ADONIS 0307777291000296
Clin Oto/urmRn/. I99 I. 16, 142- I44
Medical treatment of chronic otitis media: Steroid or antibiotic with steroid ear-drops? JOHN A.CROWTHER & D A V I D SIMPSON Department of Otolaryngology. Stobhill General Hospital. Glasgow G2I 3U W . UK Accepted for publication 13 October 1989 CROWTHER J.A. & SIMPSON D.
( 199 I ) Clin. Otolaryngol. 16, 142- I44
Medical treatment of chronic otitis media: Steroid or antibiotic with steroid ear-drops? The aim of this study was to evaluate whether, in the treatment of active noncholesteatomatous chronic otitis media, the effectiveness of gentamicin with hydrocortisone ear-drops is due solely to the contained steroid or to the combination of antibiotic and steroid. Sixty-four patients presenting to the Ear, Nose and Throat outpatient department with active non-cholesteatomatous chronic otitis media were randomly allocated to receive either gentamicin with hydrocortisone ear-drops. or betamethasone ear-drops, for up to 4 weeks. Activity in the ear was assessed at 2 and 4 weeks. Gentamicin with hydrocortisone combination drops were significantly more effective than betamethasone drops (P < 0.001) in producing inactivity of chronic otitis media. being effective in 80% as opposed to 29% of CdXS. The effectiveness of gentamicin with hydrocortisone ear-drops appears to be due to the combination of antibiotic and steroid. Keywords: chronic otitis media medical treatment
Active mucosal chronic otitis media affects approximately 2% of the adult population.' There is a defect in the tympanic membrane and the middle ear or mastoid air cell mucosa is actively inflamed with the production of mucopus. Traditionally the initial treatment has been medical'.' using aural toilet, systemic antibiotics, or ear-drops containing either antibiotic alone'or in combination with a steroid' with the aim of rendering the ear inactive. Previous studies have shown that systemic antibiotics, topical antibiotics (including gentamicin drops) and dry mopping can each obtain an inactive ear in approximately 30% of patients4 which is probably no better than the spontaneous resolution rate. Eardrops containing gentamicin and hydrocortisone combined was found to be superior in one trial, obtaining an inactive ear in 52% of cases.' Kilcoyne6 found the same combination drops to be effective in 72% of cases. It has been suggested that the steroid in these drops is the active preparation and that the contained antibiotic is unimportant.' The aim of this study was to determine whether the Corrcspondence: John A.Crowther, Department of Otolaryngology, Victoria Infirmary. Glasgow G42 9TY. U K
142
ear-drops
increased effectiveness of gentamicin with hydrocortisone drops was due to the contained steroid or to the combined effect of the antibiotic with the steroid.
Method Sixty-four patients with active non-cholesteatomatous chronic otitis media, who had not received treatment within the previous 3 weeks. were included in the study. This included patients with simple perforations and those with open mastoid cavities. Patients with aural polyps were excluded. Each patient had aural toilet performed with suction and an operating microscope. A swab was taken of the discharge for aerobic and anaerobic culture and sensitivity. Patients were then randomly allocated to receive either gentamicin with hydrocortisone eardrops or betamethasone drops in a double-blind format. Hydrocortisone ear-drops are not commercially available and so betamethasone drops were chosen because they contain a similar anti-inflammatoi-y dose of steroid to the hydrocortisone in gentamicin with hydrocortisone drops. Four drops were to be applied 4 times daily for up to 4 weeks. Patients were reviewed at 2 and 4
Treuttnent of' otitis media: sreroiii or anrihioric witti steroid'
Table 1. Results of treatment
Table 3. Organisms cultured from car swabs Active Inactive (YO) n (Yo)
Total patients
Staph. aureus Staph. ulbus Streptococcus Huemophilus
n
~
Gentamicin/hydrocortisone Betarnethasone
I43
30
6 17
24
(20) (71)
24 7
(80)
Mixed gram + v e
(19)
Pseudoomonas
Proteus
weeks, when their ear was assessed otoscopically by an independant examiner. The ears were described as inactive or active. Activity was defined as the presence of mucoid or mucopurulent secretions in the middle ear or mastoid. Those remaining active at 2 weeks were continued on the Same drops for a further 2 weeks. Compliance was assessed subjectively by asking the patient and confirmed by measuring the quantity of unused drops. Compliance was deemed satisfactory if they had used more than 75% of the e a r d r o p solution. Results were analysed using the Chi-squared test with the Yates' correction factor.
Coliforms E. coli Diphtheroids Anaerobes Commensals Yeasts
14 4 I
I 3 II 7 II I 2 I 2 3
isolated more often from perforations than from open mastoid cavities, but otherwise similar organisms were found in both. One patient discontinued using the gentamicin with hydrocortisone drops because they caused a burning sensation in the ear. but no patients showed an allergic response.
Results Of the 64 patients entered into the study 54 returned for follow-up at the requested times having completed their course of treatment (used more than 75% of the prescribed drops). Of the 54 patients, 34 were male and 20 female with an average age of 48 years. Of the 36 patients with simple perforations, 20 received gentamicin with hydrocortisone drops and 16 received betamethasone drops. Of the 18 patients with mastoid cavities, I0 received gentamicin with hydrocortisone drops and 8 received betamethasone drops. Table I illustrates the effectiveness of both drops in patients with active non-cholesteatomatous chronic otitis media. Gentamicin with hydrocortisone is significantly more effective than betamethasone ( P< 0.001). Of the 24 ears which became inactive with gentamicin and hydrocortisone, 19 were inactive after the first 2 weeks of treatment. The numbers of isolates grown from the ear swabs are shown in Table 2 and the various organisms in Table 3. Organisms grown from ears subsequently treated with gentamicin with hydrocortisone were similar to those grown from the betamethasone group. Staphylococcus aureus was
Table 2. Number of isolates Single growth Two growths Three growths Mixed coliforms Commensals No growth
30 8 I 10
2 3
Discussion Medical management of noncholesteatomatous chronic otitis media places a heavy workload on both general and hospital practice. Medical treatment may be indicated to eliminate active disease prior to surgery or may be used as an alternative to surgery. There are various possible treatments available but relatively few studies have been performed to compare their effectiveness. To maximize the use of time and resources, the most effective treatment should be identified. Browning ct al.' examined the effectiveness of several modalities: aural toilet. antiseptic powder insufflation. systemic antibiotics and topical antibiotic ear-drops were effective in approximately 30?6 of patients. which was no better than the spontaneous resolution rate. Gentamicin with hydrocortisone drops has subsequently been found 'to produce better results, being effective in 52% of ears.' That gentamicin with hydrocortisone was superior to gentamicin drops posed the question. whether it was the contained steroid which was effective or the combination of antibiotic and steroid? If steroid drops were found to be as effective as gentamicin with steroid, there would be good theoretical grounds for omitting the gentamicin. Topical antibiotics may promote the emergence of resistant organisms and may cause local allergic reactions. There is also the potential risk of ototoxicity when using aminoglycoside ear-drops. Fortunately this risk would appear to be extremely We chose to compare the effectiveness of betamethasone ear drops against gentamicin with hydrocortisone drops as the amount of steroid contained in both drops is comparable.
144 J.A.Crowther and DSimpson
A major problem when examining the effect of treatment on chronic otitis media is in differentiating active from inactive disease. Since the aim of treatment is to obtain a ‘dry’ ear. an ear was considered to have become inactive if there was no mucoid or mucopurulent discharge present in the external auditory canal, mastoid cavity or middle ear space as seen through the defect in the tympanic membrane. Our results indicate that gentarnicin with steroid is significantly more effective than steroid drops in obtaining an inactive ear after 4 weeks or less of treatment (P< 0.001). It is interesting that the success rate of betamethasone drops at 29% was no better than the rate of spontaneous resolution in another study.’ The effectiveness of gentamicin with hydrocortisone cannot be explained on bacteriological grounds as the same range of organisms grew in both groups. I t would appear to be the combination of a broad-spectrum antibiotic and a steroid which gives this ear-drop its potency. Prior to this study it was our feeling, and the finding of others,’ that medical treatment was less effective in open mastoid cavities. Surprisingly, we found the success rate of gentamicin with hydrocortisone drops was the same in both perforations and in mastoid cavities, being effective in 80% of patients in both groups. In conclusion, the evidence to date would suggest that the most effective medical treatment for noncholesteatomatous chronic otitis media is gentamicin with hydrocortisone eardrops and that its efficacy is due to the combination of broad-spectrum antibiotic and steroid. Since thorough
cleaning of the ear prior to starting the drops may enhance their efficacy, the success rate of these drops, when not preceded by aural toilet, may be less than in our study.
Acknowledgements We would like to thank M r A.Baxter. M r B.lrvine and M r B.O’Reilly for allowing their patients to be included in our study.
References I BROWNINGG.G. & DAVISA.C. (1983)Clinical chardcterisation of the hearing of the adult British population. Adv. Otol. Rhino-Laryngol. 31, 217-223
2 SHENOIP.M. (1987) Management of chronic suppurative otitis media. In Scott Brown’s Diseases of Eur. Nose and Thrwr. Volume
3. Fifth edition. pp. 215-237. Buttenvorths. London 3 SUPANCE J.S. & BLUESTONE C.D. (1983) Medical management of the chronic draining edr. Lur-vnguscupe 93, 661-662 4 BROWNING G.G.. hcozzi G.L., CALDER I.T. & SWEENEY E. (1983) Cordrolled trial of medical treatment of active chronic otitis media. Br. Med. J . 287, 1024 5 BROWNINGG.G., GATEHOUSE S. & CALDER I.T.(1988) Medical management of active chronic otitis media: a controlled study. J. Luryngol. Otol. 102, 49 1-495 6 KILCOYNE A.G. (1973) Gentamicin-hydrocortisone eardrops in chronic infections. Practirioner 211. 9 1-92 7 MCKELVIE P.. JOHNSTONE 1.. JAMIESON 1. & BROOKS C. (1975)The effect of gentamicin ear drops on the cochlea. Br. J. ,4udiol. 9, 45-47
Clin Oto/urmRn/. I99 I. 16, 142- I44
Medical treatment of chronic otitis media: Steroid or antibiotic with steroid ear-drops? JOHN A.CROWTHER & D A V I D SIMPSON Department of Otolaryngology. Stobhill General Hospital. Glasgow G2I 3U W . UK Accepted for publication 13 October 1989 CROWTHER J.A. & SIMPSON D.
( 199 I ) Clin. Otolaryngol. 16, 142- I44
Medical treatment of chronic otitis media: Steroid or antibiotic with steroid ear-drops? The aim of this study was to evaluate whether, in the treatment of active noncholesteatomatous chronic otitis media, the effectiveness of gentamicin with hydrocortisone ear-drops is due solely to the contained steroid or to the combination of antibiotic and steroid. Sixty-four patients presenting to the Ear, Nose and Throat outpatient department with active non-cholesteatomatous chronic otitis media were randomly allocated to receive either gentamicin with hydrocortisone ear-drops. or betamethasone ear-drops, for up to 4 weeks. Activity in the ear was assessed at 2 and 4 weeks. Gentamicin with hydrocortisone combination drops were significantly more effective than betamethasone drops (P < 0.001) in producing inactivity of chronic otitis media. being effective in 80% as opposed to 29% of CdXS. The effectiveness of gentamicin with hydrocortisone ear-drops appears to be due to the combination of antibiotic and steroid. Keywords: chronic otitis media medical treatment
Active mucosal chronic otitis media affects approximately 2% of the adult population.' There is a defect in the tympanic membrane and the middle ear or mastoid air cell mucosa is actively inflamed with the production of mucopus. Traditionally the initial treatment has been medical'.' using aural toilet, systemic antibiotics, or ear-drops containing either antibiotic alone'or in combination with a steroid' with the aim of rendering the ear inactive. Previous studies have shown that systemic antibiotics, topical antibiotics (including gentamicin drops) and dry mopping can each obtain an inactive ear in approximately 30% of patients4 which is probably no better than the spontaneous resolution rate. Eardrops containing gentamicin and hydrocortisone combined was found to be superior in one trial, obtaining an inactive ear in 52% of cases.' Kilcoyne6 found the same combination drops to be effective in 72% of cases. It has been suggested that the steroid in these drops is the active preparation and that the contained antibiotic is unimportant.' The aim of this study was to determine whether the Corrcspondence: John A.Crowther, Department of Otolaryngology, Victoria Infirmary. Glasgow G42 9TY. U K
142
ear-drops
increased effectiveness of gentamicin with hydrocortisone drops was due to the contained steroid or to the combined effect of the antibiotic with the steroid.
Method Sixty-four patients with active non-cholesteatomatous chronic otitis media, who had not received treatment within the previous 3 weeks. were included in the study. This included patients with simple perforations and those with open mastoid cavities. Patients with aural polyps were excluded. Each patient had aural toilet performed with suction and an operating microscope. A swab was taken of the discharge for aerobic and anaerobic culture and sensitivity. Patients were then randomly allocated to receive either gentamicin with hydrocortisone eardrops or betamethasone drops in a double-blind format. Hydrocortisone ear-drops are not commercially available and so betamethasone drops were chosen because they contain a similar anti-inflammatoi-y dose of steroid to the hydrocortisone in gentamicin with hydrocortisone drops. Four drops were to be applied 4 times daily for up to 4 weeks. Patients were reviewed at 2 and 4
Treuttnent of' otitis media: sreroiii or anrihioric witti steroid'
Table 1. Results of treatment
Table 3. Organisms cultured from car swabs Active Inactive (YO) n (Yo)
Total patients
Staph. aureus Staph. ulbus Streptococcus Huemophilus
n
~
Gentamicin/hydrocortisone Betarnethasone
I43
30
6 17
24
(20) (71)
24 7
(80)
Mixed gram + v e
(19)
Pseudoomonas
Proteus
weeks, when their ear was assessed otoscopically by an independant examiner. The ears were described as inactive or active. Activity was defined as the presence of mucoid or mucopurulent secretions in the middle ear or mastoid. Those remaining active at 2 weeks were continued on the Same drops for a further 2 weeks. Compliance was assessed subjectively by asking the patient and confirmed by measuring the quantity of unused drops. Compliance was deemed satisfactory if they had used more than 75% of the e a r d r o p solution. Results were analysed using the Chi-squared test with the Yates' correction factor.
Coliforms E. coli Diphtheroids Anaerobes Commensals Yeasts
14 4 I
I 3 II 7 II I 2 I 2 3
isolated more often from perforations than from open mastoid cavities, but otherwise similar organisms were found in both. One patient discontinued using the gentamicin with hydrocortisone drops because they caused a burning sensation in the ear. but no patients showed an allergic response.
Results Of the 64 patients entered into the study 54 returned for follow-up at the requested times having completed their course of treatment (used more than 75% of the prescribed drops). Of the 54 patients, 34 were male and 20 female with an average age of 48 years. Of the 36 patients with simple perforations, 20 received gentamicin with hydrocortisone drops and 16 received betamethasone drops. Of the 18 patients with mastoid cavities, I0 received gentamicin with hydrocortisone drops and 8 received betamethasone drops. Table I illustrates the effectiveness of both drops in patients with active non-cholesteatomatous chronic otitis media. Gentamicin with hydrocortisone is significantly more effective than betamethasone ( P< 0.001). Of the 24 ears which became inactive with gentamicin and hydrocortisone, 19 were inactive after the first 2 weeks of treatment. The numbers of isolates grown from the ear swabs are shown in Table 2 and the various organisms in Table 3. Organisms grown from ears subsequently treated with gentamicin with hydrocortisone were similar to those grown from the betamethasone group. Staphylococcus aureus was
Table 2. Number of isolates Single growth Two growths Three growths Mixed coliforms Commensals No growth
30 8 I 10
2 3
Discussion Medical management of noncholesteatomatous chronic otitis media places a heavy workload on both general and hospital practice. Medical treatment may be indicated to eliminate active disease prior to surgery or may be used as an alternative to surgery. There are various possible treatments available but relatively few studies have been performed to compare their effectiveness. To maximize the use of time and resources, the most effective treatment should be identified. Browning ct al.' examined the effectiveness of several modalities: aural toilet. antiseptic powder insufflation. systemic antibiotics and topical antibiotic ear-drops were effective in approximately 30?6 of patients. which was no better than the spontaneous resolution rate. Gentamicin with hydrocortisone drops has subsequently been found 'to produce better results, being effective in 52% of ears.' That gentamicin with hydrocortisone was superior to gentamicin drops posed the question. whether it was the contained steroid which was effective or the combination of antibiotic and steroid? If steroid drops were found to be as effective as gentamicin with steroid, there would be good theoretical grounds for omitting the gentamicin. Topical antibiotics may promote the emergence of resistant organisms and may cause local allergic reactions. There is also the potential risk of ototoxicity when using aminoglycoside ear-drops. Fortunately this risk would appear to be extremely We chose to compare the effectiveness of betamethasone ear drops against gentamicin with hydrocortisone drops as the amount of steroid contained in both drops is comparable.
144 J.A.Crowther and DSimpson
A major problem when examining the effect of treatment on chronic otitis media is in differentiating active from inactive disease. Since the aim of treatment is to obtain a ‘dry’ ear. an ear was considered to have become inactive if there was no mucoid or mucopurulent discharge present in the external auditory canal, mastoid cavity or middle ear space as seen through the defect in the tympanic membrane. Our results indicate that gentarnicin with steroid is significantly more effective than steroid drops in obtaining an inactive ear after 4 weeks or less of treatment (P< 0.001). It is interesting that the success rate of betamethasone drops at 29% was no better than the rate of spontaneous resolution in another study.’ The effectiveness of gentamicin with hydrocortisone cannot be explained on bacteriological grounds as the same range of organisms grew in both groups. I t would appear to be the combination of a broad-spectrum antibiotic and a steroid which gives this ear-drop its potency. Prior to this study it was our feeling, and the finding of others,’ that medical treatment was less effective in open mastoid cavities. Surprisingly, we found the success rate of gentamicin with hydrocortisone drops was the same in both perforations and in mastoid cavities, being effective in 80% of patients in both groups. In conclusion, the evidence to date would suggest that the most effective medical treatment for noncholesteatomatous chronic otitis media is gentamicin with hydrocortisone eardrops and that its efficacy is due to the combination of broad-spectrum antibiotic and steroid. Since thorough
cleaning of the ear prior to starting the drops may enhance their efficacy, the success rate of these drops, when not preceded by aural toilet, may be less than in our study.
Acknowledgements We would like to thank M r A.Baxter. M r B.lrvine and M r B.O’Reilly for allowing their patients to be included in our study.
References I BROWNINGG.G. & DAVISA.C. (1983)Clinical chardcterisation of the hearing of the adult British population. Adv. Otol. Rhino-Laryngol. 31, 217-223
2 SHENOIP.M. (1987) Management of chronic suppurative otitis media. In Scott Brown’s Diseases of Eur. Nose and Thrwr. Volume
3. Fifth edition. pp. 215-237. Buttenvorths. London 3 SUPANCE J.S. & BLUESTONE C.D. (1983) Medical management of the chronic draining edr. Lur-vnguscupe 93, 661-662 4 BROWNING G.G.. hcozzi G.L., CALDER I.T. & SWEENEY E. (1983) Cordrolled trial of medical treatment of active chronic otitis media. Br. Med. J . 287, 1024 5 BROWNINGG.G., GATEHOUSE S. & CALDER I.T.(1988) Medical management of active chronic otitis media: a controlled study. J. Luryngol. Otol. 102, 49 1-495 6 KILCOYNE A.G. (1973) Gentamicin-hydrocortisone eardrops in chronic infections. Practirioner 211. 9 1-92 7 MCKELVIE P.. JOHNSTONE 1.. JAMIESON 1. & BROOKS C. (1975)The effect of gentamicin ear drops on the cochlea. Br. J. ,4udiol. 9, 45-47
