Why do we put our Natural Health Products through Clinical Trials?
Testing Natural Supplements vs. Pharmaceutical Products
In general, natural supplements are not subject to the same level of regulation as a pharmaceutical product because natural supplements usually support better health management and do not generally target diseases. While pharmaceutical medicines take many years to develop and require different research phases and clinical trials to demonstrate their safety and effectiveness, natural health products can be developed more quickly in comparison.
One key reason for this is that many of these plants/herbs have been used traditionally for hundreds, sometimes thousands, of years and there is a body of historical evidence that supports the safety profile of the ingredients .
Why are Clinical Trials important?
Clinical trials are an important element in the research conducted to generate evidence for a product or medicine. While preclinical testing focuses on how a product works in the lab, clinical trials help to objectively demonstrate the effectiveness (and indication of safety profile) of a product in humans, in a controlled and unbiased manner.
In pharmaceutical medicine, you may hear clinical trials referred to as phase 1, 2, 3 or 4 clinical trials. These denote the type, complexity and scale of the study.
Phase 1 and 2 trials focus on understanding the safety and dosing profile of the medicine. In natural medicine, you won’t necessarily hear of these phase 1 or 2 trials being conducted, because there is often a history of traditional use that provides insight to the safety profile and dosing.
Phase 3 clinical trials are studies carried out in large groups of participants and compare the medicine to a placebo or alternative medicine for whether it works. They are also used to monitor adverse events. Often phase 3 trials will provide statistical data to help judge whether the medicine has made a significant difference that cannot be attributed to chance.
And then there are Phase 4 trials that can be conducted after the medicine has been marketed to gather further evidence in larger numbers of people.
While we don’t always use the same terminology in natural medicine, the clinical trials we conducted for Flordis medicines are most similar to phase 3 or 4 clinical studies.
Why aren’t all Natural Health Products clinically researched?
There are hundreds of different natural medicines to choose from, all with similar claims and ingredients. But not all of these products are put through clinical trials. Why?
One reason may be that the ‘traditional use’ or historical evidence of the ingredients is believed to be sufficient. While this is partially valid, other factors come into play -such as how we take the medicine. For example an ingredient administered as a tablet might work differently to when it is digested as a whole plant/food. This is often disregarded when basing evidence on traditional use.
Another reason is because clinical trials are expensive. They require a huge amount of time and money to plan, recruit, perform and analyse. Of course, most products will rely on some sort of research or testing, but often this can be small scale, without the statistics that help objectively demonstrate effectiveness.
Why do we test Flordis medicines in Clinical Trials?
At Flordis, we are well aware of the scepticism that surrounds natural healthcare. But while our products are derived from natural ingredients, we take a very scientific approach to developing our medicines – with steps similar to that in the pharmaceutical pathway. And that includes clinical trials. We want to provide you with credible evidence that you can have confidence in. We know that just because a particular ingredient has been associated with a benefit, it may not necessarily apply when that ingredient is extracted, processed and combined with other compounds to form the pill in your pack. Which is why we take those specific pills and put them through their own clinical trials – so that the evidence at the end is exclusive to our specific products.