Placebos without deception: a randomized controlled trial in irritable bowel syndrome.
Placebos without deception: a randomized controlled trial in irritable bowel syndrome.
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DOI：
10.1371/journal.pone.0015591
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发表时间：
2010-12-22
期刊：
影响因子：
3.7
通讯作者：
Lembo AJ
中科院分区：
文献类型：
--
作者：
Kaptchuk TJ;Friedlander E;Kelley JM;Sanchez MN;Kokkotou E;Singer JP;Kowalczykowski M;Miller FG;Kirsch I;Lembo AJ
安慰剂治疗可显著影响主观症状。然而，人们普遍认为，对安慰剂的反应需要隐瞒或欺骗。我们测试了在肠易激综合征（IBS）的治疗中，开放标签的安慰剂（非欺骗性和非隐藏性给药）是否优于无治疗对照（具有匹配的患者-提供者交互）的上级。在一个学术中心进行的两组、随机、对照3周试验（2009年8月至2010年4月），涉及80例主要为女性（70%）的患者，平均年龄47±18岁，根据罗马III标准诊断为IBS，IBS症状严重程度量表（IBS-SSS）评分≥150。患者被随机分配接受开放标签安慰剂药丸，即“由惰性物质（如糖丸）制成的安慰剂药丸，临床研究表明，这些药丸通过身心自愈过程显着改善IBS症状”或无治疗对照，与提供者的互动质量相同。主要结局是IBS总体改善量表（IBS-GIS）。次要指标为IBS症状严重程度量表（IBS-SSS）、IBS充分缓解（IBS-AR）和IBS生活质量（IBS-QoL）。开放标签安慰剂在11天中点（5.2±1.0 vs. 4.0±1.1，p<0.001）和21天终点（5.0±1.5 vs. 3.9±1.3，p = 0.002）均产生显著更高的平均（±SD）总体改善评分（IBS-GIS）。 在两个时间点也观察到症状严重程度降低（IBS-SSS，p = 0.008和p = 0.03）和充分缓解（IBS-AR，p = 0.02和p = 0.03）的显著结果;在21天终点（p = 0.08）观察到生活质量（IBS-QoL）有利于开放标签安慰剂的趋势。 没有欺骗的安慰剂可能是IBS的有效治疗方法。进一步的研究是必要的IBS，也许其他条件，以阐明医生是否可以受益于患者使用安慰剂与知情同意一致。ClinicalTrials.gov www.example.com
Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and non-concealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS). Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47±18 with IBS diagnosed by Rome III criteria and with a score ≥150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as “placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes” or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL). Open-label placebo produced significantly higher mean (±SD) global improvement scores (IBS-GIS) at both 11-day midpoint (5.2±1.0 vs. 4.0±1.1, p<.001) and at 21-day endpoint (5.0±1.5 vs. 3.9±1.3, p = .002). Significant results were also observed at both time points for reduced symptom severity (IBS-SSS, p = .008 and p = .03) and adequate relief (IBS-AR, p = .02 and p = .03); and a trend favoring open-label placebo was observed for quality of life (IBS-QoL) at the 21-day endpoint (p = .08). Placebos administered without deception may be an effective treatment for IBS. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent. ClinicalTrials.gov NCT01010191
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