To evaluate the consistency of clinical efficacy and safety between Chaihu Shugan San formula granules and traditional decoction pieces in the treatment of chronic hepatitis B (CHB) in the immune clearance phase with liver depression and qi stagnation syndrome, and to provide an evidence-based basis for clinical dosage form selection.

A multicenter, randomized, single-blind, positive-controlled clinical trial design was adopted. A total of 133 patients with CHB in the immune clearance phase with liver depression and qi stagnation syndrome were enrolled and randomly divided into a test group (formula granules) and a control group (traditional decoction pieces) using a random number table. Both groups received oral administration before meals, three times a day, with 14 days as one course of treatment, an interval of 1 day between courses, and a total of 2 consecutive courses. The treatment response rate, hepatitis B virus DNA (HBV-DNA) quantification, liver function indexes [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], TCM syndrome score and adverse reactions were used as evaluation indicators, and a consistency test was employed to analyze the consistency of efficacy and safety between the two groups.

The consistency of treatment response rate between the two groups was strong (κ=0.645); the complete response rate in the test group (8.0%) was higher than that in the control group. The consistency of improvement of AST and ALT between the two groups was strong [intraclass correlation coefficient (ICC)=0.689, 0.791], and the mean AST and ALT after treatment in the test group were lower than those in the control group. The consistency of the improvement in TCM syndrome scores between the two groups was strong (ICC=0.637), and the post treatment syndrome score in the test group was lower than that in the control group. The consistency of HBV-DNA negative conversion rate between the two groups was moderate (κ=0.332), and the negative conversion rate in the test group (42.7%) was higher than that in the control group (30.0%). The incidence of adverse reactions in the test group was 5.0%, and no adverse reactions occurred in the control group.

Chaihu Shugan San formula granules and traditional decoction pieces show strong consistency in overall response rate and liver function improvement. Formula granules demonstrate advantages in TCM syndrome improvement, HBV-DNA negative conversion rate, and complete response rate; however, they are associated with a higher incidence of adverse reactions. Therefore, the benefits and risks should be carefully weighed when selecting the dosage form in clinical practice.