Dietary Supplement Practicum (19 of 21): Dietary Supplements for Weight Loss

>>Becky Costello: Our next speaker
is Carol Haggans, and she’s a scientific and health
communications consultant with the Office
of Dietary Supplements. And she handles
a variety of health
communication activities including writing and
updating the ODS Dietary Supplement fact sheets and the consumer-focused e-newsletter called
The Scoop. How many of you received
The Scoop in your email? Well, we have
to change that, so — and Carol will tell
you about The Scoop. She also responds
to inquiries from consumers,
health professionals, and the media about
dietary supplements, so please welcome
Carol Haggans. [applause]>>Carol Haggans:
Well, thank you. And as he’s getting
my presentation up, I’d just like to say
it’s wonderful to be here again. And earlier
this morning, Dr. Dwyer took us through
some of the reasons that people take
dietary supplements. And a lot of those
are very broad, to maintain health
and improve health, bone health. But of course,
some people also take dietary supplements for very
specific reasons, and to lose weight
is one of those. And that’s what I’d like
to talk about today. I’d like to talk about
some of the unique aspects of this line
of products, and some
of the ingredients that are contained
in dietary supplements for weight loss. So, of course,
it’s no surprise that obesity is a major
public health concern. About 17
percent children and 38 percent of adults are classified as obese, which is a BMI
greater than 30. And then, others are
classified as overweight, which is a BMI
between 25 and 30. And of course, there are
a lot of comorbidities associated with obesity:
type 2 diabetes, cardiovascular disease,
metabolic syndrome. So, it is
a major concern. And if you look at
the trends over time, we do see a leveling off
among youth, which is a good thing. But among adults,
unfortunately, the rate of obesity
continues to increase. And so, it’s still
a major problem, especially among adults. But most people
who need to lose weight are trying. We know that about
45 percent of overweight and 67 percent of people who are obese are
trying to lose weight. But we know that diet and increased physical activity,
which are, of course, the basis for
long-term weight loss, are difficult. And so, many people turn
to dietary supplements for weight loss, hoping that
they will help them achieve their goals. And women tend to be
about twice as likely as men
to have tried a dietary supplement
for weight loss. And of course,
there’s no shortage of products to try. If you walk into
any health food store or grocery store, you’ll see a variety
of products on store shelves. And some of these
come at a fairly hefty price tag. Many of these were
in the $15-$25 range per bottle. And if you look
at the top-selling dietary supplements
in the U.S., weight-loss pills comes
in at number eight. So, it is a fairly
large category, and it represents about
$2 billion a year in sales. And just to draw
a distinction among the various
products that are on the market, there are of course,
what — prescription medications
for weight loss. And there are also over
the counter drugs for weight loss
such as Alli, which contains orlistat.
But there are many, many more
dietary supplements. And Joe Betz
went through this a couple of days ago,
the distinction between dietary
supplements and drugs. Of course, dietary
supplements cannot have any pharmaceutical
ingredients. They are not allowed to
make any disease claims, and they have
a Supplement Facts Panel as opposed to
a Drug Facts Panel. And one
of the challenges with studying
this line of products is that there are
such a wide variety of ingredients
and formulations and different
combinations of ingredients. And many of those
are botanical, as well. And Barbara Sorkin
talked about the fact that there a lot
of challenges with studying
botanical ingredients, and that becomes
even more so when you combine
multiple botanical ingredients in one product. On average, there’s
10 different ingredients in weight
loss supplements, and some have
as many as 96. So, it can be very
challenging to study these and compare one
product with another. And of course,
not surprisingly, the safety and efficacy
of these products can vary widely, and that’s some of what
I’ll be talking about in a few moments. So, if you look at
the various ingredients that are commonly found in weight
loss supplements, they fall into roughly
five categories. There are those that
are intended to increase satiety
or reduce your appetite, so you consume
fewer calories. Some are purported
to block fat absorption, so that you can
continue to eat and some of the — what you eat
does not get absorbed. There’s some that may
increase fat oxidation or reduce synthesis, some that may modulate
carbohydrate metabolism, and then those that increase
energy expenditure, so that you burn
more calories. But of course,
the real questions are, are they effective,
and are they safe? And when you
consider safety, it’s important
to consider both adverse effects, interactions that can
occur with drugs or other dietary
supplements, and also the purity
of the products, whether or not there
may be any contaminants and whether or not
the product contains what is stated
on the label. And it’s important
to consider the level of evidence that these claims
are based on. A lot of the times, you
see dietary supplements, a lot of weight
loss supplements, that may make
specific claims. And sometimes
those claims aren’t based on
a lot of evidence, or perhaps they’re
just based on some laboratory research or some animal studies, but that really is
preliminary evidence. It’s not until
you get toward the top of the pyramid — with
the randomized control, double-blind studies,
of course, being the gold
standard — that you really have
enough evidence upon which to base
a good judgement. And then, of course,
meta-analyses and systematic reviews
are helpful, because they can
pull the data from many studies and combine them
into a certain summary. And so, what I’d like
to do is take one or two ingredients from each of
these categories, the ones that
I’ve shown in red, and go through what
we know about the safety and effectiveness
of these ingredients. So, to start, Hoodia,
or Hoodia gordonii. Hoodia is
a succulent plant, a cactus-like plant, that grows in
the Kalahari Desert in southern Africa. And Hoodia was one of
the biggest things to hit
the weight-loss market about 10 years ago. And its popularity
was based primarily on anecdotal evidence. The San Bushmen had
traditionally used Hoodia
as an appetite suppressant
on long hunts. And based on that,
it became very popular in the U.S.
and elsewhere. But if you look at
the amount of research that actually exists in the scientific
literature, there’s very little. There were a few animal
studies indicating that it reduces
food intake, and that, combined with the traditional
use in Africa, is what allowed
Hoodia to take off as a weight-loss
supplement. There’s actually only
been two clinical trials on Hoodia, and only one of them
was a double-blind RCT. It was actually a very
well-conducted study published in AJCN
a few years back. It included 49
overweight women, and they were housed
in a clinic for 19 days. And during the time
that they were there, they were provided only certain food
and beverages. They had ad
libitum access to the food
and beverages, but they weren’t allowed
to choose any food that they wanted. So, this eliminates
a lot of the variability that you can get
in weight loss studies. And some received
Hoodia extract, the others placebo. And what they found,
looking from baseline to day 15 — this is energy intake. You can see that
their energy intake in terms of
the kilocalories did decrease in
the Hoodia group, but you can also see
that it decreased in the placebo
group as well. And so, this is
a perfect example where it’s so important,
of course, to do the placebo trial, because if you just did
an open label trial here,
you would, of course, assume that the Hoodia
was effective. But in fact, placebo
had the same pattern. And so,
not surprisingly, since there was no
effect on energy intake, there was actually
no effect on body weight either for placebo
versus the Hoodia. There were a few
adverse effects noted in the
clinical trial. The Hoodia caused
significant increase in heart rate,
blood pressure, and bilirubin
and alkaline phosphatase levels. The clinical
significance of this wasn’t clear, because there were
no other elevated liver enzymes, but these were concern. There were also some
other mild effects like headache, dizzy — dizziness, nausea,
and vomiting. And interactions
were not studied. And about the time
that Hoodia became really popular, people started to notice
that it seemed like there was more Hoodia
on the market than Hoodia that was
being grown worldwide. And the question is, “Well, how can
that happen?” So, there was a group
of researchers that collected
some Hoodia products off the store shelves and determined that many of them contained little
or no Hoodia. Only about 30 to 60
percent of the products that they tested
contained adequate amounts of Hoodia. So, this raises
a quality concern, obviously, that could be going on
with this product, as well as with others. Now, these data
are fairly old, about 10 years old. I haven’t seen any
newer data to suggest whether this is still
a concern with Hoodia, but it is something
to be aware of. So, the next product
is chitosan. And chitosan
is purported to block dietary fat absorption in the GI tract, the idea being that
you can continue to eat as you’ve always done, and you’ll
still lose weight, which, of course, would be the ultimate
magic bullet. So, chitosan
is a polysaccharide. It’s derived from
the exoskeletons of crustaceans. And, as I mentioned,
it’s purported to bind dietary fat
in the GI tract, preventing at least
some of it from being absorbed and carrying it
out of the body. And there have been
a number of small RCTs on chitosan. Cochrane Collaboration
published a review about 10 years ago
on chitosan. The review had a total
of about 1,000 subjects that were overweight
or obese. You can see that the
doses of the chitosan that were administered
were quite wide, ranging from 0.24
to 15 grams per day. And in about half
of the studies, the subjects consumed
a reduced calorie diet, and then the other half, they had
their usual diet or some sort of
behavior modification. And the studies lasted
between four and 24 weeks.
They noticed here — you can see each of
the individual studies and the standard
deviations or the confidence
intervals and the means. And down here
at the bottom, they did find
a statistically significant effect of about 1.71 kilograms
of chitosan versus placebo. But what they noticed
was that many of the trials were not
of high quality. When they looked at only
the high quality trials that received
A-grade, because they met
the allocation concealment
quality criteria, which is how
the blinding is done, there were only
three trials like that. And when they looked
at those, they saw that
the results were much less impressive
of only 0.6 kilograms, and it was not
significant. There were also
two studies that analyzed fecal fat. And of course, you would
expect fecal fat to increase if the mechanism
of action is actually working.
And they found a non-significant
increase in that, so that does raise
some questions as far as the proposed
mechanism of action. So, overall,
they concluded that there is
some evidence that chitosan is more
effective than placebo, but due to
the poor quality of most of the trials,
and the fact that the effects
are fairly minimal, it’s probably of
unlikely — has much clinical
significance. As far as
adverse effects, there was mild nausea, flatulence,
and bloating, GI effects primarily.
There is a concern that if people have
shellfish allergy, they should avoid
chitosan. And there’s also some
indications, excuse me, that they might have some
anticoagulant effects, so it might
actually increase the anticoagulant
effects of warfarin. So, the next is
Garcinia, and Garcinia is one of the more
popular products or ingredients in dietary supplements
for weight loss. They have about
66 million in sales annually. Garcinia is a
fruit-bearing tree that grows
in tropical climates. And the fruit
contains a compound called
hydroxycitric acid, or HCA. And the underlying
mechanisms for the effects
aren’t clear, but studies in rats
have found that HCA does decrease
food intake and thus weight gain. And is it effective? Well, there was a
meta-analysis published a few years back
that included nine randomized
controlled trials with about 550 subjects.
In most of the trials, the subjects consumed
a low-calorie diet. And they lasted — they
were fairly short-term, lasting up to 12 weeks. And what they found was a borderline
significant difference. The p-value here
was 0.05, not less than 0.05, so it was borderline. But the — you can see
the magnitude of the effect
was fairly small, just 0.88 kilograms
more weight loss with the Garcinia
versus placebo. The researchers
also looked at the dose effect, and how dosage
affected weight loss. Here, dosage
is on the x-axis. Weight loss
is on the y-axis. And you can see that — so a higher value
on the y-axis would be
more weight lost. You can see that in some
cases, the higher doses did produce
a greater weight loss, and they did find a
significant correlation between dose
and weight loss, but it was not linear. And the adverse effects
of Garcinia are fairly minor, again, mostly
GI symptoms. But there have been
some case reports in
the literature about mania, things like grandiosity, irritability, pressured
speech, sleeplessness. There have also been
some concerning case reports about
liver toxicity, some that required
liver transplants. And these are concerning
and definitely warrant further investigation. But it is important
to keep in mind two things
with case reports. Of course,
one thing is that they can’t prove
cause and effect. And the other is
that in many cases, the specific product in question
was not analyzed. I see this a lot
in case reports. It’s just
sort of assumed that it was a pure
Garcinia product, but you never know,
unless you actually analyze
a specific product that the person took,
whether or not there might have been
a contaminant present. So, that possibility
always exists. So, while these
raise some concerns that definitely warrant
further investigation, they aren’t definitive. There are also some
potential interactions between antidepressants and opioid
pain medications, possibly because
Garcinia might have some serotonergic
activity. The next one is
raspberry ketone. So, raspberry ketone
is an aromatic compound that’s isolated from
red raspberries, and small amounts of it are used in
the food industry as a flavoring agent. And I remember
several years back, our office received sort of a cluster
of inquiries about red raspberry,
a ketone. And they came to me. And I thought,
“Well, this is odd. I’ve never
heard of this.” So, I looked it up,
and I determined that the reason
I’ve never heard of it is that apparently, I don’t watch enough
daytime television — [laughter] — because
raspberry ketone was all over
the internet and all over television, being called things like
fat burner in a bottle. And so, of course, that piqued
consumers’ interest, and that’s why they
were contacting us. But when I looked into
the amount of research that was available, there was
virtually nothing, just a few rodent
and laboratory studies. And even to this date, there’s really
only been one trial that included
raspberry ketone as part of
another blend. And you can see all
the other ingredients that were included
in this blend. This trial did find
a significantly greater weight loss for the product
versus placebo, but because it contained so many different
ingredients, it’s impossible to know
whether raspberry ketone contributed toward
any of that. There was also
a very high dropout rate in this study. Only 45 out of
the 70 subjects completed the study, which raises
questions about it. And so, we really need
additional research. As far as the safety
of raspberry ketone, of course, if you
consume raspberries or you consume a food that has used raspberry ketone
as a flavoring agent, you’re getting very
tiny quantities, but it’s nothing
compared to the doses that are provided
in dietary supplements. And we really don’t
have enough evidence. There’s just
toxicology studies that are limited
to rats. In the RCT
that I mentioned, there were no serious
adverse effects. But researchers
have noticed that it has
a structural similarity to synephrine.
So, potentially, it could have
some stimulant effects, and we really
don’t have enough data on interactions. So, now onto chromium. It’s an ingredient
that’s been around for quite a while. And of course, chromium is an essential
trace mineral. We all needs
small amounts of it for good health. It potentiates
the action of insulin. And poor chromium status
has been hypothesized to contribute to the
incidence of impaired glucose tolerance
in type 2 diabetes. It’s also been
purported to increase lean muscle mass
and promote fat loss. And so, these are
the basis of why it has been included
in many dietary supplements
for weight loss. And there was a lot
of research on chromium in the 1990s and a few studies
since then. In 2013, there was a
meta-analysis published that included
11 of these trials, about 866 subjects that were either
overweight or obese, a fairly wide range
of chromium dose again, as you can see. And in most cases,
the subjects consumed their usual diet for up to six months. So, what they found
was a small, but significantly
greater weight loss and reduction in percent body fat for chromium
versus the placebo. It was about —
for the weight loss, it was about one pound over the course of two
to six months, so not very big. So, they concluded that
chromium supplementation does cause statistically
significant reduction in body weight
and percentage body fat, but the magnitude of
the effect is so small, you really have
to question the clinical
relevance of that. The adverse effects
of chromium tend to be fairly minor when it’s taken
at reasonable doses: watery stools, headache,
weakness, other effects. There are some
concerns, though, with interactions
between insulin because of its effect
on glucose levels. There’s also
many other drugs that could affect
chromium levels and vice versa, so it is one
to be aware of in terms of
drug interactions. So, finally, I’d like
to talk about green tea. Green tea extract
is one of the more popular herbs
and botanicals. This is a list
of the best sellers of all herbs
and botanicals, not just those in weight
loss supplements, and it comes in
at number six with about $140 million in sales annually. And of course,
green tea is an herb, and it’s a popular
beverage that’s consumed
worldwide and has a number
of reported health benefits. And green tea extract
is included in a variety of dietary supplements
for weight loss. It’s believed that
the active constituents are catechins, particularly, EGCG
as well as caffeine. And these are purported
to increase energy expenditure
and fat oxidation and possibly
reduce lipogenesis. And there seems to be
some synergism between the EGCG
and the caffeine. When researchers
have isolated the EGCG, they don’t seem to see
the same effects as they do when it’s
combined with caffeine. And so, as far as its
effectiveness, there was another
Cochrane Review published in 2012 that had a little over
1,500 subjects, a fairly wide range
of catechin doses, and in all
but four trials, the green tea product
that was analyzed did contain caffeine. But in the others
it was decaffeinated. But they were fairly
short-term trials as you can see. And what they found was
a significantly greater weight loss
with the green tea. Again,
magnitude fairly small, a little less
than a kilogram. And when the researchers
looked at the various studies, you can see
the trials listed above, and the bottom — the bottom indicates
the total difference of 0.95 kilograms of green tea
versus placebo. And what they noticed,
though, was significant heterogeneity
within the trials. And this was
particularly true with the trials that were conducted
in Japan, which are the ones
at the top. The ones that were
conducted outside of Japan had less heterogeneity. So, when they looked
at those specifically, they found that the results were
much less impressive, and, in fact, there was
a non-significant effect on weight loss. So, as far as
the safety, there’s no question
that green tea as a beverage is safe. Green tea extract, primarily
the adverse effects that you hear about
are nausea, constipation, possibly some increase
in blood pressure. But there have been
some concerning reports about potential
liver damage, particularly when
green tea extract is taken on
an empty stomach. Since 2006,
there have been over 50 case reports. And the USP
a few years back did a review of
34 of these cases and determined
that seven are probably caused by
the green tea extract, and 27 are
possibly caused. So, this is
definitely of concern. There is an EFSA
review underway, and when the results
of that come out, we’ll know more. And of course, green tea
also contains caffeine. And — so caffeine, sort of a separate
entity to consider when considering
the adverse effects. It, of course,
has GRAS status and is present in coffee and a lot
of energy drinks. The FDA states
that intakes of about 400
milligrams per day or less are considered
safe for most adults. But of course,
high doses can cause problems,
like nausea and vomiting and
more serious effects. And of course, they — caffeine can have
numerous interactions, particular with
other stimulants, or even if it’s taken
with, you know, a triple
shot of espresso. So, I wanted to take
a few moments to talk about
labeling of caffeine in particular, because the FDA’s
labeling regulations for caffeine
are fairly loose. They state that
if caffeine is added as an extra ingredient, or a separate
ingredient, it must be stated
on the label, but the amounts that are
contained in the product does not need
to be listed. So, here you have
a product that has green tea
extract listed as part of blend,
but as you can see, there’s no indication
anywhere on the label that it contains
caffeine. It may not. It may be
a decaffeinated version, but we don’t know. Here is one that shows
green tea leaf, again, as part of a blend. And at the bottom,
it does say, “This product
contains caffeine.” So, at least
the consumer is aware it contains some
caffeine, but there’s no —
is it 10 milligrams? Is it 100 milligrams?
You really don’t know. One more where the green
tea leaf is listed here. And caffeine, I think,
sort of oddly enough, is listed as
another ingredient. So, I don’t know
whether that means that it’s been
added separately or whether there might
also be some from the green
tea extract. Now, some of
the trade associations have created
voluntarily guidelines. Council for Responsible
Nutrition, for example, all of their member
companies are required to follow more
strict guidelines. They state
that if a product contains caffeine, whether it’s from
an herbal source like green tea
or guarana or yerba mate, that it must list the
caffeine and the amount, and if there’s more
than 100 milligrams per serving, that there be
a warning label. So, here’s an example
of a label that meets these
voluntary labeling regs. Here you can see the
green tea leaf extract is listed along with the milligrams
of green tea leaf, and then right above
it shows caffeine with the amount, 183 milligrams per
serving on the right. And so, as a result, because it has more
than 100 milligrams, they do have a warning
at the bottom to consult a healthcare
professional for certain conditions. So, this is a —
this is a good example of a label that provides consumers with
the kind of information that they really need to
make an informed choice. So, now, I’d like to
turn for a few minutes to a very unique
ingredient, and that is ephedra. As you undoubtedly know, ephedra is a banned dietary supplement
ingredient. And although the FDA
does have the authority to ban dietary
supplement ingredients, it’s actually very rare
that they do it, partly because
the burden of proof to prove that a — an ingredient is
unsafe falls on the FDA, and it can be
very hard to prove. But ephedra’s an example of one of those
ingredients, so I thought I’d spend
a few minutes talking about
the history of ephedra. It is a Chinese
botanical also called ma huang, and it contains
several alkaloids, including ephedrine
and pseudoephedrine. And traditionally,
ephedra had been used for nasal decongestants. It’s very effective for
asthma and bronchitis. And in fact, synthetic
ephedrine is contained in a lot of over the
counter cold remedies. Of course,
those are drugs, not dietary supplements, but they are available
over the counter, and they’re
very effective. And ephedra acts as
a central nervous system stimulant, and it might
increase thermogenesis and reduce appetite
somewhat. So, about 15
to 20 years ago, it started popping up in a lot of weight
loss supplements, and also supplements
that are promoted for — as an ergogenic aid
for working out. And AHRQ, the Agency
for Healthcare Research and Quality, commissioned
an evidence report, and ODS and NCCIH were co-sponsors
of that report. And they looked
at all the studies that were available, all of which were
short term, and they did conclude
that ephedra does have a modest
effect on weight loss. But the concern with
ephedra was safety. There were concerns
raised in some of
the controlled trials that were conducted
on ephedra. And there were even
many more that came in in the form
of adverse event reports to the FDA. Everything from nausea
and vomiting, anxiety
and mood changes, to far more serious
effects like seizures, stroke, myocardial
infarction, and even death. And many of these
occurred when ephedra was combined
with caffeine and other stimulants. So, it wasn’t
necessarily ephedra itself,
but it was the fact that it was combined
with caffeine and other stimulants
in products. And —
but because ephedra was such
a popular product, industry initially
pushed back a little bit on the FDA as they were trying
to make the case for banning ephedra.
But there were a couple of
very high profile cases. Steve Bechler,
for example, was a Baltimore Orioles
pitcher who died of heat
stroke in 2003 at the age of 24, and he was taking
a weight loss supplement that contained ephedra. And the medical examiner
concluded that that supplement contributed
toward his death. So, based on all
of the evidence that was beginning
to accrue, the FDA was successful
in banning ephedra in 2004. And the industry
was very quick to react to come up with what were called
ephedra substitutes, like bitter orange peel. In fact, a lot of them
started to formulate — reformulate
their products even before the ban
went into effect when they could sort of
see the writing on the wall, and they could see
that ephedra was sort of falling from grace as a safe ingredient. And so, even though we
obviously haven’t seen the safety concerns since that time
with ephedra substitutes like
bitter orange, the fact that many
of them are combined in products with other stimulants still raises
the possibility that adverse effects
could occur. So, now, I’d like to
turn for a few minutes to dietary
supplement quality and how you find
a quality product. And as you know,
dietary supplements don’t have to undergo
pre-market approval for safety
and effectiveness before
they are marketed, but quality is a slightly
different thing. And questions of,
you know, how do you know
if the product contains what it says it does, whether it’s pure — and it’s very difficult
for consumers to know — even though
dietary supplements do have to undergo — or they have to follow
good manufacturing practices, it’s very difficult
for consumers to know if there have been
any GMP violations. And so, there have been
some independent groups that have arisen. USP, NSF,
and are three of those
that conduct independent analyses of dietary supplements to look for things
like purity, contaminants, whether
or not they dissolve. So, those are things
that consumers can look for on product labels to give them
some assurance that they’re buying
a quality product, because, of course,
there’s no question that there are a lot
of high quality, conscientious, dietary supplement
manufacturers, but recalls can happen. In fact,
over a nine-year period, there were 237 recalls of dietary
supplement products, and about
a quarter of them were for weight
loss products. Sexual enhancement
products and body
building products were the other
big categories. These tend to be
the big three that you see
with problems. And invariably, the problem
that causes the recall is an undeclared
drug ingredient. In fact,
here’s an example of a notification from just
a few months ago from the FDA
of a product that was found
to contain a hidden
drug ingredient. And here, you can see that the ingredient
was sibutramine, which is pharmaceutical, so obviously
it cannot appear in a dietary supplement. Technically, that makes
this an unapproved drug. But as far as the
consumer’s concerned, it looks like
a supplement, it has a supplement
label, but it actually contains
this pharmaceutical. And what makes it
even worse is that sibutramine
was banned as a pharmaceutical
ingredient in 2010, because of concerns
with high blood pressure and increased heart rate and that it could
cause stroke. So, here you have
a pharmaceutical ingredient that’s banned
in a dietary supplement. And of course, it doesn’t appear
on the label, so the consumer’s
completely unaware. Another uncommon
but potential problem, is the presence
of a banned ingredient in dietary supplements. I just got finished
telling you that ephedra was banned in 2004, but there are still
products available on the market that
may contain ephedra. In fact, here was
one manufacturer that was selling
products containing ephedra until at least 2012. And just last year, they
were convicted of this. But it does happen
from time to time, so it’s another thing
to be aware of. So, what’s the
bottom line? The bottom line is that
there’s numerous ingredients and formulations in
weight loss supplements. Some might have
some modest effects, but the question is,
are they — are they clinically
significant? And there are some
concerns with safety, particularly adverse
effects, particularly
with stimulants. Drug interactions can occur
with many of these, and the quality
can vary, particularly for this
line of products as opposed to other
dietary supplements. And Pittler and Ernst,
I think, very eloquently stated in one
of their publications many years ago that when there’s a lack
of convincing data on effectiveness, even minor adverse
events shift the delicate
risk-benefit balance against their use. And I think
this really applies to weight
loss supplements, because when you look
at the magnitude of the effect,
it’s very small if any, and there are some
potential safety concerns there. And of course, we know
that physical activity and a healthy diet
are really the basis for long-term
successful weight loss. Unfortunately, there is
no magic bullet. Maybe we all
just need a lock on the kitchen door. So, as Joyce
mentioned earlier, we do have a number of dietary supplement
fact sheets, and one of them is our
weight loss fact sheet. It’s part
of your handouts in your
electronic binder. This is a — an image from our health
professional version. And as part of it,
we have a nice listing that kind of gives you
the bottom line on proposed
mechanism of action, evidence of efficacy,
safety, et cetera. We also have
a consumer version that’s in both
English and Spanish, and it has
a nice little chart that people can look at all the ingredients
that we’ve included, many of which
I’ve talked about today, and some of which
I wasn’t able to cover. But you can look
to your resource for more information. Here, if you click
on one of these, it gives them
the bottom line: does it work,
and is it safe? So, thank you very much, and if you have
any questions, I’ll be happy
to take those. [applause]>>Female Speaker:
Question, question. No questions –>>Carol Haggans: People are getting tired.>>Female Speaker:
— on weight loss?>>Male Speaker:
Ah, [unintelligible].>>Male Speaker:
So, have there been kind of the same rate
of adverse event reports with
the synthetic ephedrine and, like, Bronkaid
and those products, as there was
with herbal ephedra?>>Carol Haggans: So, you mean the products that were in
over the counter drugs?>>Male Speaker: Right,
and that still are.>>Carol Haggans: You know,
I don’t have data on that, but my gut feel is
the answer is no, because
it’s short-term use. And you know,
people tend to take — you know, if it says
take one pill every four hours, they’re going to take
one pill every four hours for that type
of condition, but — for, like, over-the
-counter cold remedies. But weight loss,
sometimes people — you know,
more is better, combine with
a cup of coffee, that kind of thing.
But I don’t — honestly, I don’t have data
on that to know specifically
whether that’s the case.>>Female Speaker: Do any of our pharmacists in the audience have an
answer to that question?>>Carol Haggans:
Yeah, does anybody know?>>Female Speaker: I’m sorry.
I didn’t hear.>>Carol Haggans: The question
was whether or not there are over the — same adverse event
reports with over-the-counter
medications that contain
the synthetic ephedrine. Yes, Steve.>>Male Speaker: I’m actually running
a bunch of data analysis in the industry regarding serious
adverse event reports that came in and have been looking
at extending to look at some drug
adverse event reporting. So, if you’d like
to get my attention, I’d be happy to look into ephedra
and synthetics as one
of the examples –>>Carol Haggans:
Great, thank you.>>Male Speaker:
— definitely as I’m working
through that.>>Carol Haggans:
Yeah, let’s talk.>>Male Speaker:
Yeah.>>Carol Haggans:
Thank you.>>Female Speaker:
Any more questions? Going once, going twice.
In the back?>>Male Speaker: I had a quick
question regarding your thoughts
on sweet peppers. So, not capsaicin,
but capsinoids, the non-spicy compounds
associated with –>>Carol Haggans: As far as whether
or not they’re effective? There’s — I haven’t seen a lot
of research on them. There’s some evidence
that they might have some stimulant effects, but I don’t think
there’s a lot of evidence
that they’re effective as a weight
loss supplement or as an ingredient
or even, you know,
consuming peppers and consuming
a lot of those. Yes, Joanna?>>Johanna Dwyer: Just two
possible resources that might be useful. I think Rick Mattes
at Purdue and one of his
doctoral students did some work
on capsaicin. And the problem is if you get up
to very high doses, it’s not very palatable. At least –>>Carol Haggans: It’s a possibility
as well.>>Johanna Dwyer:
— they found troubles on that. And I think also at
Maastricht, in the Netherlands, there have been
some studies in terms of weight loss where they did
metabolic chamber work, and I don’t think there
were very large effects.>>Carol Haggans:
Thank you.>>Female Speaker: So, let’s thank
Carol again for her presentation. [applause]