| Methods |
Randomised double‐blind paired trial.
Generation of allocation
sequence: unspecified. Allocation concealment: described as adequate.
Blinding: provider and patients.
Loss of follow‐up: none.
Jadad score=3. |
| Participants |
Ethnic: Chinese.
80 patients(54 males and 26 females; age: 17‐50
yrs).
Setting:inpatients.
Inclusion criteria: chronic
hepatitis with HBsAg positive, diagnosis confirmed by liver biopsy; and no
immune regulatory drugs were used for one year prior to the trial.
Exclusion during trial: unstated. |
| Interventions |
Experimental:
Polyporus umbellatus polysaccharide (extract of herb)
injection, 40 mg, i.m., daily, over 20 days, rest for 10 days, repeating for
three months.
Control:
Placebo (1/80 compound Salviae
miltiorrhizae), with the same appearance, usage, dosage and treatment
duration as the intervention drug. |
| Outcomes |
Symptoms and signs. Viral responses: HBsAg, HBeAg. ALT.
Histology
of liver.
Adverse effects.
Follow‐up: three months. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
