Issue:
98
Page: 28-29
Clinical Trial Shows Aged Garlic Extract™ Supplementation Reduces Blood Pressure
by Heather S. Oliff, PhD
HerbalGram.
2013; American Botanical Council
Reviewed: Ried K, Frank OR, Stocks NP. Aged Garlic Extract reduces blood pressure in hypertensives: a
dose-response trial. Eur J Clin Nutr. 2013;67(1):64-70.
Standard hypertension treatment with
medication that lowers high blood pressure is ineffective in some people.
Studies show that aged garlic (Allium sativum, Liliaceae) supplements can lower blood pressure. Aged Garlic
Extract™ contains S-allylcysteine, a bioavailable and stable water-soluble
organosulfur compound. The purpose of this randomized, double-blind,
placebo-controlled study was to evaluate the effect and tolerability of
different doses of Aged Garlic Extract as an adjunct treatment for patients
with uncontrolled hypertension.
Seventy-nine patients (mean age: 70
years) with uncontrolled hypertension (systolic blood pressure [SBP] ≥ 140 mmHg
in the past six months) from two general practices in Adelaide, South
Australia, participated in this study conducted from August 2011 to March 2012.
Included patients had taken prescription antihypertensive medication for two
months or longer, and their general practitioners did not intend to change the
medication plan during the trial. Excluded patients had an unstable or serious
illness or already were taking garlic supplements. Patients received one, two,
or four capsules per day of Kyolic® High Potency Everyday
Formula 112 (Wakunaga/Wagner; Sydney, Australia; Kyolic® Aged Garlic
Extract is produced in Japan by Wakunaga), containing 240, 480, or 960 mg of
Aged Garlic Extract (AGE) and 0.6, 1.2, or 2.4 mg Sallylcysteine, respectively,
or placebo, for 12 weeks. Sachets with a drop of liquid Kyolic were added to
the placebo containers as a method of blinding. Patients were instructed to
take their usual prescription medication.
The primary outcome measures were
SBP and diastolic blood pressure (DBP) at four, eight, and 12 weeks compared to
baseline. The baseline characteristics were similar between groups. Patients
took an average of two different types of antihypertensive medications. At 12
weeks, the two-capsule (480 mg) group showed a significant reduction in SBP
compared to placebo (P=0.03). There was no change in DBP. The authors conducted
an additional analysis that excluded five patients from the data set who had
blood pressure medication changes or poor compliance. In this additional
analysis, the two-capsule group had a significant reduction in SBP compared to
placebo at both eight and 12 weeks (P=0.006). There was no significant
improvement in the one-capsule or four-capsule group compared with placebo at
any point in either analysis. Across all groups, blood pressure changed from
-40 to +5 mmHg. SBP did not change by > 5 mmHg in one-third of the
participants. This finding was unassociated with sex, age, body mass index,
smoking status, or number of blood pressure medications. One-third of the
patients correctly guessed their treatment allocation.
Participants in the garlic groups
reported minor complaints in the first week of the trial, including
constipation, bloating, flatulence, reflux, garlic taste, and difficulty
swallowing the capsules (23 percent). The difference in reported minor adverse
side effects between those taking garlic capsules and those taking the placebo
was not statistically significant.
The authors concluded that AGE was
superior to placebo in lowering SBP in patients with uncontrolled hypertension.
The two-capsule dose was effective and well tolerated. The authors wrote that
the effect was clinically significant because the 10 percent improvement in SBP
is known to be associated with a decreased risk in cardiovascular disease. The
authors stated that the study was not powered to detect a difference in DBP
because the patients were selected based on their SBP. Currently, it is thought
that DBP is an important predictor of cardiovascular disease and may be a more
important determinant than SBP. The authors should re-examine the two-capsule
dose in a patient sample powered to determine whether AGE has an effect on DBP.
—Heather S. Oliff, PhD
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