Mb 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, see link to yrsel.com


Clinical studies

Since the AF products have such favourable results in secretory diseases of the gut, it was hypothesised if this could also be applied to other conditions where fluid imbalances are of importance or can be suspected. 

After several pilot studies a trial was performed at the department of ENT and Audiology at Sahlgrenska University Hospital under the guidance of Professor Per Hanner. The aim of the study was to examine if AF could be induced by pathologically elevated pressure in the inner ear and to study if stimulated AF production can lessen the clinical symptoms of Ménière’s patients. 

24 patients with Ménière’s disease, with a duration between ten months and thirty years, were included in the study. The patients received, in addition to their regular medication, SPC-Flakes® at a dosage of 1 g/kg bodyweight and day, for 2-4 weeks. The patients kept a diary over their subjective and auditive symptoms, and frequency, duration and characteristics of vertigo. Baseline tone and speech audiometry and neurological status was determined as well as AF plasma level before and after the treatment period. 

The concentration of AF in plasma varied between 0-0,6 units before treatment and 0-1,7 units after treatment. 83% of the patients showed an increase of AF above 0,5 units after treatment, the level at which clinical improvement of secretory diarrhoea has been shown in previous studies. In 17% of the patients, little or no increase of AF was seen and they did not experience any improvement of the clinical symptoms either. In 29% of the patients a significant increase of AF was registered but without clinical response. 

In 12,5 % of the patients hearing ability returned to normal levels and vertigo was completely eradicated. In 54% vertigo was improved. The improvements noted ranged from complete remission to remaining light and diffuse feelings of dizziness without previous attacks of rotatory vertigo. 

More than 50% of the patients with severe Ménière’s disease were improved or completely free of symptoms through a simple, cheap and side effect free method. Some patients seem, however, to be unable to produce AF or AF-inducing SPC-Flakes® must be given in a higher dose or for a longer period of time. 

Hanner, Jennische, Lange, Lönnroth and Wahlström, Increased antisecretory factor reduces vertigo in patients with Ménière’s disease: a pilot study, Hearing Research, 2004; 4803:1-6, view link  

In order to validate the positive results with SPC-Flakes® of the pilot study mentioned above, a double-blind, placebo-controlled study in a larger number of patients, has also been carried out. The study included 51 patients aged 12-80 years, in which 27 patients received SPC-Flakes® at a dose of 1 g/kg bw/day, divided on two occasions, in addition to their regular medication for three months. For the control group 24 patients were randomly assigned and they received cereals without AF-inducing properties. Patients in the placebo group were offered SPC-Flakes® after the study closure for three months in an open arm of the study. 

Also in this study, an internationally recognized scale for measuring quality of life and disability produced by experts on balance and dizziness disorders from the AAO-HHS (American Academy of Otolaryngology – Head and Neck Surgery), was used in order to document patients' dizziness symptoms. They have developed a six-point scale to assess a patient's symptoms. Factor 1 means that the patient is almost healthy with sporadic attacks of Ménière’s and factor 6, which is the most severe form, means that the patient is completely eliminated, handicapped, on sick leave, early retired and completely controlled by their illness. 

The study results showed that the AAO-HHS-factor decreased in 14 of 27 patients in the SPC-Flakes® group (p<0,001), while only 2 of 24 patients were improved in the control group. After completion of the double-blind phase of the study the control group was offered SPC-Flakes® for three months. Of the 22 patients who chose to continue with this open part of the study, 17 patients were improved. 

This study confirms therefore the results of previous studies with SPC-Flakes®. About 50% of patients may decrease dizziness as a result of treatment with SPC-Flakes®, which is in line with results of other treatments. The study also shows that the SPC-Flakes® primarily affects the dizziness component, while no effect on hearing ability was seen. The treatment effect of SPC-Flakes® was individual and appeared to be independent of dizziness severity. Of the patients with the most severe symptoms, factor 5 and 6, a significant improvement was reported in 6 of 14 patients, while 8 of 13 patients improved in the groups with less severe symptoms. 

Some patients seem not to have the ability to produce AF, or the AF-inducing cereals in the form of SPC-Flakes® must be given at a higher dose or for a longer time in some patients. Experience also shows that patients that do not respond to treatment with SPC-Flakes® can be helped by treatment with Salovum®. In order to help the body to start its own production of protein AF, it is certainly useful to introduce SPC-Flakes® in connection with or as follow-on to Salovum®

Hanner, Rask-Andersen, Lange and Jennische, Antisecretory factor-inducing therapy improves the clinical outcome in patients  with Ménière’s disease, Acta Oto-Laryngologica, 2010; 130:223-227, see link

SPC-Flakes® comes early among the treatment options According to the HRF (The Swedish Association of Hard of Hearing People), treatment of dizziness associated with Ménière's disease can be placed in a treatment “ladder”. It starts with simple treatments including SPC-Flakes® (mältat havre/malted oats). If the result is inadequate there are different types of drug treatment and more extensive surgical procedures to try, see link


Expected treatment outcome

SPC-Flakes® is a maintenance treatment and the purpose is to stimulate the body’s own production of the AF protein. A positive therapeutic response can normally be seen after 10-15 days. The treatment should last at least one month to determine the effect of the treatment. After termination of the treatment AF levels will decline again after a few weeks. If treatment is resumed, AF levels will rise within a matter of days, indicating a biological memory for AF production. 

In the absence of a treatment effect with SPC-Flakes® this may be due to the dose being too low or that some patients’ bodies are unable to produce AF. Clinical studies demonstrate that these patients might be helped with Salovum® which is a way of supplying high doses of the AF protein without having the body produce it on its own.


Dosage

Normal dosage of AF-inducing cereals, SPC-Flakes®, is 1 g/kg bodyweight daily, divided into 2-3 occasions. When treating children the dose may need to be increased and when treating elderly it may need to be reduced. The dosage should be introduced step by step and reach full dosage after 4-6 days. The cereals can be eaten with yoghurt or boiled to a porridge without loosing the effect. 1 dl of SPC-Flakes® equals approximately 50 g.

 


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. SPC-Flakes® should not replace or change the patients’ current medication. Persons with coeliac disease or gluten intolerance should not be treated with SPC-Flakes®.


Where to buy, Prescriptions

SPC-Flakes® can be bought prescription free in pharmacies or in health food shops. As of December 31, 2010, Läkemedelsverket (The Medical Products Agency) has decided to include SPC-Flakes® and Salovum® in the new revised list for food for particular nutritional use for children under 16 years of age (“Särnär”, LVFS 2010:27 ) 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 SPC-Flakes® 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).