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In the US, 10.3 million people have been diagnosed with diabetes and an
estimated additional 5.4 million have undiagnosed diabetes. Approximately
90% have type 2 diabetes and the remainder have type 1 diabetes.
The morbidity and mortality associated with diabetes are related to the
hypoglycemia and hyperglycemia, increased risk of infections, microvascular
complications (ie, retinopathy, nephropathy), neuropathic complications, and
macrovascular disease. Diabetes is the major cause of blindness in adults
aged 20-74 years, as well as the leading cause of nontraumatic lower-
extremity amputation and end-stage renal disease (ESRD).
Type 2 diabetes mellitus is more prevalent among Hispanics (10.6%),
Native Americans (12-50%, depending on the tribe), African Americans
(10.8%), and Asians/Pacific Islanders than in whites.
Incidence is essentially equal in females and males in all populations.
Type 2 diabetes is becoming increasingly common because more
people are living longer (diabetes prevalence increases with age). It is also
being seen more frequently in younger people in association with the rising
prevalence of childhood obesity. Although type 2 diabetes still occurs most
commonly in adults aged 40 years and older, the incidence of disease is
increasing more rapidly in adolescents and young adults than in other age
With this state of the art in mind there is now provided according to the
present invention a pharmaceutical composition for alleviating excess levels
of sugar in the blood of type 2 diabetic patients comprising a source of at least
one cyanogenic glucoside as active ingredient therein.
In preferred embodiments of the present invention said source is a
In especially preferred embodiments of the present invention said
natural source of at least one cyanogenic glucoside is from kernels of bitter
In further preferred embodiments of the present invention said natural
source of at least one cyanogenic glucoside is from kernels from fruits of the
In especially preferred embodiments of the present invention said
natural source of at least one cyanogenic glucoside is from a powder formed
from a dried lemon component selected from the group consisting of lemon
pulp, peel, and seeds and combinations thereof.
In a most preferred embodiment of the present invention there is
provided a pharmaceutical composition for alleviating excess levels of sugar
in the blood of type 2 diabetic patients comprising a powder formed from a
mixture of dry bitter almond kernels and from a dried lemon component
selected from the group consisting of lemon pulp, peel, and seeds and
In these preferred embodiments said powder preferably comprises
between about 70% and 90% dried and ground bitter almond kernels, and
between about 30% and 10% of a dried lemon component selected from the
group consisting of lemon pulp, peel, and seeds and combinations thereof.
In further embodiments of the present invention, there is provided a
method for alleviating excess levels of sugar in the blood of type 2 diabetic
patients comprising providing a pharmaceutical composition containing a
source of at least one cyanogenic glucoside as active ingredient therein.
In yet further embodiments the present invention is directed to the use
of a source of at least one cyanogenic glucoside for the manufacture of a
pharmaceutical composition for alleviating excess levels of sugar in the blood
of type 2 diabetic patients substantially as described herein.
As stated in its most preferred embodiment the present invention is
directed to pharmaceutical compositions containing as active ingredients
therein compounds found in bitter almonds kernels and or leaves and in
lemon pulp, peel or seeds. Both components are dried up by a hot air stream
and mixed in a ratio of 1:4 (lemon/almonds respectively). The daily dose for
an adult type 2 diabetic patient is preferably about 15,000 mg. although other
doses can also be utilized. The dry powder is administered orally 3 times a
day. Each of the components is capable of lowering blood sugar in diabetic
patients but the combined formulation is more effective than each individually.
The powder may be orally administered as a powder or as a suspension in
water or other non-sugared liquids. The daily dose ranges according to age,
body weight and degree of illness. Nevertheless a 15,000 mg per day per
adult person is the recommended dose. The formulation may be administered
It is most effective in patients that can synthesis approximately 70% or
higher of the medically considered normal levels of insulin.
It is highly effective in overweight patients that synthesize normal or
The fact that both the kernels of bitter almonds and the lemon tissues
contain cyanogenic glucosides along with other circumstantial results
suggests that CN-glucoside is an effective compound for lowering blood sugar
levels in diabetic patients. Kernels of other Prunus
cyanogenic glucosides and consequently were found effective as well to lower
blood sugar and are therefore included within the scope of the present
It is to be noted that amygdalin otherwise known as d-Mandelonitrile
glucoside or as amygdaloside is recognized as a major glucoside from bitter
almonds and was used in some of the examples herein.
While in preferred embodiments of the present invention and in the
following examples, a natural source of at least one cyanogenic glucoside
was used and tested, the invention is also directed to the utilization of
Furthermore, in other preferred embodiments of the present invention,
other components as set forth in tables 1 and 2 hereinafter, can be included in
the pharmaceutical composition to act in a complimentary or other function
While the invention will now be described in connection with certain
preferred embodiments in the following examples and with reference to the
accompanying figures so that aspects thereof may be more fully understood
and appreciated, it is not intended to limit the invention to these particular
embodiments. On the contrary, it is intended to cover all alternatives,
modifications and equivalents as may be included within the scope of the
invention as defined by the appended claims. Thus, the following examples
which include preferred embodiments will serve to illustrate the practice of this
invention, it being understood that the particulars shown are by way of
example and for purposes of illustrative discussion of preferred embodiments
of the present invention only and are presented in the cause of providing what
is believed to be the most useful and readily understood description of
formulation procedures as well as of the principles and conceptual aspects of
In the drawings: Figure 1 is a graphical representation of the mean distribution of glucose
levels in blood as a function of time after the administration of a composition
according to the present invention and administration of a placebo (sweet
Figure 2A is a graphical representation of an HPLC analysis of amygdalin in.
Figure 2B is a graphical representation of an HPLC analysis of amygdalin in
Figure 2C is is a graphical representation of an HPLC analysis of a standard
A 58 year old female patient who suffers from diabetes type II
(N.I.D.D.M.) since the age of three and who was treated previously with
glucophage tablets 1 x 3 per day for a few months stopped taking said tablets
and instead took 1 teaspoon three times a day of a powder according to the
present invention containing 85% ground dry bitter almond kernels and 15%
ground dried lemon pulp, peel and seeds.
The last blood test of this patient was carried out six months before
treatment and all were in the normal range, with the exception of the blood
sugar of this patient which was ranging between 280 mg% and 300 mg% prior
to treatment. After treatment with the powder of the present invention for two
months the average level of blood sugar dropped to 120 mg% on fasting and
A 64 year old male patient who suffers from diabetes type II
(N.I.D.D.M.) since the age of five and who was treated previously with
glucophage tablets once a day and glucomine once a day, was found to have
no other diseases and no signs of diabetic complications. His last blood tests
were done in April 2004 and were all in the normal range, with the exception
of average blood sugar which was found to be in the range of 170-200 mg%.
He began taking 1 teaspoon three times a day of a powder according
to the present invention containing 85% ground dry bitter almond kernels and
15% ground dried lemon pulp, peel and seeds, in combination with one tablet
a day of the glucophage tablet and one tablet a day of the glucomine for one
month and then continued taking 1 teaspoon three times a day of the powder
according to the present invention and only half a tablet a day of the
glucophage tablet and half a tablet a day of the glucomine and continued this
regimen for an additional three months. At the end of this four month period
the average blood sugar of this patient was down to 140-150 mg%
A 62 year old male patient who suffers from diabetes type II
(N.I.D.D.M.) for the last 14 years and who was treated previously with one
glucophage tablet three times a day stopped taking said tablets and began
taking one teaspoon three times a day of a powder according to the present
invention containing 85% ground dry bitter almond kernels and 15% ground
This patient suffers from hypertension – treated with normiten, angina
pectoris – not active and not treated, hypercholesterolemia and
hypertrigliceridemia treated with simovil and asthma which is not active.
Before treatment the average blood sugar was 285 mg% and following
the treatment the level of blood sugar dropped to 110 – 140 mg%.
As will be noted with each of the three patients there was a reduction of
blood sugar levels attributable to treatment with a composition according to
the present invention, despite the reduction or complete cessation of the
Example 4 The metabolic effect of bitter almonds-based mixture in
patients with Type 2 diabetes
A clinical experiment was carried out at the Diabetes Unit of the
Hadassah Medical Organization at Hadassah Hospital Ein Kerem Jerusalem,
in order to determine whether a mixture, based mainly on ground bitter
almonds mixed in a cup of water (the “Mixture”), had any glucose lowering
effect, at meal-time, in subjects with Type-2 diabetes, maintained on
Metformin and diet, or diet alone. It was assumed that these natural
ingredients can be used safely and will improve post-prandial blood glucose
: Type 2 diabetic subjects (7 males and 3 females) with HgA1c
between 6.5-8.5%, BMI < 32, generally healthy individuals, volunteered for
this study. After the initial screening visit, subjects attended the Diabetes Unit
twice. In each visit they received the same standard breakfast. Blood samples
for glucose evaluation, were withdrawn at timed intervals (every 10 minutes
for the first two hr. and every 30 min for the following 2 hr.), up to 4 hours
following the ingestion of the meal with the Mixture, given at the end of the
meal. On 1st visit the volunteers received the active Mixture, the "placebo" of
other natural ingredients (based on sweet almonds), was administered on the
A significant decrease in post-prandial blood glucose levels, was
demonstrated following the ingestion of the Mixture compared to the placebo.
In six subjects the response rate was much more pronounced while in four
individuals the response was less impressive.
Fig 1 is a graphical representation of the mean distribution of glucose levels in
blood as a function of time after the administration of a composition according
to the present invention and administration of a placebo and depicts the
: In Type 2 diabetic patients, the administration of a mixture
(based on natural ingredients containing ground bitter almonds) was effective
in attenuating post-prandial blood glucose levels.
Example 5: Metabolic profile of bitter and sweet almonds
In order to determine the active components in bitter almonds the
volatile and non-volatile compounds were compared by GC-MS (Gas
chromatography – Mass spectrum) and HPLC (High performance liquid
chromatography). Figures 2A and 2B respectively show the HPLC
chromatograms comparing bitter and sweet almonds, and Figure 2C shows
the HLPC chromatogram of a standard commercial amydalin.
Determination of amygdalin content in bitter and sweet almonds
0.5g of crushed almonds were overnight extracted with 10ml methanol.
Isocratic mobile phase was 85% ACN and 15% water, flow of 0.7ml/min.
Amygdalin content was calculated using standard curve of authentic standard
A nearly 9 folds higher amygdalin peak was detected in the bitter compared
to sweet almond seeds. (Fig 2A, Fig 2B).
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