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. 2019 Jun 20;2019(6):CD012673. doi: 10.1002/14651858.CD012673.pub2

Svoboda 1999.

Methods Single‐centre, open randomised clinical trial
Participants Included participants: cirrhosis and 'advanced' oesophageal varices with no history of upper gastrointestinal bleeding (n = 102) (Table 4)
Age (mean ± standard deviation):
  • banding 48.0 ± 12.0 years

  • no intervention 47.0 ± 11.0 years


Proportion of men:
  • banding 73.1%

  • no intervention 80.0%


Aetiology of cirrhosis (banding; no intervention):
  • alcohol 67.3%; 68.0%

  • chronic viral hepatitis 32.7%; 32.0%


Child‐Pugh score (A/B/C):
  • banding 32/14/6

  • no intervention 28/16/6


Presence of ascites: not reported
Interventions Intervention comparison:
Band ligation (n = 52) (Table 5)
  • participants who developed recurrent varices (31%) underwent further banding

  • participants who bled during follow‐up underwent endoscopic sclerotherapy and somatostatin


No intervention (n = 50)
  • participants who bled during follow‐up underwent endoscopic sclerotherapy and somatostatin


Cointervention: the angiotensin‐converting enzyme (ACE) inhibitor enalapril (later quinapril) (2 × 5 mg/d to 10 mg/d)
 was administered orally to participants in both groups to reduce portal pressure
Outcomes Outomces included in meta‐analyses
  • Mortality

  • Upper gastrointestinal bleeding

  • Variceal bleeding

  • Serious adverse events

Inclusion period September 1994 to September 1997
Country Czech Republic
Duration of follow‐up Mean ± SD (months): banding 25 ± 11; no intervention 26 ± 10
Notes Publication status: full paper
  • This trial also included a second intervention arm in which participants underwent endoscopic sclerotherapy (n = 55)

  • Participants in the two groups were well‐matched on basic clinical characteristics


For‐profit funding: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open randomised clinical trial without blinding
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open randomised clinical trial without blinding
Incomplete outcome data (attrition bias) 
 All outcomes High risk A total of 186 participants were randomised: 29 were lost to follow‐up; the remaining 157 were all evaluated, including 55 randomised to sclerotherapy (not included in our analyses); 52 randomised to band ligation and 50 randomised to no intervention. The number of participants lost from each group is not specified and so adjustments could not be made.
Selective reporting (reporting bias) Low risk Clinically relevant outcomes are defined and reported; we did not have access to the trial protocol.
Other bias Low risk No other biases identified
Overall bias assessment (mortality) High risk High risk of bias
Overall bias assessment (non‐mortality outcomes) High risk High risk of bias