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- Korean Red Ginseng (Panax ginseng, Araliaceae)
- Fibrosis
- Chronic Hepatitis B
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Date:
09-29-2017 | HC# 031724-577
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Re: Korean Red Ginseng as a Complementary Therapy for Chronic Hepatitis B
Choi
SH, Yang KJ, Lee DS. Effects of complementary combination therapy of Korean red
ginseng and antiviral agents in chronic hepatitis B. J Altern Complement Med. December 2016;22(12):964-969.
Despite
development of the hepatitis B virus (HBV) vaccine, people remain HBV carriers
and often suffer from chronic hepatitis B (CHB). In past research, ginseng (Panax ginseng, Araliaceae) has been
shown to have antiviral potential and may be able to play a therapeutic role.
CHB activates hepatic stellate cells, which then induces hepatic fibrosis, and results
in excess formation of type IV collagen, hyaluronic acid (HA), and transforming
growth factor-beta (TGF-β). This study measured serum levels of these 3 biomarkers
to determine the efficacy of Korean red ginseng (KRG) in combination with
antiviral treatment in patients with CHB.
This
68-week, prospective, single-blinded, randomized, controlled trial was conducted
at a single center, Daejeon St. Mary's Hospital, the Catholic University of
Korea; Daejeon, Korea. Forty-two patients who were between 18 and 65 years of
age, diagnosed with CHB within the past 6 months, HBV DNA(+) and HBeAg(+), and receiving
antiviral treatment were enrolled between April 2012 and February 2014.
Patients were randomly divided into 2 groups. The control group was given oral
antiviral treatment (lamivudine, adefovir dipivoxil, entecavir, or tenofovir)
and the experimental group was given oral antiviral treatment plus 3 g of KRG
(Korea Ginseng Corporation; Seoul, Korea) daily (1-g dose, 3x/day, 500
mg/capsule). KRG was harvested "from the roots of a 6-year-old red
ginseng, Panax ginseng Meyer" in the Republic of Korea. The fresh ginseng
was steamed at 90-100°C for 3 hours followed by drying at 50-80°C, then ground
into a powder. "The KRG extract was found to contain the major
ginsenosides -Rb1 (4.26 mg/g), -Rb2 (1.62 mg/g), -Rc (1.80 mg/g), -Rd (0.29
mg/g), -Re (1.71 mg/g), -Rf (0.67 mg/g), -Rg1 (2.61 mg/g), -Rg2 (0.20 mg/g),
-Rg3 (0.13 mg/g), and other minor ginsenosides." Type IV collagen, HA, and
TGF-β were measured at 4 and 52 weeks after the initial assessment.
"[F]our
patients were excluded because of various reasons, leaving 38 patients who were
enrolled in the study." All 38 patients completed the study, with 19
patients in each group. Ten males and 9 females were in the control group, and
17 males and 2 females were in the KRG group (P=0.293). No serious adverse
events were reported in either group.
After
treatment, there was no significant difference in type IV collagen levels
between the control and KRG groups (P=0.174). Mean ± standard deviation (SD) HA
levels changed from 65.61 ± 31.47 ng/mL (control) and 72.47 ± 37.91 ng/mL (KRG)
at baseline to 5.27 ± 2.98 ng/mL (control) and 3.21 ± 2.71 ng/mL (KRG) after
treatment, showing a statistically significant decrease in the KRG group
compared to control (P=0.032). Mean ± SD TGF-β levels changed from 186.61 ± 64.63
pg/mL (control) and 219.81 ± 145.21 pg/mL (KRG) at baseline to 4.73 ± 5.72 pg/mL
(control) and 1.38 ± 2.44 pg/mL (KRG) after treatment, showing a statistically
significant decrease in the KRG group compared to control (P=0.008). There were
no significant differences in aspartate aminotransferase (AST), alanine
aminotransferase (ALT), or HBV DNA levels between groups after treatment (P=0.517,
P=0.176, and P=0.685, respectively).
While
there was no significant change in type IV collagen levels between groups,
significant differences were found in the levels of HA and TGF-β between the 2
groups. KRG could be a helpful adjunct to antiviral treatment, as it can help
decrease some markers associated with hepatic fibrosis. However, further
double-blind investigations are warranted to confirm this conclusion. "The
work was supported by a grant from the Korean Society of Ginseng, funded by the
Korea Ginseng Corporation."
—Alexis Collins, MA,
MS
Peer Review Comments:
This report lacks sufficient evidence of potential anti-HBV effects as
follows:
- The test group (KRG administered) did not show
any antiviral effects in comparison with that of the control group (the control
group's numbers of HBV DNA copies were less than that of the test group when
the primary endpoint was HBV DNA copies).
- There were some statistically significant
differences in measurements of HA and TGF-β, but it cannot be conclusively stated whether this was due to KRG
treatment or individual different reactions.
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Based on the above, further studies are needed.
To show concrete outcomes, the clinical trials need more patients in test
groups and/or there needs to be a re-design of the clinical trial.
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