A review of evidence supporting the use of Anti-Biotics in the treatment of Acute Otitis Media in children to prevent Mastoiditis.

Word count: 1469

Module Leaders
Jeshni Amblum & Stuart Rutland Contents Page

1. Front Sheet

2. Contents Page

3. A review of evidence supporting the use of Antibiotics in the treatment of Acute Otitis Media in children to prevent Mastoiditis.

4. Reference List

5. Appendices:

i. SECAMB Clinical Management Plan/Patient Group Directive

ii. FIGURE 3 - Thompson et al (2009)

A review of evidence supporting the use of Antibiotics in the treatment of Acute Otitis Media in children to prevent Mastoiditis.
Student no 18830
Rationale
The Paramedic Practitioner (PP) role has recently adopted a number of Clinical Management plans and Patient Group Directives (PGD) increasing the scope of practice. One such PGD (Appendix i) allows for the utilisation of antibiotics, namely Amoxicillin and Clarithromycin, for the treatment of Otitis Media (OM). This essay will look at the evidence supporting the use of these antibiotics, their efficacy and if early use prevents OM from developing in to Mastoiditis. Its primary aim is to enhance a PP’s knowledge and support education working towards clinical autonomy.
Description
Otitis Media literally means inflammation of the middle ear (Merriam-Webster 2011) and is predominantly caused by an effusion with in the middle ear caused by Eustachian tube dysfunction (Dhillon and East, 1994, pp 7). This dysfunction is caused by a relative obstruction of the Eustachian tube that creates a negative air pressure within the middle ear. Over time interstitial fluid is drawn in from the surrounding tissue resulting in the effusion (Natal 2011). Eustachian tube dysfunction often follows an upper respiratory tract infection and whilst the effusion is not always infectious it is can be said to become “predisposing to viral or bacterial infections” (Elliott et al, 2007, pp 177). Respiratory viruses account for approximately fifty percent of infected effusions however common bacterial pathogens include Streptococcus pneumoniae, Haemophilus influenzae, β-haemolytic streptococci, Moraxella catarrhalis and Staphylococcus aureus (Elliott, 2007, pp 177 and Piglansky, 2003). These infections have potential to migrate causing serious systemic complications.
The most common intratemporal complication of OM is Mastoiditis (Spratley, 2000) which is a process where the mastoid bone fills with infected material and its honeycomb-like structure becomes inflamed and begins to deteriorate. “Mastoiditis is generally secondary to an acute OM but chronic cause may rarely develop as a complication of chronic OM.” (Naumann et al, 1993 pp 11). The World Health Organisation (WHO) (1998) define chronic OM as “a stage of ear disease in which there is chronic infection of the middle ear cleft, a non-intact tympanic membrane and a discharge (Otorrhoea), for at least the preceding two weeks”.
Mastoiditis predominantly affects children and before the antibiotic age was a leading cause of death in this age group (Mandell, 2005, pp 771). Mastoiditis can still be a difficult condition to treat with oral antibiotics particularly in the progressive stage when infection can be deep into the bone. Prognosis when OM is correctly diagnosed is positive with improved treatments such as intravenous antibiotics and Mastoidectomy (Mandell, 2005, pp 771). This said the view of an old proverb that states “prevention is better than cure” could have possibly influenced the decision to treat acute OM early with antibiotics.
Analysis
The clinical efficacy of Amoxicillin was examined by Dagan et al (2001) who demonstrated that high dose Amoxicillin was “Highly Efficacious” against common pathogens causing acute OM including Penicillin-resistant Streptococcus Pneumoniae. Whilst this study appeared robust in its methods, the data recorded demonstrated that out of 521 candidates 355 (68%) showed a pathogen following Tympanocentesis and overall only 180 (34.5%) were “bacteriologically evaluable”. This leaves 32% which had no pathogen detected and 65.5% who were clinically evaluable but their pathogen resolution was not recorded. This study is important from an efficacy point of view but did not offer a control group to determine if the OM would have resolved without intervention and therefore been classed as self limiting.
With concern over antibiotic resistant bacterium, Brook and Gober (1996) examined Amoxicillin prophylaxis for OM and over a nine month period were able to conclude that the number of penicillin-resistant bacteria within the oropharynx had increased as a direct result of the prophylaxis. This coupled with evidence from the National institute for Health and Clinical Excellence (NICE) (2008) who specifically looked at antibiotic prescribing strategies for respiratory tract infections (RTI) and determined that in the modern era, complications from RTIs (including Mastoiditis) are far less common than in previous times. Specifically they highlight the immediate post World War 2 era as a time when complications were higher due to the general sate of the nation’s health. NICE (2008) concluded that even when compared to other developed European countries, the prescription rate for antibiotics in the UK is still high and they offer guidelines for the prescribing of antibiotics for self-limiting RTIs. These guidelines note the possibility of three approaches for antibiotic use; immediate use, delayed prescription or no prescription dependant on the severity and location of the RTI.
The British National Formulary (BNF) (2010, pp 327-329) lists Amoxicillin as the antibiotic of choice for the treatment of OM whilst using Clarithromycin in those patients who have a penicillin-based allergy. The BNF (2010, pp 675-676) also states that many infections are viral but in those cases of OM where resolution of symptoms has not occurred after 72 hours, the antibiotic may be started. It also recommends starting treatment earlier if there is deterioration or the patient becomes systemically unwell. It lists Co-amoxiclav as an alternative treatment if there is no improvement to the patient 48 hours after the initial antibiotic has been started.
Damoiseaux et al (2000) and Little et al (2001) support a conservative approach from the results of their trials which concluded that the modest effect antibiotics offer for OM does not justify their prescription at the first visit provided that close surveillance can be guaranteed. These trials appear robust in their approach offering comparable data from placebo groups. They highlight that despite the efficacy of amoxicillin being confirmed, (reduction of analgesia use and resolution of symptoms at day three as appose to day four), the condition within the placebo groups was still self-limiting and Damoiseaux et al (2000) state that at day eleven no difference between the two groups could be identified.
Similarly an intervention review for the Cochrane library (Sanders, 2008) found no difference between immediate antibiotics and observational treatment approaches for OM, in the number of children with pain three to seven days after the initial assessment.
Whilst Mastoiditis still remains a concerning complication of OM its occurrence requires evaluation if it is to be considered when treating OM. A Retrospective Cohort study by Thompson et al (2009) looked directly at the link between the decreasing prescription rates for antibiotics to treat acute OM and the frequency of confirmed Mastoiditis. This study looked at vast amounts of data covering a sixteen year recording period using UK General Practitioners statistics, the results can be looked at in a number of ways.
The incidence of Mastoiditis following OM was reduced by half if antibiotics had been prescribed for the initial infection however the risk is relative. When antibiotics were not given the ratio for Mastoiditis developing was 3.8 per 10,000 or a risk of 0.0038% and when antibiotics were given it reduced to 1.8 per 10,000 or 0.0018%. This would equate to 4831 people being treated with antibiotics for OM to prevent 1 case of Mastoiditis. This potentially means that if antibiotics were withheld for 1 year there would be 255 more cases of Mastoiditis but prescriptions would reduce by 738,775. This in itself has large cost implications to the NHS.
Thompson et al (2009) also showed that despite a reduction in the use of antibiotics over the study time frame, the occurrence of Mastoiditis remained relatively constant (see appendix 2). They concluded that “treating these additional otitis media episodes could pose a larger public health problem in terms of antibiotic resistance” and that the treatment of otitis media with antibiotics to prevent Mastoiditis should be precluded.

Conclusion
Whilst Amoxicillin offers a confirmed efficacy in the treatment of acute OM the condition is very often self-limiting and as research suggests, the risk of developing Mastoiditis is relatively low. Mastoiditis itself is a condition that is now well treated with positive prognosis in the majority of cases. The decision as to when to use antibiotics should take into account the patients overall condition following the confirmation of OM and if they are systemically well (NICE 2008). It has been demonstrated that the blanket use of antibiotics in a systemically well patient specifically to prevent Mastoiditis is not recommended. Prudent antimicrobial administration in primary care is an important issue that is everyone’s responsibility and may effectively limit the spread of antimicrobial resistance. Paramedic Practitioners (PP) have the option to utilise a delayed Patient Group Directive to provide part of a safety net in the patients overall treatment.

Evaluation
Through this essay it has been demonstrated that a holistic approach to patient care is essential when deciding on the appropriate time to use anti-biotic therapy. As this is a relatively new process for PPs a recommendation would be to gather personal experience when an episode of OM is diagnosed by initially reviewing every case seen. This would be regardless of which application of the PGD has been utilised (immediate use, delayed use or not used). This would have the benefits of enhancing a PPs decision making by enabling them to draw on these past experiences, providing them with true evidence based practice and improving patient outcomes.

Reference List
British National Formulary (2010) BNF 60.London: Royal Pharmaceutical Society Publishing.
Brook I and Gober A.E, (Jan 1996) Prophylaxis with Amoxicillin or Sulfisoxazole for Otitis Media: Effect on Recovery of Penicillin-Resistant Bacteria from Children. Clinical Infectious Diseases Vol. 22, No. 1 pp. 143-145
Dagan, R MD; Hoberman, A; Johnson, C MD, PhD; Leibervitz, E L. MD; Arguedas, A MD; Rose, F V. PhD; Wynne, B R. MD; Jacobs, M R. MD, PhD. ( 2001) Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media. Pediatric Infectious Disease Journal: Volume 20 - Issue 9 - pp 829-837
Damoiseaux R A M J, Van Balen F A M, Hoes A W, Verheij T J M, De Melker R A. (2000) Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years. BMJ. 320 : 350 doi: 10.1136/bmj.320.7231.350
Dhillon, R.S and East, C.A (1994) An illustrated colour text Ear, Nose and Throat; and head and neck surgery. Edinburgh: Churchill Livingstone
Elliot, T. Worthington, T. Osman, H. and Gill, M. (2007) Lecture Notes; Medical Microbiology and Infection. 4th edition. Oxford: Blackwell Publishing.
Great Britain. National Institute for Health and Clinical Excellence (2008) Respiratory tract infections; Prescribing of antibiotics for self-limiting respiratory tract infections in adults and children in primary care. [Online]. Available at: http://www.nice.org.uk/CG069
Great Britain. World Health Organisation (1998) PREVENTION OF HEARING
IMPAIRMENT FROM CHRONIC OTITIS MEDIA. [Online]. Available at: http://www.who.int/pbd/deafness/en/chronic_otitis_media.pdf
Little P, Gould C, Williamson I, Moore M, Warner G, Dunleavey J, (Feb 2001) Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media BMJ 2001; 322 : 336 doi: 10.1136/bmj.322.7282.336
Mandell GL, Bennett JE, Dolin R. (2005) Principles and Practice of Infectious Diseases. 6th ed. London: Churchill Livingstone.
Merriam-Websters Medical Dictionary (Online) (2011). Available at. http://www2.merriam-webster.com/cgi-bin/mwmedsamp?book=Medical&va=sample
Natal, B.L. MD. Chao,J. H. MD. (2011) Otitis Media in Emergency Medicine. Available at: emedicine.medscape.com/article/764006-overview
Naumann, H.H. Martin, F. Scherer, H. and Schorn, K. (1993) Differential Diagnosis in Otorhinolaryngology; Symptoms, Syndroms and Interdisciplinary Issues. New York: Thieme Medical Publishers.
Piglansky L, Leibovitz E, Raiz S, Greenberg D, Press J, Leiberman A and Dagan R (2003). Bacteriologic and clinical efficacy of high dose amoxicillin for therapy of acute otitis media in children. Pediatric Infectious Disease Journal : 22(5): 405-13.
Sanders S, Glasziou PP, Del Mar CB, Rovers MM. Antibiotics for acute otitis media in children. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD000219. DOI: 10.1002/14651858.CD000219.pub2.
Spratley, J. Silveira, H. Alvarez, I. and Pais-Clemente, M (2000)
Acute mastoiditis in children: review of the current status. International journal of pediatric otorhinolaryngology : Volume 56, Issue 1, Pages 33-40
Teele D.W, Klein J.O and Rosner B. (1989) Epidemiology of Otitis Media during the First Seven Years of Life in Children in Greater Boston: A Prospective, Cohort Study. The Journal of Infectious Diseases. Vol. 160, no.1. pp. 83-94
Thompson P L, Gilbert R E, Long P F, Saxena S, Sharland M. Chi Kei Wong I, (2009) Effect of Antibiotics for Otitis Media on Mastoiditis in Children: A Retrospective Cohort Study Using the United Kingdom General Practice Research Database. Pediatrics 2009;123;424-430

Appendix i

Appendix ii

FIGURE 3
Annual incidence of mastoiditis diagnoses and antibiotic prescribing for otitis media in children 3 months to 15 years of age in UK general practices.

Thompson P L, Gilbert R E, Long P F, Saxena S, Sharland M. Chi Kei Wong I, (2009) Effect of Antibiotics for Otitis Media on Mastoiditis in Children: A Retrospective Cohort Study Using the United Kingdom General Practice Research Database. Pediatrics 2009;123;424-430