Clinical results are always presumed to be accurate and trustworthy because of the rigorous and the exhaustive expert analysis involved. However, as far as the safety and the effectiveness of supplements are concerned, the merit of all clinical research isn’t the same.
According to a study published in the Journal of the American Medical Association (JAMA) in the year 2012, the number of registered clinical trials has been on the rise over the past years. Amidst the rise in the number of clinical trials, their practice and motive have been put to question.
We had to carry out thorough research by reviewing several products and ingredients. Finally, we decided to publish this article to bring things into light.
What is a Clinical Trial?
A clinical trial refers to a practical test or research study that revolves around human subjects. The tests can be theoretical or involve animals. The trials are normally in the form of controlled experiments whose objective is to gauge the effectiveness of ingredients and identify any potential side effects.
The first clinical trial is thought to have occurred in 1747 when seafaring stereotypes such as James Lind (Royal Navy Doctor) employed a technique we can relate to today. The method is similar to the one that is used to identify Vitamin C as a treatment for scurvy.
What this genius did was put the afflicted sailors into pairs and give a remedy to each. He then discovered that those sailors that were given lemons and oranges showed a dramatic improvement. The only controversial issue that surrounded his work was giving some of the participants sulphuric acid.
This led to killings that made his first technique raise a number of ethical issues. However, putting aside the few murder-related cases, his work would have served as a blueprint for most evidence-based research today.
Even though the science has been in action for over 268 years, trying to put it all together and bring out something better, modern clinical trials are still considered as the most efficient means of determining what works and what doesn’t as far as overall health is concerned.
And now there are even services that want to help you get access to drugs that haven't made it all the way to the promise land yet, like here.
Get To Know The Basics
The word “clinical” refers to the established, standardized, and universally accepted procedures that are used to obtain medical results.
Whilst a high number of clinical trials will prove to go in line with the norm, the 2012 study done by JAMA (“Characteristics of Clinical Trails Registered in ClinicalTrials.gov, 2007-2010”) established a significant level of inconsistencies in their methodologies in a research that involved 96,346 clinical trials.
That is why nothing is taken for granted when assessing the scientific basis upon which claims for supplements or ingredients are made.
Control Group
It is important to first find out whether a control experiment was carried out when carrying out a study. Let’s say, for instance, the manufacturer of a new supplement plans to prove that the product has testosterone boosting capabilities and also improves body strength. It is expected that the company will sample out some weightlifters and put them under a regular dose.
Over time, the company will record some improvements and use the same to back their claims.However, the question is – Does this qualify their claims? The answer is a big No. The evidence is incredibly weak and doesn’t even qualify to be regarded as a clinical trial.
Besides that, who can prove that the element tested was responsible for the improvement? We all know that people tend to improve when they lift weights regularly. The trend could have perhaps been wrongly attributed to the effects of the supplement.
To rule out any doubts in the results, a cross section is done on the sample where closely matching weightlifters are split into two groups. One group receives the active ingredient while the control group is given a placebo. Because the experiment involves a control set up, an accurate judgment can be drawn from the baseline stats. We will start to see these advancements in many areas, one of special interest in the microbiome.
Randomized Trials
Checking whether a clinical trial was randomized should be the next step. A standardized clinical trial uses volunteers to reduce the effect of naturally occurring differences in the final results. Unless you’re lucky enough to find the family of hectuplets who happen to belong to a demographic that is closely related to your study, there is a high chance that variations will occur in your sample.
A trial can only be considered as random if a computer program is used in the sampling process. If the researcher groups the contributors on his own, there is a high probability the research will be biased.
For example, when a study involving men with low testosterone is done, some men will have a slightly higher level of testosterone even though their testosterone level is considered to be below the average levels.
There is always a tendency to unconsciously put men with a lower testosterone in the control group when one desires a given result. In this case, the person conducting the study may prefer a result where the testosterone agent tests positive. In this case, the study isn’t randomized because it is giving one side of the experiment an edge over the other even before the study begins.
Double-Blind Trial
Blind trials are common in clinical trials. It happens when participants are unaware whether they are taking active ingredients or the placebo. Nonetheless, a double-blind trial can be even more beneficial. It occurs when researchers themselves are completely unaware whether the participants are being given placebos or active ingredients. This sometimes goes on until the investigation comes to a conclusion. This can happen in the same way and for the same reasons as randomization.
Data Monitoring Committee (DMC)
As displayed by Richard Pryor and Gene Wilder in 1989 in their “See No Evil, Hear No Evil” movie, when there is no single part that has access to full information at any given time, the results are often farcical, if not hilarious.
It is highly advisable to set up a Data Monitoring Committee (DMC) when conducting a double-blind study so as to enhance validity. When a DMC consists of 3-7 professionals who are independent, such a trial is well run and reliably. It is expected to have one statistician while the rest of the committee members can occupy other authoritative roles.
Members will have access to all the data and should meet from time to time to review the progress of the trial. Most importantly, an effective DMC is the one with the legal powers to end a study when necessary. A study can be terminated as a result of safety concerns, overall futility, and outstanding benefit. There are a number of issues that could be raised when conducting a study – Is it worth it? Is it safe? Is it working?
An Inside Job
As depicted by the same JAMA report, 47% of the clinical trials were sponsored by the industry rather than being academically-activated as expected. This does make sense to some extent. We certainly can’t expect the supplement industry to just sit and do nothing until some professor at a university or college decides to carry out a study and boost testosterone.
As long as the researchers are willing to disclose and accept the outcomes of their study, whether successful or not, there is no single reason as to why industry-commissioned clinical trials can’t be put at the same level as their academic counterparts. This is, however, acceptable in the ideal world. In the real world, there are a number of controversial issues surrounding industry-sponsored work.
Testing the Inner Pudding
When evaluating a supplement or an ingredient, you should pay much attention to the criteria used in measuring the success. The validity of several studies has been controversial after researchers used subjective merits.
- How far can they swim?
- How many planks can they achieve?
- How many squats can you do?
There could be a million reasons why you could do more squats than usual. Perhaps the children could have kept you awake all night. Did you take porridge? How many cups of water did you take before hitting the gym? Were you stressed at the workplace?
If the main objective is to determine the testosterone levels, why not measure testosterone?
Get blood samples and carry out the tests. It may seem to be so obvious but it is not common. Such practices are common in hospitals or universities. It could also be done when patients are part of a trial that is part of a given study.
Final Verdict
Trials will never be the same. Be careful with scams that claim to achieve a 24% testosterone boost within 3 days. There is a lot to be done and it is up to you to go deeper or spend your time going through abstracts of various studies.
Always make sure that you do your own research before accepting the research of others at face value.
Then, it wouldn't be proper to conclude by just saying your health and well being comes down to how you live your life. The dietary supplements, nutritional whole foods, and productive movement routines you incorporate into your daily habits are going to be the make or break feature of your livelihood. Remember that exercising and working out are great stress relievers and can always help whatever situation you have that is going on.
