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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.

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Successive weight losses were compared for 21 patients restarting a very-low-calorie diet (VLCD) after weight regain. Patients broke VLCD2 sooner (3.8 vs 9.8 wk) and lost less (9.4 vs 19.1 kg), but weight-loss rates did not differ significantly (0.83 vs 0.71 kg/wk). Net loss post-VLCD2 was 12.0 kg. Restart patients had difficulty adhering to the repeat VLCD, which resulted in lower losses. However, similar weight-loss rates and significant net weight loss suggest repeat VLCDs can be effective.

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The safety and efficacy of a newly developed intravenous formulation of the nonionic contrast agent gadolinium diethylenetriaminepentaacetic acid-bis(methylamide), formulated as gadodiamide injection, was investigated. In 30 patients who underwent spin-echo magnetic resonance (MR) imaging before and after contrast agent enhancement, the enhanced images had characteristics judged similar to those of images enhanced by means of available gadolinium compounds. In 15 patients, contrast agent administration was of major diagnostic help, either revealing lesions not apparent without enhancement or providing important lesion characterization. In 12 patients, the lack of abnormal enhancement patterns was important in excluding the presence of disease. In three patients, the contrast agent did not provide information additional to that obtained with the unenhanced T1- and T2-weighted images. No clinically significant changes were observed in vital signs, neurologic status, or laboratory results. The authors conclude that, in this limited series, gadodiamide injection proved to be a safe and useful MR imaging contrast agent for evaluation of the central nervous system and surrounding structures.

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Radial bone mineral content and bone mineral density were measured in 1515 women referred for osteoporosis screening. A detailed questionnaire allowed the selection of 1069 normal white women for further analysis who had no historical evidence of bone disease or predisposing factors for bone disease. The nondominant radius was measured at two locations: the midradial bone density (MRBD) composed of predominantly cortical bone and the distal radial bone density at the 5 mm site (DRBD) composed of a mixture of cortical and trabecular bone. Women considered at risk were defined as those whose bone density values fell below fracture risk levels (0.550 g/cm2 for the MRBD and 0.325 g/cm2 for the DRBD). Between the ages of 20 and 70 years, the DRBD showed significantly greater sensitivity in defining subjects at risk (N = 223) than than MRBD (N = 80); P less than 0.001. Analysis of all ages showed that 684 women were above the fracture risk value (FRV) at both sites (64.0%), 260 were below the FRV at the DRBD 5 mm site (24.3%), 14 were below the FRV at the MRBD site (1.3%), and 111 were below the FRV at both sites (10.4%). Postmenopausal women age 50 to 70 years receiving estrogen replacement therapy (N = 221) had significantly higher values at both sites (P less than 0.001) than age-matched postmenopausal women not receiving replacement therapy (N = 239). Hereditary factors significantly correlated with both sites but neither site showed that calcium intake, activity level, or cigarette smoking were significant variables.(ABSTRACT TRUNCATED AT 250 WORDS)

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Thirty-five participants in a smoking cessation program met weekly for seven weeks in small groups and then were assigned to one of four follow-up procedures for an additional eight weeks. Information on smoking levels was obtained at the beginning of the program, at the end of the seven-week treatment period, at the end of the two-moth follow-up period, and during an additional five-month extended follow-up period. As hypothesized from social learning theory, individuals who held internally-oriented health locus of control beliefs and who valued health highly were most successful in achieving and maintaining changes in their smoking behavior. Thes results are discussed in terms of their implications for the problem of maintenance of behavior changes achieved by smoking cessation programs.

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