Ulcerative colitis

Indications

The cause of the disease is unknown but there are several theories about hereditary, infectious and immunological factors. Ulcerative colitis is a non-bacterial inflammation in the mucosa of the large intestine causing sores and bleeding ulcers. The disease fluctuates with periods of blood and pus stained diarrhoea and abdominal pain.

Typical symptoms are frequent watery diarrhoeas and stool containing blood and/or pus. The diarrhoea is often preceded by strong left-sided abdominal pain that is relieved by bowel emptying. Nausea, fever and weight loss are also common. The symptoms do tend to come and go, with fairly long periods in between flare-ups in which patients may experience no distress at all. The frequency can range from one flare during the entire course of life to daily problems. In more severe cases of ulcerative colitis it may be necessary to surgically remove part of or the entire intestine and replace them with a stoma (an opening on the abdomen through which waste are emptied into a pouch).

During periods of disease activity patients experience milder abdominal pain and less common fever. Symptoms are highly dependant on how widespread the disease is. In approximately ¼ of the patients, the inflammation in limited to the rectum, causing relatively mild symptoms. In 1/3 of the cases it is limited to the lower large intestine, whereas for the remainder the entire large intestine is involved.

Women tend to be affected more often and studies show there is an increasing prevalence in children. Approximately 1000 persons in Sweden are affected yearly with a prevalence of 30 000 totally.


Clinical studies

The influence of an additive treatment of orally administered AF with Salovum® was studied in patients suffering from severe acute onset of ulcerative colitis in a prospective, randomized, double-blind study. Patients were given 2 g of Salovum®  four times daily for 14 days. A control group was given egg yolk powder without AF inducing ability. 

A total of 20 patients, 10 in each group, fulfilled this study where this treatment was used as an additive to conventional medication, which also included parenteral or enteral nutrition. 

Earlier trials performed in patients with chronic IBD, endocrine diarrhoea and diarrhoea due to intestinal resection showed varying, but significant effects on the number of bowel movements following induction of AF. The aim of this study was primarily to measure the histological effects on the intestinal epithelium. In addition other laboratory parameters of inflammation and clinical effect were studied. 

During AF treatment, a reduction of inflammation in mucosal biopsies received from the mid-rectum was found. The secretory effect was not significantly different between groups. It was therefore concluded that the antisecretory effect of AF in ulcerative colitis is of importance only after the reduction of inflammation. The observation that AF treatment partially restored the intestine supports this hypothesis. It is likely that the antisecretory effect can be achieved by administering AF treatment in higher doses or through AF inducing cereals (SPC-Flakes®), triggering the endogenous production of AF protein. 

Eriksson, Shafazand, Jennische and Lange, Effect of Antisecretory Factor in Ulcerative Colitis on Histological and Laborative Outcome: A short Period Clinical Trial, Scand J Gastroenterol, 2003; 10:1045-1049, 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