Zhang 2011.
| Methods | Randomised clinical trial, China Parallel group design (four arms) |
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| Participants | 100 children diagnosed with chronic hepatitis B according to guidelines 2000 (CMA 2001), with HBsAg, HBeAg, HBV‐DNA positive for ≥ 6 months, ALT or AST > 2 upper limit of normal Male:female: not reported Mean age: 11.59 years Exclusion criteria: used antiviral drugs such as matrine and lamivudine; coinfected with other type hepatitis virus |
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| Interventions |
Experimental intervention: matrine injections, 50–100 mg (aged 5–10 years), 100–150 mg (aged 11–14 years), intravenous infusion with 10% glucose solution, once daily, 6 months (n = 50) Control intervention: lamivudine, 3 mg/kg/day, 100 mg (maximum dose), once daily, oral administration, 6 months (n = 50) Cointervention: routine liver protective treatment (diammonium glycyrrhizinate capsules, 3 mg/kg/day, twice daily; inosine tablets, 100–400 mg, 3 times daily) Post‐treatment follow‐up: none In addition to the two groups mentioned above, there were two more groups with 100 children: ‐ Participants in the combination group received matrine injections plus lamivudine plus routine liver protective treatment. ‐ Participants in baseline treatment group received routine liver protective treatment only. The dose and treatment duration are same as in the mentioned two groups. Totally, there were 200 children enrolled in this trial. And the ratio of female to male was 88:112. |
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| Outcomes | HBV‐DNA; HBeAg; HBeAg seroconversion; liver (function) tests (ALT level) | |
| Notes |
Study dates: not stated Funding information: author did not report such information. Notes: we contacted the authors on 9 November 2018 by email but received no reply. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Author used random number table to allocate the participants. |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported, but the forms and administration routes of drugs were different which could easily unseal the blinding. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data; number of participants analysed was equal to number randomised. |
| Selective reporting (reporting bias) | High risk | We could not find the protocol of the study, and author did not report any data on the 3 primary outcomes. |
| Other bias | Low risk | No other potential sources of bias |
AFP: alpha fetoprotein; ALT: alanine aminotransferase; AST: aspartate aminotransferase; CT: computer tomography; HA: hyaluronic acid; HBV‐DNA: hepatitis B virus DNA; HBeAg: hepatitis B virus e‐antigen; HBsAg: hepatitis B virus surface antigen; IVC: type IV collagen; LN: laminin; n: number of participants; PCIII: type III procollagen; TBIL: total bilirubin; TGF‐β: serum transforming growth factor beta.