ABSTRACT
The most striking feature of the history of treatment of patients with cirrhosis and
ascites is the recurring cycle of initial enthusiasm for a new modality based on uncontrolled
observations, followed by reports of complications and failures and/or negative randomized
control trials (RCTs). The RCTs tend to be performed rather late, after it is realized
that there are problems with the new treatment. In 1975 Tom Chalmers made a plea for
randomization of the first patient treated with a new modality. The appropriateness
of performing RCTs very early in the evaluation of a new treatment cannot be overemphasized
today. Carefully designed RCTs that focus on appropriate subsets of patients and evaluate
clinically important endpoints (rather than easier-to-measure, but unimportant indirect
endpoints) are the keys to “evidence-based medicine” that will lead to the best outcomes
for our patients. If we do not remember that uncontrolled studies regularly lead us
into years or even decades of “blind alleys” of investigation, we are destined to
repeat the mistakes of the past.
KEY WORDS
ascites - historical treatment - randomized controlled trials
