Recent
Article
14.08.07
Chilblains, also called perniosis
or blain, a painful abnormal reaction of the small blood
vessels in the skin when...
>> Read
more |
Did
you know?
 Most
People would rather not take a handful of pills each day...
>> Read
more |
|
| |
| News
Flashes |
|
|
Herbalife
and Rare Liver Damage
04.09.07
STOP PRESS: Liver Damage associated with Herbalife use:
Herbalife
results for weight control have been reported as good.
The only problem is historical according to the current
Wikipedia entry: "Some of the original Herbalife
weight loss products contained the active ingredient Ma
Huang or Sida cordifolia, two herbs containing ephedrine
alkaloids.
Adverse reactions involving the company's Thermojetics
original green tablets were recorded by the U.S. Food
and Drug Administration and Herbalife subsequently stopped
using ephedrine in its products in the face of rising
insurance premiums.[3][4] The U.S. FDA banned supplements
containing ephedra in 2004.[5]"
Now the following reports below of associated liver failure
appear on Medline - from Spain, then Israel and Switzerland.
It is possible that the case reports below are unrelated
to Herbalife itself , or that in those countries ephedra-containing
Herbalife was still in use at the time, or that potentially
hazardous herbs etc were added locally.
From Yahoo.com, there is an authoritative
rebuttal from Iceland dated February 2007.
A score of drugs and herbs can cause liver damage, topical
ones - albeit rarely- include mushrooms; black cohosh
and kava - see a recent
list.
Drugs like ticrynafen, methyldopa and cerivastatin were
withdrawn among other reasons because of liver problems,
which are among many reasons why necessary sex hormone
contraception and replacement should rather not use designer
patent ie synthetic drugs, and especially not by mouth
(hepatic first pass effect).
So it is always difficult to blame a single product, as
the ongoing debate about black cohosh shows - which many
"first world" regulators have "black boxed"
ie added a compulsory warning to black cohosh warnings.
As with black cohosh, with a rare adverse event report,
users of such products must weigh up for themselves.
J Hepatol. 2007 Oct;47(4):521-526. Epub 2007 Jul 24.
Herbal does not mean innocuous: Ten cases of severe hepatotoxicity
associated with dietary supplements from Herbalife((R))
products. Schoepfer AM, Engel A, Fattinger K, Marbet UA,
Criblez D, Reichen J, Zimmermann A, Oneta CM.University
Hospital Bern, Switzerland.
BACKGROUND/AIMS: Herbal agents are popular and perceived
as safe because they are supposedly 'natural'. We report
10 cases of toxic hepatitis implicating Herbalife((R))
products. METHODS: To determine the prevalence and outcome
of hepatotoxicity due to Herbalife((R)) products. A questionnaire
was sent to all public Swiss hospitals.
Reported cases were subjected to causality assessment
using the CIOMS criteria. RESULTS: Twelve cases
of toxic hepatitis implicating Herbalife((R)) preparations
(1998-2004) were retrieved, 10 sufficiently documented
to permit causality analysis. Median age of patients was
51 years (range 30-69) and latency to onset was 5 months
(0.5-144). Liver biopsy (7/10) showed hepatic necrosis,
marked lymphocytic/eosinophilic infiltration and cholestasis
in five patients. One patient with fulminant liver failure
was successfully transplanted; the explant showed giant
cell hepatitis.
Sinusoidal obstruction syndrome was observed in one case.
Three patients without liver biopsy presented with hepatocellular
(2) or mixed (1) liver injury. Causality assessment of
adverse drug reaction was classified as certain in two,
probable in seven and possible in one case(s), respectively.
CONCLUSIONS: We present a case series of toxic hepatitis
implicating Herbalife((R)) products. Liver toxicity may
be severe. A more detailed declaration of components and
pro-active role of regulatory agencies would be desirable.
J Hepatol. 2007 Oct;47(4):514-520. Epub 2007 Jul 26.
Association between consumption of Herbalife((R)) nutritional
supplements and acute hepatotoxicity. Elinav E, Pinsker
G, Safadi R, Pappo O, Bromberg M, Anis E, Keinan-Boker
L, Broide E, Ackerman Z, Kaluski DN, Lev B, Shouval D.
Hadassah-Hebrew University Medical Center, Israel.
BACKGROUND/AIMS: Nutritional supplements are frequently
considered to be harmless but indiscriminate use of unlabelled
ingredients may lead to significant adverse reactions.
METHODS: In 2004, identification of four index cases of
acute hepatitis associated with Herbalife((R)) intake
led to a ministry of health investigation in all Israeli
hospitals. Twelve patients with acute idiopathic
liver injury in association with consumption
of Herbalife((R)) products were investigated.
RESULTS: Eleven of the patients were females, aged 49.5+/-13.4
y. One patient had stage I primary biliary cirrhosis and
another had hepatitis B. Acute liver injury was diagnosed
after 11.9+/-11.1 months of initiation of Herbalife((R))
consumption. Liver biopsies demonstrated active
hepatitis, portal inflammation rich with eosinophils,
ductular reaction and parenchymal inflammation with peri-central
accentuation.
One patient developed sub-fulminant and two fulminant
episodes of hepatic failure. Hepatitis resolved in eleven
patients, while one patient succumbed to complications
following liver transplantation. Three patients resumed
consumption of Herbalife((R)) products following normalization
of liver enzymes, resulting in a second bout of hepatitis.
CONCLUSIONS: An association between intake of Herbalife((R))
products and acute hepatitis was identified in Israel.
We call for prospective evaluation of Herbalife((R)) products
for possible hepatotoxicity.
Until then, caution should be exercised by consumers,
especially among individuals suffering from underlying
liver disease.
Med Clin (Barc). 2007 Feb 17;128(6):238-9.
[Hepatotoxicity associated with the consumption of herbal
slimming products] Duque JM, Ferreiro J, Salgueiro E,
Manso G. [Article in Spanish] Letter
20070905 :The July 2007 reports of the two dozen Herbalife-associated
hepatitis cases from Israel & Switzerland reveal that
liver problems occurred after about 5 months on the products;
and that relapse occurred in about 20% on rechallenge
with Herbalife ie in this percentage the association is
proven.
As they say, since Herbalife tends to be custom-made in
each country, with numerous ingredients (some undisclosed),
it is so far impossible to incriminate whether the cause
was local product corruption, or some appreoved component,
of which the known possible culprits are ephedra and camelia.
Other known hepatotoxic herbs like black cohosh, kava
and mushrooms were not mentioned. A few of the patients
had viral hepatitis. Only 7 cases had also taken other
known potential liver sensitizers - some synthetic sex
hormones (4), aspirin (3), statin (1) and hydrochlorothiazide(1),
of which 2 cases had positive recurrence of hepatitis
on rechallenge with Herbalife.
UCT Medicines Information Centre is unaware of any such
problems locally, and can recollect only perhaps 2 queries
about Herbalife in some 23 years. Clarification is awaited
from Herbalife headquarters.
From Swiss data the estimated incidence was below 2 cases
per million Herbalife users, but both studies were based
only on hospital records.
Considering the severe global problem of hepatitis from
other causes (due to alcohol; obesity/diabetes (steatohepatitis,
sulphonylureas, glitazones); numerous infections; carbon
tetrachloride; synthetic sex hormones (oral contraception
and postmenopausal hormone therapy) , mushrooms, antibiotics
and antivirals, , autoimmune disease, antiepileptics,
nifedipine, amitryptiline, allopurinol, nonsteroidal anti-inflammatories
including aspirin and paracetamol , black cohosh, kava,
antifungals and paracetamol), and that the rare adverse
association of herbalife with liver damage may well have
been limited only to Herbalife products made in those
three "European" countries at that time, there
is clearly no cause for alarm about Herbalife - just awareness.
The urgent problem of endemic liver disease is rather
the avoidance of infections and potentially hazardous
antimicrobials; mushrooms; carbon tetrachloride, alcohol
excess; sale pf paracetamol without inclusion of protective
vitamins and N-acetyl cysteine; and avoidance of potential
hepatotoxins which are rarely if ever justified considering
their risks, and safe effective alternatives available
for eg statins, sulphonylureeas, glitazones, black cohosh,
kava, non-steroidal anti-inflammatories; oral sex hormones;
and sulphonylureas.
The centuries-proven plant galega
officinalis (extract) metformin after 85years of modern
use remains the only drug proven in longterm use to both
reduce liver damage, lipidemia, thrombosis, adiposity
and insulin resistance, and thus almost halve the incidence
of new diabetes, hypertension/vascular disease, cancer
and thus all-cause premature medical mortality.
Thus appropriate general use of metformin with long-proven
vitamins, minerals, biologicals, safe herbs, fish oil
and systemic human sex hormones - combined with prudent
lifestyle and largely natural fresh foodstuffs- - does
away with most of the well-known potential hepatitis drug
risks listed above.
In defence of free market enterprise and choices, those
who choose convenience safe proven food substitutes or
other complementary products as part of an acceptable
balanced regime advocated by suppliers like Herbalife
do well, they should just be sure of the ingredients and
supplier; and they should report and discuss what they
use with some knowledgable up-to-date healthcare provider.
Back
to top
Response
from
Herbalife
04.09.07
Herbalife's South Africa CEO responds reassuringly:
Good
day,
Herewith a statement from Herbalife in response to the
issues raised by yourself earlier in the week:
While we are aware of reports of abnormal liver function
blood tests such as those reported by Dr. Oneta, our extensive
consultation with internationally recognised liver experts
has led repeatedly to the conclusion that these associations
in time cannot be linked to any Herbalife product.
These small numbers of reports are anecdotal and millions
of satisfied customers all over the world have been using
our products for more than 27 years. All Herbalife products
are formulated and manufactured in accordance with strict
standards overseen by the Herbalife Scientific Advisory
Board, which is chaired by David Heber, M.D., Ph.D., F.A.C.P.,
F.A.C.N. Quality control is overseen by our Scientific
Affairs Group, chaired by Y. Steve Henig PhD and made
up of an international panel of experts in nutrition and
botanical dietary supplements.
Herbalife products, which are now sold in 65 countries,
are formulated, registered and labelled in accordance
with the regulatory requirements in every market where
sold. All Herbalife products are safe to consume as directed.
Many consumers who choose to use Herbalife weight-management
products for weight loss are overweight, some significantly
so. Pre-existing medical conditions such as obesity and
diabetes can be associated with non-alcoholic fatty liver
disease, a disorder that may return certain types of abnormal
blood test results. These test results, therefore, may
have nothing to do with any herbal supplement, but rather
are the result of a pre-existing medical condition. In
addition, it is possible for an individual to have an
allergic reaction to our products, the same way one might
to any food product; for example, strawberries or shellfish.
Herbalife supports the recommendation that consumers visiting
their doctors for medical treatment inform them of any
supplements they may be taking.
As a socially responsible company, we operate an adverse
event reporting procedure that deals with the small number
of queries we have from doctors and consumers and we operate
an open dialogue policy with the medical community. All
adverse event reports are investigated thoroughly in consultation
with the consumer and the physician (if they are available)
to fully understand the facts. None have resulted in the
compulsory withdrawal of any product, ever. In the United
States, Herbalife actively lobbied Congress to pass legislation
mandating the submission of all dietary supplement and
over-the-counter drug serious adverse events to the Food
& Drug Administration. That new law takes effect December
22, 2007.
We still await final comment from Herbalife USA.
Dr Neil Burman
Back
to top
Back
Pain Sufferers Need To Work
People
with conditions such as back pain and arthritis
need to stay in work as much as possible, a UK report
says.
Read
more
Depression
Leads To Worst Health
Depression
is a more disabling condition than angina, arthritis,
asthma and diabetes, World Health Organization research
shows.
Read
more
Parents
Warned Of Additives Link
Parents are advised hyperactive children may benefit
from fewer additives after new research is published.
Read
more
Back
to top
|
| Articles |
| |
Chilblains
Chilblains,
also called perniosis or blain,
a painful abnormal reaction of the small blood vessels
in the skin when exposed to cold temperatures, when occurring
on the feet, is a medical condition often confused with
frostbite and trench foot. Chilblains usually occur several
hours after exposure to the cold in temperate humid climates.
The cold causes constriction of the small blood vessels
in the skin and if rewarming of the skin happens too rapidly,
there is leakage of blood into the tissues as the blood
vessels do not respond quickly enough to this rewarming.
Chilblains are not very common in countries where the
cold is more extreme as the air is drier. The living conditions
and clothing used in these climates are protective. Chilblains
are more likely to develop in those with
poor
circulation, but chilblains
are still common in those with good circulation. . Chilblains
can be prevented by keeping the feet and hands warm in
cold weather. Smoking cessation is advised. A consultation
with a doctor is mandatory - causes are idiopathi eg Raynauds,
or manifestations of serious medical conditions that need
to be investigated eg lupus, leukemia.
Causes: Chilblains often occur in some
people every year, for the rest of their lives. In other's,
chilblains occur for several years and then just stop
occurring. The reason for these patterns of occurrence
of chilblains is not known. As they are more common in
females, there may be a hormonal influence on the development
of chilblains.
A familial tendency, poor circulation, anemia, poor nutrition,
hormonal changes, some connective tissue disorders and
some bone marrow disorders. Damp living conditions may
also increase the risk for chilblains.
As a chilblain is an abnormal reaction to cold, these
factors above increase the risk that it is going to happen.
Chilblains occur when there is too rapid a change from
cold to hot, so the chilblains occur after the foot is
cold. Some people's circulation is so sensitive that only
small changes in temperature may be enough. A typical
history for the development of chilblains is after being
outside in the cold, the foot is placed next to a heat
source (eg heater) when coming back inside. The small
blood vessels do not respond quickly enough to the change
in temperature.
Features: Chilblains appear as small
itchy, red areas on the skin. Chilblains become increasingly
painful as they get congested and take on a dark blue
appearance. They may also become swollen. As they dry
out, chilblains leave cracks in the skin so the risk of
getting an infection increases. Chilblains are common
on the toes, but can also affect the fingers and the face
(especially the nose and ears). Chilblains are also common
on areas of the feet exposed to pressure, such as
bunions
or where the toes are under pressure
from tight shoes or where there are corns
and callus.
Ulceration of the digits and toes
Itchy skin inflammation
Skin redness
Toe
skin inflammation
Finger
skin inflammation
Earlobe
inflammation
Duration:
With treatment, chilblains usually heal within 3 weeks
Once a chilblain develops:
| >> |
do
not rub or scratch chilblains. |
| >> |
avoid
direct heat (ie do not expose the feet to a heater),
but keep the feet warm by the use of woollen socks
and footwear |
| >> |
use
soothing lotions (eg calamine lotion) |
| >> |
if
the skin is broken, use an antiseptic dressing to
prevent the chilblains becoming infected |
| >> |
those
with
diabetes
or poor circulation should
see a Podiatrist.
The risk of further complications from the chilblains
in those with a foot that is 'at risk' is too high
to delay seeking professional help |
| >> |
thermal
or insulating insoles can help keep the foot warm
to prevent chilblains |
| >> |
lanolin
or a similar lotion that is rubbed into the feet
will help stimulate the circulation there are a
number of natural or homeopathic remedies that are
recommended for the treatment of chilblains. Some
of these do appear to help some people |
Podiatrists
see a lot of people with chilblains in cold humid climates
and can give advice beyond what is listed above:
| >> |
padding
and pressure relief may give some relief for the
chilblain symptoms |
| >> |
topical
steroids may need to be used in case of very swollen
severe chilblains |
| >> |
corns
and callus are common in the pressure areas where
chilblains can occur, so reduction of these will
give some pain relief |
| >> |
heparin
ointment may be used in some people to improve the
circulation in the area |
| >> |
a
course of UV light at the start of winter in those
prone to chilblains has been recommended to help
stimulate the circulation in the foot |
Back
to top
|
 |
Beauty
Skin Care
Use of glucosamine looks very exciting. Hats off to Herbal
Life for their Skin Activator Daily Replenishing Cream
- see below. This is cutting edge stuff: developing good
new safe skin products is a high and costly science. It
gives us another strong reason to motivate using oral
glucosamine, not just for arthritis prevention, but also
for skin care and wound healing.
The abstracts below report a 34% improvement in wrinkles
etc. with an oral mix of glucosamine, minerals especially
nicotinamide, vit C and E and nicotinimide, aminoacids,
bromelain, arginine, glutamine and aloe vera.
In the HealthSpan LIFE! range there is already the For-Skin
Blend containing biotin, milk thistle, calmag and vit
C; as well as vit E, bromelain, arginine and glutamine;
and as always the baseline AA Blend and fish oil. As always,
we offer the glucosamine as a separate tub on trial in
case people are allergic to shellfish, or develop allergy
- they do not then have to throw all the rest away. We
have been taking both our For-Skin and our Glucosamine-Chondroitin
and our For-Joints (incl. Bromelain) for some time without
adverse effect.
This will supplement the benefits of a good skin prep.
including aloe, like Weleda-PharmaNatura provides does.
Dr Neil Burman
Research suggests glucosamine is an effective
anti-aging treatment.
By Simon Pitman 3/28/2006
The American Academy of Dermatology says that a recent
study shows that glucosamine could prove to be an effective
topical treatment to reverse the effects of skin cells
damaged by UV exposure. Read
more
Comment from Dr Neil Burman: the abstracts
below from Medllne show what has already been published
since 1974.
Reduction in the appearance of facial hyperpigmentation
by topical N-acetyl glucosamine.
Bissett DL, Robinson LR, Raleigh PS, et al Procter &
Gamble Company, Ohio J Cosmet Dermatol. 2007 ;6;:20-6
Source
Glucosamine has been reported to inhibit melanin production
in melanocyte culture. It thus has a potential to reduce
hyperpigmentation via topical use. In a second clinical
study involving the topical combination of 2% NAG with
4% niacinamide, an agent previously shown to be clinically
active, the effect on hyperpigmentation was greater. Both
of these agents are well tolerated by the skin.
Do shrimp-allergic individuals tolerate shrimp-derived
glucosamine?
Clin Exp Allergy. 2006 ;36;1457-61 Villacis J, Rice TR,
Bucci LR, El-Dahr JM, Wild L, Demerell D, Soteres D, Lehrer
SB.Tulane University New Orleans. Source
Background: There is concern that shrimp-allergic
individuals may react to glucosamine-containing products
as shrimp shells are a major source of glucosamine used
for human consumption.. Conclusion: This
study demonstrates that glucosamine supplements from specific
manufacturers do not contain clinically relevant levels
of shrimp allergen and therefore appear to pose no threat
to shrimp-allergic individuals
Nutritional support for wound healing.
MacKay D, Miller AL.Thorne Research,Dover, ID USA. Altern
Med Rev. 2003 ;8:359-77
Source
Altern Nutritional deficiencies can impede wound healing,
and several nutritional factors required for wound repair
may improve healing time and wound outcome. Vitamin A
is required for epithelial and bone formation, cellular
differentiation, and immune function. Vitamin C is necessary
for collagen formation, proper immune function, and as
a tissue antioxidant. Vitamin E is the major lipid-soluble
antioxidant in the skin; however, the effect of vitamin
E on surgical wounds is inconclusive. Bromelain reduces
edema, bruising, pain, and healing time following trauma
and surgical procedures. Glucosamine appears to be the
rate-limiting substrate for hyaluronic acid production
in the wound. Adequate dietary protein is absolutely essential
for proper wound healing, and tissue levels of the amino
acids arginine and glutamine may influence wound repair
and immune function. The botanical medicines Centella
asiatica and Aloe vera have been used for decades, both
topically and internally, to enhance wound repair, and
scientific studies are now beginning to validate efficacy
and explore mechanisms of action for these botanicals.
To promote wound healing in the shortest time possible,
with minimal pain, discomfort, and scarring to the patient,
it is important to explore nutritional and botanical influences
on wound outcome.
The effect of an oral supplement containing glucosamine,
amino acids, minerals, and antioxidants on cutaneous aging:
a preliminary study.
Murad H, Tabibian MP.El Segundo, California 90245, USA.J
Dermatolog Treat. 2001 ;12:47-51. Source
Background: Alterations in collagen,
elastin, and glycosaminoglycans contribute to cutaneous
changes seen in aging skin. METHODS: A randomized, controlled,
single-blind study was conducted with 53 female volunteers
with an oral supplement containing glucosamine, amino
acids, minerals, and various antioxidant compounds for
5 weeks, compared with a control group of 12 individuals
who did not take the supplement. RESULTS: There was a
statistically significant reduction (34%) in both number
of visible wrinkles (P < 0.01) and the number of fine
lines (P < 0.06) in the group of women who took the
supplement. No significant changes in epidermal hydration
were observed in either the control or study groups. Conclusion:
The use of an oral supplement containing glucosamine,
minerals, and various antioxidant compounds can potentially
improve the appearance of visible wrinkles and fine lines.
It does not, however, affect epidermal hydration.
Back to top
|
| Scientific
Articles |
Diabetes Prevention And Inappropriate New Drugs: Glitazone
Woes And Ethics
Dr Neil Burman
2007.07
Why the current media glitazone hype rehashing the troglitazone
tragedy within 8 years? Glitazones were successively discredited
by the DPP 1998; then PROActive 2005, DREAM 2006 and ADOPT
2006 trials. The first hoped-for $billion Glaxo rain-check
crashed by 1999 with liver (and weight gain and heart)
problems (troglitazone-story.net) – followed within
a few years by cerivastatin(Bayer), glitazars, and now
torcetrapib (Pfizer) - under similar circumstances of
corporate denial. No metabolic corrective- statin, glitazone,
glitazar, gliptin or rimonabant - has given any reason
to expect anywhere as good or safe long term as the 85year
old gold standard metformin.
Useful weight loss in obese diabetics with metformin (dimethylbiguanide
-1922 –Germany: Werner & Bell) was already reported
by Pedersen 1965. But out-of-patent metformin was sidelined
for 50 years by corporate greed - the simultaneous birth
of insulin; and then sulphonylureas (1955) - whose lack
of long term benefit on all-cause morbidity and mortality
was first shown in the UGDP 1971 trial, confirmed in the
UKPDS 1998, but which continues to be glibly ignored by
manufacturers and most prescribing physicians. The estimated
world diabetes prevalence is >200 million, and overweight
>1billion. That’s some market. "The global
diabetes market was worth $18.6bn in 2005-of which the
US had half".(piribo.com; The Diabetes Market Outlook
to 2011: price $2990. May 2006). Why else would a billion
overweight if not diabetic patients not be on the only
proven safe prevention metformin?
Reversal of insulin resistance, prevention – approximate
halving - of new diabetes by metformin was already addressed
in BIGPRO (Fontbonne 1991), confirmed in the 3 to 4yr
China (Wenying 2001) and USA (DPP- Knowler 2002) trials
in sustained effective tolerated dose (up to ~40mg/kg/day).
By contrast, the prediabetic DREAM trial (Gerstein 2006)
showed that while glitazone also halved incidence of new
diabetes, it had no significant benefit on mortality or
cardiovascular endpoints, in fact increased the incidence
of heart-failure five fold.
Unlike all other drugs, metformin can sustain a mean weight
loss of 5 - 8% over 4 years (Glueck 2006) irrespective
of severity of overweight. In the only major long term
diabetes studies (20yr UKPDS 2002; Canada- Johnson ea
2002-6), metformin (in contrast to sulphonylureas and
all other modern chronic preventatives) almost halves
all morbidity and mortality of all major common degenerative
diseases of aging, let alone infertility and miscarriage
rates(Glueck ea) - with the lowest weight gain if any.
In the ADOPT trial (Kahn 2006), metformin’s major
adverse effect was gastro-intestinal - which is always
the prescription ceiling: slow upwards metformin titration
to tolerance just below symptoms, to limit calorie intake
and absorption; and, compared to a glitazone (let alone
sulphonylurea), metformin was associated with fall in
weight, much lower LDL cholesterol and much less vascular
disease & edema. In the European ProActive study (Dormandy
2005) in diabetics for a mean of three years, glitazone
caused far more oedema, weight gain and heart failure,
but failed to prove glitazone superiority to placebo in
its primary endpoint.
So in contrast to glitazone (let alone sulphonylurea),
metformin in appropriate maximum dose is associated with
weight loss; anti-oxidant (Bellin 2006); anti-cancer (UKPDS
1998; Evans 2005; Johnson 2006) antithrombotic(Grant 2003);
anti-lipidemic (Carlsen 1996); anti-hypertensive (Giugliano
1993); anti-heart failure (Johnson 2006); anti-arrhythmic
(Najeed 2005); anti-anginal (Jadhav ea 2006); anti-fatty
hepatitis (Uygun 2004); anti-infertility, anti-pregnancy
loss (Glueck et al); performs equally well in both obese
and non-overweight diabetics (Ong ea 2006), and in the
presence of sepsis (Gras & Lalau 2006).
No other synthetic designer drug ever for chronic preventative
use does all this, and safely –without a single
significant risk in the 20yr UKPDS or in RCTs eg COSMIC(Cryer
2006 –which BMS delayed publishing for almost 8
years, presumably because the results so strongly favoured
solo metformin). No synthetic designer drug for chronic
preventative use has ever been (or will be) tested in
a proper long term RCT (like UKPDS) for half as long as
metformin and sulphonylureas were.
Apart from metformin, the only other regime that achieves
such reduction is the evidence-based combination of safe
preventative vitamins, minerals, human biologicals, herbs;
fish oil; and appropriate balanced sex hormone replacement
for proven deficiency/imbalance (eg Salpeter 2005; Heikinen
2006).
Now in an interim analysis at 3.75 years (Home et al NEJM
5 June 2007) of the unblinded RECORD trial in Europe and
Australasia in 4447 mostly obese hypertensive diabetics
uncontrolled on either maximum sulphonylurea or metformin
(2.55g/d), addition of rosiglitazone (compared to those
on sulphonylurea and metformin) resulted in 11% more primary
endpoints (vascular disease with death or admission to
hospital). This was not yet significant, but bears out
the same trend as in the earlier glitazone trials - lack
of global benefit. One cannot deduce more from this report
without knowing the breakdown of how many “controls”
are on SU vs metformin vs SU+metformin.
Thus it may well be asked: for the major degenerative
causes of premature aging-related mortality (overweight-
metabolic syndrome- diabetes, vascular, osteoporosis)
- why are patients allowed to become obese with diabetes
before metformin and proven safe preventative supplements
are added? Why are physicians world wide not prosecuted
by Regulators for failing to first prescribe appropriate
long-proven combination (of multisystem protectants -
metformin, vitamins, minerals, human biologicals and physiological
balanced human sex hormone replacement) before prescribing
in the remaining resistant cases inferior newer therapy
with known serious risks and costs- sulphonylureas, statins,
glitazones, glitazars, gliptins, anti-obesity drugs, biphosphonates,
rimonabants, and surgery? The reason is obviously the
dominant modern human deity: profit.
Back
to top
|
|
