CPG: Ménière’s Disease – Research Needs

Research Needs section from Ménière’s Disease CPG

1. Clinical epidemiologic studies to standardize categories of disease stage, severity, and treatment response, as well as optimal follow-up time frames for outcome assessment.
2. Development and validation of clinically relevant measures of QOL.
3. Identification of true pathophysiology of the condition or conditions that would lead to a constellation of symptoms of MD.
4. Definitions: Currently there is no clear definition or standardization of stages, severity, and response to treatment that are universally accepted for MD. Here are some suggestions to consider.
   • a. Stage of disease
     • i. Active (having MD attacks weekly or monthly)
     • ii. Chronic (having MD attacks a few times per year, otherwise in good control)
     • iii. ‘‘Burned out’’ (severe to profound hearing loss with no further activity from the ear secondary to natural progression or ablative intervention)
   • b. Severity of disease
     • i. Mild (occasional mild vertigo attacks with minimal hearing loss, tinnitus, and fullness; each episode lasts no more than a few minutes)
     • ii. Moderate (occasional moderate to severe MD attacks or infrequent debilitating episodes
     • iii. Severe (frequent debilitating episodes with severe symptoms)
   • c. Failure of treatment
     • i.  Failure of conservative measures could be defined as minimal or poor response to trigger management, including salt and other dietary modifications.
     • ii. Failure of medical management could be defined as above patients with those who have also failed oral medication (eg, diuretics, betahistine, steroids).
   • d. Quality of life. There is a need for standardization of disease-specific QOL measures for this condition.
   • e. Follow-up. There is a need for standardization of follow-up for MD patients in terms of management of symptoms as well as long- term hearing and balance outcomes.
5. Audiologic testing
   • a. Can audiogram patterns differentiate MD from retrocochlear pathology? This information may prevent unnecessary imaging studies.
6. Role of imaging studies for MD.
   • a. Is there a correlation between MRI findings (post-IT or delayed intravenous contrast) and degree of MD? Can MRI be useful in diagnosing probable versus definite MD, particularly in the early stages of the disorder?
   • b. To help us make a stronger case for or against routine use of imaging, we need a study that determines the rate of retrocochlear/underlying lesions among patients who present with MD per current diagnostic criteria.
7. Role of migraine management.
   • a. Should all recalcitrant MD patients be managed with migraine prophylaxis?
8. Management of acute vertigo attacks. There is a clear need for well-designed trials for management of acute symptoms of MD patients, including antiemetic and antivertigo medications and oral steroids for acute events.
9. Better identification and documentation of individual triggers. This would help better manage disease and potentially help with distinguishing different subtypes of MD. For example, some MD patients are quite salt sensitive, yet others have no issue with salt or hydration changes but are quite sensitive to stress, allergy, or barometric pressure changes.
10. Sodium restriction. Well-designed prospective doubleblinded RCTs are needed for sodium restriction for MD patients.
    • a. There is no clear evidence if absolute levels or fluctuation has the true benefit.
    • b. It is not known if there is a specific subtype of MD patient who will have an ideal response to sodium restriction.
    • c. Patient compliance and QOL need to be assessed while on such a restricted diet.
    • d. Different methods of patient education, including nutrition consult, could be assessed.
11. Determine the optimal duration of trigger avoidance and pharmacotherapy once vertigo is controlled.
12. Endolymphatic sac decompression:
    • a. A well-designed prospective double-blinded multicenter trial is needed on endolymphatic sac decompression for MD patients who have failed conservative measures and medical management.
    • b. Does general anesthesia by itself provide any improvement in MD patients?
13. Vestibular rehabilitation and balance therapy.
    • a. Prospective trials are needed for assessing the long-term balance issues after labyrinthectomy, particularly in patients who will eventually develop bilateral disease.
    • b. Can early balance and vestibular therapy help with long-term imbalance and anxiety associated with MD?
    • c. Can virtual reality treatment, including vestibular rehabilitation home solutions, decrease fall risk in MD patients?
14. IT gentamicin injections. There is currently no standardization in terms of protocol or titration. Prospective RCTs are needed to delineate the optimal dosage as well as titration to hearing and balance.
15. IT steroid injections. There is currently no standardization in terms of protocol or titration. Prospective RCTs are needed to better delineate the optimal dosage as well as titration to hearing and balance.
16. Positive pressure therapy. There is a need to assess if there are any subpopulations of MD patients who would benefit from positive pressure therapy.
17. Cannabinoids. Well-designed RCTs are needed to assess the role for cannabinoids in treatment of MD.
18. Complementary medicine. Perspective well-designed RCTs are needed to assess the effect of acupuncture and other methods of complementary medicine for MD.

Visit www.entnet.org/MDCPG for more information.