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Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial.

Abstract Background. This study, a randomized controlled trial, aims to demonstrate a clinically significant improvement in subacute and chronic otitis media with effusion through the administration of hyaluronic acid associated with hypertonic solution compared with the administration of hypertonic solution alone. The setting was an outpatient clinic of 20 primary care pediatrician offices affiliated with the 3 Local Health Units (Azienda Sanitaria Locale) of Naples. Materials and Methods. The study was conducted for 6 months, from October 2014 to the end of March 2015. The study saw the participation of 20 pediatricians who were experts in pneumatic otoscopy, each of whom enrolled 15 children. Each investigator was randomized to carry out the treatment with 3% hypertonic solution or high-molecular-weight hyaluronic acid + 3% hypertonic solution. Results. A total of 275 children were enrolled, of whom 11(equal to 4% ) were lost to follow-up. A total of 264 children completed the trial according to the protocol, 120 in the hyaluronic acid + hypertonic solution group and 144 in the hypertonic solution group. Hyaluronic acid associated with hypertonic solution and hypertonic solution alone administered by nasal lavage have proven to be safe and effective in the treatment of prolonged otitis media with effusion (initial score of -0.5, final score of 0.9, P < 001, for the hypertonic + hyaluronic acid group; initial score of -0.3, final score of 0.2, P < .001, for the hypertonic solution group). Though starting from a less favorable initial clinical score (-0.5 vs -0.3, P < .016), hyaluronic acid associated with hypertonic solution resulted in a significant increase in clinical healing (0.9 vs 0.2, P < .001). One interesting outcome was the significant reduction in the consumption of drugs (cortisone and antibiotics) during the follow-up.
PMID
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Authors

Mayor MeshTerms
Keywords

clinic score

hyaluronic acid

hypertonic solution

otitis

Journal Title global pediatric health
Publication Year Start




PMID- 28894768
OWN - NLM
STAT- PubMed-not-MEDLINE
DA  - 20170912
LR  - 20170914
IS  - 2333-794X (Print)
IS  - 2333-794X (Linking)
VI  - 4
DP  - 2017
TI  - Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated
      With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized
      Controlled Trial.
PG  - 2333794X17725983
LID - 10.1177/2333794X17725983 [doi]
AB  - Background. This study, a randomized controlled trial, aims to demonstrate a
      clinically significant improvement in subacute and chronic otitis media with
      effusion through the administration of hyaluronic acid associated with hypertonic
      solution compared with the administration of hypertonic solution alone. The
      setting was an outpatient clinic of 20 primary care pediatrician offices
      affiliated with the 3 Local Health Units (Azienda Sanitaria Locale) of Naples.
      Materials and Methods. The study was conducted for 6 months, from October 2014 to
      the end of March 2015. The study saw the participation of 20 pediatricians who
      were experts in pneumatic otoscopy, each of whom enrolled 15 children. Each
      investigator was randomized to carry out the treatment with 3% hypertonic
      solution or high-molecular-weight hyaluronic acid + 3% hypertonic solution.
      Results. A total of 275 children were enrolled, of whom 11(equal to 4% ) were
      lost to follow-up. A total of 264 children completed the trial according to the
      protocol, 120 in the hyaluronic acid + hypertonic solution group and 144 in the
      hypertonic solution group. Hyaluronic acid associated with hypertonic solution
      and hypertonic solution alone administered by nasal lavage have proven to be safe
      and effective in the treatment of prolonged otitis media with effusion (initial
      score of -0.5, final score of 0.9, P &lt; 001, for the hypertonic + hyaluronic acid 
      group; initial score of -0.3, final score of 0.2, P &lt; .001, for the hypertonic
      solution group). Though starting from a less favorable initial clinical score
      (-0.5 vs -0.3, P &lt; .016), hyaluronic acid associated with hypertonic solution
      resulted in a significant increase in clinical healing (0.9 vs 0.2, P &lt; .001).
      One interesting outcome was the significant reduction in the consumption of drugs
      (cortisone and antibiotics) during the follow-up.
FAU - Cioffi, Luigi
AU  - Cioffi L
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - Gallo, Patrizia
AU  - Gallo P
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - D'Avino, Antonio
AU  - D'Avino A
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - Carlomagno, Francesco
AU  - Carlomagno F
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - Aloi, Giuseppe
AU  - Aloi G
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - D'Onofrio, Antonietta
AU  - D'Onofrio A
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - Del Gaizo, Donatella
AU  - Del Gaizo D
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - Giuliano, Maria
AU  - Giuliano M
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - De Franchis, Raffaella
AU  - De Franchis R
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - Sandomenico, Maria L
AU  - Sandomenico ML
AD  - FIMP (Italian Federation Pediatric Doctors), Naples, Italy.
FAU - Pecoraro, Anna
AU  - Pecoraro A
AD  - Naples University, Naples, Italy.
LA  - eng
PT  - Journal Article
DEP - 20170901
PL  - United States
TA  - Glob Pediatr Health
JT  - Global pediatric health
JID - 101670224
PMC - PMC5582658
OTO - NOTNLM
OT  - clinic score
OT  - hyaluronic acid
OT  - hypertonic solution
OT  - otitis
COI - Declaration of Conflicting Interests: The author(s) declared no potential
      conflicts of interest with respect to the research, authorship, and/or
      publication of this article.
EDAT- 2017/09/13 06:00
MHDA- 2017/09/13 06:01
CRDT- 2017/09/13 06:00
PHST- 2017/05/04 [received]
PHST- 2017/07/12 [accepted]
AID - 10.1177/2333794X17725983 [doi]
AID - 10.1177_2333794X17725983 [pii]
PST - epublish
SO  - Glob Pediatr Health. 2017 Sep 1;4:2333794X17725983. doi:
      10.1177/2333794X17725983. eCollection 2017.