In 1990 study in San Diego, CA the 5 active subjects with allergic rhinitis had a lowered total serum IgE from Day 0 to Day 90 while 4 placebo subjects, digestive (2 with allergic rhinitis, 1 with asthma and 1 with both), had flat or increased IgE levels.4 In a randomized, double-blind, placebo enzymes controlled study of symptoms and serum IgE supplement levels in digestive San Diego, CA in mid-1991, subjects had allergic rhinitis and/or enzymes asthma. Serum was drawn at Day 0 and Day supplement 30. Seven of the 10 active treated subjects had a reduction in total serum digestive IgE levels. In 10 placebo treated subjects, 5 had levels of total serum IgE that stayed the same (plus or minus 5%), 3 decreased and enzymes 2 increased.5 Statistical analysis of the open-label study as well as the double-blind randomized placebo controlled study have shown a significant effect of vitamin B12 in lowering serum IgE concentrations.

Patients gave blood serum samples prior to the treatment in 1992 and one year later in 1993. They were immunoassayed for specific IgE antibodies using a chemi-luminescent technique. Statistician Bradley Rosebrook ran T-Tests comparing average baseline supplement IgE levels to one-year. For the seasonal allergens reported, the active digestive group (n=34) had on average a greater reduction in IgE than the placebo group (n=33).7 On August 14, 1996 representatives of Broncorp, Inc. met with enzymes the Division Director, Dr. John Jenkins, and 14 other FDA officials of the Pulmonary supplement Division at a PreNDA meeting. Dr. Mansfield made a presentation on the 1995 study data (n=165) from Oregon, Washington and Idaho. He noted that together the data failed to show statistical superiority of vitamin B12 on the primary endpoint. He noted that in Washington and Idaho, during the later part of the study, there was a drop in the digestive pollen counts and marked improvements in symptoms in both the vitamin B12 and placebo groups. (This made a therapeutic benefit of the B12 treatment difficult to demonstrate.) But that the pollen counts in Oregon remained enzymes higher throughout the study and that the data supplement from Oregon showed a significant difference between the active and placebo groups.8

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