Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.
Regional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy.
Curr Pharm Des. 2022;28(20):1607-1610. doi: 10.2174/1381612828666220509152029.
Due to the tight link between undertreated pain and agitation in dementia patients, aromatherapy can be a useful approach if an essential oil (EO) with powerful analgesic activity is used. The methodological difficulties of most aromatherapy trials have not allowed any definitive conclusion about the effectiveness of aromatherapy in dementia. The objective of the present perspective is to illustrate the long rigorous process leading from preclinical research to clinical translation of the EO of bergamot (BEO) for the management of agitation in dementia. A nanotechnology-based delivery system consisting of odorless alpha-tocopheryl stearate solid lipid nanoparticles (SLN) loaded with BEO (NanoBEO), has been proven active in acute and neuropathic pain models confirming the strong antinociceptive and anti-allodynic efficacy reported for BEO in preclinical studies. In particular, prolonged physicochemical stability of NanoBEO and titration in its main components are remarkable advantages allowing reproducible antinociceptive and anti-itch responses to be measured. Furthermore, the possibility to perform double-blind clinical trials made impossible so far because of the strong smell of essential oils used in aromatherapy. Demented patients receive limited treatment for chronic pain, particularly neuropathic. The BRAINAID (NCT04321889) trial will assess the effectiveness of NanoBEO on agitation and pain in severely demented patients to offer a safe tool able to provide relief to this fragile population. This double-blind clinical trial will be the first to assess the efficacy and safety of an engineered essential oil and will provide the rationale for the safer treatment of neuropsychiatric symptoms of dementia and pain in clinic.
由于未治疗的疼痛与痴呆症患者的激越之间存在紧密联系，如果使用具有强大镇痛活性的精油，那么芳香疗法可能是一种有用的方法。由于大多数芳香疗法试验存在方法学上的困难，因此无法对芳香疗法在痴呆症中的有效性得出任何明确的结论。本综述的目的是举例说明从临床前研究到临床转化香柠檬（BEO）治疗痴呆症激越的漫长严格过程。一种基于纳米技术的递送系统，由无味的 α-生育酚硬脂酸酯固体脂质纳米粒（SLN）负载 BEO（NanoBEO）组成，已被证明在急性和神经病理性疼痛模型中具有活性，证实了 BEO 在临床前研究中报道的强大的镇痛和抗痛觉过敏作用。特别是，NanoBEO 的延长物理化学稳定性和主要成分的滴定是显著的优势，允许可重复的镇痛和抗瘙痒反应被测量。此外，由于芳香疗法中使用的精油具有强烈的气味，因此目前无法进行双盲临床试验。痴呆患者接受慢性疼痛（特别是神经病理性疼痛）的治疗有限。BRAINAID（NCT04321889）试验将评估 NanoBEO 对严重痴呆患者激越和疼痛的有效性，以提供一种安全的工具，为这一脆弱人群提供缓解。这是首次评估工程精油的疗效和安全性的双盲临床试验，为更安全地治疗痴呆症的神经精神症状和疼痛提供了依据。
