Huang 2004.
| Methods | Randomised clinical trial, China Parallel group design (four‐arms) |
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| 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 |
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| 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. |
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| 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. |
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| 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 |