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 consumers that they are offering true benefits.
Health Supplements
If companies making supplements 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.
In a double-blind study, the subjects or patients and researchers are blinded. What this means is that neither party knows who is getting treatment and who isn’t.
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 proof, especially when randomized.
We give some key reasons why supplement 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.
It is, therefore, left to each supplement maker to decide if they want to do a double-blind study. Apparently, 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 approval from 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, supplement companies 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.
One of the possible explanations for the lack of visible effects is the short duration. If people do not use supplements for a 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 supplement 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.
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 negatively impact 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. Supplement companies surely don’t want that.
Patent Concerns
When pharma companies develop a new drug and get approval following requisite trials, they usually get 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.
Things may not be that easy or work as smoothly with supplements. These products contain natural ingredients that their makers usually don’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 practically removes the incentive for natural product makers to want to invest in double-blind studies.
Conclusion
Supplements with clinical trials are an exception rather than the norm. You can easily understand why this is the case from the reasons provided in this article.
These reasons are sufficient to discourage most supplement 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 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
U.S. Food and Drug Administration. (n.d.). FDA 101: Dietary supplements. https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements
U.S. Food and Drug Administration. (n.d.). Dietary supplements. https://www.fda.gov/food/dietary-supplements
