Rheumatoid arthritis

Indications

Rheumatoid arthritis, in short RA, is one of several chronic diseases affecting the joints, characterized by the inflammation of cartilage, bone and joint lining. The inflammation will eventually result in damage to the involved joint. Inflammation can even affect skin, eyes and internal organs. 

RA is an autoimmune disease in which the immune system attacks healthy joint tissue. It is the most common inflammatory rheumatic disease. The cause of RA is not known but there seems to be an inherited tendency. A general theory among experts is that the disease develops due to disturbances in the immune system. What causes the immune system to react and attack body tissue is not yet certain. 

RA occurs in approximately one percent of the population and women are three times more prone than men. Although the disease often begins in middle age and occurs with increased frequency in older people, children and young adults also develop it.

Early in the disease, people may notice general fatigue, soreness, stiffness and aching before symptoms appear in the joints. 

Pain and swelling may occur in the same joints on both sides of the body and will usually start in the hands, fingers or wrists. The inflammation causes swelling and pain in joints. The pain and stiffness is most pronounced in the morning and diminishes during the day. Symptoms may recede in periods, but will return. Most joints in the body can be affected but it is not possible to predict which or when. 

Surgery is available if the joints become damaged and mobility is reduced. The joint is then either replaced or fixated. The pain is thus reduced and the patient is again able to perform daily chores.


Clinical studies

As earlier studies had shown that AF-inducing cereals had a positive effect on symptoms and disease processes in diseases of inflammatory nature, it became of interest to study what effect AF-inducing cereals (SPC-Flakes®) may have on the activity of rheumatoid arthritis. 

In a randomised, double-blind, placebo controlled study patients with active rheumatoid arthritis were allocated to either SPC-Flakes® or control cereals. The cereals were given at a daily dose of 0,5 g/ kg bodyweight, divided into three doses daily, for 12 weeks. This dosage is lower compared to normal dosage (1g/kg bw). Prior medication remained unchanged (methotrexate and salazopyrin) and no patients were currently on cortisones. CRP, DAS 28 (Daily Activity Score measured in 28 joints) and HAQ (Health Assessment Questionnaire) was recorded at baseline, and after 4 and 12 weeks of treatment. 16 patients in the treatment group and 18 in the control group followed through. 

The results show a significant increase of AF-levels in the SPC treated group (Table 1).

Tabell 1. Mean plasma AF-concentrations compared by paired t-test.

Test period Mean n p
Before treatment, SPC-Flakes® 0,2±0,1 5 ns
Before treatment, placebo 0,2±0,1 4  
After treatment, SPC-Flakes® 1,1±0,1 5 <0,001
After treatment, placebo 0,1±0,1 4  

Baseline comparisions and after 12 weeks treatment showed a significant difference in CRP between groups. CRP was increased by 66±29% in the control group, whereas it was reduced by 4±12% in the active treatment group (p<0,05). No difference between groups could, however, be seen in status and symptoms of the joints. 

 

Mörck, Ek, Jennische, Laurenius, Tarkowski och Lange, Anti-inflammatorisk effekt av kosttillskott med specialprocessade cerealier vid reumatoid artrit – en dubbel-blind pilotstudie, Posterpresentation vid Riksstämman, 2003


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).