Mastitis

Indications

Mastitis is an inflammation of the breast that may, or may not, be due to infection. Mastitis is caused by a blockage (of milk) in the ducts of the breast. It occurs during the first months following childbirth. It is a common and painful problem for up to one third of all breastfeeding women. 

A milk duct can become blocked by a mass of thickened milk. The block is often   one-sided. A blocked duct presents as a painful, swollen, firm mass in the breast. Most often the woman is well but some feeling of sickness can be present. A blocked duct can cause slight fever and is often caused by the exposure to a draft, incomplete emptying of a duct during feeding or pressure e.g. from a tight bra. 

A blocked duct can go on to become mastitis. Mastitis can be inflammatory or may be due to an infection, most often caused by staphylococci. An infected mastitis can appear without a prior blocked duct if bacteria gains access to the breast through a crack or sore in the nipple. Symptoms can appear suddenly and the woman can feel very sick. It can be difficult to determine if the mastitis is infected and antibiotics are often given as a preventive measure. The difference between blocked ducts and mastitis is primarily that mastitis is associated with high fever, 39-40° C, eventually needing medical care.

 Abscess, pusing, occasionally complicates mastitis. Usually the woman’s state will improve and fever go down. The infected area is soft but the pus under the skin can be felt and if pressure is applied an indentation will remain. The breast will be severely painful and can be tense and glazed. Abscess should always be looked at by a doctor.


Clinical studies

Inflammation of the mammary gland is a painful and common problem for breastfeeding women. Problems can be of a passing inflammatory nature or it may involve long term problems with severe symptoms. In cases where infection cannot be identified, inflammation may be the cause. A new theory has presented the possibility that sub-clinical mastitis may also increase the risk of transmitting HIV-1 from mother to child. 

Earlier studies had shown that women in developing countries had measurable amounts of AF in breast milk. The amounts exceeded those measured in women in the industrial world. It was therefore decided to perform a randomised double-blind study on breastfeeding mothers in Sweden at the Karolinska Hospital. 

12 women were given AF inducing cereals (SPC-Flakes®) 3-7 days post partum.16 women acted as controls, given cereals without AF-inducing ability. In the treated group only one woman developed mastitis compared to six women in the control group. Three women in the control group were diagnosed with mastitis twice and one woman three times (p=0,0086). The only woman who developed mastitis in the treatment group had misunderstood the dosage and only ate SPC on weekdays, not weekends as well. 

AF levels in breast milk were measured before and after treatment. AF levels were significantly higher in the AF treated group, mean 1,1 AF unit/ml breast milk (0,7-1,25), compared to the control group, mean 0,1 AF unit/ml breast milk (0,0-0,25) (p<0,0001). The AF levels of women with mastitis were significantly lower, 0,0 AF units/ml breast milk (0,0-0,1), than the levels of women who did not have mastitis, 0,5 units/ml breast milk (0,2-1,1) (p=0,017). The one woman in the active treatment group who did develop mastitis had the lowest AF level in the group. 

The study showed that an AF level in breast milk above 0,5 units/ml is protective against mastitis. This result is concurrent with the results seen in the animal studies, in which the same level is enough to protect the offspring from developing diarrhoea (Lange and Lönnroth, 2001). 

These results can be of great importance to developing countries since diarrhoeal diseases are still a great problem. It is of course also of great importance if

AF-inducing cereals (SPC-Flakes®) have the ability to reduce subclinical mastitis and thereby may reduce the risk of HIV-1 being transferred from an HIV-positive mother to her child. 

Svensson, Lange, Lönnroth, Widström and Hanson, Induction of antisecretory factor in human milk may prevent mastitis, Acta Paediatrica Scandinavia 93:1228-1231, 2004, view 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).