Rossle 1997.

Methods	Randomised trial. A. Generation of allocation sequence: adequate. Computer generated random numbers. B. Allocation concealment: adequate. Study groups read by person not involved in the clinical setting. Random setting could not be previewed. C. Blinding: unclear. No information. D. Follow‐up: adequate. Inclusion of all randomised participants at evaluation: yes. Time from bleeding episode to randomisation in hours (SD): TIPS 6.3 (5.5), ET 4.4 (5). Time from randomisation to treatment: 48 hrs. Total number of patients evaluated and found eligible: 190. Randomised to TIPS: 61, randomised to ET: 65. Adequate reasons provided for those not randomised: Not individually specified. Three patients lost to follow‐up in TIPS group and one in ET group. Nine patients were crossed over from ET to TIPS during follow‐up. Intention‐to‐treat analysis. Follow‐up period in months (mean, interquartile range). TIPS (14, 8‐23) ET (13, 8‐25). Assessment of suitability for shunt carried out prior to randomisation: Not mentioned. Shunt patency assessed with Duplex ultrasound at 1,3, 6 ,9, and 12 months and then every six months. Method of Child's grading: Child‐Pugh. Method of encephalopathy testing = clinical testing, trail making test, mental state examination. Rebleeding episodes endoscopically verified: yes. Specified whether rebleeding episode clinically significant: yes.
Participants	Inclusion criteria: liver cirrhosis, variceal bleeding within 2 weeks before randomisation, and age over 18 years. Exclusions (one or more of the following): hepatic encephalopathy grade 3 and 4, liver insufficiency (bilirubin more than 5mg/dl), cavernomatous portal‐vein thrombosis, advanced malignancy, contra‐indications to propranolol (obstructive lung disease, severe hypotension) and bleeding emergency Patients comparable in the two groups.
Interventions	ET: Sclerotherapy plus propranolol, technique of sclerotherapy not mentioned, sclerosant (number of patients): polidocanol (59), bucrylate or histoacryl and lipiodol mixture (5), fibrin glue (4), polidocanol plus bucrylate (8). Shunts: TIPS (Palmaz stent (n = 39), memotherm stent (n = 16), wallstent (n = 6).
Outcomes	Rebleeding. Complications. Encephalopathy. Hospital stay and mortality. Liver function and Child‐Pugh class.
Notes	Propranolol used in‐addition to sclerotherapy.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate