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首页> 外文期刊>EBioMedicine >Do You Believe It? Verbal Suggestions Influence the Clinical and Neural Effects of Escitalopram in Social Anxiety Disorder: A Randomized Trial
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Do You Believe It? Verbal Suggestions Influence the Clinical and Neural Effects of Escitalopram in Social Anxiety Disorder: A Randomized Trial

机译：你相信吗？言语建议影响依西酞普兰在社交焦虑症中的临床和神经作用：一项随机试验

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Background: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed for depression and anxiety, but their efficacy relative to placebo has been questioned. We aimed to test how manipulation of verbally induced expectancies, central for placebo, influences SSRI treatment outcome and brain activity in patients with social anxiety disorder (SAD). Methods: We did a randomized clinical trial, within an academic medical center (Uppsala, Sweden), of individuals fulfilling the DSM-IV criteria for SAD, recruited through media advertising. Participants were 18years or older and randomized in blocks, through a computer-generated sequence by an independent party, to nine weeks of overt or covert treatment with escitalopram (20mg daily). The overt group received correct treatment information whereas the covert group was treated deceptively with the SSRI described, by the psychiatrist, as active placebo. The treating psychiatrist was necessarily unmasked while the research staff was masked from intervention assignment. Treatment efficacy was assessed primarily with the self-rated Liebowitz Social Anxiety Scale (LSAS-SR), administered at week 0, 1, 3, 6 and 9, also yielding a dichotomous estimate of responder status (clinically significant improvement). Before and at the last week of treatment, brain activity during an emotional face-matching task was assessed with functional magnetic resonance imaging (fMRI) and during fMRI sessions, anticipatory speech anxiety was also assessed with the Spielberger State-Trait Anxiety Inventory - State version (STAI-S). Analyses included all randomized patients with outcome data at posttreatment. This study is registered at ISRCTN, number 98890605. Findings: Between March 17th 2014 and May 22nd 2015, 47 patients were recruited. One patient in the covert group dropped out after a few days of treatment and did not provide fMRI data, leaving 46 patients with complete outcome data. After nine weeks of treatment, overt (n=24) as compared to covert (n=22) SSRI administration yielded significantly better outcome on the LSAS-SR (adjusted difference 21.17, 95% CI 10.69-31.65, p<0.0001) with more than three times higher response rate (50% vs. 14%; @g^2(1)=6.91, p=0.009) and twice the effect size (d=2.24 vs. d=1.13) from pre-to posttreatment. There was no significant between-group difference on anticipatory speech anxiety (STAI-S), both groups improving with treatment. No serious adverse reactions were recorded. On fMRI outcomes, there was suggestive evidence for a differential neural response to treatment between groups in the posterior cingulate, superior temporal and inferior frontal gyri (all z thresholds exceeding 3.68, p@?0.001). Reduced social anxiety with treatment correlated significantly with enhanced posterior cingulate (z threshold 3.24, p=0.0006) and attenuated amygdala (z threshold 2.70, p=0.003) activity. Interpretation: The clinical and neural effects of escitalopram were markedly influenced by verbal suggestions. This points to a pronounced placebo component in SSRI-treatment of SAD and favors a biopsychosocial over a biomedical explanatory model for SSRI efficacy. Funding resources: The Swedish Research Council for Working Life and Social Research (grant 2011-1368), the Swedish Research Council (grant 421-2013-1366), Riksbankens Jubileumsfond - the Swedish Foundation for Humanities and Social Sciences (grant P13-1270:1).
机译：背景：选择性5-羟色胺再摄取抑制剂（SSRIs）通常用于抑郁症和焦虑症，但相对于安慰剂，其有效性受到质疑。我们的目的是测试对社交焦虑症（SAD）患者的言语诱发的期望值（安慰剂中心）的操作如何影响SSRI治疗结果和大脑活动。方法：我们在学术医学中心（瑞典乌普萨拉）进行了一项随机临床试验，该试验通过媒体广告招募了符合SAD的DSM-IV标准的个体。参加者年龄在18岁或以上，通过独立方通过计算机生成的顺序随机分组进行艾司西酞普兰（每天20mg）的公开或秘密治疗，持续9周。公开组接受了正确的治疗信息，而隐匿组接受了精神科医生描述为主动安慰剂的SSRI的欺骗性治疗。治疗人员必须被遮盖，而研究人员则无法进行干预分配。主要使用自我评估的利勃维茨社交焦虑量表（LSAS-SR）评估治疗效果，该量表在第0、1、3、6和9周给药，也得出了对反应者状态的二分估计（临床上显着改善）。在治疗前和治疗的最后一周，使用功能磁共振成像（fMRI）评估了情绪面部匹配任务期间的大脑活动，并且在fMRI会话期间，还使用了Spielberger状态-特质焦虑量表-状态版本评估了预期的言语焦虑。 （STAI-S）。分析包括所有随机患者的治疗后结果数据。该研究在ISRCTN上注册，编号98890605。结果：在2014年3月17日至2015年5月22日之间，共招募了47位患者。隐蔽组中的一名患者经过几天的治疗后退出了研究，没有提供功能磁共振成像数据，使46名患者获得了完整的结局数据。治疗9周后，与秘密（n = 22）相比，公开（n = 24）SSRI给药在LSAS-SR上产生了明显更好的结局（校正差21.17，95％CI 10.69-31.65，p <0.0001），并且比治疗前至治疗后的反应率高三倍（50％比14％; @ g ^ 2（1）= 6.91，p = 0.009）和两倍的效果大小（d = 2.24比d = 1.13）。预期言语焦虑（STAI-S）在组间无显着差异，两组均随治疗而改善。没有记录到严重的不良反应。在功能磁共振成像的结果上，有迹象表明后扣带回，颞上回和额下回回的组之间对治疗的神经反应不同（所有z阈值均超过3.68，p @ 0.001）。社交焦虑的降低与治疗后扣带回的增强（z阈值3.24，p = 0.0006）和杏仁核减弱（z阈值2.70，p = 0.003）显着相关。解释：依他普仑的临床和神经作用受到口头建议的明显影响。这表明SSRI治疗SAD时有明显的安慰剂成分，并且比SSRI疗效的生物医学解释模型更倾向于生物心理疗法。资金来源：瑞典工作生活和社会研究研究委员会（2011-1368拨款），瑞典研究委员会（421-2013-1366拨款），Riksbankens Jubileumsfond-瑞典人文与社会科学基金会（P13-1270拨款： 1）。

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