Xi 2010.
| Methods | Randomised clinical trial, China Parallel group design (three arms) |
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| Participants | 95 children (aged 5–14 years) diagnosed with chronic hepatitis B according to Chinese guidelines 2000 (CMA 2001), with HBV‐DNA, HBeAg, and HBsAg positive for ≥ 6 months, ALT > 2 times normal upper limit Male:female: 68:27 Mean age: 10.69 years (experimental group); 10.51 years (control group) Exclusion criteria: other diseases that may have affected liver function; used oxymatrine injections and liver protective drugs during past 6 months, and had adverse events when taking these drugs. |
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| Interventions |
Experimental intervention: matrine, 50–100 mg (for children aged 5–10 years), 100–150 mg (for children aged 11–14 years), intravenous infusion with 10% glucose solution, once daily, 2 months; then matrine capsules, 3 times daily, 4 months (n = 47) Control intervention: Chinese formula: Chai Hu (Bupleuri Radix, Bupleurum falcatum Linne, 250 g), Yin Chen (Artemisiae Capillaris Flos, Artemisia capillaris Thunberg, 250 g), Ban Lan Gen (Indigowoad root, Isatis tinctoria L, 250 g), Wu Wei Zi (Schisandrae Fructus, Schisandra chinensis Baillon, 300 g), Zhu Dan Fen (biliary power of pig, 20 g), Lv Dou (green beans, 128 g), 1–2 tablets (for children aged 1–8 years), 2–3 tablets (for children aged 9–14 years), oral administration, 6 months (n = 48) Cointervention: none Post‐treatment follow‐up: none In addition to the two groups mentioned above, there is another group of 47 participants (mean age 10.23 years, 15 females) receiving matrine plus Chinese formula. The dose and treatment duration were same as in the other two groups. |
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| Outcomes | Adverse events considered 'not to be serious;' HBV‐DNA; HBeAg; liver (function) tests (ALT, AST level) | |
| Notes |
Study dates: February 2007 to May 2009 Funding information: author did not report this 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 | Used random number table to generate random sequence. |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported, but the experimental drug was in injection form while the control drug was in tablets, 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; the 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 of the primary outcomes. |
| Other bias | Low risk | No other potential sources of bias |