A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics.

A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics.
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DOI:
10.1186/1472-6882-14-128
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发表时间:
2014-04-06
影响因子:
--
通讯作者:
Brinkhaus B
Brinkhaus B
中科院分区:
医学3区
文献类型:
--
作者:
Ortiz M;Witt CM;Binting S;Helmreich C;Hummelsberger J;Pfab F;Wullinger M;Irnich D;Linde K;Niggemann B;Willich SN;Brinkhaus B

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在一项针对季节性变应性鼻炎(SAR)患者的大型随机试验中,针灸上级假针灸和补救药物。本文的目的是描述试验参与医生的特征,并根据STRICTA(针刺对照试验干预措施报告标准)指南描述试验干预措施,使试验干预措施的细节对研究人员和医生更加透明。ACUSAR(季节性过敏性鼻炎的ACUpuncture)是一项三组、随机、对照、多中心试验。422名SAR患者随机接受半标准化针灸加补救药物(RM,西替利嗪),假针灸加RM或单独RM。我们向试验医生发送了一份调查问卷,以评估他们在提供针灸方面的教育和经验。在试验期间,针灸师被要求根据中医诊断所有患者,作为针灸组半标准化,个性化干预的基础。在每次治疗后,必须记录本试验中使用的每个穴位。(平均年龄47 ± 10岁; 24名女性/ 22名男性)(67%的研究生专业,如内科或家庭医学),并有额外的广泛的针灸培训(中位数500小时(第一个四分位数350,第三个四分位数1000小时,73%的人在针灸培训中获得B文凭(350小时))和经验(平均14年的实践)。中医传统诊断以“风寒袭肺”、“风热犯肺”最多(37%),其次为“肺脾气虚”(9%)。针刺组使用的针总数高于假针刺组(15.7 ± 2.5 vs. 10.0 ± 1.6)。试验干预由受过良好教育且经验丰富的针灸师提供。两个干预组中不同的针数可能是SAR患者临床效果更好的原因。对于未来的试验,可能更合适的是确保针灸和假针灸组都应该用类似数量的针进行治疗。ClinicalTrials.gov:NCT 00610584。
In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was ‘wind-cold invading the lung’ (37%) and ‘wind-heat invading the lung’ (37%), followed by ‘lung and spleen qi deficiency’ (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). The trial interventions were provided by well educated and experienced acupuncturists. The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients. For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles. ClinicalTrials.gov: NCT00610584.
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