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. 2019 Nov 7;2019(11):CD013090. doi: 10.1002/14651858.CD013090.pub2

Summary of findings for the main comparison. Xiao Chai Hu Tang formula compared with no intervention for chronic hepatitis B.

Xiao Chai Hu Tang formula compared with no intervention for chronic hepatitis B
Patient or population: chronic hepatitis B
 Setting: outpatient or hospital 
 Intervention: Xiao Chai Hu Tang formula
 Comparison: no intervention
Outcomes Anticipated absolute effects* (95% CI) Relative effect
 (95% CI) № of participants
 (studies) Certainty of the evidence
 (GRADE) Comments
Risk with no intervention Risk with Xiao Chai Hu Tang formula
All‐cause mortality No data
Proportion of participants with ≥ 1 serious adverse events No data
Health‐related quality of life No data
Hepatitis B‐related mortality No data
Hepatitis B‐related morbidity No data
Proportion of participants with ≥ 1 adverse events considered 'not to be serious'
(at maximum follow‐up: 3–4 months; median 3.5 months)
Study population RR 0.43
 (0.02 to 11.98) 240
 (2 RCTs) ⊕⊝⊝⊝
 Very lowa,b,c,d The review authors did not search Japanese and Korean medical databases.
58 per 1000 25 per 1000
 (1 to 699)
Proportion of participants with detectable HBV‐DNA in serum or plasma
(at maximum follow‐up: 4–12 months; median 8 months)
Study population RR 0.62
(0.45 to 0.85)
222
(3 RCTs)
⊕⊝⊝⊝
 Very lowa,e,f,g The review authors did not search Japanese and Korean medical databases.
471 per 1000 292 per 1000
(212 to 400)
Proportion of participants with detectable HBeAg in serum or plasma
(at maximum follow‐up: 8–12 months; median 10 months)
Study population RR 0.72 (0.50 to 1.02) 160
(2 RCTs)
⊕⊝⊝⊝
 Very lowa,e,h,i The review authors did not search Japanese and Korean medical databases.
688 per 1000 495 per 1000
(344 to 701)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised clinical trial; RR: risk ratio.
GRADE Working Group grades of evidenceHigh certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
 Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
 Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
 Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aDowngraded one level. Concerns with allocation concealment, blinding, and selective outcome reporting.
 bDowngraded one level. Opposite direction of effect: P value of heterogeneity < 0.1, and I2 > 50%.
 cDowngraded two levels. Number of events fewer than 300 and the CI included both no effect and potential for important harm.
 dDowngraded one level. All included studies were small. Trials conducted in another country than China may not have been identified.
 eDowngraded one level. Use of surrogate outcomes instead of clinically relevant outcomes. hepatitis B virus DNA and hepatitis B virus e‐antigen were related to chronic hepatitis B‐related mortality and morbidity (Su 2016; Osawa 2017; Kouamé 2018; Hung 2019).
 fDowngraded one level. Even though the CI did not cross the threshold of 1, the optimal information size criteria were not met and the sample size was not very large (fewer than 2000 participants). The number of events was small.
 gDowngraded one level. The two included studies were small and showed positive effect. Trials conducted in countries other than China may not have been identified.
 hDowngraded one level. The optimal information size criteria were not met and the sample size was not very large (fewer than 2000 participants). The number of events was small.
 iDowngraded one level. The two included studies were small. The fixed‐effect analysis showed positive effect. Trials conducted in countries other than China may not have been identified.