NIHR DC Discover

NIHR Signal Betahistine may be worth trying for people with undiagnosed vertigo

Published on 13 September 2016

doi: 10.3310/signal-000297

Taking the drug betahistine could reduce the feeling of vertigo, even when the cause hasn't been found. Vertigo is a feeling that the environment is moving around when it is not. It can be caused by problems in the ear or the brain. Regardless of the cause, this study found that if 100 people with vertigo are treated with betahistine, 60 will report improvement.

Side effects reported in this Cochrane review were uncommon and usually mild.

Vertigo is difficult to treat. A previous review in 2001 found no benefit of betahistine, a drug similar to antihistamines, for vertigo. Only two of the trials in this review were undertaken in the last ten years and so results need to be viewed with some caution. Provided that referral is offered for persistent symptoms, it may be worth a trying a short prescription of betahistine in primary care.

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Why was this study needed?

Vertigo is a common symptom that is often associated with dizziness. It can be a disabling symptom and increase the risk of falls. In a UK study of over 2,000 people, 7% had experienced vertigo in the previous year. A full-time GP may expect to see 10 to 20 cases of vertigo each year.

Vertigo has many different causes, and the treatments for it often do not work well. A previous Cochrane review found that betahistine reduced vertigo in people with one cause of vertigo (Meniere’s disease). However, as they didn’t look at people with other types of vertigo, this study set out to see if betahistine could reduce symptoms of vertigo in a broader range of conditions.

What did this study do?

This systematic review included 17 randomised controlled trials, with a total of 1,025 adults with vertigo, comparing betahistine with placebo. Participants had a variety of conditions including Meniere’s disease, benign paroxysmal positional vertigo and recurrent vertigo of no clear cause.

Most of the included trials were carried out in the 1980s, with only two taking place in the last ten years. The overall quality of the evidence was low as the trials were all at high to unclear risk of bias. It was mainly unclear if people were adequately randomly assigned to take betahistine or placebo and if the person or doctor knew which tablet they were taking. Only two of the trials were carried out in the UK, which may also limit how generalisable the results are.

What did it find?

  • In 11 trials with 606 participants, 60% of people taking betahistine reported an improvement in symptoms compared to 46% of people taking a placebo (risk ratio 1.30, 95% confidence interval 1.05 to 1.60).
  • In 12 trials with 819 participants, side effects were experienced by a similar number of people in each group: 16% of those taking betahistine and 15% taking placebo. These included headache and gastric symptoms such as indigestion, nausea and bloating.
  • The trials varied in terms of types of participants, diagnoses, dose of betahistine, length of time it was taken for, and measurement of vertigo symptoms. This reduces the reliability of the combined results, although the direction of effects was consistent, in that betahistine seemed to be more effective than inactive treatment in each trial.
  • No trials were identified that reported on overall quality of life or falls.

What does current guidance say on this issue?

There are no national guidelines on the management of vertigo. Clinical Knowledge Summaries, NICE summaries of evidence for primary care professionals, and local NHS guidance recommends a full clinical history and examination to identify the likely cause. Most cases are referred to secondary care for further investigations and specific treatments with the exception of benign paroxysmal positional vertigo which can usually be managed with repositioning manoeuvres by the GP. Betahistine is only licensed for treating hearing loss, tinnitus, and vertigo associated with Meniere's disease, and it is often used in clinical practice for this purpose.

What are the implications?

This review showed that participants in the trials felt there was benefit to them in taking betahistine, although the number who identified such a benefit over the placebo effect was small. Some of the studies included in this review took place several years ago and the possibility of bias in many of the studies cannot be ruled out, so this evidence in favour of betahistine is fairly weak.

The trials took place over a maximum of three months, so the longer term effects of betahistine are unknown.

All trials were conducted in specialist clinics, which imply that the cause of vertigo had been investigated and treated in addition to the use of betahistine. It is important that a proper clinical assessment is performed for anyone presenting with vertigo and clinicians should be aware that betahistine does not have a license for treating causes of vertigo other than Meniere’s disease.

Citation and Funding

Murdin L, Hussain K, Schilder AGM. Betahistine for symptoms of vertigo. Cochrane Database of Syst Rev. 2016;(6):CD010696.

Cochrane UK and the Cochrane ENT Group are supported by NIHR infrastructure funding.

Bibliography

Adrion C, Fischer CS, Wagner J, et al. 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). BMJ. 2016;352:h6816.

Clinical Knowledge Summaries. Vertigo. London: National Institute for Health and Clinical Excellence; 2010.

Joint Formulary Committee. British National Formulary. Section 4.6 Drugs used in nausea and vertigo. London: BMJ Group and Pharmaceutical Press. August 2016.

McCormick A, Fleming D, Charlton J. Morbidity statistics from general practice: fourth national study, 1991-1992. London: Office of Population Censuses and Surveys; 1995.

Osei-Lah V, West P, Saunders N, et al. Primary care guidelines – vertigo/dizziness. Worthing: Coastal West Sussex Clinical Commissioning Group, West Sussex Hospitals Trust; 2013.

Yardley L, Owen N, Nazareth I, et al. Prevalence and presentation of dizziness in a general practice community sample of working age people. Br J Gen Pract. 1998;81131-5.

Why was this study needed?

Vertigo is a common symptom that is often associated with dizziness. It can be a disabling symptom and increase the risk of falls. In a UK study of over 2,000 people, 7% had experienced vertigo in the previous year. A full-time GP may expect to see 10 to 20 cases of vertigo each year.

Vertigo has many different causes, and the treatments for it often do not work well. A previous Cochrane review found that betahistine reduced vertigo in people with one cause of vertigo (Meniere’s disease). However, as they didn’t look at people with other types of vertigo, this study set out to see if betahistine could reduce symptoms of vertigo in a broader range of conditions.

What did this study do?

This systematic review included 17 randomised controlled trials, with a total of 1,025 adults with vertigo, comparing betahistine with placebo. Participants had a variety of conditions including Meniere’s disease, benign paroxysmal positional vertigo and recurrent vertigo of no clear cause.

Most of the included trials were carried out in the 1980s, with only two taking place in the last ten years. The overall quality of the evidence was low as the trials were all at high to unclear risk of bias. It was mainly unclear if people were adequately randomly assigned to take betahistine or placebo and if the person or doctor knew which tablet they were taking. Only two of the trials were carried out in the UK, which may also limit how generalisable the results are.

What did it find?

  • In 11 trials with 606 participants, 60% of people taking betahistine reported an improvement in symptoms compared to 46% of people taking a placebo (risk ratio 1.30, 95% confidence interval 1.05 to 1.60).
  • In 12 trials with 819 participants, side effects were experienced by a similar number of people in each group: 16% of those taking betahistine and 15% taking placebo. These included headache and gastric symptoms such as indigestion, nausea and bloating.
  • The trials varied in terms of types of participants, diagnoses, dose of betahistine, length of time it was taken for, and measurement of vertigo symptoms. This reduces the reliability of the combined results, although the direction of effects was consistent, in that betahistine seemed to be more effective than inactive treatment in each trial.
  • No trials were identified that reported on overall quality of life or falls.

What does current guidance say on this issue?

There are no national guidelines on the management of vertigo. Clinical Knowledge Summaries, NICE summaries of evidence for primary care professionals, and local NHS guidance recommends a full clinical history and examination to identify the likely cause. Most cases are referred to secondary care for further investigations and specific treatments with the exception of benign paroxysmal positional vertigo which can usually be managed with repositioning manoeuvres by the GP. Betahistine is only licensed for treating hearing loss, tinnitus, and vertigo associated with Meniere's disease, and it is often used in clinical practice for this purpose.

What are the implications?

This review showed that participants in the trials felt there was benefit to them in taking betahistine, although the number who identified such a benefit over the placebo effect was small. Some of the studies included in this review took place several years ago and the possibility of bias in many of the studies cannot be ruled out, so this evidence in favour of betahistine is fairly weak.

The trials took place over a maximum of three months, so the longer term effects of betahistine are unknown.

All trials were conducted in specialist clinics, which imply that the cause of vertigo had been investigated and treated in addition to the use of betahistine. It is important that a proper clinical assessment is performed for anyone presenting with vertigo and clinicians should be aware that betahistine does not have a license for treating causes of vertigo other than Meniere’s disease.

Citation and Funding

Murdin L, Hussain K, Schilder AGM. Betahistine for symptoms of vertigo. Cochrane Database of Syst Rev. 2016;(6):CD010696.

Cochrane UK and the Cochrane ENT Group are supported by NIHR infrastructure funding.

Bibliography

Adrion C, Fischer CS, Wagner J, et al. 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). BMJ. 2016;352:h6816.

Clinical Knowledge Summaries. Vertigo. London: National Institute for Health and Clinical Excellence; 2010.

Joint Formulary Committee. British National Formulary. Section 4.6 Drugs used in nausea and vertigo. London: BMJ Group and Pharmaceutical Press. August 2016.

McCormick A, Fleming D, Charlton J. Morbidity statistics from general practice: fourth national study, 1991-1992. London: Office of Population Censuses and Surveys; 1995.

Osei-Lah V, West P, Saunders N, et al. Primary care guidelines – vertigo/dizziness. Worthing: Coastal West Sussex Clinical Commissioning Group, West Sussex Hospitals Trust; 2013.

Yardley L, Owen N, Nazareth I, et al. Prevalence and presentation of dizziness in a general practice community sample of working age people. Br J Gen Pract. 1998;81131-5.

Betahistine for symptoms of vertigo

Published on 22 June 2016

Murdin, L.,Hussain, K.,Schilder, A. G.

Cochrane Database Syst Rev Volume 6 , 2016

BACKGROUND: Vertigo is a symptom in which individuals experience a false sensation of movement. This type of dizziness is thought to originate in the inner ear labyrinth or its neural connections. It is a commonly experienced symptom and can cause significant problems with carrying out normal activities. Betahistine is a drug that may work by improving blood flow to the inner ear. This review examines whether betahistine is more effective than a placebo at treating symptoms of vertigo from different causes. OBJECTIVES: To assess the effects of betahistine in patients with symptoms of vertigo from different causes. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 8); PubMed; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. We also contacted manufacturers and researchers in the field. The date of the search was 21 September 2015. SELECTION CRITERIA: We included randomised controlled trials of betahistine versus placebo in patients of any age with vertigo from any neurotological diagnosis in any settings. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Our primary outcome was the proportion of patients with reduction in vertigo symptoms (considering together the intensity, frequency and duration those symptoms). MAIN RESULTS: We included 17 studies, with a total of 1025 participants; 12 studies were published (567 patients) and five were unpublished (458 patients). Sixteen studies including 953 people compared betahistine with placebo. All studies with analysable data lasted three months or less. The majority were at high risk of bias, but in some the risk of bias was unclear. One study, at high risk of bias, included 72 people with benign paroxysmal positional vertigo (BPPV) and compared betahistine with placebo; all patients also had particle repositioning manoeuvres. The studies varied considerably in terms of types of participants, their diagnoses, the dose of betahistine and the length of time it was taken for, the study methods and the way any improvement in vertigo symptoms was measured. Using the GRADE system, we judged the quality of evidence overall to be low for two outcomes (proportion of patients with improvement and proportion with adverse events).Pooled data showed that the proportion of patients reporting an overall reduction in their vertigo symptoms was higher in the group treated with betahistine than the placebo group: risk ratio (RR) 1.30, 95% confidence interval (CI) 1.05 to 1.60; 606 participants; 11 studies). This result should be interpreted with caution as the test for statistical heterogeneity as measured by the I2 value was high.Adverse effects (mostly gastrointestinal symptoms and headache) were common but medically serious events in the study were rare and isolated: there was no difference in the frequency of adverse effects between the betahistine and placebo groups, where the rates were 16% and 15% respectively (weighted values, RR 1.03, 95% CI 0.76 to 1.40; 819 participants; 12 studies).Sixteen per cent of patients from both the betahistine and the placebo groups withdrew (dropped out) from the studies (RR 0.96, 95% CI 0.65 to 1.42; 481 participants; eight studies).Three studies looked at objective vestibular function tests as an outcome; the numbers of participants were small, techniques of measurement very diverse and reporting details sparse, so analysis of this outcome was inconclusive.We looked for information on generic quality of life and falls, but none of the studies reported on these outcomes. AUTHORS' CONCLUSIONS: Low quality evidence suggests that in patients suffering from vertigo from different causes there may be a positive effect of betahistine in terms of reduction in vertigo symptoms. Betahistine is generally well tolerated with a low risk of adverse events. Future research into the management of vertigo symptoms needs to use more rigorous methodology and include outcomes that matter to patients and their families.

Vertigo is a symptom, not a disease or condition. People with vertigo experience a false sensation that they or their surroundings are moving or spinning. There are two main types of vertigo – peripheral and central.

Peripheral vertigo is caused by problems with the inner ears. Common types of peripheral vertigo include benign paroxysmal positional vertigo, vestibular neuronitis, labyrinthitis and Meniere’s disease.

Central vertigo is caused by problems in the brain. Commonly caused by migraine, less commonly by stroke and transient ischaemic attack.

Betahistine is similar to histamine and though it is claimed to improve the blood circulation in the inner ear, the exact mechanism of action is not known. Betahistine is licensed in the UK for vertigo, tinnitus, and hearing loss associated with Meniere's disease.

Expert commentary

The review by Murdin, et al concludes that low quality evidence “suggests that in patients suffering from vertigo from different neuro-otological causes there may be a positive effect of betahistine in terms of reduction in vertigo symptoms”. This is a very modest support, but support nevertheless, for doctors uncritically prescribing this drug. Patients with benign paroxysmal positional vertigo, the most frequent cause of vertigo, may continue to receive betahistine when they can be cured with a physical repositioning manoeuvre. Dizziness specialists never use betahistine as an anti-vertiginous drug but occasionally prescribe it for Meniere’s disease. Since Murdin’s review an excellent paper on the use of Betahistine in Meniere’s disease (Adrion, et al) concluded that betahistine, at 48 or 144mg/daily, is no different from placebo. Although Murdin, et al managed to mention this result, timing issues prevented the data to be included in the review. Undoubtedly, the inclusion of such good data would have made the weak evidence in favour of betahistine even weaker.

Adolfo Bronstein, Professor of Clinical Neuro-otology, Imperial College London; Consultant Neurologist, Charing Cross Hospital and the National Hospital for Neurology and Neurosurgery