Department of Psychiatry & Behavioral Neurosciences, McMaster University, 10b Victoria St S, Kitchener, ON, N2G 1C5, Canada.
Duke University and the Durham Veteran Affairs Medical Center, Durham, NC, USA.
Syst Rev. 2019 May 18;8(1):118. doi: 10.1186/s13643-019-1025-5.
Behavioral and psychological symptoms of dementia (BPSD) are present in a majority of patients with dementia contributing to increased morbidity, health care costs, and caregiver burden. While there are no United States Food and Drug Administration (FDA)-approved medications for these symptoms, off-label use of medications such as antipsychotics have been shown to have significant adverse effects including increased mortality. The goal of this review is to examine the efficacy and safety of anticonvulsants in the treatment of BPSD.
We will systematically search for randomized trials of anticonvulsants compared to placebo or other treatments such as antidepressants and antipsychotics from the following sources: The Cochrane Library, MEDLINE (OVID SP) in Process and Other Non-Indexed Citations (latest version), EMBASE, clinicalTrials.gov , and the WHO Clinical Trials Registry. The studies will be limited to those published in English but the study location can be worldwide. We will include studies pertaining to individuals with dementia and symptoms of BPSD. The primary outcomes will be behavioral change as measured by validated scales and secondary outcomes will include caregiver burden, quality of life, placement in long term care facility, serious adverse effects, and treatment discontinuation due to adverse effects. Two sets of reviewers will independently screen select and extract data. We will narratively describe the major findings and conclusions from individual studies. Patients who are prescribed antiepileptic drugs (AEDs) for other indications, including seizures, will be excluded. Outcomes of interest will include a change in a validated scale that measures BPSD, serious adverse events, and caregiver quality of life outcomes. If the data are found to be appropriate for a meta-analysis, we will use a random effects model to compute summary estimates of treatment effects.
This is a protocol for a systematic review addressing the anticonvulsant group of medications as a whole, and as such, our results will inform current clinical practice in the use of anticonvulsants for BPSD. It will also help clinicians and policy makers compare the efficacy of anticonvulsants compared to antidepressants and antipsychotics as well as identify areas which will need further study.
PROSPERO CRD42017079826.
痴呆患者多数存在行为和心理症状（BPSD），导致发病率增加、医疗保健费用增加和照顾者负担加重。虽然没有美国食品和药物管理局（FDA）批准用于这些症状的药物，但抗精神病药等药物的标签外使用已被证明具有显著的不良反应，包括死亡率增加。本综述的目的是检查抗惊厥药治疗 BPSD 的疗效和安全性。
我们将系统地从以下来源搜索抗惊厥药与安慰剂或其他治疗方法（如抗抑郁药和抗精神病药）比较的随机试验：Cochrane 图书馆、MEDLINE（OVID SP）在处理中和其他非索引引文（最新版本）、EMBASE、clinicalTrials.gov 和世界卫生组织临床试验注册中心。这些研究将仅限于以英语发表的研究，但研究地点可以是全球范围。我们将包括与痴呆症和 BPSD 症状相关的个体的研究。主要结局将是经过验证的量表衡量的行为变化，次要结局将包括照顾者负担、生活质量、长期护理设施安置、严重不良事件以及因不良事件而停药。两组评审员将独立筛选、选择和提取数据。我们将从个别研究中描述主要发现和结论。因其他适应症（包括癫痫发作）而服用抗癫痫药物（AEDs）的患者将被排除在外。感兴趣的结果将包括用于测量 BPSD 的经过验证量表的变化、严重不良事件和照顾者生活质量结果。如果发现数据适合进行荟萃分析，我们将使用随机效应模型计算治疗效果的综合估计值。
这是一项系统评价的方案，针对整个抗惊厥药物组，因此，我们的结果将为 BPSD 抗惊厥药物的当前临床实践提供信息。它还将帮助临床医生和决策者比较抗惊厥药与抗抑郁药和抗精神病药的疗效，并确定需要进一步研究的领域。
PROSPERO CRD42017079826。
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