The efficacy of traditional Chinese medicine on immune function in patients with hepatitis B-related liver fibrosis or cirrhosis: a systematic review and meta-analysis.

OBJECTIVE

Currently, there is no effective treatment to reverse hepatitis B-related liver fibrosis or cirrhosis. Current nucleos(t)ide analogs (NAs) control but rarely eliminate hepatitis B virus (HBV), leaving chronic hepatitis B at risk of developing liver fibrosis/cirrhosis. Traditional Chinese medicine (TCM) shows promise in slowing the progression of hepatitis B-related liver fibrosis/cirrhosis, but its impact on immune function remains debated.

METHODS

The electronic databases, including Chinese National Knowledge Infrastructure, Wanfang, SinoMed, Weipu, PubMed, Web of Science, EMBASE, and Cochrane databases, were retrieved (April 7, 2026), and the randomized controlled trials (RCTs) that met the inclusion criteria were included. Methodologic quality assessment of the included RCTs was done based on the Cochrane RoB 2 tool. Subsequently, the valid data were screened and analyzed by meta-analysis with Review Manager 5.4.1, and the quality of the evidence was assessed using the GRADE method. This study was registered in the PROSPERO (CRD420261351373).

RESULTS

Finally, 25 RCTs were included, containing 2,585 patients with hepatitis B-related liver fibrosis or cirrhosis. Risk of bias evaluations suggested some concerns for the majority of RCTs. The results of meta-analysis indicated that TCM with NAs could improve CD3 + [MD = 5.83, 95%CI (3.93, 7.73), p < 0.00001], CD4 + [MD = 4.32, 95%CI (3.56, 5.08), p < 0.00001], CD4+/CD8 + [MD = 0.24, 95%CI (0.18, 0.29), p < 0.00001], and NK cells, and decrease CD8 + cells [MD = -2.67, 95%CI (-3.46, -1.89), p < 0.00001], interleukin (IL)-6, transforming growth factor (TGF-β), tumor necrosis factor-α (TNF-α), hyaluronic acid (HA), laminin (LN), type IV collagen (IV-C), type III procollagen (PC-III), liver stiffness measurement (LSM), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and albumin in serum compared with NAs alone. Moreover, descriptive data showed that TCM was safe, and the funnel plot suggested the included research might have slight publication bias. The GRADE classification showed that the certainty of evidence was low for the immune function, liver function, and liver fibrosis indexes.

CONCLUSION

A combination of NAs and TCM could improve immune cell metrics, cytokines, liver function indexes, and liver fibrosis indexes of patients with hepatitis B-related liver fibrosis or cirrhosis. Due to the low quality of research, more high-quality RCTs are needed to improve the level of evidence.

SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261351373.