Zhang 2007.
| Methods | Randomised clinical trial, China | |
| Participants | 63 participants aged 12–60 years diagnosed with chronic hepatitis B according to guidelines 2000 (CMA 2001), with ALT level > 1 upper limit of normal, TBIL < 5 times upper limit of normal, HBeAg positive, HBV‐DNA positive or HBV‐DNA quantitative level > 103 copies/mL Male:female: 48:12 Mean age: 34.5 years (experimental group), 30.5 years (control group) Exclusion criteria: used antiviral drugs or immunomodulators during the past 6 months; decompensated cirrhosis, HCV coinfection, or autoimmune hepatitis |
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| Interventions |
Experimental intervention: kushensu, 400 mg, once daily, intramuscular injection, 6 months (n = 31) Control intervention: lamivudine, 100 mg, once daily, oral administration, 6 months (n = 32) Cointervention: either diammonium glycyrrhizinate, 150 mg, 3 times daily; or diammonium glycyrrhizinate enteric‐coated capsule, 150 mg, 3 times daily, for participants with elevated ALT level (> 5 times the upper limit of the normal) Post‐treatment follow‐up: none |
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| Outcomes | HBV‐DNA; HBeAg; HBsAg; liver (function) tests (ALT, AST level) | |
| Notes |
Study dates: June 2005 to January 2006 Funding information: author did not report this information. Notes: we contacted the authors on 2 August and 13 August 2018 by telephone but received no reply. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random sequence generated through selecting balls |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Forms and administration routes of drugs were different in 2 groups, which can 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 | 1 participant in experimental group changed to receive control drug and 1 participant was lost of follow‐up, while there was no dropouts in control group. Author used intention‐to‐treat analysis to analyse the data. |
| Selective reporting (reporting bias) | High risk | We could not find the protocol of the study, and author did not report any data on the three primary outcomes. |
| Other bias | Low risk | No other potential sources of bias |