Herbal Extract Is Faulted in Study
An herbal supplement marketed as a way to reduce cholesterol levels actually increases them slightly, according to the first U.S. clinical trial of the product, called a guggulipid extract.
The supplement, made from the resin of the mukul myrrh tree, also caused skin rashes in about one of every 10 people who took it, researchers from the University of Pennsylvania School of Medicine reported today in the Journal of the American Medical Assn.
“The bottom line is, if you are trying to lower your [cholesterol], don’t use guggulipid,” said Dr. Philippe O. Szapary, who led the study. “There are plenty of proven safe and effective therapies currently on the market” -- including soluble fibers such as psyllium, flaxseed, plant stanols and sterols, and omega-3 fatty acids.
The results were surprising because the supplement has a long history in Indian ayurvedic medicine. Clinical trials in India have shown it to be effective, but only one of those trials was a randomized, double-blind trial -- in which neither doctors nor patients knew who was receiving the drug -- similar to the study reported today.
Szapary and his colleagues noted that the Indian population studied in that trial was thinner and consumed less total fat and more fiber than the American population they studied. That large difference in diet, along with genetic factors, could explain the differences in the two studies, he said.
The Penn researchers enrolled 103 Philadelphia-area adults with high cholesterol, who were randomly divided into three groups. One took 3,000 milligrams per day of a commercial product called Gugulipid, the second took 6,000 milligrams per day and the third received a placebo. The enrollees were not placed on a special diet or directed to diet and exercise. “We were trying to imitate what a typical consumer might do when he thinks his cholesterol is a little high,” Szapary said.
The team regularly measured the patients’ blood concentrations of low-density lipoprotein cholesterol (LDL-C), the so-called bad cholesterol that is thought to be the most dangerous form. Each 1% decrease in LDL-C levels has previously been shown to be associated with a 2% decline in the risk of heart disease.
After three months, the team found, LDL-C levels had increased by an average of 4% in those taking the lower dose of guggulipids and by 5% in those taking the higher dose. The level fell by 5% in those taking the placebo. “That was a surprise to us,” said Szapary, who went into the study expecting to find a benefit provided by the supplement.
The study also found that six patients -- five of them in the high-dose group -- developed a rash that went away when they stopped taking the herb.
The results show “that we need to spend time and money investigating these products,” said Szapary, whose study was supported by the National Institutes of Health. “We can’t assume that something is safe and is going to work. It needs to be investigated in a rigorous way.”
A spokesman for Sabinsa Corp. of Piscataway, N.J., which provided Gugulipid for the study, said that the trial’s focus was too narrow. Dr. Vladimir Badmaev noted that the supplement could have a beneficial effect on other factors that affect the risk of heart disease, such as inflammation, C-reactive protein and triglycerides.
Szapary noted that his group is studying those factors as well.
