AllergX™ Scientific Studies

AllergX™ has been extensively studied in humans on over 2,500 allergic individuals in multiple, FDA-approved, multi-center, placebo-controlled randomized clinical trials. There are a number of early clinical papers and some later reports which showed a benefit of cobalamin therapy in allergic disease and inhibition of Immunoglobulin E (IgE) synthesis, in addition to several significant clinical studies conducted by the inventor and formulator of AllergX™, Ernest T. Armstrong, in association with a number of renowned Board Certified Allergists and Immunologists.  Further, a series of FDA-approved clinical trials in allergic humans were conducted to demonstrate the impact of cobalamins on the reduction of IgE. Following is a summary of the extensive research on the active ingredients in AllergX™ by leading scientists and researchers around the world, as well as specific clinical studies conducted on the AllergX™ formulation.

Research

In 1992, Dr. Richard D. O’Connor, MD, and Board Certified Allergist and Immunologist, and again in 1996, Dr. Lyndon E. Mansfield, MD, Board Certified Allergist and Immunologist, presented to the US Food and Drug Administration (FDA) on behalf of the inventor, clinical trial data on the use of cyanocobalamin on individuals with seasonal allergic rhinitis. On April 9, 1997, Dr. John K. Jenkins, MD, then Director of the FDA’s Division of Pulmonary Drug Products, wrote to the inventor: “In general, we find these two protocols to be safe and of overall reasonable design.”

Most significant was a double-blind, placebo-controlled study by Dr. O’Connor and colleagues.  All subjects had allergic rhinitis. Eleven subjects received Cyanocobalamin, USP and 11 received placebo.  Blood serum was obtained for total serum IgE levels just prior to the study, at 15 days, and at 30 days.  The total mean serum IgE decreased significantly (283 to 238) in the cobalamin group, while the placebo group showed an insignificant increase.

Dr. Mansfield, Catherine R. Posey, CCRC, et al. reported in 1992 a placebo-controlled, double-blind study with similar design to Dr. O’Connor’s.  It was a larger study that evaluated 129 subjects with allergic rhinitis during an allergy season.  Sixty-two subjects received Cyanocobalamin, USP, and 67 received placebo.  Total serum IgE was measured pre-study at baseline, at Day 16, and post-study at Day 30.  Subjects self-rated their runny nose, sneezing and nasal congestion once daily for 30 days in a 24-hour reflective diary.  A t-Test showed a significant change in mean total serum IgE levels for the cyanocibalamin group at Day 30 compared to Day 0 while the placebo group did not.  The use of antihistamines was greater for the placebo group than the cyanocobalamin group throughout the study.  Total nasal symptom scores tended to favor the cobalamin therapy, with a significant decrease at Week 3 (p=0.02).

AllergX™ Cobalamin & Pollen Study On Nasal Congestion, Sneezing, Runny Nose and Itchy Nose

STUDY METHODS:

Subjects recorded the severity of nasal congestion, sneezing, runny nose and itchy nose in their diaries every morning and evening.  Subjects started their records prior to any use of the product (baseline), and throughout the six weeks of the study.  Randomized subjects dissolved in the mouth and swallowed either one lozenge containing the active ingredient in AllergX™ or one look-alike lozenge containing placebo every morning and evening for six weeks.  Subjects also recorded any “side effects” or adverse reactions.

At the completion of the study, subjects reports of nasal congestion, sneezing, runny nose and itchy nose were averaged together for the baseline and for each week.  Separate averages were calculated for the AllergX™ group and the placebo group.  The primary objective (endpoint) of the study was a comparison of the nasal congestion, sneezing, runny nose and itchy nose scores for the AllergX™ group versus the placebo group across Weeks 4 to 6.

STUDY RESULTS:

167 subjects in the AllergX group and 165 subjects in the placebo group completed the study.

The pollen counts (mostly mountain cedar) started in earnest around Week 2, and continued to increase throughout the study, causing an increase in nasal symptoms.

There was no significant (p=0.5297) difference between the AllergX™ group and the placebo group in average scores prior to commencement of the study at baseline.

A significant (p=0.0318) difference in average score levels appeared around Week 3 (graph lines separate).  For Weeks 4 through 6, there was a significant (p=0.0262) difference in score levels between the AllergX™ group and the placebo group.

STUDY CONCLUSIONS:

The group of subjects administered AllergX™ had significantly lessened frequency and severity of nasal congestion, sneezing, runny nose and itchy nose than the placebo group for Weeks 3 through 6.  AllergX™ is safe and non-drowsy.

How To Read These Charts

The table below summarizes the results of the above-referenced study, showing the incidence of nasal congestion, sneezing, runny nose, and itchy nose between the group which received the active ingredient in AllergX™ (the red line), and the group which received placebo (the blue line).

LOWER SCORES indicate LOWER reporting of these symptoms

LOWER RESULTS MEAN FEWER SYMPTOMS (BETTER).

 

SUMMARY OF ALL NASAL SYMPTOMS REPORTED:

SUMMARY OF NASAL CONGESTION:

SUMMARY OF RUNNY NOSE:

SUMMARY OF SNEEZING:

SUMMARY OF ITCHY NOSE:

MEDICAL PROFESSIONALS:

For copies of the full clinical research protocols and study results, or if you have any questions about AllergX™ Allergy Defense Formula, please email us at info@AllergX.com, and we will be pleased to email you the full documents and analyses.

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