan Liu, Jun-Tao Feng, Cheng-Ping Hu, Pei-Yu Wang, Tie-Feng Zhang, Su-Ju Shao, Yong-Qing Yang

Abstract

Background: Although asthma symptoms can be temporarily controlled, it is recommended to use effective low-risk, non-drug strategies to constitute a significant advance in asthma management. Acupuncture has been traditionally used to treat asthma; however, the evidence for the efficacy of this treatment is still lacking. Previous clinical trials of acupuncture in treating asthma were limited by methodological defects; therefore, high-quality research is required.

Methods/design: This trial is designed as a multi-center, randomized, double-blind, parallel-group controlled trial. Patients with mild to moderate asthma will be randomly allocated to either a verum acupuncture plus as-needed salbutamol aerosol and/or prednisone tablets group or a sham acupuncture plus as-needed salbutamol aerosol and/or prednisone tablets group. Acupoints used in the verum acupuncture group are GV14 (Da Zhui), BL12 (Feng Men), BL13 (Fei Shu) and acupoints used in the sham acupuncture group are DU08 (Jin Suo), BL18 (Gan Shu), BL19 (Dan Shu). After a baseline period of 1 week, the patients in both groups will receive verum/sham acupuncture once every other day with a total of 20 treatment sessions in 6 weeks and a 3-month follow-up. The primary outcome will be measured by using the asthma control test and the secondary outcomes will be measured by using the percentage of symptom-free days, the average dosage of salbutamol aerosol and/or prednisone tablets, lung functions, daily asthma symptom scores, asthma quality of life questionnaire, and so on.

Discussion: This trial will assess the effect of acupuncture on asthma and aims to provide reliable clinical evidence for the efficacy of acupuncture in treating asthma.

Trial registration: ClinicalTrials.gov Identifier: NCT01931696 , registered on 26 August 2013.

Figures

Fig. 1
Fig. 1
The flow chart

References

    1. The Global Asthma Report 2014. Auckland, New Zealand: Global Asthma Network; 2014
    1. Pawankar R, Canonica G, Holgate S, et al. World Allergy Organization (WAO) white book on allergy, Update. 2013.
    1. Bateman ED, Hurd SS, Barnes PJ, et al. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008;31:143–78. doi: 10.1183/09031936.00138707.
    1. Legatzki A, Rosler B, von Mutius E. Microbiome diversity and asthma and allergy risk. Curr Allergy Asthma Rep. 2014;14:466. doi: 10.1007/s11882-014-0466-0.
    1. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention, Updated 2014. Available from: .
    1. Keenan CR, Salem S, Fietz ER, Gualano RC, Stewart AG. Glucocorticoid-resistant asthma and novel anti-inflammatory drugs. Drug Discov Today. 2012;17:1031–8. doi: 10.1016/j.drudis.2012.05.011.
    1. Gamble J, Stevenson M, McClean E, Heaney LG. The prevalence of nonadherence in difficult asthma. Am J Respir Crit Care Med. 2009;180:817–22. doi: 10.1164/rccm.200902-0166OC.
    1. Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev. 2012;64:450–504. doi: 10.1124/pr.111.004580.
    1. Chowdhury BA, Seymour SM, Levenson MS. Assessing the safety of adding LABAs to inhaled corticosteroids for treating asthma. N Engl J Med. 2011;364:2473–5. doi: 10.1056/NEJMp1104375.
    1. Chowdhury BA, Dal PG. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med. 2010;362:1169–71. doi: 10.1056/NEJMp1002074.
    1. Chen W, Fitzgerald JM, Rousseau R, et al. Complementary and alternative asthma treatments and their association with asthma control: a population-based study. BMJ Open. 2013;3:e003360.
    1. NIH Consensus Development Panel on Acupuncture Acupuncture. JAMA. 1998;280:1518–24. doi: 10.1001/jama.280.17.1518.
    1. Use of acupuncture in modern health care. WHO Chron. 1980;34:294–301.
    1. World Health Organization. Acupuncture: review and analysis of reports on controlled clinical trials. 2002.
    1. Acupuncture. NIH Consensus Statement 1997;15:1–34.
    1. Network BTSSIG. British guideline on the management of asthma. Thorax. 2014;69:i1.
    1. Jobst KA. A critical analysis of acupuncture in pulmonary disease: efficacy and safety of the acupuncture needle. J Altern Complement Med. 1995;1:57–85. doi: 10.1089/acm.1995.1.57.
    1. Lewith GT, Watkins AD. Unconventional therapies in asthma: an overview. Allergy. 1996;51:761–9. doi: 10.1111/j.1398-9995.1996.tb04464.x.
    1. Yang YQ, Chen HP, Wang AQ, et al. Efficacy analyses of acupuncture for the treatment of 174 asthma patients. Shanghai J Acu Moxi. 1994;13:153–4.
    1. Yang YQ, Chen HP, Wang Y, Yin LM, Xu YD, Ran J. Considerations for use of acupuncture as supplemental therapy for patients with allergic asthma. Clin Rev Allergy Immunol. 2013;44:254–61. doi: 10.1007/s12016-012-8321-3.
    1. Choi JY, Jung HJ, Kim JI, Lee MS, Kang KW, Roh YL, et al. A randomized pilot study of acupuncture as an adjunct therapy in adult asthmatic patients. J Asthma. 2010;47:774–80. doi: 10.3109/02770903.2010.485665.
    1. Shen FY, Lee MS, Jung SK. Effectiveness of pharmacopuncture for asthma: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2011;2011:678176.
    1. Kleijnen J, ter Riet G, Knipschild P. Acupuncture and asthma: a review of controlled trials. Thorax. 1991;46:799–802. doi: 10.1136/thx.46.11.799.
    1. Martin J, Donaldson AN, Villarroel R, et al. Efficacy of acupuncture in asthma: systematic review and meta-analysis of published data from 11 randomised controlled trials. Eur Respir J. 2002;20:846–52. doi: 10.1183/09031936.02.00078702.
    1. Asthma Workgroup; Chinese Thoracic Society; Chinese Society of General Practitioners. Chinese guideline for the prevention and management of bronchial asthma (Primary Health Care Version). J Thorac Dis. 2013;5:667.
    1. Chen Z, Zheng Q, Sun R. Functions of the DAS software for pharmacological calculation. Chin J Clin Pharmacol Ther. 2002;7:562–4.
    1. World Health Organization. Guidelines for clinical research on acupuncture. 1995.
    1. Jiang YL, Yin LM, Wang Y, et al. Assessments of different kinds of sham acupuncture applied in randomized controlled trials. J Acupunct Tuina Sci. 2011;9:199–203. doi: 10.1007/s11726-011-0511-7.
    1. Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, et al. Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006;117:549–56. doi: 10.1016/j.jaci.2006.01.011.
    1. Pauwels RA, Pedersen S, Busse WW, Tan WC, Chen YZ, Ohlsson SV, et al. Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial. Lancet. 2003;361:1071–6. doi: 10.1016/S0140-6736(03)12891-7.
    1. Fuhlbrigge A, Peden D, Apter AJ, Boushey HA, Camargo CA, Jr, Gern J, et al. Asthma outcomes: exacerbations. J Allergy Clin Immunol. 2012;129:S34–48. doi: 10.1016/j.jaci.2011.12.983.
    1. Lemanske RF, Jr, Mauger DT, Sorkness CA, Jackson DJ, Boehmer SJ, Martinez FD, et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975–85. doi: 10.1056/NEJMoa1001278.
    1. Kainu A, Lindqvist A, Sarna S, Lundbäck B, Sovijärvi A. FEV1 response to bronchodilation in an adult urban population. Chest. 2008;134:387–93. doi: 10.1378/chest.07-2207.
    1. Higgins BG, Britton JR, Chinn S, Jones TD, Jenkinson D, Burney PG, et al. The distribution of peak expiratory flow variability in a population sample. Am Rev Respir Dis. 1989;140:1368–72. doi: 10.1164/ajrccm/140.5.1368.
    1. FitzGerald JM, Boulet LP, Follows RM. The CONCEPT trial: a 1-year, multicenter, randomized, double-blind, double-dummy comparison of a stable dosing regimen of salmeterol/fluticasone propionate with an adjustable maintenance dosing regimen of formoterol/budesonide in adults with persistent asthma. Clin Ther. 2005;27:393–406. doi: 10.1016/j.clinthera.2005.03.006.
    1. Li F, Cai Y, Wang PL, et al. Evaluating the predigesting questionnaire for asthma quality of life in adult. Mod Rehabil. 2001;5:7–9.
    1. Yin LM, Jiang GH, Wang Y, Wang Y, Liu YY, Jin WR, et al. Use of serial analysis of gene expression to reveal the specific regulation of gene expression profile in asthmatic rats treated by acupuncture. J Biomed Sci. 2009;16:46. doi: 10.1186/1423-0127-16-46.
    1. McCarney RW, Brinkhaus B, Lasserson TJ, et al. Acupuncture for chronic asthma. Cochrane Database Syst Rev. 2004;CD000008, Re-published online with edits: 8 July 2009 in Issue 3, 2009.
    1. British Thoracic Society Scottish Intercollegiate Guidelines N. British guideline on the management of asthma. Thorax. 2008;63 Suppl 4:iv1–121.
    1. Xu YD, Cui JM, Wang Y, Yin LM, Gao CK, Liu XY, Cui JM, Wang Y, Yin LM, Gao CK, Liu XY, et al. Proteomic analysis reveals the deregulation of inflammation-related proteins in acupuncture-treated rats with asthma onset. Evid Based Complement Alternat Med. 2012;2012:850512.

Source: PubMed

3
Sottoscrivi