Liang 2006.
| Methods | Randomised clinical trial, China Parallel group design |
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| Participants | 68 participants diagnosed as chronic hepatitis B according to Chinese guidelines 2000 (CMA 2001), with HBeAg positive and HBsAg positive for > 6 months, HBV‐DNA positive twice in succession, serum ALT level > 2 times upper normal limit but < 10 times upper normal limit Male:female: 56:12 Mean age: 34.5 years Exclusion criteria: hepatitis A, C, D, or E virus infection, or HIV coinfection; decompensated cirrhosis; obvious heart, brain, or kidney diseases history; psychological diseases and diabetes history; excessive drinking and drug abuse history; pregnant or lactating women; used antiviral drug and other immunomodulators during past 1 year. |
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| Interventions |
Experimental intervention: kushensu capsules, 200 mg, 3 times daily, 3 months (n = 34) Control intervention: tiopronin tablets, 200 mg, 3 times daily, 3 months (n = 34) Cointervention: glucuronolactone, 400 mg, once daily; plus vitamin B and vitamin C Post‐treatment follow‐up: 6 months |
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| Outcomes | Adverse events considered 'not to be serious;' HBV‐DNA; liver (function) tests (ALT level); HBeAg seroconversion | |
| Notes |
Study dates: not reported Funding information: author did not report this information. Notes: we contacted the authors on 26 September 2018 by telephone and received no reply. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used computer software to generate random sequence. |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported, but experimental drug was in capsule form while the control drug was in tablet form, 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 | Number of participants included in the analysis was equal to the number of participants randomised; no missing data. |
| Selective reporting (reporting bias) | High risk | We could not find protocol of this study. Author did not report any data on the 3 primary outcomes. |
| Other bias | Low risk | No other potential sources of bias |