A Randomized Double-blind Placebo-controlled Clinical Trial on a Chinese Herbal Formula (Invigorating the Kidney and the Spleen Gelatin Capsule) in the Treatment of Chronic Hepatitis B Virus Carriers
HE Jin-song, ZHOU Da-qiao, TONG Guang-dong, et al. A Randomized Double-blind Placebo-controlled Clinical Trial on a Chinese Herbal Formula (Invigorating the Kidney and the Spleen Gelatin Capsule) in the Treatment of Chronic Hepatitis B Virus Carriers[J]. Chinese journal of experimental traditional medical formulae, 2010, 16(6): 246-249.
HE Jin-song, ZHOU Da-qiao, TONG Guang-dong, et al. A Randomized Double-blind Placebo-controlled Clinical Trial on a Chinese Herbal Formula (Invigorating the Kidney and the Spleen Gelatin Capsule) in the Treatment of Chronic Hepatitis B Virus Carriers[J]. Chinese journal of experimental traditional medical formulae, 2010, 16(6): 246-249. DOI: 10.13422/j.cnki.syfjx.2010.06.012.
Objective:The aim of this study is to investigate the anti-viral effects of a Chinese Herbal Formula(invigorating the kidney and the spleen gelatin capsule) in treating chronic hepatitis B Virus carriers.Method:This was a randomized
double-blind
placebo-controlled study.90 patients enrolled in the study who were satisfied with the following criteria:presence of hepatitis B surface antigen and hepatitis B e antigen
HBV DNA level greater than 7 log 10 copies /mL
and normal alanine aminotransferase level(30 ~ 40 U.mL-1 for male
and 20 ~ 40 U.mL-1 for female).They were randomly divided into trial group(n = 60) and control group(n = 30).During the trial period
patients in both trial group and control group received medication invigorating the kidney and the spleen gelatin capsule and a placebo for 48 weeks respectively
4 capsules per time
3 times perday.The serum HBV DNA level
serum markers of HBV(HBsAg
HBsAb
HbeAg
HBeAb
HbcAb) and serum biochemistry of liver functions(ALT
AST
GGT
TBil) were measured at the before and 48th week of the treatment.And the indexes of safety
such as blood analysis
stool analysis
urinalysis
renal functions and electrocardiogram were also detected.Result:After treatments
the median decrease in serum HBV DNA levels was 3.4 log 10 copies /mL in the trial group and 0.1 log 10copies /mL in the control group(P < 0.01).Serum HBV DNA < 3log 10copies /mL was observed in 13 of the 60 subjects(21.7%) in the trial group and 1 of the 30 subjects(3.3%) in the placebo group(P < 0.01).The proportion of patients with HBeAg loss was 20%(12 /60) and 3.3%(1 / 30) respectively in the trial group and control group(P < 0.01).The ratio of HBeAg seroconversion to anti-HBe was 15%(9 /60) in the trial group and 0%(0 /30) in the control group(P < 0.05).Conclusion:Invigorating the kidney and the spleen gelatin capsule is effective in inhibiting the copy of hepatitis B virus and increase the ratio of HBeAg seroconversion
which can be used to treat Chronic Hepatitis B Virus carriers.