Placebos are described as substances that have no active properties other than psychological ones. They are often used as a comparison product in clinical trials to help understand the real effect of a treatment – both positive benefits and also possible side effects. A person assigned to the placebo group may actually experience some changes in the effect being measured, this is called the placebo-effect. Utilizing a placebo to compare the active treatment helps us to determine how much of the effects measured in the active group are real, in other words more than the placebo-effect. As the dietary supplement industry increasingly seeks to use claims that differentiate and resonate with consumers, the ‘placebo effect’ is a necessary hurdle to overcome.
Randomized-Controlled Trials (RCTs) are regarded as the gold-standard for effectiveness research. Randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between a new treatment and outcome. Placebos are frequently used in RCTs. With placebo-controlled trials, one group gets the active treatment, the other gets the placebo. Everything else in the trial is held constant between the two groups. This way, any difference in the outcome can be attributed to the treatment being studied and not due to the placebo effect.. Placebo-controlled RCTs are critically important in ensuring the reliability and scientific validity of the research.
Using Placebo-Controls in Dietary Supplements RCTs
When it comes to using placebos in dietary supplement RCTs, the process is consistent with the process used for pharmaceuticals. RCT requirements include, but are not limited to:
- The use of defined target populations (such as “Women over 50 experiencing sleeplessness”)
- Exclusion and inclusion criteria (such as “pregnant women” and “age, gender, and race”, respectively)
- Ensuring randomization (the technique for choosing individuals for treatment and control groups entirely by chance)
- Blinding (the process for concealing the treatment and control groups from participants and researchers)
- Formalities like ethical considerations (such as voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication) and consent processes and data management (because, of course, there has to be paperwork.)
This means that everything from the tablet or capsule to the generic packaging provided is the exact same in both the placebo and the active to maintain blinding and control for bias.
Regardless of whether one is conducting pharmaceutical trials or dietary supplement trials, RCTs do not come cheap. Given the same size, medication, and oversight, it can take several years and millions of dollars. However, organizations like Radicle Science are seeking to democratize the use of clinical trials for dietary supplements making them fast and affordable while also being reliable. The Radicle Science Radicle Proof Engine delivers gold standard IRB-approved double-blind, randomized, placebo-controlled clinical trials for supplement brands, manufacturers, and ingredient suppliers, pioneering the first ever easy path for supplements products to clinically prove their true effects beyond placebo.
Leveraging Placebo-Controlled RCTs in Your Marketing and Formulations
When it comes to Placebo-Controlled RCTs, not only are they scientific best practices, they are good for the bottom line. “Clinically proven” is shaping up to be the next big power claim on dietary supplements. A recent study showed that the “Clinically proven” claim significantly increases the amount consumers are willing to pay for a product by up to 20%. While it may be tempting to use the claim, given the litigious nature surrounding label claims these days, it is wise to secure the scientific research necessary to ensure substantiation.
When it comes to proving efficacy of dietary supplements, it doesn’t have to be ‘mind over matter.’ When it comes to your dietary supplements, Placebo-controlled RCTs can be your path to a winning formulation.