Randomization to Surgery or Observation in Patients with Symptomatic Gallbladder Stone Disease: The Problem of Evidence-Based Medicine in Clinical Practice

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 ca...

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Bibliographic Details
Published in:Scandinavian journal of gastroenterology 1997, Vol.32 (6), p.611-616
Main Authors: Søndenaa, K., Nesvik, I., Solhaug, J. H., Søreide, O.
Format: Article
Language:English
Subjects:
Acute Disease
Biological and medical sciences
Cholecystectomy
Cholecystitis - epidemiology
Cholecystitis - surgery
Cholecystitis - therapy
Cholelithiasis - epidemiology
Cholelithiasis - surgery
Cholelithiasis - therapy
Evidence-Based Medicine
Feasibility Studies
Female
Gallbladder stone disease
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical sciences
Middle Aged
Norway - epidemiology
observation
Other diseases. Semiology
Outcome Assessment (Health Care)
Patient Satisfaction
Patient Selection
randomization
Research Design
surgery
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Summary: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 =
ISSN:0036-5521
1502-7708
DOI:10.3109/00365529709025108