Ml. Shiffman et al., PROPHYLAXIS AGAINST GALLSTONE FORMATION WITH URSODEOXYCHOLIC ACID IN PATIENTS PARTICIPATING IN A VERY-LOW-CALORIE DIET PROGRAM, Annals of internal medicine, 122(12), 1995, pp. 899-905
Objective: To determine whether prophylactic treatment with ursodeoxyc
holic acid can prevent gallstone formation in persons participating in
a very-low-calorie weight reduction diet program. Design: Multicenter
, double-blind, placebo-controlled, multidose clinical trial. Patients
were treated with placebo or with 300 mg/d, 600 mg/d, or 1200 mg/d of
ursodeoxycholic acid. Setting: 31 Health Management Resources weight
management centers. Patients: 1004 patients were initially enrolled in
a 16-week, 520-kcal/d, Health Management Resources liquid protein die
t program. All patients had a body mass index of 38 kg/m(2) or more an
d a normal gallbladder ultrasonogram before study entry. Bile analysis
was done in 32 patients. Measurements: Body weight and body mass inde
x were measured before the diet was started and at 2-week intervals fo
r 16 weeks. Gallbladder ultrasonography was done before enrollment and
after 8 and 16 weeks of dieting. Bile was obtained by endoscopy and a
nalyzed for cholesterol crystals and lipid levels. Results: Mean body
weight for all patients at the start of dieting was 128.2 kg +/- 23.2
kg; mean initial body mass index was 44.2 kg/m(2) +/- 6.0 kg/m(2). Gal
lstones developed in 28% (95% CI, 22% to 35%) of patients receiving pl
acebo, in 8% (CI, 5% to 13%) of patients treated with 300 mg/d of urso
deoxycholic acid, in 3% (CI, 1% to 7%) of patients treated with 600 mg
/d of ursodeoxycholic acid, and in 2% (CI, 0.5% to 5%) of patients tre
ated with 1200 mg/d of ursodeoxycholic acid. The differences between p
atients receiving placebo and patients receiving ursodeoxycholic acid
were statistically significant. The percentage of ursodeoxycholic acid
in bile increased stepwise with increasing doses of ursodeoxycholic a
cid. Conclusions: Ursodeoxycholic acid, 600 mg/d, is highly effective
in preventing gallstone formation in patients having dietary-induced w
eight reduction.