|
 There
is an evidence that the formulations with the variety of Phlebodium decumanum,
organic cultivated and processed in the factory at Yojoa Lake, can have
great value in the improvement of the quality of life, and in the evolution
of the disease, in situations where an inmune disfunction is related to
the overproduction of citokines.
Phlebodium decumanum combines
functional and nutriceutic food recquirements, by the combination of its
nutritional effect with the beneficial action on one or several specific
functions in the organism: reversionof the immune disfunction involved
in the deterioration in patients of AIDS and cancer (Caquexia and deterioration)
and in the Overtraining Syndrome and Chronic Fatigue.
Different formulations
containing a hidrosoluble fraction, purified and standardized of leaves
registered like EXPLY-37, have been developed and used as nutritional
supplies. These formulations have shown activity in the revertion of the
Caquexia in patients of AIDS and Cancer.
As revealed in First
Central American Congress of Diseases of Sexual Transmission and VIH/AIDS,
held in San Pedro Sula (Honduras) from 7th to 10th of November of 1999
(see Annex), EXPLY a formulation of the Phlebodium decumanum can constitute
an alternative processing for infected people of VIH, safe, affective
an enough cheap, mainly, for developing contries.
EXPLY (PHLEBODIUM DECUMANUM)
IN PERSONS WITH HIV-1 INFECTION IN HONDURAS: MARKERS OF DISEASE PROGRESSION
Solarzano, N., 1) Rivera, I.,2) Alcaide, A.,3) Soto, R.,4)García,
R.,5) Zelaya, J.,5) and Klaskala, W.6) 1) Instituto Nacional del Torax;
2) Universidad Nacional Autónoma de Honduras; 3) HIH. Helechos
Internacional de Honduras; 4) Ministerio de Salud, Honduras; 5)
UNAIDS; 6) University of Miami School of Medicine.
Objectives:
To assess the effect of EXPLY, a formulation obtained from Phlebodium
decumanum, one of the ferns commonly used in Central America in clinical
situations involving some kind of immune disfuntion, on HIV-1 viremia
in persons with HIV infection.
Design: A
randomised, double-blinded, placebo-controlled study in which a regimen
comprised of (EXPLY) was compared to a placebo regimen.
Methods:
The HIV-1 seropositive and asymptomatic individuals with absolute CD4
counts of <400 cells/mm3 were provided with either oral EXPLY 400 mg
twice a day (n=20), or with placebo (n=20) for six months. Measurements
of CD4 cell count and viral load using RNA 3.0 assay for the direct quantification
of HIV-1 plasma RNA concentration (The Chiron Diagnostics QuantiplexTM
bDNA System 340) were used as surrogates for therapeutic efficacy. Subjects
did not receive previously antiretroviral therapy. Prior institutional
ethical approvals of the study and written informed consent from all study
subjects were obtained.
Results: Preliminary
findings revealed a statistically significant decrease by 24% in the mean
plasma HIV-1 RNA level in the treatment group (<234 vs. <178 c/ml;
p<0.001) while an increase by 20% was observed in the placebo arm (<201
vs. <252 c/ml; p<0.0001). The change of the viral load concentration
from baseline to endpoint showed, a 44% decline in the study group and
57% increase among the controls. Subjects who were supplemented with EXPLY
had also increased their chances for a longer survival (RR=2.85; 1.05-3.2;
Maentel-Haenszel X2 =3.8; p=0.05). The viral load showed a trend towards
negative correlation with CD4 counts as has been reported in other studies.
The mean compliance to treatment regimen was 98% throughout the study
period.
Conclusion:
A sustained anti HIV-1 effect resulting in the decrease of plasma HIV-1
RNA concentration that was observed in EXPLY arm was probably due to the
ability of Phlebodium decumanum to modulate the release of certain pro-inflammatory
cytokines such as TNF (Tumor Necrosis Factor) (study in progress). Definitive
proof of EXPLY efficacy will be dependent on clinical end-points of ongoing
open label observational study and planned follow-up studies involving
a combination therapy of antiretroviral drugs with EXPLY. Meanwhile, a
supplementation with EXPLY, locally manufactured in Honduras from the
variety of Phlebodium decumanum organically cultivated and processed at
the Yojoa lake pure monocultures, can provide a potential treatment for
HIV-1 infected persons, safe and sufficiently inexpensive for developing
countries.
El Phlebodium decumanum
has shown an activity in the reversion of the Overtraining Syndrome in
athletes and other people medical instructors of sports. This product
can also be used in people who suffer of the Wasting Syndrome.
.
Sports performance, oxidative metabolism and
immune function: Effects of Phlebodium decumanum (EXPLY).
De Teresa, C., Alcaide A., Huertas J.R., Fresno M. (Centro Andaluz
de Medicina del Deporte, Granada y Centro de Biología Molecular
Severo Ochoa, Universidad Autónoma, Madrid)
II Congress of the European Federation of Sports Medicine
Abstract:
Cycling is a sport characterized by special energy requirements due to
the high competition demands: daily, high energy expenditure
stages for 1 to 3 weeks without sufficient recovery periods.
Overcharge, muscle fatigue and overtraining syndrome are common among
cyclists and are associated to a pattern of immune disfunction characterized
by overexpression of pro-inflammatory cytokines. EXPLY-37 is a purified
and standardized water-soluble fraction obtained from the leaves of
Phlebodium decumanum, a fern organically cultivated and processed
in the Yojoa Lake pure monocultures (Honduras). Different formulations
containing EXPLY-37 have shown a modulating effect on the
release of TNF induced in different cell lines by various stimulii. The
aim of this study was to investigate the effect of Phlebodium decumanum
on cycling performance and to explore the eventual correlation with the
prevention of oxidative stress and immune disfunction. 18
cyclists were submitted to intensive aerobic training. They randomly received
either Phlebodium decumanum, as a nutritional supplement, or placebo
for 4 weeks. Parameters related to performance, oxidative damage and immune
disfunction were compared at T1 (4 week training) and T0 (basal).
Overall performance was improved in the group receiving Phlebodium decumanum,
as shown by the increase in maximal aerobic work (watts) (367.5±16.87
vs 340±17.48, p=0.0005) maximal respiratory quotient
(1.43±0.20 vs 1.25±0.05, p=0.05) and maximal lactate concentration
(mmol/L) (11.64±1.5 vs 10.15±1.68, p=0.0005).
These data are analyzed in connection with those related to the enhancement
of oxidative metabolism (plasma CoQ10 and a-tocopherol levels) and to
the prevention of oxidative stress (mitochondrial lymphocyte DNA damage).
They appear to be in close relationship with the activity
of Phlebodium decumanum in the regulation of certain cytokines and their
receptors involved in the inflammatory response associated to the overtraining
syndrome, and support the use of EXPLY-37 formulations as nutritional
supplements in the prevention of overcharge, muscle fatigue and overtraining.
The effectiveness
of these formulations must be related to the property of the Phlebodium
decumanum, in the modulation of the liberation of certain proinflammatory
citokines such as TNF.
In vitro anti-inflammatory activity of Phlebodium decumanum. Modulation of tumor
necrosis factor and soluble TNF receptors .
De Carmen Punzón (1), Antonio Alcaide (2) and
Manuel Fresno(1).
Received 19 July 2002; revised 19 March 2003; accepted
18 April 2003. ; Available online 15 May 2003.
Abstract: The immunomodulatory
activity of a standardized water soluble fraction of the fern Phlebodium
decumanum (EXPLY-37®) previously shown to have "in vivo"
anti-inflammatory activity was analyzed "in vitro". This extract
inhibited tumor necrosis factor (TNF) production by macrophages activated
with lipopolysaccharide (LPS) or LPS plus interferon (IFN)- . In contrast,
nitric oxide (NO) and interleukin (IL)-1 production were not affected
in the same cultures, whereas IL-6 production was partially inhibited.
More interestingly, EXPLY-37® increased the release of soluble TNF-receptor
2 (sTNFR2) and of IL-1R antagonist (IL-1Ra) but not of sTNFR1, by activated
macrophages. EXPLY-37® had no effect on T lymphocyte activation, measured
as proliferation as well as expression of early and late cell surface
antigens CD69, CD25 (IL-2R- ) and CD71 (transferrin receptor) at the cell
membrane. At the molecular level, EXPLY-37® did not inhibit the activation
of the nuclear factor kappa B (NF- B) transcription factor by TNF. In
summary, EXPLY-37® has two anti-inflammatory activities "in vitro":
it decreases TNF production and increases IL-1Ra and sTNFR2, which may
be able to neutralize IL-1 and TNF activity, respectively.
Author Keywords: Phlebodium decumanum; Anti-inflammatory activity; Cytokine;
Cytokine receptor; Macrophages; T lymphocytes
_______________
(1) Centro de Biología Molecular (CBM), Universidad Autónoma
de Madrid, Spain
(2) HELSINT S.A.L., Granada, Spain
International Immunopharmacology. Article in Press.
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