Multiple Chemical Sensitivity Etiology
Airway Genetics and Ambient Combustion Aerosol
MCS 3ae: Treatments Unsafe? Fermented Papaya (FPP) and Ginkgo Biloba
MCS 3ae: Treatments Unsafe? Fermented Papaya (FPP) and Ginkgo Biloba
Outline
I. Fermented Papaya Preparation (FPP) Creates Abnormalcy
A. Clinical Trial to Determine Safety and Efficacy
B. Improper Subject Group May Exaggerate FPP Efficacy
C. FPP Raises Pulsometric Index (PI) to Far Above Normal in 6 of 12 Brain Temporal Lobe Areas
II. FPP Safety in Doubt - Antiplatelet Effects?
A. Harm in the Search for Good?
B. Side Effects?
C. The Importance of Platelets
I. Fermented Papaya Preparation (FPP) Creates Abnormalcy
A. Clinical Trial to Determine Safety and Efficacy
At the time of subject inclusion prior to treatment - using Ultrasonic Cerebral Tomosphygmography (UCTS) - pulsatility index (PI) was measured for 12 brain temporal lobe areas with 6 registering lower than normal PI indicating inflammatory conditions and cerebral hypoperfusion - reduced brain blood flow (BBF). The purpose of the clinical trial was to determine the safety and efficacy of FPP in improving BBF, lowering inflammatory conditions, and alleviating symptoms (Irigaray 2018b with contributing data from Irigaray 2018a and FPP further recommended in Belpomme 2020).
B. Improper Subject Group May Exaggerate FPP Efficacy
Belpomme 2015 established that occurrence of elevated inflammation and low PI was nearly identical among Electrohypersensitivity (EHS) compared to Multiple Chemical Sensitivity (MCS) subjects - a very remarkable finding. But each abnormality occurred in 50% or less of the subjects at time of testing. The FPP clinical trial involved EHS subjects only - but given the identical abnormalities as MCS demonstrated in the 2015 study - findings of the FPP trial may be applicable to MCS also.
Keeping in mind that 50% of EHS and MCS subjects have normal PI at any given time - it is unknown how much drift there is in and out of the lower than normal PI category among the subjects - as may be influenced by whether a subject had a good or bad exposure period leading up to testing.
Rather than choose a subject group that is average - 50% having a good hair week prior to testing - instead the subjects chosen for the FPP clinical trial were only those measuring low PI and at least one elevated inflammatory marker. This could exaggerate FPP efficacy because their could be some bad hair day drift back to good hair - towards what would be average were the subject group representative of the EHS population as a whole.
And there was no placebo group either.
C. FPP Raises Pulsometric Index (PI) to Far Above Normal in 6 of 12 Brain Temporal Lobe Areas
FPP was very effective in 20-35% of subjects based on testing after 3 and 6 months of treatment - improving symptoms, lowering inflammatory markers, and impressively maintaining or raising PI to normal in 6 temporal areas that were normal or low PI at the time of study inclusion. But the remaining 6 of 12 temporal areas skyrocketed to far above normal.
Carotidian (C), Subcortical (SC), Superficial MCA (SMCA) of both the right and left brain temporal lobe areas were raised to abnormally high - nearly 2-4 times normal value:
Rounded data from Irigaray 2018b
BF (before FPP treatment), AF (after 3 or 6 months FPP), Normal (values of historical controls)
Right
C BF 12, AF 23, Normal 13
CS 5, 9, and 2
SMCA 7, 13, and 5
Left
C BF 15, AF 23, Normal 13
CS 5, 9, and 2
SMCA 9, 13, and 5
Vertebro basiler (VB), capsulo-thalamic (CT), and deep MCA (DMCA) of both the right and left brain temporal lobe areas were maintained or raised to normal:
Right
VB BF 9, AF 9, Normal 9
CT 2, 5, and 5
DMCA 7, 14, and 12
Left
VB BF 5, AF 10, Normal 9
CT 3, 5, and 5
DMCA 10, 13, and 12
II. FPP Safety in Doubt - Antiplatelet Effects?
A. Harm in the Search for Good?
In fulfillment of the extraverted thinking formula (Jung 1921) - safety in doubt and not knowing how FPP works - FPP and ginkgo biloba are recommended with conflict of interest:
R.F.C. Hull Translation
Extraverted Thinking Type
"...The intellectual formula, which because of its intrinsic value might justifiably claim general recognition becomes rigidly dogmatic...truth is no longer allowed to speak for itself...
Purely ethical intentions may lead him into critical situations which sometimes have more than a semblance of being the outcome of motives far from ethical..."
"...The results suggest a beneficial clinical and biological therapeutic effect of FPP in EHS self-reporting patients. However, the precise underlying mechanism has not yet been elucidated...
we have no clear explanation how FPP can restore normal mean PI values and how it can increase mean tissue PI values in comparison with normal values at T3/T6 in the superficial MCA, cortical-subcortical and carotidian areas of the left and right temporal lobes (see Table 5). UCTS related-mean PI decrease in temporal lobes has been shown to be associated with brain dysfunction [19-20]. There is no data which demonstrates that increased mean tissue PI is pathologic. In fact, in our study the FPP-related increase in mean tissue PI in these temporal lobe areas was transitory, as several months after FPP treatment concluded mean PI values were normal or even decreased...
we conclude that FPP is a useful treatment for...EHS self reporting patients...
Conflict of interest - At the exception of Dr. Pierre Mantello, who is in charge with the marketing and communication of Immun’Age®, all the authors declare no financial conflict of interest..."
"...we showed that natural products such as fermented papaya preparation (FPP) and ginkgo biloba can restore brain pulsatility in the various middle cerebral artery-dependent tissue areas of temporal lobes, thereby improving brain hemodynamics and, consequently, brain oxygenation [33]. Since FPP was shown to possess some antioxidant, anti-inflammation, and immune-modulating properties [34–36], we recommend the use of this widely available natural product..."
B. Side Effects?
Could FPP and Ginkyo Biloba have dangerous antiplatelet effects? What is responsible for the FPP induced above normal PI in 6 temporal areas of Irigaray 2018b?
"... herbal supplements that are known to possess antiplatelet activity (ginkgo, garlic, ginger, bilberry, dong quai, feverfew, ginseng, turmeric, meadowsweet and willow)...
those containing coumarin (chamomile, motherworth, horse chestnut, fenugreek and red clover) and with tamarind, enhancing the risk of bleeding...
Ginkgo (Ginkgo biloba L.)...ginkgolides (particularly ginkgolide B) have also been shown to inhibit the binding of platelet activating factor (PAF) to its receptors on platelet membranes, resulting in reduced platelet aggregation...
It is believed that bilberry’s medicinal properties stem primarily from the anthocyanins,which also exert antagonism of platelet aggregation (9, 15, 21)..."
C. The Importance of Platelets
"...Platelets (also called thrombocytes) are minute discs 1 to 4 micrometers in diameter. They are formed in the bone marrow from megakaryocytes, which are extremely large cells of the hematopoietic series in the marrow; the megakaryocytes fragment into the minute platelets either in the bone marrow or soon after entering the blood, especially as they squeeze through capillaries. The normal concentration of platelets in the blood is between 150,000 and 300,000 per microliter...
Platelet Plugging
The platelet-plugging mechanism is extremely important for closing minute ruptures in very small blood vessels that occur many thousands of times daily. Indeed, multiple small holes through the endothelial cells themselves are often closed by platelets actually fusing with the endothelial cells to form additional endothelial cell membrane. A person who has few blood platelets develops each day literally thousands of small hemorrhagic areas under the skin and throughout the internal tissues, but this does not occur in the normal person...
Bleeding Time
When a sharp-pointed knife is used to pierce the tip of the finger or lobe of the ear, bleeding ordinarily lasts for 1 to 6 minutes. The time depends largely on the depth of the wound and the degree of hyperemia in the finger or ear lobe at the time of the test. Lack of any one of several of the clotting factors can prolong the bleeding time, but it is especially prolonged by lack of platelets..."
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