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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

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

In January 1997, 62 subjects who had been the placebos in the 1995 study were invited to receive the vitamin 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

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