Evidence map›Paper›PMID 35956935›Full record

Trial reportMolecules (Basel, Switzerland)2022

Analgesic Characteristics of NanoBEO Released by an Airless Dispenser for the Control of Agitation in Severe Dementia.

Damiana Scuteri, Laura Rombolà, Takafumi Hayashi, Chizuko Watanabe, Shinobu Sakurada, Kengo Hamamura, Tsukasa Sakurada, Paolo Tonin, Giacinto Bagetta, Luigi A Morrone and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Molecules (Basel, Switzerland), 2022. 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 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 31% 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
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

11 authors at 6 institutions in 2 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
Laura RombolàPreclinical and Translational Pharmacology, Department of Pharmacy, Health Science and Nutrition, University of Calabria, 87036 Cosenza, Italy.ORCID 0000-0002-1727-3158
Takafumi HayashiLaboratory of Pharmaceutical Sciences, Faculty of Pharmaceutical Sciences, Tohoku Medical and Pharmaceutical University, Sendai 981-8558, Japan.ORCID 0000-0003-1932-5158
Chizuko WatanabeDepartment of Physiology and Anatomy, Faculty of Pharmaceutical Sciences, Tohoku Medical and Pharmaceutical University, Sendai 981-8558, Japan.
Shinobu SakuradaDepartment of Physiology and Anatomy, Faculty of Pharmaceutical Sciences, Tohoku Medical and Pharmaceutical University, Sendai 981-8558, Japan.
Kengo HamamuraCenter for Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Saitama 362-0806, Japan.ORCID 0000-0001-9146-8554
Tsukasa SakuradaCenter for Supporting Pharmaceutical Education, Faculty of Pharmaceutical Sciences, Daiichi University of Pharmacy, Fukuoka 815-8511, Japan.
Paolo ToninRegional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy.ORCID 0000-0002-4867-1378
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
Luigi A MorronePreclinical and Translational Pharmacology, Department of Pharmacy, Health Science and Nutrition, University of Calabria, 87036 Cosenza, Italy.
Maria Tiziana CorasanitiDepartment of Health Sciences, University "Magna Graecia" of Catanzaro, 88100 Catanzaro, Italy.ORCID 0000-0001-6472-0697
Tohoku Medical and Pharmaceutical University · JPUniversity of Calabria · ITIstituto S.Anna Crotone · ITDaiichi University of Pharmacy · JPMagna Graecia University · ITNihon Pharmaceutical University · JP

Funding

MISE "Prima Vera Azione" prot. INVITALIA 37600 21/02/2021Progetto Ingegno POR Calabria FESR 2014/2020 Azione 1 1 5 - Sostegno all'Avanzamento tecnologico delle Imprese Attraverso il Finanziamento di Linee Pilota e Azioni di Validazione Precoce di Prodotti e di Dimostrazione su Larga Scala (DDG N. 12814 DEL 17/10/2019).
6 · The paper itself

Abstract

Chronic pain is one of the most common causes of the need for clinical evaluation, acquiring more importance in the elderly with cognitive impairment. Reduced self-reporting capabilities cause unrelieved pain contributing to the development of agitation. Safe and effective pain treatment can afford the management of agitation without the serious increase in death risk associated with neuroleptics. To this aim, the essential oil of bergamot (BEO), proven by rigorous evidence to have strong preclinical anti-nociceptive and anti-allodynic properties, has been engineered (NanoBEO, patent EP 4003294) to allow randomized, double-blind, placebo-controlled trials (BRAINAID, NCT04321889). The present study: (1) assesses the analgesic effects of a single therapeutic dose of NanoBEO, as supplied by an airless dispenser for clinical translation, in models of inflammatory, neuropathic, and sensitization types of pain relevant to clinic; (2) provides a dose-response analysis of the efficacy of NanoBEO on scratching behavior, a typical behavioral disturbance occurring in dementia. A single therapeutic dose of NanoBEO confirms efficacy following thirty minutes pre-treatment with capsaicin and on the central sensitization phase induced by formalin. Moreover, it has an ID50 of 0.6312 mg and it is efficacious on static and dynamic mechanical allodynia. Altogether, the gathered results strengthen the potential of NanoBEO for clinical management of pain and agitation.

Indexed as

Chronic PainDementiaOils, VolatileAgedAnalgesicsHumansHyperalgesiaAnalgesicsOils, Volatileagitationdementiaessential oil of bergamotNanoBEOnanotechnology delivery systemNPSpain

Identifiers

PMID35956935
PMCPMC9370288
OpenAlexW4292451693

What OpenQuestion holds

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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.