Methods |
Randomised clinical trial.
Generation of allocation sequence: no information.
Allocation concealment: no information.
Blinding: the trial was described as blinded, but no detail was given on appearance, taste and smell of the placebo.
Estimation of sample size: yes.
Loss during follow‐up: Ten patients in treatment group and 15 in placebo group were lost at six months follow‐up.
Jadad‐score = 2. |
Participants |
Ethnic: Thailanders;
116 patients (59 in the treatment group; 57 in placebo group), no data on gender and age.
Setting: outpatients.
Inclusion criteria: blood donors being HBsAg positive for six to 12 months and with normal biochemical and haematological tests, and with informed consent.
Exclusion criteria: unstated. |
Interventions |
Experimental:
Phyllanthus amarus, two capsules (400mg), orally, three times daily, for 30 days.
Control:
Placebo (glucose), orally, three times daily, for 30 days. |
Outcomes |
HBsAg, HBeAg; Symptoms;
Biochemical and haematological tests. Adverse effects.
Maximum follow‐up: six months.
The outcomes were assessed at one, two, and six months after the end of treatment. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |