目的:评估使用迷幻药和艾司西酞普兰口服单药治疗抑郁症状的疗效和可接受性。考虑到由于不成功的致盲而可能高估的有效性。
方法:系统评价和贝叶斯网络荟萃分析。
方法:Medline,Cochrane中央控制试验登记册,Embase,PsycINFO,ClinicalTrial.gov,和世界卫生组织的国际临床试验注册平台从数据库开始到2023年10月12日。
方法:在有抑郁症状的成人中使用迷幻药或艾司西酞普兰的随机对照试验。迷幻药(3,4-亚甲二氧基甲基苯丙胺(称为MDMA)的合格随机对照试验,麦角酰二乙胺(称为LSD),psilocybin,或ayahuasca)需要口服单一疗法,不同时使用抗抑郁药。
方法:主要结果是抑郁症的变化,由17项汉密尔顿抑郁量表测量。次要结果是全部原因停药和严重不良事件。严重不良事件是指导致任何一系列负面健康结果的事件,包括:死亡,入院,严重或持续的丧失工作能力,先天性出生缺陷或异常,和自杀企图。在贝叶斯框架内使用随机效应模型汇集数据。为了避免估计偏差,安慰剂反应在迷幻和抗抑郁试验之间有区别.
结果:迷幻药试验的安慰剂反应低于艾司西酞普兰的抗抑郁试验(平均差-3.90(95%可信区间-7.10至-0.96))。尽管在迷幻药试验中大多数迷幻药比安慰剂更好,在艾司西酞普兰的抗抑郁试验中,只有高剂量的psilocybin优于安慰剂(平均差6.45(3.19~9.41)).然而,当参考组从迷幻试验中的安慰剂反应转变为抗抑郁试验时,高剂量裸盖菇素的效应大小(标准化平均差异)从大(0.88)降至小(0.31).高剂量psilocybin的相对效果大于10mg(4.66(95%可信区间1.36至7.74))和20mg(4.69(1.64至7.54))的艾司西酞普兰。与安慰剂相比,没有任何干预措施与更高的全因停药或严重不良事件相关。
结论:在抑郁症状的可用迷幻疗法中,在抗抑郁试验中,用大剂量裸盖菇素治疗的患者比用安慰剂治疗的患者表现出更好的反应,但是效果很小。
背景:PROSPERO,CRD42023469014。
To evaluate the comparative effectiveness and acceptability of oral monotherapy using psychedelics and
escitalopram in patients with depressive symptoms, considering the potential for overestimated effectiveness due to unsuccessful blinding.
Systematic review and Bayesian network meta-analysis.
Medline, Cochrane Central Register of Controlled Trials, Embase, PsycINFO, ClinicalTrial.gov, and World Health Organization\'s International Clinical Trials Registry Platform from database inception to 12 October 2023.
Randomised controlled trials on psychedelics or
escitalopram in adults with depressive symptoms. Eligible randomised controlled trials of psychedelics (3,4-methylenedioxymethamphetamine (known as MDMA), lysergic acid diethylamide (known as LSD), psilocybin, or ayahuasca) required oral monotherapy with no concomitant use of antidepressants.
The primary outcome was change in depression, measured by the 17-item Hamilton depression rating scale. The secondary outcomes were all cause discontinuation and severe adverse events. Severe adverse events were those resulting in any of a list of negative health outcomes including, death, admission to hospital, significant or persistent incapacity, congenital birth defect or abnormality, and suicide attempt. Data were pooled using a random effects model within a Bayesian framework. To avoid estimation bias, placebo responses were distinguished between psychedelic and antidepressant trials.
Placebo response in psychedelic trials was lower than that in antidepression trials of
escitalopram (mean difference -3.90 (95% credible interval -7.10 to -0.96)). Although most psychedelics were better than placebo in psychedelic trials, only high dose psilocybin was better than placebo in antidepression trials of
escitalopram (mean difference 6.45 (3.19 to 9.41)). However, the effect size (standardised mean difference) of high dose psilocybin decreased from large (0.88) to small (0.31) when the reference arm changed from placebo response in the psychedelic trials to antidepressant trials. The relative effect of high dose psilocybin was larger than
escitalopram at 10 mg (4.66 (95% credible interval 1.36 to 7.74)) and 20 mg (4.69 (1.64 to 7.54)). None of the interventions was associated with higher all cause discontinuation or severe adverse events than the placebo.
Of the available psychedelic treatments for depressive symptoms, patients treated with high dose psilocybin showed better responses than those treated with placebo in the antidepressant trials, but the effect size was small.
PROSPERO, CRD42023469014.