Bushen Jianpi Formula Combined with Entecavir for the Treatment of HBeAg-Negative Chronic Hepatitis B: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Table 2

Comparison of efficacy endpoints between the treatment and control groups.

Endpoint	Treatment group (n = 271)	Control group (n = 272)
HBsAg loss	15 (5.5)	5 (1.8)	0.031
Decrease in HBsAg to ≥1 lg·IU/mL	30 (11.1)	16 (5.9)	0.043
HBV DNA suppression	261 (97.8)	267 (98.2)	0.770
Mean decrease in cccDNA (lg IU/mL)^†‡	3.66 ± 1.75	3.06 ± 1.32	0.636
Necroinflammatory improvement^‡	9 (29.0)	10 (29.4)	0.766
Fibrosis improvement^‡	11 (35.5)	4 (11.8)	0.031
ALT normalization^§	201 (91.8)	199 (91.3)	0.868

Values in parentheses are percentages; ^†value is the mean ± standard deviation. ^‡A total of 65 patients had liver biopsy specimens assessed both at baseline and at 96 weeks (31 in the treatment group and 34 in the control group). ^§A total of 437 patients had abnormal ALT levels at baseline (219 patients in the treatment group and 218 patients in the control group).