Beneficial effects of a Fermented Papaya Preparation for the treatment of electrohypersensitivity self-reporting patients: results of a phase I-II clinical trial with special reference to cerebral pulsation measurement and oxidative stress analysis

Abstract

Background: Electromagnetic Field Intolerance Syndrome (EMFIS), also termed Idiopathic Environmental Intolerance (IEI) attributed to Electromagnetic Fields (IEI-EMF) by WHO, is a newly identified pathological disorder occurring in electrohypersensitivity (EHS) self-reporting patients. To date, there has been no recognized treatment of this disorder. We have shown that EHS self-reporting patients experience some degree of oxidative stress, inflammation, and autoimmune response. Additionally, Fermented Papaya Preparation (FPP) has some antioxidant, anti-inflammation, and immuno-modulating properties. The objective of this phase I-II clinical trial was thus to test whether FPP treatment is well tolerated, can improve clinical outcomes, and normalize biological abnormalities. Methods: 32 EMFIS-bearing patients were serially included in this trial, among which 26 and 16 of them were evaluable after 3 and 6 months of FPP treatment, respectively. Clinical assessment was conducted during a specific face to face interview by using a validated pre-established questionnaire. Biological assessment consisted of measuring intracerebral tissue pulsometric index (PI) in the temporal lobes with ultrasonic cerebral tomosphygmography (UCTS), in addition to oxidative stress and inflammation with a battery of oxidative stress and inflammation-related peripheral blood tests.Results: Overall clinical improvement was obtained in 50-60% of the cases, among which 20-35% presented major improvement that mainly consisted of the regression of cognitive symptoms such as loss of short term memory, concentration, attention deficiencies, insomnia, and fatigue. This clinical improvement was objectively supported by a statistically significant normal recovery of mean PI in the temporal lobes and by a FPP-related antioxidative effect evidenced by a statistically significant decrease in malondialdehyde levels in the plasma (p<0.0001) and increase in the Glutathione peroxidase activity in red blood cells (p<0.01) in patients experiencing oxidative stress. Moreover, this trial evidenced some degree of FPP-related anti-inflammatory effects by demonstrating a statistically significant decrease in histamine (p=0.049) and HSP27/HSP70 chaperone proteins (p=0.007) in the peripheral blood of patients with initial increased values of these inflammation-related biomarkers.Conclusion: 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.

Oxidative stress in electrohypersensitivity self‑reporting patients: Results of a prospective in�vivo investigation with comprehensive molecular analysis

“…A major finding of the present study was that by using a limited number of oxidative stress biomarkers, 70–80% of EHS self-reporting patients were able to be characterized by the existence of oxidative stress. Consequently, as is the case for numerous chronic pathological disorders, including cancer ( 44 – 47 ), diabetes ( 48 ), cardiovascular diseases ( 49 , 50 ), neurodegenerative diseases ( 51 ), and similar pathological syndromes including CFS ( 51 – 55 ) and MCS ( 57 ), the present data strongly suggested that EMFIS may be characterized by some degree of chronic inflammation ( 3 , 4 ) in addition to oxidative stress. This means that EMFIS (as for MCS and CFS) is a novel pathological disorder which merits recognition by the international biomedical community and classification as such by the WHO.…”

“…In the present study, the term EMFIS was preferred to EHS since, according to the clinical criteria used, it was not possible to clearly assess whether the patients exhibited a decreased tolerance threshold when exposed to EMFs. Furthermore, the term EMFIS was used preferentially to IEI-EMF, which has been proposed by the WHO, as all patients included in the present study clearly reported EMF-associated clinical symptoms ( 4 ).…”

“…EHS self-reporting patients were also objectively identified and characterized by demonstrating potential associations with a number of biological abnormalities, consisting of a degree of inflammation, heat-shock protein-associated cellular stress and autoimmune responses in the peripheral blood, and an abnormal 6-hydroxy-melatonin sulfate/creatinine ratio in the urine ( 3 ). In fact, since it was reported that numerous EHS self-reporting patients present reliable clinical symptoms each time they report exposure to electromagnetic sources, and present with objective UCTS and biological abnormalities ( 4 , 5 ), the authors of the present study proposed the use of the more concise term electromagnetic field intolerance syndrome (EMFIS) to qualify the so-called newly WHO-recognized IEI-EMF pathological condition with which these patients are associated ( 4 ).…”

Beneficial Effects of Fermented Papaya Preparation (FPP®) Supplementation on Redox Balance and Aging in a Mouse Model

“…Previous reports have shown that FPP ® is able to modulate characteristic phenomena of elderly people, such as the pro-inflammatory profile [31] and the oxidative damage [44,45]. Moreover, FPP ® supplementation induced several beneficial effects in patients with neurodegenerative diseases and Electromagnetic Field Intolerance Syndrome [21,43,47,48]. Supporting these reports we have shown that plasmatic telomerase concentration and the telomeres length in bone marrow and ovarian germ cells, are significantly increased by the daily FPP ® administration.…”

“…Fermented Papaya Preparation (FPP ® , Immun'Âge ® ) is one of the fermented foods that have proven positive effects on brain health; FPP ® is a product resulting from yeast fermentation of non-genetically modified Carica Papaya Linn, which is marketed as a natural dietary functional health supplement under the brand name of Immun'Âge ® [20,21]. FPP ® is a powerful antioxidant and nutraceutical adjuvant in combined therapies against various diseases [22][23][24][25][26][27][28][29], including cancer [22,25,30].…”