Clinical Studies 101- Learn What Goes into Conducting Product Research - Wakunaga of America
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Clinical Studies 101- Learn What Goes into Conducting Product Research

Have you ever wondered what is involved in a clinical study? As a company, Wakunaga is very proud of the resources that we dedicate to scientific research to prove the efficacy of our supplements.

Q and A with Dr. Matthew Budoff

At this time, we can point to over 800 published articles that relate to our Kyolic Aged Garlic Extract. But what does that mean exactly? We asked Dr. Matthew Budoff to give us a little insight on what is involved in a study. He has conducted over 100 studies on cardiovascular conditions, including 5 studies on Kyolic AGE.

Hello Dr. Budoff!  Please introduce yourself.

I am a cardiologist and have been involved in clinical care and cardiovascular research for over 20 years.  I am a Professor of Medicine at UCLA and Director of Cardiac Research at Los Angeles Biomedical Research Institute.

Why do physicians/researchers do clinical studies?

I think there are a multitude of reasons why investigators do research. My main motivation is to identify products or activities that improve patient outcomes. Other investigators try to understand the mechanisms of health or how therapies work, yet others are just curious and want to seek an answer.

What does ‘double-blind, randomized, placebo controlled, crossover study’ mean? Is that the best method? 

Trials vary from epidemiologic (looking at large populations to understand associations) to translational (trying to understand how basic science findings can influence human systems) to randomized controlled trials (to understand cause and effect). The most careful studies are usually double-blind, placebo-controlled randomized trials. These studies keep the investigator and the patient unaware of the therapy (double blinded) so they can’t be biased by the treatment, and placebo controlled means that there are matching pills so we can assess differences between active and non-active treatment arms. Finally, a cross-over study means that first the patient is put on active treatment, then after some period of time, they are switched to placebo.  At the same time, another group of patients are put on placebo and then switched to active treatment.

Does the number of participants really matter?

Investigators always first evaluate how many patients are necessary to determine the effectiveness of a treatment. Imagine if it took 1000 patients to show a difference, but we only enrolled 200 patients.  There would be no statistically significant difference and the conclusion would be that the therapy doesn’t work, when in fact it was just not a large enough study.  Some studies only need 20-50 patients, while other studies require tens of thousands of patients to show a significant finding.

How are participants selected?

Participants are usually selected based upon certain qualities. For example, a study may require persons with diabetes, or high blood pressure.  Sometimes studies are done in certain ethnic groups or certain age categories. Some studies are done in persons with known disease (like established coronary artery disease or heart failure).

Do all studies get published?

While most studies are published, some are not. For a paper to be published the authors need to send to a journal and it needs to be reviewed by two other investigators (peer reviewed studies). If the quality of the work is low, some papers don’t get published. Also, sometimes the studies don’t demonstrate any positive results and the authors may choose not to publish. Finally, some investigators don’t finish the work by writing up the manuscript. Writing a paper may take weeks or months and some people just don’t do that extra work to get the study published.

Wow! Knowing that so much time and effort goes into each study, we can really appreciate that Wakunaga has conducted studies on their supplements for over 45 years. That shows a true commitment to the science of supplements and the pursuit of quality and efficacy in their products.

Thank you Dr. Budoff!

ABOUT  Dr. Budoff:

Dr. Matthew J. Budoff, M.D., FACC, is Professor of Medicine at the David Geffen School of Medicine and Director of Cardiac CT at the Division of Cardiology at the Harbor-UCLA Medical Center in Torrance, California. Dr. Budoff received his medical degree from the George Washington University School of Medicine in Washington, D.C. and completed an internship and residency in internal medicine, as well as a fellowship in cardiology at Harbor-UCLA Medical Center. He has co-authored over 900 research papers, 6 books, and 36 book chapters.

This article is for informational purposes only. This article is not, nor is it intended to be, a substitute for professional medical advice, diagnosis, or treatment and should never be relied upon for specific medical advice.