Crohn's disease

Indications

Crohn’s disease is a chronic inflammation of the intestines that periodically will present itself as abdominal pain, diarrhoea and weight loss; in-between periods of no or little symptoms. The disease affects patients in their twenties and once the disease begins, it tends to be a chronic, recurrent condition with periods of remission and disease exacerbation. At times symptoms are scarce but at present there is no known cure for the disease. It primarily causes ulcerations in the small and large intestines, but can affect the digestive system anywhere between the mouth and the anus. The affected parts of the intestine are red and swollen and sores and bleeding ulcers can arise. When the inflammation heals scarred tissue may result in intestinal constrictions. 

The cause of Crohn’s disease is not known, although it does seem to run in the family. One theory is that the body's immune system reacts to a virus or bacteria by causing ongoing inflammation in the intestine mucous membrane and deep tears (fistulas) in the intestine wall. The disease is more common in smokers. 

Depending on how large part of the intestine is involved the symptoms will vary accordingly. Many patients will have felt weak symptoms for several years before a diagnosis. Symptoms vary from fever, persistent diarrhoea (loose, watery or frequent bowel movements), crampy abdominal pain (due to constrictions in the intestine), fatigue (since the body’s ability to absorb nutrients from food is reduced), loss of appetite with subsequent weight loss and a sense of sickness. Some patients may develop tears (fissures), which may cause pain and bleeding, especially during bowel movements. Inflammation may also cause a fistula to develop. A fistula is a tunnel that leads from one loop of intestine to another. 

However, the disease is not always limited to the GI tract; it can also affect the joints, eyes, and skin. In certain cases it can also affect the liver and kidneys and there is an increased risk for blood clots and intestinal cancer. In general, though, people with Crohn's disease lead full or almost full, active, and productive lives. Several studies show that the life expectancy is not reduced. 

In Sweden 500 patients a year are diagnosed with Crohn’s disease and it is believed that the prevalence is 30 000 people. It is slightly more common in women than in men.


Clinical studies

Due to the positive results with AF-treatment in treating Crohn’s disease, the surgeons have begun AF-treatment of more patients undergoing GI-surgery in which through experience the outcome is known to lead to reduced intestinal function. 

The treatment is initiated by already on the first day administer Salovum® dissolved in ordinary juice. This will quickly lead to high AF levels in the intestine without first letting the body produce it by its own. Most often the patients initially treated with Salovum® for 5-10 days can then be transferred to the AF inducing SPC-Flakes® in order to stimulate the endogenous AF production. 

Björck, Bosaeus, Ek, Jennische, Lönnroth, Johansson and Lange, Food induced stimulation of the antisecretory factor can improve symptoms in human inflammatory bowel disease: A study of a concept, Gut, 2000; 46:824-829, 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