Intratympanic injection of dexamethasone for Menière’s disease. What relief can be expected? A case-series study

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Intratympanic injection of dexamethasone

for Menière’s disease. What relief can be

expected? A case-series study

Dobębenkowa iniekcja deksametazonu w chorobie

Menière’a: złagodzenia jakich objawów można oczekiwać?

Badanie serii przypadków

Olivier Plainfossé

^1,2

, Mohamed El Yagoubi

^1,2

, Mathilde Puechmaille

^1,2

, Thierry Mom

^1,2

1Department of Otolaryngology Head Neck Surgery, University Hospital, Clermont-Ferrand, France

2Mixt Unit of Research (UMR 1107) NEURODOL, School of Medicine, Université Clermont Auvergne (UCA), Clermont-Ferrand, France

Article history: Received: 01.03.2021 Accepted: 12.03.2021 Published: 23.03.2021

ABSTRACT: Introduction: In patients suffering from Menière’s disease (MD), after failure of oral medical treatment, intratympanic in- jections (IT) may be achieved, among which, IT with dexamethasone (DXM). IT DXM has been reported to be effective on vestibular symptoms but very few reports focus on auditory symptoms.

Aim: Here we assessed its efficacy both in vestibular and auditory symptoms.

Patients and method: Twenty-seven MD patients who suffered from auditory and vestibular symptoms despite previous sys- temic medical treatment, underwent at least one series of five daily consecutive IT DXM. Auditory and vestibular assessment were achieved before IT DXM, and four months afterwards. Patients were ranked according to the vestibular functional level scale of the American Academy of Otolaryngology Head Neck society (1995) at the same periods. A specifically designed questionnaire, focused on auditory symptoms was administered after IT DXM. Comparisons used a Chi-2 test for paired series, with p ≤ 0.05 considered significant.

Results: The vestibular functional level shifted significantly towards lower levels, the median shifting from level 4 to 3. There was no complication but two persistent tympanic membrane perforation. Twelve patients (44.4%) had recurrent symptoms, on average 7 months after IT DXM and required additional treatment. Tonal and speech audiometry did not improve, neither the objective auditory and vestibular assessment. Based on the questionnaire, IT DXM was effective on auditory symptoms, at least on tinnitus in 9 cases (33.3%), mainly by lowering its intensity.

Conclusion: IT DXM confirmed its capacity to relieve vestibular and auditory symptoms, in particular tinnitus, even though transiently.

KEYWORDS: Dexamethasone, intratympanic injections, Menière’s disease, tinnitus, vertigo

STRESZCZENIE: Wstęp: Po niepowodzeniu doustnej farmakoterapii u pacjentów cierpiących na chorobę Menière’a (MD), możliwe jest sto- sowanie iniekcji dobębenkowych (IT), m.in. z użyciem deksametazonu (DXM). Choć opisano skuteczność dobębenkowych iniekcji DXM w leczeniu objawów przedsionkowych, w niewielu doniesieniach zwracano uwagę na wpływ tych iniekcji na objawy słuchowe.

Cel: W niniejszym badaniu dokonaliśmy oceny dobębenkowych iniekcji DXM zarówno w zakresie objawów przedsionkowych, jak i słuchowych.

Materiał i metody: Dwudziestu siedmiu pacjentów z chorobą Menière’a, u których pomimo wcześniejszej farmakoterapii układowej doszło do wystąpienia objawów słuchowych i przedsionkowych, poddano leczeniu z podaniem co najmniej jednej serii pięciu dobębenkowych iniekcji DXM w pięciu kolejnych dniach. Ocenę objawów słuchowych i przedsionkowych wykonano przed iniekcjami DXM i cztery miesiące po ich podaniu. W tych samych punktach czasowych stan pacjentów zbadano przy użyciu skali oceny czynności przedsionkowej opracowanej przez Amerykańską Akademię Otolaryngologów Chirurgów Głowy i Szyi (1995). Po iniekcjach DXM wykonano badanie z użyciem specjalnie zaprojektowanego kwestionariusza koncentrujące- go się na objawach słuchowych. Do porównań użyto testu chi-kwadrat dla serii par, przy czym za istotne statystycznie uznano wartości p ≤ 0,05.

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aminoglycosides “on demand” are now preferred by most teams [13, 14]

and IT corticoids have been rendered more and more popular [15–17].

In particular DXM has been proven to be useful in MDM to relieve vertigo [15]. However, most series reporting results of IT DXM focus on vestibular effects and show they are often only transient [16–18]. In addition, DXM effects on other symptoms suffered by MD patients are not clear. Eventually, the efficacy of IT DXM has recently been questioned [19].

We have used in our department IT DXM for several years, and have evaluated its efficacy in vertigo and dizziness but also in hearing complaints, i.e. tinnitus, aural fullness and hearing loss, using both self- -reports by patients, and objective audiovestibular measurements.

MATERIALS AND METHODS

All adult patients suffering from MD, according to the 2015 consensus on MD, [20] have been first treated by relaxation counseling, betahistine (48 mg/day) +/- acetazolamide (250 mg/day). If the burden of the disease was not relieved, then IT DXM was proposed.

All patients had an objective assessment of their hydrops through functional testing using either distortion-product otoacoustic emissions (DPOAEs), in order to track an acoustic phase shift [21–23], or intracanal electrocochleography (EcoG), to collect the summating potential (SP) amplitude and compound action potential (AP) and to check the SP/AP ratio [24–27].

Vertigo handicap assessment

The handicap due to dizziness and vertigo was assessed by the vertigo functional level scale as suggested by the American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS-1995) [28].

Videonystagmography (VNG) and saccular Vestibular evoked myogenic potentials (VEMPs) were recorded at the same pre and post evaluation time in all patients before IT DXM and after IT DXM, provided that the tympanic membrane was healed and closed.

VNG was recorded by means of the ULMER Video nystagmo- graph device (synapsys, Marseille FRANCE). Each external ear canal was irrigated with cold (30°C) then hot (44°C) water for 30 sec, then the induced nystagmus was recorded by a video

ABBREVIATIONS

AAO-HNS – American Academy of Otolaryngology – Head and Neck Surgery

AP – action potential DF – degree of freedom

DPOAE – distortion-product otoacoustic emissions DXM – dexamethasone

EcoG – electrocochleography ELS – endolymphatic sac surgery IT – intratympanic

MD – Menière’s disease PTA – pure tone audiometry SP – summating potential

VEMPs – saccular vestibular evoked myogenic potentials VNG – videonystagmography

INTRODUCTION

Patients suffering from Menière’s disease (MD) have several types of complaints. Vertigo and dizziness are in the foreground, but patients also report tinnitus and fluctuating hearing loss.

MD can be a significantly handicapping disease that can lead to complete exclusion of patients from social life. Several therapeutic strategies have been proposed, from life counselling, medications such as betahistine, diuretics, in particular acetazolamide, to more aggressive ones, requiring surgery and/or suppressing the vestibular function, such as IT aminoglycosides or surgery [1, 2].

In between, conservative treatments have been proposed, aiming at relieving the burden of dizziness and vertigo, while preserving the vestibular function. Endolymphatic sac (ELS) surgical decompression has long been proposed, with many different techniques, such as simple ELS decompression or shunting [3], with or without corticoids injection [4, 5], ELS exclusion with endolymphatic duct blockage [6]. Even though there are controversies about its success rate [7–11], recent reports seem to show a real effect of this surgical procedure [3, 5, 12]. However, as all surgical procedures, it remains an invasive therapeutic modality.

More recently, IT injections have been aiming at relieving vestibular dysfunction, with the minimum of vestibular destruction and without any surgical procedure. Therefore, low doses of IT

Wyniki: Wynik oceny czynności przedsionkowej uległ znacznemu przesunięciu w stronę wartości niższych, z przesunięciem mediany z wartości 4 na wartość 3. Poza dwoma przypadkami trwałej perforacji błony bębenkowe, nie stwierdzono powikłań.

U 12 osób (44,4%) doszło do nawrotu objawów, średnio 7 miesięcy po dobębenkowej iniekcji DXM; u pacjentów tych wyma- gane było dodatkowe leczenie. Wyniki audiometrii tonalnej i słownej nie uległy poprawie. Nie zmieniły się również wyniki obiektywnych badań objawów słuchowych i przedsionkowych. W oparciu o wyniki kwestionariusza, dobębenkowe iniekcje DXM były skuteczne względem objawów słuchowych, przynajmniej w postaci szumu usznego w 9 przypadkach (33,3%).

Skuteczność polegała głównie na obniżeniu nasilenia objawów.

Wnioski: Potwierdzono zdolność dobębenkowych iniekcji DXM w zakresie zmniejszania objawów przedsionkowych i słucho- wych, w szczególności szumu usznego, choć obserwowany efekt był przemijający.

SŁOWA KLUCZOWE: Choroba Menière’a, deksametazon, iniekcje dobębenkowe, szum uszny, zawroty głowy

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camera and analyzed by the device software. Areflexia correspon- ded to less than 5 nystagmus, and a > 25% difference of response between ears was considered as an asymmetric vestibular response. VEMPs were recorded with an ELIOS device (EchoDia, Venis- sieux, FRANCE). A 90-dB acoustic stimulation was delivered with a low tone at 500 Hz. VEMPs were considered as present when the two pics were clearly identified, at around 10–15 ms for P13 wave and 20–25 ms for N23 wave.

Auditory complaint assessment

All patients had a pre- and post- IT DXM pure tone audiometry (PTA) and a speech audiometry. The PTA average threshold was calculated at 250–2000 Hz, given that these lower frequencies are the most sensitive ones in Menière’s disease.

Using the ELIOS device (ECHODIA, Venissieux, France), DPO- AEs were elicited by two pure tones, f1 and f2, which were chosen

so that f2/f1 was close to 1.2 and the 2f1-f2 DPOAE which was recorded by an external ear meatus probe was around 1 kHz.

Only points ≥ 4 dB above the noise floor were taken into consi- deration. The DPOAE phase was online calculated by the device.

A phase shift greater than 40° between recordings in the upri- ght and decline position was considered significant, as previo- usly reported [21–23].

Using the same ELIOS device, with a golden coated electrode placed in the external ear meatus, EcoG was achieved allowing for the recordings of the summating potential, as well as the action potential of the VIIIth cochlear nerve, by click stimulations from 1–4 kHz as well. A SP/AP ratio > 40% was considered as abnormal following Moon et al. and Chung et al. who reported a cut-off value of SP/AP ratio at around 34% [25, 26].

Auditory complaints were assessed through a short specifically designed questionnaire consisting of 4 items (Tab. I.).

Tab. I. Questionnaire on auditory burden.

QUESTION 1: ABOUT THE BURDEN OF YOUR AUDITORY SYMPTOMS, IS IT MORE OR LESS PROMINENT THAN VESTIBULAR ONE (DIZZINESS, VERTIGO)?

...

QUESTION 2: WHAT TYPE OF AUDITORY SYMPTOMS DO YOU SUFFER FROM?

PERCEPTION OF SOUND

• Difficulty in speech understanding

• Difficulty in hearing low sounds (I have to turn up TV, radio or CD player volume)

• Distortion of sound (as if my ear was out of tune)

• Fluctuation of my hearing performances TINNITUS

• Whistling

• Buzzing AURAL FULNESS

• Permanent

• Fluctuating

QUESTION 3: DID THE INTRATYMPANIC INJECTIONS YOU HAD FOR YOUR DISEASE RELIEVE YOUR AUDITORY SYMPTOMS? (PLEASE SELECT)

• YES A LOT

• YES MODERATELY

• YES A BIT

• NO

• NO, MY AUDITORY SYMPTOMS WORSENED

QUESTION 4: WHICH TYPE OF AUDITORY SYMPTOMS WERE RELIEVED?

PERCEPTION OF SOUND

• Difficulty in speech understanding

• Difficulty in hearing low sounds (I have to turn up TV, radio or CD player volume)

• Distortion of sound (as if my ear was out of tune)

• Fluctuation of my hearing performances

TINNITUS AURAL FULNESS

QUESTION 5: IF THESE INTRATYMPANIC INJECTIONS WERE EFFECTIVE IN REDUCING YOUR TINNITUS, COULD YOU TELL WHICH CHARACTERISTICS WERE MODIFIED?

• INTENSITY (my tinnitus is lower than before)

• DURATION (my tinnitus is shorter than before)

• PITCH or TIMBRE (the sound is changed)

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Post IT DXM assessment

The same functional evaluation was performed at 4 +/- 3 months on average, but at least 1.5 months after IT DXM.

Statistical Analysis

For comparisons, contingency tables were used and a Chi-square test for paired series was performed, with P ≤ 0.05 considered as significant.

RESULTS

Twenty-seven patients were treated by IT DXM. There were 13 males and 14 females (58 +/- 14 yo).

Overall, patients felt improved by the regimen of 5 consecutive IT DXM. Considering the level of handicap based on the AAO-HNS scale, a significant shift (Chi-2 = 9.308; DF = 1; P < 0.01) from higher categories of handicap through lower ones was found. The median shifted from level 4 to 3 (Fig. 1.). Recurrence occurred in 12 cases (44.4%) after one year, on average (median = 7 months, ext: 2 months – 2 years and 10 months). Seven of them had then

Injection procedure

IT DXM was achieved in an outpatient mode, under local anesthesia.

Patients were laying down on their back. Iodin disinfection of the external auditory meatus was done, then topical anesthesia with oxybuprocaine drops was administered. Occasional- ly, topical application of Bonain liquor (Cocaine chlorhydrate, plus phenol, plus menthol) was used. Radial myringotomy in the posterior inferior quadrant of the tympanic membrane was performed, giving access to the round window. DXM (4 mg/mL) was then gently injected through the myringotomy, letting the air get out by the large myringotomy, with no pain, until the whole middle ear would be filled in, and the DXM flow back in the ear canal through the myringotomy. The patient was asked not to swallow and stay in supine position for about 10 to 20 minutes at the most. Most of them swallowed after this time, having emptied their middle ear from DXM. Through the same myringotomy, with no need for additional topical anesthesia, four additional IT DXM, one per day, were applied in four following days. In four cases, a tympanic ventilation tube was placed (two before the IT DXM, and two afterwards). This precluded further VNG by irrigation.

27 patients:

14 women 13 men

RELIEF (15 patients)

12 recurrences

ADDITIONAL IT DXM (7 patients) IT gentamicin

(5 patients)

Vestibular neurectomy (one patient)

IT gentamycin (2 patients)

RELIEF (2 patients)

Controlled with ADDITIONAL IT DXM

(3 patients) RELIEF

(4 patients)

RELIEF

Fig. 1. Flow Chart.

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However, recurrence was frequent, occurring in more than 40%

of patients in the first two years. Hopefully additional DXM IT or low-dose gentamicin delivered “on demand” could relieve vestibular complaints of these patients, but one, who required radical vestibular neurectomy.

IT DXM has been reported as a successful treatment, with a dose- depending relation, the higher the dose, the higher the success [29]. The main advantage of this treatment is that it is not toxic to the labyrinth [15, 29]. In contrast, IT gentamicin can be toxic to hearing function and is well known to be deleterious to vestibular function and is used for this reason in intractable Menière’s disease [30]. Although with current acceptable low-dose on-demand protocols most patients keep the vestibular function on the injected side, and show a low rate of hearing deterioration [13, 16, 17, 31], we are reluctant to propose gentamicin as the first line of IT treatment. We thus first propose IT DXM.

Consent by our patients to this simple IT DXM procedure was always given with no reluctance. In contrast, once IT gentamicin risks were explained, most patients rejected this treatment in their first choice.

Herein we have to acknowledge the beneficial effect of this therapeutic strategy consisting of a series of 5 daily consecutive IT DXM. But the high rate of recurrence in a relatively short period of time, i.e. around one year on average, was disappointing, both for us and our patients. Some authors have also reported recurrences, and not so good results as Garduño-Anaya’s, and question arose on the real effectiveness of IT DXM [19]. Based on our results, we now inform patients that they can expect a high rate of relief, but with an approximate risk of recurrence of 40% in the first two years following the procedure. This rate of recurrence in the short outcome has to be clearly given to patients in order to avoid disappointment.

Other corticoids can be used for IT treatment. Diffusion of corticoids within the cochlea has been shown to be variable depending on their exact chemical characteristics [32]. Howe- ver, this drug can be painful when injected in the middle ear, as reported by some of our patients (not included herein) and other teams [33].

IT aminoglycosides (gentamicin, concentration at 40 mG/mL, 0.2 mL), 4 of them after having undergone an additional IT DXM series. One of these patients treated by gentamycin finally required vestibular neurectomy with complete vestibular complaint relief. Three patients were relieved by one additional series of IT DXM (Fig. 2.).

Considering the auditory status, PTA threshold did not change significantly after IT DXM, i.e. from 45 +/- 24 to 46 +/- 24 dB.

No improvement was found neither in SP/AP ratio on EcoG. After IT DXM, only one patient normalized the SP/AP ratio. The acoustic phase shift was not improved either: three patients had no more DPOAE-acoustic phase shift. All other patients still exhi- bited an abnormal SP/AP ratio or acoustic phase shift.

All patients tolerated well the procedure without complaints.

However, two of them (7.4%) had a persistent perforation of their tympanic membrane due to myringotomy and required myringoplasty.

Twenty patients answered to the questionnaire regarding the auditory complaints (Tab. II.).

Question 1 asked which type of symptoms, whether vestibular or auditory ones, were prominent. There were two times more patients complaining from vestibular symptoms (12) than from auditory complaints (5) and only one felt the same level of burden for both types of complaints (Chi-square = 4.083; DF = 1; P < 0.05).

Question 2 revealed a significant improvement from an auditory standpoint in ten patients who felt relieved from auditory complaints (Chi-square = 7.364; DF = 1; P < 0.01), and only one who felt worsening of the auditory complaints. Based on responses to question 3, the most improved symptoms were first tinnitus then aural fullness.

Question 4 focused on tinnitus. Nine patients (Chi-square = 7;

DF = 1; P < 0.01) were relieved at least partially from their tinnitus after IT DXM. Seven of them felt a lower intensity of their tinnitus, one noticed a welcome change in terms of frequency and another one shortening of the tinnitus.

DISCUSSION

Following Garduno-Anaya 2005 [15] who reported a convincing series, comparing IT placebo vs. IT DXM with good results, as well as French and IFOS recommendations [1, 2], we decided to apply the same protocols in our patients who had a level of handicap

≥ 3 on the AAO-HNS vestibular functional scale.

This report confirms that MD patients’ satisfaction is improved after IT DXM. Indeed, their level of handicap is clearly improved after this treatment with a clear shift of their handicap towards lower scores of the AAO-HNS vertigo functional level scale, as seen in Fig. 1., with 59% chance for it to be ≤ level III of the AAO-HNS vestibular functional scale.

0 2 4 6 8 10 12 14

Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 no answer

Before IT DXM After IT DXM

Fig. 2. Levels of dizziness handicap according to the vestibular functional level scale (AAO-HNS 1995).

Level 1 0 2 4 6 8 10 12 14

Level 2 Level 3

Before IT DXM After IT DXM

Level 4 Level 5 Level 6 no answer

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There was no improvement on PTA or speech audiometry. We found no improvement on objective assessment through DPOAE phase shift or SP/AP ratio either. Few reports on objective improvement of EcoG in MD patients are available after treatment. We found only one that showed such an improvement on SP/AP ratio after IT steroids (Martin-Sanz et al. 2015). Explanation of the absence of improvement of SP/AP ratio is not clear. One conclusion from these observational results is that IT DXM could be not Only one of patient had to be operated on for vestibular neurec-

tomy after failure of both IT DXM and gentamicin. This patient, of 50 y.o., was fully relieved from her vestibular complaint, and achieved a more than good vestibular compensation, but with an expected complete vestibular deafferentation. Finally, this IT therapeutic strategy combining IT DXM and gentamicin shows that it is possible in the majority of cases to relieve patients and save the vestibular nerve.

Tab. II. Answers to questionnaire.

Q1 BURDEN OF SYMPTOMS vest. S > audit. S

13 audit. S > vest. S

5 equal

2

Q2 TYPE OF AUDIT. S (SEVERAL PATIENTS CHOSE MULTIPLE ANSWERS)

Perception of sound Total

Speech understanding 12

Hearing level 13

Distortion 3

Fluctuation

6 34

Tinnitus

Whistling 15

Buzzing

8 23

Aural fullness Permanent

7 Fluctuating

6 13

Q3: GLOBAL RELIEF OF AUDIT. S

High3 Moderate

5 Low

2 Total

10 No answer

1

NO8 WORSE

1 1 8

P4: SPECIFIC RELIEF Perception of sound Speech understanding

1 Hearing level

1 Distortion

1 Fluctuation

1 Total

4 Tinnitus

4 4

Aural fullnessu

2 2

Q5: TINNITUS RELIEF Intensity

7 Duration

2 Pitch or Timbre

0 No answer

11

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question 2, related it to tinnitus, while 9 patients then reported a relief of tinnitus at question 4. As often, questionnaires can lead to some apparently contradictive answers. It is possible that some patients did not understand that tinnitus had to be considered as an auditory symptom.

Nevertheless, such a good result was not really expected, since positive effects of dexamethasone on tinnitus are seldom reported [15, 34, 35] while some reports failed to show any effect of IT DXM [36–38]. Herein, we did not conduct any clinical research protocol but took care of our patient in routine practice. Therefo- re, there was no control group and no wash-over to confirm the efficacy of IT DXM. However, since all patients had been treated for months (if not for years), with no improvement of their auditory symptoms, the good effects on auditory symptoms, including tinnitus in almost half of them, could be really significant.

The only adverse effect we have reported is a low rate of tympanic membrane perforation at less than 10%. Those cases were success- fully treated by transcanal myringotomy.

In conclusion, IT DXM seems to confirm its efficacy in relieving vestibular symptoms in MD patients and hearing complaints, in particular tinnitus, at least transiently. However, it seems to be not able to cure the pathophysiological process of the disease and patients have to be informed of a 40% rate of recurrence in the first year following the procedure that might require further treatment.

effective enough to solve the pathophysiological disturbance in MD. Indeed, DPOAE-phase shift and high SP/AP > 40% are well known to be frequently associated with MD, at least during clinical attacks with specific symptoms [27]. DPOAE phase shift is putatively related to the endolymphatic hydrops that could pertur- bate the steady state of the outer hair cells’ stereocilia bundle; this steady state is tightly linked to the DPOAE phase [22, 27]. A high SP/AP ratio has been acknowledged for decades to be related to endolymphatic hydrops, but explanation thereof remains uncer- tain. All our patients first underwent such objective evaluation, giving the following result: > 40% SP/AP, and /or > 40° DPOAE phase shift for those with good hearing, that is allowing to per- form this measurement. We expected a normalization of these recordings after IT DXM, since it was reported by the patients as effective, but improvement did not occur in our series. Although surprising at first, this may point to the fact that the pathophysiological process still remains, which in turn can account for the high rate of recurrence in the short term.

The short questionnaire sent to patients provided informative results. First, vestibular symptoms undoubtedly predominate over auditory complaints in MD patients. This result confirms the reality clinicians have to face with in case of their MD patients, and gives explanation why many functional scales in MD have been focusing on vestibular handicap. Secondly, IT DXM proved to be effective against tinnitus in about one third of patients (9), mainly in lowering its intensity. We noticed that, unexpectedly, only 4 patients, out of the ten who acknowledge a relief of auditory symptoms in

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Corresponding author: Thierry Mom MD PhD; Department of Otolaryngology Head Neck Surgery, University Hospital, CHU Gabriel Montpied, 58 rue Montalembert, 63 000 Clermont-Ferrand, France; E-mail: tmom@chu-clermontferrand.fr

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A case-series study; Pol Otorhino Rev 2021; 10 (1): 1-9

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