Active albuterol or placebo, sham acupuncture, or no intervention in asthma.
Active albuterol or placebo, sham acupuncture, or no intervention in asthma.
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DOI：
10.1056/nejmoa1103319
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发表时间：
2011-07-14
期刊：
影响因子：
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通讯作者：
Kaptchuk TJ
中科院分区：
文献类型：
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作者：
Wechsler ME;Kelley JM;Boyd IO;Dutile S;Marigowda G;Kirsch I;Israel E;Kaptchuk TJ
在哮喘患者的前瞻性实验研究中，很难确定对安慰剂的反应是否与没有任何干预的生理变化的自然过程不同。我们比较了一种支气管扩张剂、两种安慰剂干预和不干预对哮喘患者预后的影响。在一项双盲交叉试验研究中，我们随机将46名哮喘患者分为沙丁胺醇吸入剂、安慰剂吸入剂、假针灸或不干预。使用区组设计，我们在四个连续的访问期间(相隔3至7天)按随机顺序实施这四个干预措施中的每一个；在另外两个访问区组中重复这一过程(每个患者总共访问12次)。在每次访问中，重复进行肺活量测定，持续时间为2小时。测量1秒最大用力呼气量(FEV1)，并记录患者自我报告的改善程度。在完成这项研究的39名患者中，沙丁胺醇导致FEV1增加了20%，而其他三种干预措施的每一种增加了大约7%(P<；0.001)。然而，在沙丁胺醇吸入剂(改善50%)、安慰剂吸入剂(45%)或假针灸(46%)干预后，患者报告的改善情况没有显著差异，但所有这三种干预措施的主观改善显著大于未干预对照组(21%)(P<；0.001)。虽然沙丁胺醇，而不是两种安慰剂干预措施，改善了这些哮喘患者的FEV1，但沙丁胺醇在自我报告的结果方面并没有提供任何增加的好处。安慰剂效应可能具有临床意义，可以与哮喘患者的积极药物疗效相媲美。然而，从临床管理和研究设计的角度来看，患者自我报告可能是不可靠的。在评估患者报告的结果时，对哮喘未治疗反应的评估可能是必不可少的。(由国家补充和替代医学中心资助；ClinicalTrials.gov编号，NCT01143688。)
In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma. In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV1) was measured, and patients’ self-reported improvement ratings were recorded. Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV1, as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients’ reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001). Although albuterol, but not the two placebo interventions, improved FEV1 in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine; ClinicalTrials.gov number, NCT01143688.)