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Gastrointestinal tolerance of a new infant milk formula in healthy infants: multicenter study conducted in Taiwan.
Chen, N, Alarcon, PA, Comer, GM, Tressler, RL
Asia Pacific journal of clinical nutrition. 2002;(2):151-6
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Abstract
The objective of this study was to test whether the gastrointestinal tolerance of a new infant formula equalled or exceeded the tolerance of other milk-based infant formulas, and to compare the tolerance of the new formula to that of human milk. This prospective, observational, multicenter, open-label study was conducted in Taiwan. Healthy, full-term infants aged 28-98 days were enrolled on their current feeding regimen (no treatment assigned). Feeding regimens included human milk (HM), a new infant formula (NF, Similac Advance), other marketed infant formulas (OF, mainly Enfalac or S-26, HM + NF and HM + OF. Data for stool frequency, stool consistency and gastrointestinal intolerance symptoms were recorded in study diaries by parents for a period of two weeks. Gastrointestinal tolerance was evaluated in 967 infants, of whom 481 (49.7%) received NF, 312 (32.2%) received OF, 101 (10.4%) received HM + NF, 41 (4.2%) received HM + OF and 32 (3.3%) received HM. Infants fed HM only had softer and more frequent stools than those who received NF only or OF only (P < 0.001). Infants fed NF only had softer stools than those fed OF only (P < 0.001), including those fed either Enfalac or S-26 (P < 0.001). There were no significant differences between feeding groups for the incidence of general intolerance, spit-up or flatulence. All feeding regimens were well tolerated. We thereby concluded that NF is well tolerated in healthy infants and results in stool consistencies that more closely resemble those of infants fed human milk than those of infants fed other formulas.
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High dietary fiber consumption is not associated with gastrointestinal discomfort in a diet intervention trial.
McEligot, AJ, Gilpin, EA, Rock, CL, Newman, V, Hollenbach, KA, Thomson, CA, Pierce, JP
Journal of the American Dietetic Association. 2002;(4):549-51
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Iodixanol in paediatric gastrointestinal imaging: safety and efficacy comparison with iohexol.
Wright, NB, Carty, HM, Sprigg, A, Kampenes, VB, Friis, M, Petersen, KK, Stake, G, Klaveness, AJ
The British journal of radiology. 2002;(890):127-35
Abstract
Iodixanol (Visipaque) is a dimeric, non-ionic iodinated contrast medium that is isotonic with blood at all clinically relevant concentrations. Iodixanol was compared in a randomized, double blind, parallel group, phase III multicentre trial with a monomeric, non-ionic contrast medium, iohexol (Omnipaque), at two concentrations assessing safety, tolerability and radiographic efficacy during contrast enhanced gastrointestinal radiography examinations of children. 154 children entered the trial; 152 formed the safety population and 147 the efficacy population. All examinations were performed following standard departmental practice. Children were assigned into either a high or low concentration group (iodixanol, 150 mgI ml(-1) and 320 mgI ml(-1) vs iohexol, 140 mgI ml(-1) and 300 mgI ml(-1)). The primary outcome measure for efficacy was the overall quality of visualization, which was assessed using a 100 mm visual analogue scale (VAS). The secondary efficacy variables assessed were quality of contrast opacification, mucosal coating and overall quality of diagnostic information. Safety evaluation involved patient follow-up for at least 48 h. Taste acceptance was also assessed. There was no statistically significant difference between the two contrast media with regard to the primary and secondary efficacy variables assessed, although higher ratings were observed for iodixanol. The 100 mm VAS score overall was 86 mm for iodixanol and 82 mm for iohexol (95% confidence interval -2.56, 10.42). The frequency of adverse events was lower for patients receiving iodixanol. Adverse events, mainly diarrhoea, occurred in 12 patients (16.2%) in the iodixanol group and 28 patients (35.9%) in the iohexol group. This reached statistical significance (p=0.006). Overall, iodixanol is well suited for examinations of the gastrointestinal tract, giving good efficacy results and fewer adverse events than iohexol.
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One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor.
Finer, N, James, WP, Kopelman, PG, Lean, ME, Williams, G
International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity. 2000;(3):306-13
Abstract
OBJECTIVE To assess the efficacy and tolerability of orlistat (Xenical) in producing and maintaining weight loss over a 12-month period. DESIGN Patients were randomized to double-blind treatment with either orlistat 120 mg or placebo three times daily, in conjunction with a low-energy diet, for 12 months. SETTING Five centres in the UK. SUBJECTS 228 obese adult patients with body mass index between 30 and 43 kg/m2 and mean weight 97 kg (range 74-144 kg). INTERVENTIONS All patients were prescribed a low-energy diet, providing 30% of energy from fat, designed to produce an individually tailored energy deficit of approximately 600 kcal/day, for a run-in period of 4 weeks and then 12 months, plus orlistat 120 mg or placebo three times daily. MAIN OUTCOME MEASURES Change in body weight (the primary efficacy parameter), waist circumference and adverse events were reviewed regularly, together with serum lipids, insulin, glucose and plasma levels of fat-soluble vitamins and beta carotene. RESULTS Based on an intent-to-treat analysis, after 1 y of treatment patients receiving orlistat had lost an average of 8.5% of their initial body weight compared with 5.4% for placebo-treated patients; 35% of the orlistat group lost at least 5% of body weight compared with 21% of the placebo group (P < 0.05), and 28% and 17%, respectively (P = 0.04) lost at least 10% of body weight. Orlistat-treated patients showed significant decreases (P < 0.05) in serum levels of total cholesterol, low density lipoprotein cholesterol, and in the low density lipoprotein: high density lipoprotein ratio in comparison with placebo. Both groups had similar adverse-event profiles, except for gastrointestinal events, which were 26% more frequent in the orlistat group but were mostly mild and transient. To maintain normal plasma levels of fat-soluble vitamins, supplements of vitamins A, D and E were given to 1.8%, 8.0% and 3.6%, respectively, of orlistat-treated patients, compared with 0.9% of placebo-treated patients for each vitamin type. After 1 y, the decrease in vitamin E and beta carotene was significantly greater in orlistat-treated patients compared with those receiving placebo (P < 0.001). No significant change was found in the mean vitamin E:total cholesterol ratio in either group after 52 weeks. CONCLUSIONS Orlistat, in conjunction with a low-energy diet, produced greater and more frequent significant weight loss than placebo during 1 y of treatment. One-third of orlistat-treated patients achieved clinically relevant weight loss (> or = 5% initial body weight). There was also an improvement in relevant serum lipid parameters. Fat-soluble vitamin supplements may be required during chronic therapy. Orlistat was well tolerated and offers a promising new approach to the long-term management of obesity.
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Upper gastrointestinal tract safety profile of alendronate: the fracture intervention trial.
Bauer, DC, Black, D, Ensrud, K, Thompson, D, Hochberg, M, Nevitt, M, Musliner, T, Freedholm, D
Archives of internal medicine. 2000;(4):517-25
Abstract
OBJECTIVES To determine whether alendronate sodium treatment is associated with upper gastrointestinal (GI) tract adverse experiences (AEs)-particularly those of the stomach, duodenum, or esophagus-in the Fracture Intervention Trial, and to assess the relationship between alendronate use and upper GI tract events among women at increased risk for these outcomes. DESIGN Randomized, double-blind, placebo-controlled trial with a mean follow-up of 3.8 years. Women were initially randomized to receive alendronate sodium, 5 mg/d, or placebo. After 2 years, the alendronate sodium dose was increased to 10 mg/d. PARTICIPANTS A total of 6459 women aged 54 to 81 years recruited from 11 US clinical centers. All participants had low hip bone mineral density. Women with major upper GI tract disease (recent ulcers, upper GI tract bleeding, or use of daily medication for dyspepsia) were excluded. Regular nonsteroidal anti-inflammatory drug users were not excluded. MEASUREMENTS Self-reported upper GI tract AEs were ascertained by interview every 3 months. Serious upper GI tract AEs were confirmed and classified by review of hospital records and endoscopy reports, if available. Upper GI tract AEs were further analyzed in 2 specified groups-gastroduodenal and esophageal-to examine events that might be related to upper GI tract mucosal irritation. Gastric and duodenal perforations, ulcers, and bleeding events were combined for analysis of these clinically important outcomes. RESULTS The overall incidence of upper GI tract events was similar in the alendronate and placebo groups (47.5% vs. 46.2%; relative risk [RR], 1.02; 95% confidence interval [CI], 0.95-1.10). The incidence of gastroduodenal perforations, ulcers, and bleeding events was 1.6% in the alendronate group and 1.9% in the placebo group (RR, 0.86; 95% CI, 0.59-1.24). The incidence of nonspecific upper GI tract conditions, such as abdominal pain, dyspepsia, nausea, and vomiting, was also similar in the 2 groups. Esophageal events occurred in 10.0% and 9.4% of patients in the alendronate and placebo groups, respectively (RR, 1.06; 95% CI, 0.91-1.24). Esophagitis not reported as reflux was more common in the alendronate group (0.7%) than in the placebo group (0.4%), but not significantly so (RR, 1.71; 95% CI, 0.90-3.39). Alendronate use was not associated with a significant increase in upper GI tract events among women at increased risk for these events (those aged > or =75 years with previous upper GI tract disease or using nonsteroidal anti-inflammatory drugs). CONCLUSION In these older women, upper GI tract complaints, particularly dyspepsia and abdominal pain, were common, but alendronate treatment was not associated with an increased incidence of upper GI tract events, even in high-risk subgroups.