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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 IgE levels to one-year. For the seasonal allergens reported, the active 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 the Division Director, Dr. John Jenkins, and 14 other FDA officials of the Pulmonary 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 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 higher throughout the study and that the data from Oregon showed a significant difference between the active and placebo groups.8

In 1992 in El Paso, TX a randomized, double-blind, placebo controlled study of subjects (n=130) with allergic rhinitis in 1992-1993 was conducted. The average IgE level of the placebo treated subjects remained essentially flat, while the average IgE level for active treated subjects was reduced significantly from baseline to Day 30.7 In 1993 in El Paso, TX, valid subjects (n=66) returned a second set of symptom diaries which they had completed for days 365 to 395 (the same period, one year after the first set of symptom diaries). The active group had mean symptom scores showing statistically significant decreases from 1992 to 1993. The placebo group had increased symptoms in 1993. (The relevant pollen counts at the study site in 1993 were much higher than in 1992, leading to expectation of higher symptoms.)7

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, (2 with allergic rhinitis, 1 with asthma and 1 with both), had flat or increased IgE levels.4 In a randomized, double-blind, placebo controlled study of symptoms and serum IgE levels in San Diego, CA in mid-1991, subjects had allergic rhinitis and/or asthma. Serum was drawn at Day 0 and Day 30. Seven of the 10 active treated subjects had a reduction in total serum 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 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.

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