Diet Debate: Supplements II – Double Blinded by Science?

A couple of weeks ago, I wrote a post on Nutritional Supplements, and why I think they’re a waste of time and money.

Sol Orwell from Examine.com, a website dedicated to reviewing supplements, posted some of his thoughts in the comments section, you can see his points and my responses here.

Draw your own conclusions, but I think for the most part, his arguments were already addressed in the original article. He did however raise a couple of issues that I thought were worth looking at in more detail.

These points were:

• Double Blind Studies, the Gold Standard of Science, Support Supplementation – Boom!
• “Asprin itself was basically a supplement” – Sol Orwell, Examine.com

I thought that these were interesting points, which warranted further coverage, so without further ado…

Double Blinded by Science

In previous articles such as “The Problems with Nutritional Science” and “The Problems with Paleo Science”, I highlighted many of the problems with epidemiological studies, and espoused the benefits of the scientific gold standard, the Double Blind Placebo Controlled Study (DBPC).

When it comes to nutrition with real food, DBPCs are pretty much impossible to conduct (see aforementioned articles for more details).

Supplements, however, lend themselves perfectly to such studies. It is very easy to create an identical placebo supplement with no active ingredient, which neither the participants, nor the scientists, can differentiate between, so any differences between the groups can quite confidently be attributed to the actual effects of the supplement itself.

Studies such as these, have indeed shown positive health effects from supplementation, therefore supplementation must be good, no?

Unfortunately, it’s not quite that simple. Double blind studies are excellent at finding the answer to a very specific question – is intervention A better than placebo, or intervention B. What they don’t tell you, however, is how intervention A compares to interventions C-Z. Just because intervention A was better than doing nothing, or maybe even better than the alternative intervention B, we still don’t know whether it’s better than intervention C, or D, or maybe a combination of several different interventions!

Let me give an example of a hypothetical double blind study on nutritional supplements for health and well-being, and why its results are so limited.

Dave and Jim both work in IT, indoors and desk bound all day. In their free time, they both like to play computer games, again, more time spent indoors and sedentary.

Their diets both consist primarily of processed beige food. Frozen pizzas, crisps, soft drinks, with little to no fresh meat, fish or vegetables.

Both Dave and Jim sign up to take part in a study into the effects of taking multiple nutritional supplements, including a multivitamin and mineral supplement, high dose vitamin D, and fish oil capsules.

Both subjects receive a big bag of tablets, but neither of them, nor the people assigned with the task of measuring their health and signs of well-being know if they got the real tablets or not.

After three months of taking the tablets, both Dave and Jim have to go back to the centre, where they are subjected to a number of physical examinations, plus a questionnaire to assess their general level of well-being.

Jim not only has better results on numerous health markers, but also reports having much more energy, better concentration, and generally feeling much better about himself. Dave on the other hand has made no improvements, and feels no different.

Low and behold, it turns out Jim was given the active supplements, whereas Dave received the placebo. Had they been the only two in the study, this wouldn’t mean much, as it could have been random chance/other uncontrolled variables which accounted for the difference. The two were part of a much lager study however, and there is a clear and significant difference between the supplement and control groups, which make the scientists confident that the protocol does have a beneficial effect.

What this study tells us, is that if you have a typical diet of nutrient sparse, processed food, and insufficient exposure to sunlight, taking some nutritional supplements will probably bring about a significant improvement in your health and well-being.

This doesn’t, however, mean it is the only, or best way, in which to do this.

What if there had been a third arm to the study, where the intervention had been to add lots of oily fish and grass fed meat to their diet, copious quantities of fresh fruit and veg, and swapped some of his indoor leisure time for outdoor activities.

In fact, the best study design would probably have had four arms:

1. Active Supplements + Indoor Activity
2. Placebo + Indoor Activity
3. Active Supplements + Good Diet and Outdoor Activity
4. Placebo + Good Diet and Outdoor Activity

We could then see if taking supplements alone could equal the benefits of a well balanced whole foods diet, and/or whether adding extra nutrients in supplement form had any additional benefits to an already nutrient dense diet.

NB – I added in the indoor activity, as otherwise the activity component from spending time outdoors would be a confounding factor, as adding the extra exercise could contribute to improved health and well-being. In the real world, however, I’d argue that getting more activity into your schedule is really another benefit of going outside in the sun to get your vitamin D, and that taking the supplement might be just that excuse you need to stay inside on the couch.

In my previous article, my point was not that supplements can’t or won’t have any positive effects on anyone. Jim certainly felt the benefits, and having seen them, I bet Dave wished he’d been in the active arm of the study!

Being deficient in essential nutrients will most certainly lead to poor health, and possibly even death, so it is something best avoided, and supplementation is one way of doing this, as demonstrated by numerous studies.

What has never been shown, however, is that supplementing a poor diet and lifestyle, is equally as good, or better than making other, more positive changes such as eating nutritious whole foods and spending time outdoors.

Neither has it been shown that taking extra nutrients in supplement form, on top of a diet which is already replete with ample nutrition has any additional benefits. On the contrary, I’ve written before about the dangers of having too much of a good thing!

So perhaps I should re-state my previous position on nutritional supplements slightly.

If you’re resolutely intent on maintaining a nutrient deficient diet comprised of processed junk food, and refuse to go outside into the sun, then yes, you should probably look into some kind of supplementation regimen. Personally, however, I think I’ll still choose to go the real food and sunshine route myself.

Before I move onto the next point, one more chink in the armour of DBPCs, is that they can only ever realistically be conducted over a short period of time. They are therefore also notoriously bad at teasing out the long term effects of an intervention. This is one of the reasons that switching from saturated fats to vegetable oils initially seemed like a good idea, but longer term studies have failed to show benefit, and even serious dangers, to its consumption. (*Please don’t think by linking to the Weston Price website I condone all their views – there’s some serious whackyness on there too).

This is why we need to use a combination of DBPCs, and epidemiology. Microscopes are a fantastic invention, but if you only ever looked at the world through one, you’d have a pretty distorted view of things!

Q: When is a Supplement not a Supplement?

This subtle but important difference appears to have eluded Sol from Examine.com, but actually, when I’ve come to look into it, it’s not surprising, as the waters are pretty muddied!

According to the FDA…

The law defines dietary supplements in part as products taken by mouth that contain a “dietary ingredient.” Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.¹

Manufacturers are able to claim that a supplement “supports the structure and function of the body”, but, unlike drugs, “Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases”.

The other critical difference between a supplement and a drug, is that due to the fact that supplements are theoretically comprised of constituents normally present in the diet through food, and not intended to have any medical effects, there is little to no regulation of supplements.

Again from the FDA’s website:

• Federal law does not require dietary supplements to be proven safe to FDA’s satisfaction before they are marketed.
• For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA’s satisfaction that the claim is accurate or truthful before it appears on the product.
• In general, FDA’s role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency’s first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.

I’m not sure which I find the most disturbing, the fact that there is no requirement for a manufacturer to prove their product is safe or effective before releasing it, or that the FDA will only take action against a product that presents a significant or unreasonable risk of illness or injury!

How do drugs differ from supplements?

The term “drug” is defined as any substance (other than a food or device) intended for use in the diagnosis, cure, relief, treatment, or prevention of disease or intended to affect the structure or function of the body.

Drugs are subject to FDA approval. Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded.

Thus a key difference to note between a drug and a dietary supplement is the level of evidence (clinical trials, safety studies, etc.) needed to make the actual drug structure/function claim.²

Yikes, is Live Now Thrive Later secretly a puppet of Big Pharma?!

Hold your horses there matey! When I pointed out to Sol in the comments, that Asprin is not a supplement, but a regulated drug, I was accused by another commenter of “touting Asprin as a wonder medication“

Rest assured, this is not the case. There are many problems with the drug approval process. A combination of bad science and corruption means that approval of a drug is by no means a guarantee of its safety of efficacy. I’d strongly recommend reading the book Bad Pharma by Ben Goldacre for an in-depth look into the problems with Big Pharma.

So this is where it all gets rather complicated.

Sol champions berberine as an example of when “targeted supplementation” can be a “gold mine”, saying “Ask any doctor who deals with diabetics what htey think of berberine.”

Now personally, I’m not a big fan of blindly accepting advice from authority figures. Plus, in reality, I doubt all doctors are going to agree. That’s rather like saying “Ask any doctor who deals with heart disease patients what they think of statins” – I doubt you’re going to get a uniform answer!

Rather than ask a doctor, I’d say it’s better to look at the science, as there have been numerous studies into the efficacy of berberine as a treatment for type II diabetes.

Before we do however, here’s the catch 22. Berberine isn’t currently classified as a drug by the FDA. However, as it is not a substance one could normally get through diet alone, and in this case is being used to treat a disease, it shouldn’t theoretically be classed as a supplement.

Indeed, if you do currently promote the use of berberine for the treatment of diabetes, you can get a scary letter like this from the FDA as you are in fact promoting the use of an unlicensed drug.

Forget the Semantics, Look to the Evidence

Names and labels can be fairly arbitrary. Regular readers of this blog may remember that I don’t even like the label “food”!

So how about the terms dietary supplement, licensed drug, or unlicensed drug?

In what ways, if any, should these labels influence your decision as to whether or not a product is safe or effective?

I’d say the best starting point is to assess whether you have a diagnosable disease.

If you answered no, then you don’t need a drug, licensed or otherwise, and hopefully if you’ve read this article and its predecessor, you’ve realised you don’t need any supplements either.

But what if you do have a disease?

While I do promote eating whole foods, bash supplements, and think that there is a lot wrong with the ways in which medications are licensed and promoted, I am most certainly not “anti-pharmaceuticals” in all circumstances.

Life expectancy is longer than ever, despite our terrible diets and stressful lifestyles, and this is in no small part due to advances made by modern medicine.

Most diseases can be roughly categorised into 3 broad classifications: Infectious Diseases, Genetic Diseases, and Lifestyle Related Diseases.

Infectious diseases are caused by pathogens such as bacteria and viruses.

If you are exposed to the HIV virus, despite what some internet gurus might say, no amount of Fermented Himalayan Yak juice and Kombucha is going to help you. Thankfully, modern pharmaceuticals mean that rather than it being a swift death sentence, you can probably live a normal, full life (providing you, your government or insurance company can/will pay for them…but I digress).

While there is some truth to the idea that a healthy, well nourished individual, with well balanced gut flora, may have more resistance to common infections than those that don’t, it by no means makes you impervious to all pathogens.

Advances in modern medicine against infectious diseases such as vaccinations and antibiotics have saved countless millions of lives. Yes, there are potential downsides to antibiotic use, mainly due to over or inappropriate use, but this doesn’t mean we should forget all the good they’ve done.

Genetic diseases or disorders are usually congenital (i.e. from birth), and are caused by abnormalities in the genome. These may be random mutations which just affect the individual, or inheritable traits which may be passed down from generation to generation.

Genetic disorders are typically quite rare, typically only affecting one person in thousands, though Familial Hypercholestorlemia affects as many as 1 in 500.

Again, perhaps a good diet and healthy living might alleviate some symptoms and make life more pleasant for those affected, but they can’t prevent or cure such illnesses.

Despite what you might read about the life saving qualities of the paleo diet, the fact remains that during palaeolithic times the average life expectancy was around 30 years old, mainly due to high infant mortality rates. A 100% natural, organic, whole-food diet does have many potential benefits, but it is far from a panacea! When it comes to preventing and treating infectious and genetic diseases, modern pharmaceuticals are the key.

The third category, lifestyle related diseases, is perhaps where things start to get confused, and where the pharmaceutical industry begins to get a bad name (and in many cases rightly so).

As the name suggests, lifestyle related diseases are not caused by infections or genetic disorders (though some people may indeed be more genetically predisposed to them), but by lifestyle choices which are incongruent with a healthy body.

Smoking, excessive alcohol consumption, excessive calorie consumption, and lack of physical activity would be the primary behaviours generally agreed upon to be the main causes of the most common lifestyle related diseases such as heart disease, stroke, type II diabetes, and increase risk of many (but by no means all) forms of cancer.

One would think that the most common sense approach to combat these diseases would simply be to avoid these behaviours.

$130 billion worth of sales of the drug liptor, making it the biggest selling prescription drug of all time
indicate that perhaps things are not quite so straight forward.

The reasons why people persist in self harming behaviours such as those mentioned above are many, and highly complex – lack of education/deliberate misinformation, poor self esteem, lack of time or money, procrastination or ambivalence are just a few possible contributory factors.

Is it possible that drugs such as statins actually help ebable people to persist in unhealthy behaviours? Are people more likely to continue eating take away junk food everyday if they get a free packet of statins included, or would people go ahead and eat their burgers and fries regardless?

Probably there would be some people who would go ahead and eat the same junk regardless, who will probably benefit from statins, and others who might have been more compelled to change their habits, had there not been a pharmaceutical life line on offer?

Another thought is, while lifestyle changes may prevent these diseases, they might not necessarily be able to reverse them. Prevention may be better than a cure, but that’s not particularly useful advice to someone already suffering from a disease!

I also note that my own personal preferences and experiences cause me to look at these issues with considerable bias.

I enjoy cooking and eating real food, being active, and spending time outdoors, so the idea of risking illness or even death from being sedentary and eating fast food, and having to take medications with side effects to mitigate the damage, doesn’t sound very appealing.

On the flip side, however, I’ve travelled abroad and trekked through malaria infected jungle. Malaria is a horrible disease, and the best way to avoid it is to stay well away. We now have medications to prevent and treat the disease, albeit with some unpleasant side effects. Would I have still travelled to these areas without them? Hard to say. Do the people sitting at home on the sofa washing down statins with a sugary soft drink think I’m crazy? Probably! Who am I to say my lifestyle choices are any more valid than theirs?

Just to clarify, I still think %^$£ supplements

I do hope I didn’t lose you there, going off on my big philosophical rant.

The point I was trying to make, was that as a healthy individual, who eats a varied real food diet, is active, and gets ample sun, I have no need for either supplements or medication, however you choose to define them. There is simply no evidence that they will enrich my life, or have any health benefits.

If, on the other hand, you are resolute in your desire to live a sedentary life, and eat as much beige, homogeneous, highly processed junk as possible, some astute supplementation and perhaps even medication, may allow you to keep doing this for longer than you otherwise would (providing the active ingredient hasn’t been swapped for heavy metals).

If, woe betide, something were to happen to my health outside of my control – say I contracted a disease, got poisoned, developed a spontaneous cancer, or something else similarly hideous and unexpected, I would of course seek professional, licensed, medical attention.

I wouldn’t blindly accept the diagnosis and prescription of the doctor due to their position of authority, nor would I arbitrarily reject it in the belief that they were under the evil influence of “Big Pharma”.

Rather, I’d take their expert recommendation (of what you’d hope to be) evidence based treatment, as a great starting point for my own research, and would follow their recommendations providing I was convinced of the quality of the evidence, and that there were no better alternatives that they may be unaware of or unable to recommend for whatever reason.

But fingers crossed none of that will be necessary!

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1) http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm

2) A Timely Review: Defining Dietary Supplements vs. Drugs Q and A By Jana Hildreth and Patricia Blue

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