A Double-Blind Placebo-Controlled Randomized Trial of Melissa officinalis Oil and Donepezil for the Treatment of Agitation in Alzheimer's Disease
A Double-Blind Placebo-Controlled Randomized Trial of Melissa officinalis Oil and Donepezil for the Treatment of Agitation in Alzheimer's Disease
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DOI：
10.1159/000324438
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发表时间：
2011-01-01
影响因子：
2.4
通讯作者：
Ballard, Clive
中科院分区：
文献类型：
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作者：
Burns, Alistair;Perry, Elaine;Ballard, Clive
背景/目标：行为和心理症状（BPSD）在阿尔茨海默病患者中很常见，并给患者及其护理人员造成相当大的压力。抗精神病药物已被广泛用作一线治疗，仅在英国就估计有1,800例中风和1,600例死亡。迫切需要安全有效的替代品。根据临床试验的初步证据，蜂花精油芳香疗法可能是这样一种选择，但最初的研究规模不大，充分的盲法一直存在问题。我们的目的是评估蜂花芳香疗法在治疗阿尔茨海默病患者激越方面的疗效，在一项充分的动力和强有力的盲法随机对照试验中将其与多奈哌齐进行比较，多奈哌齐是一种抗胆碱酯酶药物，用于治疗BPSD有一定的益处。方法和发现：这项研究是一项双盲平行组安慰剂对照随机试验，在英格兰的3个老年精神病专科中心进行。受试者可能患有或可能患有阿尔茨海默病，居住在护理院，具有临床显著的激越（定义为Cohen曼斯菲尔德激越量表评分为39分或以上），并且至少2周内未使用抗精神病药和/或抗胆碱酯酶药。参与者被分配到3组中的1组：安慰剂药物和活性芳香疗法;活性药物和安慰剂芳香疗法或两者的安慰剂。主要结局：主要结局指标是4周时通过匹兹堡激越量表（PAS）评估的激越减少。这是一个观察性量表，要求评定者佩戴鼻夹，以确保保持完全盲态。在基线、4周和12周随访时完成PAS、神经精神量表（NPI; BPSD的另一种测量）和其他结局测量。114名参与者被随机分组，其中94名完成了第4周的评估，81名完成了第12周的评估。芳香疗法和多奈哌齐耐受良好。在第4周和第12周，芳香疗法，多奈哌齐和安慰剂之间没有显着差异，但重要的是，所有3组都有实质性改善，PAS改善了18%，NPI改善了37%。结论：当使用严格的设计进行评估，确保治疗组的盲法时，没有证据表明梅丽莎芳香疗法在治疗阿尔茨海默病患者的激动方面上级安慰剂或多奈哌齐。然而，安慰剂组的相当大的改善强调了触摸和互动在治疗阿尔茨海默病患者躁动中的潜在非特异性益处。版权所有（C）2011 S. Karger AG，巴塞尔
Background/Aims: Behavioural and psychological symptoms (BPSD) are frequent in people with Alzheimer's disease and cause considerable stress to patients and their carers. Antipsychotics have been widely used as a first-line treatment, resulting in an estimated 1,800 excess strokes and 1,600 excess deaths in the UK alone. Safe and effective alternatives are urgently needed. Based upon preliminary evidence from clinical trials, aromatherapy with melissa oil may be such an alternative, but initial studies have been modest in size, and adequate blinding has been problematic. Our objective was to assess the efficacy of melissa aromatherapy in the treatment of agitation in people with Alzheimer's disease in an adequately powered and robustly blinded randomized controlled trial comparing it with donepezil, an anticholinesterase drug used with some benefit to treat BPSD. Methods and Findings: The study was a double-blind parallel-group placebo-controlled randomized trial across 3 specialist old age psychiatry centres in England. Participants had probable or possible Alzheimer's disease, were resident in a care home, had clinically significant agitation (defined as a score of 39 or above on the Cohen Mansfield Agitation Inventory) and were free of antipsychotics and/or anticholinesterase for at least 2 weeks. Participants were allocated to 1 of 3 groups: placebo medication and active aromatherapy; active medication and placebo aromatherapy or placebo of both. Main Outcome: The primary outcome measure was reduction in agitation as assessed by the Pittsburgh Agitation Scale (PAS) at 4 weeks. This is an observational scale, and raters were required to wear nose clips to ensure that full blinding was maintained. The PAS, Neuropsychiatric Inventory (NPI; another measure of BPSD) and other outcome measures were completed at baseline, 4-week and 12-week follow-ups. 114 participants were randomized, of whom 94 completed the week 4 assessment and 81 completed the week 12 assessment. Aromatherapy and donepezil were well tolerated. There were no significant differences between aromatherapy, donepezil and placebo at week 4 and week 12, but importantly there were substantial improvements in all 3 groups with an 18% improvement in the PAS and a 37% improvement in the NPI over 12 weeks. Conclusion: When assessed using a rigorous design which ensures blinding of treatment arms, there is no evidence that melissa aromatherapy is superior to placebo or donepezil, in the treatment of agitation in people with Alzheimer's disease. However, the sizeable improvement in the placebo group emphasizes the potential non-specific benefits of touch and interaction in the treatment of agitation in people with Alzheimer's disease. Copyright (C) 2011 S. Karger AG, Basel