ORIGINAL CONTRIBUTION

otitis media, treatment

Acute Otitis Media in Children:

Are Decongestants or
Antihistamines Necessary?

This study was designed to investigate the efficacy of a decongestant- Kanta Bhambhani, MD*
antihistamine preparation in combination with antibiotic treatment of D. Michael Foulds, MDt
acute otitis media. The effectiveness of a n e w Dimetapp ® (DIM) preparation Kumar N. Swamy, MD*
was assessed in comparison with each of its components (brompheniramine Frances E. Eldis, PhD*
Janet E. Fischel, PhD~
maleate [BPM] and phenylephrine hydrochloride [PEH]) as well as a placebo
(PL) vehicle in the treatment of acute otitis media. In a randomized double
blind study, 98 children were treated in the emergency department or outpa- From the Departments of Pediatrics*
and Audiology, ~ Children's Hospital of
tient medical clinics at Children's Hospital of Michigan with amoxicillin Michigan and Wayne State University
and either DIM, BPM, PEH, or PL. They were evaluated at two weeks by School of Medicine, Detroit; the
clinical examination, pneumatoscopy, and tympanometry. Fifty-eight pa- Department of Pediatrics, t University of
tients (59%) continued to have evidence of fluid in the middle ear. These Texas Health Science Center, San
patients were continued on the test medications for another two weeks and Antonio; and the Department of
then reevaluated. There were significant differences between the treatment Pediatrics, § Health Sciences Center, State
groups (DIM, BPM, and PEH) and the control PL group; the patients receiv- University of New York at Stony Brook,
ing Dimetapp ® or placebo fared better than those receiving BPM or PEH.
However, there was no difference in the overall response between Dime- Supported by a grant from the AH Robins
tapp® and placebo. Antihistamine-decongestant therapy does not appear to Company.
be necessary in the treatment of acute otitis media in children. [Bhambhani
K Foul& DM, Swamy KN, Elch's FE, Fischel JE: Acute otitis media in chil- Presented in part at the meeting of the
dren: Are decongestants or antihistamines necessary? Ann Emerg Med Ambulatory Pediatric Association in San
12:13-16, January 1983.] Antonio, Texas, April 1980. Submitted for
publication March 1982.

Address for reprints: Kanta Bhambhani,

INTRODUCTION MD, Department of Pediatrics, Children's
Acute oti[is media (AOM) is one of the more common acute infections of Hospital of Michigan, 3901 Beaubien
early childhood. Because of high fever, earache, restlessness and irritability, Boulevard, Detroit, Michigan 48201.
the child with AOM is often brought to the emergency department or a
pediatric office. The concern is not only the morbidity of acute episodes, but
also the resultant persistent middle ear effusion seen in many children.1
Recurrent otitis media, especially with persistent middle ear effusion
(OME, previously known as serous otitis media), is almost always accompa-
nied by some degree of conductive hearing loss. z Hearing complications, if
prolonged, may in turn affect the development of cognitive, speech, and lan-
guage skills.
• 34
' These concerns have led to the empiric use of antihistamines
and/or decongestants, with an appropriate antibiotic, in the treatment of
AOM in the belies that they prevent OME by improving eustachian tube
patency. Despite the lack of supportive data, 5 emergency physicians, pediatri-
cians, and family physicians continue to use such preparations for as long as
four to six weeks in the hope of improving eustachian tube function.
We conducted a double-blind study to evaluate the efficacy of a deconges-
tant and an antihistamine, either alone or in combination, with amoxicillin,
in the treatment of AOM and the subsequent development of OME.

MATERIALS A N D M E T H O D S
The population consisted of 98 children with the diagnosis of acute otitis
media seen in the emergency department of the outpatient medical clinic at
the Children's Hospital of Michigan between February 1978 and March 1979.
Forty-three were initially seen in the emergency department, and 55 in the
outpatient medical clinic. In each case, the diagnosis was verified by one of

12:1 January 1983 Annals of Emergency Medicine 13/37

OTITIS MEDIA
Bhambhani et al
the authors. All patients had erythema
and immobility of the tympanic mem-
brane by pneumatoscopy. In addition,
patients had one or more of the fol-
lowing: opacification, yellow color,
loss of light reflex, obliteration of
landmarks, bullae, and/or perforation
of the tympanic membrane. A history
of allergy and previous ear infections
was recorded. Tympanometry was per-
formed to obtain objective data in sup-
port of the diagnosis of AOM. An in-
formed consent was obtained from the
parent(s)/guardian of each child parti-
cipating in the study.
All children were given amoxicillin
20 to 40 mg/kg/day in three divided
doses for a period of 14 days. In addi-
tion, children were randomly assigned
to one of three treatment groups or a
placebo control group. The treatment
groups received: 1) Dimetapp ® (DIM-
AH Robins, Richmond, VA), a pro-
posed new combination of phenyl-
ephrine hydrochloride (PEH) 10 rag/5
ml, and brompheniramine maleate
(BPM) 4 mg/5 ml; 2) BPM only; or 3)
PEH only. The placebo used was the
vehicle for all study preparations, and
consisted of a sorbitol base, sweetened
with saccharin, flavored with artificial
grape, and containing 2.3% alcohol.
The DIM group included 26 children,
the BPM group included 22, the PEH
group had 24, and 26 children received
the placebo.
The study medications (DIM, BPM,
and PEH) and the placebo were bot-
tled, coded, and supplied by AH
Robins Company. The coding was un-
known to the patients, their families,
and the investigators; decoding was
done at the completion of the study.
The dose of all the study medications
varied from one-fourth of a teaspoon-
ful three times a day for a six-month-
old infant to one teaspoonful four
times a day for a 12-year-old child.
At the time of the initial diagnosis,
a tympanometric evaluation was done
independently by the audiologist. The
tympanic m e m b r a n e mobility was
assessed by an A m e r i c a n Electro-
medics Impedance Audiometer, Mod-
el 83 (American Electromedics, Dobbs
Ferry, NY). This tympanometer uses
an electro-acoustic impedance bridge.
The tympanograms were interpreted
by the audiologist. Tympanograms
were classified a c c o r d i n g to the
criteria used by Paradise et al 6 with
modifications: normal (type A), abnor-
mal (type B), and borderline (types As
and C).
38/14
Patients were asked to return in
four to six days for both clinical eval-
uation and verification of compliance.
Throughout the first two-week course
of each treatment, the parents were
telephoned by the investigators every
48 hours, questioned regarding pres-
ence of fever, irritability and/or ear-
ache, decreased appetite and drowsi-
ness, and reminded to give the medi-
cation as prescribed. In addition an
effort was made to help patients keep
their return appointments by provid-
ing transportation, or by a home visit
from a community health technician.
Patients were reevaluated 14 days
after initiation of treatment by clinical
examination and tympanometry. Pa-
tients were considered to have recur-
rent otitis media if they had recur-
rence of clinical symptoms with fever,
earache, and signs of an acute infec-
tion after an initial improvement.
Children with a normal tympano-
gram and no clinical evidence of otitis
media at the two-week follow-up visit
were considered cured and discharged.
Children with an abnormal tympano-
gram and/or clinical evidence of OME
were continued on the study medica-
tions with no antibiotic and asked to
return in two weeks for reevaluation.
A clinical examination and tympa-
nometry were done again at the four-
week evaluation. Children who had a
normal clinical examination and a
• normal tympanogram were considered
cured; children who still had tympa-
nometric and/or clinical evidence of
OME were considered treatment fail-
ures.
A general assessment of compliance
was made by determining the amount
of medication left in the bottle at each
follow-up visit.
RESULTS
One hundred eight patients were
initially registered in the study. Ten
withdrew within the first two weeks.
These patients did not return for the
four- to six-day evaluation and could
not be contacted by telephone, tele-
gram, or home visit. Thus results for
98 patients were available for analysis.
There were 53 boys (54%) and 45 girls
(46%). The ages of patients ranged
from six months to 12 years;= 43% of
children were between the ages of six
months and two years, 47% were be-
tween two and six years, and 10%
were between six and 12 years. Ninety
percent of patients were black. This
generally parallels the racial distribu-
Annals of Emergency Medicine
tion of patients seen in our ambula-
tory facilities. The t r e a t m e n t and
placebo groups were comparable in
numbers with regard to age, sex, his-
tory of allergy, history of past ear in-
fections, and severity of the existing
acute otitis media.
Ninety-eight patients returned for a
four- to six-day follow-up physical ex-
amination. Two patients still had
earache (one on BPM and one on
PEH), which resolved after eight and
six days, respectively. One patient on
PEH still had fever (37.2 C) and irrita-
bility, which resolved after eight days.
The results of the two- and four-
week examination are shown (Table).
Fifty-eight of the patients (59%) con-
tinued to have persistent middle ear
fluid as documented by physical ex-
amination and tympanometry at the
two-week evaluation. The treatment
failure rates (persistence of middle ear
fluid) for the placebo, DIM, BPM, and
PEH groups were 61%, 54%, 73%, and
50%, respectively. These results were
assessed with a chi-square in which
the control group findings were used
as the expected values. The differ-
ences were not statistically significant
(xz = 1.18 (2), P > .05).
Six of the 58 patients were lost to
follow-up after the two-week evalua-
tion. Amoxicillin was stopped after
the t w o - w e e k evaluation, and the
study medications were continued for
the next two weeks in patients who
were considered treatment failures.
Twenty-six patients still had evi-
dence of OME at the four-week eval-
uation (Table). The treatment failure
rates at the four-week evaluation for
the placebo, DIM, BPM, and PEH
groups were 16%, 21%, 47%, and
33%, respectively. The failure rate
observed in the placebo group was sig-
nificantly lower (x2 = 16.20 (2), P <
.01} compared to each of the three
treatment groups using the same test
described for the two-week results.
To further assess this finding, the
failure rate for each of the three treat-
m e n t groups was compared to the
placebo failure rate using the binomial
distribution. Let the probability of
treatment success equal .84 and the
probability of treatment failure equal
.16 (as derived f r o m the placebo
group). Then, the chance of obtaining
as many or more failures of treatment
as occurred in the DIM group is P ~<
.338, as in the PEH group is P ~< .029,
and as in the BPM group is P ~< .001.
Thus the PEH and BPM treatments re-
12:1 January 1983

TABLE. Follow-up by physical examination and tympanometry
After Two Weeks of Therapy
DIM BPM
Cured 12 (46.2%) 6 (27.3%)
Treatment
failures 14 (53.8%) 16 (72.7%)
Total 26 (100%) 22 (100%)
x2 = 1.18, P > .05
After Four Weeks of Therapy
DIM BPM
Lost to
follow-up 2 3
Cu red 19/24 10/19
Treatment
failures 5/24 9/19
Treatment
failures (%) 21 47
x2 = 16.20, P < .01
sulted in significantly greater failures
than the PL group, w h i l e the D I M
group did not differ from the PL group.
While the patients receiving DIM
fared better than those receiving PEH
and BPM, they did not seem to have
an advantage over the placebo group.
Seven of the treatment-failure patients
had recurrent otitis media during the
second week of treatment after an ini-
tial improvement as noted at the four-
to s i x - d a y f o l l o w - u p . A l l t h e s e pa-
tients were continued on amoxicillin
for 14 days after the bout of recurrent
otitis media. N o n e of these patients
was on DIM, one was on PEH, four
were on BPM, and two were on the
placebo. The possibility of antibiotic-
resistant bacteria carmot be ruled out,
as there were no bacteriologic cultures
done by tympanocentesis. If this pos-
sibility is accepted and the seven pa-
tients in question are excluded from
statistical analysis, the treatment fail-
ure rates for the placebo, DIM, BPM,
and PEH groups are 9%, 21%, 33%,
and 30%, respectively. The failure rate
for the placebo group still r e m a i n s
s i g n i f i c a n t l y lower (x2 = 25.33 (2),
P < .01) than for the three treatment
groups.
The correlation b e t w e e n clinical ex-
a m i n a t i o n and t y m p a n o m e t r y was
high. Eighty-three percent of patients
judged to have abnormal physical ex-
a m i n a t i o n s had a b n o r m a l t y m p a n o -
12:1 January 1983
PEH PL Total
12 (50%) 10 (38.5%) 40 (41%)
12 (50%) 16 (61%) 58 (59%)
24 (100%) 26 (100%) 98 (100%)
PEH PL Total
0 1 6 subsequent incidence of OME com-
16/24 21/25 66/92
8/24 4/25 26/92
33 16 28
grams, and 83% of normal examina-
tions had normal tympanograms. The
assessment of patient compliance was
generally high throughout the study:
85% of the patients had taken over
three-fourths of the study medication,
and 97% had taken more than half the
prescribed drug. The degree of com-
p l i a n c e was u n i f o r m l y d i s t r i b u t e d
over all groups.
Reported side effects were minimal.
Diarrhea and skin rash were noted by
two patients who were receiving
amoxicillin and DIM.
DISCUSSION
The rationale for inclusion of anti-
histamines and/or decongestants has
been t h a t t h e y i m p r o v e e u s t a c h i a n
tube fianction. There are studies show-
ing both a beneficial effect 7,s and lack
of beneficial effect s'9 of such drugs on
e u s t a c h i a n t u b e f u n c t i o n or in t h e
overall cure rate of otitis media. In a
s m a l l u n c o n t r o l l e d study, M i l l e r a
demonstrated objective i m p r o v e m e n t
of eustachian tube function in 13 pa-
tients with serous otitis media using
an a n t i h i s t a m i n e - d e c o n g e s t a n t com-
bination.
The data from our study support the
previous observations of Rubenstein
et al 9 and Olson et als that the addi-
tion of a d e c o n g e s t a n t or antihista-
m i n e to an antibiotic is neither associ-
ated with an increase in the cure rate
of A O M nor effective in the preven-
Annals of Emergency Medicine
tion of OME. Further, the vc~y ~ . ~
f a i l u r e r a t e s in our s t u d y w i t h ~'~
antihistamine (BPM) or dccongcsta:_~
(PEH) given alone suggest that thc~
use m a y in fact be detrimental to d-..-
r e s o l u t i o n of m i d d l e ear f[uid. The
detrimental effects m a y be duc to tb.c
rebound vasodilation obser~,cd on m~
cous m e m b r a n e s w i t h such prcpar.-~
tions, m A vasoconstrictor and an a n t
histamine used in a combination form
m a y a c t in a s y n e r g i s t i c f a s h i o ~
Perhaps the rebound vasodi[ation sec~
with ephedrine-like agents Js inhib~*~c,i
by the simultaneous use of a~. anfihi:~
tamine. 1~ However, the use oI such
combination (DIM) in our study did
not alter the course of A O M or the
pared to the placebo. Our data once
again demonstrate the lack of any be-
neficial effect in preventing rniddie e;n
effusion w h e n such preparations arc
used. Perhaps persistence of middle
ear effusion is a part of the natura1
course of otitis media. Our experience
suggests t h a t t h i s r e s o l v e s spont~v
n e o u s l y w i t h time, as noted ir~ the
placebo group.
T h e r o u t i n e use of decongestam~s
and/or antihistamines for eveE¢ child
that is diagnosed as having A O M dc,::=s
not appear warranted.
The authors thank Emily M. Morle.y, NlI),
and Audrey B. Simmons, RN~ olf AIF[
Robins Company, for their continued ihe,.Jp
in making this study possible; Mrs. Jewel
Graham for her secretarial help; Ms. Leslie
Green and Kathryn Boyer for helping witfl
the tympanometry; and the nurses irl dhe
Outpatient Medical Clinic for their hel~
and patience.
REFERENCES
1. Shurin PA, Pelton SI, Donner A, 'G a]!:
Persistence of middle ear effusion after
acute otitis media in children. N Ez;!.gl ]
Med 300:1121-1123, 1979.
2. Olmsted RW, Alvarez MC, Moroney ~D,,
et ah The pattern of hearing following
acute otitis media. J Pediatr 65:252.255,
1964.
3. Howie VM: Developmental sequelae of
chronic otitis media: A review. J Dev &~,..
hav Pediatr 1:34-38, 1980.
4. Zinkus PW, Gottlieb MI: Patte:m~ of
perceptual and academic deficits related, to
early chronic otitis media. Pediatrics 66::
246-253, 1980.
5. Olson AL, Klein SW, Chamey E, et al::
Prevention and therapy of serous otitis
media by oral decongestants: A double-
blind study in pediatric practice. Pediatrics
61:679-684, 1978.
15/39
OTITIS MEDIA
8hambhani et al

6. Paradise JL, Smith CG, Bluestone CD:
Tympanometric detection of middle ear
effusion in infants and young children.
Pediatrics 58:198-210, 1976.
7. Stickler GB, Rubenstein, MM, McBean
JB, et al: Treatment of acute otitis media in
children. Am J Dis Child 114:123-130, 1967.
8. Miller GF: Influence of an oral decon-
gestant on eustachian tube function in
children. J Allergy 45:187-193, 1970.
9. Rubenstein MM, McBean JB, Hedgecock
LD, et al: The treatment of acute otitis
media in children. A third clinical trial.
Am J Dis Ch~dd 109:308-313, 1965.
10. Therapeutic uses of sympathomimetic
drugs, in Gilman AG, Goodman L8 (eds):
The Pharmacological Basis of Therapeu-
tics, ed 6. New York, MacMillan, 1980, p
168-169.
11. Histamine antagonists: H1 and H2
blocking agents, in Gilman AG, Goodman
LS (eds): The Pharmacological Basis of
Therapeutics, ed 6. New York, MacMillan,
1980, p 622-629.

UAEM Call for Abstracts

The Copley Plaza Hotel in Boston, Massachusetts, will be the site of the 13th UAEM Annual Meeting June 2-4,
1983.
Program Chairman Richard F. Edlich, MD, PhD, has announced that he will accept abstracts for the scientific
papers to be presented at the Annual Meeting. Members and others in the field are urged to submit original contribu-
tions relating to emergency medicine. Papers submitted by non-UAEM members must be accompanied by a letter of
sponsorship from a UAEM member.
Abstracts should be limited to 250 words and typed double-spaced on 81/£xll " paper. Abstracts must be au-
thored, co-authored, or sponsored by a UAEM member. The abstract must not include the identities of the authors or
the sponsoring institution to insure anonymity while the abstracts are being reviewed by the Program Committee. A
cover sheet must be attached to the abstract and must include the full names and titles of all authors, as well as the
institution. A notation must be included indicating which author will present the paper at the Annual Meeting should the
paper be accepted for presentation. Include the appropriate category (see below).
Deadline for submission is February 1, 1983/ Mail five copies of the abstract to: UAEM, 900 West Ottawa,
Lansing, Michigan 48915.
Presentations at the Annual Meeting will be limited to 10 minutes followed by a five minute discussion period. A
completed manuscript must be submitted no later than the day of the presentation at the meeting. Annals of Emergen-
cy Medicine, the official journal of the American College of Emergency Physicians and the University Association for
Emergency Medicine, reserves the right of first refusal on all scientific papers presented at the UAEM Annual Meeting.
If Annals does not notify authors, in writing, of its intent to publish by September 1, 1983, authors reserve the right to
submit papers to other publications.

SUGGESTIONS FOR WRITING ABSTRACTS

An abstract should be factual, clearly conveying the reason for the work, the methods, the results and their signifi-
cance. To make your abstract more readable, follow these guidelines:
1. Brief introduction stating why the work was done.
2. Tables and charts are not appropriate for abstracts.
3. Clearly state methods used, as well as whatever limitations the
methods may have.
4. Clearly state results in numerical or tabular form, if appropriate. Has
statistical significance been achieved?
5. Brief discussion of what the results indicate.
6. Conclusion stating the relevance of these particular findings to
emergency medicine. Check appropriate category:
Be sure to present the data in the abstracts. Avoid generalities such as [ ] Gastrointestinal
"the significance of these results.will be discussed," or "the management will [ ] Cardiovascular
be outlined." [ ] EMS
[ ] Trauma
[ ] Methods and Techniques
[ ] Infections
[ ] ED Administration
[ ] Psychosocial
[ ] Respiratory
[ ] Burns
[ ] Prehospital Care

40/16 Annals of Emergency Medicine 12:1 January 1983