Skip to main content
. 2021 Apr 6;2021(4):CD013121. doi: 10.1002/14651858.CD013121.pub2

Wang 2006.

Study characteristics
Methods Randomised clinical trial
Participants Country: Taiwan
Period of recruitment: 2002–2004
Number randomised: 61
Postrandomisation dropouts: 0 (0.0%)
Revised sample size: 61
Mean age (years): 61
Females: 23 (37.7%)
Small varices: 39 (63.9%)
High risk of bleeding: 61 (100.0%)
Other features of decompensation: 1 (1.6%)
Alcohol‐related cirrhosis: 11 (18.0%)
Viral‐related cirrhosis: 47 (77.0%)
Autoimmune disease‐related cirrhosis: not stated
Other causes of cirrhosis: 3 (4.9%)
Other inclusion criteria: portal hypertension caused by cirrhosis; oesophageal varices of moderate or severe grade, associated with any red colour signs (red wale marking, cherry red spots, haematocystic spots); no history of haemorrhage from oesophageal varices; no current treatment with beta‐blockers or nitrates, diagnosis of cirrhosis was based on liver biopsy or clinical examination, biochemical tests, and imaging studies
Other exclusion criteria: aged > 75 years or < 20 years; presence of malignancy, uraemia, or other serious medical illness that could reduce life expectancy; refractory ascites, hepatic encephalopathy, or marked jaundice (serum bilirubin > 10 mg/dL); history of shunt operation, transjugular intrahepatic portosystemic stent shunt, or endoscopic therapy (sclerotherapy or endoscopic variceal ligation); contraindications to beta‐blockers or nitrates, e.g. asthma, chronic obstructive airway disease, diabetes mellitus with documented hypoglycaemic episodes, congestive heart failure, peripheral vascular disease, hypotension
(systolic blood pressure < 90 mmHg) and bradycardia
Interventions Group 1: beta‐blockers + nitrates (n = 31)
Further details: nadolol to reduce the pulse rate by 25% and isosorbide mononitrate 20 mg once or twice daily
Group 2: variceal band ligation (n = 30)
Further details: variceal band ligation using multiband ligator repeated at 4‐weekly intervals until obliteration
Outcomes Mortality at maximal follow‐up, serious adverse events (number of participants), any adverse events (number of participants), variceal bleed at maximal follow‐up (any) (number of participants)
Follow‐up (months): 23.3
Notes Source of funding (quote): "The study was supported by a grant from the Medical Research and Advancement Foundation in Memory of Dr Chi‐Shuen Tsou in Taiwan."
Trial name/trial registry number: not stated
Attempted to contact the authors in February 2020; received no additional information
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was by means of opaque, sealed envelopes numbered according to a table of random numbers."
Allocation concealment (selection bias) Low risk Quote: "Randomization was by means of opaque, sealed envelopes numbered according to a table of random numbers."
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 Low risk Comment: no postrandomisation dropouts
Selective reporting (reporting bias) Low risk Comment: prepublished protocol not available, but the authors reported mortality, adverse events, and variceal bleed adequately.
Other bias Low risk Comment: no other bias noted