Sunday 20 May 2012

Salovum & SPC-Flakes: How Antisecretory Factor (AF) Can Decrease Meniere’s Disease Vertigo


One of my wonderful readers (Kim from Cairns) asked me if I knew anything about two products that she’d heard may assist with Meniere’s Disease vertigo: Salovum & SPC-Flakes.

I must say that I’d never heard of either product, so I’ve spent the last few days extensively searching news articles, press releases, PubMed articles, IP patents & corporate websites (in languages including: Swedish, Norwegian, and English) and this is what I came up with.

It’s a lot of information, but considering how hard it was to find anything on the products, I thought it best to just get as much as possible on one page. Readers of this post will then be able to make an informed decision when considering adding either or both of these products to their Meniere’s management program.

In Brief: What are Salovum® & SPC-Flakes®?

Salovum® & SPC-Flakes® are genetically modified foods classified as “food for special medical purpose”. Both products deal with a protein called Antisecretory factor (AF) which normalizes fluid and ion transport across cell membranes in the body's cells. (Read more about Ions below.)

Salovum® is a source of protein AF in the form of the concentrated egg yolk powder B221®, while SPC-Flakes® is a specially produced oatmeal engineered to stimulate the body’s own production of protein AF.
 

What is Antisecretory Factor (AF)?

Antisecretory factor (AF) is a protein secreted in plasma and other tissue fluids in mammals with proven antisecretory and anti-inflammatory activity; its immunohistological distribution suggests a role in the immune system. The expression level and the distribution of AF protein are altered during an immunological response.
Note: If you haven’t already read my post on PNI & Herpes Viruses which discusses the immunological response and how I believe it contributes to Meniere’s Disease, I recommend you read it. Ménière’s Disease: Is Psychoneuroimmunology (PNI) & Herpes the Cause?

Antisecretory factor (AF) (or ASF as it was abbreviated in the 1980’s) was discovered by Swedish Microbiologists / Immunologists Stefan Lange & Ivar Lönnroth in the early 1980’s. Most of these early studies focused on cholera associated diarrhoea, as well as post-weaning diarrhoea in piglets.

Some of AF’s uses are for conditions caused by a traumatic, auto-immune or degenerative disorders. 

AF is also claimed by the patent owner to be useful for:
“…inducing improved rescue of injured or diseased nervous tissue, proliferation, apoptosis, differentiation and/or migration of an embryonic stem cell, adult stem cell, progenitor Cell and/or a cell derived from a stem cell or progenitor cell, for treating a condition characterised by or associated with loss and/or Gain of cells. In a preferred embodiment, the condition is a neurotrauma or a condition or disease of the CNS and/or PNS and/or ANS, for example, Alzheimer’s disease.”

Note:
I think it’s interesting that Antisecretory factor (AF) can inhibit diarrhoea. A number of people I have met who have Meniere’s Disease have stated that they have experienced diarrhoea in conjunction with a Meniere’s attack. On a few occasions I have had the need to stagger/run to the restroom during acute Meniere attacks to deal with vomiting & diarrhoea.

Most ENTs &GPs are not aware that diarrhoea can be a symptom during a Meniere’s attack. Once I was admitted to a major public hospital emergency room in Brisbane (Queensland) during an acute Meniere’s attack (4+ hours). I informed the young doctor of my symptoms. Upon hearing that one of the symptoms was diarrhoea he promptly dismissed my claim that I was having a Meniere’s attack and foolishly diagnosed me with food poisoning, saying that diarrhoea is not a symptom of Meniere’s attacks. This was about eight months after my official Meniere’s Disease diagnosis, so I knew the difference between a Meniere’s attack & food poisoning. That was the first & last time I went to that hospital for treatment.

Who Makes Salovum® & SPC-Flakes®?

Salovum® & SPC-Flakes® are registered trademarks of a Swedish company, Lantmännen AS-Faktor AB.

According to Lantmännen AS-Faktor’s website, they develop and produce highly refined products from Swedish farms. Some of the research and development is based on the Swedish discovery of a protein called AF. The company has operations in the areas of medical food and special animal feeds. The company also engages in extensive research in pharmaceutical development with several high-profile Swedish universities and researchers.

Products developed by Lantmännen AS-Faktor include Trygge, SPC-Flakes, Magiform and Salovum.

Many of the company's products are patent-protected, for such purposes as for the use of malted cereals or egg yolk for producing a food or medical food for the treatment and/or prevention of a condition associated with or characterised by a pathological loss and/or gain and/or rescue of nervous tissue.



What is Salovum®?

Salovum® egg yolk powder contains protein with antisecretory properties in a much higher (500 times) concentration than found in normal hen eggs. This is achieved by feeding hens with specially-processed cereals, capable of inducing production of protein with antisecretory properties in the yolk, from which an egg powder is produced.

Salovum® can/has:
·         be used in the acute phase or as the beginning treatment of patients with a presumed low amount of AF.
·         normalize fluid flow. This is of clinical significance within bowel diseases, diarrhea, Mèniére and Mastitis.
·         also been shown to have an anti-inflammatory effect which was seen in studies of inflammatory bowel disease (IBD) like Colitis Ulcerosa and Crohn’s disease.

Although Salovum appears to be safe for short-term studies, I could not find any information on potentially long-term adverse effects.

Description: Food for special purposes.
Application: Meniere and secretory bowel disorders.
Important: Salovum should be applied in consultation with your doctor or dietician. Recommended for children over 1 year and adults. Must not be given parenterally.
Dosage: 1 serving 3 times daily or as your doctor's instructions. The recommended dose should not be exceeded.
Preparation: Salvoum dissolved in cold liquid / juice. Best results are obtained with the juice. Salovum can be sprinkled on bread or stirred into an omelette.
Warning: People with egg allergies should avoid Salovum.
Further information: Contact your doctor or dietician.
Packaging: 1 pack of 25 sachets x 4 g each

Excerpt from:
CLINICAL STUDIES AND CASE REPORTS:
The AF Protein a Clinical Innovation of Endogenous Origin

Treating Mb Ménière with Egg yolk powder B221®
As the study above showed, there are some patients that are non-responders when treated with AF inducing specially processed cereals (SPC). Due to the positive results of Egg yolk powder B221® in the treatment of secretory diarrhoea, it was tested on Ménière’s disease as well.

AF-inducing SPC was tested during a two month period on a 67 year old woman with a thirty year history of Mb Ménière. She had frequent attacks lasting for 8 hours up to three days with nausea, vertigo, diarrhoea and vomiting. When the SPC diet did not improve neither the duration of the attacks nor the severity, she was given Egg yolk powder B221® 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 Egg yolk powder B221® 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 Egg yolk powder B221®. To stimulate the body’s own production of AF it is likely that an introduction of AF-inducing cereals in connection with or as a follow-up to Egg yolk powder B221® treatment will be found valuable.

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



What are SPC-Flakes®?

SPC-Flakes® (specially processed cereals) are specially produced oatmeal made with a unique and patented production method. SPC-Flakes® are used as  ”maintenance” treatment to stimulate the body’s own production of protein AF.

In 1998 the Sahlgrenska University Hospital undertook a study of SPC-Flakes on patients with Meniere’s Disease with successful results (see pages 6 & 7 of the PDF).  

SPC-Flakes® can/have:
·         normalize fluid flow. This is of clinical significance within bowel diseases, diarrhea, Mèniére and Mastitis.
·         also been shown to have an anti-inflammatory effect which was seen in studies of inflammatory bowel disease (IBD) like Colitis Ulcerosa and Crohn’s disease, rheumatoid arthritis and mastitis.

SPC Flakes should be used in consultation with a physician or clinical nutritional physiologist.

Mechanism of action: Stimulates the body to increase production of AF (Antisecretory factor), a protein that normalizes fluid and ion transport across cell membranes in the body's cells.
Dosage: 1g/kg body weight or the physician's recommendations. (Therefore a person weighing 80kg might take 80gms of SPC-Flakes. Should be used (2 to 3 times) a day. 1 ml of SPC-Flakes is equivalent to approx. 50 g
How do you eat SPC-Flakes:   SPC-Flakes can be eaten plain, for instance buttermilk or yoghurt. SPC-Flakes may be cooked like porridge: 1 cup SPC-Flakes boiled for 3 minutes with water and a pinch of salt. Let the porridge sit for a few minutes before it is eaten, add raisins and/or cinnamon for taste. Can be used in baking.
Warning:  Must be eaten with caution in gluten allergies (see more information on a gluten free option below). 
More information: Contact your doctor or clinical nutritional physiologist.

Excerpt from:
CLINICAL STUDIES AND CASE REPORTS:
The AF Protein a Clinical Innovation of Endogenous Origin

SPC-treatment of Ménière’s disease
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 Sahlgrenska University Hospital under the guidance of Per Hanner. The aim of the study was to examine if AF could be induced in cases of pathologically elevated pressure of the inner ear and to study if stimulated AF production can lessen the clinical symptoms of Mb Ménière patients.

24 patients with Mb Ménière, with a duration between ten months and thirty years, were included in the study. The patients received, in addition to their regular medication, a SPC-diet at a dosage of 1 g/kg body weight a 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 eradica-ted. 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.

Symptoms were either reduced or in complete remission in more than half of the patients with severe Ménière’s disease who were treated with a simple, inexpensive and well tolerated treatment. Some of the patients, however, did not seem to have the ability to produce AF. They may need AF inducing cereals in higher concentrations or for longer treatment duration.

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

Can People with Gluten Intolerances Eat SPC-Flakes®?

No, however Lantmännen AS-Faktor has joined forces with Svalöf Weibull (SW) and Lantmännen Mills to formulate a process chain which allows rolled oats to be produced without the addition of wheat, rye or corn, in order to cater for people with a gluten intolerance. These 100% rolled oats will be sold by Semper - one of the largest players in gluten-free products in Sweden.

Some IKEA stores stock Semper food products, so next time you’re at an IKEA (the small goods section outside the checkout area) ask if they stock an AF SPC 100% oat product by Semper. They may not know what you’re talking about but it doesn’t hurt to ask.

I’m not sure if this link is Semper’s AF SPC 100% oat product, but you can always email the company to ask. Semper Gluten Free Products


Where Can You Buy Salovum® & SPC-Flakes®?

I have only found two online stockist of Salovum® & SPC-Flakes®. POA Pharma Scandinavia and an independent distributor.

Considering the cost of the products & their weight, I think that Salovum® would be the most cost effective product for international residents to start with. Salovum® offers more “bang for the buck” because it is more highly concentrated. If you live outside of Scandinavia, you might need to order 2 or 3 boxes of SPC-Flakes® just to get you through two weeks, and I’m sure international postage & handling costs would make this an expensive endeavour.


POA Pharma Scandinavia

Buy Salovum®
25 x 4gm sachets
120,00 Euro. (currently AUD $156) Shipping expenses will be added. 
Note: The above study used 10gms daily (2gms x 5 times). Based on this you might need 300gms (3 boxes) to try the product for one month. It's not cheap, but it could make all the difference if you've exhausted other Meniere's management options.

450 g box 
12,00 Euro. (currently AUD $15.60) Shipping expenses will be added. 
Note: The above study used 1gm per 1kg of body weight daily. Based on this an 80kg person woiuld need 80gms daily. Over 2 weeks 2.5 boxes would be needed as there would only be 5.5 servings per box for a person weighing 80kg. This would be cheaper to try than the Salovum (although postage & handling would likely be more expensive due to the bulk of the product), however it would likely be less effective. Still, it's an option.

Independent Distributor
Note: Use the Google translation function to view these pages in English.

Buy Salovum®
            No price currently listed.

Norwegian Kr. 99.00 (currently AUD $16.85)


MORE INFORMATION:

Product Info Contacts:

POA Pharma Scandinavia
Phone: +46 31 788 0599
Email:  info@poaab.com

AS-Faktor

Lantmännen AS-Faktor

Semper


What’s an Ion & What’s its Role in the Inner Ear?

An Ion is an atom or molecule in which the total number of electrons is not equal to the total number of protons, giving it a net positive or negative electrical charge. Ions allow a current to pass between electrodes in a solution when an electric field is applied.

Water is comprised primarily by the following ions:
Cations (positively charged Ions) – Calcium (Ca²+), Magnesium (Mg²+), Sodium (Na+) & Potassium (K+)
Anions (negatively charged Ions) – Bicarbonate (HCO3-) / Carbonate (CO32-), Sulphate (SO42), Chloride (Cl-)

Those with Meniere’s Disease reading this will recognise the mention of Sodium & Potassium, as these ions make up the Perilymph and Endolymph that regulate the electrochemical impulses of the inner ear hair cells.

Sodium (Na+) is the main Cation in Perilymph. Potassium (K+) is the main Cation in Endolymph. The electric potential of Endolymph is ~80-90 mV more positive than Perilymph due to a higher concentration of Potassium compared to Sodium .

For more on Ions read this Wikipedia page HERE


PubMed Articles

Antisecretory Factor (AF)

2003

European Patent for NOVEL USE OF ANTISECRETORY FACTOR


Antisecretory factor-inducing therapy improves the clinical outcome in patients with Meniere’s disease.pdf


ANTISECRETORY FACTOR AND ITS BIOLOGICAL ACTIVITIES PDF


SPC-Flakes®

2010
Italy

2010
Sweden

Salovum®

2011
Bangladesh & Switzerland

2007
Pakistan

 Disclaimer
This website contains general information about medical conditions and treatments. The information is not advice, and should not be treated as such. The medical information on this website is provided without any representations or warranties, express or implied. Beatrice T via the Inner Ear Journey blog makes no representations or warranties in relation to the medical information on this website. Without prejudice to the generality of the foregoing paragraph, Beatrice T via the Inner Ear Journey blog does not warrant that:
- the medical information on this website will be constantly available, or available at all; or
- the medical information on this website is complete, true, accurate, up-to-date, or non-misleading.
You must not rely on the information in this document as an alternative to medical advice from your doctor or other professional healthcare provider. If you have any specific questions about any medical matter you should consult your doctor or other professional healthcare provider. If you think you may be suffering from any medical condition you should seek immediately medical attention.
You should never delay seeking medical advice, disregard medical advice, or discontinue medical treatment because of information on this website. Nothing in this medical disclaimer will limit any of our liabilities in any way that is not permitted under applicable law, or exclude any of our liabilities that may not be excluded under applicable law.

HAVE YOU USED SALOVUM &/OR SPC-FLAKES TO CONTROL YOUR MENIERE’S DISEASE? If so, share your comments below.

8 comments:

  1. Hi Beatrice, thanks for the well researched information above. I have another question! I read your posts about your Dexamethasone injections and how you backed off from the idea of Gentamicin. I have just been referred by my ENT to a Dr Black in Brisbane who apparently specialises in low dosage Gentamicin injections as opposed to the higher dosages that have been traditionally used. I see Tim Hain from the US is a big supporter of this procedure. I'm wondering if you have come across any quality evidence of its effectiveness.
    Kim

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    Replies
    1. Hi Kim,

      Thank you again for commenting.

      There’s a study published on PubMed a few months ago titled, “INTRATYMPANIC TREATMENT OF INTRACTABLE UNILATERAL MENIERE DISEASE: GENTAMICIN OR DEXAMETHASONE? A RANDOMIZED CONTROLLED TRIAL”.

      It concluded that “Low-dose ITG achieved better outcome than ITD in the control of vertigo attacks in patients suffering from unilateral MD, with a very low incidence of hearing deterioration. ITD offers poorer vertigo control rate, and hearing preservation is achieved only in cases with no vertigo recurrences.” Based on that study alone, it would appear that low level Gentamicin is preferable over low level Dexamethasone.

      I haven’t personally haven’t had a Gentamicin injection. I have spoken with a few older people (in their 70’s) who have had a couple of intratympanic Gentamicin injections and found it to worked well for them, which is great. However I am still young-ish and I would prefer to hold onto as much of my balance & hearing mechanism as I possibly can. Gentamicin might be a good option for an older person who already has a relatively sedate lifestyle, some age related hearing loss and who is willing to wipe out their vestibular for the potential cessation of all vertigo attacks.

      But as a young person, why would anybody be willingly kill their vestibular AND their hearing with the ototoxic Gentamicin when there is another option. The steroid Dexamethasone isn’t ototoxic. It won’t kill your vestibular or cochlea. An intratympanic Dexamethasone injection will supress the immune reaction in the inner ear, which reduces inflammation, which then allows the fluid to move better, which then stops the accumulation of Endolymph which causes the Cochlear Hydrops of Meniere’s Disease and vertigo attacks. Simple.

      By contrast Gentamicin kills the hair cells of the inner ear (both vestibular & cochlea). This stops the treated ear from sending any hearing or balance signals to the brain. Over the coming months (with vestibular rehabilitation therapy) the brain gets used to no signal and learns to compensate. Vertigo attacks should stop because there is no signal. Patient is left with no hearing in that ear and a constant sense of disequilibrium. Not so simple.

      Furthermore, if I had the choice between multiple smaller injections OR a larger once-off injection, I know I’d take the latter. Getting to a medical appointment is a hassle. It takes time & money (taxis, time off work) plus more appointments mean more fees for the ENT. Plus who wants to have their eardrum sliced open more than necessary or kept open with a grommet? Not me. Also I suspect that many ENTs are unfamiliar with Dexamethasone and prefer to tread the well-worn path of Gentamicin.

      I had a high dosage (40mg) of Dexamethasone injected once 9 months ago and it has worked well for me. I have booked in for another intratympanic Dexamethasone injection next month as I feel that I could do with another one.

      Everybody is different, but for my money I’d go a high dose of Dexamethasone over a low dose of Gentamicin any day.

      Kim, I really hope that whichever way you decide to go that it works well for you. Keep me posted on your outcome.

      Best wishes,

      Beatrice :-)

      Delete
    2. Hi Kim,

      If you're reading this post, I just wanted to see how you went with the intratympanic injection? It would be good to hear an update from you.

      Cheers,

      Beatrice

      Delete
  2. I suffered terribly for the first 6 months of my menieres. I had several dexamethasone injections which? Only gave temporary relief. After one terrible episode the attacks stopped 3 months ago. I still have some tinnitus and hearing loss. I took the spc flakes a month into my remission and used them daily for 4 weeks. Not sure if it helped but it is 4 weeks after and I just had my first taste or a relapse waking up to a few seconds of rotary vertigo. I just took 2 packets of the salovum. I will continue it now over the next week. I may then order more.

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    Replies
    1. Hi Robin,

      Thank you for your feedback on Dexamethasone & SPC-Flakes.

      I have read that some people require more than one intratympanic Dexamethasone injection to control their vertigo.

      The SPC-flakes are meant to stimulate your body to produce anti-secretory factor, whereas Salovum is more of a supplement.

      I will be ordering some Salovum & SPC-Flakes soon to try myself.

      Let me know how you go with it.

      Cheers,

      Beatrice ;-)

      Delete
    2. Did someone tried Salovum for Meniere treatment?

      Delete
  3. The products are now available from Orpharma in Australia
    Www.orpharma.com
    Enquiries@orpharma.com

    ReplyDelete
  4. Beatrice, Do you have a view about the oto -104, as it has been hyped up as a miracle answer for MD, but from what I understand it is only dexamethasone but a slow release formulation.

    ReplyDelete