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Ear, nose and throat

Ménière's disease

Last revised in March 2023

Meniere's disease is a disorder affecting the inner ear which can affect balance and hearing.

Ménière's disease: Summary

  • Ménière's disease is a disorder of the inner ear that is characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and a feeling of fullness in the affected ear.
  • The precise pathophysiology of Ménière's disease is unknown, but it may be associated with endolymphatic hydrops (raised endolymph pressure in the membranous labyrinth of the inner ear).
  • Ménière's disease is the term for the idiopathic form of the disorder. If a cause is identified, it is referred to as Ménière's syndrome
  • Ménière's disease is an uncommon cause of vertigo.
  • Complications of Ménière's disease include falls, and adverse psychological and social impacts.
  • A definite diagnosis of Ménière's disease requires all of the following criteria:
    • Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours.
    • Audiometrically documented low-to-medium frequency sensorineural hearing loss in one ear, defining and locating to the affected ear on at least one occasion before, during, or after an episode of vertigo. 
    • Fluctuating aural symptoms (hearing loss, tinnitus, or fullness) in the affected ear.
    • Not better accounted for by an alternative vestibular diagnosis. 
  • A probable diagnosis of Ménière's disease requires all of the following criteria:
    • Two or more episodes of vertigo or dizziness, each lasting 20 minutes to 24 hours.
    • Fluctuating aural symptoms (hearing loss, tinnitus, or fullness) in the affected ear.
    • Not better accounted for by an alternative vestibular diagnosis. 
  • Confirmation of the diagnosis requires referral to an Ear, Nose, and Throat consultant and a formal audiology assessment.
  • People who have frequent, sudden attacks should be advised to keep medication readily accessible, and to consider the risks before starting potentially dangerous activities like driving, swimming, or operating machinery.
  • To help alleviate nausea, vomiting, and vertigo in people with acute Ménière's disease, a short course of prochlorperazine or an antihistamine should be considered.
  • If symptoms are severe, people may require hospital admission for intravenous labyrinthine sedatives and fluids to maintain hydration and nutrition.
  • A trial of betahistine can be considered to reduce the frequency and severity of attacks. 

Have I got the right topic?

From age 18 years onwards.

This CKS topic covers the management of Ménière's disease in adults.

This CKS topic does not covers the management of Ménière's disease in children and young people.

This CKS topic also does not cover the management of other causes of vertigo, dizziness, nausea, deafness, or tinnitus.

There are separate CKS topics on Benign paroxysmal positional vertigo, Tinnitus, Vestibular neuronitis, and Vertigo.

The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare.

How up-to-date is this topic?

Changes

March 2023 — reviewed. A literature search was conducted in February 2023 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of this topic. No major changes to recommendations have been made.

Previous changes

December 2022 — minor update. Based on an updated manufacturer’s summary of product characteristics (SPC), information on the QT interval prolongation effect of phenothiazine derivatives has been included

October to November 2017 — reviewed. A literature search was conducted in August 2017 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of this topic. The diagnostic criteria for Meniere's disease have been updated. The lower age range of the topic has been changed to 18 years. The lower age range of the topic has been changed to 18 years. No major changes to clinical recommendations have been made. 

July 2013 — minor update. Links to the Driver and Vehicle Licensing Agency (DVLA) website have been updated.

September 2012 — reviewed. A literature search was conducted in August 2012 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of this topic. The diagnosis and assessment scenarios have been restructured, and links are provided to the CKS topics on Tinnitus and Vertigo, which contain more detailed information on determining the diagnosis in a person presenting with these symptoms. Minor amendments have been made to the section on driving. No major changes to clinical recommendations have been made. 

March 2011 — the topic structure has been revised to ensure consistency across CKS topics. No changes to clinical recommendations have been made.

January 2010 — minor update. Additional text regarding use of promethazine teoclate in pregnancy has been added. 

January 2008 — minor update. References corrected in the Prevalence section. 

June to October 2007 — converted from CKS guidance to CKS topic structure. The evidence base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence. The key message about diagnosing Meniere's disease is more explicit in that the diagnosis can only be confirmed by referral to Ear, Nose, and Throat (ENT) services. While awaiting referral, attacks of Meniere's disease–like symptoms may have to be managed in primary care.

November 2005 — minor technical update. 

March 2004 — reviewed. Validated in June 2004 and issued in July 2004.

June 2001 — reviewed. Validated in July 2001 and issued in October 2001.

March 1999 — written. Validated in April 1999 and issued in August 1999.

Update

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 February 2023.

HTAs (Health Technology Assessments)

No new HTAs since 1 February 2023.

Economic appraisals

No new economic appraisals relevant to England since 1 February 2023.

Systematic reviews and meta-analyses

No new systematic reviews published since 1 February 2023.

Primary evidence

No new primary evidence which reaches the CKS threshold for inclusion published since 1 February 2023.

New policies

No new national policies or guidelines since 1 February 2023.

New safety alerts

No new safety alerts since 1 February 2023.

Changes in product availability

No changes in product availability since 1 February 2023.

Goals and outcome measures

Goals

To support primary healthcare professionals to:

  • Make a working diagnosis of Ménière's disease.
  • Refer to a specialist to confirm the diagnosis.
  • Provide appropriate information and advice on Ménière's disease.
  • Manage symptoms during an acute attack of Ménière's disease.
  • Reduce the frequency and severity of acute attacks of Ménière's disease.

Outcome measures

No outcome measures were found during the review of this topic.

Audit criteria

No audit criteria were found during the review of this topic.

QOF indicators

No QOF indicators were found during the review of this topic.

QIPP - Options for local implementation

No QIPP indicators were found during the review of this topic.

NICE Quality standards

No NICE Quality standards were found during the review of this topic.

Background information

What is Ménière's disease?

  • Ménière's disease is a disorder of the inner ear that is characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and a feeling of fullness in the affected ear [Goebel, 2016; Ahmadzai, 2020; Basura, 2020; BMJ, 2021].
    • It is primarily a unilateral disorder; however, bilateral disease may occur in 2–73% of people [BMJ, 2021]. This broad range may depend on the definition of bilateral involvement, given that hearing abnormalities without the appearance of the classic symptoms of Ménière's disease are frequently found in the contralateral ear [Casani, 2018]. 
  • Ménière's disease is the term for the idiopathic form of the disorder. If a cause is identified, it is referred to as Ménière's syndrome [Pullens, 2013; Wipperman, 2014; BMJ, 2021].

What causes it?

  • The precise pathophysiology of Ménière's disease is unknown [Goebel, 2016; Basura, 2020; BMJ, 2021]. 
    • The most consistent histologic abnormality is endolymphatic hydrops: a progressive swelling of the membranous labyrinth in the inner ear. However, not everyone with documented hydrops develops Ménière's disease.
    • The exact pathophysiology of endolymphatic hydrops is also unknown, but the most common theory suggests an imbalance between the production and absorption of endolymph (inner ear fluid).
    • During an acute attack of Ménière's disease, the excessive endolymphatic fluid pressure causes distension and rupture of the Reissner's membrane. This results in the release of endolymph into the perilymphatic space and injury to the sensory and neural elements of the inner ear, which manifest as the classic symptoms of vertigo, sensorineural hearing loss, tinnitus, and aural fullness [BMJ, 2021].
    • These ruptures can occur frequently in Ménière's disease and have been found in all parts of the inner ear in people with the condition, in association with healed scars. This may explain the nature of sudden attacks and fluctuation of symptoms [Mirza and Gokhale, 2017].
    • Between attacks, the ruptured membrane heals, chemical balance is restored, and symptoms remit. However, some experts have questioned this theory because membrane ruptures have been found post-mortem in the temporal bones of people with no history of vertigo [BMJ, 2021].
  • The underlying cause of Ménière's disease is unknown. However, some experts believe that in up to 55% of cases, a specific cause can be identified, including [Wipperman, 2014; Espinosa-Sanchez, 2016; BMJ, 2021; McNiven, 2021]:
    • Allergic responses (especially to food).
    • Autoimmunity (usually presents with bilateral symptoms).
    • Genetic susceptibility.
    • Stenosis of the internal auditory canal.
    • Trauma (acoustic or physical).
    • Metabolic disturbances involving the balance of sodium and potassium in the fluid of the inner ear.
    • Vascular factors (there is an association between migraine and Ménière's disease).
    • Viral infection.
    • Congenital or acquired syphilis.
    • Lyme disease.
    • Hypothyroidism.

How common is Ménière's disease?

  • The incidence and prevalence of Ménière's disease are hard to estimate due to the episodic nature of the condition [Wipperman, 2014].  
    • The lifetime prevalence has been estimated at 34–190 cases per 100,000 [McNiven, 2021].
    • A population-based study on the epidemiology of Ménière's disease found an overall incidence rate in the UK of 13.1 per 100,000 person-years [Bruderer, 2017]. 
    • Ménière's disease is an uncommon cause of new-onset vertigo [Dommaraju and Perera, 2016], and a GP may only see a new case a few times over their career [Harcourt, 2014].
  • Ménière's disease is a disease of middle-age, with average age at onset in the fourth decade of life (usually between 30–60 years of age) [Harcourt, 2014; Wright, 2015; BMJ, 2021].   

What are the complications?

  • Complications of Ménière's disease include:
    • Falls — related to imbalance, unsteadiness, and drop attacks [BMJ, 2021].
    • Hearing loss — the incidence of bilateral, severe to profound hearing loss is estimated at 1–6% [BMJ, 2021].
    • Psychological effects — such as anxiety, depression, and agoraphobia [Harcourt, 2014].  
    • Social effects — for example, work-related issues, effect on the ability to drive, and limitations on shopping and household activities [Gurkov, 2016].

What is the prognosis?

  • Symptoms of Ménière's disease tend to get worse over time, regardless of medical intervention [BMJ, 2021]. 
    • Symptoms can initially fluctuate, resolving completely between episodes [Harcourt, 2014; Wright, 2015]. Later in the course of the disease, hearing loss progresses and tinnitus becomes persistent. The frequency of episodes of vertigo often decreases [Harcourt, 2014; Wright, 2015; Espinosa-Sanchez, 2016]. 
    • After 5–15 years, vertigo is no longer experienced when the condition 'burns out', but tinnitus, unilateral hearing loss, sensations of aural pressure, and a sense of general imbalance or disequilibrium may persist despite treatment [Harcourt, 2014; Wipperman, 2014; Wright, 2015]. 

Diagnosis of Ménière's disease

How should I make a diagnosis of Ménière's disease?

There are no specific diagnostic tests for Ménière's disease. Diagnosis is based on the presence of key clinical features.

  • Take a history. Ask about the symptoms experienced, the presence of causative factors (such as recent viral illness or autoimmune disorders), and the presence of other symptoms.
    • Suspect Ménière's disease if the person has:
      • Episodes of spontaneous vertigo attacks (described as spinning or rocking) with or without nausea and vomiting. Unsteadiness can persist for several days after the acute attack of vertigo.
      • Tinnitus, usually described as 'roaring'. Initially, this appears during attacks, but later becomes permanent and may significantly affect quality of life.
      • Fluctuating sensorineural hearing loss, initially in low frequencies (usually unilateral). Eventually, as the disease progresses, hearing loss becomes permanent and does not fluctuate.
      • Aural fullness (a sensation of pressure in the ear, or ear discomfort), which often occurs in advance of a vertigo attack but may also be present during the episode. However, it may not be experienced once the disease has progressed.
    • Acute attacks of Ménière's disease:
      • May be preceded by a change in tinnitus, increased hearing loss, or a sensation of aural fullness shortly before the onset of vertigo.
      • Are present for at least 20 minutes, but typically last a few hours (no more than 24 hours).
      • Can occur in clusters over a few weeks, although months or years of remission can also occur.
      • Can involve predominantly aural symptoms (hearing loss, tinnitus, or ear fullness in the affected ear) and/or vertigo.
      • Are typically unilateral. Although bilateral disease has been reported, symptoms do not usually arise in both ears simultaneously.
    • Other symptoms that may be described include:
      • Drop attacks without loss of consciousness that occur without warning (Otholitic crises of Tumarkin). Normal activities can be resumed immediately afterwards. They affect fewer than 1 in 10 people with Ménière's disease.
      • Balance or gait problems, particularly during attacks of vertigo.
      • Postural instability.
  • Examine the person.
    • In a person with Ménière's disease:
      • Head and neck examination findings are usually normal.
      • Horizontal and/or rotatory nystagmus that can be suppressed by visual fixation may be present.
      • The person may be unable to stand with their feet together and eyes closed (Romberg's test) or walk heel-to-toe (tandem) in a straight line.  
      • If asked to march on the spot with their eyes closed (Unterberger's test), the person may be unable to maintain their position and will turn to the affected side.
  • Rule out a cerebrovascular event in people with acute vertigo.
    • Red flags for central pathology that require immediate hospital admission include:
      • New unilateral hearing loss.
      • Focal neurological signs (facial weakness, diplopia, or limb weakness).
      • New-onset headache.
      • Normal head thrust test.
  • If Ménière's disease is suspected, refer to Ear, Nose, and Throat (ENT) services to confirm the diagnosis.
    • A definite diagnosis requires all of the following criteria:
      • Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours.
      • Audiometrically documented low-to-medium frequency sensorineural hearing loss in one ear, defining and locating to the affected ear on at least one occasion before, during, or after an episode of vertigo. 
      • Fluctuating aural symptoms (hearing loss, tinnitus, or fullness) in the affected ear.
      • Not better accounted for by an alternative vestibular diagnosis. 
    • A probable diagnosis requires all of the following criteria:
      • Two or more episodes of vertigo or dizziness, each lasting 20 minutes to 24 hours.
      • Fluctuating aural symptoms (hearing loss, tinnitus, or fullness) in the affected ear.
      • Not better accounted for by an alternative vestibular diagnosis. 
    • While awaiting referral, attacks of Ménière's disease–like symptoms may have to be managed in primary care.

Basis for recommendation

Diagnosis based on clinical features

  • The information that the diagnosis of Ménière's disease is based on key clinical features due to a lack of specific diagnostic tests is based on the Equilibrium Committee Amendment to the 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) Guidelines for the Definition of Meniere’s Disease [Goebel, 2016]. 

Suspecting Ménière's disease

Physical examination findings

Ruling out a cerebrovascular event in people with acute vertigo

  • This recommendation is based on expert opinion in a review article [McNiven, 2021].

Diagnostic criteria

  • The criteria for a definite or probable diagnosis of Ménière's disease are based on Diagnostic criteria for Menière’s disease [Lopez-Escamez, 2015].

Referral for confirmation of the diagnosis

  • Experts acknowledge that the diagnosis of Ménière's disease is challenging because of the remitting and relapsing nature of the disease [Wipperman, 2014]. CKS recommends referral to an Ear, Nose, and Throat (ENT) specialist for confirmation of the diagnosis based on expert opinion in a review article [van Vugt, 2017].  
    • Audiometry is recommended by many experts to confirm the sensorineural hearing loss found in Ménière's disease [Wipperman, 2014; Dommaraju and Perera, 2016; Espinosa-Sanchez, 2016]. Expert opinion in a review article advises referral to a specialist centre if audiometry is not available in primary care [Harcourt, 2014]. 
    • Other investigations may also be required to exclude other causes of vertigo before a definite diagnosis of Ménière's disease can be made [Tassinari, 2015]. 
  • During an acute attack, it may be impractical to refer to ENT, and due to time delays in the referral system, many early attacks of Ménière's disease–type symptoms will have to be managed in primary care before a firm diagnosis is established.

What else might it be?

  • A diagnosis of Ménière's disease should only be made after other conditions have been ruled out, including:
    • Tumours (for example acoustic neuroma).
    • Otosyphilis.
    • Multiple sclerosis.
    • Perilymph fistula.
    • Vascular events (for example transient ischaemic attack).
    • Migraine.
    • Benign paroxysmal positional vertigo.
    • Vestibular neuronitis.
    • Acute labyrinthitis.
  • For more information on conditions that may present in a similar way to Ménière's disease, see the CKS topics on Tinnitus and Vertigo.

Basis for recommendation

Differential diagnoses of Ménière's disease are based on Diagnostic and therapeutic strategy in Menière's disease. Guidelines of the French Otorhinolaryngology-Head and Neck Surgery Society [Nevoux, 2017] and on expert opinion in review articles [Harcourt, 2014; Dommaraju and Perera, 2016; BMJ, 2021].   

Management

Scenario: Management of Ménière's disease

From age 18 years onwards.

What self-care advice should I give a person with Ménière's disease?

  • Provide appropriate information and advice on Ménière's disease.
    • Reassure the person that although Ménière's disease is a long-term condition, vertigo usually significantly improves with treatment. 
    • Advise that an acute attack of vertigo will normally settle within 24 hours in most people. If there is no improvement after 5–7 days, or there is any deterioration in symptoms, alternative diagnoses should be excluded. 
    • Ideally, involve the support of the multidisciplinary healthcare team early on so that people can benefit from their expertise.
      • This includes Ear Nose, and Throat (ENT) services, a physiotherapist, a hearing therapist, an audiologist, a counsellor, or a psychologist.
      • Availability of some multidisciplinary support services may vary depending on locality.
  •  Advise people experiencing sudden attacks of vertigo to:
    • Keep their medication readily accessible.
    • Consider the risks before undertaking activities such as driving, operating dangerous machinery, using ladders or scaffolding, or going swimming.
  • Offer sources of additional information and support, such as:

Basis for recommendation

Reassurance
Advice to return if no improvement to exclude an alternative diagnosis
  • This recommendation is pragmatic, based on what CKS considers to be good clinical practice.
  • There are a number of differential diagnoses of Ménière's disease, and it is important to exclude these before making a firm diagnosis [Harcourt, 2014; Dommaraju and Perera, 2016; Nevoux, 2017]. This is emphasized in Diagnostic criteria for Menière’s disease, which includes 'not better accounted for by another vestibular diagnosis' as a criterion for a definite or probable diagnosis of Ménière's disease [Lopez-Escamez, 2015].
Involving the multidisciplinary healthcare team
  • This recommendation is pragmatic, based on what CKS considers to be good clinical practice. 
Advice for people with sudden attacks of vertigo
  • The recommendation to keep medication readily accessible and consider the risks of certain activities is pragmatic, based on what CKS considers to be good clinical practice. 
Offering information and support
  • This recommendation is pragmatic, based on what CKS considers to be good clinical practice.
  • The choice of treatment will depend on the type and severity of symptoms experienced.
    • To help alleviate nausea, vomiting, and vertigo:
      • Consider prescribing a short course (up to 7 days) of prochlorperazine or an antihistamine (such as cinnarizine, cyclizine, or promethazine teoclate). 
      • If the person has had previous attacks of Ménière's disease and responded well to one of these treatments, consider trying that treatment first line. Always consider the person's preferences when choosing the drug and delivery route. For more information, see Prescribing information.
    • If rapid relief is required in a person with (severe) nausea or vomiting:
      • Consider buccal prochlorperazine or a deep intramuscular injection of prochlorperazine or cyclizine.
      • If symptoms are very severe, hospital admission may be required for intravenous (IV) labyrinthine sedatives and fluids to maintain hydration and nutrition.
    • If the person's symptoms deteriorate or do not improve after 5–7 days:
  • If the person has symptoms and signs suggestive of hearing loss:
    • Refer for an audiology assessment (if not already carried out by Ear Nose, and Throat services).

Basis for recommendation

Symptomatic drug treatment
  • Evidence for the use of symptomatic drug treatment for Ménière's disease is lacking.
  • The recommendation to consider prochlorperazine or an antihistamine (cinnarizine, cyclizine, or promethazine teoclate) to relieve nausea, vomiting, or vertigo is based on expert opinion in review articles [Harcourt, 2014; Foster, 2015; Espinosa-Sanchez, 2016; BMJ, 2021].
  • In addition: 
    • Prochlorperazine is licensed for the treatment of vertigo due to Ménière's disease, labyrinthitis, and other causes, and for nausea and vomiting from whatever cause [ABPI, 2022].
    • Cinnarizine is licensed to be used as maintenance therapy for symptoms of labyrinthine disorders, including vertigo, tinnitus, nystagmus, nausea, and vomiting such as is seen in Ménière's disease [ABPI, 2021a].
    • Cyclizine is licensed for the treatment of vomiting and vertigo associated with Ménière's disease and other forms of vestibular disturbance [ABPI, 2018].
    • Promethazine teoclate is licensed for the treatment of vertigo due to Ménière's syndrome, labyrinthitis, and other causes [MHRA, 2022].
  • The recommendations to try a treatment that has previously been effective and to consider the person's preferences are pragmatic, based on what CKS considers to be good clinical practice.
  • Some experts note that the sedative and anxiolytic effects of benzodiazepines may be useful [Harcourt, 2014; Foster, 2015], but CKS does not recommend their use because there is a lack of evidence, they are not licensed for this indication [BNF, 2023], and there is the potential for dependence [BMJ, 2021].
  • Anticholinergics (such as hyoscine and atropine) are not commonly prescribed due to their significant adverse effect profile [BMJ, 2021].
Hospital admission for very severe symptoms
  • This recommendation is pragmatic and is based on what CKS considers to be good clinical practice. 
Short-term use of symptomatic drug treatment
  • CKS only recommends short-term use of symptomatic drug treatments because experts are of the opinion that regular, long-term use of vestibular suppressants can interfere with vestibular compensation [Harcourt, 2014]. Other experts only recommend use during acute attacks, noting that they do not affect the progression of the disorder [Foster, 2015]. 
Reassessment after 5–7 days
  • This recommendation is pragmatic, based on the fact that there are a number of differential diagnoses of Ménière's disease, and severe vertigo associated with an acute attack of Ménière's disease does not usually last longer than 24 hours [Harcourt, 2014]. 

How should I prevent recurrent attacks of Ménière's disease?

  • Consider prescribing a trial of betahistine to reduce the frequency and severity of attacks of hearing loss, tinnitus, and vertigo. For prescribing information, see the section on Betahistine.
  • If betahistine does not provide the clinical benefit required, and there are recurrent attacks of Ménière's disease despite its use, refer to an Ear, Nose, and Throat (ENT) specialist for consideration of alternative interventions.

Basis for recommendation

Betahistine
  • Betahistine, a weak histamine 1 receptor agonist and an effective histamine 3 receptor antagonist, is licensed for the treatment of vertigo, tinnitus, and hearing loss associated with Ménière's disease [ABPI, 2023]. It is frequently prescribed to reduce recurrent vertigo attacks, but the effects on hearing and other audiological symptoms remain unclear [Casani, 2018]. 
    • A Cochrane systematic review on the use of betahistine for the symptom of vertigo found 16 studies comparing betahistine with placebo (n = 953). Five studies specifically included people with clinically defined Ménière's disease. On the basis of this low-quality evidence, the Cochrane authors concluded that betahistine may be beneficial in terms of reducing vertigo symptoms in people with vertigo from a variety of causes. However, there was a high level of heterogeneity between the studies, necessitating caution in the interpretation of the results [Murdin, 2016]. 
    • A subsequent long-term randomized controlled trial studied the efficacy and safety of betahistine treatment in people with Ménière's disease and found that although betahistine was well tolerated, there was no clear evidence that nine months of betahistine treatment (at low or high dose) results in a clinical reduction in the number of attacks compared with placebo [Adrion, 2016]. 
    • A systematic review assessed the effect of betahistine for Ménière's disease. One study with a low risk of bias found no significant difference between the betahistine groups and placebo with respect to vertigo after a long-term follow-up period. No differences in hearing loss, tinnitus, or well-being and disease-specific health-related quality of life were found (low to very low certainty of evidence). Data on aural fullness could not be extracted [Van Esch, 2022]. 
  • In a consensus conference on betahistine for Ménière’s disease, betahistine was considered useful for the treatment of dizziness and vertigo during the intercritical phase of the disease (87% agreement). However, during the acute phase of the disease, betahistine was considered less effective and useful only when used with other drugs (71% agreement). Similarly, the efficacy of the drug was considered low when used to reduce progressive hearing loss, tinnitus, and ear fullness. The experts advocated the use of betahistine during the intercritical phase of Ménière’s disease to reduce the number and severity of vertigo attacks [Casani, 2018].
Referral if no clinical benefit with betahistine

Prescribing information

Important aspects of prescribing information relevant to primary healthcare are covered in this section specifically for the drugs recommended in this CKS topic. For further information on contraindications, cautions, drug interactions, and adverse effects, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

Betahistine

  • The recommended dosage for vertigo, tinnitus, and hearing loss associated with Ménière's disease is 16 mg three times a day, preferably taken with food. The usual maintenance dose is 24–48 mg daily.

[ABPI, 2023; BNF, 2023]

What are the contraindications and cautions when prescribing betahistine?

  • Do not prescribe betahistine to people with:
    • Phaeochromocytoma — may induce the release of catecholamines from the tumour. resulting in severe hypertension.
  • Prescribe betahistine with caution to people with:
    • Asthma.
    • Severe hypotension.
    • History of peptic ulcer — may cause dyspepsia.
    • Urticaria, rashes, or allergic rhinitis — may aggravate symptoms.

[ABPI, 2023; BNF, 2023]

What are the adverse effects of betahistine?

  • Adverse effects of betahistine include:
    • Common or very common — gastrointestinal discomfort, headache, and nausea.
    • Frequency not known — thrombocytopenia, hypersensitivity reactions (such as anaphylaxis), and cutaneous and subcutaneous hypersensitivity reactions (in particular angioneurotic oedema, urticarial, rash, and pruritus).

[ABPI, 2023; BNF, 2023]

What drug interactions occur with betahistine?

  • Drug interactions include:
    • Antihistamines — antihistamines (such as cetirizine and loratadine) are predicted to decrease the effects of betahistine. The manufacturer makes no recommendation.
    • Monoamine oxidase inhibitors (MAOIs)— in vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit MAOIs, including MAOI subtype B (such as selegiline). Concurrent use should be done cautiously.
  • See the electronic Medicines Compendium (eMC) or the British National Formulary (BNF) for a comprehensive list of possible drug interactions with betahistine.

[ABPI, 2023; BNF, 2023]

Can betahistine be used during pregnancy or breastfeeding?

  • Pregnancy
    • The manufacturer advises that it is preferable to avoid the use of betahistine during pregnancy. There are no adequate data from the use of betahistine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, embryonal/foetal development, parturition, and postnatal development at clinically relevant therapeutic exposure. 
  • Breastfeeding
    • It is not known whether betahistine is excreted in human milk. Therefore, it should be used during pregnancy only if potential benefit outweighs risk. 

[ABPI, 2023; BNF, 2023]

 

Cinnarizine

  • The recommended dosage for the relief of symptoms of vestibular disorders, such as vertigo, tinnitus, nausea, and vomiting in Ménière's disease is 30 mg three times a day. 

[ABPI, 2021b; BNF, 2023]

What are the contraindications and cautions when prescribing cinnarizine?

  • Do not prescribe cinnarizine to people with:
    • Porphyria.
  • Prescribe cinnarizine with caution to people with:
    • Hepatic or renal impairment.
    • Epilepsy.
    • Prostatic hypertrophy.
    • Pyloroduodenal obstruction.
    • Susceptibility to angle closure glaucoma.
    • Urinary retention.
    • Parkinson’s disease — use only if the advantages outweigh the risk of disease exacerbation.

[ABPI, 2021b; BNF, 2023]

What are the adverse effects of cinnarizine?

  • Adverse effects of cinnarizine include:
    • Common or very common — drowsiness, somnolence, nausea, and weight gain.
    • Uncommon — hypersomnia, vomiting, fatigue, hyperhidrosis, and lichenoid keratosis (including lichen planus).
    • Rare — upper abdominal pain and dyspepsia.
    • Frequency not known — dry mouth, headache, dyskinesia, extrapyramidal disorder, Parkinsonism, tremor, cholestatic jaundice, subacute cutaneous lupus erythematosus, movement disorders, and muscle rigidity.

[ABPI, 2021b; BNF, 2023]

What drug interactions occur with cinnarizine?

  • Drug interactions include:
    • Alcohol, central nervous system (CNS) depressants, and tricyclic antidepressants — concurrent use with cinnarizine may result in increased sedative effects. This may influence the ability to perform skilled tasks, such as driving.
    • Isocarboxazid and phenelzine — predicted to increase the risk of antimuscarinic adverse effects when given with cinnarizine. Avoid concurrent use.
  • See the the electronic Medicines Compendium (eMC) or the British National Formulary (BNF) for a comprehensive list of possible drug interactions with cinnarizine.

[ABPI, 2021b; BNF, 2023]

Can cinnarizine be used during pregnancy or breastfeeding?

  • Pregnancy
    • The manufacturer states that it is not advisable to use cinnarizine during pregnancy because the safety in human pregnancy has not been established, although studies in animals have not demonstrated teratogenic effects. 
  • Breastfeeding
    • The manufacturer advises that the use of cinnarizine during breastfeeding is not recommended because there are no data on the excretion of cinnarizine in human breast milk. 

[ABPI, 2021b; BNF, 2023]

Cyclizine

  • For nausea, vomiting, vertigo, or labyrinthine disorders, the recommended dosage is 50 mg orally up to three times a day. 
  • If the oral route is not appropriate, cyclizine 50 mg by intramuscular injection can be given up to three times a day. 

[ABPI, 2018; BNF, 2023]

What are the contraindications and cautions when prescribing cyclizine?

  • Do not prescribe cyclizine to people with:
    • Porphyria.
    • Acute alcohol intoxication — the anti-emetic properties of cyclizine may increase the toxicity of alcohol.
  • Prescribe cyclizine with caution to people with:
    • Epilepsy.
    • Prostatic hypertrophy.
    • Pyloroduodenal obstruction.
    • Susceptibility to angle-closure glaucoma.
    • Urinary retention.
    • Obstructive disease of the gastrointestinal tract.
    • Hepatic disease.
    • Phaeochromocytoma.
    • Hypertension.
    • Neuromuscular disorders — increased risk of transient paralysis with intravenous use.
    • Severe heart failure or acute myocardial infarction — cyclizine may cause a fall in cardiac output associated with increases in heart rate, mean arterial pressure, and pulmonary wedge pressure.

[ABPI, 2018; BNF, 2023]

What are the adverse effects of cyclizine?

  • Adverse effects of cyclizine include:
    • Rare or very rare — agitation (more common at high doses), angle closure glaucoma, and depression.
    • Frequency unknown — abdominal pain, agranulocytosis, angioedema, anxiety, apnoea, arrhythmias, asthenia, bronchospasm, constipation, decreased appetite, decreased level of consciousness, diarrhoea, disorientation, dizziness, drowsiness, dry mouth, dry throat, euphoric mood, haemolytic anaemia, hallucinations, headache, hepatic disorders, hypertension, hypotension, increased gastric reflux, insomnia, leucopenia, movement disorders, muscle complaints, nasal dryness, nausea, oculogyric crisis, palpitations, paraesthesia, photosensitivity reaction, seizure, skin reactions, speech disorder, thrombocytopenia, tinnitus, tremor, urinary retention, vision blurred, and vomiting.
    • Frequency unknown (with parenteral use) — chills, impaired consciousness, injection site necrosis, pain, paralysis, a sensation of pressure, and thrombophlebitis. 

[ABPI, 2018; BNF, 2023]

What drug interactions occur with cyclizine?

  • Drug interactions include:
    • Antimuscarinic drugs — there is a risk of increased antimuscarinic adverse effects when cyclizine is given with other antimuscarinic drugs, such as atropine and some antidepressants (tricyclics and monoamine oxidase inhibitors).
    • Central nervous system (CNS) depressant drugs — cyclizine may have additive effects with other CNS depressants, such as alcohol, opioid analgesics, hypnotics, antipsychotics, and barbiturates.
    • Clozapine — both clozapine and cyclizine can cause constipation. Concurrent use may increase the risk of developing intestinal obstruction. The manufacturer advises caution.
    • Isocarboxazid and phenelzine — predicted to increase the risk of antimuscarinic adverse effects when given with cyclizine. Avoid concurrent use.
    • Ototoxic drugs — concurrent use with cyclizine may mask the warning signs of damage caused by ototoxic drugs (such as aminoglycoside antibiotics).
  • See the the electronic Medicines Compendium (eMC) or the British National Formulary (BNF) for a comprehensive list of possible drug interactions with cyclizine.

[ABPI, 2018; BNF, 2023]

  • Pregnancy
    • The manufacturer states that the use of cyclizine in pregnancy is not advised due to the absence of definitive human data. However, there is no evidence of teratogenicity [BNF, 2023].
  • Breastfeeding
    • Cyclizine is excreted in human milk, but the amount has not been quantified. Although not known to be harmful, most manufacturers advise avoiding their use in women who are breastfeeding. 

[ABPI, 2018; BNF, 2023]

Prochlorperazine

  • For vertigo and Ménière's disease, the recommended dosage is 5 mg three times a day, increased if necessary to 30 mg daily in divided doses. After several weeks, the dosage may be reduced gradually to 5–10 mg daily.
  • If the oral route is not appropriate, consider one of the following:
    • Prochlorperazine buccal tablets 3–6 mg twice a day (to be placed high in the buccal cavity and allowed to dissolve).
    • A one-off dose of prochlorperazine 12.5 mg by deep intramuscular injection followed by oral medication after an interval of 6 hours, if required.

[ABPI, 2019; ABPI, 2021c; ABPI, 2022]

What are the contraindications and cautions when prescribing prochlorperazine?

  • Do not prescribe prochlorperazine to people with:
    • Liver or renal dysfunction.
    • Parkinson's disease.
    • Heart failure.
    • Phaeochromocytoma.
    • Myasthenia gravis.
    • Hypothyroidism.
    • Prostate hypertrophy.
    • A history of angle closure glaucoma.
    • A history of agranulocytosis.
    • Jaundice.
    • Central nervous system (CNS) depression.
  • Prescribe prochlorperazine with caution to:
    • People with epilepsy or a history of seizures — close monitoring is required in this group of people as prochlorperazine may lower the seizure threshold.
    • People with psychiatric disorders.
    • People with cardiovascular disease or a family history of QT prolongation — cases of QT interval prolongation have been very rarely reported with prochlorperazine.
      • An alternative anti-emetic should be considered for people with predisposing factors for ventricular arrhythmias, or they should be carefully monitored (check electrolytes and ECG), particularly during the initial phase of treatment.
      • Cardiac disease; metabolic abnormalities, such as hypokalaemia, hypocalcaemia, or hypomagnesaemia; starvation; alcohol misuse; and concurrent treatment with other drugs known to prolong the QT interval may predispose people to ventricular arrhythmias.
    • Elderly people — use with caution, especially during very hot or cold weather due to the risk of hyper- or hypothermia. In addition:
      • Postural hypotension is a common adverse effect of prochlorperazine, and elderly people are particularly susceptible to postural hypotension.
      • A lower initial dosage is recommended in elderly people due to their susceptibility to drugs acting on the CNS.
      • There is an increased risk of drug-induced Parkinsonism in the elderly, particularly after prolonged use. Care should also be taken not to confuse the adverse effects of prochlorperazine, for example, orthostatic hypotension, with the effects due to the underlying disorder.

[ABPI, 2022; BNF, 2023]

What are the adverse effects of prochlorperazine?

  • Adverse effects of all antipsychotic drugs include:
    • Common or very common — agitation, amenorrhoea, arrhythmias, constipation, dizziness, drowsiness, dry mouth, erectile dysfunction, fatigue, galactorrhoea, gynaecomastia, hyperglycaemia, hyperprolactinaemia, hypotension (dose-related), insomnia, leucopenia, movement disorders, muscle rigidity, neutropenia, parkinsonism, postural hypotension (dose-related), QT interval prolongation, rash, seizure, tremor, urinary retention, vomiting, and weight gain.
    • Uncommon — agranulocytosis, confusion, embolism and thrombosis, and neuroleptic malignant syndrome (discontinue—potentially fatal).
    • Rare or very rare — sudden death.
  • Adverse effects of oral prochlorperazine include:
    • Frequency not known — atrioventricular block, autonomic dysfunction, impaired consciousness, hyperthermia, nasal congestion, oculogyric crisis, respiratory depression, and skin reactions.
  • Adverse effects of buccal prochlorperazine include:
    • Rare or very rare — blood disorders and hepatic disorders.
    • Frequency not known — oral disorders and skin eruption.
  • Adverse effects of intramuscular prochlorperazine include:
    • Frequency not known — eye disorders, nasal congestion, respiratory depression, and skin reactions.
  • Adverse effects of all formulations of prochlorperazine include:
    • Rare or very rare — glucose tolerance impaired, hyponatraemia, and syndrome of inappropriate secretion of antidiuretic hormone (SIADH).
    • Frequency not known — photosensitivity reaction.

 [ABPI, 2022; BNF, 2023]

What drug interactions occur with prochlorperazine?

  • Drug interactions include:
    • Alcohol — the sedative effects of alcohol on driving and operating heavy machinery may be enhanced by prochlorperazine. 
    • Amantadine — prochlorperazine is predicted to decrease the effects of amantadine. In addition, both Prochlorperazine and Amantadine can increase the risk of hypotension and antimuscarinic effects.
    • Antihypertensive drugs — the hypotensive effect of most antihypertensive drugs (particularly alpha-adrenoceptor blockers and calcium channel blockers) may be increased by prochlorperazine.
    • Antimuscarinic drugs — there is a risk of increased antimuscarinic adverse effects when prochlorperazine is given with other antimuscarinic drugs.
    • Central nervous system (CNS) depressants — the CNS depressant actions of prochlorperazine may be increased by barbiturates, opioid analgesics, anxiolytics, and hypnotics, raising the risk of respiratory depression.
    • Clozapine — both clozapine and prochlorperazine can cause constipation; concurrent use may increase the risk of developing intestinal obstruction. The manufacturer advises caution.
    • Drugs which prolong the QT interval — there is an increased risk of ventricular arrhythmias when prochlorperazine is used concurrently with drugs that prolong the QT interval, for example, anti-arrhythmics, sotalol, antidepressants (tricyclics, citalopram, and escitalopram), antihistamines (terfenadine), methadone, and risperidone.
    • Hypoglycaemic drugs — hypoglycaemic effect may be antagonized by prochlorperazine. Dose adjustment of the hypoglycaemic drug may be required.
    • Isocarboxazid — predicted to increase the risk of neuroleptic malignant syndrome when given with prochlorperazine. 
    • Lithium — there is an increased risk of extrapyramidal adverse effects and possibly neurotoxicity when prochlorperazine is given with lithium.
    • Myelosuppressive drugs — there is an increased risk of agranulocytosis when neuroleptics are used concurrently with drugs with myelosuppressive potential, such as carbamazepine or certain antibiotics and cytotoxics.
    • Phenelzine — predicted to increase the risk of neuroleptic malignant syndrome when given with prochlorperazine. 
  • In addition:
    • Absorption of prochlorperazine may be decreased by:
      • Antacids.
      • Lithium.
      • Anti-Parkinson drugs.
    • Prochlorperazine may decrease the effects of some drugs, including:
      • Levodopa
      • Clonidine
      • Adrenaline 
      • Pramipexole
      • Ropinorole.
      • Rotigotine.
  • See the the electronic Medicines Compendium (eMC) or the British National Formulary (BNF) for a comprehensive list of possible drug interactions with prochlorperazine.

 [ABPI, 2022; BNF, 2023]

Can prochlorperazine be used during pregnancy or breastfeeding?

  • Pregnancy
    • The manufacturer advises that prochlorperazine should be avoided during pregnancy unless the potential benefits outweigh the potential risks.
      • There is inadequate evidence of safety in pregnancy. Data from epidemiological studies do not suggest a risk of congenital malformations in children exposed in utero to prochlorperazine.
      • Animal studies are insufficient with respect to reproductive toxicity. However, potential harmful effects in animals cannot be ruled out. 
      • Neonates exposed to prochlorperazine during the third trimester of pregnancy are at risk of adverse reactions, including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborn children should be monitored carefully.
  • Breastfeeding
    • The manufacturer advises that prochlorperazine may be excreted in milk; therefore, breastfeeding should be suspended during treatment.

[ABPI, 2022; BNF, 2023]

Promethazine teoclate

  • For nausea and vomiting, one 25 mg tablet at night is often sufficient, but two or three tablets are sometimes necessary. Alternatively, more frequent administration such as 25 mg two or three times a day may be required for some people. It is often not necessary to give more than four of the 25 mg tablets in 24 hours. 

[MHRA, 2022]

What are the contraindications and cautions when prescribing promethazine teoclate?

  • Do not prescribe promethazine teoclate to people with:
    • Coma or central nervous system (CNS) depression of any cause.
    • Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Prescribe promethazine teoclate with caution in people with:
    • Severe coronary artery disease.
    • Narrow-angle glaucoma.
    • Epilepsy.
    • Hepatic or renal impairment.
    • Bladder neck or pyloroduodenal obstruction.
    • Urinary retention or prostatic hypertrophy.
    • Asthma, bronchitis, or bronchiectasis — promethazine teoclate may thicken or dry lung secretions and impair expectoration.

[MHRA, 2022; BNF, 2023]

What are the adverse effects of promethazine teoclate?

  • Adverse effects include:
    • Uncommon — anticholinergic adverse effects, such as blurred vision, dry mouth, and urinary retention. 
    • Rare — anaphylaxis and blood dyscrasias (including haemolytic anaemia). 
    • Frequency not known — anticholinergic syndrome, anxiety, arrhythmia, blood disorder, bronchial secretion viscosity increased, confusion, decreased appetite, dizziness, drowsiness, epigastric discomfort, fatigue, haemolytic anaemia, headache, hypotension, jaundice, movement disorders, muscle spasms, nightmare, palpitations, and photosensitivity reaction (strong sunlight should be avoided during treatment).
  • Promethazine may delay the early diagnosis of intestinal obstruction or raised intracranial pressure through suppression of vomiting.

[MHRA, 2022; BNF, 2023]

What drug interactions occur with promethazine teoclate?

  • Drug interactions include:
    • Alcohol — the sedative effects of alcohol on driving and operating heavy machinery may be enhanced by promethazine. 
    • Antimuscarinic drugs, tricyclic antidepressants, sedatives, and hypnotics — concurrent use with promethazine enhances the antimuscarinic and/or sedative action of these drugs.
    • Central nervous system (CNS) depressants — concurrent use with other CNS depressants may enhance the hypotensive, sedative, and respiratory depressant effects of promethazine. 
    • Clozapine — both promethazine and clozapine can cause constipation. Concurrent use may increase the risk of developing intestinal obstruction. In addition, both promethazine and clozapine can have CNS depressant effects, which might affect the ability to perform skilled tasks, and both drugs can cause antimuscarinic effects.
    • Monoamine oxidase inhibitors (MAOIs) — promethazine should not be given to people who have taken MAOIs within the previous 14 days.
    • Ototoxic drugs —  promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs, such as salicylates. 
  • Promethazine may interfere with immunologic urine pregnancy tests to produce false-positive and false-negative results. Promethazine should be discontinued at least 72 hours before any skin tests using allergen extracts as it may inhibit the cutaneous histamine response thus producing false-negative results. 
  • See the British National Formulary (BNF) for a comprehensive list of possible drug interactions with promethazine teoclate.

[MHRA, 2022; BNF, 2023]

  • Pregnancy
    • The manufacturer advises that promethazine teoclate should not be used in pregnancy unless it is considered essential. The use of promethazine teoclate is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate.
  • Breastfeeding 
    • Available evidence suggests that the amount excreted in milk is insignificant. However, there are risks of neonate irritability and excitement. 

[MHRA, 2022; BNF, 2023]

Supporting evidence

This CKS topic is largely based on the Diagnostic criteria for Menière’s disease, a consensus document published by the Classification Committee of the Bárány Society, The Japan Society for Equilibrium Research, the European Academy of Otology and Neurotology (EAONO), the Equilibrium Committee of the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS), and the Korean Balance Society [Lopez-Escamez, 2015]; 2015 Equilibrium Committee amendment to the 1995 AAO-HNS guidelines for the definition of Meniere's disease [Goebel, 2016]; and on expert opinion in several review articles.

The rationale for the diagnosis, referral, and primary care management of people with Meniere's disease is outlined in the relevant basis for recommendation sections of the topic.

How this topic was developed

This section briefly describes the processes used in developing and updating this topic. Further details on the full process can be found in the About Us section and on the Clarity Informatics website.

Search strategy

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of Meniere's disease.

Search dates

August 2017 - February 2023

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

  • exp Meniere's Disease/, menier$.tw., exp Endolymphatic Hydrops/, endolymphatic hydrops.tw.

Sources of guidelines

Sources of systematic reviews and meta-analyses

  • The Cochrane Library:
    • Systematic reviews
    • Protocols
    • Database of Abstracts of Reviews of Effects
  • Medline (with systematic review filter)
  • EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

Sources of randomized controlled trials

  • The Cochrane Library:
    • Central Register of Controlled Trials
  • Medline (with randomized controlled trial filter)
  • EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

Sources of national policy

Patient experiences

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

  • Clinical accuracy.
  • Consistency with other providers of clinical knowledge for primary care.
  • Accuracy of implementation of national guidance (in particular NICE guidelines).
  • Usability.

Principles of the consultation process

  • The process is inclusive and any individual may participate.
  • To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
  • Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
  • Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
  • External reviewers are not paid for commenting on the draft topics.
  • Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
  • All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
  • All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

  • Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
  • Stakeholders identified from the following groups are invited to review draft topics:
    • Experts in the topic area.
    • Professional organizations and societies (for example, Royal Colleges).
    • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
    • Guideline development groups where the topic is an implementation of a guideline.
    • The British National Formulary team.
    • The editorial team that develop MeReC Publications.
  • Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

  • Topic selection
  • Scoping of topic
  • Selection of clinical scenarios
  • First draft internal review
  • Second draft internal review
  • External review
  • Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

  • Animal studies
  • Original research is not written in English

Possible exclusions for reviewed literature:

  • Sample size too small or study underpowered
  • Bias evident or promotional literature
  • Population not relevant
  • Intervention/treatment not relevant
  • Outcomes not relevant
  • Outcomes have no clear evidence of clinical effectiveness
  • Setting not relevant
  • Not relevant to UK
  • Incorrect study type
  • Review article
  • Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

  • Feasibility
    • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
  • Organizational and Financial Impact Analysis
  • Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
    • Eligible population
    • Current interventions
    • Likely uptake of new intervention or recommendation
    • Cost of the current or new intervention mix
    • Impact on other costs
    • Condition-related costs
    • In-direct costs and service impacts
    • Time dependencies
  • Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

  • Personal financial interests
  • Personal family interest
  • Personal non-financial interest
  • Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.

References

  • ABPI (2018) SPC for Cyclizine 50mg Tablets. Electronic Medicines Compendium. Datapharm Communications Ltd. https://www.medicines.org.uk/emc [Free Full-text]
  • ABPI (2019) SPC for Prochlorperazine 3 mg Buccal Tablets. Electronic Medicines Compendium. Datapharm Communications Ltd. https://www.medicines.org.uk/emc [Free Full-text]
  • ABPI (2021a) SPC for cinnarizine 15 mg tablets. Electronic Medicines Compendium. Datapharm Communications Ltd. https://www.medicines.org.uk/emc [Free Full-text]
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  • Adrion, C., Fischer, C.S., Wagner, J., et al. (2016) Efficacy and safety of betahistine treatment in patients with Meniere's disease: primary results of a long term, multicentre, double blind, randomised, placebo controlled, dose defining trial (BEMED trial). British Medical Journal 352, h6816. [Abstract] [Free Full-text]
  • Ahmadzai, N., Cheng, W., Kilty, S., et al. (2020) Pharmacologic and surgical therapies for patients with Meniere's disease: A systematic review and network meta-analysis. PloS one 15(9), e0237523. [Abstract] [Free Full-text]
  • American Academy of Otolaryngology (1995) Committee on Hearing and Equilibrium Guidelines for the Diagnosis and Evaluation of Therapy in Meniere's Disease. Otolaryngology - Head and Neck Surgery 113(3), 181-185. [Abstract]
  • Basura, G. J., Adams, M. E., Monfared, A., et al. (2020) Clinical Practice Guideline: Ménière's Disease. Otolaryngology - head and neck surgery 162(2 supp), S1-S55. [Abstract] [Free Full-text]
  • BMJ Best Practice (2021) Meniere's disease. BMJ Publishing Group. https://bestpractice.bmj.com
  • BNF (2023) British National Formulary. National Institute for Health and Care Excellence. https://bnf.nice.org.uk
  • Bruderer, S.G., Bodmer, D., Stohler, N.A., et al. (2017) Population-Based Study on the Epidemiology of Meniere's Disease. Audiology and Neurotology 22(2), 74-82. [Abstract]
  • Casani, A. P., Guidetti, G. and Schoenhuber, R. (2018) Report from a Consensus Conference on the treatment of Ménière's disease with betahistine: rationale, methodology and results. ACTA Otorhinolaryngologica Italica 38(5), 460-467. [Free Full-text]
  • Crowson, M.G., Patki, A. and Tucci, D.L. (2016) A systematic review of diuretics in the medical management of Meniere's disease. Otolaryngology - head and neck sugery 154(5), 824-834. [Abstract]
  • Dommaraju, S. and Perera, E. (2016) An approach to vertigo in general practice. Australian Family Physician 45(4), 190-194. [Abstract] [Free Full-text]
  • Espinosa-Sanchez, J.M. and Lopez-Escamez, J.A. (2016) Meniere's disease. Handbook of Clinical Neurology 137, 257-277. [Abstract]
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  • Goebel, J.A. (2016) 2015 Equilibrium Committee Amendment to the 1995 AAO-HNS Guidelines for the Definition of Meniere’s Disease. Otolaryngology - Head and Neck Surgery 154(3), 403-404. [Abstract]
  • Gurkov, R., Pyyko, I., Zou, J. and Kentala, E. (2016) What is Meniere's disease? A contemporary re-evaluation of endolymphatic hydrops. Journal of Neurology 263(Suppl 1), S71-S81. [Abstract] [Free Full-text]
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  • Ludman, H. (2014) Vertigo and imbalance. BMJ 348. [Abstract]
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