Efficacy and Safety of a Chinese Herbal Formula (Invigorating Kidney and Strengthening Spleen) in Chronic Hepatitis B Virus Carrier: Results from a Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial
Table 4
Virological response and change of serum HBV DNA level after treatment.
Treatment response
Treatment group ()
Control group ()
values
24 weeks
Patients with HBV DNA level decline >2 log10 IU/mL, (%)
14 (7.00)
3 (3.00)
1.9954
0.1578※
Patients with undetectable HBV, (%)
1 (0.5)
0 (0)
0.0000
1.0000※★
Reduction in HBV DNA level, mean (SD), log10 IU/mL
Total
0.34 (0.92)
0.06 (0.62)
3.2094
0.0015△
baseline level 5 to <7 log10 IU/mL
0.48 (0.98)
0.05 (0.39)
1.9532
0.0584△
baseline level 7 to <9 log10 IU/mL
0.26 (0.96)
0.06 (0.67)
1.7470
0.0822△
baseline level >9 log10 IU/mL
0.63 (0.58)
0.05 (0.46)
3.3742
0.0016#
52 weeks
Patients with HBV DNA level decline >2 log10 IU/mL, (%)
38 (19.00)
5 (5.00)
10.6416
0.0011※
Patients with undetectable HBV a, (%)
1 (0.5)
1 (1.00)
0.0000
1.0000※★
Reduction in HBV DNA level, mean (SD), log10 IU/mL
Total
0.86 (1.27)
0.05 (0.86)
6.4772
0.0000△
baseline level 5 to <7 log10 IU/mL
1.10 (0.79)
0.05 (0.47)
4.0849
0.0002#
baseline level 7 to <9 log10 IU/mL
0.76 (1.38)
0.05 (0.47)
4.4885
0.0000△
baseline level >9 log10 IU/mL
1.05 (1.06)
0.06 (0.68)
3.8132
0.0005△
SD: standard deviation; HBV: hepatitis B virus.
aHBV DNA < 12 IU/mL. ※Chi-square test.
#-test. △Adjusted -test. ★Continuity correction.
