Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial.
Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial.
复制标题
针灸治疗慢性哮喘的疗效：随机对照试验的研究方案
DOI：
10.1186/s13063-015-0947-z
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发表时间：
2015-09-23
期刊：
影响因子：
2.5
通讯作者：
Yang YQ
中科院分区：
文献类型：
--
作者：
Yin LM;Wang Y;Fan L;Xu YD;Wang WQ;Liu YY;Feng JT;Hu CP;Wang PY;Zhang TF;Shao SJ;Yang YQ
虽然哮喘症状可以暂时控制，但建议使用有效的低风险、非药物策略来构成哮喘管理的重大进步。传统上，针灸被用来治疗哮喘；然而，这种治疗的有效性仍然缺乏证据。以往针灸治疗哮喘的临床试验受到方法学缺陷的限制，因此需要高质量的研究。本试验设计为多中心、随机、双盲、平行分组对照试验。轻至中度哮喘患者将被随机分配到真针加按需沙丁胺醇气雾剂和/或强的松片组，或假针刺加按需沙丁胺醇气雾剂和/或强的松片组。真针组取穴为GV14(大椎)、BL12(凤门)、BL13(肺俞)，假针刺组取穴为督索08(金锁)、BL18(肝俞)、BL19(丹俞)。基线治疗1周后，两组患者均隔日接受真假针灸治疗1次，共治疗20次，疗程6周，随访3个月。用哮喘控制试验评定一期疗效，用无症状天数百分比、沙丁胺醇气雾剂和/或强的松片平均用量、肺功能、每日哮喘症状评分、哮喘生活质量问卷等评定二次疗效。本试验旨在评价针刺治疗哮喘的疗效，旨在为针刺治疗哮喘的疗效提供可靠的临床依据。ClinicalTrials.gov标识：NCT01931696，注册日期：2013年8月26日
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. 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. 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. ClinicalTrials.gov Identifier: NCT01931696, registered on 26 August 2013