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Treatment Controversies Treatment Controversies in Meniere’s Diseasein Meniere’s Disease
Shashidhar S. Reddy, MD, MPHShashidhar S. Reddy, MD, MPHShawn D. Newlands, MD, PhDShawn D. Newlands, MD, PhD
UTMB Otolaryngology UTMB Otolaryngology Grand RoundsGrand RoundsMay 18, 2005May 18, 2005
OutlineOutline
History and Meniere’sHistory and Meniere’sDefinition of Meniere’sDefinition of Meniere’sPhysiology, Pathophysiology of Meniere’sPhysiology, Pathophysiology of Meniere’sMedical Management of Meniere’sMedical Management of Meniere’sMeniet DeviceMeniet DeviceIntratympanic GentamicinIntratympanic GentamicinEndolymphatic Sac SurgeryEndolymphatic Sac SurgeryVestibular Nerve SectionVestibular Nerve SectionConclusionsConclusions
History of Meniere’sHistory of Meniere’s
1861 – Prosper Meniere describes classic 1861 – Prosper Meniere describes classic symptoms and attributes to labyrinthsymptoms and attributes to labyrinth1871 – Knappin theorizes dilatation of 1871 – Knappin theorizes dilatation of membranous Labyrinthmembranous Labyrinth1938 – Hallpike and Portman confirm 1938 – Hallpike and Portman confirm endolymphatic hydrops via temporal bone endolymphatic hydrops via temporal bone histologyhistology1995 – Latest revision of AAOHNS 1995 – Latest revision of AAOHNS definitiondefinition
Definition of Meniere’s DiseaseDefinition of Meniere’s DiseaseAAO-HNS Committee on Hearing and Equilibrium revised definition in AAO-HNS Committee on Hearing and Equilibrium revised definition in 19951995
Possible Meniere's diseasePossible Meniere's diseaseEpisodic vertigo of the Meniere's type without documented hearing loss, orEpisodic vertigo of the Meniere's type without documented hearing loss, orSensorineural hearing loss, fluctuating or fixed, with dysequilibrium but without Sensorineural hearing loss, fluctuating or fixed, with dysequilibrium but without definitive episodesdefinitive episodesOther causes excludedOther causes excluded
Probable Meniere's diseaseProbable Meniere's diseaseOne definitive episode of vertigoOne definitive episode of vertigoAudiometrically documented hearing loss on at least one occasionAudiometrically documented hearing loss on at least one occasionTinnitus or aural fullness in the treated earTinnitus or aural fullness in the treated earOther causes excluded Other causes excluded
Definite Meniere's diseaseDefinite Meniere's diseaseTwo or more definitive spontaneous episodes of vertigo 20 minutes or longerTwo or more definitive spontaneous episodes of vertigo 20 minutes or longerAudiometrically documented hearing loss on at least one occasionAudiometrically documented hearing loss on at least one occasionTinnitus or aural fullness in the treated earTinnitus or aural fullness in the treated earOther cases excluded Other cases excluded
Certain Meniere's diseaseCertain Meniere's diseaseDefinite Meniere's disease, plus histopathologic confirmationDefinite Meniere's disease, plus histopathologic confirmation
Committee on Hearing and Equilibrium Guidelines for Diagnoses and Evaluation of Therapy in Meniere’s Disease, AAOHNS Board of Directors March 1994
Definition of Meniere’sDefinition of Meniere’s
Staging of Hearing Loss in Definite/Certain Staging of Hearing Loss in Definite/Certain Meniere’s:Meniere’s:
StageStage Four Tone Average Four Tone Average dBdB
11 <=25<=25
22 26-4026-40
33 41-7041-70
44 >70>70
Committee on Hearing and Equilibrium Guidelines for Diagnoses and Evaluation of Therapy in Meniere’s Disease, AAOHNS Board of Directors March 1994
Definition of Meniere’sDefinition of Meniere’s
Functional Level ScaleFunctional Level Scale Regarding my current state of overall function, not just during attacks (check the Regarding my current state of overall function, not just during attacks (check the
ONE that best applies):ONE that best applies): 1. My dizziness has no effect on my activities at all.1. My dizziness has no effect on my activities at all. 2. When I am dizzy I have to stop what I am doing for a while, but it soon passes 2. When I am dizzy I have to stop what I am doing for a while, but it soon passes
and I can resume activities. I continue to work, drive, and engage in any activity I and I can resume activities. I continue to work, drive, and engage in any activity I choose without restriction. I have not changed any plans or activities to choose without restriction. I have not changed any plans or activities to accommodate my dizziness.accommodate my dizziness.
3. When I am dizzy, I have to stop what I am doing for a while, but it does pass 3. When I am dizzy, I have to stop what I am doing for a while, but it does pass and I can resume activities. I continue to work, drive, and engage in most and I can resume activities. I continue to work, drive, and engage in most activities I choose, but I have had to change some plans and make some activities I choose, but I have had to change some plans and make some allowance for my dizziness.allowance for my dizziness.
4. I am able to work, drive, travel, take care of a family, or engage in most 4. I am able to work, drive, travel, take care of a family, or engage in most essential activities, but I must exert a great deal of effort to do so. I must essential activities, but I must exert a great deal of effort to do so. I must constantly make adjustments in my activities and budge my energies. I am barely constantly make adjustments in my activities and budge my energies. I am barely making it.making it.
5. I am unable to work, drive, or take care of a family. I am unable to do most of 5. I am unable to work, drive, or take care of a family. I am unable to do most of the active things that I used to. Even essential activities must be limited. I am the active things that I used to. Even essential activities must be limited. I am disabled.disabled.
6. I have been disabled for 1 year or longer and/or I receive compensation 6. I have been disabled for 1 year or longer and/or I receive compensation (money) because of my dizziness or balance problem.(money) because of my dizziness or balance problem.
Committee on Hearing and Equilibrium Guidelines for Diagnoses and Evaluation of Therapy in Meniere’s Disease, AAOHNS Board of Directors March 1994
Definition of Meniere’sDefinition of Meniere’sReporting Results of Treatment:Reporting Results of Treatment: Divide frequency of spells 18-24months by Divide frequency of spells 18-24months by
number 6months prior to tx and multiplyx100number 6months prior to tx and multiplyx100
Numerical ValueNumerical Value ClassClass
00 AA
1 to 401 to 40 BB
41 to 8041 to 80 CC
81-12081-120 DD
>120>120 EE
Secondary TreatmentSecondary Treatment FFCommittee on Hearing and Equilibrium Guidelines for Diagnoses and Evaluation of Therapy in Meniere’s Disease, AAOHNS Board of Directors March 1994
PhysiologyPhysiology
Perilymph – Similar in composition to CSFPerilymph – Similar in composition to CSF High Na+, Low K+High Na+, Low K+
Endolymph – Similar in compostion to ICFEndolymph – Similar in compostion to ICF Low Na+ High K+Low Na+ High K+ Believed to be produced in Stria VascularisBelieved to be produced in Stria Vascularis
Membranous Labyrinth separates the twoMembranous Labyrinth separates the two Difference of 80mV in chargeDifference of 80mV in charge No difference in pressureNo difference in pressure
PhysiologyPhysiology
Production and flow of Endolymph - Production and flow of Endolymph - TheoriesTheories Longitudinal – produced in membranous Longitudinal – produced in membranous
labyrinth, flows to endolymphatic sac, then to labyrinth, flows to endolymphatic sac, then to dural venous sinusesdural venous sinuses
Diffuse – produced and absorbed along the Diffuse – produced and absorbed along the membranous labyrinthmembranous labyrinth
Periodic Flow – endolymph flows only with Periodic Flow – endolymph flows only with changes in volume or pressurechanges in volume or pressure
Andrews, JC, Intralabyrinthine fluid dynamics: Meniere disease 12(5) Oct 2004 pp408-412
PathophysiologyPathophysiology
Endolymphatic hydrops leads to distortion of Endolymphatic hydrops leads to distortion of membranous labyrinthmembranous labyrinth
PathophysiologyPathophysiology
Build up in pressure may lead to micro-Build up in pressure may lead to micro-ruptures of membranous labyrinth (Minor ruptures of membranous labyrinth (Minor et alet al)) Ruptures are confirmed by various histologic Ruptures are confirmed by various histologic
studiesstudies May responsible for episodic nature of attacksMay responsible for episodic nature of attacks Healing of ruptures may account for return of Healing of ruptures may account for return of
hearinghearing
Review Article: Minor, Lloyd et al, Meniere’s Disease, Current Opinion in Neurology 17(1) Feb2004
PathophysiologyPathophysiology
What causes hydrops?What causes hydrops? Obstruction of endolymphatic duct/sacObstruction of endolymphatic duct/sac
Obstruction of endolymphatic sac in does not Obstruction of endolymphatic sac in does not cause hydrops in all animals and causes vertigo in cause hydrops in all animals and causes vertigo in fewfew
Alteration of absorption of endolymphAlteration of absorption of endolymph Immunologic insult to inner earImmunologic insult to inner ear
Elevated levels of IG’s in endolymphElevated levels of IG’s in endolymph
PathophysiologyPathophysiology
Hydrops role in causation of Meniere’s is Hydrops role in causation of Meniere’s is not entirely clearnot entirely clear Rauche Rauche et alet al 1998 – Study of 19 temporal 1998 – Study of 19 temporal
bone histologies with hydrops-bone histologies with hydrops-13/19 patients with hydrops by histology showed 13/19 patients with hydrops by histology showed Meniere’s symptoms by chart reviewMeniere’s symptoms by chart review
6/19 showed no Meniere’s symptoms by chart 6/19 showed no Meniere’s symptoms by chart reviewreview
Rauch SD, et al Meniere’s syndrome and endolymphatic hydrops: double blind temporal bone study. Ann Otol Rhinol Laryngol 1989; 98:873-883
PathophysiologyPathophysiology
Silverstein Silverstein et alet al found that in pts. who found that in pts. who refused surgical tx., there was resolution refused surgical tx., there was resolution of vestibular symptoms of vestibular symptoms 57-60% of patients in 2 years57-60% of patients in 2 years 71% at eight years.71% at eight years. Long term PTA in affected ear is 50dBLong term PTA in affected ear is 50dB Speech discrimination is 53%Speech discrimination is 53% Caloric response reduction is 50%Caloric response reduction is 50%
Silverstein H., Smouha E. & Jones R. (1989) Natural history vs surgery for Ménière's disease. Otolaryngol. Head Neck Surg. 100, 6-16
Medical ManagementMedical Management
Acute TherapyAcute Therapy
Maintenance TherapyMaintenance Therapy
Medical ManagementMedical Management
Acute TherapyAcute Therapy Relatively non-controversialRelatively non-controversial
Brookes, G.B. The pharmacological treatment of Meniere’s disease. Clinical Otolaryngology 21(1) Feb1996, pp3-11
Medical ManagementMedical Management
Maintenance TherapyMaintenance Therapy No conclusive studies show efficacy of drugs No conclusive studies show efficacy of drugs
intended to alter disease course of Meniere’sintended to alter disease course of Meniere’s
Medical ManagementMedical Management
Diuretics and Salt restrictionDiuretics and Salt restriction ? Alter fluid balance in inner ear leading to ? Alter fluid balance in inner ear leading to
depletion of endolymphdepletion of endolymph Shinkawa/Kimura unable to demonstrate Shinkawa/Kimura unable to demonstrate
beneficial effect on hydrops in animal modelbeneficial effect on hydrops in animal model
Shinkawa H. & Kimura R.S. (1986) Effect of diuretics on endolymphatic hydrops. Acta. Otolaryngol. (Stockh.)101, 43-52
Medical ManagementMedical Management
Diuretics and Salt RestrictionDiuretics and Salt Restriction Ruckenstein Ruckenstein et alet al evaluated data from two double evaluated data from two double
blind studies by Klockhoff and Lindblom on HCTZ vs. blind studies by Klockhoff and Lindblom on HCTZ vs. Placebo and showed no difference in Diuretics vs. Placebo and showed no difference in Diuretics vs. placeboplacebo
Ruckenstein M.J., Rutka J.A. & Hawke M. (1991) The treatment of Meniere's disease: Torok revisited.
Laryngoscope101, 211-218
Medical ManagementMedical Management
Osmotic Diuretics (Urea, Glycerol)Osmotic Diuretics (Urea, Glycerol) Have been consistently shown to reduce Have been consistently shown to reduce
symptoms in a proportion of patients, but the symptoms in a proportion of patients, but the effects only last for a few hourseffects only last for a few hours
Objective data includes alteration of the Objective data includes alteration of the SP:AP ratio on ElectrocochleographySP:AP ratio on Electrocochleography
Acetazolamide – was actually shown to Acetazolamide – was actually shown to increase hydrops and hearing loss when increase hydrops and hearing loss when given IV and had no benefit p.o.given IV and had no benefit p.o.
Medical ManagementMedical Management
VasodilatorsVasodilators Purported to work by decreasing ischemia in Purported to work by decreasing ischemia in
the inner ear and allowing better metabolism the inner ear and allowing better metabolism of endolymphof endolymph
Betahistine is a popular choice, with several Betahistine is a popular choice, with several studies showing decreased vertigo with usestudies showing decreased vertigo with use
Cochrane Database Review (2004) – Only one Cochrane Database Review (2004) – Only one Grade B study and four Grade C studies, none of Grade B study and four Grade C studies, none of which produced convincing evidence for use.which produced convincing evidence for use.
James, AL, et al. Betahistine for Meniere’s disease or syndrome. Cochrane Database of Systematic Reviews (2) 2005
Medical ManagementMedical Management
Immunologic ManagementImmunologic Management Systemic steroids and intratympanic Systemic steroids and intratympanic
dexamethasone have been studied and dexamethasone have been studied and showed no conclusive benefit.showed no conclusive benefit.
Double-blinded prospective crossover study Double-blinded prospective crossover study by Silverstein by Silverstein et alet al showed no difference from showed no difference from placebo with intratympanic dexamethasone placebo with intratympanic dexamethasone injectionsinjections
Silverstein, Herbert et al Dexamethasone inner ear perfusion for the treatment of meniere’s disease: a prospective, randomized, double-blind, crossover trial. American Journal of Otology. 1998. 19:196-201
Mechanical ManagementMechanical Management
Transtympanic Transtympanic “Micropressure” “Micropressure” TreatmentTreatment
Meniett Device (Xomed) – Meniett Device (Xomed) – FDA approved in 1999 as a FDA approved in 1999 as a class II deviceclass II device
Advocates present no Advocates present no strong case for why the strong case for why the device should workdevice should work
Portably, low intensity Portably, low intensity alternating pressure alternating pressure generatorgenerator
Mechanical ManagementMechanical Management
Gates Gates et alet al 2004 2004 Prospective, randomized, placebo control trial of Prospective, randomized, placebo control trial of
Meniett deviceMeniett device
Gates GA. Green JD Jr. Tucci DL. Telian SA. The effects of transtympanic micropressure treatment in people with unilateral Meniere's disease. Archives of Otolaryngology -- Head & Neck Surgery. 130(6):718-25, 2004 Jun.
Did not use standardized vertigo assesment
Did not comment on severity of vertigo
Did not give good data on objective testing
Intratympanic TherapyIntratympanic Therapy
Goal is to maximize local effects in inner Goal is to maximize local effects in inner ear while minimizing systemic effectsear while minimizing systemic effects
Round window is point of diffusion to inner Round window is point of diffusion to inner earear
Intratympanic dexamethasone already Intratympanic dexamethasone already discusseddiscussed
Aminoglycoside Antibiotics: affect hair Aminoglycoside Antibiotics: affect hair cells of crista, ampulla, and cochleacells of crista, ampulla, and cochlea
Intratympanic TherapyIntratympanic Therapy
Fowler in 1948, and later Schuknecht Fowler in 1948, and later Schuknecht established role of systemic streptomycin established role of systemic streptomycin for bilateral disease (2gIVPB qd until for bilateral disease (2gIVPB qd until vestibular symptoms were noted)vestibular symptoms were noted)
Hearing loss and oscillopsia were a Hearing loss and oscillopsia were a problem with this therapy, though reducing problem with this therapy, though reducing dosage seemed to helpdosage seemed to help
Intratympanic GentamicinIntratympanic Gentamicin
Preferred because of Gentamicin’s Preferred because of Gentamicin’s vestibuloselectivityvestibuloselectivity
Side effects can include temporary Side effects can include temporary imbalance or nystagmusimbalance or nystagmus
Hearing lossHearing loss
Many methods of delivery existMany methods of delivery exist
Intratympanic GentamicinIntratympanic Gentamicin
Titration TherapyTitration Therapy Martin and Perez 2003 (prospective study, Martin and Perez 2003 (prospective study,
n=71)n=71)Serial daily injections of buffered (pH 6.4) Serial daily injections of buffered (pH 6.4) 26.7mg/cc gentamicin solution via 27 gauge 26.7mg/cc gentamicin solution via 27 gauge needle into middle earneedle into middle earInjections repeated until vestibular symptoms Injections repeated until vestibular symptoms developed (spontaneous or evoked nystagmus)developed (spontaneous or evoked nystagmus)At 2 years, 69% had Class A vertigo control, At 2 years, 69% had Class A vertigo control, 14.1% had Class B14.1% had Class B32.4% had hearing loss32.4% had hearing loss
Martin E, Perez N: Hearing loss after intratympanic gentamicin therapy for unilateral Meniere’s Disease. Otol Neurotol 2003, 24:800-806
Intratympanic GentamicinIntratympanic Gentamicin
Ablation via Multiple Daily DosingAblation via Multiple Daily Dosing Jackson and Silverstein – Study on 92 Jackson and Silverstein – Study on 92
patients who underwent myringotomy and patients who underwent myringotomy and wick placement through to round window wick placement through to round window niche.niche.
Pts. self-administered gentamicin drops TID until Pts. self-administered gentamicin drops TID until 100% reduction on ENG of vestibular response100% reduction on ENG of vestibular response
85% relief of vertigo, 67% improvement in aural 85% relief of vertigo, 67% improvement in aural pressurepressure
36% hearing loss36% hearing loss
Jackson, LE; Silverstein, H: Chemical perfusion of the inner ear. Otolaryngol Clin North Am 2002, 35:639-653
Intratympanic GentamicinIntratympanic Gentamicin
Low dose therapyLow dose therapy Harner Harner et alet al 2001 – retrospective study of 51 2001 – retrospective study of 51
patients who received 1 dose of 40mg/mL patients who received 1 dose of 40mg/mL injection and were re-evaluated in 1 month injection and were re-evaluated in 1 month and given another if neededand given another if needed
At 2 years, 86% had vertigo class A or BAt 2 years, 86% had vertigo class A or B He reported minimal change in PTA but drop He reported minimal change in PTA but drop
in SRT’sin SRT’s Claimed better hearing preservation with thisClaimed better hearing preservation with this
Harner, Stephen et al: Long-term follow-up of transtympanic gentamicin for Meniere’s Syndrome. Otology & Neurotol 22:210-214, 2001
Intratympanic GentamicinIntratympanic Gentamicin
Other methods of deliveryOther methods of delivery Weekly administrationWeekly administration
Single dose of gentamicin once a week for four Single dose of gentamicin once a week for four treatmentstreatments
Continuous administrationContinuous administrationMicrocatheter delivery of gentamicin using a Microcatheter delivery of gentamicin using a continuous perfusion methodcontinuous perfusion method
Results in extremely variable amount of gentamicin Results in extremely variable amount of gentamicin deliverydelivery
Better perfusion techniques may be neededBetter perfusion techniques may be needed
Intratympanic GentamicinIntratympanic GentamicinChia Chia et alet al performed a meta-analysis of different performed a meta-analysis of different modalities of application in 2004modalities of application in 2004
Chia, Stanley H, et al Intratympanic Gentamicin Therapy for Meniere’s Disease: a Meta-Analysis. Otology&Neurotol 25(4) July 2004 pp 544-552
Class A or BVertigo Control
Intratympanic GentamicinIntratympanic Gentamicin
Hearing loss was greatest for multiple Hearing loss was greatest for multiple daily dosingdaily dosing
Hearing loss was least for titration therapyHearing loss was least for titration therapy
Hearing loss was not lower than average Hearing loss was not lower than average for low-dose therapyfor low-dose therapy
Endolymphatic Sac SurgeryEndolymphatic Sac Surgery
Purported to address the site of Purported to address the site of obstruction causing hydropsobstruction causing hydrops 4 types:4 types:
Decompression – removal of bone around the sacDecompression – removal of bone around the sac
Shunting – placement of synthetic shunt to drain Shunting – placement of synthetic shunt to drain endolymph into mastoidendolymph into mastoid
Drainage – incision of the sac to allow drainageDrainage – incision of the sac to allow drainage
Removal of sac – to address the possibility that the Removal of sac – to address the possibility that the sac may actually play a role in endolymph sac may actually play a role in endolymph productionproduction
Endolymphatic Sac SurgeryEndolymphatic Sac Surgery
Coker, Newton J. et al Atlas of Otologic Surgery. W.B. Saunders 2001
Endolymphatic Sac SurgeryEndolymphatic Sac Surgery
Jens Thomsen Jens Thomsen et alet al 1981 1981 Double-blinded placebo-control study with Double-blinded placebo-control study with
sham surgery (cortical mastoidectomy) vs sham surgery (cortical mastoidectomy) vs endolymphatic shunt placement in 30 patientsendolymphatic shunt placement in 30 patients
No difference in any outcome between sham No difference in any outcome between sham surgery and endolymphatic sac shunt groupsurgery and endolymphatic sac shunt group
Thomsen, Jen et al. Placebo Effect in Surgery for Meniere’s Disease. Arch Otolaryngol – Vol 107, May 1981, pp271-277
Vestibular Nerve SectionVestibular Nerve Section
Can achieve vestibular suppression Can achieve vestibular suppression without any effect on hearingwithout any effect on hearing
Single step procedureSingle step procedure
Can have intraoperative complications of Can have intraoperative complications of damage to facial nerve, cochlear nerve, or damage to facial nerve, cochlear nerve, or CSF leak (rate of CSF leak is about 13%)CSF leak (rate of CSF leak is about 13%)
Approaches: Middle Fossa, Approaches: Middle Fossa, Retrolabyrinthine/RetrosigmoidRetrolabyrinthine/Retrosigmoid
Vestibular Nerve SectionVestibular Nerve Section
Coker, Newton J. et al Atlas of Otologic Surgery. W.B. Saunders 2001
Vestibular Nerve SectionVestibular Nerve Section
Hillman Hillman et al et al 2004 retrospectively compared v. nerve 2004 retrospectively compared v. nerve section to intratymp. Gent.section to intratymp. Gent.
Performed via combined mastoidectomy/retrosig approachPerformed via combined mastoidectomy/retrosig approach
Hillman, Todd A, et al. Vestibular Nerve Section Versus Intratympanic Gentamicin for Meniere’s Disease. Laryngoscope 114:pp 216-224
Vestibular Nerve SectionVestibular Nerve Section
Hillman Hillman et alet al continuedcontinued
Vestibular Nerve SectionVestibular Nerve Section
Hillman Hillman et alet al continued continued No incidence of wound infection or meningitis No incidence of wound infection or meningitis
in this groupin this group 12.6% incidence of CSF leak requiring LP and 12.6% incidence of CSF leak requiring LP and
extended hospitalizationextended hospitalization Rates of disequilibrium were similar but Rates of disequilibrium were similar but
persisted longer in the nerve section grouppersisted longer in the nerve section group
Other Ablative SurgeriesOther Ablative Surgeries
LabyrinthectomyLabyrinthectomy Useful in patients with no serviceable hearing Useful in patients with no serviceable hearing
and those who cannot tolerate intracranial and those who cannot tolerate intracranial procedureprocedure
Similar in efficacy to vestibular nerve sectionSimilar in efficacy to vestibular nerve section
ConclusionsConclusions
Therapies that definitely reduce vertigo in Therapies that definitely reduce vertigo in Meniere’s Disease:Meniere’s Disease: Vestibular suppressant medicationsVestibular suppressant medications Intratympanic Gentamicin (especially when Intratympanic Gentamicin (especially when
titrated)titrated) Vestibular Nerve SectionVestibular Nerve Section LabyrinthectomyLabyrinthectomy
Other therapies discussed are unproven or Other therapies discussed are unproven or controversialcontroversial