Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trialReportar como inadecuado




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Trials

, 16:424

First Online: 23 September 2015Received: 11 May 2015Accepted: 08 September 2015DOI: 10.1186-s13063-015-0947-z

Cite this article as: Yin, LM., Wang, Y., Fan, L. et al. Trials 2015 16: 424. doi:10.1186-s13063-015-0947-z

Abstract

BackgroundAlthough 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-DesignThis 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.

DiscussionThis 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 registrationClinicalTrials.gov Identifier: NCT01931696, registered on 26 August 2013

KeywordsAcupuncture Chronic asthma Efficacy RCT Study protocol AbbreviationsACTasthma control test

ANCOVAanalysis of covariance

AQLQAsthma Quality of Life Questionnaire

CRFcase report form

EOSeosinophils

FEV1forced expiratory volume in 1 second

ICSinhaled corticosteroids

LOCFlast observation carried forward

mITTmodified intent-to-treat

NIHNational Institutes of Health

PEFpeak expiratory flow

PPper-protocol

RCTrandomized clinical trials

SDstandard deviation

SFDssymptom-free days

TCMtraditional Chinese medicine

WHOWorld Health Organization

Lei-Miao Yin and Yu Wang contributed equally to this work.

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Autor: 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

Fuente: https://link.springer.com/







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