Exercise & Fitness
Fact: Regular physical activity - even at moderate levels - reduces
the risk of heart disease, cancer, high blood pressure, and obesity.
Here's another fact: 65% of Americans are considered obese. So while
the risks associated with not exercising are clear, we don't seem to
be doing anything to change our sedentary ways.
Prevention of Disease
The likelihood of contracting heart disease, diabetes, and other
health issues can be directly impacted by our every-day choices. A
good place to start for healthy lifestyle habits that can positively
affect your health and wellness for years to come:
1.Try reducing your stress levels.
2. Adopt some stress-management techniques.
3. Focus on your emotional wellness.
Emotional health and well-being is just as important as physical
4. Supplement your diet with fresh vegetables and fruits and natural diet supplements
Supplement for Lou Gehrig's
Full-Length Doctor's Interview In this full-length doctor's
interview, Bob Pascuzzi, M.D., explains how creatine may help
people with Lou Gehrig's Disease.
Interview with Bob Pascuzzi, M.D., Neurologist Indiana
University School of Medicine, Indianapolis, Indiana
Topic: Supplement for Lou Gehrig's
What is creatine? How does it affect the body?
Dr. Pascuzzi: Creatine is an amino acid. It is a health food
supplement, and the body normally makes it in the liver. It's
stored largely in muscle, but is present in other tissues in
the body also. Its role seems to be largely that of energy for
cells and for many years, people have used creatine as a
health food supplement. The feeling is that this form of
supplement may improve muscle bulk and possibly muscle
strength and muscle endurance -- that's why physical fitness
people around the country and the world have for many years
been looking to creatine as one of a number of supplements
that might help improve performance in muscle. It's an
interesting substance in that, while it's normally made in the
body, because it is involved with energy metabolism, it's been
a focus of interest in diseases where energy may be limited or
suspect, and that includes a number of neurological
conditions. Not just one, but a number of them that have been
targets of a therapeutic strategy for creatine because a lot
of neurological problems involve cells that fail either in the
brain, spinal cord, nerves, or muscles. Part of that failure
involves the energy processing of the cells. If you can think
of a way to help improve the energy function, deliver them
more energy, help protect them from degrading and if you have
a safe way of doing that, it offers some logical strategy for
treating a whole host of neurological problems. That's really
the basis for its consideration as a treatment option for not
muscle diseases but brain and spinal cord diseases, which is
what ALS is.
I know some of the research has been done with mice. How has
creatine shown to be effective against ALS in those mice?
Dr. Pascuzzi: Well, there is a mouse version of ALS. It is a
genetically based version, so it's an animal model. The
importance of having a model is it allows research to be done
in a lot more thorough and controlled and methodical way. It
allows research to be done a lot faster than what could be
done in just studying the course of an illness in humans.
Those studies would suggest that mice with this genetically
determined form of ALS live longer, they survive longer, if
they take creatine than those who don't take creatine. It's a
difference that is sufficient to make people interested in
going the next step, which would be to treat patients, humans,
who have ALS with creatine supplements and see if a similar
benefit can be found in those folks.
That's what the ongoing study is now with patients? Can you
explain a little about how the study is working?
Dr. Pascuzzi: Here at Indiana, we're in a network of medical
centers around the country that has an interest in a variety
of neurologic diseases and one of those that we have focused
on is ALS. In many medical centers around the country, in fact
around the world, there are individuals really focused on
trying to deal with treatment of ALS. We work closely together
whenever possible to pool our resources, including trying to
perform multi-center studies of new treatment options for
people with serious neurological problems including ALS. We're
one of, I would guess, 15 or so centers around the country
involved with a specific protocol testing creatine to see if
it is beneficial for people who have ALS or not and also to
establish that if it is beneficial, how beneficial is it? Also
to establish, is it safe? We always like to think that the
things we expose our patients to are safe, but a formal trial
like this is an excellent way of trying to make sure we're
doing the right thing and that the patients are not put at
risk from the treatment. So, we're trying to establish whether
or not there's reason to think it's an important therapy for
ALS patients to take, does it offer them some meaningful
benefit or not, and is it a safe form of treatment? It is a
multi-center study that's going on at many fine medical
centers around the country and we just happen to be fortunate
to be one of those that has this to offer to patients in the
Are there any preliminary results, or have you seen any
Dr. Pascuzzi: We have patients here that are seen periodically
according to our protocol. It's a six-month protocol where
patients are followed meticulously, acidulously, methodically
for six months, very carefully both for any evidence of
benefit and any evidence of a safety problem. We're in the
midst of that follow-up now. What we need to do is wait until
the study is completed. Then we will pool all of the data from
the 15 sites around the country and compare those patients
that took creatine supplements with those who took a placebo.
The way these studies are set up, the patients don't know
whether they were on the real drug or the placebo, and we the
clinicians don't know that either -- that is so that we aren't
too biased in thinking that we see what we want to see. We
want at the end of the day to be sure that we give patients
and physicians and everyone else correct information, real
information that they can use. Does this form of treatment
work or not, does it work well or not, is it safe or not? So
we do these in what's called a blinded fashion.
Everything is rolling along smoothly but I don't have any
results to share with you. You'll have to come back in six
months. The way these studies work, and this is fairly
typical, where some of the patients are randomly assigned to
the active drug, the real drug, and some are assigned to a
placebo. At the end of the study period, which in this case is
six months, all the patients are offered the real drug for
real following that. That's the standard protocol for studies
of ALS and other similar serious neurological problems.
Can you talk a little about ALS and how if affects patients?
Dr. Pascuzzi: ALS is a brain and spinal cord disease that
shows up by making the muscles malfunction. Your muscles work
only because the brain and spinal cord talk to them and while
there are many diseases that affect muscle primarily, like
muscular dystrophy for example, ALS is a bit different. ALS is
a problem with the motor nerves that are located in the brain
and in the spinal cord. These motor nerves send wires --
called axons -- from the spinal cord out to the muscle. If
these wires fail, the muscles don't work well. The problem in
ALS is the motor nerves located in the brain and spinal cord
malfunction prematurely, and over the course of several years,
patients lose function.
The disease may initially show up with some very subtle loss
of function in an arm, maybe some loss of muscle in a hand or
arm, some muscles cramps or twitches. Everybody gets cramps
and twitches now and again, but these patients may get more.
It may start with some trouble walking, like a foot drop. It
may start with some malfunction of the muscles in the face or
throat, so slurred speech or something like that could be the
initial symptom, but it's a very gradual thing. The onset is
difficult to place because it doesn't come on overnight, it
doesn't come on abruptly like a stroke. It's a very gradual
indolent onset. Wherever it starts, it typically then spreads
slowly, so if it starts in an arm, it will spread into the
other limbs and eventually usually spread up into the speech
and swallowing and breathing area. So, it slowly creeps along.
There is an old name for this disease that's very appropriate
and gives people a good sense of what the disease really does
and that's creeping paralysis. Typically most patients run a
course of two to five years where the paralysis creeps along.
At the end of that point in time, if their breathing muscles
become too severely affected, that's what limits their
survival -- that's what really threatens their long-term
survival -- unless they then go on a breathing machine or
unless they have a slower course, then we have a real problem
with their survival.
Some patients have a rapidly progressive course and may not
survive for a year, but most people have a two to five year
course. I think Lou Gehrig, after whom the disease is named in
this country, probably had a two or three year course of
Another important issue is that not all patients are within
this two to five year window. We have about 20 percent of
patients, about one in five, that have a course that runs
longer than five years and about 1 in 10, 10 percent, longer
than 10 years. We have some people who are on year 15, year
19, year 21, and they come back and see us and they said,
'well, you told me that this was going to run two to five
years and I'm still here' and they're correct. There is a
group of patients where it creeps along even more slowly. It's
just a gradual progressive condition. It doesn't come and go;
it continues to run on a slope, if you will. You can have a
steep slope or a real, real gentle slope, but whatever slope
you're on is the slope you stay on.
The idea behind a treatment is to try to ideally get the slope
to turn around and get it stronger. If we can't do that, get a
treatment that will let the slope level off so it plateaus so
people don't lose more ground, kind of arrest the disease.
Then if we can't do that, if we can get treatments that will
change the slope so that people won't progress as rapidly,
that would also be hugely important for a disease like this.
Is the theory behind this study that creatine could help
change that slope?
Dr. Pascuzzi: Correct.
When you think creatine, many people think body builders or
performance and health. Why is it so important for ALS
patients to increase that performance or strength?
Dr. Pascuzzi: The interesting thing about creatine and ALS is
that, although most people out there taking creatine for
bodybuilding and its effect on muscle, the ALS patient is
probably taking it for effect on brain and spinal cord
function. Those cells that are malfunctioning, the motor
nerves, are the ones where the creatine is intended to be
playing a role to help save them, to help provide those cells
with more energy, to help keep them from braking down, to help
protect them. I think that's the theory behind using creatine
in ALS. Now, in the patient, the idea is that if you can
preserve or protect some function in your hand, it means you
can mow your grass longer and you can button buttons longer,
you can open jars longer, and you can turn the keys in the
ignition. That's function, and the bottom line is it doesn't
really matter what your grip strength is, its function. Can
you use your hand for things? If your arms, shoulders, are too
weak to lift things above your head, then there are a whole
set of functions you can't do during the day. You can't put
the dishes away, you can't do your hair, so if we can preserve
some function and keep it from dropping off, then for a longer
period of time, for more months or more years, the patient
will be able to do more things. If somebody's function is
limited in the legs where they can't walk, if we can have a
treatment that keeps them walking longer, that's a function
that would mean a lot to them. And the same with speech, the
longer we can keep speaking with just a limited Hoosier drawl,
probably the more function we get and our quality of life is
I think the idea is if you can preserve some function, even if
it's not perfect, if you can keep it reasonable so that the
patient can do more, then their quality of life is affected in
a favorable way and the quality of their family life, their
friends, their work and colleagues is affected in a positive
With the creatine, I know your research it still early to say,
but my understanding is there has been other research here
that has shown some positive effects. That's why you moved
into phase II. Is that correct?
Dr. Pascuzzi: Yes. In fact, there are a variety of
neuromuscular conditions in humans and there are investigators
in North America, in particular, who have looked at creatine
supplementation in a whole variety of nerve and muscular
diseases with some positive results, some beneficial effects
noted, and a good safety profile as well, which has actually
added to the interest in pursuing this for the treatment of
I think at this point in time, it's fair to say the jury is
still out until a trial like this is completed and we really
see for sure over an extended period of six months of
treatment comparing two groups -- one that took the
supplement, one that took a blank -- patients that have been
studied very, very carefully. I think that's what it's going
to take to really answer the question: Is there something
meaningful there for our patients? I would think that if this
study were to suggest that there is something substantially
beneficial then there will be an even larger study that will
really try to fine tune how useful is the drug, how well does
it work, and in what patients does it work best.
Have you seen any side effects with your patients?
Dr. Pascuzzi: Not really. I think our patients, just like
those athletes around town that use it, tolerate it very well.
Although it has been pointed out by a number of observers over
the years that safety information on creatine is limited and
there are occasional patients that have been reported with
some kidney trouble from taking a lot of creatine, it's in the
doses being used. I think it is, in my view, a very safe
program, so I'm not uneasy about our patients in the protocol.
In the protocol, they are being followed for safety very
carefully, so if there's one good thing about a trial like
this, it offers everybody else interested in creatine an
opportunity to really be certain about what its safety profile
really is. Beyond that, people in the community, athletes
taking creatine, I think that it's a relatively safe form of
supplement. That's my honest view of the thing.
We have a number of other experimental options for treating
patients with ALS and it's important to realize that it's not
as though creatine is going to be the only one out there that
might make us or break us in having a good treatment for ALS.
We have trials of other neuroprotective drugs, we have trials
of what are called nerve growth factors, which are like
fertilizers for motor nerves, and the important point is that
we, like the other major medical centers around the country,
try to work as closely together as possible in exploring what
are logical, reasonable strategies for treating the disease.
If we get to the point where a clinical trial in humans is
appropriate, then we try to work together and collectively get
answers as effectively as possible and as safely as possible.
Is the dosage any different than what an athlete takes?
Dr. Pascuzzi: Not really. The dose of creatine that is being
used in this trial is actually very consistent with the common
doses that the typical athlete or fitness individual would be
How did the idea come up in the first place to try creatine?
Dr. Pascuzzi: Creatine has been of interest in a variety of
neurological diseases. It's not the case that ALS is the only
one that it's been considered. Even more specific brain
diseases like Huntington's disease have been the subject of
considerable interest for creatine therapy because it's
something that's involved with energy metabolism. A lot of
these neurological diseases involve the failure at some point
in the series of events of energy to cells and for nerve
cells, that's real important because once a nerve cell dies,
for the most part, it doesn't get remade. It's not like skin
and can just be rebuilt. You have to protect them. It's a drug
that's been considered for a whole host of neurological
diseases for good reason because of its involvement with
END OF INTERVIEW
If you would like more information, please contact:
Mary Hardin Indiana University School of Medicine 1110 W.
Michigan, LO 401 Indianapolis, IN 46202 (317) 274-7722
Article Compliments of SS.
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