a lot of viewers ask about cholesterol-lowering supplements like red yeast rice or phytosterols
and a brand new trial just came out looking at those, so let's take a look.
they compared a Statin to several different types of supplements side by side and they
also had a placebo group, so people taking an inert pill, as a reference.
by the way, I don't make any money from any of these products, I think regular viewers
already know this, I don't make money from statins or any other drug, I don't sell supplements,
we don't make any commercial deals on the channel, so I don't have a horse in this race.
so in this trial, rosuvastatin, that's the Statin they used, lowered LDL-cholesterol
by about 35% compared to the group given the placebo.
LDL-cholesterol was 133 mg/dL average before the trial, it came down by 46 points, so to
about 86 mg/dL average, so that's a substantial drop.
on the other hand, most supplements had no statistically significant effect.
phytosterols lowered LDL-cholesterol by about 4%, and red yeast rice by about 6%, but neither
was statistically significant compared to the placebo. and the Statin also lowered total
cholesterol and triglycerides.
now, this trial was funded by the pharmaceutical industry, so a lot of people asked about that,
so this is another opportunity to address this common question and these concerns with
Pharma and funding.
what we said in previous videos is we don't dismiss scientific studies based on funding
alone, we still have to scrutinize them, we still have to assess them scientifically,
and importantly, we have to look at balance of evidence, what else is known on this topic,
in this field, and does the new study align with that prior data or is it an outlier?
and of course we still have to go through this appraisal process regardless of funding
source, even if the investigators pay the for the research out of pocket, we still got
to do it, this is why I tend to not pay too much attention to funding, because it doesn't
really change this process, but that said, if people want to note funding source, I don't
have a problem with that, as long as we don't fall in the trap of starting to dismiss results
we don't like because of funding, I sometimes see people on social media dismissing entire
bodies of evidence, entire fields that don't agree with their views based on some vague
funding concern, and that's a massive red flag so we don't want to fall into that.
so are the findings of this new trial believable?
are there any caveats?
I see two main sources of uncertainty, and both have to do with dosage.
I'm just wondering if maybe a different dose would work and so we can't take the results
of the trial and extrapolate to say that the supplements don't work, period.
the second caveat, which is related, is whether the supplements they used actually contain
the amount of the molecule written on the box.
some trials actually measure the amount of the active ingredients, and that's fantastic,
but that's not the norm from what I've seen and this one did not do that.
and we know this is a problem with supplements because they're very loosely regulated and
so there's massive variation in the market.
the active ingredients in red yeast rice are called monacolins, the main one being monocolin
K, and some studies have found a 100-fold difference in the content of monacolin K between
different commercial products, even though they were all labeled with the same dose of
red yeast rice.
unfortunately, most of the studies that I've seen that do this type of measurements don't
disclose which products exactly they're looking at, they're usually coded, but here's an example
of a study that both measured monacolin K content and disclosed the source.
they used a red yeast rice formulation called Dif1stat, from Difass International in Italy,
and they confirmed it contained monacolin K.
This is not me recommending this company, I don't know anything about them, I´m not
affiliated in any way, I´m just sharing the information I´ve seen.
Also, this trial is from 2017 and there are some recent developments in European legislation
that may change everything and we´ll touch on that in a minute.
So, I went back and looked at other trials that have been conducted looking at these
supplements to see how this new one compares.
For example, this large analysis looked at 20 randomized controlled trials using red
yeast rice and in average it did lower LDL-cholesterol by about 40 points.
40 mg/dL.
So that's similar to the effect of statins seen in the newer trial and in fact in this
older analysis that cholesterol-lowering effect of red yeast rice was not significantly different
from the cholesterol-lowering effect of statins.
A different meta-analysis also showed an effect of red yeast rice, it lowered LDL-cholesterol
by about 28 points average.
okay, so why is the new trial giving us a different result?
some people might go, "aha!
so it was the funding after all.
we should go back and dismiss studies based on funding".
unfortunately it's not that simple because some of the studies that show an effect of
supplements are funded by the supplement industry, right?
so there's no way around it, we have to always do the scientific assessment.
so the doses the different trials are aiming for are not that different, if anything the
dose in the new trial is higher than a lot of the older trials that did work, so my main
suspicion is my second caveat from earlier, that maybe the supplement they used didn't
contain the amount that it said on the package.
and the older trials generally report how much monacolin K was included in the supplements
they used, but this new trial doesn't mention it, so maybe they used a supplement that didn't
report monacolin K content and maybe it included very little.
so we might conclude, "oh, so the new trial is trash, we just ignore it", but it actually
gives us really important information, it's a really important cautionary tale because
it drives home this idea that the effect of the supplement can vary dramatically depending
on where we get our bottle.
we'll come back to this idea in a minute, but first let's take a look at the phytosterol
supplements.
I also found some prior evidence of efficacy for phytosterols. in this analysis of clinical
trials, phytosterols lowered LDL-cholesterol by about 8 to 10% average, which amounted
to 12 points, 12 mg/dL, and the dose of phytosterols used was about 1.6 grams a day, which is the
same dose as a new trial.
this actually makes total sense because the new trial was statistically powered to pick
up a 15% or larger effect on LDL-cholesterol so this 8 to 10% seen in older trials of phytosterols
wouldn't make the cut, it wouldn't reach statistical significance, so phytosterols probably do
lower cholesterol, it's just a mild effect.
quick caveat regarding phytosterol supplements: some people are hyperabsorbers of sterols
in the intestine, they absorb a large amount, and for those people phytosterol supplements
are not a good idea, they can cause problems, we actually covered this recently with Dr
Tom Dayspring, so for more details check out that video.
another option on the market is called a stanol, which is a slightly different molecule, it
has a similar effect in the intestine to the phytosterols but it doesn't get absorbed so
it's safer for those people.
two last caveats regarding supplements, the first one is safety, most available evidence
looking at red yeast rice points to a pretty low level of adverse effects, of side effects,
but most of those trials are pretty short, they're mainly looking at LDL-cholesterol
changes and they last for a few weeks, a few months maybe, and so there's a certain level
of uncertainty regarding long-term intake, and in fact some of the meta-analyses voice
this concern, and second caveat, at the end of the day what we really care about are outcomes,
does the risk come down?
the cardiovascular risk, the risk of actual heart attacks and strokes and death, that's
the standard by which medication is evaluated, like statins and other meds, we look for a
reduction of risk, not just the reduction of cholesterol.
I've only seen one trial looking at red yeast rice and actual risk, so a long-term outcome
trial, it was carried out in China, where they use this extract of red yeast rice called...
however you pronounce that
10,000 Chinese viewers just went, "unsubscribe".
their results were actually really encouraging, after four years, people taking that extract
had lower risk of coronary events like heart attacks and even lower death.
and this was in an older population with a history of heart attacks, so it was secondary
prevention.
so from the evidence I've seen, I think red yeast rice is interesting, it could potentially
be a viable option if it were regulated and standardized, and maybe had more outcome trials
validating it.
I'm not going to speculate on why it is or isn't approved and regulated, whether it's
financial interest from Big Pharma or the FDA, but I'm sure those conversations are
going to be going on in the comments.
to add more fuel to the fire, it seems the FDA considers it illegal to sell red yeast
rice products if they contain significant monacolin K, because they consider it a drug,
not a supplement.
and in fact, they have tried to clamp down on companies selling it.
in Europe, monacolin K is also being restricted, new legislation just came out this year restricting
the dosage.
honestly, I don't know what effect all of these measures are going to have, because
nowadays people get everything online anyway from all over the world, and I did a quick
Google search and I found several supplements advertising substantial amounts of monacolin
K. whether they really contain it or not is another story.
so that's the bulk of the evidence I've seen on this topic, hopefully that helps you make
some educated decisions, I don't really like to tell people what to do or what they have
to do, it's not really my style, I can tell you what I would do if I had high cholesterol.
if I'm not at very high risk, so relatively young, healthy overall, no history of heart
disease but cholesterol is a bit high, first and foremost I would lower it with lifestyle,
and we have like a hundred videos on that.
alright, maybe not 100, but like eight or nine.
if that doesn't get me quite where I want to be, I like to see my LDL-cholesterol and
my ApoB under 80 mg/dL, different doctors, different lipidologists might have different
thresholds, if the lifestyle alone doesn't get me quite there, might I play around with
a stanol or with a red yeast rice that isn't a crazy high dose, that reports monacolin
K content?
Maybe, and if that pushes me another 10 or 20 points, cool, but I'm not going to bet
the farm on those, if I have very high apoB, if I have very high risk, if I've had a heart
attack before, or a stroke, or if I have angina or if I have extensive plaque shown in imaging
or a high calcium score or like a crazy family history or something like that, I wouldn't
play any games, I would go straight to something that is regulated and has more outcome and
safety data.
in terms of not knowing how much is in the supplement, I guess I could just measure my
blood work and if the cholesterol comes down after I take the supplement, that's a good
sign, but because it's not regulated, how do I know the next batch isn't going to be
a lower dose, or somewhere down the line they change the process and the supplement changes?...
yeah, I guess I could keep measuring routinely and keep an eye on that.
it's kind of a pain in the backside.
another thing to bear in mind is monacolin K is essentially a statin.
the chemical structure is the same as Lovastatin, they're the same molecule, and the physiological
effect is the same, monacolin K inhibits the same step of cholesterol synthesis as statins
do.
now, of course red yeast rice is not just pure monacolin K, it contains other components,
and some of the concerns over safety are related to those.
if this was 20 years ago and I have a Statin intolerance and I can't be on a Statin, yeah,
I would consider red yeast rice as an alternative, but now that we have all these options with
outcome trials, with safety data long term, ezetimibe, pcsk9 Inhibitors, all these things
coming out, if I'm at risk, I would focus on those.
so that's me, let me know your thoughts below, and also, if you have experience with some
of these supplements, please share with everybody.
here's the video with Dr Dayspring on phytosterols, and here's some more information on statins.
I'll catch you guys next week, peace