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- Birch (Betula pubescens) Bark
- Chronic Hepatitis C
| Date:
12-30-2011 | HC# 101134-439
|
Re: Birch Bark Extract Produces Beneficial Effects in Patients with Hepatitis C
Shikov
AN, Djachuk GI, Sergeev DV, et al. Birch bark extract as therapy for chronic
hepatitis C ― A pilot study. Phytomedicine.
2011;18(10):807-810.
Infections
of hepatitis B virus (HBV) and hepatitis C virus (HCV), which affect about 400
to 500 million persons worldwide, are associated with significant morbidity and
mortality. Chronic infections may develop into cirrhosis and primary
hepatocellular carcinoma. Treatment of HCV by pegylated interferon plus
ribavirin eradicates the virus in 60% of patients; however, a significant
number of patients do not respond to therapy, relapse following treatment, or
have significant adverse side effects that necessitate the discontinuation of
treatment. Many patients have turned to complementary and alternative medicines
for treatment. Herbal preparations, including birch (Betula pubescens) bark, have long been used to treat various
ailments. Noting that there are no clinical data on the hepatoprotective effect
of birch bark extract (BBE), the authors report on their open, prospective
pilot study to investigate its effect in patients with chronic HCV.
The
outer bark of birch contains pentacyclic triterpenes, including betulin,
betulinic acid, oleanolic acid, lupeol, and erythrodiol. These triterpenes have
known antiallergic, antiviral, antimicrobial, hepatoprotective, and antitumor
effects. In animal studies, BBE exhibited a preventive effect in HCV-infected
mice,1 and betulin exhibited a hepatoprotective effect on rats in
models of paracetamol- and ethanol-induced hepatitis.2
This
study included 42 patients aged 20 to 71 years with serologically confirmed
chronic HCV. All had alanine aminotransferase (ALT) levels greater than
1.5-fold above the upper limit of normal for at least 4 months before the
study. Of the patients included, 6 had been diagnosed with arterial
hypertension, 4 with chronic gastritis and gastroduodenitis, 4 with chronic
cholecystitis, 3 with chronic bronchitis, and 2 with thyroiditis. Twenty-eight
patients had relapsed or were nonresponders to combination therapy with
pegylated interferon and ribavirin, and 14 were not eligible for interferon
treatment for various reasons.
BBE
(SNS-Pharma; St. Petersburg, Russia) was given orally as hard gelatin capsules
containing 20 mg of dry alcohol extract from birch bark per capsule. Standard
solutions of both betulin and betulinic acid were prepared in methanol to a
final concentration of 1 mg/ml. The patients took 8 capsules daily (2 in the
morning, 3 before lunch, and 3 in the evening) for 90 days.
The
primary outcome measure was the rate of ALT levels (a marker for liver damage),
quantitative HCV RNA levels (a measure of the viral load), subjective symptoms
associated with chronic HCV (fatigue, abdominal discomfort, depression, and
dyspepsia), safety, and compliance.
The
authors report that after 4 weeks of treatment, none of the patients had
normalized ALT levels. After 12 weeks, however, significant differences in mean
ALT and HCV RNA levels were observed. ALT levels decreased in 54% of patients
and returned to normal levels (P=0.046). HCV RNA was reduced in 43.2% of patients
(P=0.016). At baseline, mean bilirubin was within normal limits and tended to decrease
after 12 weeks of treatment.
At
12 weeks, the majority of patients reported the disappearance or alleviation of
their chief clinical symptoms. Subjective complaints improved after 4 weeks of
treatment. Reductions of 4-fold were reported for fatigue (P=0.049), and of
2-fold for abdominal discomfort (P=0.012), depression (P=0.045), and dyspepsia (P=0.038).
At 12 weeks, fatigue was reduced 6-fold (P=0.028), and abdominal discomfort was
reduced 3-fold (P=0.05). Dyspepsia was no longer reported (P=0.042), which was
significantly different from baseline.
Compliance
was moderate: 60% of capsules were taken.
This
study demonstrated beneficial effects of 12 weeks of BBE treatment in patients
with chronic HCV infection. "However, because this study lacked a control
group, clinical relevance of the data can only be estimated in the future by
following controlled clinical trials," say the authors.
―Shari
Henson
References
1Nosik NN, Deriabin PG,
Isaeva EI, et al. [Interferon-inducing properties of dry birch bark extract and
its effect on experimental infection caused by hepatitis C virus]. Vopr Virusol. 2005;50(5):29-32.
2Djachuk GI, Yurchenko
IV, Vishnevetskaya TP, Karlina MV. Study of Hepatoprotective Properties of Betulin.
Vestnik Dermatologii i Venerologii. St.
Petersburg State Medicinal Academy; 2004;1:142-145.
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