Phyllanthus niruri versus Placebo for Chronic Hepatitis B Virus Infection: A Randomized Controlled Trial.

2018
Complementary medicine research 25(6)
- Chiara Baiguera
- Arianna Boschetti
- Elena Raffetti
- Barbara Zanini
- Massimo Puoti
- Francesco Donato

PubMed: 30372693
DOI: 10.1159/000484927

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 50 eligible subjects with chronic hepatitis B virus infection
Methods: placebo-controlled, parallel-group double-blind trial
Blinding: Double-blind
Duration: 12 months
Funding: Unclear

Background

This study aimed to investigate the efficacy and safety of a 12-month treatment with Phyllanthus niruri in subjects with chronic hepatitis B virus (HBV) infection.

Patients and methods

A placebo-controlled, parallel-group double-blind trial was performed. Clinical assessments took place at baseline and at 1, 3, 9, and 12 months after the treatment start and 6 months after treatment end.

Results

In the first 2 years, 50 eligible subjects with chronic HBV accepted to participate. Of those, 47 completed all the study-related visits (6% drop-out rate): 24 of the 26 (92%) allocated to the Phyllanthus group and 23 of the 24 (96%) allocated to the placebo group completed the study. No statistically significant differences in viral load were found between the intervention and placebo groups after 12 months and no subjects showed HBsAg clearance. With regards to safety, there were no changes in renal function parameters in both groups after 12 months and no serious adverse events occurred due to the treatment. The study was stopped at the end of the second year because there was no apparent benefit of the treatment.

Conclusion

This study does not support the use of Phyllanthus niruri for the treatment of chronic hepatitis B.

Research Insights

Chanca Piedra→Achieved HBsAg Clearance
no subjects showed HBsAg clearance
Effect
Neutral
Effect size
Small
Chanca Piedra→Reduced Viral Load
No statistically significant differences in viral load were found between the intervention and placebo groups after 12 months
Effect
Neutral
Effect size
Small

Adverse Events Reported

Chanca Piedra→renal function
no changes in renal function parameters in both groups after 12 months
Finding
No significant difference
Chanca Piedra→Overall tolerability
no serious adverse events occurred due to the treatment
Finding
Reported
Severity
Serious adverse event