| | | | by Caroline Wellberry, M.D.
Guggul, an extract from a tree resin,
has potential lipid-lowering properties that have been studied in previous
clinical trials. Guggulipid is marketed in the United States as a dietary
supplement intended to lower cholesterol levels, or as part of a
combination herbal product for "heart health", weight loss, and
arthritis. Szapary and colleagues conducted a randomized clinical trial
comparing placebo with usual-dose and high-dose guggulipid to determine
the safety of this supplement and its efficacy in reducing low-density
lipoprotein (LDL) cholesterol levels.
Trial participants were at
least 19 years of age and had primary hypercholesterolemia. Eligibility in
the study required participants to have LDL levels of 130 to 200 mg per dL
(3.36 to 5.17 mmol per L) and fasting triglyceride levels of less than 400
mg per dL (4.52 mmol per L). Participants were randomized to receive
placebo, guggulipid in a standard dose (1,000 mg), or guggulipid in a high
dose (2,000 mg), each taken three times daily with meals. Additional
stratification according to baseline LDL levels was performed to determine
whether guggulipid might have a different effect on patients with severe
hypercholesterolemia. Patients maintained their usual dietary
habits.Weight, vital signs, and lipid and blood chemistry analyses were
performed at baseline and at weeks 4 and 8. Participants also were asked
about any adverse events. The study's primary end point was percentage
change from baseline in levels of LDL at eight weeks. Secondary end points
included percentage changes in total cholesterol level, high-density
lipoprotein (HDL) cholesterol level, very-low-density lipoprotein
cholesterol level, and triglyceride level at four to eight weeks, and
laboratory test results for electrolyte levels, renal function, and
hepatic function.
Of the 103 eligible participants, 85 completed
the study. There were no significant differences in demographic, dietary,
or laboratory characteristics in the three randomized groups except for
body mass index. After eight weeks, LDL levels decreased by 5 percent in
the placebo group and increased by 4 percent in the standard-dose
guggulipid group, and increased by 5 percent in the high-dose guggulipid
group. The LDL levels were 9 to 10 percent higher in the treatment groups
than in the placebo group, with no differences found between low-dose and
high-dose groups. There was no difference in LDL levels in the groups
stratified according to LDL cholesterol severity. There was a borderline
significant trend toward reduced HDL levels in standard-dose and high-dose
guggulipid groups at eight weeks, but only in the per-protocol analysis
for the standard-dose group did this difference achieve statistical
significance. This same analysis determined that patients with baseline
LDL levels of 160 mg per dL (4.14 mmol per L) or higher had reductions of
14 and 10 percent in triglyceride levels in the standard-dose and
high-dose guggulipid groups, respectively, compared with the placebo
group.
This randomized, placebo-controlled study, which used a
standardized guggulipid preparation, found that guggulipid did not lower
cholesterol levels in patients eating a usual Western diet. It appeared to
increase LDL levels compared with placebo. Some patients taking
guggulipid, especially in the higher dosage, developed a hypersensitivity
reaction.
SOURCE: American Family Physician (2004)
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| | | References | | | Szapary PO, et al. Guggulipid for the treatment of hypercholesterolemia. A randomized controlled trial. JAMA August 13, 2003;290:765-72.
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