Ménière's disease

Indications

Ménière’s disease is characterised by recurrent attacks of dizziness, nausea, tinnitus and deafness. Quite a large number of patients also suffer from gastrointestinal disorders and diarrhoea is not uncommon. Attacks of dizziness last between 20 minutes up to a day, but can in some cases last even longer. Attacks are preceded by a few days of tinnitus and reduced hearing in the affected ear. The intensity of the symptoms can vary. Early in the disease the symptoms will disappear in the reverse order they appeared; balance returns to normal, hearing returns and tinnitus disappears. If the disease is in an active phase the attacks may come several times a week and the hearing loss does not have time to heal in between. If the disease is allowed to continue, the loss of hearing and harm to the balance becomes permanent. 

The cause of the disease is unknown, although it is believed it may be due to an elevated pressure in the inner ear leading to severe attacks of vertigo and nausea. The elevated pressure may be caused by hypersecretion of fluids by endolymph cells in the section of the ear connecting the cochlea with the balance organ. The elevated pressure may also be caused by insufficient drainage of fluids from the inner ear. Increased pressure in the inner ear will cause rotatory vertigo. Pressure on the cochlea may cause hearing loss and/or tinnitus. 

Every year 400 persons are subject to the disease. Many believing they are having a brain aneurysm or something even worse. In total it is estimated that 40 000-50 000 Swedes are currently contracted with the disease. 

For more information, view link to yrsel.com


Clinical studies

As the studies with SPC-Flakes® showed, there are some patients that are non-responders when treated with AF inducing specially processed cereals (SPC-Flakes®). Due to the positive results of Salovum®in the treatment of secretory diarrhoea, it was tested on Ménière’s disease as well. 

AF-inducing SPC-Flakes® was tested during a two month period on a 67 year old woman with a thirty year history of  Ménière’s disease. She had frequent attacks lasting for 8 hours up to three days with nausea, vertigo, diarrhoea and vomiting. When the SPC-Flakes ®diet did not improve neither the duration of the attacks nor the severity, she was given Salovum® at a dose of 2 g five times daily to see if this exogenous administration of AF in high concentrations could offer positive clinical results. 

On day 18 of the treatment the patient was completely relieved of her symptoms and her Ménière status was improved from 6 to 1 (American Academy of Otolaryngology). After six months of symptomatic relief the patient lowered the dosage of Salovum® with the result that her attacks with rotatory vertigo returned. Returning to the original dosage level led to immediate improvement without the need for further medication. No improvement, however, could be seen on her right-sided hearing impairment. 

The results show that patients who do not respond to treatment with AF-inducing cereals can be favourably treated with Salovum®. To stimulate the body’s own production of AF it is of value that an introduction of AF-inducing cereals is made in connection with or as a follow-up to Salovum®  treatment. 

Hanner, Jennische and Lange, Antisecretory Factor: A clinical innovation in Ménière’s disease?, Acta Otolaryngol, 2003; 123:779-780, view link  


Expected treatment outcome

A positive treatment effect with Salovum® can normally be seen within a few hours.

After termination of the AF products, a reduced effect can be noticed after a few weeks. If treatment is resumed, AF levels will rise within a matter of days, indicating a biological memory for AF production. 

Salovum® is the recommended AF treatment for patients who have difficulties eating large amounts of SPC-Flakes®. Studies also indicate that patients not responding to treatment with SPC-Flakes® may respond to Salovum®

For seriously ill patients or in patients with suspected low AF-levels, treatment with Salovum® quickly raises AF-levels directly in the intestine. Most often the patients initially treated with Salovum® can thereafter be transferred to the AF-inducing SPC-Flakes® in order to stimulate the body’s own production of AF.


Dosage

The normal dosage of Salovum® is 4 g three times daily. The powder is blended with a cold liquid, e.g juice or water, preferably using a whisk or a blender. 

To stimulate the endogenous production of AF it is favourable to introduce AF inducing cereals, SPC-Flakes®, during treatment with, or as a follow-up treatment towards the end to, Salovum®.


Side effects, interactions and precautions

AF products have been eaten by tens of thousands of individuals and no side effects of medical nature have been reported. A few patients have experienced occasional constipation, but this discomfort can be reduced by a step-by-step introduction of the treatment. 

There are no reported interactions with concomitant medications. This is of importance as the patients should continue with their regular medical treatment. Salovum® should not replace or change the patients’ current medication. Persons with allergy to eggs should not be treated with Salovum®.


Where to buy, Prescriptions

Salovum® can be bought prescription free in pharmacies. As of December 31, 2010, Läkemedelsverket (The Medical Products Agency) has decided to include Salovum® and SPC-Flakes® in the new revised list for food for particular nutritional use for children under 16 years of age  and the cost will thus be included within the national benefit scheme for prescription drugs.

For patients 16 years of age or older, dieticians and most doctors can prescribe Salovum® as “sär-när”, foods for particular nutritional uses certified by the National Food Administration (Livsmedelsverket). The cost of the products varies between the different counties (landsting). 

Sweden: The pharmacies may not have Salovum® in stock, but they can in that case order it within 1-2 days. The reference number (varunummer) for Salovum is 21 06 81 .

Norway: In Norway, both SPC-Flakes® and Salovum® can be prescribed by physicians (blå resept), see links, [http://www.helfo.no/helsepersonell/lege/legemidler/Sider/neringsmidler.aspx] [http://www.legemiddelverket.no/upload/Bl%C3%A5reseptforskriften.pdf]. and link to the Product Catalogue (p 8, Spesialløsninger) [http://www.helfo.no/SiteCollectionDocuments/Vedlegg%20helsepersonell/Grossister%20og%20leverand%C3%B8rer/Produkt-og%20prislister%20fra%2001.07.10/N%C3%A6ringsmidler%2001.07.2010.pdf] Salovum® can also be ordered from Poa Pharma Scandinavia AB, see link  

Denmark: Salovum® can be ordered from Poa Pharma Scandinavia AB, see link  

Finland: Salovum® can be ordered from Poa Pharma Scandinavia AB, see link