enteralandparenteralnutrition

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Studies indicate that ingested oral cyanocobalamin tablets are ineffective in the treatment of allergic disease, perhaps because once ingested, they are directly metabolized in the liver. When B12 is 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 and migraine headache...as diseases in which IgE-mediated allergy may be involved."1 In 1988, asthma and allergic rhinitis subjects were treated 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

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 the end-points of sneezing, nasal congestion and runny nose; and p = .005 for IgE reductions. In 1992, the above mentioned data from 1988 on were presented by Dr. O''Connor to the FDA. The FDA panel acknowledged the safety of the treatment. The panel seemed to be in agreement that the statistics indicated a significant reduction in IgE and that a quantitative drop in symptoms was demonstrated. In 1992, Belen Anibarro, MD, studied five children with asthma with metabisulfite intolerance confirmed by oral challenge testing. The test was repeated after premedication with 1.5 mg of oral cyanocobalamin. In four of the five patients treated, bronchospasm did not develop in the second metabisulfite 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 a chemi-luminescent technique. Statistician Bradley Rosebrook ran T-Tests comparing average baseline IgE levels to one-year. For the seasonal allergens reported, the enteralandparenteralnutrition 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 enteralandparenteralnutrition 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 enteralandparenteralnutrition between the active and placebo groups.8

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