In 1990 study in San Diego, CA the 5 active subjects with allergic rhinitis had a lowered total serum IgE from Day 0 to Day 90 while 4 placebo subjects, (2 with allergic rhinitis, 1 with asthma and 1 with both), had flat or increased IgE levels.4 In a randomized, double-blind, placebo controlled study of symptoms and serum IgE levels in San Diego, CA in mid-1991, subjects had allergic rhinitis and/or asthma. Serum was drawn at Day 0 and Day 30. Seven of the 10 active treated subjects had a reduction in total serum IgE levels. In 10 placebo treated subjects, 5 had levels of total serum IgE that stayed the same (plus or minus 5%), 3 decreased and 2 increased.5 Statistical analysis of the open-label study as well as the double-blind randomized placebo controlled study have shown a significant effect of vitamin B12 in lowering serum IgE concentrations.

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

In 1992 in El Paso, TX a randomized, double-blind, placebo controlled study of subjects (n=130) with allergic rhinitis in 1992-1993 was conducted. The average IgE level of the placebo treated subjects remained essentially flat, while the average IgE level for active treated subjects was reduced significantly from baseline to Day 30.7 In 1993 in El Paso, TX, valid subjects (n=66) returned a second set of symptom diaries which they had completed for days 365 to 395 (the same period, one year after the first set of symptom diaries). The active group had mean symptom scores showing statistically significant decreases from 1992 to 1993. The placebo group had increased symptoms in 1993. (The relevant pollen counts at the study site in 1993 were much higher than in 1992, leading to expectation of higher symptoms.)7