| Methods |
Randomised clinical trial.
Generation of allocation sequence: no information. Allocation concealment: no information.
Blinding: not blinded.
Estimation of sample size: no information.
Loss during follow‐up: unstated.
Jadad score=1. |
| Participants |
Ethnic: Chinese;
80 patients (50 in the treatment group, 27 males and 23 females, average age 15 yrs, from 7‐32 yrs; 30 in control group, 16 males and 14 females, average age 15 yrs, from 8‐31 yrs).
Setting: outpatients and inpatients.
Inclusion criteria: carriers of HBsAg for more than six months, with normal liver function, and no clinical symptoms and signs of liver disease.
Exclusion criteria: unstated. |
| Interventions |
Experimental:
Jianpi Wenshen recipe (self‐prescription of 11 herbs), one dose decoction orally, two times daily, for three months.
Control:
interferon‐alpha, one mega unit (MU) i.m., two times daily (for children, one time daily), for three months. |
| Outcomes |
HBsAg, HBeAg, anti‐HBe and anti‐HBc IgM.
Follow‐up: at three, six and 12 months after the end of treatment.
The outcomes were assessed at three, six and 12 months of follow‐up. |
| Notes |
The distribution of patients in the two arms of the trial showed a ratio of 1.7:1 and the trial report did not explain how this happened. We have sent a letter, requesting an explanation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
