Meniere's Disease treatments that may be placebos
Timothy C. Hain, MD Page last modified: August 20, 2016
It is best to be skeptical about new treatments for Meniere's.
Because Meniere's disease fluctuates, very large numbers are needed to prove that a treatment is effective. In other words, one can easily by chance have a sequence of patients who do well on any particular medication or device, which is actually a placebo. Considerable data supporting this idea has been put forth by Torok (1977) and Ruckenstein (Ruckenstein et al. 1991). Torok (1977) reviewed an immense number of bizarre devices. We are fortunate to live in a country with considerable ingenuity, but although more bizarre devices have been developed since them, so far, there is no magic bullet for Meniere's.
Here is the bottom line --
So, the rational approach to Meniere's is to confirm your diagnosis, exhaust the medical treatment, and if things are really bad, go on to a destructive treatment (especially low-dose gentamicin).
A full discussion is under the link. We recommend a try of betahistine in Meniere's because the cost/benefit ratio is reasonable.
This is a homeopathic remedy, and therefore it is almost certainly a placebo. It is advocated for Meniere's disease, and nearly any ear condition. As a placebo, it has no side effects.
This is a multivitamin preparation. The literature documents that it contains small amounts of various vitamins and lemon extract. The pamphlet presents no evidence or data that it works. It is marketed by the same group that markets "all natural ear wax removal system" (active ingredient -- olive oil).
The endolymphatic shunt is used by some doctors hoping to relieve pressure in the inner ear. It involves opening up the endolymphatic sac, with the thought that this may reduce pressure in the inner ear. Generally, opening up the sac also does damage to the sac, so this procedure may actually just be a method of damaging the sac (see below).
Shunts are often recommended by otologic surgeons (Kim et al, 2005). Unfortunately, while the shunt would seem to be a logical thing to do, in most studies, the shunt procedure does not appear to be better than doing nothing (e.g. Silverstein and Rosenberg, 1992), or doing a sham (placebo) surgery (Bretlau et al, 1981; Thomsen et al, 1981, see references below). This lack of effect may be because the shunt can easily get plugged up, because what it is treating (hydrops) is a symptom itself rather than a cause of symptoms, or because the whole concept of the sac being a drain is just wrong. We favor the first and third explanations.
Similar to shunt surgery is endolymphatic sac decompression surgery. This is a process where an ear surgeon drills bone around the area of the sac in the mastoid bone. Again, we advise against this surgical procedure.
We do not presently recommend this procedure for our patients except in very unusual situations. These may include a person who has perfectly normal hearing, or an older person who might not tolerate the gentamicin procedure described above (Pensak and Friedman, 1998; Gianoli et al, 1998).
Sac ablations ?
A recent trend that runs completely opposite to the logic of the shunt is to purposefully damage the sac -- crushing it, drilling it out, drilling around the sac, or putting clips on it. As the sac is the immune organ of the ear, damaging the sac makes a some sense if one is attempting to immunosuppress the ear.
More about shunt surgery can be found here.
Fattori et al, Audiology 35(6):322-34, 1996. These authors report the results of treatment for 15 days with 90 min. sessions of a pressure chamber. They report better hearing results in the treated patients. Comment: lacking a reasonable mechanism and also considering the general problems with placebo responses in Menieres (see the classic paper entitled Old and New in Menieres, by N. Torok), this treatment remains unsubstantiated.
|Intratympanic injection of medication.|
We have recently moved this discussion into the main Menieres page, as it seems now to be a "emergent" treatment rather than a placebo. Perhaps "passing fad" would be a better word than emergent -- we find it hard to follow the logic of using a drug that is gone in a few days, to treat a chronic illness. Nevertheless, there is a literature to support this endeavor.
(Adunka, Moustaklis et al. 2003) In this treatment, lidocaine and Kinetin are instilled into the middle ear using transtympanic injection. A remission was reported in 66% of patients. It is difficult to see why a local anesthetic that is gone in hours at most should cause a long lasting remission. Kinetin is a plant growth factor, pesticide, and an ingredient in skin preparations. Perhaps Kinetin has a positive effect on Meniere's disease.
Latanoprost. Rask-Andersen et al . (Otol HNS 2005, 133, 441-443). These authors from Sweden report injections of this drug through the ear drum once/daily for 3 days. 9 patients were studied. They report improvements in vertigo (30%) and hearing. This drug, used for treatment of glaucoma, has been here tried in the ear. The apparent rationale is reduction of hydrops. This small study shows that it is feasible to use this drug. It is too small to say if it is truly useful. It is difficult to see how one would administer this drug chronically. Still, there is some promise here.
Price et al (Arch Otol HNS 120:209-11, 1994) reported a case where Lupron alleviated the symptoms of Menieres. Comment: Lupron is a drug which shuts down natural production of sex hormones. Our assessment at this writing is that the cost/benefit ratio of this drug is not reasonable.
|Meniett device ($3500)||Aquarium pump ($35)|
This device, developed in Sweden, and sold in the US by Medtronics, incorporates a ventilation tube and pulsed pressure to the ear using a device that appears rather similar to an aquarium pump. The Meniett costs $3500 -- roughly 100 times as much as an aquarium pump. It is reported to reduce attacks by roughly a factor of two. We have not observed this effect in patients that we have followed. According to a recent systemic review that included 18 studies (Ahsan et al, 2014), there was "a trend toward improvement". This is not a factor of two.
A systemic review of the Meniett device (Syed et al, 2015) stated that "No evidence was found to justify the use of the Meniett device in Meniere's syndrome/disease." A Cochrane review (von Sonsbeek et al, 2015) similarly concluded that " There is no evidence, from five included studies, to show that positive pressure therapy is effective for the symptoms of Meniere's disease. " Russo et al (2016) found no difference between Meniett patients and Placebo.
The method is to have a ventilation tube put into the symptomatic ear, and then to apply pulsed pressure 5 times/day using a pump as shown on the upper left.
It is claimed to improve Meniere's disease by means of altering endolymphatic pressure. It is difficult to comprehend why pulsed pressure should be beneficial. Some have suggested that this device "milks endolymph through the endolymphatic valve". We are just not familiar with the anatomic location of the "endolymphatic valve". Nevertheless, the Meniett "process" might be effective in people who actually have a perilymphatic fistula and who are misdiagnosed as Meniere's disease. In this case, we would think that the "active effect" is from the ventilation tube rather than the Meniett pump. We think that those who are dead-set on using this device should consider just having the tube put in first, and seeing how they do, prior to purchasing the Meniett.
Cost: Surgery is required to use this device to put in a tube, and the device itself is expensive (about $3500). According to the manufacturers web site (see link), less than 100 patients have been used in studies which suggest its effectiveness. An industry funded study by Gates et al (2004) suggested that the device is helpful (based on 66 more patients). However, there are some potential problems with the study in that it may not be possible to "blind" people to use of an active device. It is also difficult to see any reason why this device might work, especially considering contemporary theories of the etiology of Menieres. Fortunately, one can get a refund of the $3500 price of the Meniett device itself if it is ineffective (at 6 weeks).
Bottom line: At this writing (mid 2016), we advise avoiding this device. It might be considered just prior to going on to a destructive treatment (but we wouldn't suggest doing it). Less than 10% of practicing otologists routinely recommend this device (Kim et al, 2005). We do not recommend this device in our practice in Chicago. We are NOT recommending use of an aquarium pump for Meniere's either! (:
(Gabapentin). Comment: This new drug which is indicated for treatment of seizures and pain also may be helpful in patients with vestibular disorders. No studies are available regarding this use. We have had encouraging results in patients with ongoing nystagmus.
This is a berry extract sold by "Young Living", containing "essential oils". One of my patients had a a substantial hearing improvement, associated in time with using this product. We ourselves have no opinion at all about this product's utility in Meniere's.
Oatmeal -- Salovum and SPC-Flakes (Antisecretory factor)
SPC-Flakes are a variety of oatmeal, rolled oats, advocated for Meniere's disease. The idea that oatmeal might improve Meniere's is of course, implausible, and logically one would be wondering if this was a statistical problem as plagues most studies of Meniere's (e.g. Torok, 1977; Ruckenstein et al, 2001). There have been a whole series of underpowered (i.e. too few patients) studies of this oatmeal product. This commercial product was initially based on a study done in 1998 at a Swedish Hospital, which is not accessible through Pubmed. Hanner et al (2010), another Swedish group, studied 51 patients, and reported decreased vertigo in about half. Hanner and associates have published 3 positive studies regarding this product. Leong et al (2013) in 39 patients, suggested that more than half of patients reported subjective improvement. A more recent tiny study based in Denmark of 32 patients suggested that it was a placebo. (Ingvardsen and Klokker, 2015). These studies are small and as they deal with an expensive commercial product, bias could be a problem.
At this writing, early 2016, it appears to us that the jury is still out on oatmeal treatment for Meniere's. Our guess is that it is a placebo given that the studies are underpowered. Meniere's is not uncommon -- in the author's practice, we have more than 500 patients in our database. One would think that a larger study would not be so difficult. At some point, a Cochrane review process might be in order.
It has been reported that section of middle ear muscles is useful in Meniere's disease (Franz et al, 2003). The rationale for this procedure is difficult to follow, and we would like to see more studies before recommending this procedure. It may be another placebo treatment.
This is another multi-ingrediant preparation, that seems aimed mainly at dizziness and nausea. It has two main active ingredients -- dimenhydrinate (dramamine), and ginger root. As of 2/2011, they sold 60 tablets for $14. We can easily find better deals on the web. These components are also available in the drugstore under their ordinary names.
Treatment in general. Several authors from the Cleveland clinic (Am J Otol 18:67-73, 1997) surveyed long term hearing results and quality of life in patients with Meniere's. They concluded that no statistically significant results was detected in long-term hearing in medically or surgically treated patients compared to untreated patients. Comment: this study adds more support to the general opinion that there is no effective treatment that prevents hearing loss in Meniere's. However, nearly everyone agrees that treatment does influence dizziness.
In a dramatic and misleading article, Anu Passary, evidently a writer for "Tech Times", put an article online titled "Cure for Meniere's disease discovered ?"
Here Anu interviewed Dr. Carol Foster, an otolaryngologist at U. Colorado, suggesting that Meniere's was linked to migraine. Somehow Anu turned this into "cure for Meniere's". Unfortunately, this is just wrong. It is well known that Meniere's and Migraine are linked -- from papers going back far before Dr. Foster's work. This is irresponsible journalism to suggest that a well known link between two illnesses is somehow the same as a "Cure for Meniere's disease". Both the writer and the "tech times" should be ashamed that they published an misleading article like this. If Tech times were a scientific journal, a retraction would be in order. However, it is just an online newspaper, evidently with no "fact checking".
There is a mixed literature about implantation of ventilation tubes for Meniere's disease. It may be another placebo treatment, but it is easily done, and generally harmless too (see "last resort" section). Eustachian tube malfunction does not appear to generally modulate Meniere's disease (Maier et al, 1997).
A homeopathic medication. A variant of cocculus, almost certainly a placebo. A recent study suggested that Vertigo-Heel was equally effective to betahistine (Serc) (Klein, 1998). This doesn't say much for Serc.
In 2010, Dr. Jay Rubinstein at the University of Washington implanted a "vestibular prosthesis" in a human being, with the idea that when the vestibular nerve is temporarily shut down during a Meniere's attack, the patient can turn on the prosthesis to stimulate the nerve until the inner ear recovers (in a few hours). Thus, during the attack, one would have one inner ear that is disabled, and another that is still working (responding to head motion). This would be an improvement over the natural situation where the neural activity in one ear is disrupting function of the entire balance system.
Lets look at the logic of this device. The goal is to block vertigo for a few hours by returning the vestibular nerve function on one side to baseline. There are very substantial practical problems involving in matching the adjusting the output of the stimulator, both in amplitude and vector. Even if it were to work perfectly, the individual with Meniere's would still be working with half of their vestibular function -- not enough we would think for most people to walk or drive. The input to the ear from the prosthesis, very likely not perfect in amplitude or direction, may cause an unnatural input that could be very disturbing. In other words -- this device can't "fix" Meniere's due to very substantial engineering challenges.
The risks and costs of this device are substantial -- surgery to implant the device with all the associated medical risks, and the cost of the device itself. Overall, we think that there are very few people for whom this device might be helpful, but it will be interesting to see what emerges from this trial.
This element has also been suggested as being helpful for vertigo. There are no references on this in Pubmed. Most feel that Zinc is a placebo when used to treat Meniere's disease.
Zyvestra -- placebo
This homeopathic medication is almost certainly a placebo, supplied as a cream and as a pill. Homeopathic preparations are nearly always placebos due to their nature involving very high dilutions.
More -- on this page, we have more commentary about devices for dizziness (not necessarily Meniere's).