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. 2020 Jan 16;2020(1):CD013123. doi: 10.1002/14651858.CD013123.pub2

Chang 1997.

Methods Randomised clinical trial
Participants Country: Taiwan, China
 Period of recruitment: not stated
 Number randomised: 26
 Post‐randomisation dropouts: not stated
 Revised sample size: 26
 Average age (years): 59
 Females: 0 (0.0%)
 Ascites grade 2: 0 (0.0%)
 Ascites grade 3: 26 (100.0%)
 Refractory or recurrent ascites: not stated
 Alcohol‐related cirrhosis: 0 (0.0%)
 Viral‐related cirrhosis: 26 (100.0%)
 Autoimmune disease‐related cirrhosis: 0 (0.0%)
 Other causes for cirrhosis: 0 (0.0%)
Prophylactic antibiotics for subacute bacterial peritonitis: not stated
Exclusion criteria
 1. Cardiac or respiratory disorders
 2. Other features of decompensated cirrhosis
Interventions Group 1: Aldosterone antagonists plus loop diuretics (n = 13)
 Further details: Spironolactone 100 to 400 mg/day and furosemide 80 to 240 mg/day oral for 4 to 9 days
 Group 2: Paracentesis plus fluid replacement (n = 13)
 Further details: Large volume paracentesis + albumin 6 to 8 g/litre of ascites removed
Outcomes None of the outcomes of interest were reported.
Notes Source of funding (quote): "This work was supported by a grant from the National Science Council of the Republic of China (NSC842331‐B075‐005)".
 Trial name/trial registry number: not stated
 Attempts were made to contact the authors in November 2018.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were then randomly allocated to two groups (random number table)".
Allocation concealment (selection bias) Unclear risk Comment: this information was not available.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: this information was not available.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: this information was not available.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: two patients were excluded from the analysis it was not clear whether this was pre‐randomisation or post‐randomisation.
Selective reporting (reporting bias) Unclear risk Comment: pre‐published protocol was not available.
Other bias Low risk Comment: no other bias noted