Abstract
Introduction
Menière's disease causes recurrent vertigo, hearing loss, tinnitus, and fullness or pressure in the ear, which mainly affects adults aged 40-60 years. Menière's disease is at first progressive but fluctuating, and episodes can occur in clusters. Vertigo usually resolves but hearing deteriorates, and symptoms other than hearing loss and tinnitus usually improve regardless of treatment.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for acute attacks of Menière's disease; and of interventions to prevent attacks and delay disease progression of Menière's disease? We searched: Medline, Embase, The Cochrane Library and other important databases up to January 2006 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 17 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: anticholinergics, benzodiazepines, betahistine, cinnarizine, dietary modification, diuretics, phenothiazines, psychological support, trimetazidine, vestibular rehabilitation.
Key Points
Menière's disease causes recurrent vertigo, hearing loss, tinnitus, and fullness or pressure in the ear, which mainly affects adults aged 40-60 years.
Menière's disease is at first progressive but fluctuating, and episodes can occur in clusters.
Vertigo usually resolves but hearing deteriorates, and symptoms other than hearing loss and tinnitus usually improve regardless of treatment.
We do not know whether anticholinergic drugs, benzodiazepines, phenothiazines, cinnarizine, or betahistine improve symptoms in an acute attack of Menière's disease, as no good quality studies have been found.
Betahistine seems to be no more effective than placebo at preventing hearing loss in people with Menière's disease.
We do not know whether betahistine reduces the frequency or severity of vertigo, tinnitus or aural fullness.
We do not know whether diuretics, trimetazidine, dietary modification, psychological support, or vestibular rehabilitation improve tinnitus or hearing, or reduce the frequency of attacks of Menière's disease.
About this condition
Definition
Menière's disease is characterised by recurrent episodes of spontaneous rotational vertigo, sensorineural hearing loss, tinnitus, and a feeling of fullness or pressure in the ear. It may be unilateral or bilateral. Acute episodes can occur in clusters of about 6-11 a year, although remission may last several months. The diagnosis is made clinically. It is important to distinguish Menière's disease from other types of vertigo that might occur independently with hearing loss and tinnitus, and respond differently to treatment (e.g. benign positional vertigo, acute labyrinthitis). Strict diagnostic criteria help to identify the condition. In this review, we have applied the classification of the American Academy of Otolaryngology — Head and Neck Surgery to assess the diagnostic rigour used in RCTs (see table 1 ).
Table 1.
American Academy of OtolaryngologyHead and Neck Surgery definition of the certainty of diagnosis of Menire's disease (see text).
| Certain | Definite Menière's disease plus postmortem confirmation |
| Definite | Two or more episodes of vertigo* plus audiometrically confirmed sensorineural hearing loss; tinnitus or aural fullness plus other causes excluded |
| Probable | One episode of vertigo* plus audiometrically confirmed sensorineural hearing loss plus tinnitus or aural fullness; other causes excluded |
| Possible | Episodes of vertigo* with no hearing loss, or sensorineural hearing loss with dysequilibrium; other causes excluded |
*Defined as spontaneous, rotational vertigo lasting more than 20 minutes.
Incidence/ Prevalence
Menière's disease is most common between 40-60 years of age, although younger people may be affected. In Europe, the incidence is about 50-200/100 000 a year. A survey of general practitioner records of 27 365 people in the UK in the 1950s found an incidence of 43 affected people in a 1 year period (157/100 000). Diagnostic criteria were not defined in this survey. A survey of over 8 million people in 1973 in Sweden found an incidence of 46/100 000 a year with diagnosis strictly based on the triad of vertigo, hearing loss, and tinnitus. From smaller studies, the incidence appears to be lower in Japan (17/100 000, based on national surveys of hospital attendances in 1977, 1982, and 1990) and in Uganda.
Aetiology/ Risk factors
Menière's disease is associated with endolymphatic hydrops (raised endolymph pressure in the membranous labyrinth of the inner ear), but a causal relationship remains unproved. Specific disorders associated with hydrops (such as temporal bone fracture, syphilis, hypothyroidism, Cogan's syndrome, and Mondini dysplasia) can produce symptoms similar to those of Menière's disease.
Prognosis
Menière's disease is at first progressive but fluctuates unpredictably. It is difficult to distinguish natural resolution from the effects of treatment. Significant improvement in vertigo is usually seen in the placebo arm of RCTs. Acute attacks of vertigo often increase in frequency during the first few years after presentation and then decrease in frequency in association with sustained deterioration in hearing. In most people, vertiginous episodes eventually cease completely. In one 20 year cohort study in 34 people, 28 (82%) people had at least moderate hearing loss (mean pure tone hearing loss > 50 dB) and 16 (47%) developed bilateral disease. Symptoms other than hearing loss improve in 60-80% of people irrespective of treatment.
Aims of intervention
To prevent attacks of Menière's disease; to reduce the severity of vertigo in acute attacks; to relieve chronic symptoms of hearing loss and tinnitus; to improve quality of life, with minimum adverse effects of treatment.
Outcomes
Frequency and severity of acute attacks of vertigo; hearing acuity; severity of tinnitus; sensation of aural fullness; functional impairment and quality of life; adverse effects of treatment.
Methods
BMJ Clinical Evidence search and appraisal January 2006. The following databases were used to identify studies for this systematic review: Medline 1966 to January 2006, Embase 1980 to January 2006, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2005, Issue 4. Additional searches were carried out using the following websites: NHS Centre for Reviews and Dissemination (CRD), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA), Turning Research into Practice (TRIP), and National Institute for Health and Clinical Excellence (NICE). Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the author for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for evaluation in this review were: published systematic reviews and RCTs in any language, at least single blinded, and containing more than 20 individuals of whom more than 80% were followed up. There was no minimum length of follow up required to include studies. We excluded all studies described as "open", "open label", or not blinded, unless blinding was impossible. We use a regular surveillance protocol to capture harms alerts from organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. The authors excluded RCTs that did not comply with the American Academy of Otolaryngology — Head and Neck Surgery diagnostic criteria. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table ).
Table.
GRADE evaluation of interventions for Menière’s disease
| Important outcomes | Symptom relief, prevention of attacks, adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of treatments for acute attacks of Menière's disease? | |||||||||
| 1 (37) | Symptom relief | Anticholinergics v placebo | 4 | –2 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results and for non-randomised study |
| What are the effects of interventions to prevent attacks and delay disease progression of Menière's disease? | |||||||||
| 5 (192) | Prevention of attacks | Betahistine v placebo | 4 | –3 | –1 | –2 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, methodology flaws, and uncertainty about diagnosis. Consistency point deducted for conflicting results. Directness point deducted for uncertainty about measurement of outcomes and for heterogeneity among RCTs |
| 1 (33) | Prevention of attacks | Diuretics v placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, for incomplete reporting of results and for lack of statistical analysis |
| 2 (65) | Prevention of attacks | Trimetazidine v betahistine | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Consistency point deducted for conflicting results |
| 4 (111) | Prevention of attacks | Betahistine v placebo | 4 | –3 | –1 | –1 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and for mthodological flaws. Consistency point deducted for heterogeneity among RCTs. Directness point deducted for uncertainty about diagnosis |
Type of evidence: 4 = RCT; 2 = Observational. Consistency: similarity of results across studies. Directness: generalisability of population or outcomes. Effect size: based on relative risk or odds ratio.
Glossary
- Cogan's syndrome
Episodic vertigo of the Menière's type, hearing loss, and interstitial keratitis, without syphilis.
- Mondini dysplasia
A congenital deformity of the cochlea in which only the basal turns are present.
- Very low-quality evidence
Any estimate of effect is very uncertain.
- Vestibular rehabilitation
Involves a series of exercises intended to improve the sense of balance through controlled movements of the head and body. It is usually recommended for stable vestibular disorders.
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients.To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.
Contributor Information
Adrian L James, Department of Otolaryngology, Southmead Hospital, Bristol, UK.
Marc A Thorp, Department of Otolaryngology, Corner Brook, Newfoundland, Canada.
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