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 |
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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 |
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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 |
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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 |
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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 |