Prospect Clinic for Otorhinolaryngology & Neurology, Kaohsiung, Taiwan.
Institute of Biomedical Sciences, National Sun Yat-sen University, Kaohsiung, Taiwan.
Curr Neuropharmacol. 2022;20(10):1816-1833. doi: 10.2174/1570159X20666220420122322.
While Alzheimer's dementia (AD) has a prevalence as high as 3-32% and is associated with cognitive dysfunction and the risk of institutionalization, no efficacious and acceptable treatments can modify the course of cognitive decline in AD. Potential benefits of exogenous melatonin for cognition have been divergent across trials.
The current network meta-analysis (NMA) was conducted under the frequentist model to evaluate the potential beneficial effects of exogenous melatonin supplementation on overall cognitive function in participants with AD in comparison to other FDA-approved medications (donepezil, galantamine, rivastigmine, memantine, and Namzaric).
The primary outcome was the changes in the cognitive function [measured by mini-mental state examination (MMSE)] after treatment in patients with Alzheimer's dementia. The secondary outcomes were changes in the quality of life, behavioral disturbance, and acceptability (i.e., drop-out due to any reason and rate of any adverse event reported).
The current NMA of 50 randomized placebo-controlled trials (RCTs) revealed the medium-term lowdose melatonin to be associated with the highest post-treatment MMSE (mean difference = 1.48 in MMSE score, 95% confidence intervals [95% CIs] = 0.51 to 2.46) and quality of life (standardized mean difference = -0.64, 95% CIs = -1.13 to -0.15) among all of the investigated medications in the participants with AD. Finally, all of the investigated exogenous melatonin supplements were associated with similar acceptability as was the placebo.
The current NMA provides evidence for the potential benefits of exogenous melatonin supplementation, especially medium-term low-dose melatonin, in participants with AD.
阿尔茨海默病（AD）的患病率高达 3-32%，与认知功能障碍和住院风险相关，但目前尚无有效的、可接受的治疗方法可以改变 AD 患者的认知衰退进程。外源性褪黑素对认知功能的潜在益处在不同试验中存在差异。
本研究采用频率论模型进行网络荟萃分析（NMA），以评估外源性褪黑素补充剂与其他经美国食品药品监督管理局（FDA）批准的药物（多奈哌齐、加兰他敏、利斯的明、美金刚和 Namzaric）相比，对 AD 患者整体认知功能的潜在有益作用。
主要结局是 AD 患者治疗后认知功能（采用简易精神状态检查量表（MMSE）测量）的变化。次要结局是生活质量、行为障碍和可接受性（即因任何原因停药和报告任何不良事件的发生率）的变化。
本研究纳入了 50 项随机安慰剂对照试验（RCT）的 NMA 结果显示，中剂量褪黑素与 AD 患者治疗后 MMSE 评分最高（MMSE 评分差值=1.48，95%置信区间[95%CI]：0.51 至 2.46）和生活质量改善（标准化均数差值=-0.64，95%CI：-1.13 至 -0.15）相关。最后，所有研究的外源性褪黑素补充剂与安慰剂的可接受性相似。
本 NMA 提供了外源性褪黑素补充剂，尤其是中剂量褪黑素补充剂对 AD 患者潜在益处的证据。
