Author/Authors :
Taghipour Ali نويسنده , Noras Mohammadreza نويسنده Phd student, Students Research Committee, Faculty of Traditional Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. , Ghanaei Omid نويسنده Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran , Yousefi Mahdi نويسنده School of Persian and Complementary Medicine,Mashhad University of Medical Sciences,Mashhad,Iran , al-Reza Hosseini Seyyd Musa نويسنده MD, Assistant Professor, Department of Gastroenterology,
Faculty of Medicine, Mashhad University of Medical Sciences,
Mashhad, Iran , Zibaee Said نويسنده PhD in Microbiology, Assistant Professor, Razi Vaccine and
Serum Research Institute, 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 (non-cirrhotic) 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.
