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):
Proportion of men:
Aetiology of cirrhosis (banding; no intervention):
Child‐Pugh score (A/B/C):
Presence of ascites: not reported |
|
| Interventions |
Intervention comparison: Band ligation (n = 52) (Table 5)
No intervention (n = 50)
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
|
|
| 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
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 |