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

Huang 2004.

Methods Randomised clinical trial, China
Parallel group design (four‐arms)
Participants 73 participants diagnosed with chronic hepatitis B according to Chinese guidelines 2000 (CMA 2001), with HBeAg positive, HBV‐DNA positive, and ALT > 100 U.
Male:female: 58:15
Mean age: 35.7 years (experimental group), 41.2 years (control group)
Exclusion criteria: concomitant jaundice and other viral infections such as hepatitis virus A, C, D, E, or F infections
Interventions Experimental intervention: kushensu capsules, 200 mg, 3 times daily, oral administration, 6 months (n = 36)
Control intervention: interferon‐a 2b, 5 MU, intramuscular injection, every other day, 6 months (n = 37)
Cointervention: liver protective drugs (e.g. silymarin and vitamin C), oral administration, 6 months
Post‐treatment follow‐up: 6 months
In addition to the two groups mentioned above, there were two more groups:
‐ 37 participants (mean age 37.4 years, 5 females) receiving kushensu capsules plus interferon‐a 2b plus liver protective drugs.
‐ 36 participants (mean age 39.5 years, 6 females) receiving liver protective drugs.
The dose and treatment duration were same as with the mentioned two groups above, of interest to our review.
Outcomes HBV‐DNA; HBeAg; liver (function) tests (ALT level); TGF‐β, serum liver fibrosis biomarkers (HA, LN, IVC, PCIII); liver histology tests
Notes Study dates: June 2001 to May 2003
Funding information: study received no funding.
Notes: we contacted the authors on 28 June 2018 by telephone and received the reply on missing data.
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) High risk Author reported they did not conceal the allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Author did not report that they blinded participants and personnel, and the administration route was different between groups, which can easily unseal the blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessors were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes High risk There were dropouts, but author did not remember the number and did not include those people in the analysis.
Selective reporting (reporting bias) High risk We could not find protocol of this study, and author did not report any data on the primary outcomes.
Other bias Low risk No other potential sources of bias