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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

In January 1997, 62 subjects who had been the placebos in the 1995 study were invited to receive the vitamin vitamins B12. In June 1997, the 62 placebo subjects were sent a questionnaire asking: How 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 in overall allergy symptoms, and 1 of the 5. Improvement ratios - 12:3 having received treatment, 1:4 not having received treatment.8 A bioequivalence study showed that a 3000 mcg lozenge delivered an equivalent amount of cyanocobalamin to the blood as a 15 mcg injection.9 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 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 medication for the active group compared to the placebo for weeks 2, 6, 8 and 9. The results tend to replicate those of the studies on injectable cyanocobalamin.10

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 vitamins 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 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 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

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