Altered placebo and drug labeling changes the outcome of episodic migraine attacks.

Altered placebo and drug labeling changes the outcome of episodic migraine attacks.
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DOI:
10.1126/scitranslmed.3006175
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发表时间:
2014-01-08
影响因子:
17.1
通讯作者:
Burstein R
Burstein R
中科院分区:
医学1区
文献类型:
--
作者:
Kam-Hansen S;Jakubowski M;Kelley JM;Kirsch I;Hoaglin DC;Kaptchuk TJ;Burstein R

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提供给患者的信息被认为会影响安慰剂和药物效应。我们在一项发作性偏头痛的前瞻性、受试者内、重复测量研究中调查了治疗标签与其结果之间的潜在关系。一个由66名参与者组成的队列记录了7次单独的偏头痛发作:一次未经治疗的发作,随后随机分配6次发作,分别接受利扎曲普坦(10 mg Maxalt)或安慰剂治疗,每种治疗一次标记为“Maxalt”,一次标记为“安慰剂”,一次标记为“Maxalt或安慰剂”(459次记录发作)。采用广义线性混合模型统计分析数据。虽然Maxalt通常上级于安慰剂,但安慰剂效应和Maxalt疗效(在较小程度上)随治疗标签单调增加,如下所示:"安慰剂"标签<"Maxalt或安慰剂"标签≤ "Maxalt"标签。误标为安慰剂的Maxalt的疗效与误标为Maxalt的安慰剂的疗效无显著差异。在每种标记条件下,安慰剂效应相对于无治疗是显著的,在相应的标记条件下,安慰剂效应的大小达到大于Maxalt效应的50%。因此,在偏头痛发作期间,安慰剂和药物治疗的"积极"信息增量产生增量疗效。
Information provided to patients is thought to influence placebo and drug effects. We investigated the potential relationship between treatment labeling and its outcome in a prospective, within-subjects, repeated measures study of episodic migraine. A cohort of 66 participants documented 7 separate migraine attack: one untreated attack, followed by six attacks that were randomly assigned for either rizatriptan (10 mg Maxalt) or placebo treatments, each of which labeled once as ‘Maxalt’, once as ‘Placebo’, and once as ‘Maxalt or Placebo’ (459 documented attacks). Data were analyzed using generalized linear mixed model statistics. While Maxalt was generally superior to placebo, the placebo effect, and to a lesser extent Maxalt efficacy, increased monotonically with treatment labeling as follows: ‘Placebo’ label < ‘Maxalt or placebo’ label ≤ ‘Maxalt’ label. Efficacy of Maxalt mislabeled as placebo was not significantly different from the efficacy of placebo mislabeled as Maxalt. The placebo effect was significant under each labeling condition relative to no treatment, amounting in magnitude to >50% of Maxalt effect under the corresponding labeling condition. Thus, incremental “positive” information yielded incremental efficacy of placebo and medication during migraine attacks.
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