Comparison of six treatments of ascites in patients with liver cirrhosis. A clinical trial.

UNLABELLED: A national multicenter study (34 centers) compared six treatments in 328 patients with cirrhotic ascites. Excluded were patients with g.i. bleeding within the last six months, chronic encephalopathy, cancer, tuberculosis or the following complications persisting after three weeks: acute encephalopythy, fever greater than 38 degrees C, infected ascites or biochemical abnormalities: blood urea greater than 8 mmol/l, natremia less than 130 mmol/l, kaliemia less than 2.5 or greater than 5.5 mmol/l, WBC greater than 12000 mm3, total bilirubin greater than 85.5 mumol/l. In each center patients were randomized into two treatment groups, each center using 2 of 6 proposed treatments: (1) Spironolactone and 500 mg Na p.d (77 patients), (2) Spironolactone + furosemide or Moduretic (amiloride + hydrochlorothiazide) and 500 mg Na p.d (80 patients), (3) Spironolactone + Furosemide or Moduretic and unrestricted sodium diet (86 patients), (4) Concentrated ascites reinfusion and 500 mg Na p.d. (36 patients), (5) Unmodified ascites reinfusion and 500 mg Na p.d. (23 patients), (6) Slow ascites drainage and 500 mg Na p.d. (31 patients). Statistical analysis methods were X2, variance analysis and Spotvoll-Stoline and Dunn-Sidak tests. Before treatment, there was no significant difference between the 6 groups.
RESULTS: After one month of treatment, no difference was found in the frequency of total or partial regression of ascites, complications of cirrhosis, mortality, acceptability of treatment. Mechanical treatments induced more rapid weight loss but more frequent recurrence; comparison of groups 2 and 3 did not confirm any benefit associated with unrestricted Na diet. Duration of treatment and hospitalization were shorter in group 4 than in groups 3 and 6.

RCT Entities:   Population Interventions Outcomes