Evidence map›Paper›PMID 33809385›Full record

ArticlePharmaceutics2021

Development and Translation of NanoBEO, a Nanotechnology-Based Delivery System of Bergamot Essential Oil Deprived of Furocumarins, in the Control of Agitation in Severe Dementia.

Damiana Scuteri, Roberta Cassano, Sonia Trombino, Rossella Russo, Hirokazu Mizoguchi, Chizuko Watanabe, Kengo Hamamura, Soh Katsuyama, Takaaki Komatsu, Luigi Antonio Morrone and 9 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04321889 (Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Defurocumarinized Bergamot Loaded in a Nanotechnological System for the Release of Essential Oil in the Treatment of Agitation in Severe Dementia Patients.), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
4.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04321889 naunknown statusnot on this map

Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Defurocumarinized Bergamot Loaded in a Nanotechnological System for the Release of Essential Oil in the Treatment of Agitation in Severe Dementia Patients.

TypeinterventionalSponsorS.Anna Rehabilitation InstituteRan2020 to 2021Enrolled134ConditionsSevere Dementia, StrokeArmsdefurocumarinized bergamot loaded in a nanotechnological essential oil release system, Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 6 institutions in 3 countries.

Damiana ScuteriPharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.ORCID 0000-0001-5846-7058
Roberta CassanoDepartment of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.ORCID 0000-0001-6980-6799
Sonia TrombinoDepartment of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.
Rossella RussoPreclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.ORCID 0000-0001-8758-6523
Hirokazu MizoguchiDepartment of Physiology and Anatomy, Tohoku Pharmaceutical University, 981-8558 Sendai, Japan.
Chizuko WatanabeDepartment of Physiology and Anatomy, Tohoku Pharmaceutical University, 981-8558 Sendai, Japan.
Kengo HamamuraDepartment of Pharmacology, Daiichi University of Pharmacy, 815-8511 Fukuoka, Japan.ORCID 0000-0001-9146-8554
Soh KatsuyamaDepartment of Physiology and Anatomy, Tohoku Pharmaceutical University, 981-8558 Sendai, Japan.
Takaaki KomatsuDepartment of Pharmacology, Daiichi University of Pharmacy, 815-8511 Fukuoka, Japan.
Luigi Antonio MorronePreclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.
Laura RombolàPreclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.ORCID 0000-0002-1727-3158
Annagrazia AdornettoPreclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.ORCID 0000-0003-1869-2642
Annarita S LaganàDepartment of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.
Maria Tiziana CorasanitiDepartment of Health Sciences, University "Magna Graecia" of Catanzaro, 88100 Catanzaro, Italy.ORCID 0000-0001-6472-0697
Paolo ToninRegional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy.
Shinobu SakuradaDepartment of Physiology and Anatomy, Tohoku Pharmaceutical University, 981-8558 Sendai, Japan.
Tsukasa SakuradaDepartment of Pharmacology, Daiichi University of Pharmacy, 815-8511 Fukuoka, Japan.
Pierluigi NicoteraGerman Center for Neurodegenerative Diseases (DZNE), 53127 Bonn, Germany.
Giacinto BagettaPharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.ORCID 0000-0001-8540-6218
University of Calabria · ITTohoku Medical and Pharmaceutical University · JPDaiichi University of Pharmacy · JPIstituto S.Anna Crotone · ITGerman Center for Neurodegenerative Diseases · DEMagna Graecia University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dementia is one of the most common causes of disability worldwide characterized by memory loss, cognitive impairment, and behavioral and psychological symptoms (BPSD), including agitation. Treatment of the latter consists of the off-label use of harmful atypical antipsychotics, though a significant reduction is afforded by pain control. The use of an essential oil endowed with analgesic properties and devoid of toxicity would represent an important option for the management of agitation in dementia. Therefore, the aim of this study was to engineer a nanotechnology delivery system based on solid lipid nanoparticles loaded with bergamot essential oil (BEO) and devised in the pharmaceutical form of an odorless cream (NanoBEO) to confirm its analgesic efficacy for further development and application to control agitation in dementia. BEO has proven strong antinociceptive and anti-allodynic properties and, in its bergapten-free form, it is completely devoid of phototoxicity. NanoBEO has been studied in vivo confirming the previously reported analgesic activity of BEO to which is now added its anti-itching properties. Due to the nanotechnology delivery system, the stability of titrated BEO components is guaranteed. Finally, the latter invention, currently under patent consideration, is smell-devoid allowing efficacy and safety to be established in double-blind clinical trials; until now the latter studies have been impeded in aromatherapy by the strong odor of essential oils. A clinical trial NCT04321889 has been designed to provide information about the efficacy and safety of NanoBEO on agitation and pain in patients suffering from severe dementia.

Indexed as

agitationBPSDdementiaessential oil of bergamotnanotechnology delivery systempain

Identifiers

PMID33809385
PMCPMC7999378
OpenAlexW3137275358

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.