Mao 2014.
| Methods | Randomised clinical trial, China Parallel‐group design |
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| Participants | 70 participants with diagnosis of chronic hepatitis B according to Chinese guidelines 2000 (CMA 2000) Male:Female = 40:30 Mean age: 44 years Exclusion criteria: concomitant with other hepatic viral infection |
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| Interventions |
Experimental intervention: kushensu injection, 600 mg, intravenous infusion with 250 mL 5% glucose solution, once daily, 1 month (n = 36) Control intervention: no intervention (n = 34) Co‐intervention: tanshinone IIA, 60 mg, intravenous infusion with 250 mL 5% glucose solution, once daily; antiviral and liver protective drugs (vitamin, liver protective tablets, oral administration; potassium aspartate and magnesium aspartate, vitamin K, intravenous infusion), 1 month |
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| Outcomes | Liver function tests (ALT, AST, TBIL); serum liver fibrosis indexes (HA, LN, PCIII, IVC) | |
| Notes |
Study dates: August 2012 to June 2013 Funding information: the study authors did not provide any information on study support or sponsorship. Notes: we contacted study authors on 9 November 2015 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 | Study authors used random numbers table to allocate participants |
| Allocation concealment (selection bias) | Unclear risk | Study authors did not report such information |
| 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 | Unclear risk | Study authors did not report such information |
| 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 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 |