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Patients gave 20 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) 20 and eyecare had on average a greater reduction in IgE than the placebo group (n=33).7 On August 14, 1996 representatives of Broncorp, 20 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 20 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 The high CD4/CD8 ratio and suppressed NK cell activity were improved by methyl-B12 treatment. The Japanese researchers state: We conclude that vitamin B12 acts as an immunomodulator for cellular immunity.11 B12 was used successfully in the treatment of IgE-mediated skin disorders. The German researchers conclude that B12 (cobalamin) when applied to the skin one or more times per day exhibited ...excellent results in topical treatment of skin disorders and in particular of inflammatory and hyperproliferative skin ailments and/or cutaneous manifestations of illness which are immunologic in origin, e.g. psoriasis, atopic dermatitis, contact dermatitis, and other eczematous dermatitises...12 Click here for Allergy medication online.
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