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 |