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- Licorice (Glycyrrhiza glabra)
- Helicobacter pylori
- GutGard®
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Date:
02-14-2014 | HC# 091381-490
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Re: GutGard®, a Licorice Extract, Aids in the Management of Helicobacter pylori
Puram S, Suh HC, Kim SU, et al. Effect of GutGard®
in the management of Helicobacter pylori:
A randomized double blind placebo controlled study. Evid Based Complement Alternat Med. 2013;2013:263805. doi:
10.1155/2013/263805. Helicobacter pylori
(H. pylori) are a helical-shaped
gram-negative bacteria inhabiting gastric epithelial cells of half the world's
population. Presence of the bacterium is associated with increased risk of
developing peptic ulcer disease, gastric cancer, and gastric MALT lymphoma.
With the increasing prevalence of resistance to antibiotics, herbal supplements
have been explored as an alternative for the management of H. pylori. A randomized double-blind, placebo-controlled study on
GutGard® (Natural Remedies; Bangalore, India), a deglycyrrhizinated
extract of licorice (Glycyrrhiza glabra), was conducted to evaluate its efficacy
in the management of Helicobacter pylori
gastric load. Investigators at D2L Pharma Research Centre, Bangalore,
Karnataka, India, conducted the trial from July 2011 to November 2011 in
subjects, aged between 18-45 years, with positive response to H. pylori stool antigen test (HpSA) and 13C-urea
breath test (13C-UBT). Subjects were excluded if they had a history
of bleeding duodenal ulcer, MALT lymphoma, gastroesophageal reflux, surgery for
ulcers, or had advanced chronic illness, mental illness, dementia, or were suffering
with concomitant symptoms of irritable bowel syndrome. Also, subjects taking antibiotics
and/or proton pump inhibitors (PPIs) and/or H2-antagonists 2 weeks
prior to the administration of the investigational product or who were using
non-steroidal anti-inflammatory drugs, steroids, bismuth preparation, or were alcohol
and drug abusers were excluded. First-level relatives to patients with gastric
cancer and pregnant or lactating women were also excluded. A total of 100 subjects randomly assigned to GutGard (n =
50) or placebo (n = 50) completed the study. Each subject was either
administered GutGard (150 mg) or placebo, 1 capsule in the morning before food,
for a period of 60 days. GutGard is a flavonoid-rich root extract of licorice
and has the following phytochemical specifications: glabridin (≥3.5% per weight),
glabrol (≥0.5% per weight), eicosanyl caffeate (≥0.1% per weight), docosyl caffeate
(≥0.1% per weight), glycyrrhizin (≤0.5% per weight), and total flavonoids (≥10%
per weight). The gastric H. pylori
load in the subjects was assessed using 13C-UBT and HpSA test at
days 0, 30, and 60. The proportion of subjects with initial positive 13C-UBT
and HpSA test results found to be negative at day 30 and day 60 were assessed.
Repeated measures of analysis of variance, chi-square, and Fisher's exact
probability tests were used to analyze the treatment outcomes. At baseline, all subjects were diagnosed to be positive for H. pylori in 13C-UBT and HpSA
test. There were no significant differences between the mean demographic
characteristics of placebo and GutGard-treated groups. A significant
interaction effect between group and time (P = 0.00) and time effect (P = 0.00)
were observed between the groups. Significant difference in mean delta over
baseline (13C-UBT results expressed as delta over baseline) values
was observed between GutGard and placebo-treated groups after the intervention
period (P = 0.02). At day 30, all placebo and treated patients remained
positive for 13C-UBT and HpSA test. At day 60, 28 (56%) subjects in
the GutGard-treated group showed a negative response to the HpSA test, and 24
(48%) subjects showed a negative response to 13C-UBT, compared to 2
(4%) and 1 (2%), respectively, for the placebo group. The differences between
the proportion of subjects who showed a negative response to 13C-UBT
and the HpSA test in GutGard and placebo-treated groups were statistically
significant. The frequencies of adverse side effects in GutGard and
placebo-treated groups were comparable and non-significant.
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Botanical Council provides this review as an educational service. By providing this service, ABC does not
warrant that the data is accurate and correct, nor does distribution of the
article constitute any endorsement of the information contained or of the
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The authors conclude
that GutGard is both safe and effective in the management of H. pylori. This provides a potential
option to antibiotic monotherapy. Further study is warranted in subjects who
are antibiotic-resistant or in combination with antibiotics and/or PPIs.
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