Department of Oriental Neuropsychiatry, Dong-eui University College of Korean Medicine, Busanjin-gu, Busan.
Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon, Republic of Korea.
Medicine (Baltimore). 2021 Feb 12;100(6):e24341. doi: 10.1097/MD.0000000000024341.
Dementia is a major mental health problem worldwide, and an optimal anti-dementia drug that could modify its core symptoms has not been developed yet. Behavioral and psychological symptoms of dementia (BPSD), an important clinical manifestation of dementia, is closely related to disease burden, caregiver burden, and consequent social burden. In general, many experts and international guidelines prefer non-pharmacological interventions, including psychosocial intervention, and complementary and integrative medicine in the management of BPSD. However, in clinical settings, psychotropic drugs are frequently used; therefore, the need to establish and actively use effective non-pharmacological interventions is emphasized. Therefore, in this systematic review, we will evaluate the effectiveness and safety of acupuncture, a promising non-pharmacological complementary and integrative medicine, for BPSD.
A comprehensive search will be conducted in 13 electronic medical databases. Regardless of its design, original clinical studies, such as randomized controlled clinical trials, nonrandomized controlled clinical trials, and before-after studies, will be included to assess the beneficial effects and safety of acupuncture on BPSD. The severity of BPSD symptoms assessed by the validated tool will be considered as a primary outcome. The secondary outcome included the total effective rate, daily living activities and quality of life of patients, burden and quality of life of caregiver, placement in a long-term care facility from home, and safety data. The study selection, data extraction, and quality assessment process were performed by 2 independent researchers. The methodological quality of the included studies will be assessed using validated tools according to its design, such as the Cochrane Collaboration's risk of bias tool. RevMan version 5.3 will be used to perform the meta-analysis, with mean differences for continuous outcomes and risk ratio for binary outcomes, and 95% confidence intervals. A fixed- or random-effects model will be used according to the heterogeneity and number of included studies.
As this protocol is for a systematic review, ethical approval is not required. The results of the systematic review will be disseminated by the publication of a manuscript in a peer-reviewed journal or presentation at a relevant conference.
OSF (URL: https://osf.io/hu5ac), PROSPERO (CRD42020211005) (URL: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020211005).
痴呆是全球范围内一个主要的精神健康问题，目前尚未开发出能够改善其核心症状的最佳抗痴呆药物。痴呆的行为和心理症状（BPSD）是痴呆的一个重要临床表现，与疾病负担、照顾者负担以及随之而来的社会负担密切相关。一般来说，许多专家和国际指南都倾向于在 BPSD 的管理中使用非药物干预措施，包括心理社会干预和补充与整合医学。然而，在临床环境中，精神药物经常被使用；因此，强调需要建立和积极使用有效的非药物干预措施。因此，在本次系统评价中，我们将评估针灸作为一种有前途的非药物补充与整合医学方法，对 BPSD 的有效性和安全性。
将在 13 个电子医学数据库中进行全面检索。无论其设计如何，只要是原始的临床研究，如随机对照临床试验、非随机对照临床试验和前后对照研究，都将被纳入，以评估针灸对 BPSD 的有益效果和安全性。将使用经过验证的工具评估 BPSD 症状严重程度作为主要结局。次要结局包括患者 BPSD 症状的总有效率、日常生活活动和生活质量、照顾者负担和生活质量、从家中安置在长期护理机构以及安全性数据。研究选择、数据提取和质量评估过程由 2 名独立研究人员进行。将根据研究设计，如 Cochrane 协作风险偏倚工具，使用经过验证的工具评估纳入研究的方法学质量。RevMan 版本 5.3 将用于进行荟萃分析，连续结果采用均数差，二分类结果采用风险比，95%置信区间。根据异质性和纳入研究数量，将使用固定或随机效应模型。
由于本方案是系统评价，因此不需要伦理批准。系统评价的结果将通过在同行评议期刊上发表文章或在相关会议上发表报告来传播。
