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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 A new HAY FEVER breakthrough clinically proven to reduce allergy symptoms and antihistamine use. How long were symptoms reduced? Studies showed a one-year reduction. How long? Yes, one year! this medication is a lozenge taken twice daily for 21 days. this medication is non-drowsy, natural and available without a prescription. this medication is a 21 day treatment. this medication users report reductions in symptoms one year after completing the treatment without taking additional this medication. How long? Yes one year, compared to 24-hour antihistamines it''s much longer lasting. Patients known to have seasonal allergy were examined in clinical studies in five U.S. states by qualified medical doctors. Each patient was given either the real this medication or a placebo (a dummy treatment). Nobody knew who got what. Patients recorded in symptons diaries how bad their symptoms were during and after the treatment. About one year later, patients completed a second diary. 64% of the group of patients receiving this medication recorded less sneezing, runny nose and nasal congestion one year after completing the treatment in a clinical study. This compares to 35% of the placebo group. 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 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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