The Clinical Outcome of the Combination Regimen of Ginkgo biloba Extract with Ursodeoxycholic acid in Chronic Hepatitis C Egyptian Patients.

Abstract

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 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 transami-nases and increased oxidative stress evidenced by lower levels of serum TAC. They showed increased serum level of TGF-β1 and Hyaluronic acid. • 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 inter-vention groups except for a significant decrease in hemoglobin the EGb+UDCA-group.