The Efficacy of Oral Steroids in the Treatment of Persistent Otitis Media With Effusion Ludwig Podoshin, MD; Milo Fradis, MD; Yacov Ben-David, MD; David Faraggi, \s=b\ One hundred thirty-six children with otitis media with effusion of at least 2 months' duration were investigated in a strict, double-blind, randomized prospective study to evaluate the efficacy of oral steroids in the treatment of this disease. The results of our study showed a significant complete and partial recovery from otitis media with effusion in the group treated by a combination of antibiotics (amoxicillin) and oral steroids (prednisone), compared with an amoxicillin\x=req-\ treated group and a placebo-treated group. We believe that this treatment mostly benefits children aged 4 to 10 years without oversized adenoids. The findings of our study imply that a combined course of antibiotics and oral steroids deserves its place as a routine conservative trial before surgery. (Arch Otolaryngol Head Neck Surg.
1990;116:1404-1406)
Accepted for publication June 19,1990. From the Department of Otolaryngology, Bnai
Zion Medical Center (Drs Podoshin, Fradis, and Ben-David), the Department of Medicine, Technion-Israel Institute of Technology (Drs Podoshin, Fradis, and Ben-David), and the Department of Statistics, Haifa University (Dr Faraggi), Haifa, Israel. Presented in part at the Conference on the Eustachian Tube and Middle Ear Diseases, Gene-
Switzerland, October 29,1989. Reprint requests to Department of Otolaryngology, Bnai Zion Medical Center, PO Box 4940, va,
Haifa 31096, Israel.
PhD
Otitis
media with effusion (OME) is of the most common diseases in otolaryngological practice and if not treated in time is apt to be accompa¬ nied by a wide range of complica¬ tions.13 In the conservative treatment of OME, the role of oral steroids is controversial. In 1975 Oppenheimer4 treated 922 children with oral steroids and re¬ ported that children older than 8 years one
responded favorably. In a later study, Persico et al3 found
that 53% of children treated with a combination of prednisone and ampi¬ cillin achieved complete otoscopie, au¬ diometrie and tympanometric resolu¬ tion of the effusion. More recently, Schwartz et al5, in a double-blind study of 41 children who had persistent OME for 3 weeks or more and who were treated with a short course of prednisone, reported resolution of OME in 70% by pneumootoscopy and in 64% by tympanome-
try.
Niederman et al6 studied 22 children with middle ear effusion of at least 2 months' duration and found that after 2 weeks of treatment with dexametha¬ sone twice as many ears were clear as compared with the placebo group. Other studies challenged the good re-
suits of steroids in the conservative treatment of OME. Thus, Macknin and Jones7 found no difference between
dexamethasone and placebo, and Lambert8 reported that the combina¬ tion of prednisone and amoxicillin was no more effective than placebo or amoxicillin alone in double-blind study of 60 children with OME of at least 2 months' duration. In our department we have used the combination of oral steroids and anti¬ biotics in the treatment of OME for approximately 20 years, with good re¬ sults. To avoid the criticism of other investigators,7-8 we decided to perform a double-blind, strictly randomized study to evaluate the efficacy of oral steroids in the treatment of persistent OME. PATIENTS AND METHODS A total of 136 children with OME of at least 2 months' duration entered this study.
They were seen in the Department of Oto¬ laryngology, Bnai Zion Medical Center, Haifa, Israel, between September 1987 and
December 1988. The children were referred us by otolaryngologists associated with our department; they were treated ran¬ domly by our directions and were followed up in their outpatient clinics. The children so treated were sent up for a final evalua¬ tion 2 months after the beginning of treatto
Downloaded From: http://archotol.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/25/2015
(mean age, 6.7 years) who were treated by placebo alone (divided into two capsules). The placebo consisted of lactose powder placed in capsules that were identical to those containing the pulverized prednisone. Two months after the beginning of the trial, a clinical and audiologic (including a tympanogram) réévaluation was performed. The amoxicillin, prednisone, and placebo capsules were specially prepared in the hospital pharmacy, and the amount of med¬
ment. All the children that entered this no previous treatment for
study received
their OME. Children with recurrent acute otitis me¬ dia, cleft palate, and hypertrophie adenoids and those younger than 4 years were ex¬ cluded from the study. The diagnosis of hy¬ pertrophie adenoids was made by anamne¬ sis clinical evaluation and lateral skull roentgenography. The adenoidal-nasopharyngeal ratio was measured as described by Fujioka et al.' Children with an adenoidalnasopharyngeal ratio greater than 073,10 which was indicative of pathologic enlarge¬ ment of the adenoids, were also excluded from this study. The diagnosis of OME was made by pneumo-otoscopy using a 3.5-V
Welch-Allyn
halogen-illuminated
ication for every child that entered this study was given to the treating physicians. The criteria for success were a normal eardrum, a closure of the air-bone gap, and a normal tympanogram (type A). The pres¬ ence of tympanic retraction, some conduc¬ tive hearing loss, or a tympanogram type C was considered as partial improvement and as a need for further treatment. No im¬ provement at all was the third possibility. The initial number of the children that entered this study was 150 (50 for every age group). Unfortunately, not all of the treated children showed up for the final evaluation, so the statistical evaluation had to be made on unidentical groups. The audiometrie and tympanometric evaluations were per¬ formed only on the ear with the worst airbone gap, and the results of the differences between pretreatment and posttreatment were calculated. The tympanometric find¬
oto¬
scope.
Children with signs of fluid lines, air bubbles, or yellow fluid, which indicated an already resolving effusion, were not in¬ cluded in the study." Each child underwent pure tone and speech audiometry (GresonStadler GSI10 audiometer). A tympanogram was obtained with a middle ear ana¬ lyzer (GSI-1723). If OME was diagnosed by pneumo-otoscopy and the tympanogram was flat (Jerger type B), the child was included in the study. The children who met these criteria were randomly divided into three groups. The first group of 49 children (mean age, 7.3 years) received amoxicillin (50 mg/kg) and placebo for 2 weeks. The second group of 50 children (mean age, 6.5 years) received amoxicillin (50 mg/kg) and prednisone (1 mg/kg). The dosage was reduced by 5 mg every 2 days. The treatment was accord¬ ingly administered for 14 days. The tablets of prednisone were pulverized and packed in unmarked gelatin capsules. The third group consisted of 37 children
ings were graded according to severity us¬ ing the following types: type A, 1; type C, 2; and type B, 3. The otoscopie findings were graded according to four degrees of severity as follows: normal eardrum, 0; no light re¬ flex, 1; tympanic retraction, 3; and presence of fluid, 4. The continuous results of the air-bone gap were evaluated using the one-way anal¬
ysis of variance procedure and the Duncan test, to evaluate differences between the treatment groups.
The results of otoscopy and tympanometry were statistically evaluated using the 2
Table 1.—Age and Sex Distribution Treat-
ment
No. of
Group Subjects 49 50 37
1
2 3
Age
Mean
Range,
Age,
y_y^ 4-8
3-7 3-7
Table
test for
contingency tables. RESULTS
Sex
The age and sex distribution of the different treatment groups is pre¬ sented in Table 1, which shows that there is much similarity between the
,- —
7.3 6.5
27
22
25
6.7
20
25 17
2.—Improvement
Rate of Air-bone
Gap
and
Tympanometric Severity
three
groups.
The
posttreatment
change rate is summarized in Table 2.
In Table 3 pretreatment and posttreat¬ ment differences between the three groups are summarized using the ap¬ propriate tests. A clear statistical dif¬ ference between the treated groups is obtained. The results of the differences between the three treated groups are summarized in Table 4. COMMENT
The common pathophysiologic fac¬ tor in most cases of OME is believed to be some degree of eustachian tube
dysfunction leading to hypoventilation and deficient drainage of the middle ear.12 Sade13 tends to blame the mucociliary
drainage system dysfunction
of the Different
Groups
Effect of Treatment, No. (%)
Complete Improvement
Partial
Treatment
Group
Audiometry 20 (40) 20 (40) 0(0)
Tympanometry 15 (30)
20 (40) 0 (0)
Audiometry 9 (20) 25 (50) 21 (57)
Improvement Tympanometry 5(10) 20 (40) 5 (14.5)
as
the major factor responsible for OME. The logic of using a combined antimi¬ crobial and steroid treatment in OME is to facilitate the surfactant pro¬ duction,3 thereby decreasing the vis¬ cosity of middle ear fluid, reducing the edema around the torus,5 and destroy¬ ing the bacteria in the nasopharynx14 and the potential pathogens in the fluid itself.15 The favorable results of short-term steroid therapy combined with antibiotic therapy reported ear¬ lier in the literature3·416 were criticized as being retrospective and poorly controlled.8 Niederman et al6 reported good re¬ sults in treating 22 children with OME with dexamethasone, but because of the small number of patients, the re¬ sults were not statistically significant. In the study of Macknin and Jones,7 the effusion disappeared within 6 weeks in only 6% of 49 patients treated with dexamethasone. Lambert8 conducted a double-blind, prospective, random¬ ized, crossover study and found no dif¬ ference between the group treated with amoxicillin and placebo and the
No Improvement
Audiometry 20 (40) 5(10) 16 (43)
Downloaded From: http://archotol.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/25/2015
Tympanometry (60) (20) 32 (85.5)
29
10
Table 3. Pretreatment and Posttreatment Differences Between the Three Groups
Table 4.—Results of
Otoscopy Severity
Tail
_Probability Otoscopy Tympanometry Air-bone gap
2 2
F
=
» =
35.5 35.5 16.38
< .000 < .000
Otoscopie, Tympanometric,
and Air-Bone
Gap Severity
Differences, Before and After Treatment*
—
Groups Compared
< .000
Value
1 and 2
20.0
1 and 3
5.2
.001
Tympanometry Severity Value
2 16.0
.000
Air-bone
Difference
Gap (Duncan's) Significance
6.03 4.68
2 and 3
*Plus sign
group treated wtih amoxicillin and
prednisone. Our study, which was also doubleblind and randomized, showed that the
group treated with amoxicillin and steroids had a much better response than the group treated with placebo or amoxicillin alone. As the number of patients was 50, these results are sta¬ tistically significant (Tables 2 through
4). Our results contradict those of Lambert,8 who did not find any sub¬ group of patients that benefited from the steroid therapy.
We think that the main differences between Lambert's8 results and ours can be explained by the age of the pa¬ tients and the size of the adenoids. The children who entered Lambert's study were between 2 and 15 years of age while in our study the age range was 4 to 10 years. Children younger than 3 years are prone to suffer from recur¬ rent acute otitis media17 and are not good candidates for oral steroid ther-
indicates
positive.
apy. Also, according to our previous experience, children with hypertrophic adenoids do not benefit from steroid therapy. In the work of Lam¬ bert, the size of the adenoids was not a
so this may be a factor in the differences between his and our results. The most common pathophysiologic factor of OME in children 4 to 10 years of age is some degree of eustachian tube dysfunction leading to hypoven¬ tilation and deficient drainage of the middle ear.12 One of the causes of this dysfunction could be the lack of sur¬ factant, and steroids could play a ben¬ eficial role in facilitating tubai surfac¬
parameter,
tant
production,35 thereby enhancing
the return of normal tubai function. The anti-inflammatory and antiedematous properties of steroids could con¬ tribute to this result.5-14 Based on the results of our study, it seems to us that short-term treatment
with a combination of steroids and an¬ tibiotics should have a place in the final stages of the conservative ther¬ apy before a surgical procedure is ini¬ tiated. We think that this course of treatment should not be given indis¬ criminately to all children suffering from persistent OME. The patients who are more likely to benefit from this type of treatment are those aged 4 to 10 years who do not have oversized adenoids. More investigations should be car¬ ried out to find the optimal time for initiation of treatment and the opti¬ mal dose of steroids. Meanwhile, we believe that our proposed combined treatment of steroids and antibiotics deserves its place as a routine conser¬ vative trial before surgery. We wish to thank Hilel Pratt, PhD, of the Evoked Potentials Laboratory of the TechnionIsrael Institute of Technology, Haifa, Israel, for his help.
References 1. Smyth GDL. Postoperative cholesteatoma in combined approach tympanoplasty: fifteen-year report on tympanoplasty. J Laryngol Otol. 1975; 90:597-623. 2. Cowan DL, Brown JKM. Seromucinous otitis media and its sequelae. J Laryngol Otol. 1974; 88:1237-1247. 3. Persico M, Podoshin L, Fradis M. Otitis media with effusion: a steroid and antibiotic therapeutic trial before surgery. Ann Otol Rhinol
Laryngol. 1978;87:191-197. 4. Oppenheimer RP. Serous otitis media: a review of 922 patients. Ear Nose Throat J. 1975;
54:37-40. 5. Schwartz RH, Puglese J, Schwartz DM. Use of a short course of prednisone for treating middle ear effusion: a double-blind crossover study. Ann Otol Rhinol Laryngol. 1980;89:296-300. 6. Niederman LG, Walter-Bucholz V, Jabalay T. A comparative trial of steroids versus placebos for treatment of chronic otitis media with effu-
sion. In: Lim DJ, Bluestone DC, Klein JO, Nelson JD, eds. Recent Advances in Otitis Media With Effusion. Philadelphia, Pa: BC Decker Inc;
Laryngol. 1980;89:5-6. 12. Paparella MM. Pathogenesis of middle ear effusion. Ann Otol Rhinol Laryngol. 1976;85(suppl
1986;95:193-199. 9. Fujioka M, Young LW, Girdong BR. Radio-
rent and chronic otitis media with effusion. J Pe-
1984:273-375. 7. Macknin ML, Jones PK. Oral dexamethasone for treatment of persistent middle ear effusion. Pediatrics. 1985;75:329-335. 8. Lambert PR. Oral steroid therapy for chronic middle ear perfusion: a double-blind crossover study. Otolaryngol Head Neck Surg.
logic evaluation of adenoidal size in children: adenoidal-nasopharyngeal ratio. Am J Radiol. 1979;
133:401-404. 10. Elweny S. The adenoidal-nasopharyngeal ratio (AN ratio): its validity in selecting children for adenoidectomy. J Laryngol Otol. 1987;101:569\x=req-\ 573. 11. Teele DW, Klein JO, Rosner BA. Epidemiology of otitis media in children. Ann Otol Rhinol
25):63-65. 13. Sade J. Mucociliary flow in middle ear. Ann Otol Rhinol Laryngol. 1971;80:336-372. 14. Brookler KH. Factors in nonsuppurative otitis media. Laryngoscope. 1975;85:1882-1886. 15. Riding KH, Bluestone CD, Michaels RH, Cantekin ET, Doyle WJ. Microbiology of recur-
diatr. 1978;93:736-743. 16. Heisse JW. Secretory otitis media treatment with depomethyl prednisolone. Laryngoscope.
1963;73:54-59. M, Podoshin L, Fradis M,
17. Persico
et al. Re-
prophylactic penicillin treatment; a prospective study: part I. Int J Pediatr Otorhinolaryngol. 1985;10;37-46. current acute otitis media
Downloaded From: http://archotol.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/25/2015
1990;116:1404-1406)
Accepted for publication June 19,1990. From the Department of Otolaryngology, Bnai
Zion Medical Center (Drs Podoshin, Fradis, and Ben-David), the Department of Medicine, Technion-Israel Institute of Technology (Drs Podoshin, Fradis, and Ben-David), and the Department of Statistics, Haifa University (Dr Faraggi), Haifa, Israel. Presented in part at the Conference on the Eustachian Tube and Middle Ear Diseases, Gene-
Switzerland, October 29,1989. Reprint requests to Department of Otolaryngology, Bnai Zion Medical Center, PO Box 4940, va,
Haifa 31096, Israel.
PhD
Otitis
media with effusion (OME) is of the most common diseases in otolaryngological practice and if not treated in time is apt to be accompa¬ nied by a wide range of complica¬ tions.13 In the conservative treatment of OME, the role of oral steroids is controversial. In 1975 Oppenheimer4 treated 922 children with oral steroids and re¬ ported that children older than 8 years one
responded favorably. In a later study, Persico et al3 found
that 53% of children treated with a combination of prednisone and ampi¬ cillin achieved complete otoscopie, au¬ diometrie and tympanometric resolu¬ tion of the effusion. More recently, Schwartz et al5, in a double-blind study of 41 children who had persistent OME for 3 weeks or more and who were treated with a short course of prednisone, reported resolution of OME in 70% by pneumootoscopy and in 64% by tympanome-
try.
Niederman et al6 studied 22 children with middle ear effusion of at least 2 months' duration and found that after 2 weeks of treatment with dexametha¬ sone twice as many ears were clear as compared with the placebo group. Other studies challenged the good re-
suits of steroids in the conservative treatment of OME. Thus, Macknin and Jones7 found no difference between
dexamethasone and placebo, and Lambert8 reported that the combina¬ tion of prednisone and amoxicillin was no more effective than placebo or amoxicillin alone in double-blind study of 60 children with OME of at least 2 months' duration. In our department we have used the combination of oral steroids and anti¬ biotics in the treatment of OME for approximately 20 years, with good re¬ sults. To avoid the criticism of other investigators,7-8 we decided to perform a double-blind, strictly randomized study to evaluate the efficacy of oral steroids in the treatment of persistent OME. PATIENTS AND METHODS A total of 136 children with OME of at least 2 months' duration entered this study.
They were seen in the Department of Oto¬ laryngology, Bnai Zion Medical Center, Haifa, Israel, between September 1987 and
December 1988. The children were referred us by otolaryngologists associated with our department; they were treated ran¬ domly by our directions and were followed up in their outpatient clinics. The children so treated were sent up for a final evalua¬ tion 2 months after the beginning of treatto
Downloaded From: http://archotol.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/25/2015
(mean age, 6.7 years) who were treated by placebo alone (divided into two capsules). The placebo consisted of lactose powder placed in capsules that were identical to those containing the pulverized prednisone. Two months after the beginning of the trial, a clinical and audiologic (including a tympanogram) réévaluation was performed. The amoxicillin, prednisone, and placebo capsules were specially prepared in the hospital pharmacy, and the amount of med¬
ment. All the children that entered this no previous treatment for
study received
their OME. Children with recurrent acute otitis me¬ dia, cleft palate, and hypertrophie adenoids and those younger than 4 years were ex¬ cluded from the study. The diagnosis of hy¬ pertrophie adenoids was made by anamne¬ sis clinical evaluation and lateral skull roentgenography. The adenoidal-nasopharyngeal ratio was measured as described by Fujioka et al.' Children with an adenoidalnasopharyngeal ratio greater than 073,10 which was indicative of pathologic enlarge¬ ment of the adenoids, were also excluded from this study. The diagnosis of OME was made by pneumo-otoscopy using a 3.5-V
Welch-Allyn
halogen-illuminated
ication for every child that entered this study was given to the treating physicians. The criteria for success were a normal eardrum, a closure of the air-bone gap, and a normal tympanogram (type A). The pres¬ ence of tympanic retraction, some conduc¬ tive hearing loss, or a tympanogram type C was considered as partial improvement and as a need for further treatment. No im¬ provement at all was the third possibility. The initial number of the children that entered this study was 150 (50 for every age group). Unfortunately, not all of the treated children showed up for the final evaluation, so the statistical evaluation had to be made on unidentical groups. The audiometrie and tympanometric evaluations were per¬ formed only on the ear with the worst airbone gap, and the results of the differences between pretreatment and posttreatment were calculated. The tympanometric find¬
oto¬
scope.
Children with signs of fluid lines, air bubbles, or yellow fluid, which indicated an already resolving effusion, were not in¬ cluded in the study." Each child underwent pure tone and speech audiometry (GresonStadler GSI10 audiometer). A tympanogram was obtained with a middle ear ana¬ lyzer (GSI-1723). If OME was diagnosed by pneumo-otoscopy and the tympanogram was flat (Jerger type B), the child was included in the study. The children who met these criteria were randomly divided into three groups. The first group of 49 children (mean age, 7.3 years) received amoxicillin (50 mg/kg) and placebo for 2 weeks. The second group of 50 children (mean age, 6.5 years) received amoxicillin (50 mg/kg) and prednisone (1 mg/kg). The dosage was reduced by 5 mg every 2 days. The treatment was accord¬ ingly administered for 14 days. The tablets of prednisone were pulverized and packed in unmarked gelatin capsules. The third group consisted of 37 children
ings were graded according to severity us¬ ing the following types: type A, 1; type C, 2; and type B, 3. The otoscopie findings were graded according to four degrees of severity as follows: normal eardrum, 0; no light re¬ flex, 1; tympanic retraction, 3; and presence of fluid, 4. The continuous results of the air-bone gap were evaluated using the one-way anal¬
ysis of variance procedure and the Duncan test, to evaluate differences between the treatment groups.
The results of otoscopy and tympanometry were statistically evaluated using the 2
Table 1.—Age and Sex Distribution Treat-
ment
No. of
Group Subjects 49 50 37
1
2 3
Age
Mean
Range,
Age,
y_y^ 4-8
3-7 3-7
Table
test for
contingency tables. RESULTS
Sex
The age and sex distribution of the different treatment groups is pre¬ sented in Table 1, which shows that there is much similarity between the
,- —
7.3 6.5
27
22
25
6.7
20
25 17
2.—Improvement
Rate of Air-bone
Gap
and
Tympanometric Severity
three
groups.
The
posttreatment
change rate is summarized in Table 2.
In Table 3 pretreatment and posttreat¬ ment differences between the three groups are summarized using the ap¬ propriate tests. A clear statistical dif¬ ference between the treated groups is obtained. The results of the differences between the three treated groups are summarized in Table 4. COMMENT
The common pathophysiologic fac¬ tor in most cases of OME is believed to be some degree of eustachian tube
dysfunction leading to hypoventilation and deficient drainage of the middle ear.12 Sade13 tends to blame the mucociliary
drainage system dysfunction
of the Different
Groups
Effect of Treatment, No. (%)
Complete Improvement
Partial
Treatment
Group
Audiometry 20 (40) 20 (40) 0(0)
Tympanometry 15 (30)
20 (40) 0 (0)
Audiometry 9 (20) 25 (50) 21 (57)
Improvement Tympanometry 5(10) 20 (40) 5 (14.5)
as
the major factor responsible for OME. The logic of using a combined antimi¬ crobial and steroid treatment in OME is to facilitate the surfactant pro¬ duction,3 thereby decreasing the vis¬ cosity of middle ear fluid, reducing the edema around the torus,5 and destroy¬ ing the bacteria in the nasopharynx14 and the potential pathogens in the fluid itself.15 The favorable results of short-term steroid therapy combined with antibiotic therapy reported ear¬ lier in the literature3·416 were criticized as being retrospective and poorly controlled.8 Niederman et al6 reported good re¬ sults in treating 22 children with OME with dexamethasone, but because of the small number of patients, the re¬ sults were not statistically significant. In the study of Macknin and Jones,7 the effusion disappeared within 6 weeks in only 6% of 49 patients treated with dexamethasone. Lambert8 conducted a double-blind, prospective, random¬ ized, crossover study and found no dif¬ ference between the group treated with amoxicillin and placebo and the
No Improvement
Audiometry 20 (40) 5(10) 16 (43)
Downloaded From: http://archotol.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/25/2015
Tympanometry (60) (20) 32 (85.5)
29
10
Table 3. Pretreatment and Posttreatment Differences Between the Three Groups
Table 4.—Results of
Otoscopy Severity
Tail
_Probability Otoscopy Tympanometry Air-bone gap
2 2
F
=
» =
35.5 35.5 16.38
< .000 < .000
Otoscopie, Tympanometric,
and Air-Bone
Gap Severity
Differences, Before and After Treatment*
—
Groups Compared
< .000
Value
1 and 2
20.0
1 and 3
5.2
.001
Tympanometry Severity Value
2 16.0
.000
Air-bone
Difference
Gap (Duncan's) Significance
6.03 4.68
2 and 3
*Plus sign
group treated wtih amoxicillin and
prednisone. Our study, which was also doubleblind and randomized, showed that the
group treated with amoxicillin and steroids had a much better response than the group treated with placebo or amoxicillin alone. As the number of patients was 50, these results are sta¬ tistically significant (Tables 2 through
4). Our results contradict those of Lambert,8 who did not find any sub¬ group of patients that benefited from the steroid therapy.
We think that the main differences between Lambert's8 results and ours can be explained by the age of the pa¬ tients and the size of the adenoids. The children who entered Lambert's study were between 2 and 15 years of age while in our study the age range was 4 to 10 years. Children younger than 3 years are prone to suffer from recur¬ rent acute otitis media17 and are not good candidates for oral steroid ther-
indicates
positive.
apy. Also, according to our previous experience, children with hypertrophic adenoids do not benefit from steroid therapy. In the work of Lam¬ bert, the size of the adenoids was not a
so this may be a factor in the differences between his and our results. The most common pathophysiologic factor of OME in children 4 to 10 years of age is some degree of eustachian tube dysfunction leading to hypoven¬ tilation and deficient drainage of the middle ear.12 One of the causes of this dysfunction could be the lack of sur¬ factant, and steroids could play a ben¬ eficial role in facilitating tubai surfac¬
parameter,
tant
production,35 thereby enhancing
the return of normal tubai function. The anti-inflammatory and antiedematous properties of steroids could con¬ tribute to this result.5-14 Based on the results of our study, it seems to us that short-term treatment
with a combination of steroids and an¬ tibiotics should have a place in the final stages of the conservative ther¬ apy before a surgical procedure is ini¬ tiated. We think that this course of treatment should not be given indis¬ criminately to all children suffering from persistent OME. The patients who are more likely to benefit from this type of treatment are those aged 4 to 10 years who do not have oversized adenoids. More investigations should be car¬ ried out to find the optimal time for initiation of treatment and the opti¬ mal dose of steroids. Meanwhile, we believe that our proposed combined treatment of steroids and antibiotics deserves its place as a routine conser¬ vative trial before surgery. We wish to thank Hilel Pratt, PhD, of the Evoked Potentials Laboratory of the TechnionIsrael Institute of Technology, Haifa, Israel, for his help.
References 1. Smyth GDL. Postoperative cholesteatoma in combined approach tympanoplasty: fifteen-year report on tympanoplasty. J Laryngol Otol. 1975; 90:597-623. 2. Cowan DL, Brown JKM. Seromucinous otitis media and its sequelae. J Laryngol Otol. 1974; 88:1237-1247. 3. Persico M, Podoshin L, Fradis M. Otitis media with effusion: a steroid and antibiotic therapeutic trial before surgery. Ann Otol Rhinol
Laryngol. 1978;87:191-197. 4. Oppenheimer RP. Serous otitis media: a review of 922 patients. Ear Nose Throat J. 1975;
54:37-40. 5. Schwartz RH, Puglese J, Schwartz DM. Use of a short course of prednisone for treating middle ear effusion: a double-blind crossover study. Ann Otol Rhinol Laryngol. 1980;89:296-300. 6. Niederman LG, Walter-Bucholz V, Jabalay T. A comparative trial of steroids versus placebos for treatment of chronic otitis media with effu-
sion. In: Lim DJ, Bluestone DC, Klein JO, Nelson JD, eds. Recent Advances in Otitis Media With Effusion. Philadelphia, Pa: BC Decker Inc;
Laryngol. 1980;89:5-6. 12. Paparella MM. Pathogenesis of middle ear effusion. Ann Otol Rhinol Laryngol. 1976;85(suppl
1986;95:193-199. 9. Fujioka M, Young LW, Girdong BR. Radio-
rent and chronic otitis media with effusion. J Pe-
1984:273-375. 7. Macknin ML, Jones PK. Oral dexamethasone for treatment of persistent middle ear effusion. Pediatrics. 1985;75:329-335. 8. Lambert PR. Oral steroid therapy for chronic middle ear perfusion: a double-blind crossover study. Otolaryngol Head Neck Surg.
logic evaluation of adenoidal size in children: adenoidal-nasopharyngeal ratio. Am J Radiol. 1979;
133:401-404. 10. Elweny S. The adenoidal-nasopharyngeal ratio (AN ratio): its validity in selecting children for adenoidectomy. J Laryngol Otol. 1987;101:569\x=req-\ 573. 11. Teele DW, Klein JO, Rosner BA. Epidemiology of otitis media in children. Ann Otol Rhinol
25):63-65. 13. Sade J. Mucociliary flow in middle ear. Ann Otol Rhinol Laryngol. 1971;80:336-372. 14. Brookler KH. Factors in nonsuppurative otitis media. Laryngoscope. 1975;85:1882-1886. 15. Riding KH, Bluestone CD, Michaels RH, Cantekin ET, Doyle WJ. Microbiology of recur-
diatr. 1978;93:736-743. 16. Heisse JW. Secretory otitis media treatment with depomethyl prednisolone. Laryngoscope.
1963;73:54-59. M, Podoshin L, Fradis M,
17. Persico
et al. Re-
prophylactic penicillin treatment; a prospective study: part I. Int J Pediatr Otorhinolaryngol. 1985;10;37-46. current acute otitis media
Downloaded From: http://archotol.jamanetwork.com/ by a University of Arizona Health Sciences Library User on 05/25/2015
