Phyllanthus Niruri for Hepatitis B: Does It Work?

Key Findings

The study found no statistically significant differences in hepatitis B virus (HBV) viral load reduction between the Phyllanthus niruri group and placebo group after 12 months of treatment. Zero participants in either group achieved HBsAg clearance (a key marker of viral eradication). The trial was terminated early at 24 months due to futility, as interim analysis showed no apparent treatment benefit. Safety assessments revealed no renal function changes or treatment-related serious adverse events in either group.

Study Design

This was a placebo-controlled, parallel-group, double-blind randomized controlled trial (RCT). It enrolled 50 eligible adults with chronic HBV infection, with 47 completing all study visits (24 in P. niruri group, 23 in placebo group; 6% dropout rate). Clinical assessments occurred at baseline, 1, 3, 9, and 12 months during treatment, and 6 months post-treatment. The study duration was 18 months total (12 months treatment + 6 months follow-up), though terminated early at 24 months from initial enrollment due to lack of efficacy.

Dosage & Administration

The study summary does not specify the exact dosage, formulation (e.g., extract type, standardization), or administration frequency of Phyllanthus niruri used. It only states that participants received either the active intervention or placebo for 12 months.

Results & Efficacy

Primary efficacy analysis showed no statistically significant differences in HBV viral load reduction between groups at 12 months (specific p-values or confidence intervals not provided in the summary). Critically, 0% of participants in both the P. niruri group (0/24) and placebo group (0/23) achieved HBsAg clearance. Secondary outcomes, including safety parameters (renal function), showed no significant changes. The lack of observable benefit led to early trial termination.

Limitations

Key limitations include the small sample size (n=50 initially, n=47 completers), which limited statistical power to detect modest effects. The absence of detailed dosage information prevents replication or assessment of dose-response relationships. Early termination due to futility means long-term effects beyond 12 months couldn't be evaluated. The study did not report participant demographics (e.g., age, sex, baseline viral load, HBeAg status), limiting subgroup analysis. As a single trial, it cannot definitively rule out efficacy in specific HBV subpopulations.

Clinical Relevance

This high-quality RCT provides no evidence supporting the use of Phyllanthus niruri for treating chronic HBV infection. Supplement users with HBV should not rely on this herb as a substitute for established antiviral therapies (e.g., tenofovir, entecavir), which demonstrably suppress viral replication and reduce complications. While the herb showed a favorable short-term safety profile in this trial, its lack of efficacy against viral load or HBsAg clearance means it offers no clinical benefit for HBV management based on this evidence. Patients should consult healthcare providers for evidence-based HBV treatment.