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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 remove placebo group (n=33).7 On August 14, 1996 representatives of Broncorp, back 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 hair the data failed to show statistical superiority of vitamin B12 on remove 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 back and hair 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

Studies indicate that ingested oral cyanocobalamin tablets are ineffective in the treatment of allergic disease, perhaps because once ingested, remove they are directly metabolized in the liver. When B12 is back 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 hair and migraine headache...as diseases in which IgE-mediated allergy may be involved."1 In 1988, asthma and remove allergic rhinitis back subjects hair were treated remove 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 January 1997, 62 subjects who had been the placebos in the 1995 study were invited to receive the vitamin B12. In June 1997, the 62 placebo subjects were sent back a questionnaire asking: How hair would you compare your overall allergy (hay fever) symptoms this spring to the last two springs? 20 people responded, with 15 reporting having had the B12 treatment, and 5 not. 12 of the 15 reported at least a slight improvement remove in overall back allergy symptoms, and 1 of the 5. Improvement ratios - 12:3 having received hair treatment, 1:4 not having received treatment.8 A bioequivalence remove study showed that a 3000 mcg lozenge delivered an equivalent amount back of cyanocobalamin to the blood as a 15 mcg injection.9 hair From the spring to the summer patients with demonstrated allergic rhinitis received with the cyanocobalamin (or placebo) containing lozenge twice daily for 21 consecutive days. All subjects also received C and B oral multivitamins remove for 21 days. Twice daily subjects maintained a nine-week diary on sneezing, runny nose, nasal congestion, itchy eyes, itchy nose and antihistamine (chlorpheniramine) use. In the post-treatment period, the active group (n=15) recorded on average a greater reduction in symptoms and in antihistamine use than the placebo group (n=9). The results yielded reductions (0.1>p>0.01) in total weekly symptom/rescue back medication for the active group compared to the placebo for weeks 2, 6, 8 and 9. The results tend to replicate those hair of the studies on injectable cyanocobalamin.10