Document Type : Research articles
Authors
- Seyyd Musa al-Reza Hosseini 1
- Said Zibaee 2
- Mahdi Yousef 3
- Ali Taghipour 4
- Omid Ghanaei 5
- Mohammadreza Noras 6
1 MD, Assistant Professor, Department of Gastroenterology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
2 PhD in Microbiology, Assistant Professor, Razi Vaccine and Serum Research Institute, Mashhad, Iran
3 PhD in Iranian Traditional Medicine, Assistant Professor, Faculty of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad
4 PhD in Epidemiology, Associate Professor, Faculty of Health, Mashhad University of Medical Sciences, Mashhad, Iran
5 MD, Department of Gastroenterology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
6 PhD in Iranian Traditional Medicine, Faculty of Persian Traditional and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Abstract
Background: Chronic hepatitis C is one of the most important causes of cirrhosis and hepatocellular carcinoma (HCC). Camel milk (CM) is a new candidate therapy for chronic hepatitis C (CHC).
Objectives: The present study assessed the safety and efficacy of pegylated interferon alfa-2a and ribavirin with CM (CM + Peg IFN/RBV) and without CM (Peg IFN/RBV) in CHC genotype 2/3 infections.
Methods: This study was an open-label, randomized, phase 2 trial. Sampling strategy and date was computer–generated randomization. The researchers randomly selected 45 adult patients (ages > 18 years), who were treatment-naive with CHC infection (noncirrhotic) to receive Peg IFN/RBV with standard-dose alone (group A, n = 23), CM + Peg IFN/RBV: 500 cc orally per day (group B, n = 22) for 24 weeks in Iran. The primary efficacy outcomes were early virological response (EVR12) and end-of-treatment response (ETR24), the secondary efficacy outcome was sustained virological response (SVR24), and the safety outcomes were adverse events and laboratory tests at end-treatment to assess.
Results: The EVR12 was 60% (12/20), ETR24 90% (18/20), and SVR24 100% (18/18) of CM + Peg IFN/RBV therapy. The EVR12 was 15% (3/20), ETR24 70% (14/20), and SVR24 rates were 71% (10/14) in Peg IFN/RBV therapy (P < 0.05). Rates of discontinuation due to adverse events were 8.6% (2/23) in control and no discontinuation in intervention group. The most common adverse events were fatigue, anemia, and insomnia.
Conclusions: Combination of CM with Peg IFN/RBV for 48 weeks showed significant improvements in the viral response and decreased adverse effects in CHC genotype 2/3 (P < 0.05). The data of the study supported the CM synergistic antiviral activity of Peg IFN/RBV. Large clinical trials are needed to confirm the results.
Keywords
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