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Self-limiting respiratory tract and ear infections – antibiotic prescribing

About

What is covered

This NICE Pathway covers prescribing of antibiotics for self-limiting respiratory tract and ear infections in adults and children in primary care.

Updates

Updates to this NICE Pathway

16 January 2020 Footnote added to the antibiotic prescribing tables for sore throat in children and young people and adults to clarify the duration of prescribing for phenoxymethylpenicillin.
12 November 2019 Rapid tests for group A streptococcal infections in people with a sore throat (NICE diagnostics guidance 38) added to assessment, advice and self care in sore throat.
6 February 2019 Recommendations from cough (acute): antimicrobial prescribing (NICE guideline NG120) added.
27 March 2018 Recommendations from otitis media (acute): antimicrobial prescribing (NICE guideline NG91) added.
25 January 2018 Recommendations from sore throat (acute): antimicrobial prescribing (NICE guideline NG84) added.
26 October 2017 Recommendations from sinusitis (acute): antimicrobial prescribing (NICE guideline NG79) added.

Sinusitis

  • Acute sinusitis (also known as rhinosinusitis) is self-limiting and usually triggered by a viral infection of the upper respiratory tract (for example, a common cold).
  • Only about 2% of cases are complicated by bacterial infection, but it is very difficult to distinguish these.
  • Symptoms can last for 2 to 3 weeks – most people will get better within this time without treatment, regardless of cause (bacteria or virus).
  • Antibiotics are not needed for most people. The number of people improving with antibiotics is similar to the number getting adverse effects, such as diarrhoea.
  • Complications of acute sinusitis are rare (about 2.5 to 4.3 per million people per year). Withholding antibiotics is unlikely to lead to complications.
  • Previous antibiotic use may lead to resistant organisms if the same antibiotic is used again.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Short Text

Everything NICE has said on antibiotic prescribing for self-limiting respiratory tract and ear infections in primary care in an interactive flowchart

What is covered

This NICE Pathway covers prescribing of antibiotics for self-limiting respiratory tract and ear infections in adults and children in primary care.

Updates

Updates to this NICE Pathway

16 January 2020 Footnote added to the antibiotic prescribing tables for sore throat in children and young people and adults to clarify the duration of prescribing for phenoxymethylpenicillin.
12 November 2019 Rapid tests for group A streptococcal infections in people with a sore throat (NICE diagnostics guidance 38) added to assessment, advice and self care in sore throat.
6 February 2019 Recommendations from cough (acute): antimicrobial prescribing (NICE guideline NG120) added.
27 March 2018 Recommendations from otitis media (acute): antimicrobial prescribing (NICE guideline NG91) added.
25 January 2018 Recommendations from sore throat (acute): antimicrobial prescribing (NICE guideline NG84) added.
26 October 2017 Recommendations from sinusitis (acute): antimicrobial prescribing (NICE guideline NG79) added.

Sources

NICE guidance and other sources used to create this interactive flowchart.
Cough (acute): antimicrobial prescribing (2019) NICE guideline NG120
Alere Afinion CRP for C-reactive protein testing in primary care (2016) NICE medtech innovation briefing 81
QuikRead go for C-reactive protein testing in primary care (2016) NICE medtech innovation briefing 78

Quality standards

Quality statements

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

Information for the public

NICE has written information for the public on each of the following topics.

Pathway information

Sinusitis

  • Acute sinusitis (also known as rhinosinusitis) is self-limiting and usually triggered by a viral infection of the upper respiratory tract (for example, a common cold).
  • Only about 2% of cases are complicated by bacterial infection, but it is very difficult to distinguish these.
  • Symptoms can last for 2 to 3 weeks – most people will get better within this time without treatment, regardless of cause (bacteria or virus).
  • Antibiotics are not needed for most people. The number of people improving with antibiotics is similar to the number getting adverse effects, such as diarrhoea.
  • Complications of acute sinusitis are rare (about 2.5 to 4.3 per million people per year). Withholding antibiotics is unlikely to lead to complications.
  • Previous antibiotic use may lead to resistant organisms if the same antibiotic is used again.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Supporting information

Antibiotic course length

  • There was no evidence directly comparing different antibiotic course lengths. From a systematic review in people with acute bronchitis, antibiotic course length varied from 5 to 10 days typically depending on the antibiotics used.
  • The committee agreed that, when an antibiotic is appropriate, the shortest course that is likely to be effective should be prescribed.
  • Based on evidence, their experience and resistance data, the committee agreed that a 5-day course for all the recommended antibiotics was sufficient to treat acute cough, where an antibiotic was appropriate. This takes into account the overall efficacy and safety evidence for antibiotics, and minimises the risk of resistance. Studies in the evidence review for specific antibiotics in acute bronchitis sometimes had course lengths of more than 5 days.
For more information see antibiotic course length in the NICE guideline on cough (acute): antimicrobial prescribing.

Choice of antibiotic

  • There was no evidence directly comparing different antibiotics. However, subgroup analysis from a systematic review in people with acute bronchitis did find some differences between antibiotics compared with placebo.
  • Individually, doxycycline compared with placebo showed a significant reduction in the following outcomes: mean number of days feeling ill, cough at follow-up and mean number of days of productive cough, where other antibiotics (amoxicillin and erythromycin) did not.
  • Individually, cefuroxime also showed benefit over placebo for the following outcomes: clinical improvement at follow-up, improvement at physician follow-up and night cough at follow-up, where other antibiotics did not. This was based on a trial of over 300 people, which contributed much of the weight in meta-analyses. The committee discussed this finding and had some concerns that the study design of the cefuroxime study in particular influenced this result.
  • Cefuroxime is a broad-spectrum antibiotic (a second generation cephalosporin). The committee discussed that, if an antibiotic is needed to treat an infection that is not life-threatening, a narrow-spectrum antibiotic should generally be first choice. Indiscriminate use of broad-spectrum antibiotics creates a selective advantage for bacteria resistant even to these 'last-line' broad-spectrum agents, and also kills normal commensal flora leaving people susceptible to antibiotic-resistant harmful bacteria such as Clostridium difficile.
  • Based on evidence, their experience and resistance data, the committee agreed to recommend doxycycline at usual dose, as the first-choice antibiotic for adults with acute cough (including acute bronchitis), where an antibiotic is appropriate. This is a tetracycline, which is only suitable for non-pregnant adults, and for acute cough, in young people over 12 years. Doxycycline was preferred over amoxicillin because there was limited evidence from subgroup analyses that showed benefits on some outcomes where amoxicillin did not. But more importantly, they agreed that amoxicillin should be reserved, when possible, for use in more serious infections where bacterial infection is more common, for example pneumonia. This is because of concerns that amoxicillin drives resistance not just in pneumococci but also in gram-negative organisms. The committee was aware of evidence that the risk of resistance to amoxicillin is significantly increased in urinary isolates of Escherichia coli following a course of amoxicillin. These effects are greatest in the first month after use, but are detectable for up to 12 months. There is a concern that using amoxicillin in conditions such as acute cough, where the benefits of antibiotics are marginal, drives resistance without adding benefit.
  • Alternative first-choice antibiotics (at usual doses) for adults unable to take doxycycline, which have good activity against common causal bacteria, are:
    • amoxicillin (a penicillin)
    • clarithromycin (or erythromycin in pregnancy), which are macrolides.
  • The committee agreed that because the evidence of benefit of doxycycline over amoxicillin, clarithromycin or erythromycin is limited, these antibiotics should be offered as alternative first choices. This also reflects concerns that doxycycline is contraindicated in pregnancy, and this should be considered when choosing antibiotics for women of child bearing age.
  • For children and young people, amoxicillin is recommended as the first choice antibiotic, with clarithromycin, erythromycin or doxycycline (in young people aged 12 to 17 years only) as alternative choices.
For more information see choice of antibiotic in the NICE guideline on cough (acute): antimicrobial prescribing.

No antibiotics, back-up antibiotics and immediate antibiotics

  • The committee discussed that acute cough, either associated with an upper respiratory tract infection or acute bronchitis, is usually a self-limiting infection. It is often a viral infection, and antibiotics are not usually needed.

Acute cough associated with an upper respiratory tract infection

  • No evidence was found for antibiotics to treat an acute cough specifically associated with an upper respiratory tract infection, which is usually a viral infection. Based on the lack of evidence and experience, the committee agreed that antibiotics should not be offered to people (adults or children) with an acute cough associated with an upper respiratory tract infection. People should be given advice that an acute cough can last up to 3 or 4 weeks and does not need an antibiotic. They should also be given safety netting advice to seek medical help if symptoms worsen rapidly or significantly, do not improve after 3 or 4 weeks, or they become systemically very unwell.

Acute cough associated with acute bronchitis

  • Based on evidence and experience, the committee agreed that antibiotics should not routinely be offered to people (adults or children) with an acute cough associated with acute bronchitis. Antibiotics had a beneficial effect on some outcomes, but not others, and any benefit from antibiotics needs to be weighed up against their potential to cause adverse effects. Even where statistically significant effects were seen, these were often difficult to interpret and may not be clinically meaningful for many people.
  • Antibiotics did not improve the overall clinical condition of people with acute bronchitis, or the number of people with improvement at physician follow-up. Antibiotics did improve abnormal lung examination at follow up, but the committee agreed this was not an important patient-orientated outcome for people with acute bronchitis, and this outcome was heavily influenced by 1 study of cefuroxime.
  • Antibiotics reduced the number of people who had 'any cough' or 'night cough' at follow-up, with a number needed to treat of 6 or 7. However, the timing of follow-up is unclear, varying between studies from 2 to 18 days after treatment started.
  • Antibiotics made little difference to how long the symptoms of acute bronchitis lasted. They reduced the mean number of days of cough by about 0.5 days (range 0 to 1 day), which the committee agreed may not be clinically meaningful for many people when an acute cough lasts up to 3 or 4 weeks.
  • Antibiotics have possible adverse effects, particularly diarrhoea and nausea. In people with acute bronchitis, antibiotics increased adverse effects, with a number needed to harm of 25.
  • Based on experience, the committee discussed that withholding antibiotics in acute cough is unlikely to lead to complications in people who are not systemically very unwell or at higher risk of complications. However, they acknowledged the limited evidence base, which was solely for no increased risk of acute otitis media or pneumonia in children with acute undifferentiated respiratory tract infection.
  • The committee recognised the usefulness of back-up antibiotic prescriptions in managing self-limiting illnesses. However, from the evidence, back-up antibiotics were not significantly different to immediate antibiotics or no antibiotics for how long a cough lasts.
  • Based on evidence, experience and the principles of antimicrobial stewardship, the committee recommended a no antibiotic prescribing strategy (routinely) for people with acute cough associated with acute bronchitis. They recognised that antibiotics may be an option for some people on an individual patient basis, but this should not be routine practice. For most people with an acute cough (which is a condition that can persist for some weeks) they felt a back-up antibiotic prescribing strategy sent the wrong message that antibiotics may be needed at some point.
  • The committee was also aware of recommendations in the NICE guideline on pneumonia to consider a point of care C-reactive protein test if after clinical assessment a diagnosis of pneumonia has not been made and it is not clear whether antibiotics should be prescribed. This guideline has recommendations on prescribing antibiotics according to C-reactive protein results.

Acute cough in people who are systemically very unwell or at higher risk of complications

  • Based on evidence and experience, the committee agreed that an immediate antibiotic prescription should be offered to people (adults or children) with an acute cough (associated with an upper respiratory tract infection or acute bronchitis) who are identified at a face-to-face clinical examination as systemically very unwell, because these people require prompt treatment with an antibiotic.
  • Based on evidence and experience, the committee agreed that an immediate antibiotic prescription or a back-up antibiotic prescription could be considered for people with an acute cough (associated with an upper respiratory tract infection or acute bronchitis) who are identified at a face-to-face clinical examination as at higher risk of complications.
  • The committee recognised that the NICE guideline on respiratory tract infections (self-limiting): prescribing antibiotics recommends that people with acute cough are likely to be at higher risk of developing complications because of pre-existing comorbidity (significant heart, lung, renal, liver or neuromuscular disease, immunosuppression, cystic fibrosis, and young children who were born prematurely) or because of older age and the presence of certain criteria (type 1 or type 2 diabetes, congestive heart failure, use of oral corticosteroids, hospitalisation in previous year). The committee agreed that for some of these people an immediate antibiotic may not be clinically required, and a back-up antibiotic could be considered.
  • The committee recommended that antibiotics should only be considered after people have been assessed face-to-face to allow clinical examination.
  • The committee agreed that a back-up antibiotic prescription could be used if symptoms worsen rapidly or significantly at any time. Giving safety netting advice is also important to ensure people seek medical help if symptoms worsen rapidly or significantly despite taking the antibiotic, or they become systemically very unwell.
  • Based on experience, the committee agreed that people with acute cough who present with any symptoms or signs suggesting a more serious illness or condition (for example sepsis, a pulmonary embolism or lung cancer) should be referred to hospital, or specialist advice should be sought on further investigation and management.

Antibiotics for moist cough of greater than 10 days duration in children

  • The committee discussed the evidence for antibiotics reducing clinical failure in children with a prolonged moist cough. However, they noted the limitations with this evidence base and did not make a recommendation specifically for this population. Many children had a cough for over 3 weeks at baseline, and therefore did not have an acute cough. Also, there was no benefit of antibiotics when children with Bordetella pertussis were excluded (9% of all children), and in an intention-to-treat analysis using those not lost to follow-up.
For more information see no antibiotic in the NICE guideline on cough (acute): antimicrobial prescribing.

Mucolytics

  • The committee agreed that the evidence for mucolytics (acetylcysteine and carbocisteine) was mixed. There was some evidence that a mucolytic reduced cough symptoms in children with acute upper and lower respiratory tract infections but other evidence that it had no effect.
  • The clinical significance of any benefit of mucolytics is unclear, and the committee agreed that they should not be offered for people (adults or children) with an acute cough. Any prescribed alternatives to antibiotics have workload implications as people are likely to re-consult and expect similar treatments in the future, sending the wrong message that prescribed treatment is needed for a largely self-limiting condition.
For more information see mucolytics in the NICE guideline on cough (acute): antimicrobial prescribing.

Corticosteroids

  • The committee agreed that the evidence for inhaled corticosteroids was mixed. There was some evidence that it reduced cough symptoms in adults with an acute or subacute cough (particularly in non-smokers) but other evidence that it had no effect. No evidence for oral corticosteroids was found.
  • Corticosteroids have well-recognised systemic (mineralocorticoid and glucocorticoid) effects, including a range of psychological or behavioural effects (particularly in children) and the committee agreed that, weighing up the potential risks and benefits, oral or inhaled corticosteroids should not be offered for people (adults or children) with an acute cough (including acute bronchitis).
  • The committee discussed the evidence that inhaled corticosteroids reduced additional treatments being sought, and they could reduce the prescribing of antibiotics for acute cough. However, any prescribed alternatives to antibiotics have workload implications as people are likely to re-consult and expect similar treatments in the future, sending the wrong message that prescribed treatment is needed for a largely self-limiting condition.
  • The committee agreed that there may be instances when people with an acute cough and underlying airways disease, such as asthma, require corticosteroids. Therefore, they agreed that an oral or inhaled corticosteroid should not be offered to people (adults or children) with an acute cough unless they had underlying airways disease, such as asthma.
For more information see corticosteroids in the NICE guideline on cough (acute): antimicrobial prescribing.

Bronchodilators

  • Based on evidence, the committee agreed that bronchodilators, such as oral or inhaled salbutamol, did not benefit cough symptoms and increased adverse events, such as tremor. The committee agreed that there may be instances when people with an acute cough and an underlying airways disease, such as asthma, require bronchodilators. Therefore, they agreed that bronchodilators should not be offered to people (adults or children) with an acute cough unless they had underlying airways disease, such as asthma.
  • The committee discussed the evidence for oral salbutamol plus dextromethorphan but no recommendation was made because no such product is available in the UK.
For more information see bronchodilators in the NICE guideline on cough (acute): antimicrobial prescribing.

Self-care

  • Overall, the committee recognised that the quality of the evidence on self-care treatments for cough was limited. In many studies it was not clear what outcomes were being measured, or these measures were subjective. The sweet, glycerine-like consistency of many cough remedies, rather than the 'active ingredients' themselves may also have an effect, and the placebo effect of taking something rather than nothing to ease symptoms could be marked. However, promoting the role of self-care may help to reduce the amount of antibiotic prescriptions, and repeated or future consultations in general practice.

Honey

  • The committee agreed that there was some evidence that suggests honey reduced cough symptoms in children and young people with an acute cough caused by an upper respiratory tract infection. The clinical significance of the benefit of honey on cough symptoms is unclear, particularly because follow-up was for 1 day only.
  • Honey was well tolerated in the studies, and is readily available. However, it should not be given to children under 1 year of age because of concerns about infant botulism. It also contains sugars, and the committee discussed concerns about tooth decay.
  • In the studies, honey was given as a single 10-g dose in 1 trial, and 2 trials reported that honey was given before bedtime. A range of types of honey were used, with no studies using the same variety.
  • Based on evidence, the committee agreed that that limited evidence suggests that honey may have some benefit on cough symptoms and people over 1 year of age may wish to try this for the treatment of acute cough.

Herbal medicines

  • The committee found that the evidence for many of the herbal medicines was limited by poorly defined populations, outcomes, length of follow-up and a lack of safety data or data on adverse outcomes.
  • The committee reviewed evidence for several herbal products: Andrographis paniculata, ivy, primrose and thyme as a combined product, echinacea, and pelargonium.
  • The committee agreed that there was some evidence that suggests Andrographis paniculata (A. paniculata) reduced cough symptoms. However, as the clinical significance of this benefit is unclear, safety data was not available, and no A. paniculata product has been granted a traditional herbal registration with the MHRA, the committee agreed that no recommendation on its use for the treatment of acute cough could be made.
  • The committee agreed that there was some evidence that suggests ivy, primrose or thyme as various combined or single products reduced cough symptoms. However, as the clinical significance of this benefit is unclear and safety data was not available, the committee agreed that no recommendation on the use of these herbal products for the treatment of acute cough could be made. Several combined products containing ivy, primrose or thyme have been granted traditional herbal registrations with the MHRA to relieve coughs and catarrh associated with the common cold based on traditional use only.
  • Most studies in a systematic review of echinacea did not report a benefit on cough symptoms, and no safety data was available. Therefore, the committee agreed that no recommendation on the use of echinacea for the treatment of acute cough could be made. Numerous echinacea products have been granted traditional herbal registrations with the MHRA to relieve the symptoms of the common cold and influenza type infections based on traditional use only.
  • The committee agreed that there was some evidence that suggests pelargonium (Pelargonium sidoides, P.sidoides) reduced cough symptoms in people with acute bronchitis, with a liquid preparation being more beneficial than a tablet preparation. However, P. sidoides increased the number of people with adverse events (mainly gastrointestinal). The clinical significance of the benefit of P. sidoides on cough symptoms is unclear, and the committee noted that all the RCTs were conducted in Russia or Ukraine and were initiated and funded by a single manufacturing company. However, several P. sidoides products have been granted traditional herbal registrations with the MHRA to relieve symptoms of the common cold, sore throat, cough and blocked or runny nose.
  • The committee agreed that limited evidence suggests that pelargonium may have some benefit on cough symptoms and people over 12 years may wish to try it for the treatment of acute cough. Because of the limited evidence of benefit, and possible adverse effects, the committee agreed not to recommend pelargonium for children.

Non-steroidal anti-inflammatory drugs (NSAIDs)

  • Based on evidence, the committee agreed that NSAIDs did not benefit cough symptoms and no recommendation for their use to treat acute cough should be made. Paracetamol or ibuprofen are often used to manage any associated pain.

Cough expectorant medicines

  • The committee agreed that there was some evidence that suggests guaifenesin reduced cough symptoms in adults and young people with an acute cough or upper respiratory tract infection, with no increase in adverse effects. The clinical significance of any benefit is unclear, but the committee agreed that people over 12 years may wish to try cough medicines containing guaifenesin for the treatment of acute cough.
  • Over-the-counter cough medicines containing the expectorants guaifenesin and ipecacuanha are subject to MHRA advice. They should not be used in children under 6 years of age and are only available in pharmacies for use in children from 6 to 12 years where advice can be given.

Cough suppressant (antitussive) medicines

  • The committee agreed that the evidence for dextromethorphan was mixed. There was some evidence that suggests a single, high dose reduced cough symptoms in adults with an acute cough but other evidence that it had no effect, and it may increase adverse effects (mainly gastrointestinal and dizziness). The clinical significance of any benefit it may have is unclear.
  • Based on evidence, the committee agreed that codeine had no benefit on cough symptoms.
  • The systematic review of over-the-counter cough medicines did not include evidence specifically on pholcodine. However, the committee recognised that a randomised control trial comparing pholcodine with dextromethorphan is available.
  • Taking all the evidence, and their experience, into account the committee agreed that some people over 12 years may wish to try cough medicines containing cough suppressants (apart from codeine) for the treatment of acute cough.
  • Over the counter cough medicines containing the cough suppressants dextromethorphan and pholcodine are subject to MHRA advice. They should not be used in children under 6 years of age (pholcodine) or 12 years of age (dextromethorphan) and pholcodine is only available in pharmacies for use in children from 6 to 12 years where advice can be given. Over the counter cough medicines containing codeine should not be used in children under 12 years and are not recommended for young people under 18 years with breathing problems (MHRA advice).

Antihistamines and decongestants

  • The committee agreed that, from the limited evidence found, antihistamines (loratidine, clemastine, diphenhydramine and promethazine) and decongestants (pseudoephedrine) had no benefit on cough symptoms, and increased adverse effects (including drowsiness and dry mouth).
  • Over-the-counter cough medicines containing the antihistamines diphenhydramine and promethazine are subject to MHRA advice on how to use cough and cold medicines safely for children under 12 years.
For more information see self-care in the NICE guideline on cough (acute): antimicrobial prescribing.
Acute cough is commonly defined as a cough that lasts less than 21 days (3 weeks). The average duration is 18 days, although it can sometimes last for up to 29 days (over 4 weeks). It is most commonly caused by an upper respiratory tract infection, such as a cold or flu, which are viral infections. It can also be caused by acute bronchitis, a lower respiratory tract infection, which is usually viral infection but can be bacterial.
Other infective causes of cough include COVID-19, pneumonia, acute exacerbations of asthma, chronic obstructive pulmonary disease or bronchiectasis (which may also be non-infective exacerbations), and viral-induced wheeze, bronchiolitis, croup or whooping cough. Non-infective causes may include lung cancer, a foreign body, interstitial lung disease, pneumothorax, pulmonary embolism, heart failure, use of certain medicines (for example an angiotensin-converting enzyme inhibitor), upper airway cough syndrome (post-nasal drip), or gastro-oesophageal reflux disease. (NICE clinical knowledge summaries on cough, chest infections – adult, cough – acute with chest signs in children and Ebell et al. 2013).
Acute bronchitis is a lower respiratory tract infection with temporary inflammation of the airways (the trachea and major bronchi) that causes cough and mucus production lasting for up to 3 weeks. It is usually caused by a viral infection, but may be caused by a bacterial infection (NICE clinical knowledge summary on chest infections – adult).

Common symptoms and signs of acute sinusitis

  • Adults with acute sinusitis usually present with:
    • nasal blockage or congestion
    • nasal discharge
    • dental or facial pain or pressure
    • reduction or loss of the sense of smell.
  • Children (particularly young children) often present with non-specific symptoms in the upper respiratory tract. Symptoms of acute sinusitis in children may include the following, but these can be present for many upper respiratory tract infections:
    • nasal blockage or congestion
    • discoloured nasal discharge
    • cough during the day or at night.

Factors that might make a bacterial cause more likely

It is difficult to distinguish viral and bacterial acute sinusitis. A bacterial cause may be more likely if several of the following are present.
  • symptoms for more than 10 days
  • discoloured or purulent nasal discharge
  • severe localised unilateral pain (particularly pain over teeth and jaw)
  • fever
  • marked deterioration after an initial milder phase.
Consider paracetamol or ibuprofen for pain or fever (assess and manage children aged under 5 who present with fever as outlined in NICE's recommendations on fever in under 5s).
Explain that some people may wish to try nasal saline or nasal decongestants, although there is not enough evidence to show that they help to relieve nasal congestion.
Explain that no evidence was found for using oral decongestants, antihistamines, mucolytics, steam inhalation, or warm face packs.

No antibiotic

  • Acute sinusitis usually follows a common cold, and symptoms for around 10 days or less are more likely to be associated with a cold rather than viral or bacterial acute sinusitis. Therefore, the committee agreed that an antibiotic prescription should not be offered to people presenting with acute sinusitis symptoms for around 10 days or less.
  • Prolonged symptoms (for around 10 days or more with no improvement) could be due to either viral or bacterial acute sinusitis. Viral acute sinusitis is more likely, but even bacterial sinusitis is usually self-limiting and does not routinely need antibiotics.
  • The committee recognised that people with symptoms that worsen rapidly or significantly should be reassessed to rule out alternative diagnoses and to identify any signs or symptoms suggesting a more serious illness or condition.
  • The committee acknowledged the recommendation in the previous NICE guideline on upper respiratory tract infections for a 'no' or back-up (delayed) antimicrobial prescribing strategy in acute sinusitis.
For more information see no antibiotic in the NICE guideline on sinusitis (acute): antimicrobial prescribing.

Self-care

  • Based on experience, the committee agreed that it was reasonable to consider paracetamol or ibuprofen for acute sinusitis despite no evidence for their use in this condition. This is because these medicines have well-established efficacy and safety profiles for managing pain and fever generally.
  • Based on experience, the committee agreed that people with acute sinusitis may wish to try self-care with nasal saline or nasal decongestants to relieve nasal congestion, but it should be explained that there is not enough evidence to recommend these. It should be explained to people that no evidence was found for using oral decongestants, antihistamines, mucolytics, steam inhalation, or warm face packs in acute sinusitis.
For more information see self-care in the NICE guideline on sinusitis (acute): antimicrobial prescribing.

Back-up antibiotics

  • Based on evidence, the committee agreed that no antibiotic prescription or a back-up antibiotic prescription could be considered for people presenting with prolonged acute sinusitis symptoms (symptoms for around 10 days or more with no improvement).
  • The committee discussed that prescribers need to weigh up the small clinical benefits from antibiotics against their potential to cause adverse effects.
  • A back-up antibiotic prescription could be used if symptoms worsen rapidly or significantly, or do not improve within the next 7 days (by which time most self-limiting acute sinusitis infections would be starting to resolve).
  • The committee recognised that people with symptoms that worsen rapidly or significantly despite taking an antibiotic should be reassessed to rule out alternative diagnoses and to identify any signs or symptoms suggesting a more serious illness or condition. They were aware that previous antibiotic use may lead to resistant organisms if the same antibiotic is used again (see the committee discussion on choice of antibiotic).
  • The committee discussed that prolonged acute sinusitis symptoms could have a viral or a bacterial cause, and distinguishing between these is difficult. Viral acute sinusitis is more likely, but a bacterial cause may be more likely if several of the following are present: symptoms for more than 10 days, discoloured or purulent nasal discharge, severe localised unilateral pain (particularly pain over teeth and jaw), fever, or marked deterioration after an initial milder phase. The committee discussed that a back-up antibiotic may be preferred when multiple factors suggest a bacterial cause is more likely.
  • The committee acknowledged the recommendations in the previous NICE guideline on upper respiratory tract infections for a 'no' or a back-up antimicrobial prescribing strategy in acute sinusitis. An immediate antibiotic prescription is not recommended unless people are systemically very unwell, have symptoms or signs of a more serious illness, or are at high risk of serious complications because of pre-existing comorbidity.
For more information see back-up antibiotics in the NICE guideline on sinusitis (acute): antimicrobial prescribing.

Choice of antibiotic

  • Based on evidence of no major differences in clinical effectiveness between classes of antibiotics, the committee agreed that the choice of antibiotic should largely be driven by minimising the risk of resistance.
  • The committee recognised the need to balance a person's need for antibiotics against their risk of developing a resistant organism following antibiotic treatment. The committee was aware of evidence that the risk of resistance to amoxicillin is increased following a course of amoxicillin. The effect is greatest in the month immediately after treatment but may persist for up to 12 months.
  • The committee discussed that, if an antibiotic is needed to treat an infection that is not life-threatening, a narrow-spectrum antibiotic should generally be first choice. Indiscriminate use of broad-spectrum antibiotics creates a selective advantage for bacteria resistant even to these 'last-line' broad-spectrum agents, and also kills normal commensal flora leaving people susceptible to antibiotic-resistant harmful bacteria such as C. difficile. For infections that are not life-threatening, broad-spectrum antibiotics need to be reserved for second-choice treatment when narrow-spectrum antibiotics are ineffective.
  • Based on evidence, their experience and resistance data, the committee agreed to recommend the narrow-spectrum antibiotic phenoxymethylpenicillin as the first choice. Phenoxymethylpenicillin has a narrower spectrum of activity than amoxicillin and its use will have the lowest risk of resistance, while having equivalent microbiological activity to amoxicillin. The committee agreed that organisms causing acute sinusitis that are resistant to phenoxymethylpenicillin are also likely to be resistant to amoxicillin.
  • The dosage of phenoxymethylpenicillin 500 mg four times a day agreed for adults (with corresponding usual doses in children), is lower than that used in studies in the evidence review, but dose formulations to give these higher doses are not available in the UK.
  • Based on evidence, their experience and resistance data, the committee agreed to recommend co-amoxiclav as the first-choice antibiotic for people presenting at any time who are systemically very unwell, have symptoms and signs of a more serious illness or condition, or are at high-risk of complications. These people are more likely to have an infection that is resistant to phenoxymethylpenicillin. Co-amoxiclav is a broad-spectrum antimicrobial that combines a penicillin (amoxicillin) with a beta-lactamase inhibitor, making it active against beta-lactamase-producing bacteria that are resistant to amoxicillin alone. The dosage of 500/125 mg three times a day for adults (with corresponding usual doses in children) was used in studies in the evidence review.
  • Based on evidence, their experience and resistance data, the committee agreed to recommend the following alternative first-choice antibiotics for use in penicillin allergy or phenoxymethylpenicillin intolerance:
    • doxycycline (a tetracycline; adults and young people over 12 years only). The dosage of doxycycline 200 mg on the first day, then 100 mg once a day for a further 4 days was used in studies in the evidence review.
    • clarithromycin (or erythromycin in pregnancy), which are macrolides. The dosage of clarithromycin 500 mg twice a day for adults (with corresponding usual doses in children) was used in studies in the evidence review. No studies of erythromycin were included in the evidence review, so the committee discussed and agreed a dosage of 250mg to 500 mg four times a day or 500mg to 1000 mg twice a day.
  • Based on evidence, their experience and resistance data, the committee agreed to recommend co-amoxiclav as the second-choice antibiotic for use only if symptoms get worse on a first-choice antibiotic taken for at least 2 to 3 days. People with suspected bacterial infection who do not respond to a first-choice antibiotic may be more likely to have an infection that is resistant to phenoxymethylpenicillin or a viral infection, and if their condition is worsening they should be reviewed. The dosage of 500/125 mg three times a day for adults (with corresponding usual doses in children) was used in studies in the evidence review and is appropriate for people in whom first-line treatment has failed.
For more information see choice of antibiotic in the NICE guideline on sinusitis (acute): antimicrobial prescribing.

Antibiotic course length

  • The committee agreed that, when an antibiotic is appropriate, the shortest course that is likely to be effective should be prescribed.
  • Based on evidence, their experience and resistance data, the committee agreed that a 5-day course for all the recommended antibiotics was sufficient to treat acute sinusitis in adults and children. This takes into account the overall efficacy and safety evidence for antibiotics, and minimises the risk of resistance. Studies in the evidence review for specific antibiotics in acute sinusitis sometimes had longer course lengths than 5 days.
For more information see antibiotic course length in the NICE guideline on sinusitis (acute): antimicrobial prescribing.

Nasal corticosteroids

  • The committee agreed, based on the evidence, that a high-dose nasal corticosteroid could be considered for adults and children aged 12 years and over presenting with prolonged symptoms of acute sinusitis (symptoms for more than 10 days with no improvement).
  • However, the committee discussed that prescribers need to weigh up the small improvement in symptoms, which may not be clinically important, against possible systemic effects. The committee also recognised that it may be difficult for some people to use a nasal spray correctly.
  • The committee acknowledged that some of the evidence did not include people with a suspected bacterial cause of acute sinusitis.
For more information see nasal corticosteroids in the NICE guideline on sinusitis (acute): antimicrobial prescribing.

FeverPAIN criteria

  • Fever (during previous 24 hours)
  • Purulence (pus on tonsils)
  • Attend rapidly (within 3 days after onset of symptoms)
  • Severely Inflamed tonsils
  • No cough or coryza (inflammation of mucus membranes in the nose)
Each of the FeverPAIN criteria score 1 point (maximum score of 5). Higher scores suggest more severe symptoms and likely bacterial (streptococcal) cause. A score of 0 or 1 is thought to be associated with a 13 to 18% likelihood of isolating streptococcus. A score of 2 or 3 is thought to be associated with a 34 to 40% likelihood of isolating streptococcus. A score of 4 or 5 is thought to be associated with a 62 to 65% likelihood of isolating streptococcus.

Centor criteria

  • Tonsillar exudate
  • Tender anterior cervical lymphadenopathy or lymphadenitis
  • History of fever (over 38°C)
  • Absence of cough
Each of the Centor criteria score 1 point (maximum score of 4). A score of 0, 1 or 2 is thought to be associated with a 3 to 17% likelihood of isolating streptococcus. A score of 3 or 4 is thought to be associated with a 32 to 56% likelihood of isolating streptococcus.

Self-care

  • Based on evidence, experience and safety data the committee agreed that it was reasonable to consider paracetamol (first-line) or ibuprofen for self-care of pain or fever associated with acute sore throat. Although no studies were identified on paracetamol and ibuprofen in children with sore throat, the committee noted that these medicines have well-established efficacy and safety profiles for managing pain and fever in children.
  • Based on evidence and experience, the committee agreed that people may wish to try self-care with medicated lozenges (containing a local anaesthetic, an NSAID or an antiseptic agent) to help reduce pain in acute sore throat, but should be told that the benefit is likely to be small.
  • Based on evidence and experience, the committee agreed that it is unclear whether throat sprays containing an antiseptic plus a local anaesthetic help symptoms. Furthermore, the combination product used in the study is not available in the UK.
  • The committee agreed that prescribers should be aware that no evidence was found on non-medicated lozenges, mouthwashes or local anaesthetic mouth sprays (without an antiseptic).
  • The committee was aware of the potential benefits of avoiding GP appointments if people access self-care and seek advice from other health professionals, particularly their community pharmacist rather than making an appointment to see their GP. The committee agreed that community pharmacists are often more accessible to people than GPs to offer advice.
For more information see self-care in the NICE guideline on sore throat (acute): antimicrobial prescribing.

No antibiotics, back-up antibiotics and identifying people more likely to benefit from antibiotics

  • Based on evidence and experience, the committee agreed that acute sore throat is a self-limiting infection, and most people will get better within a week without antibiotic treatment. Based on evidence and experience, the committee agreed that complications are rare in adults and children, and the committee noted the adverse effects associated with antibiotic use.
  • The committee agreed that prescribers need to weigh up the small clinical benefits from antibiotics against their potential to cause adverse effects.
  • Based on evidence and experience, the committee agreed that no or back-up antibiotic prescribing was as effective as immediate antibiotic prescribing for people with acute sore throat. A back-up antibiotic prescription could be used if symptoms deteriorate rapidly or significantly, or do not improve within the next 3 to 5 days.
  • The committee discussed the clinical scoring systems available to help identify people with acute sore throat who may be more likely to benefit from antibiotics. The committee noted that FeverPAIN and Centor criteria have not been validated in a UK population.
  • The committee was aware that the FeverPAIN criteria were developed in a UK primary care setting in 2013 and has not been assessed in children under 3 years. External validation has not been carried out, but the criteria have been tested in a randomised control trial setting.
  • The FeverPAIN scoring tool can help prescribers to determine if a person's sore throat is more likely to benefit from antibiotics. The scoring tool includes the FeverPAIN criteria plus additional parameters to help prescribers determine the severity of the sore throat. The additional parameters do not affect the overall FeverPAIN score. The committee was aware that the tool may help prescribers implement FeverPAIN criteria in practice and supports shared decision-making in consultations with people.
  • The committee noted that the Centor criteria were developed in the US in an emergency department setting in 1981 and has only been assessed in an adult population. The committee was aware that the previous NICE guideline on upper respiratory tract infections used Centor criteria. FeverPAIN criteria were not available at the time this guideline was published.
  • The committee noted that a FeverPAIN score of 4 or 5 is thought to be associated with a 62 to 65% probability of having a bacterial infection, which is slightly higher than 32 to 56% probability associated with a Centor score of 3 or 4. The committee was aware that using FeverPAIN in preference to Centor may increase the use of back-up antibiotic prescribing. However, the committee discussed that if more back-up antibiotic prescribing strategies are implemented the overall use of antibiotics may reduce, assuming that around two thirds of people will not collect (and take) the antibiotics.
  • The committee acknowledged the recommendation in the previous NICE guideline on upper respiratory tract infections for a no or back-up antibiotic prescribing strategy in acute sore throat, with an immediate antibiotic prescribing strategy also an option for people with an acute sore throat when 3 or more Centor criteria are present.
  • The committee discussed FeverPAIN scores of 4 or 5, or Centor scores of 3 or 4. In some cases people may have these scores but may have milder symptoms. To ensure people with milder and improving symptoms are not issued an immediate antibiotic prescription the committee used its expertise and agreed that a back-up prescription may also be appropriate for this group of people. Withholding antibiotics is unlikely to lead to complications.
  • The committee discussed FeverPAIN scores of 0 or 1, or Centor scores of 0,1 or 2. The committee was aware that the previous NICE guideline on upper respiratory tract infections recommended either a no antibiotic or a back-up antibiotic prescribing strategy for people with these Centor scores. However, based on evidence, experience and the principles of antimicrobial stewardship the committee recommended a no antibiotic prescribing strategy for this group.
  • The committee was aware that FeverPAIN criteria had not been tested in populations under 3 years and that the Centor criteria were developed in an adult population. However, the committee, using its experience, advised that young children (under 3 years) are unlikely to present with sore throat symptoms alone. Prescribers should follow the NICE guideline on fever in under 5s to assess and manage fever in this population.
  • The committee agreed that there is currently uncertainty about which scoring tool is more effective in a UK population. They noted that both criteria are used in clinical practice and that using a scoring tool is preferential to not using any tool. The committee concluded that either FeverPAIN or Centor criteria should be used to identify people with acute sore throat who may be more likely to benefit from antibiotics.
For more information see no antibiotic in the NICE guideline on sore throat (acute): antimicrobial prescribing.

Antibiotic choice, dose and frequency of dosing

  • The committee discussed that, generally, if an antibiotic is needed to treat an infection that is not life threatening, narrow-spectrum antibiotics should be used as the first choice. Indiscriminate use of broad-spectrum antibiotics is undesirable because it creates a selective advantage for bacteria resistant even to these 'last-line' broad-spectrum agents, and also kills normal commensal flora leaving people susceptible to antibiotic-resistant harmful bacteria such as Clostridium difficile. For infections that are not life threatening, broad-spectrum antibiotics need to be reserved for second-choice treatment when narrow-spectrum antibiotics are ineffective. Based on evidence, clinical experience and resistance data, the committee agreed to recommend phenoxymethylpenicillin as the first-choice antibiotic. This is a narrow-spectrum penicillin with the lowest risk of causing resistance.
  • The committee discussed whether amoxicillin would be a suitable alternative to phenoxymethylpenicillin to support medicines adherence. However, it was aware of evidence that the risk of resistance to amoxicillin is significantly increased in urinary isolates of Escherichia coli following a course of amoxicillin. These, effects are greatest in the first month after use, but are detectable for up to 12 months. Also, if the sore throat is due to glandular fever, the BNF states that erythematous rashes are common in people with glandular fever who take amoxicillin.
  • The committee discussed the systematic review by Lan and Colford (2000) that suggested twice daily dosing was as effective as four times daily dosing. The committee noted that four times daily dosing was the standard dose frequency for phenoxymethylpenicillin and the dose used most frequently in the included studies. The committee noted that this is low quality evidence, using data from only 6 studies and used bacteriological cure at follow-up as an efficacy outcome (rather than a patient-oriented outcome).
  • The committee discussed the benefits and harms of using twice daily dosing of phenoxymethylpenicillin. Twice daily dosing would support medicines adherence in those people who may struggle to take 4 doses at 6-hourly intervals before food, such as children at school. The committee was concerned that if a twice daily dose was used, phenoxymethylpenicillin levels may fall below the minimum inhibitory concentration. However, it also discussed that streptococci are highly sensitive to phenoxymethylpenicillin, and that antibiotic penetration in sore throat tissue is good, therefore even small concentrations of antibiotic will treat the infection.
  • Based on evidence and clinical experience, the committee agreed that if phenoxymethylpenicillin was prescribed, twice daily or four times a day dosing could be used, providing the same total daily dose was given.
  • Based on evidence, clinical experience and resistance data, the committee agreed to recommend the following alternative first-choice antibiotics for use in penicillin allergy or for phenoxymethylpenicillin intolerance: clarithromycin or erythromycin (which is preferred in pregnancy), which are macrolides, given at usual doses.
  • Based on the evidence that there are no major differences in clinical effectiveness between classes of antibiotics, the committee used its experience to agree that the choice should largely be driven by minimising the risk of resistance.
For more information see antibiotic choice in the NICE guideline on sore throat (acute): antimicrobial prescribing.

Antibiotic course length

  • The committee agreed that, when an antibiotic is appropriate, the shortest course that is likely to be effective should be prescribed to reduce the risk of antimicrobial resistance and minimise the risk of adverse effects.
  • The committee noted that most studies involving clarithromycin or erythromycin used a 5-day course, whereas, most studies involving phenoxymethylpenicillin used a 10-day course.
  • The committee noted that no studies were identified that compared 10-day and 5-day courses of phenoxymethylpenicillin given at the current recommended dose (500 mg four times daily). However, the committee was aware from its experience that many people do not complete a 10-day course.
  • Based on evidence, the committee recognised that microbiological cure may be better with a 10-day course of phenoxymethylpenicillin compared with a 5- or 7-day course, although there were no differences in relapse or recurrence. They agreed that, in situations where bacterial eradication is not specifically needed, and where symptomatic cure is the goal, if a decision to prescribe an antibiotic is made, a shorter course of phenoxymethylpenicillin may be sufficient. However, in situations where there is recurrent infection, a 10-day course may increase the likelihood of microbiological cure.
  • Based on evidence, clinical experience and resistance data, the committee agreed that when an antibiotic was appropriate, a 5- to 10-day course of phenoxymethylpenicillin was needed.
  • The committee was aware that bottles of phenoxymethylpenicillin suspension expire within 7 days once reconstituted and a second bottle would be needed to complete a 10-day course. Prescribing a 7-day course may help with medicines adherence.
  • A 5-day course of clarithromycin or erythromycin (which is preferred in pregnancy) is an alternative for people with penicillin allergy or intolerance. This course length takes into account the overall efficacy and safety evidence for antibiotics, and minimises the risk of resistance.
For more information see antibiotic course length in the NICE guideline on sore throat (acute): antimicrobial prescribing.

Self-care for acute otitis media

  • The committee discussed the importance of managing a child's pain and felt that for parents this is the main priority. They agreed that paracetamol or ibuprofen needs to be taken at the right time and at the right dose, with maximum doses being used for severe pain.
  • Based on evidence and their experience, the committee agreed that paracetamol or ibuprofen should be offered for pain associated with acute otitis media. Parents or carers could be advised to buy paracetamol or ibuprofen over the counter in line with local policies on the prescribing of such medicines.
  • Based on evidence, the committee agreed that anaesthetic ear drops (in addition to oral analgesics) may relieve pain in children aged 3 years and over without eardrum perforation, but there is no product licensed for use in the UK.
  • The committee agreed that evidence does not support using decongestants or antihistamines to help symptoms of acute otitis media.
For more information see self-care in the NICE guideline on otitis media (acute): antimicrobial prescribing.

No antibiotics for acute otitis media

  • Acute otitis media can be caused by viral or bacterial infections, both of which are usually self-limiting and do not routinely need antibiotics.
  • Based on evidence, the committee agreed that antibiotics make little difference to ear pain or to the rates of more common complications, such as recurrence of infection. The small increased risk of perforation was noted, but 33 children (range 20 to 100) would need to be treated with antibiotics to avoid 1 child experiencing perforation. Antibiotics also made little difference to short-term hearing loss as assessed by the surrogate marker of tympanometry.
  • More serious complications of acute otitis media, such as mastoiditis, are rare and the number needed to treat with antibiotics to prevent 1 child from developing mastoiditis is approximately 5,000.
  • The committee acknowledged the recommendation in the NICE guideline on respiratory tract infections (self-limiting): prescribing antibiotics for no antibiotic or a back-up antibiotic prescription for most children with acute otitis media
For more information see no antibiotic in the NICE guideline on otitis media (acute): antimicrobial prescribing.

Back-up antibiotics for acute otitis media

  • Based on evidence, the committee agreed that no antibiotic prescription or a back-up antibiotic prescription could be considered for most children with acute otitis media.
  • The committee discussed that acute otitis media could have a viral or a bacterial cause, and distinguishing between these is difficult. However, both are usually self-limiting and do not routinely need antibiotics. The committee discussed that a back-up antibiotic prescription may be preferred over no antibiotic in some children, but that prescribers need to weigh up the small clinical benefits from antibiotics against their potential to cause adverse effects.
  • The committee agreed that a back-up antibiotic prescription could be used if symptoms significantly worsen or do not improve within 3 days (by which time most self-limiting infections would be starting to resolve), or if they worsen rapidly or significantly at any time.
  • The committee acknowledged the recommendations in the NICE guideline on respiratory tract infections (self-limiting): prescribing antibiotics that, for acute otitis media, a no antibiotic prescribing strategy or a back-up antibiotic prescribing strategy should be agreed, but that depending on clinical assessment of severity, immediate antibiotics can also be considered for children under 2 years with infection in both ears or children of any age with otorrhoea (discharge following perforation of the eardrum). For these subgroups the committee agreed that an immediate antibiotic prescription could also be considered as an option, because antibiotics may be more likely to be beneficial in these subgroups. The committee discussed that an immediate antibiotic may be preferred over no antibiotic or a back-up antibiotic prescription in some children based on clinical judgement.
  • The committee agreed that immediate antibiotics are important for children who are systemically very unwell, have symptoms or signs of a more serious illness, or are at high risk of serious complications because of pre-existing comorbidity. This includes children with significant heart, lung, renal, liver or neuromuscular disease, immunosuppression, cystic fibrosis, and young children who were born prematurely.
For more information see back-up antibiotics in the NICE guideline on otitis media (acute): antimicrobial prescribing.

Choice of antibiotic for acute otitis media

  • Based on evidence of no major differences in clinical effectiveness between classes of antibiotics, the committee agreed that the choice of antibiotic should largely be driven by minimising the risk of resistance.
  • The committee discussed that, if an antibiotic is needed to treat an infection that is not life-threatening, a narrow-spectrum antibiotic should generally be first choice. Indiscriminate use of broad-spectrum antibiotics creates a selective advantage for bacteria resistant even to these 'last-line' broad-spectrum agents, and also kills normal commensal flora leaving people susceptible to antibiotic-resistant harmful bacteria such as Clostridium difficile. For infections that are not life-threatening, broad-spectrum antibiotics need to be reserved for second-choice treatment when narrow-spectrum antibiotics are ineffective.
  • Based on evidence, their experience and resistance data, the committee agreed to recommend amoxicillin as the first choice because this is current practice for antibiotic treatment in children with acute otitis media, and the risk of resistance is acceptable. The dosage of 125 mg to 500 mg three times a day (based on age) is the usual dose, and was similar to that used in studies in the evidence review. The committee discussed that phenoxymethylpenicillin has a lower risk of resistance than amoxicillin, and microbiologically would be expected to be equivalent. However, medicines adherence is particularly important for children, and acute otitis media most commonly presents in young children. Amoxicillin has a three times a day dosage rather than four times a day for phenoxymethylpenicillin, and the liquid formulation is more palatable.
  • Based on evidence, their experience and resistance data, the committee agreed to recommend clarithromycin or erythromycin as alternative first-choice antibiotics for use in penicillin allergy or amoxicillin intolerance. The doses recommended (based on weight and age) are the usual doses for children, and were similar to those used in studies in the evidence review. The committee discussed that there was evidence for another macrolide, azithromycin. However, they agreed not to recommend this because clarithromycin or erythromycin are current practice for antibiotic treatment for children with acute otitis media who have penicillin allergy or are intolerant to amoxicillin, and azithromycin should be reserved for more serious infections.
  • Based on evidence, their experience and resistance data, the committee agreed to recommend co-amoxiclavas the second-choice antibiotic for use if symptoms worsen on a first-choice antibiotic taken for at least 2 to 3 days. This broad-spectrum treatment combines a penicillin (amoxicillin) with a beta-lactamase inhibitor, making it active against beta-lactamase-producing bacteria that are resistant to amoxicillin alone. People who do not respond to amoxicillin may be more likely to have an infection that is resistant to it. The dosage of 0.25 ml/kg of 125/31 suspension to 250/125 mg or 500/125 mg three times a day (based on weight and age) is the usual dose for children, and was similar to that used in studies in the evidence review.
For more information see choice of antibiotic in the NICE guideline on otitis media (acute): antimicrobial prescribing.

Antibiotic course length for acute otitis media

  • The committee agreed that, when an antibiotic is appropriate, the shortest course that is likely to be effective should be prescribed to minimise the risk of antimicrobial resistance.
  • Based on evidence, their experience and resistance data, the committee agreed that a 5- to 7-day course of all the recommended antibiotics was sufficient to treat acute otitis media in children. This takes into account both the evidence for clinical effectiveness and the evidence for safety and tolerability of antibiotics, and minimises the risk of resistance. Studies on the use of specific antibiotics to treat acute otitis media sometimes had longer course lengths than 7 days.
  • The committee noted that no studies were identified that directly compared a 5-day course of antibiotics with a 7-day course.
  • Based on evidence, the committee recognised that more children may have treatment failure with an antibiotic course of less than 7 days compared with a course of 7 days or more. However, the absolute difference is small. At 8 to 19 days, 82% of children taking antibiotics for less than 7 days were better, compared with 86% of those taking antibiotics for 7 days or more. They agreed that, if a decision to prescribe an antibiotic is made, a 5-day course may be sufficient for many children, reserving 7-day courses for those with a clinical assessment of more severe or recurrent infection.
For more information see antibiotic course length in the NICE guideline on otitis media (acute): antimicrobial prescribing.

Glossary

(prescription given in a way to delay the use of an antibiotic, and with advice to only use it if symptoms worsen or don't improve within a specified time; the prescription may be given during the consultation [which may be a post-dated prescription] or left at an agreed location for collection at a later date)
non-steroidal anti-inflammatory drug
(a medicine with an existing UK marketing authorisation that is used outside the terms of its marketing authorisation, for example, by indication, dose, route or patient population)
(self-care treatments available for acute cough include honey, herbal medicines and and over-the-counter cough medicines [for example, expectorants and cough suppressants, also called antitussives])

Paths in this pathway

Pathway created: August 2012 Last updated: May 2021

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