Evidence map›Paper›PMID 36011184›Full record

ArticleHealthcare (Basel, Switzerland)2022

Single-Center-Single-Blinded Clinical Trial to Evaluate the Efficacy of a Nutraceutical Containing Boswellia Serrata, Bromelain, Zinc, Magnesium, Honey, Tyndallized Lactobacillus Acidophilus and Casei to Fight Upper Respiratory Tract Infection and Otitis Media.

Antonio Della Volpe, Pietro De Luca, Antonietta De Lucia, Francesco Martines, Piera Piroli, Luca D'Ascanio, Angelo Camaioni, Ignazio La Mantia, Arianna Di Stadio

Open access · goldAbstract read
In one paragraph

Article in Healthcare (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 24% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Adelmidrol to fight upper airways inflammation in children: a pilot case control study to safety and efficacy.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 · 2025
    Trial
  3. Review
  4. 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

9 authors at 4 institutions in 1 country.

Antonio Della VolpeCochlear Implant and Middle Ear Unit, Santobono-Posilipon Hospital, 80129 Naples, Italy.
Pietro De LucaDepartment of Medicine, Surgery and Dentistry, University of Salerno, 84084 Salerno, Italy.ORCID 0000-0002-6505-1680
Antonietta De LuciaCochlear Implant and Middle Ear Unit, Santobono-Posilipon Hospital, 80129 Naples, Italy.
Francesco MartinesA.O.IU.P. Paolo Giaccone-Palermo Dipartimento BiND-Sezione di Audiologia, Università degli Studi di Palermo, Via del Vespro 129, 90100 Palermo, Italy.
Piera PiroliCochlear Implant and Middle Ear Unit, Santobono-Posilipon Hospital, 80129 Naples, Italy.
Luca D'AscanioOtolaryngology Department, AORMN, 61032 Fano, Italy.ORCID 0000-0002-5351-326X
Angelo CamaioniOtolaryngology Department, San Giovanni-Addolorata Hospital, 00184 Rome, Italy.
Ignazio La MantiaUnit of Otorhinolaryngology, Department of Medical Sciences Surgical and Advanced Technologies "GF Ingrassia", University of Catania, 95124 Catania, Italy.
Arianna Di StadioUnit of Otorhinolaryngology, Department of Medical Sciences Surgical and Advanced Technologies "GF Ingrassia", University of Catania, 95124 Catania, Italy.ORCID 0000-0001-5510-3814
University of Catania · ITAzienda Ospedaliera San Giovanni Addolorata · ITUniversity of Palermo · ITUniversity of Salerno · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Some nutraceuticals have been studied as supportive treatment for fighting upper respiratory tract infection and middle ear disease. Our study aims at evaluating the effect of a specific oral supplementation in the treatment of pediatric otits media. The subjects were randomly assigned by the physician (single-blinded study) to one of three groups: Control Group (CG), Treatment Group 1 (TG1), or Treatment Group 2 (TG2). Both TG were treated with Flogostop Duo (for 20 days-TG1 or 30 days-TG2) in combination with the standard treatment, while CG underwent standard treatment only. The standard treatment was nasal aerosol with Fluticasone and Mucolytic, and nasal washing with hypertonic solution. All patients were analyzed by otoscopy, impedance, fibroscopy, and pure auditory test at the baseline (T0), after 20 days (T1) and 35 days (T2). 120 children were included in the study, 40 in the CG, 40 in the TG1, and 40 in the TG2. Both TG1 and TG2 presented statistically significant differences with respect to controls in otoscopy, impedance, fibroscopy, and PTA at T2. The otoscopy improved at T2 with statistically significant value only in TG2. The impedance and fibroscopy improved at T1 both in TG1 and TG2 compared to CG. A statistically significant improvement was observed in TG2 at T2 in comparison to both CG and TG1. Statistically significant differences were observed in PTA at T2 only compared with controls. This study confirmed the efficacy of nutraceutical as supporting therapy in the upper respiratory tract infection in children. In particular, the supplement containing Boswellia serrata and Bromelain, which are molecules with strong anti-inflammatory and pain-control capacities, could add the benefit without the adverse effects which are related to NSAID use.

Indexed as

auditory testBoswelliabromelainclinical trialnasal spraynutraceuticalsOtitis Mediaquality of lifeupper respiratory infection

Identifiers

PMID36011184
PMCPMC9408187
OpenAlexW4291464849

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.