22 June 2009

The saga of dietary supplements

Alexey Vodovozov (uncle_doc)

Biologically active additives (dietary supplements) did not just enter our lives, in the troubled 90s they burst into it in a huge crowd - with bright advertising brochures, icons "If you want to lose weight, ask me how" and loud promising slogans. Sellers of treasured bottles promise to finally and irrevocably cure all diseases, using only natural, natural, environmentally friendly, exclusive, hitherto secret raw materials and components.

"Free shipping", "Buy one bottle — the second as a gift", free seminars-shows, mass mailing by e—mail, attracting doctors to the sale of supplements, a competently built aggressive advertising campaign combined with active anti-propaganda of official medicine methods - all this has done its job, and dietary supplements in our country have gained incredible popularity, comparable only to the popularity of TV series.

What kind of animal is this and what is it eaten with? Can supplements be dangerous or, conversely, will they eventually replace all existing medications? Let's figure it out.

What 's in my name for youLet's start, perhaps, with the dry phrases of the definition.

So, biologically active additives are "concentrates of natural or biologically active substances identical to natural ones, intended for direct intake or introduction into the composition of food products in order to enrich the human diet with individual biologically active substances or their complexes" (document).

Actually, this could be the end of the article. It seems that everything is clear – the enrichment of the diet, a mixture of biologically active substances, natural and synthetic ... But no. The problem is that manufacturers of dietary supplements persistently disown the provisions of orders and SanPiNs, constantly emphasizing the exceptional naturalness of their products, highlighting the unique preventive and even therapeutic effects of additives, trying to squeeze into the territory of medicines.

You have a shortageSo, in order to bring any product to the market, you need to create a steady demand for it.

It is quite problematic to find any mass disease. After all, there must be some symptoms, at least some clinical manifestations. In the case of dietary supplements, the solution was found simple, elegant, and at the same time ingenious – all people eat incorrectly. That's all completely. There are a lot of reasons: either the nutrition is unbalanced, or the products are of poor quality, and they lack the necessary nutrients – this is no longer so important. The main thing is that the food of absolutely every person on the planet lacks something vital.

The consequences of the shortage accumulate over the years, have a blurred picture – increased fatigue, periodic weakness, drowsiness, low mood (did you recognize yourself in this description?). And over time, if you do not eliminate the cause of the shortage, terrible things can happen – heart attack, stroke, cancer and the like. And only the constant intake of dietary supplements can save, since they are created precisely for the purpose of saving humanity.

By constantly dripping on the brains of consumers, the food product, which is dietary supplements, has been elevated to the status of a panacea. In addition, MLM (multi-level marketing) representatives became interested in supplements as a very profitable business. As a result, we have the dominance of dietary supplements that can be observed today.

100% naturalOh, and manufacturers and, especially, sellers of additives love this phrase.

"Only natural ingredients", "living vitamins", "bioavailable forms" - as opposed to "chemistry", "synthetics" and other "unnaturalness". Well, then. There are many natural things in nature: arsenic, for example, or fly agaric, or hemlock (which was executed in ancient Greece). So "natural" does not mean "useful" or "effective" at all. And it's certainly not a synonym for "safe."

The story of aristolochiic acid is indicative in this regard. The compound is as natural as possible, it is present in the fruits of kirkazon (Aristolochia). The plant has been widely used in various dietary supplements for weight correction. The first alarm bells began to be heard back in 1993, when data on patients of the Belgian "slimming" clinic, which practices herbal supplements treatment, appeared in one of the medical journals. 105 patients developed kidney pathology, and 18 women had kidney cancer.

It took almost 10 years for doctors and consumer protection organizations to prove the high nephrotoxicity and carcinogenicity of the acid. And only in 2001 it was banned for sale in the USA, and then in many other countries. However, Chinese supplements, for example, with kirkazon Manchurian (Aristolochia manshuriensis) periodically pop up on the Russian market, and recipes are still posted on slimming websites in Runet, where an infusion of the same kirkazon Manchurian is recommended for "cardiac and renal edema".

There can be no question of any naturalness if concentrates or plant extracts were used in the manufacture of this or that additive – in this case, the raw materials are chemically treated using, at best, ethyl alcohol, or even esters, and aldehydes, and much more. On the other hand, almost all riboflavin (vitamin B2), which is used in industry (and after all, the production of dietary supplements is by no means manual mixing of ingredients and compounding, but quite an industrial process), is biotechnological production. It is given to the mountain by "tamed" bacteria. And wherever it is in 2, in dietary supplements or in a drug, it will be natural, natural, produced by a living organism.

And also to the question of naturalness. How much is stored, for example, a broken-off aloe leaf containing quite biologically active phytoncides? And what is the shelf life of dietary supplements based on it? Preservatives, stabilizers, fragrances, dyes, flavor enhancers – all this is present in dietary supplements. Another question is that manufacturers "forget" or "hesitate" to write about it on boxes with "natural" tablets.

Better than medicine?"Today, when ancient recipes are forgotten, pharmacy drugs only temporarily relieve pain and inflammation, without eliminating the cause of the disease.

And it is impossible to drink "chemistry" all the time," – the pathos of one of the dietary supplements is argued in the advertisement. Dietary supplements are carefully disguised as medicines – the same dosage forms (tablets, capsules, syrups) are used, the same principles of packaging design, even the names resemble the names of medicines. Yes, and sellers of all kinds of "magic pills" really dislike the phrase "biologically active supplement", they prefer the term "drug". And what is this word associated with in the vast majority of the population? That's right, with the medicine.

Why is this done? To expand the target audience. In theory, dietary supplements are shown to everyone under the sauce of prevention and treatment. More than six billion sales market. The most interesting thing is that dietary supplements are presented as "drugs" that have no contraindications, but at the same time are extremely effective in a huge range of various diseases. The same supplement can be offered as a means of improving vision, strengthening bones and getting rid of chronic inflammation of the uterine appendages. However, this is still modest, the lists of indications usually contain dozens of pathologies.

Contraindications. Let's start with the fact that in medicine there is an immutable rule for all – natural or synthetic components used, including by manufacturers of dietary supplements: the wider the spectrum of action, the more side effects the drug will have. At least because a wide spectrum means action at the upper, non-specific levels of regulation. And yet, any, even the most supernatural ingredient will always have at least one contraindication – individual intolerance. Huge lists of contraindications for medicines are the result of many years of clinical studies on thousands or even tens of thousands of patients. This means that buying a medicine, a person buys some guarantees and a fairly long history of research.

It is interesting to follow those individual dietary supplements that have been re-registered as medicines after some time. At the same time, information about the effectiveness became much more modest, the list of indications was significantly reduced, but a tangible number of contraindications were added.

Composition. In medicine, there is such a thing as polypragmasia, that is, the simultaneous unjustified appointment of a variety of medicines to a patient. Most manufacturers of dietary supplements are engaged in polypragmasia, their formulations contain dozens of ingredients. Amino acids, vitamins, extracts of a dozen plants can be mixed in one "preparation". Who and when checked their cumulative effect is a mystery. Plants themselves are multicomponent mixtures, and the neighborhood of antagonistic substances is more the rule than the exception. And how a mixture of mixtures will act – no one will undertake to predict.

Safety. The weakest link in dietary supplements. Yes, they are certainly examined before obtaining a certificate of state registration. They are only studying the presence of dangerous and toxic ingredients for humans in the presented sample of dietary supplements. No one will evaluate the clinical effectiveness, determine the list of indications and contraindications. Simply because dietary supplements are not medicines. But after that, the quality of the additive is entirely on the conscience of the manufacturer. And very, very often the actual composition of the "drug" can be very different from the stated one. Especially if the supplement is falsified. If the state monitors the counterfeiting of medicines, then each manufacturer of dietary supplements should "graze" their products independently.

This practice is accepted not only in Russia, but also in the USA. On each package of a food additive sold in America, there is such an inscription:
«The statements on this package have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease».
"The information stated on this package has not been evaluated by the Food and Drug Administration. This product is not intended for the diagnosis, treatment or prevention of any diseases."

The same option for the Internet:

 

 


 

However, there is another danger. A person taking a supplement advertised as a panacea may stop taking medications prescribed by his doctor. Sometimes the manufacturers and sellers themselves talk in advertising or write in the instructions about the possibility of reducing the dose of anti-inflammatory or other drugs, as well as about the prospect of completely abandoning drugs in favor of dietary supplements.

What will happen in this case is easy to imagine. Especially if the patient turned to dietary supplements, for example, after the diagnosis of "cancer". All the pillars within a radius of half a kilometer from the Cancer Center on Kashirskoye highway in Moscow are plastered with advertisements for miracle cures for oncology. And a person, instead of undergoing a course of chemotherapy or deciding on an operation, buys dietary supplements and begins to "be treated". As a result, he still gets to the doctor, only instead of the I-th or II-th stage of the disease (when it is possible to help with a huge probability of a successful outcome), the doctor is faced with the III-th or terminal, IV-th stage, when the intervention of medicine is limited only to pain relief. And the patient and his relatives often consider the doctor to be to blame in such a situation. They tell their friends about it, post information in online communities and forums, as a result of which more and more patients with the initial stages of diseases are leaving in the direction of "alternative" medicine.

And not necessarily oncological. With the same glaucoma, there is a six-month "light" interval, after which you can forget about the hope of saving your vision. If at this time you drink dietary supplements with blueberries and other "benefits" for the eyes, the chances of a successful outcome will melt every day.

A word in defenseA logical question may immediately arise – is every single dietary supplement bad and useless?

Actually, no. In some cases, and under certain circumstances, dietary supplements not only turn out to be useful, but also become almost the only way out of the situation.

There is, for example, such a severe hereditary disease – celiac disease. This is a digestive disorder in which all foods containing gluten protein have to be excluded from food. Everything would be fine, but it is in all cereals, including wheat, rye, oats. It is very difficult to follow a gluten-free diet, especially for children. And that's where special dietary supplements come to the rescue, which help in this difficult task.

In addition, the hypothesis about the insufficient content of vitamins and trace elements in modern food is not without reason. However, with quite significant reservations. At the same time, the power supply should be noticeably tilted in one direction or another. For example, high-carbohydrate (due to flour products) and fatty (due to animal fats) food with a relative protein deficiency. If a person is forced to eat like this for years, the lack of nutrients may well make itself felt.

Or food from extremely popular fast food in our time. Long-term abuse of it also leads to a certain imbalance in the body. So we should not be surprised about the same aggressiveness of advertising fast food eateries and dietary supplements, their coexistence can be safely called a symbiosis. And extremely successful and tenacious. People are inspired by the following: if you eat fast food and eat it with special additives, then this tactic will smooth out all the disadvantages of improper nutrition. Who benefits from this state of affairs is clear, however (with a sooooo big stretch) this may well pass as a justification for the existence of dietary supplements.

In general, one of the characteristics of dietary supplements given in the governing documents sounds like "the implementation of the physiological boundaries of the regulation of body functions." A very precise definition. Everything that concerns the variants of the norm – and there may be a great many of them, in fact – is a potential diocese of dietary supplements. As soon as we are talking about pathology, that is, deviation from the norm, medicines should come into play. Only in this scenario is the peaceful coexistence of "drugs" and medicines possible.

The case of advertisingThe situation with the advertising of dietary supplements can be briefly characterized by a phrase from a famous joke about a brothel: "Horror, horror!".

Theoretically, there is a law of the Russian Federation "On Advertising", where the rules of the advertising game for all categories of goods are clearly spelled out. Even for dietary supplements, a special article has been allocated. However, practically, as we know, the strictness of our laws is more than compensated by the non-necessity of their execution. On the fingers, you can count the cases when the Federal Antimonopoly Service made a stand for sellers of dietary supplements. These are mostly high-profile and scandalous incidents that have been widely covered in the press and received a wide response from the masses. As was the case, for example, with the infamous "Gravicoll XXI", the attention of the FAS to which was drawn only thanks to the avalanche-like reaction of Livejournal users.

And you can not say that it is so difficult to find incorrect (or rather, unreliable – this is the term used in the legislation) advertising of "drugs". It is enough to turn on the "Morning rounds" on the radio "Echo of Moscow", or listen to similar programs on "Radio of Russia" or "Mayak", take "AIF" or "Komsomolka", look at the Internet materials will be enough.

Let's look at the main provisions of the law "On Advertising" and find out how unscrupulous sellers of dietary supplements mislead gullible buyers. And where are the guarantees that the one who cheats from the very beginning of contact with the consumer will be honest in terms of quality, compliance with the recipe and many other subtleties?

So, one of the main provisions of the law.

Article 5. Advertising is not allowed:
6) an indication of the medicinal properties, that is, a positive effect on the course of the disease, of the advertised object, with the exception of such indication in the advertising of medicines, medical services, including treatment methods, medical devices and medical equipment.So, if the words "heals", "helps with certain diseases" sound in an advertising block or article in relation to dietary supplements, this is a direct violation of the law.


As we have already figured out, dietary supplements cannot be treated in principle, although they are made from the same raw materials as medicines. It's all about the dose, as the great Renaissance physician Philip Aureolus Theophrastus Bombast von Hohenheim, better known as Paracelsus, correctly noted at the time.

The following 5 paragraphs relate to article 25. Advertising of biologically active additives and food additives, baby food products.

Advertising of biologically active additives and food additives should not:
1) create the impression that they are medicinal products and (or) have medicinal properties;We have already sorted this out.


In order for the consumer to distinguish the drug from the "drug", the phrase "Biologically active additive" should be on the packaging of dietary supplements. It is not a medicine." The most interesting thing is that the size and placement of this text is not stipulated by law. As a result, even pharmacists in the pharmacy twist the box with the newly received drug for a very long time, and only after careful targeted searches find the desired inscription. By the way, the same phrase should be in the ad block. And in its entirety, and not just one of its halves.

2) contain references to specific cases of healing people, improving their condition as a result of the use of such additives;A classic example is allegedly letters from grateful patients.

For example:
---
Patient L, 58 years old
March 27, 2004 — stroke with hemorrhage and paralysis of the right limbs, impaired speech, memory, high blood pressure 300/120 mmHg. I took chemicals for 8 months, the improvements were insignificant. Since October 2004, he began taking the colloidal phytoformula Brain Booster for 2 months with a short break (2 weeks) of 5ml. x 3 p., then there was a break of 2 months. During the treatment, memory was fully restored, speech was 100%, I began to raise my hand, move my fingers, walk better, sensitivity was restored. thank you very much!
---
Firstly, well, which patients write reviews with such refined formulations with a lot of terminology and an indispensable full indication of the "drug", dosage and duration of the course? Secondly, I'm sorry, but with an upper arterial pressure of 300 mm Hg, only the aorta will survive (if, of course, it survives), the remaining vessels of a smaller caliber will be torn to shreds. Thirdly, see the explanations about the therapeutic effects of dietary supplements above.

3) contain an expression of gratitude by individuals in connection with the use of such additives;This technique is used quite rarely.

Theoretically, gratitude can be addressed to some celebrity who allegedly took this supplement. The rarity of the application is most likely due to the reluctance to get involved with various kinds of "stars", there is a risk of running into a lawsuit.

4) encourage the rejection of a healthy diet;It is also rare.

At best, they talk about 18 cutlets and 1.5 kg of black bread, which would have to be eaten to meet the daily need for B vitamins (although cutlets are very different, and B vitamins have a lot of other food sources).

5) to create an impression about the benefits of such additives by referring to the fact of conducting studies that are mandatory for state registration of such additives, as well as to use the results of other studies in the form of a direct recommendation for the use of such additives.But this technique has been used very often lately.

Three-phase clinical trials are mandatory only for medicines, it is during such studies that accurate indications are determined, doses are selected, possible side effects and contraindications are identified. In an attempt to mimic drugs, dietary supplements sellers post, for example, on Internet sites, reports on "clinical trials" that were conducted on the basis of large research institutions.

Unfortunately, the blue seals with the words of the Research Institute and the Russian Academy of Medical Sciences, as well as the big names in the signatures, do not mean anything yet. The factor of financial interest has not been canceled yet. Which is noticeable by the frankly "far-fetched", or even falsified reports. However, in order to notice this, you need to have not only a medical education, but also experience working with scientific articles. Because the rules for drawing up experimental and control groups, evaluation methods, and interpretation of results are rather muddy and complicated things. Even doctors do not tend to delve into such subtleties, preferring to read the conclusions. This is what unscrupulous businessmen play on. In fact, none of the "reports" taken at random on the Internet could not withstand an elementary check for correctness (arthrovitis, atheroclifitis, drink "Your health").

What to do?The basic rule is not to self–medicate.

But what if the doctor tries to convince you to buy a supplement in addition to the prescribed medications? And even in a certain pharmacy or in a warehouse lost in industrial zones, and even with a separate prescription with his personal number (ID)? The case is complicated. If a doctor simply wants to eat, and distributors of supplements feed him with percentages from each drug, this is one thing. Tell the doctor that you understand everything, but you won't buy anything. However, there are also fans of dietary supplements among doctors. It is better not to mess with such, go to another specialist, to the third, fourth – not all doctors sell supplements.

To determine the deficiency of certain vitamins or trace elements, there are medical diagnostic techniques, first of all, a blood test for electrolytes and other biochemical parameters. If the deficit of something cannot be objectified, then it does not exist. Quack pseudo-methods like bioresonance diagnostics or the study of a "live" drop of blood do not count in this case. They are just designed to find a non-existent pathology and force a person to be "treated" with a course of dietary supplements.

Do they call you at home, tell you about some national project, a special program for providing preferential categories of citizens and at the same time offer to purchase a certain drug at a "special price"? Are they calling on the radio to call "right now" and get a miracle remedy "at an advertising price" with a huge discount? Don't fall for this simple trick. Think about the free cheese and the mousetrap. If possible, punch the "drug" according to the Rospotrebnadzor register, it lists all the supplements by name, their composition, what they can be used for, what contraindications they have. If in doubt, call the representative office of Rospotrebnadzor or Roszdravnadzor.

Be critical of any advertising information. After all, the main task of those who compose the texts of ads and articles is to force you to buy their products. And your task is to try not to harm your body. And in this case, a doctor is much preferable as an adviser than a manager of a dietary supplement company.

Useful phone numbersReference and information service "PharMcontrol".


Hotline: (495) 737-75-25

Rossdravnadzor Hotline 8-916-290-34-80
(weekdays 10.00-12.30; 14.30-17.00)

"Hotline" of the Department of Health of the City of Moscow:
(495) 251-83-00 (around the clock),
(495) 251-14-55 (weekdays, 8.00-20.00),
(495) 923-46-36 (weekdays 10.00-17.00)

Pharmaceutical Information Center of the Department of Health:
(495) 627-05-61


The most dangerous among the widespread components of dietary supplements (according to the Consumers Report magazine).

Dietary supplement ingredientWhat is the danger

Definitely dangerous (there is documentary evidence)

Aristolochiic acid

Carcinogen; renal insufficiency, often requiring hemodialysis or
kidney transplants.

Dangerous with a high probability (banned in a number of countries or the effects are being studied)Comfrey officinale (Symphytum officinale)

Hepatic veno-occlusive syndrome, with possible development of cirrhosis
liver. 1 case of death has been officially registered.
Dwarf oak (Larrea divaricata), common Dubrovnik (Teucrium
chamaedrys), kava-kava (Pipermethysticum)
Liver damage, cases of fatal outcomes have been reported.

Potentially dangerous (there are consumer complaints or theoretical risks)Orange (Citrus aurantium)

Increased blood pressure, risk of arrhythmias, cardiac
attack or stroke
Extracts and extracts from animal glands or organs Potential risk of contracting "mad cow disease"
Lobelia inflated (Lobelia inflata) Breathing problems, tachycardia, low blood pressure,
diarrhea, tremor, possible death.
Hedeoma oil (from the mint flea - Hedeoma pulegioides) Impaired kidney and liver function, seizures. burning in the throat, toxic
neuropathies. Possible fatal outcome.
Side-flowered skullcap (Scutellaria lateriflora) Liver dysfunction, toxic hepatitis
Yohimbe (Pausinystalia yohimbe) Jumps in blood pressure, arrhythmias, respiratory depression, risk of development
angina attack, possible fatal outcome.

Portal "Eternal youth" http://vechnayamolodost.ru/22.06.2009

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