Antihistamines could prolong the duration of middle ear effusion

[Guest guest]

http://www.idinchildren.com/200402/frameset.asp?article=mee.asp

Respiratory Infections

Antihistamines could prolong the duration of middle ear effusion

In clinical study, antihistamines and corticosteroids coupled with

antibiotics did not prove efficacious in the treatment of AOM.

by Judith Rusk

Staff Writer

February 2004

There is no statistically significant benefit in the five-day use of

antihistamines and/or corticosteroids with antibiotics for treatment

of acute otitis media (AOM).

Tasnee Chonmaitree, MD, professor of pediatrics and pathology in the

department of pediatrics, pediatric infectious diseases division at

the University of Texas Medical Branch, et al, also found in a recent

study that antihistamine treatment lengthened the duration of fluid

in the middle ear.

" We believe that the adverse effect of antihistamine found in our

study is important, since antihistamine is often used to relieve

acute respiratory symptoms that accompany AOM, " researchers said.

In their randomized, placebo-controlled study, researchers gave

participants one intramuscular injection of ceftriaxone (Rocephin,

Roche) and depending on the random treatment group, the antihistamine

chlorpheniramine maleate and/or the corticosteroid prednisolone.

" The observation by Chonmaitree and colleagues that use of an

antihistamine prolonged middle ear effusion is provocative, " said

Jerome O. Klein, MD, professor of pediatrics at Boston University

School of Medicine, and a member of the Infectious Diseases in

Children editorial board. " The results need corroboration at another

time, in another place, but the data are persuasive that in the

absence of benefit and the documented increased duration of middle

ear fluid, the use of chlorpheniramine maleate should be avoided in

infants and children with acute otitis media. "

How the study worked

A total of 179 children between the ages of 3 months and 6 years were

enrolled for this study between July 1995 and June 2000. Each child,

at risk for recurrent AOM episodes, was assigned to one of the

following treatment groups: group one, antibiotics and two placebos;

group two, antibiotic, corticosteroid and placebo; group three,

antibiotic, antihistamine and placebo or group four, antibiotic,

antihistamine and corticosteroid. Treatment or placebo was given over

five days and they were followed for up to nine months. The children

included in the study had two or more previous AOM occurrences, with

the first episode occurring before their first birthday.

" We believe that the adverse effect of antihistamine found in our

study is important, since antihistamine is often used to relieve

acute respiratory symptoms that accompany AOM. "

— Study researchers

AOM was defined as fever, irritability or otalgia by history,

inflammation of the tympanic membrane and the presence of middle ear

effusion (MEE) as detected by pneumatic otoscopy and tympanomentry.

Treatment failure was defined by the condition persisting or

relapsing within the first two weeks, with inflammation of the

tympanic membrane that required retreatment with an antibiotic, the

study said.

Out of the 179 children, 126 had bilateral AOM and 53 had unilateral

AOM, including 305 AOM ears (154 right ears and 151 left).

Of the children, 33 had failure or relapse of AOM during the first

two weeks and there was no statistically significant difference in

failure among the four treatment groups (P=.35 by Pearson x2). The

failure rate in groups three and four, the antihistamine-treated

groups (18.2%), was compared with the failure rates of the first two

groups, the no antihistamine-treated groups (18.7%) to assess the

overall effect of the antihistamines.

No statistically significant difference was discovered (P=.93; 95%

confidence interval on the difference was –10.9% to 11.9%).

Groups two and four (corticosteroid, 13.5%) were compared to one and

three (no corticosteroid, 23.3%) and again, no statistically

significant differences were found (P=.09; 95% confidence interval, -

1.4% to 21.1%).

MEE was prolonged in the antihistamine-treated group (73 days)

compared with the other three groups (23-26 days, P=.04).

" We unexpectedly found an adverse effect of antihistamine in

lengthening duration of MEE, " the researchers wrote. " Prolonged

duration of MEE may compromise hearing and may lead to recurrent

acute infections and the need for ventilating tubes. "

Therefore, practicing clinicians should beware when recommending over-

the-counter cold and cough remedies to children, Chonmaitree said.

" Although the sample size is modest, the prolongation of time of

middle ear effusion in the children who received antihistamines is

significant, " Klein said.

Source: J Pediatr. 2003;143(3):377-385.

While there remains opportunity to further study the efficacy of a

seven to 10 day treatment of AOM with antibiotics and

corticosteroids, researchers advise against further study on the

effect of antihistamines on MEE.

" The effect of steroid might become significant if the sample size

were higher, " Chonmaitree said.

With regard to antihistamines Chonmaitree stated, " when a drug has

been shown to cause adverse effect, it almost seems unethical to keep

studying. "

The study was funded by a grant from the NIH.

For more information:

Chonmaitree T, Saeed K, Uchida T. A randomized, placebo-controlled

trial of the effect of antihistamine or corticosteroid treatment in

acute otitis media. J Pediatr. 2003;143(3):377-385.

Dr. Chonmaitree has no direct financial interest in the products

mentioned in this article, nor is she a paid consultant for any

companies mentioned