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. 2001 Apr 23;2001(2):CD002231. doi: 10.1002/14651858.CD002231

Leelarasamee 1990.

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