Abstract
Background: Otitis media is mainly caused by pneumococci and is one of the most common diseases in children. It can lead to hearing problems, thereby resulting in learning and behavioral problems. This study aimed to compare the synergistic effects of zinc, probiotics, and amoxicillin in treating the otitis media. Materials and Methods: In this double-blinded randomized clinical trial, 94 children aged between 6 months and 6 years with acute otitis media were studied. Children were divided into three groups who were administered with: amoxicillin, amoxicillin plus probiotics, and amoxicillin plus zinc per day. The first group received 80-90 mg/kg amoxicillin; the second group had one sachet of protexin in addition to amoxicillin; while the third group received 10 mg zinc in addition to amoxicillin. The treatment lasted for ten days. Results: Overall, 72.3% of patients responded to primary therapy and 5.31% had complications among which 5 had perforation. All these 5 cases belonged to the amoxicillin-receiving group. None of the patients showed relapse. In addition, 30 (60%) in the amoxicillin group, 19 (82.6%) in the amoxicillin and zinc group, and 19 (90.47%) in the amoxicillin and protexin group responded to the treatment. There was no statistically significant difference between the three groups in terms of responses to the treatment. Considering the gender of children, 37 girls (82.22%) and 32 boys (65.3%) responded to the treatment. Conclusion: The results showed that 10-day application of probiotics and zinc along with amoxicillin arose no significantly different response in acute childhood otitis media compared to the treatment with amoxicillin alone; however, it could reduce the complications of the disease. Considering the difference in the results of studies on probiotic effects on the treatment of infections in children, further studies are recommended.
Highlights
Otitis media is the inflammatory response of the middle ear due to various factors including infection and dysfunction of the eustachian tube [1, 2]
The results showed that risk of type A tympanometry in both male and female subjects was not statistically different (OR = 1.08;; P = 0.90) (Table 2)
The results of adjusted logistic regression displayed that patients who received amoxicillin with zinc were at risk of type A tympanometry 2.44 times less than the patients who received only amoxicillin though this was not statistically significant (OR = 0.41, 95% CI: 0.11-1.51; P = 0.181)
Summary
Otitis media is the inflammatory response of the middle ear due to various factors including infection and dysfunction of the eustachian tube [1, 2]. Children with respiratory problems are more likely to develop acute otitis media [6, 7] If not cured, this disease may lead to otitis media with effusion with probable hearing problems in the child which may cause learning and behavioral problems in the future [3, 8]. Results: Overall, 72.3% of patients responded to primary therapy and 5.31% had complications among which 5 had perforation All these 5 cases belonged to the amoxicillin-receiving group. Conclusion: The results showed that 10-day application of probiotics and zinc along with amoxicillin arose no significantly different response in acute childhood otitis media compared to the treatment with amoxicillin alone; it could reduce the complications of the disease. Considering the difference in the results of studies on probiotic effects on the treatment of infections in children, further studies are recommended.
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