Evidence map›Paper›PMID 37380908›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2023

Treatment of COVID-19 olfactory dysfunction with olfactory training, palmitoylethanolamide with luteolin, or combined therapy: a blinded controlled multicenter randomized trial.

Arianna Di Stadio, Salvatore Gallina, Salvatore Cocuzza, Pietro De Luca, Angelo Ingrassia, Simone Oliva, Federico Sireci, Angelo Camaioni, Fabio Ferreli, Giuseppe Mercante and 4 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07631455 (Effects of Ultramicronized Palmitoylethanolamide on Smell, Taste, and Sensory Sensitivity in Children With Autism Spectrum Disorder.), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
4.1field-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.

NCT07631455 nacompletednot on this mapstarted 2024, after this paper: background citation

Effects of Ultramicronized Palmitoylethanolamide on Smell, Taste, and Sensory Sensitivity in Children With Autism Spectrum Disorder.

TypeinterventionalSponsorUniversity of Campania Luigi VanvitelliRan2024 to 2025Enrolled80ConditionsAutism, Smell Dysfunction, Taste Alterations, Sensorial DisturbanceArmssupplement (Paidinil® HD, Epitech Group SpA, Saccolongo, Padova, Italy) containing 12% umPEA, Lactobacillus and Omega Fatty acids
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Therapeutic effect of anti-neuroinflammatory supplement combined with olfactory training on post-covid olfactory dysfunction: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
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  12. Inflammatory pathways in patients with post-acute sequelae of COVID-19: The role of the clinical immunologist.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2024
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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

14 authors at 5 institutions in 2 countries.

Arianna Di StadioOtolaryngology Unit, GF Ingrassia Department, University of Catania, Catania, Italy. ariannadistadio@hotmail.com.ORCID http://orcid.org/0000-0001-5510-3814
Salvatore GallinaOtolaryngology Department, University of Palermo, Palermo, Italy.
Salvatore CocuzzaOtolaryngology Unit, GF Ingrassia Department, University of Catania, Catania, Italy.
Pietro De LucaOtolaryngology Department, San Giovanni-Addolorata Hospital, Rome, Italy.
Angelo IngrassiaOtolaryngology Department, University of Palermo, Palermo, Italy.
Simone OlivaOtolaryngology Department, University of Palermo, Palermo, Italy.
Federico SireciOtolaryngology Department, University of Palermo, Palermo, Italy.
Angelo CamaioniOtolaryngology Department, San Giovanni-Addolorata Hospital, Rome, Italy.
Fabio FerreliOtolaryngology Department, Humanitas University Hospital, Milan, Italy.
Giuseppe MercanteOtolaryngology Department, Humanitas University Hospital, Milan, Italy.
Francesca GainoOtolaryngology Department, Humanitas University Hospital, Milan, Italy.
Gian Marco PaceOtolaryngology Department, Humanitas University Hospital, Milan, Italy.
Ignazio La MantiaOtolaryngology Unit, GF Ingrassia Department, University of Catania, Catania, Italy.
Michael J BrennerDepartment of Otolaryngology-Head and Neck Surgery, University of Michigan Medical School, Ann Arbor, MI, USA.
Humanitas University · ITUniversity of Palermo · ITUniversity of Catania · ITAzienda Ospedaliera San Giovanni Addolorata · ITUniversity of Michigan · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFew evidence-based therapies are available for chronic olfactory dysfunction after COVID-19. This study investigated the relative efficacy of olfactory training alone, co-ultramicronized palmitoylethanolamide with luteolin (um-PEA-LUT, an anti-neuroinflammatory supplement) alone, or combined therapy for treating chronic olfactory dysfunction from COVID-19.

methodsThis double-blinded controlled, placebo-controlled multicenter randomized clinical trial was conducted in 202 patients with persistent COVID-19 olfactory dysfunction of > 6 month duration. After a screening nasal endoscopy, patients were randomized to: (1) olfactory training and placebo; (2) once daily um-PEA-LUT alone; (3) twice daily um-PEA-LUT alone; or (4) combination of once daily um-PEA-LUT with olfactory training. Olfactory testing (Sniffin' Sticks odor identification test) was performed at baseline and at 1, 2, and 3 months. The primary outcome was recovery of over three points on olfactory testing, with outcomes compared at T

resultsAll patients completed the study, and there were no adverse events. At 90 days, odor identification scores improved by > 3 points in 89.2% of patients receiving combined therapy vs. 36.8% receiving olfactory training with placebo, 40% receiving twice daily um-PEA-LUT alone, and 41.6% receiving once daily um-PEA-LUT alone (p < 0.00001). Patients receiving treatment with um-PEA-LUT alone demonstrated subclinical improvement (< 3 point odor identification improvement) more often than patients receiving olfactory training with placebo (p < 0.0001.)

conclusionsOlfactory training plus once daily um-PEA-LUT resulted in greater olfactory recovery than either therapy alone in patients with long-term olfactory function due to COVID-19.

trial registration20112020PGFN on clinicaltrials.gov. LEVEL OF EVIDENCE: 1b (Individual Randomized Clinical Trial).

Indexed as

COVID-19Olfaction DisordersAmidesEthanolaminesHumansLuteolinOlfactory TrainingPalmitic AcidsSmellAmidesEthanolaminesLuteolinpalmidrolPalmitic AcidsAnosmiaClinical trialCoronavirusCOVID-19HyposmiaLuteolinNeuroinflammationOlfactory trainingPalmitoylethanolamidePEAPEA–LUTPost-acute sequelae of COVID-19Randomized trialSARS-CoV-2Smell disorders

Identifiers

PMID37380908
PMCPMC10562315
OpenAlexW4382393472

What OpenQuestion holds

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LicenceCC BY
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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.