Li 2008.
| Methods | Randomised clinical trial, China Parallel‐group design |
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| Participants | 146 participants with diagnosis of chronic hepatitis B according to Chinese guidelines 2000 (CMA 2000) Male:Female = 107:39 Mean age: 30.2 years Exclusion criteria: not stated |
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| Interventions |
Experimental intervention: kushensu, 600 mg, intravenous or intramuscular injection, once daily, 6 months (n = 70) Control intervention: no intervention (n = 76) Co‐intervention: adefovir capsules, 10 mg, once daily, 6 months |
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| Outcomes | Adverse events considered 'not to be serious'; HBV‐DNA; HBeAg; liver function test (ALT level) | |
| Notes |
Study dates: January 2005 to June 2006 Funding information: the study was funded by municipal health bureau projects. Notes: we contacted study authors on 15 August 2018 by email and received their reply |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Study authors allocated participants by grabbing balls |
| Allocation concealment (selection bias) | High risk | Study authors did not seal the allocation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Except for equally implemented co‐interventions, experimental group used Radix Sophorae flavescentis and control group received nothing, which can easily unseal the blinding |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Study authors said that researchers collected and assessed the data |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data; number of participants analysed was equal to number of participants randomised |
| Selective reporting (reporting bias) | High risk | We could not find the protocol for this study; study authors did not report any of the 3 primary outcomes |
| Other bias | Low risk | We did not identify any other potential sources of bias that would put the study at risk of bias |