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对目前正在进行的探索大麻二酚可能的抗焦虑作用的临床试验的综述。

Review of the current ongoing clinical trials exploring the possible anti-anxiety effects of cannabidiol.

作者信息

Bhuller Rhenu, Schlage Walter K, Hoeng Julia

机构信息

Vectura Fertin Pharma Switzerland SA, Avenue de Rhodanie 50, Lausanne, 1007, Switzerland.

, Biology Consultant, Max-Baermann-Strasse 21, Bergisch Gladbach, 51429, Germany.

出版信息

J Cannabis Res. 2024 Oct 12;6(1):40. doi: 10.1186/s42238-024-00250-y.

DOI:10.1186/s42238-024-00250-y
PMID:39394179
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11481052/
Abstract

BACKGROUND

Anxiety disorders (ADs) are a complex group of mental disorders and majorly contribute to the global health-related burden. Symptoms and clinical management differ widely depending on the specific diagnosis. There is a need for new, more effective pharmacological treatments for these patients as many patients do not respond to treatment and treatment is not available for several types of AD. The increased interest in the potential effects of cannabidiol (CBD) on symptoms of AD has led to several preclinical and clinical studies that suggest that CBD may be effective in some patients with AD. However, it remains unclear whether and how CBD can be used in the clinical management of ADs due to a lack of sufficiently robust clinical evidence.

COMPARATIVE EVALUATION

This narrative review provides a critical analysis of the current state of the art for ADs and summarizes six recently completed and 22 currently ongoing clinical trials investigating the effects of CBD on ADs or anxiety. The aim was to examine whether the ongoing trials are likely to provide the necessary solid evidence, or whether new studies with more robust design parameters can help to overcome the prevailing lack of solid clinical data for this CBD indication. Most of the trials reviewed are considered exploratory and do not focus on specific types of clinical anxiety or ADs as the primary condition studied. Participant numbers, CBD dose, treatment duration, and CBD formulation vary widely among the studies, and all but two are single-center studies.

CONCLUSION

For an effective clinical management of ADs using CBD, there is a need for sufficiently powered and appropriately designed clinical trials (RCT, multicenter, defined doses and exposure monitoring, robust primary outcomes) investigating the effect of CBD in specific ADs, such as social anxiety disorder and panic disorder, or in post-traumatic stress disorder.

摘要

背景

焦虑症是一组复杂的精神障碍,是全球健康相关负担的主要成因。症状和临床管理因具体诊断而异。由于许多患者对治疗无反应且几种类型的焦虑症尚无可用治疗方法,因此需要为这些患者开发新的、更有效的药物治疗方法。大麻二酚(CBD)对焦虑症症状潜在影响的关注度不断提高,引发了多项临床前和临床研究,这些研究表明CBD可能对部分焦虑症患者有效。然而,由于缺乏足够有力的临床证据,CBD能否以及如何用于焦虑症的临床管理仍不明确。

比较评估

本叙述性综述对焦虑症的当前技术水平进行了批判性分析,并总结了六项最近完成以及22项正在进行的研究CBD对焦虑症或焦虑影响的临床试验。目的是研究正在进行的试验是否可能提供必要的确凿证据,或者具有更强有力设计参数的新研究是否有助于克服目前该CBD适应症缺乏确凿临床数据的问题。所审查的大多数试验被认为是探索性的,并未将特定类型的临床焦虑或焦虑症作为主要研究病症。各项研究中的参与者数量、CBD剂量、治疗持续时间和CBD制剂差异很大,除两项研究外均为单中心研究。

结论

为了使用CBD对焦虑症进行有效的临床管理,需要开展有足够效力且设计合理的临床试验(随机对照试验、多中心、确定剂量和暴露监测、有力的主要结局指标),以研究CBD对特定焦虑症的影响,如社交焦虑症、恐慌症或创伤后应激障碍。