Meniere's Disease treatments that may be placebos
Timothy C. Hain, MD Page last modified: December 25, 2011
It is best to be skeptical about new treatments for Meniere's.
because the 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 # 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 because the cost/benefit ratio is reasonable.
This is a homeopathic remedy, and therefore 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 docments that it contains small amounts of various vitimins 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 ingrediant -- olive oil).
The endolymphatic shunt is used by some doctors 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.
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, or because what it is treating (hydrops) is a symptom itself rather than a cause of symptoms. We favor the first explanation.
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). A recent trend is to make an attempt to damage the sac, in addition to improving its drainage. As the sac is the immune organ of the ear, this idea makes 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.
(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 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, which is 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.
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. A recent 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 autoimmune based 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 2010), we advise extreme caution. 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 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.
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 ingrediants -- 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.
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.
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