الفهرس 
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Abstract
Summary
Hepatitis C is a disease with a significant global impact. Particularly in
Egypt, it is considered a major public health problem in which around 14.7%
of the population is estimated to be infected with hepatitis C virus (HCV)
(Mohamoud et al., 2013).
The standard treatment of HCV genotype 4, the most predominant
genotype in Egypt, is a combination of pegylated interferon alpha by
subcutaneous injection once weekly and oral ribavirin daily (Lever and Nash,
2011).
Unluckily, the sustained virological response is only achieved in
approximately 60% of the patients with genotype 4 (Kamal et al., 2007). The
high number of non-responders to the standard treatment, together with the
increase in the rate of adverse effects, high cost of therapy and the many
contraindications (Modi and Liang, 2008) lead the patients to look for
complementary and alternative therapies.
HCV is known to cause pathologic consequences as a result of a direct
expression of viral proteins, as well as, inflammation related to the immune
recognition of the virus. This leads to an increase in the oxidative stress and
promotion of fibrogenesis (Neumann-Haefelina and Thimme, 2013; Yamane
et al., 2013). Hence, antioxidants and anti-inflammatory therapies aiming at
decreasing the oxidative stress and rate of inflammation have received
considerable attention in liver protection.
The extract of Ginkgo biloba has been reported in my animal and
clinical studies to have hepatoprotective activities due to its antioxidant and
Summary
105
anti-inflammatory effect leading to inhibition of the rate of fibrosis
progression (Zhang et al., 2008; Al-Attar, 2012).
The current study was designed to evaluate the therapeutic effect and
safety of the extract of Ginkgo biloba, ursodeoxycholic acid separately and the
combination of both treatments in Egyptian patients diagnosed with chronic
hepatitis C. This was accomplished by assessing liver transaminases,
Complete blood count, albumin, total bilirubin, serum TAC, serum TGF-β1,
and serum HA, as well as, their effect on the quality of life through RAND
SF-36 questionnaire. This study was conducted on 67 patients with chronic
hepatitis C who were randomized into one of the three groups:
EGb-group; [n=22, received one capsule of 260 mg EGb (Ginkgo
biloba®) once daily for 4 weeks].
UDCA-group; [n=23, received one capsule of 300 mg ursodeoxycholic
acid (Ursogall®) three times daily for 4 weeks].
EGb+UDCA-group; [n=22, received one capsule of 260 mg EGb
(Ginkgo biloba®) once daily in addition to one capsule of 300 mg
ursodeoxycholic acid (Ursogall®) three times daily for 4 weeks].
Six patients dropped out due to non compliance with the study and one patients
dropped out due to elevation of the liver transaminases to more than 5
times the normal limit. Only 20 patients in each group continued the study.
The current study showed that:
Patients with chronic hepatitis C had baseline elevated liver transaminases
and increased oxidative stress evidenced by lower levels of serum
TAC. They showed increased serum level of TGF-β1 and Hyaluronic
acid.
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106
There was a significant decrease in liver transaminases in the UDCAgroup
and the EGb+UDCA-group only, but no significant decrease was
observed in the EGb-group.
No significant change was observed in the level of bilirubin, albumin
and INR in all the intervention groups.
Significant increase in serum TAC was detected in the 3 intervention
groups while a significant decrease in the level of TGF-β1 and HA was
detected in the 3 intervention groups.
Quality of Life (QOL) assessed by RAND SF-36 questionnaire showed
low baseline scores.
QOL in the EGb-group didn’t show improvement during the treatment
period except for an increase in the physical functioning domain, while
the UDCA-group showed a significant improvement in both the Physical
and Mental Component summary scores and an improvement in only
the Mental Component summary score in the EGb+UDCA-group.
Both EGb and UDCA were safe and well-tolerated.
There was no significant change in compete blood count in all the intervention
groups except for a significant decrease in hemoglobin the
EGb+UDCA-group.
Conclusions:
from these results, we can conclude that:
Administration of EGb at a dose of 260 mg/day for 4 weeks in patients
with chronic hepatitis C exhibited antioxidant actions and ability to
lower fibrosis markers and profibrotic growth factors; yet, this hepatoprotective
action of EGb wasn’t reflected on the liver transaminases.
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107
UDCA has a hepatoprotective action in chronic hepatitis C patients,
seen in improvement in liver transaminases, oxidative stress, fibrosis
markers and profibrotic growth factors.
Improvement in the QOL variables was shown in the UDCA-group but
not in the EGb-group.
Adding EGb to UDCA didn’t show a beneficial effect.
Administration of EGb and UDCA was safe and tolerable with no complications.
Recommendations:
Further studies on larger sample sizes and for longer durations with different
doses of EGb are needed to be conducted on patients with different
stages of hepatitis C and with different genotypes.
Studies with biopsies to see the changes on the histological level are also
recommended.