| Methods |
Randomised trial.
Generation of allocation sequence and allocation
concealment: no details. Blinding: unblinded.
Loss to follow‐up:
unstated.
Jadad score=1. |
| Participants |
Ethnic: Chinese.
120 patients (60 in treatment group, 48 males and
12 females, age range 13˜60 yrs; 60 in control group, 50 males and 10
females, age range 14˜59 yrs).
Setting: inpatients.
Inclusion criteria: chronic hepatitis B with mediate and severe disease, and
positive serum HBeAg and HBV DNA, diagnosed according to the criteria set by
the National Conference on Viral Hepatitis in China (CMA 1995).
Exclusion criteria: unstated. |
| Interventions |
Experimental:
HB‐Granule‐3 (compound of 11 herbs, major of genus
Phyllanthus), 10 g orally, t.i.d, for 90 days.
Control:
gamma‐IFN 5 MU, subcutaneous injection, thrice weekly, for 90 days. |
| Outcomes |
Symptoms and signs.
Liver function, and hepatofibrotic indices.
Viral responses: HBsAg, HBeAg, HBV DNA.
Maximum follow‐up: three
months. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
