Huang 2005.
| Methods | Randomised clinical trial, China Parallel group design (three arms) |
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| Participants | 118 participants diagnosed with chronic hepatitis B according to Chinese guidelines 2000 (CMA 2001), with HBeAg positive and HBV‐DNA positive Male:female: not reported Mean age: 36.8 years (experimental group), 35.7 years (control group) Exclusion criteria: concomitant other viral infections such as hepatitis A, C, D, E, or F virus infection; used antiviral drug or other immunomodulators in past 6 months |
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| Interventions |
Experimental intervention: kushensu, 600 mg, with glucose solution, intravenous infusion, once daily, 3 months (n = 58) Control intervention: thymosin injection, 80 mg, with 10% glucose solution 250 mL, intravenous infusion, once daily, 3 months (n = 56) Cointervention: liver protective drugs (e.g. diammonium glycyrrhizinate and vitamin C), 3 months Post‐treatment follow‐up: 6 months In addition to the two groups mentioned above, there is another group of 64 participants (mean age 35.3 years) receiving kushensu plus thymosin injection plus liver protective drugs. The dose and treatment duration were the same as in the above two groups. |
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| Outcomes | HBV‐DNA; HBeAg; clinical effective rate; liver (function) tests (ALT level); serum TGF‐β | |
| Notes |
Study dates: October 2001 to January 2004 Funding information: study received no funding. Notes: we contacted the authors on 28 June 2018 by telephone and received author's reply on missing information. |
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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 | Unclear risk | Not reported |
| 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 6 dropouts in intervention group and 5 dropouts in control group. Although author reported all dropouts were owing to economic reasons, we assessed it as high risk considering the overall dropouts rate was 9%. |
| Selective reporting (reporting bias) | High risk | We could not find protocol, and author did not report any data on the primary outcomes. |
| Other bias | Low risk | No other potential sources of bias |