CraniYums Study II-SA (download PDF)
Summary
The study examined the effect of taking CraniYums over a six-week period on 23 associated symptoms of Neurotransmitter Deficiencies. In this double-blinded study, sixteen women volunteers were given CraniYums Essential Balance containing either the active ingredients (Active) or CraniYums made with no active ingredients (Placebo). Each group contained 8 women at the beginning of the study. One of the 'Active' women did not complete the study. Each week the participants completed a detailed symptom-rating sheet. By the end of the six-week study, a significant difference in symptom rating occurred in 19 of the 23 symptoms, when comparing the two groups. The average improvement over all of the 23 symptoms was 3.5 times greater (+350%) in the Active than the Placebo group. The top 7 most affected symptoms were improved 55 times more (5500%) in the Active group than in the Placebo group.
Purpose of the Study
The study was done to see if taking CraniYums as directed could alleviate the known symptoms of neurotransmitter deficiencies. Since it has been scientifically determined that CraniYums increases serotonin and dopamine -- two important neurotransmitters -- it was hypothesized that the use of this product would also alleviate the symptoms of deficiencies when the participants increased their internal production of serotonin and dopamine.
Study Methodology
Sixteen women participants, that were not patients of Dr. Hart, were randomly divided into two equal groups -- Active and Placebo. The Active group participants were given the actual CraniYums Essential Balance product, while the Placebo group was given the same product with no active ingredients. The participants were provided with enough product to take 2 lozenges, three times per day -- 6 total per day. They were instructed to dissolve the CraniYums slowly in their mouth and not chew them.
The participants filled out the symptom rating responses on a weekly basis. Each of 23 symptoms of neurotransmitter deficiencies was listed in a chart. The participants rated how strongly each symptom applied to them on a zero to five point scale, a '5' being the strongest, and '0' being non-existent.
Symptoms of Deficiencies
Twenty-three common symptoms of deficiencies of either serotonin or dopamine were on the Symptom Rating sheet. These were: depressed mood, fatigue, low motivation, poor focus, poor muscle strength or feeling weak, anxiety or worry, fearfulness, PMS-related moodiness, irritability, anger, chronic pain, achy muscles, sleep problems, cravings in the afternoon or evening, eating large food portions, feeling not satisfied after eating, thinking about food often, crave chocolate, crave caffeine, crave nicotine, crave starchy foods, crave sweets, and crave alcohol.
Discussion of Study Results
There were originally 8 participants in each group of either Active ingredients or the Placebo lozenge. During the study, one of the 'Active' participants dropped out. The results from the remaining 7 participants in the Active group show a decrease in the severity of 22 out of the 23 symptoms of neurotransmitter deficiencies. However, the decrease in 3 of the symptoms was not significantly greater than the Placebo group.
We are describing a decrease in the severity of a symptom as an ' improvement '. The percent improvement is based on the lessening of the severity as compared to the initial rating. For instance, if a symptom was rated at a '3' at the beginning of the study and as at a '1' at the end, then the symptom has declined by 2/3 or 66.7%. Similarly if a symptom goes from a '4' to a '3' it has declined (or improved) by 1/4 or 25%. Whenever an existing symptom (i.e. the initial rating was '1' or more) goes to a rating of '0', it has decreased (improved) by 100%.
The percent change of each symptom during the six-week period for each participant was figured. The average percent change of each symptom for the entire group was then figured, and appears in the following chart.
In the 19 symptoms that had significant improvement, the average improvement of the 'Active' group was 59% with the range from 30% to 81%. In these same 19 symptoms, the 'Placebo' group averaged 18% improvement with a range of 0 to 34 %.
The most meaningful results relate to each symptom separately. There were 7 symptoms in which the improvement of the Active group was more than 10 times (>1000%) that of the Placebo group. These were: depressed mood, fatigue, anxiety or worry, achy muscles, sleep problems and not feeling satisfied after eating (eating satiation).
The Active group had significantly more improvement than Placebo in the symptoms of: fearfulness (500%), PMS moodiness (440%), muscle strength (460%), thinking a lot about food (260%), irritability (210%), focus (190%), craving starchy carbohydrates (190%), cravings in p.m.(170%), craving sweets (110%), motivation (100%), food portions (100%), and chocolate cravings (50%).
Conclusions
From this study it can be concluded that the use of CraniYums as directed over a six week period affects the symptoms of neurotransmitter deficiencies in the following ways: improves eating satisfaction, improves mood, lowers anger and irritability, lessens fatigue, lowers anxiety and fearfulness, relieves achy muscles, improves sleep, lessens appetite and cravings especially for starchy or sweet carbohydrates; and improves motivation, mental focus and muscle strength.
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