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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
Studies indicate that ingested oral cyanocobalamin tablets are ineffective in the treatment of allergic disease, perhaps because once ingested, they are directly metabolized in the liver. When B12 is delivered via injection or lozenge it passes throughout the bloodstream before arriving at the liver. It is during this first pass in its native form that it is believed to exert its therapeutic effect. CLINICAL RESEARCH: "The World Health Organization (WHO) recognizes allergic rhinitis (hay fever), sinusitis, asthma,...conjunctivitis, urticaria, eczema, dermatitis (contact and atopic)...allergic and migraine headache...as diseases in which IgE-mediated allergy may be involved."1 In 1988, asthma and allergic rhinitis subjects were treated with B12. Total IgE, specific IgE and pulmonary lung functions were taken at days 45, 150 and 180 from baseline. Eight of the 9 subjects had reduced IgE. 2 In 1989 open label studies at two sites in Riverside County, CA in 1989. Sixteen of the 17 subjects had lowered IgE levels from Day 0 to Day 30.3
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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