http://www.ncbi.nlm.nih.gov/pubmed/26208913 Eur Arch Otorhinolaryngol. 2015 Jul 25. [Epub ahead of print] Expression of histamine receptors in the human endolymphatic sac: the molecular rationale for betahistine use in Menieres disease. Møller MN1, Kirkeby S, Vikeså J, Nielsen FC, Caye-Thomasen P. Author information 1Department of Oto-rhino-laryngology, Head and Neck Surgery, and Audiology, Coepnhagen University Hospital Rigshospitalet, Copenhagen, Denmark, [email protected]. Abstract The human endolymphatic sac (ES) is situated in a duplicature of the dura in the posterior cranial fossa and constitutes a part of the inner ear. The sac possesses immunological capacities and is responsible for a major part of the trans-epithelial ion transport occurring within the inner ear, via molecular mechanisms similar to that of the kidney collecting duct epithelia. Dysfunction of the trans-epithelial ion transport has been hypothesized as the reason for the endolymphatic hydrops occurring in Menieres diseases. Thus, candidate drug selection for medical treatment of Menieres disease has been based on a potential capability of improving trans-epithelial ion transport. However, recent human studies seems to rule out diuretic therapy and The Committee for Medicinal Products for Human Use redrew the recommendation for trimetazidine (Vastarel) treatment in the management of Meniere disease in 2012. This leaves betahistine (Betaserc) as the only drug for potential prevention of the incapacitating attacks of dizziness, tinnitus and hearing loss. However, the histamine receptors targeted by betahistine have never been demonstrated in the human ES. Accordingly, this study aims to investigate the expression of histamine receptors of the human ES epithelium and sub-epithelial stroma. Following sampling of human endolymphatic sac tissue during translabyrinthine surgery, the expression of histamine receptor genes was determined by cDNA microarray analysis. Results were subsequently verified by immuno-histochemistry. The combined results of microarrays and immuno-histochemistry showed expression of the histamine receptor HRH1 in the epithelial lining of the ES, whereas HRH3 was expressed exclusively in the sub-epithelial capillary network. Receptors HRH2 and -4 were not expressed. The present data provide the first direct evidence of a molecular rationale for betahistine treatment in Menieres disease. A potential betahistine effect in Menieres disease may primarily be through the H3-receptor antagonism, leading to inhibition of vestibular neuro-transmission and central vaso-dilation. The H1-receptor localization in the ES epithelium suggests an immuno-regulatory effect.
Interesting to take notice of this statement "However, recent human studies seems to rule out diuretic therapy and The Committee for Medicinal Products for Human Use redrew the recommendation for trimetazidine (Vastarel) treatment in the management of Meniere disease in 2012" SERC 9betahistine) has helped many people with their symptoms and it is exciting to see the researchers found out why. Maybe the FDA will change their minds about it in the near future ad we in the USA can get it more readily and covered by insurance.
Thank you once again Vicky, I don't quite understand what they are Talking about lol but It looks very hopeful
SERC is a drug given to MM patients in most countries of the world, the FDA in the USA feels is does nothing for MM but allows people to get it at a compounding pharmacy (Walgreens has a compounding pharmacy). This study is the first to give evidence why this drug is a useful treatment for MM. I hope that clears it up for you
This is a European study, by European researchers, in the context of European understandings and treatments for Meniere's --- all of which is very different from American perspectives on the disease. Betahistine is virtually unknown and unused in American medical practice for Meniere's. Don't be expecting American practitioners to be rushing to prescribing Betaserc in the coming weeks or months. Instead, the vast majority will continue the first-line treatment of low salt and diuretics; which the abstract of this study indicates is no longer recommended (diuretics: "recent human studies seems to rule out diuretic therapy..."). The FDA prohibits the common prescription and use of commercially fabricated betahistine in the US, claiming it has no usefulness in Meniere's therapy. Physicians can prescribe it, but it must be in a pharmicist-compounded form only. In Europe, the usefulness of betahistine (SERC) has been understood for many years, and it's a first-line treatment of preference. Any quesses on whether or not this lone article in a European medical journal might cause the FDA green eye shade types to post a regulatory notice that SERC can now be conventionally made, sold, and used in the US? Fortunately, we'll continue to be kept safe, both medically and financially from questionable molecules such as betahistine. I'll continue to sleep well each night, knowing I so well-protected. --John of Ohio
My oto prescribes serc. I'm in my first month of it- so far so good. I only take 24 mg per day, but I've read that others take higher doses and it's more effective. When I went to the compounding pharmacy, the pharmacist told me that it's not FDA approved in the U.S. because of the yellow dye they use.
hmm I have read it is because the FDA has not seen any evidence that it does anything for MM but feels it is not harmful which is why they allow us to get it from a compounding pharmacy. I wonder which version is true. Well I found something interesting http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm290733.pdf it is a meeting of FDA officials Pharmacy Compounding Advisory Committee (1999) on page 61 is Agenda Item: Discussion and Vote on Betahistine Dihydrochloride Interesting reading if you have the time. one paragraph states: betahistine was actually approved for marketing in the U.S., labeled for use in Meniere's syndrome. Betahistine under the trade name CERC(?), was the subject of NDA 14-241, approved in the 1960s for marketing. The commercial sponsor was UniMed. In 1970, the Commissioner of FDA withdrew approval of the NDA after the discovery that the submission contained unsubstantiated information about some patients in the efficacy studies upon which approval was based. Betahistine has continued to be marketed in other countries however.
I'm in the U.S. and have been taking Betahistine since last fall, about 9 months. 24mg 3x/day. I have to pay out of pocket and order online through a canadian pharmacy. It ends up being about $95/month... it would have been triple that at a local Walgreens (compounding). While overall, most of my symptoms have slowly gotten worse during that time (cyclical fullness, tinnitus, regular dizziness), I have NOT had a vertigo attack since starting Betahistine, knock wood. Based on my progressive hearing loss my oto is pretty surprised I've NOT had any further vertigo. So, still not a magic bullet for me, but the fact is, even though I might be feeling cruddy a lot of the time, I can take care of my young kids without the fear I used to have about the vertigo returning. KNOCK WOOD.
You might be interested in this study, maybe your dosage is too low? High-dosage betahistine dihydrochloride between 288and 480 mg/day in patients with severe Meniere’s disease:a case series http://www.mediafire.com/view/lpb0v991ew69v66/High-dosage_betahistine.pdf and here is a thread about high dose SERC from our forums http://menieres.org/talk/index.php?topic=28.0
I find interesting the part of the statement: "The sac possesses immunological capacities" With that statement, it makes me wonder why anti-viral treatment is difficult to get approved or your doctor to prescribe? Also, there was on the previous board I believe a topic about LDN (low dose naltrexone) which in the low doses helps to boost your body's own immune response - which would seem to correspond that it could be a more viable treatment option than the randomness that I have read about it being tried. What I read is that naltrexone is a very cheap pill and at the very low dose used for this (1mg or less) it is pennies..
I was taking serc for about two years 2006 to 2008 and it worked well for me. When I was bad with vertigo i took a higher dose but my ent said that taking a higher dose will be of no better benefit than the 3 x 16mg I was taking each day. For tackling and reducing the vertigo he gave me buccastem which I think is similar to ativan, dissolves under the top lip and that worked very well too.
nicmger, there are several new studies out some of which I have posted previously from USA researchers too, how the ES has immunological capabilities and yet many of us have fight to get an AV for MM .
I would love to try the serc , would be scared to get online From another country though. How do you know if its a Reputable company your getting it from? My current oto Teaches in a hospital in France going see what he thinks. Maybe this new study with move things along with this drug.
Lisa you can get it in the USA Walgreens has a compounding pharmacy but you need a prescription for it.
I give credit to Betahistine for much of my progress, probably not all. I've been on 16 mg 3xs a day for around eight years. I get it from a local compounding pharmacy, prescribed originally by an otolaryngologist but now by my ENT. It's expensive and insurance doesn't cover it, but I don't care. It's worth every penny. Margie
I will ask for'a script thank u Vicky , Is it the same drug? What is compounding? The article Mentioned it helps hearing and I believe Tinitus . Is that true?