Effect of Silymarin as an Adjunct Therapy in Combination with Sofosbuvir and Ribavirin in Hepatitis C Patients: A Miniature Clinical Trial

Abstract

Silymarin is proclaimed to be a blend of flavonolignans or phytochemicals. An era of new generation of direct-acting antivirals (DAAs) has commenced to have facet effect in swaying of the hepatitis C virus (HCV). Nonetheless, this therapy has serious side effects that jeopardize its efficacy. This study is aimed at probing the effects of ribavirin (RBV) and sofosbuvir (SOF) along with silymarin as an adjunct therapy on hematological parameters and markers of obscured oxidative stress. The effect of DAAs along with silymarin was also examined on variable sex hormone level and liver function markers such as alanine aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), and bilirubin. The study was followed to determine viral load and viral genotypes. A total of 30 patients were randomly divided into two equal groups comprising the control group (n = 15) and treatment group (n = 15). The control group was solely administered with DAAs (SOF and RBV; 400 mg/800 mg each/day). Conversely, the treatment group was dispensed with DAAs, but with adjunct therapy of silymarin (400 mg/day) along with DAAs (400/800 mg/day) over period of 8 weeks. Sampling of blood was performed at pre- and posttreatment levels for the evaluation of different propound parameters. Our data showed that silymarin adjunct therapy enhances the efficiency of DAAs. A decrease in menace level of liver markers such as ALT, ALP, AST, and bilirubin was observed (p > 0.05). The adjunct therapy concurrently also demonstrated an ameliorative effect on hematological indices and oxidative markers, for instance, SOD, TAS, GSH, GSSG, and MDA (p < 0.05), diminishing latent viral load. The silymarin administration was also found to revamp the fluster level of sex hormones. Our outcomes provide evidence that systematic administration of silymarin effectively remits deviant levels of hematological, serological, hormonal, and antioxidant markers. This demonstrates a possibly unique role of silymarin in mitigating hepatitis C.

Figure 1

(a) Line plot of RT-qPCR levels in the control and treatment groups before and after adjunct therapy. (b) Standard curve generated by plotting the number of RNA copies vs. the corresponding RT-qPCR threshold cycle (Ct) value of three independent experiments.

Figure 2

Effect of silymarin on liver function markers (a) AST, (b) ALT, (c) ALP, and (d) total bilirubin in group 1 (control group) and group 2 (treated group) at pre- and posttreatment level. Comparison was made by using one-way ANOVA test. Values were expressed as the mean ± SD. AST-I: initial aspartate aminotransferase; AST-F: final aspartate aminotransferase level; ALT-I: initial alanine aminotransferase level; ALT-F: final alanine aminotransferase; ALP-I: initial alkaline phosphatase; ALP-F: final alkaline phosphatase; Bilirubin-I: initial bilirubin level; Bilirubin-F: final bilirubin level.

Figure 3

The level of (a) TAS, (b) GSH, (c) GSSG, (d) MDA (e) GGT, and (f) SOD oxidative stress markers in group 1 (control) and group 2 (treated group) at pre- and posttreatment level. Values were statistically nonsignificant at p > 0.05. One-way ANOVA was conducted to analyze the results. Data are expressed as the mean ± standard deviation. TAS: total antioxidant status; GSH: reduced glutathione; GSSG: oxidized glutathione; MDA: malondialdehyde; GGT: gamma-glutamyl transferase; SOD: superoxide dismutase.

Figure 4

The level of (a) LH, (b) FSH, (c) progesterone, and (d) testosterone hormones in male and female control (group 1) and HCV-treated group (group 2), at pre- and posttreatment level. Values were statistically nonsignificant at p > 0.05. One-way ANOVA was conducted to analyze the results. Data are expressed as the mean ± standard deviation. M: male patients; F: female patients; LH: luteinizing hormone; FSH: follicle-stimulating hormone.