title: Effects of Nigella sativa on outcome of hepatitis C in Egypt.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Eman Mahmoud Fathy Barakat, Department of Tropical Medicine, Faculty of Medicine, Ain Shams University, Cairo 11566, Egypt.
authors.forename: Eman Mahmoud Fathy
authors.initials: EM
authors.lastname: Barakat
authors.forename: Lamia Mohamed
authors.initials: LM
authors.lastname: El Wakeel
authors.forename: Radwa Samir
authors.initials: RS
authors.lastname: Hagag
mesh_terms: D000328:Adult; D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D004347:Drug Interactions; D004534:Egypt; D005260:Female; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D031881:Nigella sativa; D018384:Oxidative Stress / Q000187:drug effects; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D010938:Plant Oils / Q000009:adverse effects / Q000627:therapeutic use*; D010946:Plants, Medicinal; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D029974:Carum
chemical_list: D000975:Antioxidants; D000998:Antiviral Agents; D015415:Biomarkers; D001786:Blood Glucose; D010936:Plant Extracts; D010938:Plant Oils; C104525:caraway oil
keywords: Hepatitis C virus; Nigella sativa; Oxidative stress; Viral load