Yan 2017.
| Methods | Randomised, double‐blind, placebo‐controlled trial with 2 parallel groups, China | |
| Participants | 100 participants aged 18–65 years diagnosed with chronic hepatitis B according to guidelines 2010 (CMA 2011), conforming to the TCM standard of "zheng" differentiation for chronic hepatitis B Male:female: 49:33 (excluding 18 dropouts) Mean age: 38.45 years (excluding 18 dropouts) Exclusion criteria: used related medicine for treating chronic hepatitis B within half a month; coinfected with other type hepatitis virus; had autoimmune hepatitis or hepatitis caused by drug intoxication and alcohol; severe hepatitis, hepatic failure, cirrhosis, hepatocellular carcinoma; serious primary disease in cardiovascular, cerebrovascular, kidney, lung, endocrine system, haematopoietic system or mental disease; pregnant or lactating women; allergic physique or allergic to multiple drugs |
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| Interventions |
Experimental intervention: matrine capsules, 200 mg, 3 times daily; plus mimetic Longchai formula used for placebo control, twice daily, half dose a time, infused with water, 3 months (n = 50) Control intervention: mimetic matrine capsules, 200 mg, 3 times daily; plus Longchai formula (consisting of 6 medicinal herbs: Solanum nigrum L, Bupleurum chinense DC., Hedyotis diffusa Willd, Sedum sarmentosum Bunge, Gardenia jasminoides Ellis and Scutellaria baicalensis Georgi), twice daily, half dose a time, infused with water; 3 months (n = 50) Cointervention: none Post‐treatment follow‐up: none |
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| Outcomes | Clinical symptom; HBV‐DNA; HBeAg; HBsAg; liver (function) tests (ALT, AST); damage assessment (composite outcome involving clinical symptom, liver (function) tests, etc); efficacy assessment (composite outcome involving liver (function) tests, HBV‐DNA, HBeAg, HBsAg) | |
| Notes |
Study dates: December 2010 to December 2012 Funding information: supported by governmental funds: Scientific and Technological Innovation and Achievements Transformation Special Projects of Jiangsu Province (BM2009903). Notes: we contacted the authors on 2 August and 13 August 2018 by telephone but received no reply. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used software SAS 9.1 to generate random sequence |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind placebo‐controlled design |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 18 dropouts and withdrawals, containing 10 cases in experimental group and 8 cases in control group. The overall dropouts rate was 18%. |
| Selective reporting (reporting bias) | Low risk | We obtained the trial registration information (www.chictr.org.cn/showprojen.aspx?proj=9976). Author reported all outcomes predefined in protocol. |
| Other bias | Low risk | No other potential sources of bias |