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All of the active B12 group reporting showed reduction in severity of symptoms ranging from 31% to 70%, while the placebo controls reported either no change or a worsening of symptoms. Wilcoxon-Rank of .002 for the end-points of sneezing, nasal congestion and runny nose; and p = .005 for IgE reductions. In 1992, the above mentioned data from 1988 on were presented by Dr. O''Connor to the FDA. The FDA panel acknowledged the safety of the treatment. The panel seemed to be in agreement that the statistics indicated a significant reduction in IgE and that a quantitative drop in symptoms was demonstrated. In 1992, Belen Anibarro, MD, studied five children with asthma with metabisulfite intolerance confirmed by oral challenge testing. The test was repeated after premedication with 1.5 mg of oral cyanocobalamin. In four of the five patients treated, bronchospasm did not develop in the second metabisulfite challenge.6

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.

With no further treatment, the 1996 ten-month follow-up data (n=92) from a high pollen period in Oregon, Washington and Idaho together showed a greater reduction in the active group (n=43) than the placebo group (n=49) on the primary endpoint, defined as a combination of symptom and rescue medication scores.8 Patients gave blood serum samples prior to the treatment in 1995 and one year later in 1996. 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=27) had on average a greater reduction in IgE than the placebo group (n=34) for 13 out of 16 allergens.8

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