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Antihistamines As the name indicates, an antihistamine counters the effects of histamine, which is released by the mast cells in the body''s tissues and contributes to allergy symptoms. For many years, antihistamines have proven useful in relieving sneezing and itching in the nose, throat, and eyes and in reducing nasal swelling and drainage. Many people who take antihistamines experience some distressing side effects: drowsiness and loss of alertness and coordination. In children, such reactions can be misinterpreted as behavior problems. During the last few years, however, antihistamines that cause fewer of these side effects have become available by prescription. These new nonsedating antihistamines are as effective as other antihistamines in preventing histamine-induced symptoms, but do so without causing sleepiness.

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

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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