Santangelo 1988.
| Study characteristics | ||
| Methods | Randomised clinical trial | |
| Participants | Country: USA Period of recruitment: 1985–1987 Number randomised: 101 Postrandomisation dropouts: 6 (5.9%) Revised sample size: 95 Reasons for postrandomisation dropouts: did not want to continue sclerotherapy or lost to follow‐up Mean age (years): 42 Females: 25 (26.3%) Small varices: 0 (0.0%) High risk of bleeding: not stated Other features of decompensation: 22 (23.0%) Alcohol‐related cirrhosis: 85 (89.5%) Viral‐related cirrhosis: 3 (3.2%) Autoimmune disease‐related cirrhosis: 4 (4.2%) Other causes of cirrhosis: 3 (3.2%) Other exclusion criteria: ≤ grade 2 or lower varices, or no varices |
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| Interventions | Group 1: sclerotherapy (n = 49) Further details: sclerotherapy: 1% sodium tetradecyl 10–20 mL per treatment session, repeated every 10–14 days until varices decrease markedly in size or were obliterated Group 2: no active intervention (n = 46) Further details: no treatment |
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| Outcomes | Mortality at maximal follow‐up, length of hospital stay (days) (all admissions until maximal follow‐up) Follow‐up (months): 13 |
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| Notes | Source of funding: not stated Trial name/trial registry number: not stated Attempted to contact the authors in February 2020; received no additional information |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: information not available |
| Allocation concealment (selection bias) | Unclear risk | Comment: information not available |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: information not available |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: information not available |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: there were postrandomisation dropouts, which were probably related to the intervention and outcome. |
| Selective reporting (reporting bias) | Unclear risk | Comment: no prepublished protocol available |
| Other bias | Low risk | Comment: no other bias noted |