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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 low Director, Dr. John Jenkins, and 14 other FDA officials of the Pulmonary Division at calorie 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 diet 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 A recent study in Japan indicates that B12 treatment helps in the growth and division of certain immune system cells.11 These cells function to prevent the immune system from over-reacting to allergens such as animals, mold, dust, and pollen. They are called suppressor cells or CD8+ lymphocytes. They “put the brakes on the immune system”. this medicationTM is a 21-day treatment of B12 lozenges sucked on twice daily. this medicationTM may help patients with plans hay fever by providing the patient’s suppressor cells with the sustained and elevated blood B12 level they need to grow and divide. It appears that by helping the immune system to become what it is genetically capable of becoming, this medicationTM turns at least some allergic people into non-allergic or moderately-allergic people.
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