Phytosterol Supplements May Not Offer Additional Cholesterol-Lowering Benefits For Consumers

PHILADELPHIA - July 11, 2013 - PRLog -- Philadelphia, PA - An independently funded study just published in The American Heart Journal found that phytosterols – cholesterol-like molecules found in many types of foods and supplements that have recently gained popularity for their ability to lower cholesterol levels – provide no added cholesterol-lowering benefit to patients currently using red yeast rice, (RYR) which contains the same active ingredients as prescription statins.

Numerous clinical studies have shown that a daily intake of 1.5-2.0 gram of phytosterols can result in a 10-15 % reduction in LDL levels. In fact, the effectiveness of phytosterols is so strong that The National Cholesterol Education Program recommends people with high cholesterol consume 2 grams of phytosterols each day. As a result, many people are now turning to foods and supplements before trying prescription drugs to lower their LDL cholesterol, and the food industry is responding with foods fortified with phytosterols. In 2008, Leatherhead Food International estimated the global market for phytosterols was $555-585 million.

Although statins are often successfully prescribed to lower cholesterol, there is a population that either cannot tolerate statins because of side effects, or who just refuse to take a doctor's prescription for a statin. In prior studies, David Becker, MD, and his research team found that RYR, a natural statin alternative, combined with lifestyle changes, is a very effective non-prescription method to lower cholesterol. In this trial, Dr. Becker aimed to determine the cumulative cholesterol lowering effects of phytosterol tablets and lifestyle change on top of RYR therapy in patients with a history of statin refusal or statin intolerance.

The study followed 187 participants with an LDL-C greater than 100 mg/dl and less than 210 mg/dl over the course of one year. All participants took 1800 mg of RYR twice each day. Participants were randomized in blocks of four. Half of the participants were randomized to participate in a lifestyle program which incorporated a Mediterranean-inspired diet, an exercise program and relaxation techniques. The other half adhered to their standard lifestyle. Half of the participants took a phytosterol supplement (450 mg tablets, twice daily) and half took an identical placebo. 153 participants ultimately completed the yearlong trial. All participants completed laboratory testing, measurements, and questionnaires at baseline and at weeks 12, 24, and 52.

Resulting data proved that the initial study premise was wrong. There were no significant differences in lipoprotein levels between the phytosterol and placebo groups at week 12, 24, or 52. Likewise, there was no significant difference between groups in the odds of achieving an LDL-C less than 100 mg/dL. The combination of the RYR and phytosterol did not provide any additional cholesterol decrease or any benefit of any parameter researchers examined. It was no different than placebo. However, participants in the lifestyle change group dropped their cholesterol almost 30%, much more than RYR alone.

It’s important for the consumer to know that if they are not currently taking a statin drug or RYR, they may indeed see a reduction in LDL levels with The National Cholesterol Education Program’s recommended use and dosage of phytosterols. While the addition of phytosterols will do no harm to patients already on a statin or RYR protocol, they will likely see zero additional benefit from these products.

The trial was funded by unrestricted grants from the Commonwealth of Pennsylvania, Abington Memorial Hospital, and the Edna G. Kynett Memorial Foundation.

Link to full American Health Journal article: (http://download.journals.elsevierhealth.com/pdfs/journals...) http://download.journals.elsevierhealth.com/pdfs/journals/0002-8703/PIIS0002870313002251.pdf

Video of Dr. David Becker commenting on study and common phytosterol-enhanced products:
https://www.dropbox.com/sh/gkj0lh6u11x9qmw/_WPVCuhpiQ/201...

www.healthychangeofheart.com

ABOUT THE STUDY AUTHOR

David Becker M.D., the originator of the Healthy Change of Heart™ Program, is board certified in Internal Medicine and Cardiovascular Diseases. His clinical interests include preventative cardiology, nuclear cardiology, and alternative cholesterol treatments. Dr. Becker is a fellow in the American College of Cardiology and won the Golden Apple award for excellent teaching of residents at Chestnut Hill Hospital in 1990, 1995, and 2002.  In 1993, after extensive research, Dr. Becker launched Healthy Change of Heart™, an innovative 10-week program designed to reverse heart disease and improve quality of life through diet, exercise, and stress management. Since then, thousands of patients have participated in the program, achieving significant results in improving cardiac wellness. Dr. Becker’s research has been spotlighted in national media, including National Public Radio and top-tier medical publications, including the Annals of Internal Medicine and Mayo Clinic Proceedings. He joined Chestnut Hill Temple Cardiology in 1990 where he continues to see patients, work on his research, and run the Healthy Change of Heart™ Program.