The perceived effects of cannabis products in the management of seizures in CDKL5 Deficiency Disorder
The perceived effects of cannabis products in the management of seizures in CDKL5 Deficiency Disorder
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DOI：
10.1016/j.yebeh.2021.108152
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发表时间：
2021-09-02
影响因子：
2.6
通讯作者：
Leonard, Helen
中科院分区：
文献类型：
--
作者：
Dale, Tristan;Downs, Jenny;Leonard, Helen
简介：CDKL5缺乏症（CDD）是一种严重的治疗抵抗性早发性癫痫。目前的治疗方案往往无效，并伴有不良反应，迫使家庭为子女寻求替代疗法，包括大麻衍生产品。奇迹般的治愈和公众对“自然”疗法的偏好的报道引起了公众的极大兴趣，因此本研究旨在描述这些人使用大麻的特征，并将护理人员对疗效和安全性的看法与癫痫控制的客观证据和使用的抗癫痫药物数量进行比较。研究方法：来自国际CDKL5疾病数据库的家庭被邀请填写问卷，其中包括与他们孩子当前和过去治疗有关的数据，包括使用任何大麻衍生制剂。报告了对癫痫控制的感知效果以及其他获益和不良反应。癫痫发作频率和抗癫痫药物的数量之间进行了比较，积极使用大麻产品和那些谁没有。对研究人群的一个子集进行纵向分析，以比较治疗前和治疗后时间点的这些相同变量。结果：312名护理人员回答了有关孩子使用抗癫痫药物的问题。其中，82人（26%）描述了目前或过去使用大麻制剂，最常见的是大麻二酚。在70名描述其对癫痫控制的感知效果的护理人员中，超过三分之二的人报告癫痫控制有所改善，无论是暂时的（16%）还是持久的（54%）。其他益处包括注意力、认知和睡眠的改善。大多数应答（78%）将不良反应描述为“无”，尽管一些应答报告镇静和胃肠道不适增加。对于那些积极使用大麻产品的人来说，与那些没有使用大麻产品的人相比，癫痫发作频率中位数和不同抗癫痫药物的数量都没有减少。同样，在初始时间点未使用大麻产品的人在开始使用这种治疗的第二个时间点的癫痫发作频率和抗癫痫药物数量没有差异。结论：虽然这是一项观察性研究，但由于潜在的参与偏倚和非盲自我评估的不可靠性，它表明护理人员认为大麻产品，特别是大麻二酚，具有可耐受的不良反应特征和足够的疗效。尽管如此，与非使用者相比或与治疗前相比，大麻与癫痫发作频率和抗癫痫药物数量的减少无关。迫切需要随机对照试验来更可靠地评估这种治疗的安全性和有效性。(c)2021爱思唯尔公司All rights reserved.
Introduction: CDKL5 Deficiency Disorder (CDD) is a severe treatment-resistant form of early-onset epilepsy. Current treatment options are often ineffective and associated with adverse effects, forcing families to seek alternative therapies for their children including products derived from cannabis. Reports of miraculous cures and a public preference for 'natural' therapies have resulted in considerable public interest, and so this study aimed to characterize the use of cannabis in these individuals, as well as compare caregiver perceptions of efficacy and safety to objective evidence of seizure control and number of antiepileptic drugs used. Methods: Families from the International CDKL5 Disorder Database were invited to complete questionnaires which included data relating to their child's current and past treatments, including use of any cannabis-derived preparations. Perceived effects on seizure control, as well as additional benefits and adverse effects were reported. Seizure frequency and number of antiepileptic drugs were compared between those actively using cannabis products and those who were not. Longitudinal analysis was performed on a subset of the study population to compare these same variables at pre-treatment and posttreatment time points. Results: Three hundred and twelve caregivers answered questions regarding their child's use of antiepileptic medications. Of these, 82 (26%) described use of cannabis preparations either at present, or in the past, with the most common being cannabidiol. Of 70 caregivers that described their perceived effect on seizure control, more than two thirds reported an improvement in seizure control, either temporary (16%) or lasting (54%). Additional benefits included improvements in attention, cognition, and sleep. The majority of responses (78%) described adverse effects as 'none', though some reported an increase in sedation and gastrointestinal upset. There was no reduction in the median seizure frequency nor the number of different antiepileptic drugs, for those who were actively using cannabis products compared to those who were not. Similarly, individuals who were not using cannabis products at an initial time point had no differences in seizure frequency nor number of antiepileptic drugs at a second timepoint when they had started using this treatment. Conclusions: Although this is an observational study, limited by potential participation bias and the unreliable nature of unblinded self-assessment, it suggests that caregivers perceive cannabis products, especially cannabidiol, to have a tolerable adverse effect profile and adequate efficacy. Despite this, cannabis was not associated with a reduction in seizure frequency nor number of antiepileptic drugs when compared to non-users or when compared to pre-treatment. Randomized controlled trials are urgently needed to more reliably assess this treatment's safety and efficacy. (c) 2021 Elsevier Inc. All rights reserved.