Lo 1999.
| Methods | Single‐centre, open randomised clinical trial | |
| Participants |
Included participants: cirrhosis and oesophageal varices at high risk of bleeding but no previous history of upper gastrointestinal bleeding (n = 133) (Table 4) Age (mean ± standard deviation):
Proportion of men:
Aetiology of cirrhosis (banding; no intervention):
Child‐Pugh score (A/B/C):
Presence of ascites:
|
|
| Interventions |
Intervention comparison (see notes) Band ligation: (n = 64) (Table 5)
No intervention: (n = 63)
Cointerventions: sucralfate given routinely to participants in the band ligation group |
|
| Outcomes |
Outcomes included in the meta‐analyses
|
|
| Inclusion period | January 1992 to March 1995 | |
| Country | Taiwan | |
| Duration of follow‐up | Median ‐ banding: 2 years and 4 months; no intervention ‐ 2 years and 6 months | |
| Notes |
Publication status: full‐paper
For‐profit funding: not described |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Allocation sequence based on computer generated random numbers |
| 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 | Six of the original 133 participants were lost to follow‐up: banding (n = 2); no intervention (n = 4); they were not included in the analyses |
| Selective reporting (reporting bias) | Low risk | Clinically relevant outcomes were defined and reported. We did not have access to the trial protocol. |
| Other bias | Unclear risk | Sucralfate given routinely to participants in the band ligation group |
| Overall bias assessment (mortality) | High risk | High risk of bias |
| Overall bias assessment (non‐mortality outcomes) | High risk | High risk of bias |