All of the active B12 group reporting showed reduction in severity of symptoms ranging from 31% to 70%, while the placebo controls reported either no change or a worsening of symptoms. Wilcoxon-Rank of .002 for pharmaceutical the end-points of sneezing, nasal congestion and runny nose; and p = research .005 for IgE reductions. In 1992, the above mentioned data from 1988 site on were presented pharmaceutical by Dr. O''Connor to the FDA. The FDA panel acknowledged research the safety of the treatment. site The panel seemed to be in agreement that pharmaceutical the research statistics indicated a significant reduction in IgE and that a quantitative drop in symptoms was demonstrated. In 1992, site Belen Anibarro, pharmaceutical MD, studied five research children with site asthma with metabisulfite intolerance confirmed by pharmaceutical oral challenge testing. The test was repeated after premedication with research 1.5 mg of oral cyanocobalamin. In four of the five patients treated, bronchospasm did not develop in the second metabisulfite site challenge.6

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 pharmaceutical a chemi-luminescent technique. research Statistician Bradley site 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 pharmaceutical 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, research and 14 other FDA site 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 pharmaceutical later part research 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 site that the pollen counts pharmaceutical in Oregon remained higher throughout the study research and site that the data from Oregon showed a significant difference between the active and placebo groups.8