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External otitis and its treatment: is a group III steroid without antibiotics sufficent therapy? Experimental and clinical studies
Umeå universitet, Medicinsk fakultet, Klinisk vetenskap, Öron- näs- och halssjukdomar. Umeå universitet, Medicinsk fakultet, Klinisk mikrobiologi, Klinisk bakteriologi.
2005 (engelsk)Doktoravhandling, med artikler (Annet vitenskapelig)
Abstract [en]

ABSTRACT

External otitis and its treatment. Is a group III steroid without antibiotics sufficient therapy? – Experimental and clinical studies

Per Emgård, Department of Otorhinolaryngology, University of Umeå and Ystad Hospital, Umeå and Ystad, Sweden

External otitis is one of the most common ear, nose and throat (ENT) diagnoses in out-patient clinics. The clinical course of external otitis includes itching, pain, redness, swelling and effusion of the external auditory canal (EAC) with normal tympanic membrane status. The inflammatory condition is often associated with infection by bacteria, e.g. Pseudomonas aeruginosa, or skin bacteria such as Staphylococcus species. Fungi are present only in a low percentage of cases and if present Candida albicans infection is the most frequent in northern countries such as Sweden and the UK. Topical therapy is recommended in most countries and dominates the therapy in most studies. Topical drugs used are usually a combination of antibiotics and a steroid. However, external otitis is treated with surprisingly many strategies – eleven different ones in Sweden, for example, and 18 in the UK.

The aims of the present studies were to –

-establish an animal model, infected and uninfected, suitable for testing various treatment strategies of external otitis; and

-perform a clinical study in patients to elucidate whether a group III steroid alone is as efficient for treatment of external otitis as is the commonly used topical drug containing a combination of a steroid and antibiotics.

The animal model was established through mechanical irritation of the external ear canal skin of Sprague-Dawley rats. An evaluation scale for characterization of the clinical status of the ear canal was introduced, recording redness, swelling and occurrence of effusion in a standardized way. Specimens of the ear canal skin were analysed by histological techniques. A topical solution of 0.05% bethametasone dipropionate (BD) was compared with a 1% hydrocortisone solution with antibiotics oxytetracycline and polymyxin B added (HCPB), administered in the external otitis model infected or non-infected with bacteria (P. aeruginosa) and a fungus (C. albicans).

The same drugs were tested in a randomized parallel-group multi-centre study in 51 patients. The clinical status of the external otitis patients was evaluated on a similar scale as used in the animal model. Early normalization of the ear canal skin status and frequency of relapses during the 6-month follow-up period were used as end-points of the study.

The studies showed the following:

-An animal model for external otitis, infected or uninfected, could be established.

-A new scale for evaluation of the external ear canal status with regard to redness, swelling and occurrence of effusion was introduced for the animal model as well as for the investigations in patients.

-Treatment with a group III steroid topical solution without antibiotics was superior to treatment with a group I steroid with antibiotics added in achieving resolution of external otitis.

-The effectiveness of the topical drugs in the clinical studies in external otitis patients was similar to that in animal external otitis models.

We conclude that a group III steroid solution cures external otitis more effectively than does a solution containing a group I steroid combined with antibiotics, whether infected by bacteria or by fungi. No difference was evident regarding adverse effects. Furthermore, costs favour a solution without any antibiotic components. In view of these observations a group III steroid solution is preferred for remedy of external otitis in the clinical situation.

Key words: external otitis, external auditory canal (EAC), animal model, treatment, betamethasone, hydrocortisone, antibiotics, human study, Pseudomonas aeruginosa, Candida albicans.

sted, utgiver, år, opplag, sider
Umeå: Klinisk vetenskap , 2005. , s. 87
Serie
Umeå University medical dissertations, ISSN 0346-6612 ; 988
Emneord [en]
Medicine, external otitis, external auditory canal (EAC), animal model, treatment, betamethasone, hydrocortisone, antibiotics, human study, Pseudomonas aeruginosa, Candida albicans.
Emneord [sv]
Medicin
HSV kategori
Forskningsprogram
oto-rhino-laryngologi
Identifikatorer
URN: urn:nbn:se:umu:diva-607ISBN: 91-7305-953-6 (tryckt)OAI: oai:DiVA.org:umu-607DiVA, id: diva2:143960
Disputas
2005-10-27, sal b (rosa salen, 9tr), tandläkarhögskolan, tandläkarhögskolan, Umeå, 10:00 (engelsk)
Opponent
Veileder
Tilgjengelig fra: 2005-10-11 Laget: 2005-10-11 Sist oppdatert: 2009-11-11bibliografisk kontrollert
Delarbeid
1. An animal model for external otitis.
Åpne denne publikasjonen i ny fane eller vindu >>An animal model for external otitis.
1997 (engelsk)Inngår i: European Archives of Oto-Rhino-Laryngology, ISSN 0937-4477, E-ISSN 1434-4726, Vol. 254, nr 3, s. 115-119Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

External otitis was produced in 12 Sprague-Dawley rats by mechanical stimulation through a plastic micropipette inserted into the right external auditory canal (EAC). The EAC was later evaluated regarding the color of the skin, swelling and the presence of fluid. Within 1 day all rats developed an external otitis that was characterized by a red, swollen ear canal containing an opalescent fluid. The tympanic membrane and middle ear cavity appeared to be normal. No healed EACs were seen within the initial 10 days of follow-up and 4 of 6 rats still exhibited external otitis at day 21. Light microscopy of biopsy specimens revealed pronounced edema of the dermis of the ear canal. Mast cells were more numerous in the early phase of the otitis present, although very few inflammatory cells were found in tissues despite the marked inflammatory reaction produced. Findings show that this animal model for external otitis can be used to investigate pathogenesis as well as to test various treatment strategies.

Identifikatorer
urn:nbn:se:umu:diva-27110 (URN)10.1007/BF02471273 (DOI)9112030 (PubMedID)
Tilgjengelig fra: 2009-11-11 Laget: 2009-11-11 Sist oppdatert: 2017-12-12
2. Effects of betamethasone dipropionate plus an antihistamine in patients with external otitis
Åpne denne publikasjonen i ny fane eller vindu >>Effects of betamethasone dipropionate plus an antihistamine in patients with external otitis
1999 (engelsk)Inngår i: Current Therapeutic Research: Clinical and Experimental, ISSN 0011-393X, E-ISSN 1879-0313, Vol. 60, nr 7, s. 364-370Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

In a prospective multicenter, randomized, double-masked trial, 30 patients with external otitis received betamethasone dipropionate in a 0.05% solution for 11 days. Fifty percent of the patients were assigned randomly to receive concomitant treatment with loratadine to help control itching, and 50% received placebo. The status of the external auditory canal (EAC) was assessed on days 0, 3, 7, 11, and 21 according to a new scoring system that graded color, the extension of redness outside the EAC, swelling, and effusion. Eighteen patients underwent sampling for a bacteriologic culture at the start of treatment; 14 cultures showed positive findings. The EAC status improved rapidly, and by day 11 it was almost normal in all patients. Pain and sleep disturbances disappeared by day 7; at which point itching was either nonexistent or mild. All patients were able to resume work after 3 days of treatment. At the end of the study, 29 (97%) of the 30 patients were cured. The addition of loratadine to the treatment did not improve results significantly. External otitis is generally treated with a combination of a steroid and an antibiotic. Results of this study suggest that external otitis, whether culture-positive or not, can be cured using a group III steroid alone.

Emneord
external otitis, steroid, loratadine
HSV kategori
Identifikatorer
urn:nbn:se:umu:diva-4732 (URN)10.1016/S0011-393X(99)80014-9 (DOI)
Tilgjengelig fra: 2005-10-11 Laget: 2005-10-11 Sist oppdatert: 2018-03-15bibliografisk kontrollert
3. A topical steroid without an antibiotic cures external otitis efficiently: a study in an animal model.
Åpne denne publikasjonen i ny fane eller vindu >>A topical steroid without an antibiotic cures external otitis efficiently: a study in an animal model.
2001 (engelsk)Inngår i: European Archives of Oto-Rhino-Laryngology, ISSN 0937-4477, E-ISSN 1434-4726, Vol. 258, nr 6, s. 287-291Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

In an animal external otitis model, inflammatory reactions were evoked by mechanical stimulation of the rat ear canal skin. The rats were in four groups: group A treated with a group III steroid, betamethasone dipropionate; group B treated with hydrocortisone combined with oxytetracycline; group C treated with hydrocortisone with oxytetracycline and polymyxin B added; Group D, the controls, treated with saline. All rats were observed otomicroscopically daily during the first 7 days after treatment and then on days 10 and 20. A standardized scoring system was used to evaluate colour, swelling and effusion of the ear canal. Histological specimens were collected on days 3, 7, 10 and 20. The most rapid improvement in the ear canal status occurred in the animals treated with betamethasone dipropionate. The inflammatory reaction of the ear canal skin caused by mechanical stimulation was characterized by oedema of the stroma but few inflammatory cells were present. The surface of the epithelium towards the connective tissue layer was smooth in the group III-treated animals (group A) whereas other groups had irregularities of the basal membrane. From this study it is inferred that the group III steroid betamethasone dipropionate alone heals experimentally induced external otitis more rapidly than hydrocortisone with oxytetracycline, with or without polymyxin B. These findings should be considered in future clinical trials of external otitis.

Emneord
External otitis, Ear canal skin, Betamethasone dipropionate, Animal model
Identifikatorer
urn:nbn:se:umu:diva-27111 (URN)10.1007/s004050100332 (DOI)11583468 (PubMedID)
Tilgjengelig fra: 2009-11-11 Laget: 2009-11-11 Sist oppdatert: 2017-12-12
4. External otitis caused by infection with Pseudomonas aeruginosa or Candida albicans cured by use of a topical group III steroid, without any antibiotics
Åpne denne publikasjonen i ny fane eller vindu >>External otitis caused by infection with Pseudomonas aeruginosa or Candida albicans cured by use of a topical group III steroid, without any antibiotics
2005 (engelsk)Inngår i: Acta Oto-Laryngologica, ISSN 0001-6489, E-ISSN 1651-2251, Vol. 125, nr 4, s. 346-352Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

CONCLUSIONS: Irrespective of the microbial agent, group III steroid solution cured external otitis efficiently in a rat model. The addition of antibiotic components to steroid solutions for the treatment of external otitis is of questionable validity. OBJECTIVE: External otitis, caused by infection with either Pseudomonas aeruginosa or Candida albicans, was established in a rat model and the treatment efficacy of a group III steroid solution was studied. MATERIAL AND METHODS: Three treatments were studied: (i) a group III steroid solution; (ii) a group I steroid combined with two antibiotic components; and (iii) a saline solution. A scoring scale was used to evaluate the characteristics of the ear canal skin. Bacteriological and fungal samples were collected for culturing and ear canal skin biopsies were taken for structural analyses. RESULTS: It was possible to cause P. aeruginosa and C. albicans infections in an animal model. In the P. aeruginosa-infected animals, only the group III steroid treatment cured all the animals. In the C. albicans-infected animals, group III steroid treatment resolved external otitis faster than the other treatment modalities.

Emneord
Administration; Topical, Animals, Anti-Bacterial Agents/*administration & dosage, Betamethasone/administration & dosage/*analogs & derivatives, Candidiasis/*drug therapy/microbiology/pathology, Colony-Forming Units Assay, Disease Models; Animal, Dose-Response Relationship; Drug, Drug Therapy; Combination, Ear Canal/drug effects/microbiology/pathology, Hydrocortisone/administration & dosage/*analogs & derivatives, Male, Otitis Externa/*drug therapy/microbiology/pathology, Oxytetracycline/administration & dosage, Polymyxin B/administration & dosage, Pseudomonas Infections/*drug therapy/microbiology/pathology, Rats, Treatment Outcome
Identifikatorer
urn:nbn:se:umu:diva-7737 (URN)10.1080/00016480510027529 (DOI)15823803 (PubMedID)
Tilgjengelig fra: 2008-01-11 Laget: 2008-01-11 Sist oppdatert: 2017-12-14bibliografisk kontrollert
5. A group III steroid solution without antibiotic components: an effective cure for external otitis.
Åpne denne publikasjonen i ny fane eller vindu >>A group III steroid solution without antibiotic components: an effective cure for external otitis.
2005 (engelsk)Inngår i: Journal of Laryngology and Otology, ISSN 0022-2151, E-ISSN 1748-5460, Vol. 119, nr 5, s. 342-7Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

The present study was undertaken to compare the clinical benefits of prescribing ear drops containing 0.05% solution of betamethasone dipropionate (BD), and ear drops containing hydrocortisone with oxytetracycline hydrochloride and polymyxin B (HCPB), for topical treatment of external otitis. Fifty-one patients were enrolled in this open randomized, parallel-group, multicentre study, performed in eight different ENT departments. The patients were randomly assigned to one of the two treatment groups: BD (n = 26) and HCPB (n = 25). Only ENT specialists investigated the patients. Bacterial and fungal cultures were raised on days 1 and 11, using swabbed material from ear canals. Twice daily the patients recorded their symptoms during the acute phase, using special diary cards.BD proved a significantly more effective cure than HCPB during the acute phase of external otitis and afforded a lower relapse frequency during a six-month follow-up period. The patients of the BD group were significantly less troubled by itching (p < 0.01) than those in the HCPB group. On day 11, at the end of the acute phase, growth of bacteria (p = 0.03) and fungi (p < 0.01) was less frequent in the BD group than in the HCPB group. No serious adverse events occurred, and those minor events observed were comparable between the two groups.Our conclusion is that the group III steroid solution, BD, cured the external otitis more effectively than did the HCPB solution, whether infected by bacteria or by fungi. No difference was evident regarding adverse effects. Furthermore, price favours a solution without any antibiotic component. In view of these observations, a group III steroid solution ought to be the preferred remedy for external otitis, whether infected or not.

Emneord
Administration; Topical, Adult, Aged, Anti-Bacterial Agents/*administration & dosage, Anti-Inflammatory Agents/*administration & dosage, Betamethasone/administration & dosage/adverse effects/*analogs & derivatives, Drug Combinations, Ear Canal/microbiology, Female, Humans, Hydrocortisone/administration & dosage/adverse effects, Male, Middle Aged, Otitis Externa/*drug therapy/microbiology, Oxytetracycline/administration & dosage/adverse effects, Polymyxin B/administration & dosage/adverse effects, Treatment Outcome
Identifikatorer
urn:nbn:se:umu:diva-7735 (URN)10.1258/0022215053945705 (DOI)15949095 (PubMedID)
Tilgjengelig fra: 2008-01-11 Laget: 2008-01-11 Sist oppdatert: 2017-12-14bibliografisk kontrollert

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