Unclear what this means
Here is the PR, rather oddly written, I think. It is notable for lack of any statistical analysis of the differences in IgE levels in the study arms, instead relying on the raw numbers. So we are left to guess or try to figure out for ourselves if the results are statistically significant. Of course, the IgE levels were not primary prespecified endpoints, so the data is good for hypothesizing and speculation, not basis for scientific claims.
Press Release Source: Cobalis
Allergy Patients Treated with PreHistin Had Rise in Ragweed IgE Antibodies Blunted During Pollen Season
Monday August 27, 6:57 pm ET
IRVINE, Calif.--(BUSINESS WIRE)--Cobalis Corp. (OTCBB:CLSC - News), a pharmaceutical company specializing in anti-allergy medications, today reported that seasonal allergy patients who received PreHistin had on average less ragweed IgE after the treatment than those who received placebo.
This is important because IgE is a key chemical mediator in allergic reactions. Developing a drug that can safely reduce specific IgE levels is a goal of drug companies.
These findings - along with the previously reported 250% average increase in blood cobalamin levels and the established safety of PreHistin - are testament to PreHistin's marketability to the over 50 million Americans with allergies.
The research
1,551 ragweed allergy patients received either 3.3mg of PreHistin twice daily for 42 days or placebo. Blood samples were taken from patients before and after treatment, that is, pre-seasonally and during the ragweed pollen season. The samples were analyzed by chemiluminescent immunoassay at Medtox Labs.
The results demonstrated changes in serum ragweed specific IgE levels from pre-treatment to post-treatment (in kU/mL): The average for the 737 PreHistin patients went from 6.27 to 7.68 (an increase of 1.41), while the average for the 735 placebo patients went from 6.34 to 9.20 (an increase of 2.86), a difference of 1.50 between the groups. IgE levels in allergic individuals generally increase during the allergy season. PreHistin blunted this expected seasonal rise in IgE.
Similar supporting studies in humans and mice
"The current anti-IgE results tend to replicate earlier findings that cobalamin treatment prior to the allergy season can affect the amount of ragweed specific IgE levels in humans. Allergy patients in the Pacific Northwest were given 15 mcg cyanocobalamin IM for 15 days (n=27) or placebo (n=34). Blood samples were collected prior to the treatment and approximately 10 months later during the next season. Chemiluminescent lab assays showed reductions in the ragweed specific IgE levels for the active group and increases for the placebo group," said Ernest Armstrong, chief scientific officer.
Funada, et al, reported serum IgE content was significantly higher in cobalamin-deficient mice than in the controls, and that IgE levels in the cobalamin-treated group showed a tendency to recover to control levels. In allergic mice, the serum IgE and pulmonary histamine concentrations were significantly lower in all cobalamin-administered groups than placebos. (International Journal Vit Nutr Research, 71 (1):p 60-65 January, 2001).
What is IgE?
Antibodies help to capture unwanted invaders. People who have allergies have an antibody called Immunoglobulin E, or IgE. Each type of IgE has specific "radar" for one type of allergen - ragweed, dog, cat, mold, etc. When the specific IgE comes in contact with such an invader, it causes the release of histamines and the symptoms of an allergic reaction: sneezing, nasal congestion, wheezing and coughing.
The existence of IgE antibodies is common to all forms of allergic disease, including: allergic rhinitis "hay fever," asthma, atopic dermatitis, urticaria, and other allergic reactions.
Studies have shown that IgE levels, and the prevalence of allergic disease, are now higher in children than in their parents. This problem is worsening over time around the world.
AI
