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. 2019 Jun 24;2019(6):CD013106. doi: 10.1002/14651858.CD013106.pub2

Wang 2013.

Methods Randomised clinical trial, China
Participants 131 participants diagnosed with chronic hepatitis B according to Chinese guidelines 2005 (CMA 2005), with HBsAg positive for > 6 months, HBeAg positive, serum HBV‐DNA > 105 copies/ mL, elevated ALT level in serum at least once during the past 6 months (1.5–8 upper limit)
Male:female: not reported
Mean age: 32.8 years
Exclusion criteria: B‐mode ultrasound or imaging test found suspicious lesion; continuously elevated serum AFP or AFP > 100 μg/L, clinical manifestation of decompensated liver diseases, and blood creatinine > 130 μmol/L; transient hepatic decompensation induced by severe and acute liver diseases; serum amylase > 2 times the normal upper limit; hepatitis C or D virus infection, HIV coinfection, autoimmune hepatitis, or other active liver diseases; other severe or active diseases which may have interfered with the participants' adherence and evaluation; excessive drinking or drug abuse history; used immunosuppressants, immunomodulators, cytotoxic drugs, or antiviral drug in past 6 months; used transaminase drugs during the past month; used other research drugs; allergic to nucleoside drugs or nucleoside analogues
Interventions Experimental intervention: kushensu capsules, 200 mg, 3 times daily, 12 months (n = 62)
Control intervention: adefovir capsules, 10 mg, once daily, 12 months (n = 69)
Cointervention: basic treatment
Post‐treatment follow‐up: none
Outcomes HBV‐DNA; liver (function) tests (ALT, AST, TBIL); HBeAg seroconversion
Notes Study dates: May 2009 to March 2011
Funding information: author did not report this information.
Notes: we contacted the author on 29 June 2018 by telephone, but author said he could not remember the details as it was long time ago and provided us with an email address. We sent email again on 3 August but have not received a reply.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table used.
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 3 participants in experimental group and 5 in control group dropped out due to loss of follow‐up, violation of protocol, or safety problems. The overall the dropout rate was 6.1%. Author used both intention‐to‐treat and per‐protocol analysis methods 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 primary outcomes.
Other bias Unclear risk This paper only had 1 author, and author did not mention any acknowledgements. If the trial was conducted by a single person, there would be potential risks of bias in every step.