The use of perioperative Sofradex eardrops in preventing tympanostomy tube blockage: a prospective double-blinded randomized-controlled trial

Around 11-12% of tympanostomy tubes are reported to become blocked by middle ear secretions or blood immediately following surgery, and so no longer function. Many otologists routinely instil an antibiotic and steroid-containing solution at the time of surgery in the belief that this may reduce this complication. The aim of the study was to investigate the efficacy of instilling the antibiotic and steroid-containing solution Sofradex at the time of grommet insertion in preventing grommet blockage. Double-blind randomized-controlled trial, comparing rates of grommet blockage in ears treated with Sofradex drops against control (no drops) in patients undergoing bilateral grommet insertion. Sixty-one pairs of results were obtained. There was a significant difference between the rates of grommet blockage in the two groups. Grommets with Sofradex drops instilled perioperatively were nine times less likely to be blocked than controls [1.6%versus 13.1%, odds ratio (Sofradex/control) = 9.06, 95% confidence interval (CI): 1.04-78.82, P = 0.05]. There was no association between grommet blockage and perioperative bleeding or the nature and presence of middle ear secretions. Sofradex eardrops are effective in reducing the rate of grommet blockage when instilled perioperatively.     

Three-year follow-up (1983–1986) of children undergoing bilateral grommet insertion in Sheffield

A retrospective study with review, after 3 years, of 43 children between the ages of 4 and 13 years, who had bilateral otitis media with effusion treated surgically purely by the insertion of grommets is described. The results shows that the younger the child at initial grommet insertion, the greater the likelihood of more than 1 grommet insertion being required (P < 0.05). A younger patient is likely to make a greater number of outpatient visits (P < 0.05), and the number of outpatient visits correlates with the number of grommets inserted (P < 0.01). At 3 years, 49% of children remained on regular outpatient follow-up, while 34% of children had persisting effusion in 1 or more ears. Whilst grommets are in place, otorrhoea is not adversely influenced by swimming. The role of adenoidectomy in the management of otitis media with effusion is not assessed by this study.     

Eosinophilic otitis media diagnosis using flow cytometric immunophenotyping

Objectives: (1) To assess the ability of flow cytometric immunophenotyping to detect and quantitate eosinophils in patients with eosinophilic otitis media (EOM). (2) to evaluate the association of EOM to bronchial asthma.

Methods: Twenty-one patients with chronic otorrhea or middle ear effusion (MEE) were included in this prospective cohort study. Group I composed of 10 patients (14 ears) and associated to bronchial asthma. Group II included 11 patients (11 ears) without bronchial asthma. Samples of MEE were sent for flow cytometric analysis at initial presentation. Patients with positive eosinophils on flow cytometric immunophenotyping were analyzed after one-month course of dexamethasone eardrops.

Results: EOM was diagnosed in all patients of group I and in three patients of group II. The mean eosinophils percentage was 43.5% and 14.2% for group I and group II, respectively (p?=?.006). Those patients showed a significant response to dexamethasone eardrops, both on clinical examination and on flow cytometric analysis with a decrease in eosinophil levels post-treatment. However, this improvement was temporary and symptoms recurred after treatment cessation. Bronchial asthma was not associated to all patients with EOM.

Conclusion: Diagnosis of EOM remained mostly clinical; flow cytometry immunophenotyping of MEE may be helpful as an additional tool in diagnosis and monitoring the response to treatment, particularly in non-asthmatic patients.     

Serum IgA and IgG functional antibodies and their subclasses to Streptococcus pneumoniae capsular antigen found in two aged‐matched cohorts of children with and without otitis media with effusion

Serum IgA and IgG functional antibodies and their subclasses to Streptococcus pneumoniae capsular antigen found in two aged‐matched cohorts of children with and without otitis media with effusion The relationship between acute otitis media and otitis media with effusion (OME) is uncertain and the aetiology of OME is multifactorial. Otitis media with effusion may be an inflammatory condition; both bacteria and viral infections could play a part in this inflammation. The four bacteria Streptococcus pneumoniae, Haemophilus influenza, Staphylococcus aureus and Branhamella catarrhalis cause 60% of the infections whereas S. pneumoniae accounts for up to 35%. IgA provides the dominant surface response to polysaccharide and lipopolysaccharide antigens, of which IgA₂ is the main subclass. Once the mucosa has been breached, most protection is provided by IgG. IgG₂ acts mainly against bacterial capsular antigens. This study looked at two groups of 50 children with and without OME who were aged between 3 and 10 years. The aims were to determine if, firstly, the levels of the serum immunoglobulins were different in the two groups, secondly whether these children made the appropriate antibody response to the capsular antigen to S. pneumoniae (PCP), and finally if there was a delay in the maturity of the IgA response. The total IgG, IgA and all subclass levels were measured using radial immunodiffusion. Levels of functional IgA and IgG were measured using ELISAs (25 patients in each group). The results were analysed with non‐parametric tests. The immunoglobulin levels were within the normal levels for both groups. There were very good correlations between the IgG total anti‐PCP and the IgG₂ anti‐PCP (R > 0.9, p = 0.001). There was a good correlation between the levels of both IgG total and IgG₂ anti‐PCP against IgA total anti‐PCP in both groups (R > 0.85, p > 0.01). This confirms a normal antibody response between both groups of patients. The ages of the controls and patients (50 samples) were correlated with increasing titres of circulating functional antibodies (P = 0.001). This is highly suggestive of a normal age‐related response. In conclusion, the findings were contradictory to our original hypothesis that there is a subtle difference in surface protection between children with and without OME. We believe that a previous history of recurrent acute otitis media is unrelated to the development of OME after 3 years of age.     

Bacterial biofilm in adenoids of children with chronic otitis media. Part I: a case control study of prevalence of biofilms in adenoids,risk factors and middle ear biofilms

Background: Biofilms are communities of bacteria embedded in a self-produced glycocalyx matrix. Adenoids have been shown to harbor bacterial biofilms.

Aim/objectives: To compare the prevalence of biofilms in adenoid of children with chronic otitis media (COM) (group1) versus a control group without any COM (group 2) having adenoids removed because of hypertrophy.

Material and methods: One hundred and three children were prospectively enrolled in this case-control study, group 1 (n?=?52) and group 2 (n?=?51). The main outcome measurement was the prevalence of biofilm in adenoidectomy specimens analyzed using confocal laser scanning microscopy. Children in group 1 who had middle ear (ME) effusion and requiring the insertion of a tympanostomy tube underwent biopsy of the ME mucosa and effusion sampling.

Results: Biofilms were found in adenoids’ specimens of both groups and in the ME biopsy and effusion. The biofilm prevalence in adenoids was 63.5% (33/52) in group 1 and 47.1% (24/51) in group 2. Day nursery and previous antibiotics intake were significantly more frequent in group 1 than in group 2.

Conclusions and significance: This case-control study demonstrates that adenoid tissue in children with COM contains more mucosal biofilms than adenoid tissue removed for hypertrophy. Biofilm was seen in ME biopsies and effusion.     

Analysis of risk factors for childhood persistent middle ear effusion

Conclusions

Although exposure to infectious agents and parental smoking are known to influence the overall risk of otitis media, these risk factors do not appear to be linked with the tendency to develop chronic otitis media with effusion (COME) instead of recurrent acute otitis media (RAOM). The genetic inflammatory response type of the child appears to influence the risk of persistent middle ear effusion in COME.

Objective

Two different clinical presentations of childhood otitis media are encountered: RAOM; and COME, which is associated with persistent effusion in the middle ear. The objective of this study was to assess putative factors that may regulate the development of persistent middle ear effusion in COME.

Material and methods

In total, 159 children with RAOM and their parents (n=304), and 55 children with COME and their parents (n=110) were evaluated. All the children with COME or RAOM were aged <4 years.

Results

There was no difference in the frequency of attendance at day care outside the home, number of siblings or parental smoking between children with RAOM and those with COME. The frequency of parental allergy and asthma was lower among children with COME than those with RAOM.     

Otic drops used to clear a blocked grommet: an in vitro prospective randomized controlled study with blinded assessment

Clinicians often prescribe otic drops anecdotally to try and clear grommets blocked with blood. We carried out an in vitro double-blind randomized controlled study comparing the efficacy of sodium bicarbonate, Locorten Vioform and olive oil drops in clearing Shah grommets placed in 'artificial ears' and blocked with blood in a standardized fashion. There were 33 grommets in each group, and drops were inserted three times a day for 7 days. Olive oil drops cleared 17 of 33 (51.51%), Locorten Vioform cleared one of 33 (3%) and sodium bicarbonate cleared zero of 33 (0%) blocked grommets. Statistical comparison between pairs indicates that olive oil was significantly better than both Locorten Vioform (P < 0.001) and sodium bicarbonate drops (P < 0.001) at clearing grommets blocked with blood.     

The use of perioperative Sofradex® eardrops in preventing tympanostomy tube blockage: a prospective double‐blinded randomized‐controlled trial

Around 11–12% of tympanostomy tubes are reported to become blocked by middle ear secretions or blood immediately following surgery, and so no longer function. Many otologists routinely instil an antibiotic and steroid‐containing solution at the time of surgery in the belief that this may reduce this complication. The aim of the study was to investigate the efficacy of instilling the antibiotic and steroid‐containing solution Sofradex^® at the time of grommet insertion in preventing grommet blockage. Double‐blind randomized‐controlled trial, comparing rates of grommet blockage in ears treated with Sofradex^® drops against control (no drops) in patients undergoing bilateral grommet insertion. Sixty‐one pairs of results were obtained. There was a significant difference between the rates of grommet blockage in the two groups. Grommets with Sofradex^® drops instilled perioperatively were nine times less likely to be blocked than controls [1.6%versus 13.1%, odds ratio (Sofradex^®/control) = 9.06, 95% confidence interval (CI): 1.04–78.82, P = 0.05]. There was no association between grommet blockage and perioperative bleeding or the nature and presence of middle ear secretions. Sofradex^® eardrops are effective in reducing the rate of grommet blockage when instilled perioperatively.     

Adenoidectomy With Laser or Incisional Myringotomy for Otitis Media With Effusion

Objective To compare the effectiveness of CO₂ laser myringotomy to incisional myringotomy at the time of adenoidectomy for refractory otitis media with effusion (OME). Study Design Controlled retrospective consecutive case series. Methods All children undergoing myringotomy and adenoidectomy for OME in the spring of 1999 had 1.7‐mm‐diameter perforations created in their tympanic membranes using a CO₂ laser and conventional microslad. Their ears were evaluated at first postoperative visit (mean, 16.65 days after surgery) by a validated otoscopist to determine the presence or absence of perforations and middle ear effusions. These patients were compared with historical controls comprising all children undergoing incisional myringotomy and adenoidectomy in 1998. A χ² analysis was performed to compare the results of these two myringotomy techniques. Results Twenty‐three children (39 ears) underwent laser myringotomy and adenoidectomy in 1999, compared with 26 children (48 ears) who underwent incisional myringotomy and adenoidectomy in 1998. In the laser myringotomy group, 8 of the 39 ears had a persistent opening at first follow‐up; 4 of the 39 ears showed evidence of effusion. In the incisional myringotomy group, all 48 ears had healed; 7 of these ears showed evidence of effusion. Conclusion Myringotomies created using the CO₂ laser are more likely to be patent at first postoperative visit than those made with incisional technique (P < .01). However, this prolonged middle ear ventilation does not significantly decrease the prevalence of effusion (P > .1).     

Expression of aquaporins mRNAs in patients with otitis media

Objective: This study analyzed the associations between measured levels of aquaporin (AQP) mRNAs and clinical manifestations in patients with various types of otitis media (OM).

Methods: AQP1, 2, 3, 4, 5, 6, 8, and 10 mRNA levels were assayed by real-time PCR from 57 patients with chronic otitis media (COM), 24 patients with cholesteatomatous otitis media (choleOM), and 82 patients with otitis media with effusion (OME). The relationships of these mRNA levels with the presence of bacteria, the type of hearing loss, and clinical manifestations of OM types were evaluated.

Results: All eight AQP mRNAs were expressed in inflammatory tissue, chole matrix, and effusion fluid obtained from all 163 patients with OM. The levels in OME of AQP2, 4, 6, and 10 mRNA; and the levels in choleOM of AQP1, 3, 4, and 10 mRNA were elevated significantly compared to the corresponding levels in COM (p?p?Conclusions: The levels of expression of AQP mRNA are associated with the pathophysiology of OM.     

PERSISTENCE OF MIDDLE EAR DYSFUNCTION AFTER RECURRENT ACUTE OTITIS MEDIA

The presence of otitis media with effusion (OME) and high negative pressure (-200 to -400 mm H₂O)₃ were investigated in follow-up of a randomized double-blind placebo-blind placebo-controlled trial on the efficacyu of amoxicilin/clavulanic acid in the treatment of acute otitis media. All children in this study were recruited from a general practice population. Tympanometry results 1 month from the start of an episode of acute otitis media were taken as outcome criteria. Bilateral middle ear dysfunction was defined as bilateral OME, unilateral OME and contralateral or bilateral high negative pressure. Bilateral middle ear dyusfunction was present in 47.9% of the patients. Of all teh investigated factors of possible influence (age, sex, season, laterality of acute otitis media, therapy, and clinical course of acute otitis media), only season showed a statistically significant influence on the persistence of OME/high negative pressure (P = 0.001). Bilateral middle ear dysfunction was shown to be of prognostic value for the risk of a recurrence of acute otitis media (odds ratio 3.75). shown to be of prognostic value for the risk of a recurence of acute otitis media (odds ratio 3.75).     

Evaluation of the protective effect of Botulinum toxin type A injection on otitis media with effusion*

Objective: This study makes an analysis of the effect of Botulinum toxin type A on otitis media with effusion in rats.

Method: As part of the study, 24 male Wistar Albino rats were divided into three groups: Group 1: Botulinum toxin Type A and Histam?ne (intratympanic 0.2?ml?=?20 unit BTA); Group 2: Saline and Histamine (intratympanic 0.2?ml 0.9%); Group 3: Histamine (intratympanic 0.2?ml). Histamine (intratympanic 0.2?ml) was administered into the right ear for all groups. DPOAE and ABR tests were carried out on days 5, 10, 15 and 20 from the beginning of the study.

Results: There was no significant difference between DPOAE and ABR scores of the groups. In each group, the DPOAE scores for the right ear significantly decreased on day 5 when compared to the basal scores. In each group, there was no significant difference between days 5, 10 and 15 for the right ear.

Conclusions: Botulinum toxin type A blocked the secretion of glands in the middle ear and showed no effect to prevent the formation of serous otitis. In addition, it was found out that Botulinum toxin did not lead to any morphological change in the cochlea     

Clinical and audiological findings in children with acute otitis media

Conclusion: It is recommended to perform follow-up tympanometry and if necessary tonal audiometry in children who have normal plain otoscopy findings after recovering from acute otitis media (AOM). Children with Type B tympanogram, 3 months following the onset of AOM, are very likely to have a conductive hearing loss. Type B tympanogram is a much better indicator of effusion in the middle ear compared to plain otoscopy. Objective: This study was undertaken to investigate the frequency and duration of middle ear effusion in children following an episode of acute otitis media, to track changes in tonal audiometry and tympanometry findings in the post-AOM period, and recognize the optimal timing for performing both tests. Methods: In this study, 125 children aged 5–7 years with bilateral AOM were randomly selected and separately followed up for 3 months. The children underwent six ear, nose, and throat (ENT 1–6) examinations, six tympanometries (TM 1–6), and three tonal audiometries (TA 1–3). Evaluation of nasopharynx was done at the ENT 1 examination. Children who received ventilation tubes were followed for 21 month altogether. Results: At the first otoscopy, pathological findings were recorded in 250 ears/125 children (100.0%). The number of pathological otoscopy findings decreased at each subsequent examination. At ENT 6 all children had normal otoscopy findings. Type B tympanogram was detected in 49/250 (19.6%) ears at TM 6, performed 3 months following the onset of the disease. At the TA 1 conductive hearing impairment was recorded in 158/250 (63.2%) ears, at TA 2 in 66/250 (26.4%), and at TA 3 in 39/250 (15.6%). Most of them were associated with Type B tympanogram.     

Middle ear mucosa and secretory otitis media

Summary Recent investigations have identified the viscous middle ear effusion in secretory otitis media (S.O.M.) as being of the same nature as true mucus — the backbone of which is glycoprotein. The source of the mucus is mucusproducing cells in greater number than found in the normal middle ear lining. The pathological state which leads to excessive mucus production and maturation of numerous mucus cells is an inflammation associated with deficient ventilation of the middle ear. In the presence of inflammation, especially when CO₂ tension is high, mucosal stem cells differentiate metaplastically into numerous mucus-producing cells, as demonstrated by us in tissue cultures. The higher CO₂ tension in S.O.M. is due to eustacian tube insufficiency (not blockage) which is a smaller than normal amount of air introduced into the middle ear per unit of time. Ventilating tubes restore CO₂ tension to normal and equalize the slight barometric negative pressure (average 3.35 H₂O) — the latter being related to mucociliary clearance. Evidence for an allergic factor as a pathogen is also not available. The mucus in the middle ear is probably not noxious by itself and ears should be ventilated surgically only when hearing is below social level perception. Most S.O.M. ears will clear sooner or later spontaneously. A minority of these ears will progress with time into atelectatic ears and some might perforate later on.Presented at the Fifth International Workshop on microsurgery and fluctuating hearing loss, Chicago, March 1976These studies were supported in part by N.I.H. Grant C-5-RO1NS-10048-02Established investigator of the Chief Scientist's Bureau, Ministry of Health, Meir Hospital and Weizmann Institute of Science     

Grommets in otitis media: a 25-year follow up

Abstract

Background: This study is unique as it is the first study which can describe the long term sequelae of treatment of otitis media with effusion (OME) with insertion of grommets in the Primary Health Sector in Denmark.

Objectives: Eardrum pathology and hearing acuity 25 years after treatment of OME by insertion of grommets, in a private ear-, nose-, and throat practice.

Material and methods: 262 children with OME were treated from 1975 to 1978. The patients were re-examined by otomicroscopy, tympanometry and pure tone audiometry after 7.5, 12, and 25 years.

Results: Hearing level, flaccida retraction and incudo pexi was equivalent. For atrophy and myringosclerosis no equivalence was shown using 95% confidence intervals. Tympanometry was fairly unchanged.

Conclusion and significance: The insertion of a grommet in treating OME has no influence on hearing acuity in the long term. The prevalence of myringosclerosis and atrophy was unchanged in 70–80% of the eardrums. Most important is that the small increase in myringosclerosis and atrophy does not seem to influence the hearing acuity. We show that long term sequelae from the Primary Health Sector are similar to those from the Secondary Health sector.     

Unilateral grommet insertion and adenoidectomy in bilateral secretory otitis media: preliminary report of the results in 91 children

This study evaluates whether the use of grommets in the primary treatment really changes the course of secretory otitis media. The patient acts as his own control. Bilateral cases are selected and one ear is treated by a grommet, the other left intact, and all have their adenoids removed. Until now 91 children have been entered. A repeated operation was done in 13, and 6 of them had a contralateral grommet because of persisting middle ear effusion. A discharge occurred from 25% of the operated ears. After the operation the intact ears showed a great improvement in the function of the Eustachian tube according to the tympanograms. The hearing level was normalized within 3 months in both intact and operated ears. In 28 children the grommets had been extruded for more than one month. By comparing the intact and the operated ears no significant statistical difference was found.     

Long-term middle ear pressure measurements in inner ear disorders

Conclusion This is a suitable model for studying different aspects of the pathophysiology of chronic suppurative otitis media. Objective To analyze the methodological features of an animal model of chronic suppurative otitis media induced by intratympanic inoculation of Pseudomonas aeruginosa. Material and methods Otitis media was induced by inoculation of P. aeruginosa through the inferior aspect of the rat bulla and cauterization of the Eustachian tube via a transpalatal approach. Inspection of the tympanic membrane, culturing of middle ear effusion and processing of the temporal bones for light microscopy were performed. Results Abnormal otomicroscopic findings and persistence of infection were correlated with the histopathological changes found in middle ear tissues.     

In vitro efficacy of the successive or staggered use of eardrops

Chronic suppurative otitis media is still a significant health problem. Several topical agents such as antibacterials, steroids and acid media eardrops are widely used alone or in combination to control active otorrhea and obtain a dry ear. Patients frequently ask if there is any benefit or loss in the effect of these due to their use in a successive or staggered manner. This question led us to design this in vitro study to investigate the effect of the acetic acid solution and dexamethasone sodium phosphate on the antimicrobial effects of some ototopical antibiotics during their successive or staggered usage. Staphylococcus aureus, Pseudomonas aeruginosa, Proteus mirabilis and Escherichia coli were used for testing the antimicrobial activities of the selected antibiotic drops. Six microliters of acetic acid solution and dexamethasone sodium phosphate were used alone or together with 6 µl each of ciprofloxacin HCl, tobramycin and ofloxacin solution. Drops were placed on Whatman no. 1 paper disks with a diameter of 6 mm, and the disks were placed onto Mueller-Hinton agar plates on which bacteria had been swabbed over the entire surface. After overnight incubation of the plates at 35°C, the diameters of the inhibition zones were recorded. There was no antibacterial effect in response to either acid solution or dexamethasone used alone. The inhibition zones of the antibiotics did not change with either steroid or acid media solution added onto the antibiotic disks alone or together. Acid solution or steroids should be preferred to use in combination with antibacterial otic drugs in in-vivo settings; no negative or positive effects were seen in in-vitro conditions. Therefore, prescribed eardrops can be used in a successive or staggered manner without any influence on the treatment results.