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裸盖菇素治疗饮食失调:文献及注册临床试验的系统评价

Psilocybin in the treatment of eating disorders: a systematic review of the literature and registered clinical trials.

作者信息

Bevione Francesco, Lacidogna Maria Carla, Lavalle Raffaele, Abbate Daga Giovanni, Preti Antonio

机构信息

Department of Neuroscience, University of Turin, Via Cherasco 15, 10126, Turin, Italy.

出版信息

Eat Weight Disord. 2025 Jul 29;30(1):58. doi: 10.1007/s40519-025-01771-y.

Abstract

BACKGROUND

Fluoxetine remains the only pharmacological treatment approved for Bulimia Nervosa, and no other drugs have been approved for eating disorders (EDs). The rationale for exploring psilocybin as a treatment for EDs is compelling, both from biological and psychological perspectives. Moreover, its safety profile in healthy individuals appears favorable. This systematic review aims to examine original research articles and registered clinical trials to assess the current psilocybin's therapeutic potential in EDs.

METHODS

Systematic review following the indications of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched PubMed, Excerpta Medica Database (EMBASE), and the Cochrane Library from inception until 29 July 2024, with key terms: "psilocybin" and "eating disorders". Quality was assessed through the Quality Assessment Tool for Before-After (Pre-Post) Studies With No Control Group released by the National Heart, Lung, and Blood Institute (NHLBI). We performed an additional search on the registry of clinical trials available at the website https://clinicaltrials.gov .

RESULTS

Two studies met the inclusion criteria for our analysis. The first was an open-label feasibility study involving 10 individuals with Anorexia Nervosa (AN), without a control group. The second was a single case report describing the use of psilocybin in a person with AN. In addition, six registered clinical trials of psilocybin in individuals with EDs were identified.

CONCLUSIONS

The initial evidence shows that psilocybin might be safe and well-tolerated in AN. The promising results and the need for tests in enlarged samples encourage further research on psilocybin in EDs.

LEVEL OF EVIDENCE VIII

Evidence from nonrandomized controlled clinical trials, nonrandomized clinical trials, cohort studies, case series, case reports, and individual qualitative studies.

摘要

背景

氟西汀仍然是唯一被批准用于治疗神经性贪食症的药物治疗方法,尚无其他药物被批准用于治疗饮食失调症(EDs)。从生物学和心理学角度来看,探索裸盖菇素作为饮食失调症治疗方法的基本原理都很有说服力。此外,其在健康个体中的安全性似乎良好。本系统评价旨在审查原始研究文章和注册临床试验,以评估目前裸盖菇素在饮食失调症中的治疗潜力。

方法

按照系统评价和Meta分析的首选报告项目(PRISMA)指南的指示进行系统评价。我们从数据库创建至2024年7月29日在PubMed、医学文摘数据库(EMBASE)和Cochrane图书馆进行检索,关键词为:“裸盖菇素”和“饮食失调症”。通过美国国立心肺血液研究所(NHLBI)发布的无对照组前后研究质量评估工具对质量进行评估。我们还在网站https://clinicaltrials.gov上的临床试验注册库中进行了额外检索。

结果

两项研究符合我们分析的纳入标准。第一项是一项开放标签可行性研究,涉及10名神经性厌食症(AN)患者,无对照组。第二项是一篇单病例报告,描述了一名神经性厌食症患者使用裸盖菇素的情况。此外,还确定了六项裸盖菇素在饮食失调症个体中的注册临床试验。

结论

初步证据表明,裸盖菇素在神经性厌食症中可能是安全且耐受性良好的。这些有前景的结果以及对扩大样本进行测试的需求鼓励对裸盖菇素在饮食失调症中的应用进行进一步研究。

证据水平VIII:来自非随机对照临床试验、非随机临床试验、队列研究、病例系列、病例报告和个体定性研究的证据。

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