Abstract
Objective: There is only limited knowledge of the factors influencing the results of nonsurgical treatment of secretory otitis media (SOM). The present study was carried out to determine the effect of middle ear inflation and to examine the factors affecting the results of conservative treatment of SOM in children. Methods: A total of 158 children with SOM were randomized to either a group receiving treatment with middle ear (ME) inflation for 10 days 3/day, or to a group receiving ME inflation and antibiotics (oral Amoxicillin 50 mg/kg 3/day) for 10 days, or to a control group. A wide variety of anamnestic and clinical pre-treatment variables were assessed by administered questionnaires. Pneumo-otoscopy, tympanometry and pure-tone audiometry were performed before the treatment and at the 3rd–5th, 10th±2 and 60th±5 days of the study. For the prognostic factors, univariate analyses were first performed to determine the significant predictors, which were afterwards entered into a stepwise logistic regression model. Results: There was no difference in the effectiveness of treatment between Groups A and B, neither on the 10th (46.1% and 52.2%, respectively, controls: 9%, p<0.001) nor on the 60th day (37.3% and 42.4%, control group: 15.7%, p<0.001), of the study. The most important prognostic criteria were defined by analysing the dynamics of tympanometry (OR: 3.24) and audiometry (OR: 8.77) during conservative treatment. The results of the treatment were related to age, the duration of the disease, the previous otologic history, and the nasopharyngeal colonization and the position of the adenoids. Conclusion: The results suggest that daily middle ear inflation can be an effective treatment of SOM for children, having regard to the factors significant for the prognosis of treatment.
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doi:10.1016/S0531-5131(03)01087-2
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Contents
1. Introduction
Secretory otitis media (SOM) is the inflammatory middle ear disease with a heterogeneous and unpredictable course. The effectiveness of conservative methods of treatment of SOM (middle ear inflation or antibiotic therapy) is insufficient, and there is no one opinion concerning their application. There is only limited knowledge about the factors that influence the results of nonsurgical treatment of secretory otitis media in children. Therefore, the present study was carried out to determine the effect of middle ear inflation and to examine the factors affecting the results of conservative treatment of SOM in children.
2. Methods
A total of 158 children with SOM were enrolled in this study. Their ages ranged from 3 to 16, with the average of 8.5±3.6 years. The inclusion criteria included untreated unilateral or bilateral SOM for at least 4 weeks, abnormal tympanometric traces (type B in 85.6% of cases, C2 in 14.4%), air-bone gap equal to or greater than 20 dB at the four-frequency pure tone average. A wide variety of anamnestic and clinical pre-treatment variables were assessed by administered questionnaires. Hearing results were reported using a four-frequency (0.5, 1, 2 and 4 kHz) pure-tone average air-bone gap (PTA-ABG).
The patients were randomized to either a group receiving treatment with middle ear inflation 2/day for 10 days (56 patients, 102 ears, Group A) or to a group receiving ME inflation 2/day and antibiotics (oral Amoxicillin 40 mg/kg/day) for 10 days (50 patients, 92 ears, Group B) or to a control group being observed without treatment (52 patients, 89 ears). All the patients were prescribed nasal decongestants (Sol. Xylomethasolini 0.05% 3/day for 7 days). The inflations were performed by the Politzer method using controlled airflow pressure. Pneumo-otoscopy, tympanometry and pure-tone audiometry were performed before the treatment and at the 3rd–5th, 10th±2 and 60th±5 days of the study. An original score system (from 1 to 4 scores) was applied to assess the results of each test. Based on the sum of the scores, the result of treatment was then assessed as not effective (unimproved), insufficient (improved) or effective (recovered). Interrelation between the study factors and the treatment results was assessed using c2 test.
3. Results
On the 10th day of the study, treatment was effective for 46.1% of cases in Group A and 52.2% in Group B (controls: 9.0%, p<0.001). On the 60th day, the number of recovered cases substantially decreased in Group A (p<0.001) and in Group B (p<0.01). On the 60th day of study, there were 37.3% recovered cases in Group A and 42.4% in Group B (controls: 15.7%, p<0.001). No improvement on the 60th day of study was assessed for 34.3% ears in Group A, 25.0% in Group B and 58.5% ears in the control group, respectively. The treatment was more effective for patients with the unilateral course of the disease (p<0.001).
To determine the relative importance of analyzed findings as a prognostic contributive factor, and because of intercorrelation between these variables, stepwise logistic regression was carried out and positive/negative prognostic value of these factors was assessed (Table 1).
| OR | 95% CI | p value | |
|---|---|---|---|
| Positive prognostic factors | |||
| Duration<8 weeks | 2.34 | 1.52–3.63 | 0.000 |
| Unilateral | 1.72 | 1.19–2.48 | 0.016 |
| No previous episodes of SOM | 1.83 | 1.3–2.62 | 0.001 |
| Negative history of atopy | 1.45 | 1.05–2.00 | 0.024 |
| Nasopharyngeal bacteriology (no growth) | 2.12 | 1.56–2.89 | 0.000 |
| PTA-ABG<30 dB before treatment | 2.48 | 1.62–3.79 | 0.000 |
| A, C1 tympanogram on the 3rd–5th days | 3.24 | 2.57–4.08 | 0.049 |
| A or C1 tympanogram on the 10th day | 3.54 | 2.39–5.25 | 0.000 |
| Negative prognostic factors | |||
| Age 3–6 years | 2.03 | 1.45–2.85 | 0.000 |
| Blocked pharyngeal orifice of ET | 2.42 | 1.29–4.51 | 0.002 |
| The distance from the vomer to the adenoids | 2.16 | 1.42–3.27 | 0.000 |
| <5 mm | 4.71 | 1.57–14.08 | 0.001 |
| B tympanogram before treatment | 26.96 | 3.89–189.24 | 0.000 |
| Tw<150 mmho on the 3rd–5th days | 3.98 | 2.34–6.77 | 0.000 |
| Tw<150 mmho on the 10th day | 8.77 | 2.88–26.72 | 0.000 |
| PTA-ABG ³ 15 dB on the 3rd–5th days | 5.51 | 2.59–10.85 | 0.000 |
| PTA-ABG ³ 15 dB on the 10th day | |||
4. Conclusions
- The results suggest that daily middle ear inflation can be effective treatment for children with SOM, having regard to the factors significant for the prognosis of treatment.
- The most important prognostic criteria were defined by the dynamic changes of tympanometry and pure tone audiometry during and following conservative treatment.