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Therapeutic effects of reduced glutathione on liver function, fibrosis, and HBV DNA clearance in chronic hepatitis B patients.

  • 2025-02-07
  • BMC gastroenterology 25(1)
    • Qiyao Wei
    • Jing Zhao

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 90
Population
90 patients diagnosed with chronic hepatitis B, randomly divided into two groups (observation group and control group), with 45 patients in each group
Methods
randomized controlled trial, using a random number table; control group received standard entecavir treatment (0.5 mg/time, once a day, continuous treatment for 3 months), observation group received combination therapy of reduced glutathione and standard entecavir treatment
Duration
3 months
Funding
Unclear

Objective

To evaluate the therapeutic impact of reduced glutathione combined with entecavir on liver function, fibrosis, and HBV-DNA clearance in chronic hepatitis B patients.

Methods

This was a randomized controlled trial. This study included 90 patients diagnosed with chronic hepatitis B, who were randomly divided into two groups (observation group and control group) using a random number table, with 45 patients in each group. The control group received standard entecavir treatment (0.5 mg/time, once a day, continuous treatment for 3 months), while the observation group received a combination therapy of reduced glutathione and the standard entecavir treatment. Liver function markers (ALT, TBIL, AST, ALB), fibrosis markers (HA, PC III, LN), and liver fibrosis grades were assessed pre-and post-treatment. HBV-DNA negative conversion rates were recorded at 4, 12, 24, and 48 weeks. The incidence of adverse reactions, including nausea, vomiting, headache, and mild gastric discomfort, was recorded and compared between the two groups during the treatment period.

Results

ALT decreased from 348.96 ± 31.47 U/L to 31.11 ± 9.78 U/L in the observation group and from 347.90 ± 31.40 U/L to 56.90 ± 16.32 U/L in the control group (P < 0.05). TBIL decreased from 61.78 ± 4.94 µmol/L to 18.82 ± 2.93 µmol/L in the observation group and from 61.32 ± 4.93 µmol/L to 26.70 ± 4.44 µmol/L in the control group (P < 0.05). ALB increased from 29.65 ± 0.94 g/L to 48.76 ± 4.85 g/L in the observation group and from 29.77 ± 0.90 g/L to 34.12 ± 0.84 g/L in the control group (P < 0.05). The observation group showed greater reductions in HA, PC III, and LN, and improved liver fibrosis grades (P < 0.05). HBV-DNA negative conversion rates in the observation group were 15.56%, 35.56%, 60.00%, and 68.89% at 4, 12, 24, and 48 weeks, respectively, compared to 2.22%, 6.67%, 17.78%, and 42.22% in the control group (P < 0.05). Adverse reaction rates were 8.89% in the observation group and 20.00% in the control group (P > 0.05).

Conclusion

Reduced glutathione combined with entecavir significantly improves liver function, reduces liver fibrosis, and enhances HBV-DNA clearance in chronic hepatitis B patients without increasing adverse reactions.

Research Insights

  • Glutathione→Improved Alanine Aminotransferase Level

    ALT decreased from 348.96 ± 31.47 U/L to 31.11 ± 9.78 U/L in the observation group and from 347.90 ± 31.40 U/L to 56.90 ± 16.32 U/L in the control group (P < 0.05).

    Effect
    Beneficial
    Effect size
    Large
  • Glutathione→Improved Bilirubin Level

    TBIL decreased from 61.78 ± 4.94 µmol/L to 18.82 ± 2.93 µmol/L in the observation group and from 61.32 ± 4.93 µmol/L to 26.70 ± 4.44 µmol/L in the control group (P < 0.05).

    Effect
    Beneficial
    Effect size
    Large
  • Glutathione→Improved Liver Fibrosis Grade

    The observation group showed greater reductions in HA, PC III, and LN, and improved liver fibrosis grades (P < 0.05).

    Effect
    Beneficial
    Effect size
    Moderate
  • Glutathione→Improved Liver Function

    ALB increased from 29.65 ± 0.94 g/L to 48.76 ± 4.85 g/L in the observation group and from 29.77 ± 0.90 g/L to 34.12 ± 0.84 g/L in the control group (P < 0.05).

    Effect
    Beneficial
    Effect size
    Large
  • Glutathione→Improved Liver Function (AST)

    Liver function markers (ALT, TBIL, AST, ALB) were assessed ... The observation group showed significantly greater improvements in AST (data not fully numeric but stated as P < 0.05).

    Effect
    Beneficial
    Effect size
    Large
  • Glutathione→Reduced HBV DNA Level

    HBV-DNA negative conversion rates in the observation group were 15.56%, 35.56%, 60.00%, and 68.89% at 4, 12, 24, and 48 weeks, respectively, compared to 2.22%, 6.67%, 17.78%, and 42.22% in the control group (P < 0.05).

    Effect
    Beneficial
    Effect size
    Large
  • Glutathione→Reduced Liver Fibrosis

    The observation group showed greater reductions in HA, PC III, and LN, and improved liver fibrosis grades (P < 0.05).

    Effect
    Beneficial
    Effect size
    Moderate

Adverse Events Reported

  • Glutathione→headache

    Adverse reaction rates were 8.89% in the observation group and 20.00% in the control group (P > 0.05).

    Finding
    No significant difference
    Significant
    No
  • Glutathione→mild gastric discomfort

    Adverse reaction rates were 8.89% in the observation group and 20.00% in the control group (P > 0.05).

    Finding
    No significant difference
    Grade
    mild
    Significant
    No
  • Glutathione→nausea

    Adverse reaction rates were 8.89% in the observation group and 20.00% in the control group (P > 0.05).

    Finding
    No significant difference
    Significant
    No
  • Glutathione→vomiting

    Adverse reaction rates were 8.89% in the observation group and 20.00% in the control group (P > 0.05).

    Finding
    No significant difference
    Significant
    No
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