Hk. Berthold et al., EFFECT OF A GARLIC OIL PREPARATION ON SERUM-LIPOPROTEINS AND CHOLESTEROL-METABOLISM - A RANDOMIZED CONTROLLED TRIAL, JAMA, the journal of the American Medical Association, 279(23), 1998, pp. 1900-1902
Context.-Garlic-containing drugs have been used in the treatment of hy
percholesterolemia even though their efficacy is not generally establi
shed. Little is known about the mechanisms of action of the possible e
ffects on cholesterol in humans. Objective.-To estimate the hypocholes
terolemic effect of garlic oil and to investigate the possible mechani
sm of action. Design-Double-blind, randomized, placebo-controlled tria
l. Setting.-Outpatient lipid clinic. Patients.-We investigated 25 pati
ents (mean age, 58 years) with moderate hypercholesterolemia. Interven
tion.-Steam-distilled garlic oil preparation (5 mg twice a day) vs pla
cebo each for 12 weeks with wash-out periods of 4 weeks. Main Outcome
Measures.-Serum lipoprotein concentrations, cholesterol absorption, an
d cholesterol synthesis. Results.-Baseline lipoprotein profiles were (
mean [SD]):total cholesterol, 7.53 (0.75) mmol/L (291 [29] mg/dL); low
-density lipoprotein cholesterol (LDL-C), 5.35 (0.78) mmol/L (207 [30]
mg/dL); high-density lipoprotein cholesterol (HDL-C), 1.50 (0.41) mmo
l/L (58 [16] mg/dL); and triglycerides, 1.45 (0.73) mmol/L (127 [64] m
g/dL). Lipoprotein levels were virtually unchanged at the end of both
treatment periods (mean difference [95% confidence interval]): total c
holesterol, 0.085 (-0.201 to 0.372) mmol/L (3.3 [-7.8 to 14.4] mg/dL),
P=.54; LDL-C, 0.001 (-0.242 to 0.245) mmol/L (0.04 [-9.4 to 9.5] mg/d
L), P=.99; HDL-C, 0.050 (-0.028 to 0.128) mmol/L (1.9 [-1.1 to 4.9] mg
/dL), P=.20; triclycerides, 0.047 (-0.229 to 0.135) mmol/L (4.2 [-20.3
to 12.0]) mg/dL, P=.60. Cholesterol absorption (37.5% [10.5%] vs 38.3
% [10.7%], P=.58), cholesterol synthesis (12.7 [6.5] vs 13.4 [6.6] mg/
kg of body weight per day, P=.64), mevalonic acid excretion (192 [66]
vs 187 [66] mu g/d, P=.78), and changes in the ratio of lathosterol to
cholesterol in serum (4.4% [24.3%] vs 10.6% [21.1%], P=.62) were not
different in garlic and placebo treatment. Conclusions.-The commercial
garlic oil preparation investigated had no influence on serum lipopro
teins, cholesterol absorption, or cholesterol synthesis. Garlic therap
y for treatment of hypercholesterolemia cannot be recommended on the b
asis of this study.