Do not Give Antihistamines and Decongestants for Otitis Media in Children

Antihistamines and decongestants are often given to children with otitis media, even though there is no scientific evidence to support this. Otitis media is one of the most common causes of pediatric patient visits to the doctor. Approximately 50–85% of children will experience at least one episode of acute otitis media by the age of 3 years.

 

Acute otitis media (AOM) and otitis media with effusion (OME) are 2 different types of otitis media. Although this disease is common, the exact definition of AOM is still not understood by clinicians. AOM is characterized by 3 components, namely acute onset within 48 hours, fluid in the middle ear, and clinical manifestations such as otalgia, fever, and hyperemic tympanic membrane.

 

OME is characterized by fluid in the middle ear without acute inflammation, which can trigger or be followed by AOM. OME is the highest cause of hearing loss that occurs in childhood. [1,2]

 

In Indonesia, otitis media is more common in rural areas than urban areas, with the majority of cases occurring under the age of 3 years. A study in Indonesia examined 7,005 children aged 6–15 years and found that the prevalence of AOM was 5 cases per 1,000 people and the prevalence of OME was 4 cases per 1,000 people. [3]

 

Hypothesis of the Role of Antihistamines and Decongestants for Otitis Media in Children

The cause of OME in children is still not known with certainty. Several theories have proposed the hypothesis that inflammation of the rhinopharyngeal infection, mucosal biofilm formation, gastroesophageal reflux, and allergy are the causes of OME. The high prevalence of otitis media in children can also be caused by ear anatomy, namely the immaturity of the child's Eustachian tube in terms of angle, length, and ability to close. [4]

 

It was the course of the disease that initially sparked the possible potential of antihistamines and decongestants in the treatment of otitis media. Decongestants are thought to reduce mucosal edema at the mouth of the Eustachian tube and fluid in the middle ear.

 

Both viruses and bacteria can produce histamine, so the administration of antihistamines is expected to reduce the inflammatory response and congestion of the mucous membranes, which is then expected to reduce the duration of otitis media. [5,6]

 

Antihistamines and Decongestants Efficacy for Otitis Media in Children

Despite the hypothesized potency of antihistamines and decongestants, various clinical trials conducted in the last 30 years have shown that neither drug is effective against otitis media with effusion in children. [5]

 

A Canadian study investigated the efficacy of a single decongestant, pseudoephedrine, in children with OME and compared it with placebo. The proportion of resolution of tympanic membrane inflammation was not significantly different between the two groups. [1]

 

A Cochrane review by Griffin et al also examined 16 randomized controlled trials with 1,800 subjects and compared decongestant and placebo administration in children with OME. Study results did not demonstrate any benefit in resolution of signs and symptoms of OME at 1 month. [2]

 

Similarly, studies examining the use of a combination of the two drugs. The combination of antihistamines and decongestants has shown no benefit in children with OME. Several studies have shown that taking antihistamines alone has a negative impact on patients with otitis media. [1]

 

Although there is no evidence of benefit from antihistamines and decongestants in children with otitis media, several investigators have reviewed that both agents have potential in otitis media involving allergies. However, this is only supported by studies conducted on animals, not humans. [1,2,6]

 

Side Effects of Antihistamines and Decongestants in Children

Significant rates of adverse events have been reported from the use of antihistamines and/or decongestants in children with OME. Side effects that arise in the form of sedation, irritability, and gastrointestinal disturbances.

 

In the use of decongestants, such as phenylephrine and pseudoephedrine, the side effect rates in children with OME were 24% and 6%, respectively. A UK study of children aged 3–10 years reported that 12 children experienced side effects related to decongestant drug withdrawal. Nine out of 12 children who take pseudoephedrine experience bad emotions, irritability, dizziness, malaise, and sleep disturbances. [1]

 

Meanwhile, antihistamines, such as chlorpheniramine maleate, are known to prolong the duration of middle ear effusion. This is due to the anticholinergic potential of antihistamines as well as a decrease in mucociliary function which can interfere with the function of the Eustachian tube. Antihistamines are also thought to impair the function of the secretory cells of the middle ear, affecting fluid drainage and absorption, and leading to an increase in the viscosity of the middle ear fluid. [1]

 

However, these side effects were found to occur less frequently with the use of type 2 antihistamines, such as cetirizine, because they have no anticholinergic activity and cannot cross the blood-brain barrier. [1]

 

The same thing was conveyed in the Cochrane review conducted by Griffin et al. There is no evidence of benefit from therapy with antihistamines, decongestants, or a combination of the two in patients with OME. Instead, there was an increase in the side effects of both drugs in patients. These results are consistent from the various studies reviewed. [2]

 

Guidelines for the Management of Otitis Media in Children

The American Academy of Otolaryngology (AAO) – Head and Neck Surgery Foundation and Internal consensus (ICON) issued strong recommendations against using antihistamines, decongestants, or both for the management of otitis media. These recommendations aim to reduce ineffective interventions, prevent the risk of side effects, and reduce the burden of treatment costs. [7,8]

 

This is also in line with the guidelines of the Canadian Pediatric Society. Recent guidelines from the American Academy of Pediatrics on the management of otitis media do not even mention antihistamines and decongestants for the treatment of otitis media. [9,10]

 

Conclusion

Various studies have concluded that antihistamines and decongestants are not recommended as therapy for otitis media in children. This is in line with the recommendations of several related associations that do not recommend the administration of these two agents for otitis media in children.

 

References

1.     Bonney AG, Goldman RD. Antihistamines for children with otitis media. Canadian Family Physician. 2014 Jan;60(1):43.

2.     Griffin G, Flynn CA. Antihistamines and/or decongestants for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2011;2011(9):CD003423. Published 2011 Sep 7. doi:10.1002/14651858.CD003423.pub3

3.     Anggraeni R, Hartanto WW, Djelantik B, Ghanie A, Utama DS, Setiawan EP, et al. Otitis media in indonesian urban and rural school children. Pediatr Infect Dis J. 2014 Oct;33(10):1010–5.

4.     Vanneste P, Page C. Otitis media with effusion in children: Pathophysiology, diagnosis, and treatment. A review. J Otol. 2019 Jun;14(2):33–9.

5.     Principi N, Marchisio P, Esposito S. Otitis media with effusion: benefits and harms of strategies in use for treatment and prevention. Expert Review of Anti-infective Therapy. 2016 Apr 2;14(4):415–23.

6.     Roditi RE, Caradonna DS, Shin JJ. The Proposed Usage of Intranasal Steroids and Antihistamines for Otitis Media with Effusion. Curr Allergy Asthma Rep. 2019 05;19(10):47.

7.     Rosenfeld RM, Shin JJ, Schwartz SR, Coggins R, Gagnon L, Hackell JM, et al. Clinical Practice Guideline: Otitis Media with Effusion (Update). Otolaryngol Head Neck Surg. 2016 Feb;154(1_suppl):S1–41.

8.     Simon F, Haggard M, Rosenfeld RM, Jia H, Peer S, Calmels M-N, et al. International consensus (ICON) on management of otitis media with effusion in children. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Feb;135(1S):S33–9.

9.     Forgie S, Zhanel G, Robinson J. Management of acute otitis media. Paediatr Child Health. 2009;14(7):457–64.

10. Diagnosis and Management of Acute Otitis Media | American Academy of Pediatrics [Internet]. [cited 2020 Oct 18]. Available from: https://pediatrics.aappublications.org/content/113/5/1451/tab-article-info