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A standardized polyphenol mixture extracted from poplar-type propolis for remission of symptoms of uncomplicated upper respiratory tract infection (URTI): A monocentric, randomized, double-blind, placebo-controlled clinical trial.

Identifieur interne : 000588 ( Main/Exploration ); précédent : 000587; suivant : 000589

A standardized polyphenol mixture extracted from poplar-type propolis for remission of symptoms of uncomplicated upper respiratory tract infection (URTI): A monocentric, randomized, double-blind, placebo-controlled clinical trial.

Auteurs : Cristina Esposito [Italie] ; Emanuele Ugo Garzarella [Italie] ; Bruno Bocchino [Italie] ; Maria D'Avino [Italie] ; Giuseppe Caruso [Italie] ; Antonio Riccardo Buonomo [Italie] ; Roberto Sacchi [Italie] ; Fabio Galeotti [Italie] ; Gian Carlo Tenore [Italie] ; Vincenzo Zaccaria [Italie] ; Maria Daglia [République populaire de Chine]

Source :

RBID : pubmed:33091857

Abstract

BACKGROUND

The most common symptoms of mild upper respiratory tract infections (URTIs) are sore throat, muffled dysphonia, and swelling and redness of the throat, which result from the inflammation process following acute bacterial or viral infection.

HYPOTHESIS/PURPOSE

As propolis is a natural resinous substance traditionally used to maintain oral cavity and upper respiratory tract health due to its antimicrobial and anti-inflammatory properties, the aim of this study is to evaluate the efficacy of an oral spray based on poplar-type propolis extract with a known and standardized polyphenol content, on the remission of the symptoms associated with mild uncomplicated URTIs.

STUDY DESIGN

A monocentric, randomized, double-blind, placebo-controlled clinical trial was performed.

METHODS

This study was conducted in 122 healthy adults who had perceived mild upper respiratory tract infections. Participants, randomly assigned to receive either propolis oral spray (N = 58) or placebo (N = 64), underwent four visits (baseline = t0, after 3 days = t1 and after 5 days = t2 and after a follow-up of 15 days = t3) in an outpatient setting. Propolis oral spray total polyphenol content was 15 mg/ml. The dosage was 2-4 sprays three times/day (corresponding to 12-24 mg of polyphenols/day), for five days. The duration of the study was 8 weeks.

RESULTS

After 3 days of treatment, 83% of subjects treated with propolis oral spray had remission of symptoms, while 72% of subjects in the placebo group had at least one remaining symptom. After five days, all subjects had recovered from all symptoms. This means that resolution from mild uncomplicated URTIs took place two days earlier, instead of taking place in five days as recorded in the control group. There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.

CONCLUSION

Propolis oral spray can be used to improve both bacterial and viral uncomplicated URTI symptoms in a smaller number of days without the use of pharmacological treatment, leading to a prompt symptom resolution.


DOI: 10.1016/j.phymed.2020.153368
PubMed: 33091857


Affiliations:


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<name sortKey="Daglia, Maria" sort="Daglia, Maria" uniqKey="Daglia M" first="Maria" last="Daglia">Maria Daglia</name>
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<nlm:affiliation>Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China. Electronic address: maria.daglia@unina.it.</nlm:affiliation>
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<p>
<b>BACKGROUND</b>
</p>
<p>The most common symptoms of mild upper respiratory tract infections (URTIs) are sore throat, muffled dysphonia, and swelling and redness of the throat, which result from the inflammation process following acute bacterial or viral infection.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>HYPOTHESIS/PURPOSE</b>
</p>
<p>As propolis is a natural resinous substance traditionally used to maintain oral cavity and upper respiratory tract health due to its antimicrobial and anti-inflammatory properties, the aim of this study is to evaluate the efficacy of an oral spray based on poplar-type propolis extract with a known and standardized polyphenol content, on the remission of the symptoms associated with mild uncomplicated URTIs.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>STUDY DESIGN</b>
</p>
<p>A monocentric, randomized, double-blind, placebo-controlled clinical trial was performed.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>This study was conducted in 122 healthy adults who had perceived mild upper respiratory tract infections. Participants, randomly assigned to receive either propolis oral spray (N = 58) or placebo (N = 64), underwent four visits (baseline = t0, after 3 days = t1 and after 5 days = t2 and after a follow-up of 15 days = t3) in an outpatient setting. Propolis oral spray total polyphenol content was 15 mg/ml. The dosage was 2-4 sprays three times/day (corresponding to 12-24 mg of polyphenols/day), for five days. The duration of the study was 8 weeks.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>After 3 days of treatment, 83% of subjects treated with propolis oral spray had remission of symptoms, while 72% of subjects in the placebo group had at least one remaining symptom. After five days, all subjects had recovered from all symptoms. This means that resolution from mild uncomplicated URTIs took place two days earlier, instead of taking place in five days as recorded in the control group. There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSION</b>
</p>
<p>Propolis oral spray can be used to improve both bacterial and viral uncomplicated URTI symptoms in a smaller number of days without the use of pharmacological treatment, leading to a prompt symptom resolution.</p>
</div>
</front>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The most common symptoms of mild upper respiratory tract infections (URTIs) are sore throat, muffled dysphonia, and swelling and redness of the throat, which result from the inflammation process following acute bacterial or viral infection.</AbstractText>
<AbstractText Label="HYPOTHESIS/PURPOSE" NlmCategory="UNASSIGNED">As propolis is a natural resinous substance traditionally used to maintain oral cavity and upper respiratory tract health due to its antimicrobial and anti-inflammatory properties, the aim of this study is to evaluate the efficacy of an oral spray based on poplar-type propolis extract with a known and standardized polyphenol content, on the remission of the symptoms associated with mild uncomplicated URTIs.</AbstractText>
<AbstractText Label="STUDY DESIGN" NlmCategory="METHODS">A monocentric, randomized, double-blind, placebo-controlled clinical trial was performed.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">This study was conducted in 122 healthy adults who had perceived mild upper respiratory tract infections. Participants, randomly assigned to receive either propolis oral spray (N = 58) or placebo (N = 64), underwent four visits (baseline = t0, after 3 days = t1 and after 5 days = t2 and after a follow-up of 15 days = t3) in an outpatient setting. Propolis oral spray total polyphenol content was 15 mg/ml. The dosage was 2-4 sprays three times/day (corresponding to 12-24 mg of polyphenols/day), for five days. The duration of the study was 8 weeks.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">After 3 days of treatment, 83% of subjects treated with propolis oral spray had remission of symptoms, while 72% of subjects in the placebo group had at least one remaining symptom. After five days, all subjects had recovered from all symptoms. This means that resolution from mild uncomplicated URTIs took place two days earlier, instead of taking place in five days as recorded in the control group. There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Propolis oral spray can be used to improve both bacterial and viral uncomplicated URTI symptoms in a smaller number of days without the use of pharmacological treatment, leading to a prompt symptom resolution.</AbstractText>
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<LastName>Esposito</LastName>
<ForeName>Cristina</ForeName>
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<Affiliation>Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.</Affiliation>
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<ForeName>Emanuele Ugo</ForeName>
<Initials>EU</Initials>
<AffiliationInfo>
<Affiliation>Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.</Affiliation>
</AffiliationInfo>
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<ForeName>Bruno</ForeName>
<Initials>B</Initials>
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<Affiliation>Samnium Medical Soc. Cooperative, 82100 Benevento, Italy.</Affiliation>
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<LastName>Buonomo</LastName>
<ForeName>Antonio Riccardo</ForeName>
<Initials>AR</Initials>
<AffiliationInfo>
<Affiliation>Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II, via Sergio Pansini 5, 80131 Naples, Italy.</Affiliation>
</AffiliationInfo>
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<Initials>R</Initials>
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<Affiliation>Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, viale Taramelli 24, 27100 Pavia, Italy.</Affiliation>
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<LastName>Galeotti</LastName>
<ForeName>Fabio</ForeName>
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<Affiliation>Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 213/D, 41121 Modena, Italy.</Affiliation>
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<LastName>Tenore</LastName>
<ForeName>Gian Carlo</ForeName>
<Initials>GC</Initials>
<AffiliationInfo>
<Affiliation>Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.</Affiliation>
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<LastName>Zaccaria</LastName>
<ForeName>Vincenzo</ForeName>
<Initials>V</Initials>
<AffiliationInfo>
<Affiliation>B Natural R&D Unit, via Gran Sasso 33, 20011 Corbetta (MI), Italy.</Affiliation>
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</Author>
<Author ValidYN="Y">
<LastName>Daglia</LastName>
<ForeName>Maria</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China. Electronic address: maria.daglia@unina.it.</Affiliation>
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<ArticleDate DateType="Electronic">
<Year>2020</Year>
<Month>10</Month>
<Day>08</Day>
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<Country>Germany</Country>
<MedlineTA>Phytomedicine</MedlineTA>
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<ISSNLinking>0944-7113</ISSNLinking>
</MedlineJournalInfo>
<CitationSubset>IM</CitationSubset>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">Poplar-type propolis</Keyword>
<Keyword MajorTopicYN="N">Randomized controlled clinical trial</Keyword>
<Keyword MajorTopicYN="N">Standard polyphenol mixture</Keyword>
<Keyword MajorTopicYN="N">Upper respiratory tract infection</Keyword>
</KeywordList>
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<Year>2020</Year>
<Month>04</Month>
<Day>12</Day>
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<PubMedPubDate PubStatus="revised">
<Year>2020</Year>
<Month>10</Month>
<Day>03</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2020</Year>
<Month>10</Month>
<Day>07</Day>
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<Month>10</Month>
<Day>23</Day>
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<PubMedPubDate PubStatus="entrez">
<Year>2020</Year>
<Month>10</Month>
<Day>22</Day>
<Hour>20</Hour>
<Minute>20</Minute>
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<PublicationStatus>aheadofprint</PublicationStatus>
<ArticleIdList>
<ArticleId IdType="pubmed">33091857</ArticleId>
<ArticleId IdType="pii">S0944-7113(20)30199-9</ArticleId>
<ArticleId IdType="doi">10.1016/j.phymed.2020.153368</ArticleId>
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<affiliations>
<list>
<country>
<li>Italie</li>
<li>République populaire de Chine</li>
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</list>
<tree>
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<noRegion>
<name sortKey="Esposito, Cristina" sort="Esposito, Cristina" uniqKey="Esposito C" first="Cristina" last="Esposito">Cristina Esposito</name>
</noRegion>
<name sortKey="Bocchino, Bruno" sort="Bocchino, Bruno" uniqKey="Bocchino B" first="Bruno" last="Bocchino">Bruno Bocchino</name>
<name sortKey="Buonomo, Antonio Riccardo" sort="Buonomo, Antonio Riccardo" uniqKey="Buonomo A" first="Antonio Riccardo" last="Buonomo">Antonio Riccardo Buonomo</name>
<name sortKey="Caruso, Giuseppe" sort="Caruso, Giuseppe" uniqKey="Caruso G" first="Giuseppe" last="Caruso">Giuseppe Caruso</name>
<name sortKey="D Avino, Maria" sort="D Avino, Maria" uniqKey="D Avino M" first="Maria" last="D'Avino">Maria D'Avino</name>
<name sortKey="Galeotti, Fabio" sort="Galeotti, Fabio" uniqKey="Galeotti F" first="Fabio" last="Galeotti">Fabio Galeotti</name>
<name sortKey="Garzarella, Emanuele Ugo" sort="Garzarella, Emanuele Ugo" uniqKey="Garzarella E" first="Emanuele Ugo" last="Garzarella">Emanuele Ugo Garzarella</name>
<name sortKey="Sacchi, Roberto" sort="Sacchi, Roberto" uniqKey="Sacchi R" first="Roberto" last="Sacchi">Roberto Sacchi</name>
<name sortKey="Tenore, Gian Carlo" sort="Tenore, Gian Carlo" uniqKey="Tenore G" first="Gian Carlo" last="Tenore">Gian Carlo Tenore</name>
<name sortKey="Zaccaria, Vincenzo" sort="Zaccaria, Vincenzo" uniqKey="Zaccaria V" first="Vincenzo" last="Zaccaria">Vincenzo Zaccaria</name>
</country>
<country name="République populaire de Chine">
<noRegion>
<name sortKey="Daglia, Maria" sort="Daglia, Maria" uniqKey="Daglia M" first="Maria" last="Daglia">Maria Daglia</name>
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</country>
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</affiliations>
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