Micropressure therapy for refractory Meniere's disease

# Guidance
Current evidence on the safety of micropressure therapy for refractory Meniere's disease is inadequate in quantity. There is some evidence of efficacy, but it is based on limited numbers of patients. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Clinicians wishing to undertake micropressure therapy for refractory Meniere's disease should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about the procedure's efficacy and provide them with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having micropressure therapy for refractory Meniere's disease (see section 3.1).
NICE encourages further research into micropressure therapy for refractory Meniere's disease. Research studies should report long-term outcomes, in particular the need for subsequent surgical treatment.# The procedure

# Indications and current treatments
Meniere's disease is characterised by symptoms of tinnitus, vertigo and deafness. Diagnosis of the disease is based on the American Academy of OtolaryngologyHead and Neck Surgery (AAOHNS) Foundation's guidelines, based on the presence of recurrent, spontaneous episodic vertigo, hearing loss, aural fullness and tinnitus. It is thought to be caused by raised endolymph pressure in the inner ear (endolymphatic hydrops).
Surgery may be indicated for patients who are refractory to medical management and/or a low-salt diet. Surgical treatments include gentamicin vestibular ablation, labyrinthectomy, endolymphatic sac decompression and vestibular neurectomy.

# Outline of the procedure
Micropressure therapy for refractory Meniere's disease aims to reduce endolymph pressure in the inner ear by administering low-pressure air pulses through the tympanic membrane onto the round window membrane, with the aim of stimulating the flow of endolymphatic fluid.
With the patient under local or general anaesthesia, a grommet (ventilation tube) is inserted into the tympanic membrane of the affected ear. A few weeks later, after checking for patency of the grommet by the Valsalva manoeuvre, a hand-held air pressure generator forms an airtight seal in the outer ear. The device administers computer-controlled micropressure pulses across the tympanic membrane.
Three 60-second pulses are administered per treatment, with rest periods (usually less than 1 minute) between each pulse. Micropressure therapy is administered by the patient at home, usually 3 times per day. Treatment is normally continued for 46 weeks, but it can be used for longer.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

# Efficacy
A randomised controlled trial of 40 patients (20 treated by micropressure therapy and 20 treated by a sham procedure) reported a mean number of vertigo attacks of 1.9 and 4 respectively during the last 4 weeks of treatment (p = 0.09) (maximum follow-up 8 weeks). The same study reported a significantly improved functional level (measured using AAOHNS criteria on a scale of 1 to 6, lower score indicates better functional level) in the micropressure therapy group compared with the sham group (2.4 compared with 3.5, p = 0.0014) during the last 4 weeks of treatment.
A case series of 36 patients reported a positive response (defined as a shift from Class D to Class A; AAOHNS criteria) at 2-year follow-up after treatment in 69% (25/36) of patients (that is, patients went from having 81 to 120 vertigo spells over 6 months to no vertigo after treatment). A study of 22 patients reported a significant reduction in the mean number of vertigo attacks after 20 days: from 9.22 to 1.28 (p = 0.001) when the patients had grommet insertion only (n = 20), and from 9.22 to 1.67 (p < 0.001) when micropressure therapy was started (n = 18). There was no significant difference in the number of vertigo attacks between the two groups at 40 days.
In a case series of 37 patients, 79% (27/34) reported that the treatment had been helpful and had substantially improved their ability to perform daily tasks and work at 2-year follow-up.
The Specialist Advisers listed key efficacy outcomes as reduced frequency and severity of vertigo, improved hearing threshold, reduced tinnitus and reduced need for further therapy.

# Safety
Middle ear infection was reported in 5 patients in the case series of 37 patients; micropressure treatment was resumed after local antibiotics and grommet replacement.
Immediate postoperative ear discharge was reported in 6% (2/36) of patients in the case series of 36 patients.
The Specialist Advisers listed adverse events reported in the literature or anecdotally as post-tympanostomy otorrhoea, repeated need for short-stay ventilation tube insertion and permanent ear drum perforation if a long-stay ventilation tube is used. The Specialist Advisers considered theoretical adverse events to include infection of the grommet, loss of the ventilation tube in the middle ear, scarring of the ear drum and hearing loss.

# Other comments
The Committee noted that vertigo causes significant disability for some patients and that there is a lack of predictably efficacious conservative treatments for chronic vertigo in Meniere's disease. Therefore, if micropressure therapy were shown to be efficacious it could offer a useful option to improve quality of life in selected patients.
The Committee recognised the fluctuating course of Meniere's disease, which complicates the interpretation of evidence on its treatment.# Further information
This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).
Information for patients
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedures guidance process.
We have produced a summary of this guidance for patients and carers. Tools to help you put the guidance into practice and information about the evidence it is based on are also available.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence, 2012. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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