Brief Article
Copyright ©2013 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. Apr 28, 2013; 19(16): 2529-2536
Published online Apr 28, 2013. doi: 10.3748/wjg.v19.i16.2529
Effects of Nigella sativa on outcome of hepatitis C in Egypt
Eman Mahmoud Fathy Barakat, Lamia Mohamed El Wakeel, Radwa Samir Hagag
Eman Mahmoud Fathy Barakat, Department of Tropical Medicine, Faculty of Medicine, Ain Shams University, Cairo 11566, Egypt
Lamia Mohamed El Wakeel, Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo 11566, Egypt
Radwa Samir Hagag, Department of Clinical Pharmacy, Faculty of Pharmacy, Egyptian Russian University, Cairo 16686, Egypt
Author contributions: Barakat EMF contributed to study concept and design, acquisition and interpretation of data, and critical revision of the manuscript for important intellectual content; El Wakeel LM contributed to acquisition, analysis and interpretation of data, and critical revision of the manuscript for important intellectual content; Hagag RS contributed to data collection and material support; all authors contributed to drafting of the manuscript and final approval of the version to be published.
Correspondence to: Lamia Mohamed El Wakeel, PhD, Assistant professor of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, 4 Street 292, New Maadi, Cairo 11566, Egypt. lamywak@yahoo.com
Telephone: +20-100-5201099   Fax: +20-100-5201099
Received: December 14, 2012
Revised: January 30, 2013
Accepted: February 5, 2013
Published online: April 28, 2013
Processing time: 139 Days and 4.1 Hours
Abstract

AIM: To evaluate the safety, efficacy and tolerability of Nigella sativa (N. sativa) in patients with hepatitis C not eligible for interferon (IFN)-α.

METHODS: Thirty patients with hepatitis C virus (HCV) infection, who were not eligible for IFN/ribavirin therapy, were included in the present study. Inclusion criteria included: patients with HCV with or without cirrhosis, who had a contraindication to IFN-α therapy, or had refused or had a financial constraint to IFN-α therapy. Exclusion criteria included: patients on IFN-α therapy, infection with hepatitis B or hepatitis I virus, hepatocellular carcinoma, other malignancies, major severe illness, or treatment non-compliance. Various parameters, including clinical parameters, complete blood count, liver function, renal function, plasma glucose, total antioxidant capacity (TAC), and polymerase chain reaction, were all assessed at baseline and at the end of the study. Clinical assessment included: hepato and/or splenomegaly, jaundice, palmar erythema, flapping tremors, spider naevi, lower-limb edema, and ascites. N. sativa was administered for three successive months at a dose of (450 mg three times daily). Clinical response and incidence of adverse drug reactions were assessed initially, periodically, and at the end of the study.

RESULTS: N. sativa administration significantly improved HCV viral load (380808.7 ± 610937 vs 147028.2 ± 475225.6, P = 0.001) and TAC (1.35 ± 0.5 vs 1.612 ± 0.56, P = 0.001). After N. sativa administration, the following laboratory parameters improved: total protein (7.1 ± 0.7 vs 7.5 ± 0.8, P = 0.001), albumin (3.5 ± 0.87 vs 3.69 ± 0.91, P = 0.008), red blood cell count (4.13 ± 0.9 vs 4.3 ± 0.9, P = 0.001), and platelet count (167.7 ± 91.2 vs 198.5 ± 103, P = 0.004). Fasting blood glucose (104.03 ± 43.42 vs 92.1 ± 31.34, P = 0.001) and postprandial blood glucose (143.67 ± 72.56 vs 112.1 ± 42.9, P = 0.001) were significantly decreased in both diabetic and non-diabetic HCV patients. Patients with lower-limb edema decreased significantly from baseline compared with after treatment [16 (53.30%) vs 7 (23.30%), P = 0.004]. Adverse drug reactions were unremarkable except for a few cases of epigastric pain and hypoglycemia that did not affect patient compliance.

CONCLUSION: N. sativa administration in patients with HCV was tolerable, safe, decreased viral load, and improved oxidative stress, clinical condition and glycemic control in diabetic patients.

Keywords: Hepatitis C virus; Nigella sativa; Oxidative stress; Viral load