New Study on Respen-A in Autism Spectrum Disorders Shows Respen-A to Have a Significant Effect in Treating the Core Symptoms.

Dr. Anju Usman specializes in Autism Spectrum Disorders (ASD). She has found that many of her patients with ASD have a single or double mutation on their MAO-A gene. Dr. Usman stated that those patients with a double mutation often failed to respond to traditional or complementary treatments and therapies. Respen-A is a homeopathic topical disc containing a 12C dilution of reserpine, which is a very old blood pressure medication. Resperine has been shown to double the activity of MAO-A. Thus, Dr. Usman evaluated the effect of Respen-A in 9 of her patients having MAO-A mutations, utilizing the Autism Evaluation Checklist (ATEC) and the Childhood Autism Rating Scale (CARS). The ATEC is a parent-rated measure and the CARS is completed by a health professional. Research has shown a significant correlation between total ATEC and CARS scores. Evaluations were conducted before starting the Respen-A (“Pre” Score) and after wearing the Respen-A topical disc for 3 months (“Post” Score).

The ATEC is a validated tool developed by the Autism Research Institute to evaluate the effectiveness of a treatment to improve the core symptoms of ASD. The core symptoms of ASD are impaired speech/language, impaired socialization, impaired sensory/cognitive awareness, and restrictive health/physical behaviors. The ATEC scores consist of individual scores for each category of core symptoms as well as a total score which is the sum of all of the symptom category scores. The higher the score, the greater the severity of the symptoms.

ATEC scores range from zero to 180. If a child scores zero or close to zero, that child can no longer be distinguished from non-autistic children and thus can be considered fully recovered. The important benchmarks in scoring are as follows:

A total ATEC score < 30. This level places the child in the top 10 percentile. A child with score of less than 30 – or, better still, less than 20 – would have some ability to conduct normal, two-way conversations, and more or less behave normally. Such children have high chances of leading normal lives as independent individuals.

A total ATEC score < 50. This places the child in the 30th percentile level. The child has good chances of being semi-independent. More importantly, he or she will not likely need to be placed in an institution or residential home. For many parents of autistic children, being able to achieve improvement up to this level is already considered very significant.

A total ATEC score > 104. Even though the maximum score is 180, any person with a score of more than 104 would already be in the 90th percentile, and be considered very severely autistic.

The CARS is a 15-item behavioral rating scale developed to identify autism as well as to quantitatively describe the severity. The items are: I. Relating to People; II. Imitation; III. Emotional Response; IV Body Use; V. Object Use; VI. Adaptation to Change; VII. Visual Response; VIII. Listening Response; IX. Taste, Smell, and Touch Response and Use; X. Fear or Nervousness; XI. Verbal Communication; XII. Nonverbal Communication; XIII. Activity Level; XIV. Level and Consistency of Intellectual Response; and XV. General Impressions. Each item is scored from 1 to 4 in 0.5 intervals. A total score of 15-29.5 is considered nonautistic; a score of 30-36.5 is considered mild to moderate autism; and a score of 37-60 is considered moderate to severe autism.

Eight of the nine patients evaluated had moderate to severe autism and one patient had mild to moderate autism according to their baseline total CARS score. The improvements in the total CARS scores were significant with a p value of 0.01.

The total ATEC scores showed highly significant improvements with a p value of 0.001.

Because of the strong effect size of the Respen-A, the power of the study was well above .80, which is the acceptable power for scientific studies. The fact that Dr. Usman’s study only included 9 patients, the Respen-A homeopathic treatment would need to have a very strong effect size to show a statistical significant effect. The larger the study the less effect size of a treatment is needed to show statistical significance. For instance, it only takes one person wearing a very strong perfume to walk into a room for everyone in the room to notice the scent of the perfume. But if a person is wearing a weak perfume, it would take several people wearing that weak perfume before there would be a noticeable scent of the perfume in the room. Despite the very small number of patients analyzed in the study, Respen-A showed a highly statistical significant effect with a p value of 0.001. The p value measures the probability of getting these results by chance alone. A p value of 0.05 or less is considered statistically significant, meaning there is only 5 in 100 chances that the results were in error. The improvement in the total ATEC scores with patients applying the Respen-A topical disc for three months achieved a p value of 0.001, meaning there are only 1 in 1,000 chances that the improvements seen with the Respen-A disc were simply by chance alone.

Below are the Pre and Post scores for both the ATEC and the CARS. Evaluations were conducted before starting the Respen-A (“Pre” Score) and after wearing the Respen-A topical disc for 3 months (“Post” Score).

Patient ATEC

Speech/

Language

ATEC

Socialization

ATEC

Sensory/

Cognitive

ATEC

Health/Physical Behaviors

ATEC

Total

CARS

Total

Pre Post Pre Post Pre Post Pre Post Pre Post Pre Post
1. 19 14 8 7 16 16 19 12 62 49 49 40
2. 11 11 15 15 19 16 30 29 75 71 46 42
3. 9 9 15 9 15 10 2 16 41 44 43 41
4. 14 14 15 15 20 19 46 41 95 89 57 57
5. 9 9 4 3 12 11 5 6 30 29 31 30
6. 13 11 13 11 13 12 22 15 61 49 46 41
7. 4 4 3 3 2 2 17 15 26 24 42 38
8. 22 24 33 38 29 32 41 56 125 150 68 69
9. 15 12 5 5 11 12 7 4 38 33 40 38

A study conducted at the New England Center for Children found that most therapies need to be started before age two and continued for at least a year before significant benefits may be noticed. Dr. Usman states, “Using Nutrigenomics, MAO-A SNPs and cholesterol levels to individualize treatment, the homeopathic Respen-A patches provided a statistically significant improvement in my patients. These results were unexpected because of the small study size, the older age of the patients and the chronic nature of their issues that improved in just 3 months.” The average age of the patients in the small Respen-A study was 13.5 years of age and patients showed significant improvement within just 3 months of starting Respen-A.

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