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1/11/2023: Whats new: We are more enthusiastic now about IT steroids for Meniere's disease, based on recent data.
|Figure 1B. Steroid injected into the middle ear. Multiple injections are usually required for this method.|
In severe cases of episodic vertigo, such as due to Meniere's disease, treatments administered into the middle ear may be considered. This is a near last resort treatment for persons who have severe attacks of vertigo. The goal of these treatments is to affect the inner ear using medication that enters the ear through the round window. The presumption is that the mechanism of disease is immune mediated. Corticosteroids decrease inflammation in the ear and may increase labyrinthine circulation. There also has been some suggestion that steroids affect the salt metabolism in the inner ear.
Steroids can be also given orally, and this method is discussed here.
The author of this article, Dr. Hain, is not especially enthusiastic about IT steroids for Meniere's disease. The reason is that the drug is gone in a few days, and even if it works, it has to be repeated every 3 months. It also seems to us to be a inferior method to use of IT gentamicin, which provides a durable solution. This has also been noted by others (Casani et al, 2011; Gabra and Saliba, 2013).
Wildly different to this position, Patel et al (2016) reported that in 30 patients with Meniere's, two injections of methylprednisolone was as effective as gentamicin injections (about 90% in each group of 30). The same fortunate patients were followed up in a subsequent paper (Harcourt et al, 2019), and they continued to do well. As steroids are neither curative nor long-lasting agents, brief intratympanic steroid treatments are obviously not able to cure Meniere's disease (Barrs, 2004; Dodson et al, 2004). That is why we say those patients were fortunate.
A recent meta-analysis (analysis of other people's data) was done by Hao. Hao et al 2022, found in a network metaanalysis of about 450 patients that the response of vertigo was about the same for gentamicin and steroids, but they did not report on the durability of the response. So gradually, there seems to be more support for IT steroids in Meniere's.
Evidence or not, our view is that one-time steroid treatment (defined as a brief burst) does not have a reasonable scientific basis (Doyle et al, 2005). The core logical difficulty is that steroids don't make any permanent alterations to the inner ear, and that they are gone from the ear in a short period of time (Harugnani et al, 2006). Meniere's is a chronic ear disorder. The hypothesis that one or two injections of steroids can "cure" a chronic ear disorder is very hard to understand. We do not think it is wise to rely on an temporary treatment for Meniere's, especially in dangerous situation such as drop attacks or unpredictable spells while driving.
Farhood and Lambert (2016), presumably in an attempt to explain long term results from a short term drug, wrote that "Glucocorticoid receptors have been shown to exist in the human inner ear and several studies propose they influence mechanisms of blood flow, fluid regulation, and ion regulation, with recent evidence describing the latter two. Corticosteroids have been shown to upregulate aquaporins and ion channels in the inner ear, and may have a positive effect on labyrinthine blood flow. Additionally, processes have been described in genomic and non-genomic manners." We still don't understand how a temporary drug can cure a chronic illness. This seems a little fuzzy.
Steroid injections may be reasonable when one is attempting to diagnose autoimmune inner ear disease. It may also be justifiable for sudden hearing loss.
Steroid injections (like endolymphatic shunt surgery for Meniere's disease) are a procedure that seems to be very popular as a surgical intervention. Both procedures lack a good rationale, but they are rarely do harm. As the dictum goes -- "Primum, no nocere" -- First do no harm.
Steroid injections are rapidly growing in popularity. At the present time in the author's practice in Chicago, he will recommend it to a patient who is having a flare of well defined Meniere's disease, or a sudden hearing loss. Steroids don't seem to work unless given over a long period, and there are alternatives (i.e. low dose gentamicin) that are much more durable. We are skeptical that it is a good idea to give multiple injections of steroids into the middle ear over a long period of time as there are more ear drum perforations and infections. Still, things are changing with this treatment, and it does little or no harm and risk is also low.
Injections of steroid can be given through the ear drum, by way of a small needle (figure 1B), or administered as drops through a ventilation tube (figure 1A). IT steroids allows one to treat one side, without affecting the other. It also avoids complications of systemic steroids, may avoid surgery, and may work when other treatments fail.
Usually either dexamethasone or methylprednisolone is used. (Li et al, 2022)
The dexamethasone solution should be prepared fresh (preservatives can cause intense pain). A mixture last about 1 week. Make two small incisions - -one for the injection and one for ventilation. Allow the dexamethasone to warm to room temperature (to avoid dizziness). Inject the dexamethasone through the posterior incision (Minor, 2008).
The protocol suggested for most patients begins with a single intratympanic injection of dexamethasone (12 mg/ml). Follow up in 2-3 weeks. Repeat the injection at 6-8 weeks if vertigo recurs. (Minor, 2008). Garduno-Anaya and associates (2005) as well as Barrs and associates(2001) used a much lower dose of dexamethasone, 4 mg/ml. Garduno-Anaya et. al. injected through the anterior-superior quadrant previously anesthetized with EMLA cream (2005). Thus they used both a different location and a lower dose than the later study of Minor in 2008. Later studies tend to use even more drug such as 24 mg (e.g. Haynes et al, 2007) for similar endeavors.
We think ear surgery like this, although minor, should be done by otologic surgeons, rather than surgical assistants or technicians.
|Authors||number patients treated||Protocol||response||Comment|
Silverstein et al. (1998). "
|20||3 injections in 3 days||None||Short duration|
Hirvonen, et al, 2000
|17||3 injections over 1 week||76% control of vertigo , no response of hearing||Short duration|
Barrs, et al. (2001).
|21||2 injections in 2 weeks||43% response at 6 mo (similar to placebo)||Short duration|
|Sennaroglu et al. 2001||24||drops instilled every other day for 3 months||72% relief of vertigo, no response of hearing or tinnitus||Long duration, perforation of TM would seem a risk.|
|Arriaga et al. 2003;||15||Single dose||None||Short duration|
|Dodson et al, 2004||22||Various||Short term relief|
|Bolea-Aguirres et al, 2007||129||3-4 injections/year||"Acceptable" vertigo control in 91%||Long duration, fuzzy outcome.|
|Patel et al, 2016, also Harcourt et al, 2019 (same patients)||30||2 injections, 2 weeks apart in 30 patients.||Reduced vertigo attacks. Same control as gentamicin injection||Difficult to follow, very different results than other studies|
|Leng et al, 2017||51||Repeated on demand||"Vertigo disappeared or was substantially controlled in 58.8% and 23.5% of the patients, respectively, after the first ITD course. A repeated course further raised the complete vertigo control rate by 15.7% and intra-tympanic gentamycin injection could be postponed or avoided in 78.6% of the patients who required repeated IT treatment."||No control population (i.e. no sham injection). Similar results to natural history of Meniere's as well as other studies placebo treatments.|
|Yin et al, 2022||124||Comparison of steroids to placebo (lidocaine)||"Vertigo was improved in 65% of patients who received ITD compared with 55% of patients who received ITL patients (P < .05). Three patients in the ITD2 group had from otomycosis, and 2 of these patients had a perforation;"||It is very nice to have a placebo controlled trial ! Steroid results are similar to placebo, but have more complications (fungal ear infection in about 2%, and perforations)|
Syed et al (2015) reported that "On the basis of 6 RCT's (n=242) there is evidence to support the effectiveness of intratympanic steroids and gentamicin to control symptoms of vertigo in MS/D albeit with a risk of hearing loss in gentamicin. However, there was no consensus found on doses or treatment protocols. " We ourselves are dubious that gentamicin does not control vertigo.
Li et al (2022) reported that "The effectiveness of IT methylprednisolone (ITM) on vertigo control seems to be somewhat better than that of IT dexamethasone (ITD), and ITM can restore hearing in some cases. " We find this surprising.
Intratympanic steroids has been reported to improve the ECOG (Martin-Sanz et al, 2013).
Most practitioners use a simple protocol of an injections of steroids, delivered weekly or longer intervals. However, the most successful methods reported to date, such as the studies of Sennaroglu and Boleas, involve a longer periods of administration.
Dexamethasone has the longest half-life: 36-54 hours. We would expect that steroids in the inner ear would persist for a shorter period than in the body, because in the inner ear, steroids are not at equilibrium with the body at large. Thus, one would think that all single injection protocols would be likely to fail.
Certain steroids seem to cause more pain than others. Dexamethasone seems to be the best tolerated, in a dose of 12-24 mg/ml. Solumedrol was reported by Parnes to be more painful (1999).
A trial is being conducted using a gel form of steroids to extend the duration of effect for Meniere's. We feel similarly about this as we do for steroids in general -- it is a temporary treatment for a permanent disease.
The simplest procedure (and the least expensive) reported so far is that of Sennaroglu et al (2001). They had simply had the patient administer dexamethasone themselves through a ventilation tube. A tube is placed in the posterio-inferior quadrant of the TM. Patients are instructed to lie on their side and place 5 drops into the affected ear once every other day. After the instillation, they are to lie with the ear upright for 15 minutes. A low concentration of dexamethasone is used -- 1 mg/ml. This is far less than the amount (4 to 24 mg/ml) used when the drug is injected. We are a bit dubious about this method, as we think that it would be difficult to be know how much steroids entered the ear, and also one would think that perforations would be more common.
While ITS is generally thought to be safe, there are many possible (probably minor) complications (see Doyle et al, 2004).
The common risks are pain, short-lasting vertigo, otitis media, and tympanic membrane perforation.
Pain during the insertion of the drug is common. This is not unexpected as puncturing ones body with needles is usually painful. Pain from the drops themselves are rare, especially if dexamethasone is used, but preservatives in the drops may be painful.
Otitis media was reported in only 1/24 patients using the method of Sennaroglu et al (drops through tube). It seems to be even more rare in patients who have direct injections. When otitis media occurs with a tube in place, the option of using a ear drop such as Floxin is available.
Perforation of the ear drum is a possible complication. Topf et al (2016) reported that 1.6% of 192 patients had persistent TM perforations. All three of their perforation patients recieved multiple injections. This is logical as steroids impair wound healing and one might expect slower closure. Perforation risk is increased by radiation of the ear. This complication can generally be handled by an otologist and the perforation can be closed. However, in our view, the repairs are rarely as "good" as the original equipment, and we think it is best to reserve repeated steroid injections for severe problems that are steroid responsive.
Vertigo. Temporary vertigo can occur when the solutions being used are not at body temperature or if the solutions contain lidocaine. Most patients are able to walk around unassisted after 20-30 minutes after injections. Permanent vertigo and imbalance have not been reported.
Hearing loss: most physicians using intratympanic steroids feel that there is little of any risk of hearing loss (Doyle et al, 2005).
Cost: Otologic surgeons may bill moderately for this 45 minute procedure, possibly repeated 4 times per year. Other similar methods of treating Menieres, such as use of gentamicin instead, cost the same amount but don't need multiple repetitions. Thus, the cost to the health care system of gentamicin treatment is much lower than steroid treatment.
- wrong diagnosis
- microvascular compression
- Poorly defined vertigo syndrome
- Mechanism for Meniere's that is not steroid responsive
- bilateral Meniere's disease
- drug delivery failure
- round window adhesions
- drug rapidly leaving ear via eustachian tube
- Irrational treatment -- as discussed above, it seems rather bold to propose that treatment with a drug that rapidly goes into and out of the inner ear can cure a chronic disease.
Generally it is provided by ear doctors (Otologists -- a subspecialty of ENT). In our clinical practice in Chicago, we refer patients to an otologist. We advise careful investigation of the protocol offered by your local practitioners. We favor the longer durations methods described above. Be sure that someone can monitor your treatment closely.