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A randomized, controlled, crossover study in patients with mild and moderate asthma undergoing treatment with traditional Chinese acupuncture

机译:接受中医针灸治疗的轻度和中度哮喘患者的随机对照研究

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OBJECTIVES:This study sought to verify the effects of acupuncture as an adjuvant treatment for the control of asthma.METHODS:This was a randomized, controlled, crossover trial conducted at the Hospital das Clínicas da Faculdade de Medicina da Universidade de S?o Paulo. A total of 74 patients with mild/moderate, persistent asthma were randomized into two therapeutic groups: Group A - 31 patients underwent 10 real weekly acupuncture sessions, followed by a 3-week washout period and 10 sham weekly acupuncture sessions; and Group B - 43 patients underwent 10 sham weekly acupuncture sessions, followed by a 3-week washout period and 10 real weekly acupuncture sessions. Patients used short- and long-acting β-2 agonists and inhaled corticosteroids when necessary. Prior to treatment and after each period of 10 treatment sessions, the patients were evaluated for spirometry, induced sputum cell count, exhaled nitric oxide (NO) and with the Short Form 36 (SF-36) and Questionnaire on Quality of Life-Asthma (QQLA) questionnaires. Daily peak flow and symptom diaries were registered. The level of significance adopted was 5% (α=0.05).RESULTS:In Group B, after real acupuncture, there was a decrease in eosinophils (p=0.035) and neutrophils (p=0.047), an increase in macrophages (p=0.001) and an improvement in peak flow (p=0.01). After sham acupuncture treatment, patients experienced less coughing (p=0.037), wheezing (p=0.013) and dyspnea (p=0.014); similarly, after real acupuncture, patients reported less coughing (p=0.040), wheezing (p=0.012), dyspnea (p0.001) and nocturnal awakening episodes (p=0.009). In Group A, there was less use of rescue medication (p=0.043). After the sham procedure, patients in Group A experienced less coughing (p=0.007), wheezing (p=0.037), dyspnea (p0.001) and use of rescue medication (p0.001) and after real acupuncture, these patients showed improvements in functional capacity (p=0.004), physical aspects (p=0.002), general health status (p0.001) and vitality (p=0.019). Sham acupuncture also led to significant differences in symptoms, but these were not different from those seen with real acupuncture. Spirometry and exhaled NO levels did not show a difference between sham and real acupuncture treatment. In addition, no significant difference was demonstrated between treatments regarding the quality of life evaluation.CONCLUSION:Real and sham acupuncture have different effects and outcomes on asthma control. The crossover approach was not effective in this study because both interventions led to improvement of asthma symptoms, quality of life and inflammatory cell counts. Thus, sham acupuncture cannot serve as a placebo in trials with acupuncture as the main intervention for asthma.
机译:目的:本研究旨在验证针灸作为控制哮喘的辅助治疗方法的效果。方法:这是在圣保罗大学医学院进行的一项随机,对照,交叉试验。总共74例轻度/中度,持续性哮喘患者被随机分为两个治疗组:A组-31名患者每周接受10次真正的每周针灸治疗,然后进行3周的清除期和10次假每周针灸治疗。 B组-43名患者每周接受10次假针刺治疗,然后进行3周的冲洗期和10次真正的每周针刺治疗。患者使用短效和长效β-2激动剂并在必要时吸入皮质类固醇。在治疗前和每10疗程之后,对患者进行肺活量测定,诱导的痰​​细胞计数,呼出气一氧化氮(NO)以及简短表格36(SF-36)和生活质量哮喘问卷( QQLA)问卷。记录每日峰值流量和症状日记。结果的显着性水平为5%(α= 0.05)。结果:在B组中,针刺后,嗜酸性粒细胞(p = 0.035)和嗜中性粒细胞(p = 0.047)减少,巨噬细胞(p = 0.001)和峰值流量的改善(p = 0.01)。假针灸治疗后,患者的咳嗽(p = 0.037),喘息(p = 0.013)和呼吸困难(p = 0.014)较少;同样,在真正的针灸后,患者的咳嗽次数(p = 0.040),喘息(p = 0.012),呼吸困难(p <0.001)和夜间觉醒次数较少(p = 0.009)。在A组中,急救药物的使用较少(p = 0.043)。假手术后,A组患者的咳嗽(p = 0.007),喘息(p = 0.037),呼吸困难(p <0.001)和使用急救药物(p <0.001)较少,并且在针刺后这些患者表现出改善在功能能力(p = 0.004),身体方面(p = 0.002),总体健康状况(p <0.001)和活力(p = 0.019)方面。假针灸也导致症状的显着差异,但与真正针灸所见无异。肺活量测定法和呼出的一氧化氮水平在假针刺治疗和实际针刺治疗之间未显示出差异。此外,两种治疗方法在生活质量评估上无显着差异。结论:实针和假针灸对哮喘控制的效果和结局均不同。交叉方法在本研究中无效,因为两种干预措施均可以改善哮喘症状,生活质量和炎性细胞计数。因此,在以针灸为哮喘主要干预措施的试验中,假针灸不能用作安慰剂。

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