ArticlePhytotherapy research : PTR2021
Bergamot rehabilitation AgaINst agitation in dementia (BRAINAID): Study protocol for a randomized, double-blind, placebo-controlled trial to assess the efficacy of furocoumarin-free bergamot loaded in a nanotechnology-based delivery system of the essential oil in the treatment of agitation in elderly affected by severe dementia.
Article in Phytotherapy research : PTR, 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 17 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
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.
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Exploitation of Autophagy Inducers in the Management of Dementia: A Systematic Review.International journal of molecular sciences · 2024Pooled it
- Pooled it
- Efficacy of Essential Oils in Relieving Cancer Pain: A Systematic Review and Meta-Analysis.International journal of molecular sciences · 2023Pooled it
- Analgesic Characteristics of NanoBEO Released by an Airless Dispenser for the Control of Agitation in Severe Dementia.Molecules (Basel, Switzerland) · 2022Trial
- Gas Chromatography-Mass Spectroscopy (GC-MS) Simultaneous Determination of Limonene, Linalool, and Linalyl Acetate in Rat Plasma Following Transdermal Administration of the Essential Oil of Bergamot Loaded Onto Solid Lipid Nanoparticles (NanoBEO).Phytotherapy research : PTR · 2026Article
- Article
- Efficacy of therapeutic intervention with NanoBEO to manage agitation and pain in patients suffering from severe dementia: a pilot clinical trial.Frontiers in pharmacology · 2024Article
- Plant Essential Oils as Healthy Functional Ingredients of Nutraceuticals and Diet Supplements: A Review.Molecules (Basel, Switzerland) · 2023Review
- Effects of Palmitoylethanolamide (PEA) on Nociceptive, Musculoskeletal and Neuropathic Pain: Systematic Review and Meta-Analysis of Clinical Evidence.Pharmaceutics · 2022Review
- Transgenic Mice for the Translational Study of Neuropathic Pain and Dystonia.International journal of molecular sciences · 2022Review
- Translational Value of the Transdermal Administration of Bergamot Essential Oil and of Its Fractions.Pharmaceutics · 2022Article
- Article
- Antispasmodic Effect of Bergamot Essential Oil on Rat Isolated Gut Tissues.Pharmaceutics · 2022Article
- Dementia and COVID-19: A Case Report and Literature Review on Pain Management.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Preclinical Characterization of Antinociceptive Effect of Bergamot Essential Oil and of Its Fractions for Rational Translation in Complementary Therapy.Pharmaceutics · 2022Article
- ROBOCOP (ROBOtic Care of Poststroke Pain): Study Protocol for a Randomized Trial to Assess Robot-Assisted Functional and Motor Recovery and Impact on Poststroke Pain Development.Frontiers in neurology · 2022Article
- Aromatherapy in Stroke Patients: Is it Time to Begin?Frontiers in behavioral neuroscience · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pain is underdiagnosed and often not adequately treated, contributing to behavioral and psychological symptoms of dementia (BPSD). BPSD are treated with atypical antipsychotics that are associated with severe cerebrocardiovascular effects. Interestingly, treatment of pain may reduce agitation. Research is focusing on nonpharmacological treatment, such as aromatherapy, for pain and BPSD in dementia. This clinical study will assess the effect on agitation in severely demented elderly of BEO loaded in a nanotechnological odorless cream indistinguishable from placebo. This is a protocol for a randomized, double-blind, placebo-controlled trial (NCT04321889). A total of 134 patients aged ≥65 years with severe dementia (mini-mental state examination <12) will be recruited and randomly allocated 1:1 to either BEO or placebo group. After baseline screening, BEO (80 mg) cream or placebo cream will be trans-dermally applied on both arms twice a day for 4 weeks with a 4-week follow-up period. The effect on agitation will be the primary endpoint. Any adverse events will be reported. A double-blind, clinical trial evaluating efficacy and safety of an essential oil endowed with strong analgesic properties has never been carried out before. This study could form the basis for a safer and more effective treatment of BPSD in severe dementia.
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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.