养老院痴呆老年人的针刺治疗：一项评估者盲法随机对照试验。
完整摘要 · 中文译文
背景：痴呆损害老年人的心理健康，并造成显著的照护者负担。本研究旨在评估针刺在管理痴呆老年人认知衰退及相关症状方面的有效性和安全性。 方法：在一项评估者盲法、随机对照试验中，从中国香港19家当地安老院舍招募符合条件的参与者，招募时间为2021年10月5日至2024年8月27日。118名参与者被随机分配至针刺组和常规照护对照组（每组n=59），干预12周。分析基于意向性治疗人群。主要结局为蒙特利尔认知评估（MoCA）评分从基线至终点的平均变化。次要结局包括功能独立性、疼痛、抑郁和睡眠症状。 结果：85.6%（101/118）的参与者完成了研究。主要结局MoCA在第12周未见显著改善。亚组分析显示，针刺对MoCA的治疗效果在不同痴呆严重程度分层间似乎存在差异。针刺在改善功能独立性方面优于对照组（中文版改良Barthel指数，平均差=4.12，95%置信区间=0.81，7.44，P=0.015；标准化效应量=0.29）。所有治疗相关不良事件均为轻度，并报告了2例非治疗相关死亡病例。 结论：虽然未观察到对认知功能的显著影响，但针刺与功能独立性的改善相关，且对认知的治疗效果 可能在不同痴呆严重程度分层中存在差异。这需要进一步验证这些探索性结果，以识别出可从针刺改善认知功能中获得更多益处的痴呆老年亚群。 试验注册：www.ClinicalTrials.gov：NCT04305951，注册日期：2020年3月10日。
完整摘要 · 英文原文
BACKGROUND: Dementia harms the mental health of older adults and poses a significant caregiver burden. This study aimed to evaluate the effectiveness and safety of acupuncture in managing cognitive decline and related symptoms in older adults with dementia. METHODS: Eligible participants were recruited from 19 local residential care homes for older people in Hong Kong, China, from 5 October 2021 to 27 August 2024, in an assessor-blinded, randomised controlled trial. 118 participants were randomised to acupuncture and care-as-usual control (n=59 in each group) for 12 weeks. The analyses were on the intention-to-treat population. The primary outcome was the mean baseline-to-endpoint change of the Montreal Cognitive Assessment (MoCA) score. Secondary outcomes included the functional independence, pain, depressive and sleep symptoms. RESULTS: 85.6% (101/118) of participants completed the study. The primary outcome, MoCA, was not significantly improved in week 12. Subgroup analyses showed that the treatment effect on MoCA appeared to differ across dementia severity strata. Acupuncture was superior over control in improving functional independence (the Chinese version of the Modified Barthel Index, mean difference=4.12, 95% confidence interval=0.81, 7.44, P=0.015; standardised effect size=0.29). All treatment-related adverse events were mild, and 2 nontreatment-related death cases were reported. CONCLUSIONS: While no significant effect in cognitive function was observed, acupuncture was associated with an improvement in functional independence, and the treatment effect on cognition might differ across dementia severity strata. This warrants further validation of the exploratory results, identifying a subpopulation of older adults with dementia who could gain more benefits from acupuncture in improving cognitive function. TRIAL REGISTRATION: www.ClinicalTrials.gov: NCT04305951, date of registration: 10/03/2020.