Reasons Supplement Makers Don’t Carry Out Double-Blind Clinical Trials

It is very rare to see dietary supplements that have clinical studies carried out to confirm their efficacy. Yet, this can be a good way of showing to consumers that they are offering true benefits.

Health Supplements

Health Supplements

If companies making supplements would want you to believe they are providing top quality products, why don’t they usually have a double-blind study to back up claims? We address that question in this article.

What is a Double-Blind Study?

A double-blinded study is a type of blind or blinded experiment. It aims to reduce or eliminate the bias that can influence the effects or outcomes of a study.

A blinded experiment involves holding back the information that can influence the behavior of subjects and so result in bias. The number of parties to an experiment that is “kept in the dark” determines the description: single-, double- or triple-blind.

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In a double-blind study, the subjects or patients and researchers are blinded. What this means is that neither party knows who is getting a treatment and who isn’t it.

Let’s make this a bit clearer by imagining a drug or supplement maker wanting to assess the efficacy of a new product. The patients won’t know whether they are getting the product or a placebo and the researchers won’t either.

Double-blind clinical trials are seen as arguably the best scientific proofs, especially when randomized.

We give some key reasons supplements companies hardly carry out these studies in the following sections.

Non-Compulsory

Unlike pharmaceuticals, supplements do not require clinical trials. Dietary products are not subject to that requirement because they contain or claim to contain only natural ingredients. The case is different for drugs containing chemicals and synthetic substances whose safety is uncertain.

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It is, therefore, left to each supplement makers to decide if they want to do a double-blind study. Apparent, the majority of companies choose to do without one. The other reasons that follow should help you to better understand this decision.

Cost Implications

It is not cheap to carry out a standard clinical trial. A lot of money goes into one and manufacturers aren’t sure of what would come out of it.

Clinical trials are essential before any drug can get the approval of the U.S. Food and Drug Administration (FDA). Only a very negligible fraction of drug applications get such approval.

There are three main phases of clinical trials. These assess proper dosages, best administration methods, efficacy, and safety. There may also be a Phase IV to study the long-term effects, especially when it concerns safety.

It is clear that huge investments must be made to carry out standard clinical trials with these phases in mind. Thankfully for supplement companies, they don’t need to do these studies before selling their products.

Too-Short Duration

Supplements usually take a long time before producing significant effects, compared to drugs. And, considering how costly clinical trials can be to execute, it might not be daunting to let them run for a long time.

It is not uncommon to hear that researchers couldn’t observe the significant effects of natural supplements in human trials. This is despite possible earlier findings in animals and laboratories showing positive effects.

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One of the possible explanations for lack of visible effects is a short duration. If people do not use supplements for long enough time, they might not produce the desired results. This probably explains why many consumers complain that these natural products don’t work.

Compliance Problem

Let’s assume that supplements companies can afford to sponsor long-term double-blind studies. Another problem they may have to contend with is the adherence of consumers to provided instructions.

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It is a fact that many users fail to comply strictly with usage instructions. Initially, there may not be an issue in this regard. But compliance typically drops in the longer term and this can impact negatively on efficacy.

Higher Prices

Spending on clinical trials increases the overall costs of drugs, resulting in higher prices for consumers. The same trend should be expected if supplement makers were to carry out double-blind studies.

Apart from safety, cheaper prices are another major selling point for natural products. The problem here is that higher prices caused by the addition of trial costs can scare away consumers. Supplements companies surely don’t want that.

Patent Concerns

When pharma companies develop a new drug and get approval following requisite trials, they get usually patents. This grants them exclusive rights to make and sell their inventions for a number of years. Through this, the companies can recoup their investments plus possibly some profits.

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Things may not be that easy or work as smoothly with supplements. These products contain natural ingredients that their makers usually didn’t develop. Anyone else can use the same ingredients to try and achieve similar effects after a company proves efficacy in its trials.

This patent concern practically removes the incentive for natural product makers to want to invest in double-blind studies.

Supplements Backed with Clinical Studies

It’s a rarity of sorts coming across an herbal or natural supplement with its own clinical trial. But it is not impossible to find any.

The products GenF20 Plus and VigRX Plus are examples of very few with studies to show their efficacy.

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GenF20 Plus is a natural alternative to human growth hormone (HGH) injections. It contains ingredients that supposedly boost the natural production of the hormone in your body. The efficacy of the HGH releaser was shown in a double-blind study executed by Vedic Lifesciences Pvt. Ltd.

In its case, VigRX Plus: Counterfeits are in The Market Warns Leading Edge Health is a male enhancer – a natural alternative to ED drugs, such as Viagra. This product was shown to improve the ability of men to maintain an erection by roughly 63 percent in a double-blind study. It also increased overall sex drive and desire by 47 percent while boosting sexual and intercourse satisfaction by 71.43 percent.

Conclusion

Supplements with clinical trials are an exemption rather than the norm. You could easily understand why this is the case from the reasons provided in this article.

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These reasons are sufficient to discourage most supplements companies from even thinking of doing trials. Unfortunately, the fact that clinical studies aren’t compulsory to prove efficacy gives room for dubious companies to sell ineffective offerings.

Only manufacturers well convinced of the quality of their products that can afford to carry out double-blind studies. If you found any supplement backed by a double-blind study, you may feel more assured of its potency and safety.

References

Clinical Trials Guidance Documents

FDA 101: Dietary Supplements

https://www.fda.gov/food/dietary-supplements

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