Huang 2011.
| Methods | Randomised clinical trial, China Parallel‐group design |
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| Participants |
Included participants: 60 randomised participants diagnosed with chronic hepatitis B according to "The guideline of prevention and treatment for chronic hepatitis B" (CSH‐CMA and SID‐CMA 2006); disease history of chronic hepatitis B or hepatitis B virus infection, 2 × ULN ≤ alanine aminotransferase (ALT) ≤ 10 × ULN, total bilirubin (TBil) ≤ 2 × ULN, positive HBsAg and HBeAg in serum, HBV‐DNA in serum ≥ 1 × 10⁵ copies/mL, 18 to 65 years old, and signing the informed consent form. One participant in the control group was excluded from data analysis because the participant quit the trial; study authors did not report why and when the participant quit the trial Male:Female = 47:12 Mean age: experimental group 25 years, control group 23 years Exclusion criteria: participants infected by hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, other hepatitis viruses, or other viral infections; participants with probable liver decompensation |
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| Interventions | Experimental intervention: acupoint injection: Astragalus was injected into both sides of the Zu San Li (ST36) acupoints, 2 mL for each acupoint per time, once every other day, for 6 months (n = 30) Control intervention: no intervention (n = 29) Co‐intervention: recombinant human interferon (IFN)‐alpha 2a 6 million units subcutaneously, 3 times a week, for 6 months |
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| Outcomes | Liver function bio markers, HbsAg, HbeAg, HbeAb, HbcAb, HBV‐DNA, and TC level in serum, response rate (a compound outcome measure defined by trialists) | |
| Notes |
Study dates: 2009.08 to 2009.11 We called the telephone number of the authors' hospital on 28 April 2018, but we could not contact the people. We could not obtain their email addresses or any other contact details |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random numbers table |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Except for equally implemented co‐interventions, the experimental group used acupuncture injection, and the control group used nothing, which can easily unseal the blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There was a small proportion of participants (1.7%) with missing data. One participant in the control group was excluded from data analysis |
| Selective reporting (reporting bias) | High risk | We could not find any protocols for this study, and this study did not report any outcomes that were defined as primary outcomes in our protocol |
| Other bias | Low risk | This study appeared to be free of other factors that could put it at risk of bias |