Tags

Type your tag names separated by a space and hit enter

Prophylaxis against gallstone formation with ursodeoxycholic acid in patients participating in a very-low-calorie diet program.
Ann Intern Med. 1995 Jun 15; 122(12):899-905.AIM

Abstract

OBJECTIVE

To determine whether prophylactic treatment with ursodeoxycholic 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 diet program. All patients had a body mass index of 38 kg/m2 or more and a normal gallbladder ultrasonogram before study entry. Bile analysis was done in 32 patients.

MEASUREMENTS

Body weight and body mass index were measured before the diet was started and at 2-week intervals for 16 weeks. Gallbladder ultrasonography was done before enrollment and after 8 and 16 weeks of dieting. Bile was obtained by endoscopy and analyzed 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/m2 +/- 6.0 kg/m2. Gallstones developed in 28% (95% CI, 22% to 35%) of patients receiving placebo, in 8% (CI, 5% to 13%) of patients treated with 300 mg/d of ursodeoxycholic 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 treated with 1200 mg/d of ursodeoxycholic acid. The differences between patients receiving placebo and patients receiving ursodeoxycholic acid were statistically significant. The percentage of ursodeoxycholic acid in bile increased stepwise with increasing doses of ursodeoxycholic acid.

CONCLUSIONS

Ursodeoxycholic acid, 600 mg/d, is highly effective in preventing gallstone formation in patients having dietary-induced weight reduction.

Authors+Show Affiliations

Hepatology Section, Medical College of Virginia, Richmond 23298-0711, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

7755224

Citation

Shiffman, M L., et al. "Prophylaxis Against Gallstone Formation With Ursodeoxycholic Acid in Patients Participating in a Very-low-calorie Diet Program." Annals of Internal Medicine, vol. 122, no. 12, 1995, pp. 899-905.
Shiffman ML, Kaplan GD, Brinkman-Kaplan V, et al. Prophylaxis against gallstone formation with ursodeoxycholic acid in patients participating in a very-low-calorie diet program. Ann Intern Med. 1995;122(12):899-905.
Shiffman, M. L., Kaplan, G. D., Brinkman-Kaplan, V., & Vickers, F. F. (1995). Prophylaxis against gallstone formation with ursodeoxycholic acid in patients participating in a very-low-calorie diet program. Annals of Internal Medicine, 122(12), 899-905.
Shiffman ML, et al. Prophylaxis Against Gallstone Formation With Ursodeoxycholic Acid in Patients Participating in a Very-low-calorie Diet Program. Ann Intern Med. 1995 Jun 15;122(12):899-905. PubMed PMID: 7755224.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prophylaxis against gallstone formation with ursodeoxycholic acid in patients participating in a very-low-calorie diet program. AU - Shiffman,M L, AU - Kaplan,G D, AU - Brinkman-Kaplan,V, AU - Vickers,F F, PY - 1995/6/15/pubmed PY - 1995/6/15/medline PY - 1995/6/15/entrez SP - 899 EP - 905 JF - Annals of internal medicine JO - Ann Intern Med VL - 122 IS - 12 N2 - OBJECTIVE: To determine whether prophylactic treatment with ursodeoxycholic 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 diet program. All patients had a body mass index of 38 kg/m2 or more and a normal gallbladder ultrasonogram before study entry. Bile analysis was done in 32 patients. MEASUREMENTS: Body weight and body mass index were measured before the diet was started and at 2-week intervals for 16 weeks. Gallbladder ultrasonography was done before enrollment and after 8 and 16 weeks of dieting. Bile was obtained by endoscopy and analyzed 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/m2 +/- 6.0 kg/m2. Gallstones developed in 28% (95% CI, 22% to 35%) of patients receiving placebo, in 8% (CI, 5% to 13%) of patients treated with 300 mg/d of ursodeoxycholic 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 treated with 1200 mg/d of ursodeoxycholic acid. The differences between patients receiving placebo and patients receiving ursodeoxycholic acid were statistically significant. The percentage of ursodeoxycholic acid in bile increased stepwise with increasing doses of ursodeoxycholic acid. CONCLUSIONS: Ursodeoxycholic acid, 600 mg/d, is highly effective in preventing gallstone formation in patients having dietary-induced weight reduction. SN - 0003-4819 UR - https://www.unboundmedicine.com/medline/citation/7755224/Prophylaxis_against_gallstone_formation_with_ursodeoxycholic_acid_in_patients_participating_in_a_very_low_calorie_diet_program_ L2 - https://www.acpjournals.org/doi/10.7326/0003-4819-122-12-199506150-00002?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -