Intratympanic gentamicin for the treatment of unilateral Meniere's disease

OBJECTIVE: To determine the efficacy of intratympanic gentamicin instillation as treatment of incapacitating unilateral Meniere's disease, using a predetermined regimen with a fixed dose. STUDY DESIGN: A prospective study from a single institution between 1988 and 1998. METHODS: One hundred fourteen patients were enrolled in this study. Gentamicin (26.7 mg/mL) was administered three times daily for 4 consecutive days. The Committee on Hearing and Equilibrium Guidelines for Reporting Treatment Results in Meniere's Disease of the American Academy of Otolaryngology and Head and Neck Surgery (1985) were used. RESULTS: Comprehensive data were available for 90 individuals. Complete control of vertigo was achieved in 76 (84.4%), substantial control in 8 (9.0%), limited control in 2 (2.2%), and insignificant control in 4 (4.4%) patients. Disability scores at the end of 2 years were as follows: 76 patients (84.4%) had no disability, 5 (5.6%) had mild disability, 2 (22%) had moderate disability, and 7(7.8%) had severe disability. Caloric testing responses, as determined using electronystagmography, were as follows: 71% of the patients had an absent ice-water response, 16% had a positive ice-water response, and in 13% there continued to be present a bithermal response. Hearing was worse in 22 patients (25.6%), unchanged in 41 (48.2%), and improved in 22 (25.6%). CONCLUSIONS: Intratympanic gentamicin administration using this particular protocol is an effective treatment option for patients with disabling unilateral Meniere's disease. Hearing loss is a distinct possibility, and patients should be advised accordingly.     

Vestibular nerve section versus intratympanic gentamicin for Meniere's disease

OBJECTIVES/HYPOTHESIS:Vestibular nerve section and transtympanic gentamicin administration are procedures with proven efficacy in the treatment of vertigo associated with Meniere's disease refractory to medical management. Hearing loss is a known complication of each of these procedures; however, there has not been a report of hearing results of both treatments from a single institution. STUDY DESIGN: Retrospective review. METHODS: Review was made of 25 patients undergoing gentamicin injection and 39 patients undergoing vestibular nerve section for Meniere's disease. Rate of vertigo control and pretreatment and post-treatment pure-tone average values and speech discrimination scores were reported. RESULTS: The mean preoperative pure-tone average for patients having vestibular nerve section was 47.2 dB, with a speech discrimination score of 75.4%. In these patients, the postoperative pure-tone average was 49.1 dB and the speech discrimination score was 75%. Patients undergoing gentamicin injection had a mean pretreatment pure-tone average of 55.9 dB and a speech discrimination score of 62%. The post-treatment pure-tone average and speech discrimination score for the gentamicin group were 68.8 dB and 49.3%, respectively. Five of 25 patients (20%) in the gentamicin treatment group and 1 of 39 (3%) in the vestibular nerve section treatment group had an increase in bone-conduction threshold greater than 30 dB. The amount of postprocedure hearing loss was significantly greater in the gentamicin treatment group (P =.006). Control of vertigo was good to excellent in 95% of the patients treated with vestibular nerve section and in 80% of the patients treated with gentamicin. CONCLUSION: Although vestibular nerve section and transtympanic gentamicin are both acceptable treatment options for vertigo associated with Meniere's disease, gentamicin causes a higher level of hearing loss related to treatment and vestibular nerve section has higher vertigo control rates.     

Endolymphatic sac decompression as a treatment for Meniere's disease

OBJECTIVES/HYPOTHESIS: Endolymphatic sac decompression is a surgical treatment option for patients with medically intractable Meniere's disease. However, effectiveness is debated because published data show great variability. Outcome-based research studies are useful in incorporating the patient's perspective on the success of treatment. To further assess effectiveness of endolymphatic sac decompression, we performed a prospective study to examine both symptom-specific and general health outcomes. STUDY DESIGN: Prospective, observational outcome study. METHODS: Nineteen patients with endolymphatic sac decompression responded to symptom-specific questionnaires and the Medical Outcomes Short-Form 36 Health Survey (SF-36) before and after surgery. Follow-up ranged from 6 to 58 months with a mean duration of 50 months. RESULTS: Overall measures of physical health were significantly improved following endolymphatic sac decompression (P = .04), whereas overall measures of mental health were unchanged (P = .74). Role Physical and Social Functioning scores were significantly improved following endolymphatic sac decompression (P = .04 and P = .03, respectively). Study patients scored significantly lower (P < .05) than SF-36 normative data in 6 of 10 categories before endolymphatic sac decompression but patient scores were not significantly different from normal scores in all but one category (General Health) following endolymphatic sac decompression. The mean number of vertigo episodes was significantly reduced from an average of 8.3 times per month to an average of 2.6 times per month following endolymphatic sac decompression (P = .006). Ninety-five percent of patients (18 of 19 patients) reported improvement in symptoms (frequency, duration, or intensity) of vertigo and 37% (7 of 19 patients) reported complete resolution of vertigo. CONCLUSION: Endolymphatic sac decompression significantly improved perception of physical health, as well as symptom-specific outcomes, in patients with medically intractable Meniere's disease.     

Low-Dose Intratympanic Gentamicin and the Treatment of Meniere's Disease: Preliminary Results

The most disabling symptom for most patients with unilateral Meniere's disease is vertigo. Eradication of the diseased end organ is effective in eliminating the vertigo. Labyrinthectomy remains the “gold standard”; unfortunately, residual hearing is sacrificed to obtain this end. The purpose of this study is to evaluate low-dose intratympanic gentamicin for the control of vertigo and for the preservation of hearing. A single dose of gentamicin(10-80 mg) was injected into the middle ear space of 23 patients with unilateral Meniere's disease as an office procedure. Eighty-four percent of the patients had no episodes of vertigo during the last 6 months of follow-up. Pure tone average and word discrimination scores were unchanged as a group. Ninety-five percent of patients had a hearing loss at 6 and 8 kHz that averaged 7.5 dB. Caloric function was reduced in 93%. Low-dose intratympanic gentamicin is a safe, simple, office procedure that is effective in controlling the definitive vertiginous episodes in most patients with unilateral Meniere's disease. Control of vertigo can be obtained with preservation of hearing.     

Intratympanic Gentamicin for Treatment of Intractable Meniere's Disease: A Preliminary Report

Topical administration of aminoglycoside antibiotics in the middle ear can achieve “chemical labyrinthectomy” in patients with intractable Meniere's disease. Herein we report our results of intratympanic gentamicin therapy in 21 patients using two different dosing protocols, twice weekly and twice daily(b.i.d.). Both hearing and vertigo outcome were evaluated. Complete control of episodic vertigo was achieved initially in 20 of 21 patients (95.2%). However, 6 of 20 responders (30%) developed relapsing symptoms within 12 months. Retreatment was successful in 75% of these patients. Overall, hearing was preserved or improved in 62% of cases, worse in 24%, and not yet tested in 14%. When the cumulative dose of gentamicin was ≤4 injections in the first week, only 1 of 14 (7.1%) lost hearing. Intratympanic gentamicin offers better risk/benefit outcome than other invasive therapies for intractable Meniere's disease.     

Update on Intratympanic Gentamicin for Meniere's Disease

Objective: To review the literature relating to intratympanic gentamicin injection therapy for Meniere's disease to detect consistencies and differences that might suggest optimal technique. Design: Retrospective literature review. Methods: Eighteen papers from the literature regarding clinical experience with intratympanic gentamicin injections for treatment of Meniere's disease were reviewed and tabulated. Results: All papers reported high success rates in treating episodic vertigo of Meniere's disease, but technique, dose, duration, and treatment philosophy varied considerably. Hearing loss was typically reported in about 30% of patients. Conclusion: No single technique of gentamicin injection has a significant medical advantage over the others. Until controlled studies indicate otherwise, nonmedical needs such as convenience and safety may be considered when choosing a technique.     

Use of the Round Window Microcatheter in the Treatment of Meniere's Disease

Objectives/Hypothesis Transtympanic gentamicin is an increasingly popular treatment for Meniere's disease. The present report examines the 2‐year follow‐up of our first 27 patients with Meniere's disease treated with the use of microdose gentamicin through the Round Window Microcatheter. We applied the 1995 American Academy of Otolaryngology—Head and Neck Surgery criteria to this patient group to analyze the results of treatment. Study Design This study is an evaluation of consecutive patients with predetermined data collection on each patient. Methods Patients with confirmed Meniere's disease underwent placement of the Round Window Microcatheter, which was filled with 10 mg/mL gentamicin, after placement into the round window niche was confirmed. Ten milligrams per milliliter of gentamicin was injected into the catheter by hand on two occasions after device placement in the first several patients. The remaining patients had continuous infusion of 10 mg/mL gentamicin at 1μL/h for the next 10 days. The catheter was removed 10 days after placement. All patients underwent an extensive set of hearing and vestibular tests on several occasions before, during, and after treatment. Results In the patients in the study, vertigo was eliminated in 92.6%, with 3.7% of patients (1/27) demonstrating a mild permanent threshold shift in hearing. Tinnitus and pressure were significantly reduced in more than 65% of patients. Only one patient demonstrated a reduction of vestibular function after treatment. Conclusions Results of this study on this group of patients indicate that vertigo can be controlled in the long term using microdose gentamicin without a significant reduction in cochlear or vestibular function in most of the patients in our series. Our results are compared with the published literature examining transtympanic injection. In addition, the underlying science supporting this type of treatment is examined.     

Serum antidiuretic hormone levels in patients with unilateral Meniere's disease

OBJECTIVES/HYPOTHESIS: Prior studies have indicated a possible role of antidiuretic hormone (ADH) in the pathogenesis of Meniere's disease. Animal studies have shown presence of ADH receptors in the inner ear, and chronic vasopressin administration has been shown to induce endolymphatic hydrops. Furthermore, elevation of serum ADH levels in human has been noted in patients with Meniere's disease. The goal of the study report was to analyze ADH levels in a series of patients with definite unilateral Meniere's disease to further investigate this relationship. STUDY DESIGN: Retrospective analysis METHODS: Antidiuretic hormone levels were obtained from 26 consecutive patients with a diagnosis of definite Meniere's disease as defined by the 1995 guidelines from the Committee of Hearing and Equilibrium (American Academy of Otolaryngology-Head and Neck Surgery). The ADH levels were drawn for each patient within one week of an acute episode of vertigo. These values were compared to ADH levels from 31 healthy volunteers. Statistical analysis was performed using a two-tailed t test. RESULTS: Mean ADH level for patients with Meniere's disease was 4.07 pg/mL (SD = 2.82 pg/mL) and for the control group, 3.37 pg/mL (SD = 1.48 pg/mL). The difference in ADH levels was not statistically significant (P >.05). CONCLUSIONS: Although previous reports have demonstrated a possible role of ADH in the pathogenesis of Meniere's disease, the study did not show a statistically significant elevation of ADH levels in patients with unilateral Meniere's disease. Before excluding an ADH-inner ear pathogenic relationship, ADH levels in patients with bilateral Meniere's disease should be investigated.     

Meniett therapy may avoid vestibular neurectomy in disabling Meniere's disease

Conclusion. In those patients for whom vestibular neurectomy has been selected due to the disabling recurrence of vertigo spells, Meniett® therapy has been shown to allow avoidance of this surgical procedure in a fairly high percentage of patients with Meniere's disease (MD). Our data would also support a better result when pressure treatment is acting on MD of short duration. Objective. To test the possibility that low pressure treatment (Meniett®) could avoid vestibular neurectomy in patients with MD that was refractory to medical treatment. Patients and methods. The setting was a tertiary referral centre in a university hospital. Thirty-six MD patients, for whom vestibular neurectomy was indicated, underwent Meniett® treatment and composed a group in which a long-term (>2 years) follow-up was achieved. Additionally, different durations of MD (‘young’ and ‘old’ MD) were distinguished and analysed separately. Results. Twenty-five patients (69.4%) were treated satisfactorily by using Meniett® treatment and therefore avoided vestibular neurectomy. In half of them only one cycle of treatment was necessary.     

Intratympanic gentamicin treatment after endolymphatic sac surgery

Conclusions. Interval treatment with up to three intratympanic gentamicin injections once weekly effectively controlled vertigo while preserving hearing in patients with Ménière's disease and recurrent or resistant vertigo after saccotomy. Objectives. Recurrent or resistant incapacitating vertigo may occur after endolymphatic sac surgery (saccotomy) in patients with Ménière's disease. In these patients, revision saccotomy, vestibular nerve section or labyrinthectomy are the established treatment options. We advocate a once-weekly application of intratympanic gentamicin (12 mg) as an effective alternative in this group of patients. Material and methods. Five patients (age range 39–65 years) with definite Ménière's disease according to the 1995 American Academy of Otolaryngology—Head and Neck Surgery (AAO—HNS) criteria and incapacitating vertigo underwent gentamicin treatment after saccotomy. Control of vertigo and hearing preservation were the aims of treatment. The follow-up period ranged from 26 to 59 months. History and pure-tone audiometry were used to assess vertigo control and hearing, respectively. The frequency of vertigo in the 6-month period before gentamicin treatment ranged between 0.5 and four definitive episodes per month. Hearing stage (AAO—HNS criteria) before gentamicin treatment ranged between 2 and 4. Pre- and post-treatment pure-tone hearing thresholds at 0.5, 1, 2 and 3 kHz were compared by means of the Mann–Whitney U-test. Results. Complete vertigo control (class A; AAO—HNS) and hearing preservation at 0.5, 1, 2 and 3 kHz were achieved.     

Intratympanic gentamicin for unilateral Menière's disease: results of therapy

Intratympanic gentamicin for unilateral Menière's disease: results of therapy Patients with Menière's disease that remains refractory to conservative treatment have traditionally been subjected to ablative surgery. The purpose of this prospective study was to evaluate the use of intratympanic gentamicin in eliminating incapacitating vertigo, while preserving hearing. Over the past 8 years, 83 patients have received between 1 and 6 intratympanic injections of gentamicin in an out‐patient setting, with duration of therapy titrated to individual symptom response and effect on hearing. Using established AAO‐HNS guidelines, we present data on 50 patients who have a minimum of 2 years follow‐up. Control or significant improvement of definitive Menière's attacks was achieved in 92% of patients and hearing preserved or improved in 76%. Only one patient experienced profound sensorineural hearing loss. We feel this treatment option should be considered and offered to patients in whom medical treatment has failed.     

Long-term results of endolymphatic sac drainage with local steroids for intractable Meniere's disease

Objectives

Meniere's disease is a common inner ear disease characterized by vertigo, hearing loss and tinnitus. Since Meniere's disease is thought to be triggered by an immune insult to inner ear hydrops, we examined endolymphatic sac drainage with intra-endolymphatic sac application of large doses of steroids for intractable Meniere's patients and observed long-term results from 2 years to over a decade until 13 years.

Methods

Between 1998 and 2009, we enrolled and assigned 286 intractable Meniere's patients to two groups: group-I (G-I) included patients who underwent endolymphatic sac drainage with steroid instillation and group-II (G-II) included those who declined endolymphatic sac drainage. Definitive spells and hearing improvement in these two groups were determined for 2–13 years after treatment.

Results

According to the established criteria, vertigo was completely controlled in 88% of patients in G-I in the 2nd year, in 73% in the 12th year and in 70% in the 13th year. These results in G-I were significantly better than those in G-II for 13 years after treatment. Hearing was improved in 49% of patients in G-I in the 2nd year, in 27% in the 12th year and in 25% in the 13th year. These results in G-I were significantly better than those in G-II for 12 years after treatment, but this was not significant in the 13th year.

Conclusions

Endolymphatic sac drainage with intra-endolymphatic sac application of large doses of steroids could improve long-term follow-up results of hearing as well as vertigo control. This means that the drainage with local steroids could also improve patients’ long-term quality in the prime of life.     

Caloric test as a predictor tool of postural control in CI users

Conclusions: Balance was improved at 365 days after CI in all patients. Caloric test findings were important determinants of balance outcomes over a year after CI. Pre-operative vestibular assessment findings should be documented because postural recovery over time depends on this information. Objective: To verify the importance of the caloric test as a pre-operative predictor tool of postural control after CI surgery. Methods: Prospective observational study made with 24 post-lingual deafness patients who underwent unilateral CI surgery. Vestibular assessments: questionnaire assessing vertigo, caloric tests, rotary chair (RC) testing, and computerized dynamic posturography (CDP), were sequentially performed for all patients before and 60, 120, 180, and 365 days after CI. Results: Thirteen patients (54.2%) reported dizziness before CI. At the end of the study, dizziness remained unchanged in one (7.7%) patient, ameliorated in 11 (84.6%), and worsened in one (7.7%). Baseline caloric tests identified 29.2% patients with normal reflexes, 33.3% with unilateral areflexia or hyporeflexia, 12.5% with bilateral hyporeflexia, and 25% with bilateral vestibular loss (BVL). Most patients exhibited objective improvements in postural stability. At 365 days, the CDP condition (particularly C5) and CS were higher for caloric tests responders at baseline than for those with BVL at baseline.     

Intentional ablation of vestibular function using commercially available topical gentamicin-betamethasone eardrops in patients with Meniere's disease: further evidence for topical eardrop ototoxicity

OBJECTIVE: To determine whether the controversial findings of suspected ototoxicity from commercially available gentamicin sulfate and betamethasone sodium phosphate eardrops can be used in a therapeutic fashion to ablate (or attenuate) vestibular function in patients with unilateral Meniere's disease. STUDY DESIGN: Prospective case review. METHODS: At a tertiary care dizziness unit at the University Health Network, Toronto General Hospital, University of Toronto (Toronto, Ontario, Canada), adults with unilateral Meniere's disease undergoing intratympanic ablation therapy were studied. After insertion of a tympanostomy tube with the patient under local anesthesia, patients instilled gentamicin containing eardrops three times daily until they became vertiginous for longer than 24 hours and then for an additional 2 days longer or for 1 month, whichever came first. Electronystagmographic caloric test responses were measured before treatment using bithermal water caloric and after treatment using air caloric tests. Main outcome measures included clinical titration of drops to the onset of prolonged vertigo. As well, post-treatment findings on electronystagmography and audiometry were compared with pretreatment testing. RESULTS: Twenty patients were available for review. Fifteen patients had a significant reduction in caloric test responses compared with pretreatment values; among them, 10 patients had absent air caloric test responses on the treated side. In 10 patients hearing worsened according to the 1995 American Academy of Otolaryngology-Head and Neck Surgery Committee on Hearing and Equilibrium Guidelines for reporting in Meniere's disease. CONCLUSIONS: Topical gentamicin-betamethasone eardrops can pass through a tube into the middle ear, where they may prove primarily vestibulo-ototoxic patients with Meniere's disease. The study further confirms clinical observations that gentamicin-containing eardrops might prove ototoxic, especially in noninflamed ears with a tympanic membrane defect.     

Clinical and vestibulometric status following labyrinthectomy or vestibular nerve section for Meniere's disease *

A clinical and vestibulometric comparison of 10 patients following labyrinthectomy, 5 following vestibular nerve section, and 10 control subjects was undertaken in order to evaluate the long-term effectiveness of these procedures. Testing was performed a mean of 8.5 years after surgery. Vestibulometry assessed time constants, gain, and phase advance of the vestibulo-ocular reflex (VOR) in both horizontal and vertical planes of head movement. Loss of the anticipated increase in phase advance in the vertical VOR of the labyrinthectomy group, significantly different from the vestibular nerve section group (P < 0.05 and P < 0.01 for each direction of rotation), suggests that posterior and superior semicircular canal function remains intact following per-meatal labyrinthectomy. Although stabilometry suggested that balance in the labyrinthectomy group was poorer than in the two other groups (P < 0.025 without optic fixation), clinical assessment demonstrated excellent functional results. Per-meatal labyrinthectomy remains a safe and effective procedure for the relief of vestibular symptoms, although vestibular nerve section may provide more complete removal of contributory end-organ function.     

Oculomotor findings mimicking a cerebellar disorder and postural control in severe Meniere's disease

Objective

We explored whether vestibular derangement in patients with severe Meniere's disease is related to gaze and fixation difficulties and could explain complains of visual blurring and visual neglect.

Methods

Twenty-six patients with severe Meniere's disease treated with intratympanically applied gentamicin of the affected ear were examined. Saccades (with pseudo-random timing, size and side of the step) and pursuit eye movements (PEMs; pseudo-random target trajectory made of a combination of two sinusoidal waves of different frequencies) and posturography were tested in patients. For normative data of voluntary eye movements, 45 control subjects were tested, and for posturography 29 control subjects. Severity of symptoms in Meniere patients was assessed according to the total handicap score of AAO-HNSF (1985).

Results

Saccadic eye movements and postural stability were severely deteriorated in Meniere patients, and these disturbances correlated significantly with each other. Most of PEM parameters were significantly worse in Meniere patients than in control subjects. Prolongation of saccadic latency and reduced gains due to saccadization in PEMs were characteristic features for Meniere's patients. Severity of symptoms in Meniere patients correlated with prolongation of latency in saccades and with poorer gains in PEMs. Postural instability measured with posturography correlated with saccadic latency and PEMs.

Conclusion

In severe Meniere's disease, programming of oculomotor and postural responses show the same pattern of disturbance, an increased delay of processing and inaccuracy in the motor output. A fluctuant vestibular lesion with advanced severity can cause disorders of voluntary eye movements that are reflected with clinical complaints of difficulties in reading and visual scanning of surrounding.