Randomization to surgery or observation in patients with symptomatic gallbladder stone disease. The problem of evidence-based medicine in clinical practice.

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Abstract
Background: The description and understanding of gallbladder stone disease in the medical literature are difficult because an assessment of the natural course of this symptomatic disease, with separation of patients in strictly defined groups, is generally lacking. Method: A multicenter study was carried out with patients randomized to either surgery or conservative, expectant treatment to examine optimal treatment and natural history in well-defined groups of symptomatic gallbladder stone disease with pain episodes only (study group 1) or acute cholecystitis (study group 2). The patients were between 18 and 80 years of age and had right upper quadrant or midline epigastric pain and ultrasonographic evidence of gallbladder stone, with or without acute cholecystitis. Medical treatment was ordinated on the basis of signs and symptom severity. Patients randomized to surgery were placed on the hospital's waiting list and electively operated on with cholecystectomy as soon as conveniently possible. Preliminary results of follow-up are based on questionnaires mailed at regular intervals and consultations if required by the patients' symptoms. Quality of life and freedom from pain are study end points for evaluation. Results: Five hundred and one patients were considered for the study, 318 patients (63.5 %) belonging to group 1 and 183 (36.5%) to group 2. One hundred and eighty-four patients (36.7%) were randomized, 120 (24%) in group 1 and 64 (12.7%) in group 2. Three hundred and seventeen patients (63.3%), with an equal proportion from each study group, were excluded, the largest number of patients because of incapacitating pain or serious presenting symptoms (26%). More women (81%) than men (19%) had pain alone (group 1), but the sex ratio was reduced, 56% women and 44% men, in patients with acute cholecystitis (group 2), with a highly significant difference (P = Conclusions: A randomized trial of this nature is feasible but extremely difficult to perform because of the heterogeneous nature of gallbladder stone disease, leading to exclusion of many patients and difficulties in measuring and evaluating outcome variables.