Context Herbal extracts from Commiphora mukul (guggul)
have been widely used in Asia as cholesterol-lowering agents, and their popularity
is increasing in the United States. Recently, guggulsterones, the purported
bioactive compounds of guggul, have been shown to be potent antagonists of
2 nuclear hormone receptors involved in cholesterol metabolism, establishing
a plausible mechanism of action for the hypolipidemic effects of these extracts.
However, there are currently no published safety or efficacy data on the use
of guggul extracts in Western populations.
Objective To study the short-term safety and efficacy of 2 doses of a standardized
guggul extract (guggulipid, containing 2.5% guggulsterones) in healthy adults
with hyperlipidemia eating a typical Western diet.
Design Double-blind, randomized, placebo-controlled trial using a parallel
design, conducted March 2000-August 2001.
Participants and Setting A total of 103 ambulatory, community-dwelling, healthy adults with hypercholesterolemia
in the Philadelphia, Pa, metropolitan area.
Intervention Oral, 3 times daily doses of standard-dose guggulipid (1000 mg), high-dose
guggulipid (2000 mg), or matching placebo.
Main Outcome Measures Percentage change in levels of directly measured low-density lipoprotein
cholesterol (LDL-C) after 8 weeks of therapy. Secondary outcome measures included
levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C),
triglycerides, and directly measured very low-density lipoprotein cholesterol
(VLDL-C), as well as adverse events reports and laboratory safety measures
including electrolyte levels and hepatic and renal function.
Results Compared with participants randomized to placebo (n = 36), in whom levels
of LDL-C decreased by 5%, both standard-dose guggulipid (n = 33) and high-dose
guggulipid (n = 34) raised levels of LDL-C by 4% (P =
.01 vs placebo) and 5% (P = .006 vs placebo), respectively,
at 8 weeks, for a net positive change of 9% to 10%. There were no significant
changes in levels of total cholesterol, HDL-C, triglycerides, or VLDL-C in
response to treatment with guggulipid in the intention-to-treat analysis.
While guggulipid was generally well tolerated, 6 participants treated with
guggulipid developed a hypersensitivity rash compared with none in the placebo
Conclusions Despite plausible mechanisms of action, guggulipid did not appear to
improve levels of serum cholesterol over the short term in this population
of adults with hypercholesterolemia, and might in fact raise levels of LDL-C.
Guggulipid also appeared to cause a dermatologic hypersensitivity reaction
in some patients.