Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones. (ClinicalTrials.gov number, NCT00000611.).
BackgroundHigher intake of calcium and vitamin D has been associated with a reduced risk of colorectal cancer in epidemiologic studies and polyp recurrence in polyp-prevention trials. However, randomized-trial evidence that calcium with vitamin D supplementation is beneficial in the primary prevention of colorectal cancer is lacking. MethodsWe conducted a randomized, double-blind, placebo-controlled trial involving 36,282 postmenopausal women from 40 Women's Health Initiative centers: 18,176 women received 500 mg of elemental calcium as calcium carbonate with 200 IU of vitamin D 3 twice daily (1000 mg of elemental calcium and 400 IU of vitamin D 3 ) and 18,106 received a matching placebo for an average of 7.0 years. The incidence of pathologically confirmed colorectal cancer was the designated secondary outcome. Baseline levels of serum 25-hydroxyvitamin D were assessed in a nested case-control study. ResultsThe incidence of invasive colorectal cancer did not differ significantly between women assigned to calcium plus vitamin D supplementation and those assigned to placebo (168 and 154 cases; hazard ratio, 1.08; 95 percent confidence interval, 0.86 to 1.34; P = 0.51), and the tumor characteristics were similar in the two groups. The frequency of colorectal-cancer screening and abdominal symptoms was similar in the two groups. There were no significant treatment interactions with baseline characteristics. ConclusionsDaily supplementation of calcium with vitamin D for seven years had no effect on the incidence of colorectal cancer among postmenopausal women. The long latency associated with the development of colorectal cancer, along with the seven-year duration of the trial, may have contributed to this null finding. Ongoing follow-up will assess the longer-term effect of this intervention. (ClinicalTrials.gov number, NCT00000611.) Calcium plus Vitamin D and Colorectal-Cancer Risk n engl j med 354;7 www.nejm.org february 16, 2006 * Plus-minus values are means ±SD. SEER denotes Surveillance, Epidemiology, and End Results.† Hazard ratios, 95 percent confidence intervals (CIs), and P values were derived from Cox proportional-hazards analyses stratified according to age, randomized assignment in the Hormone Therapy and Dietary Modification trials, and presence or absence of corresponding prevalent condition. ‡ This category includes the cecum, the ascending colon, the hepatic flexure, and the transverse colon. § This category includes the splenic flexure, the descending colon, and the sigmoid colon. ¶ This category includes cancers of both the rectum and the rectosigmoid junction. ‖ Data were available only for centrally adjudicated cases. ** Information on intestinal polyps and kidney stones is from self-reported data and was not centrally confirmed.
OBJECTIVES:To examine the benefits and harms of behavioral and pharmacologic weight-management interventions for overweight and obese children and adolescents. METHODS:Our data sources were Ovid Medline, PsycINFO, the Education Resources Information Center, the Database of Abstracts of Reviews of Effects, the Cochrane databases, reference lists of other reviews and trials, and expert recommendations. After 2 investigators reviewed 2786 abstracts and 369 articles against inclusion/exclusion criteria, we included 15 fair-to good-quality trials in which the effects of treatment on weight, weight-related comorbidities, and harms were evaluated. Studies were quality rated by 2 investigators using established criteria. Investigators abstracted data into standard evidence tables. RESULTS:In the available research, obese (or overweight) children and adolescents aged 4 to 18 years were enrolled, and no studies targeted those younger than 4 years. Comprehensive behavioral interventions of medium-to-high intensity were the most effective behavioral approach with 1.9 to 3.3 kg/m 2 difference favoring intervention groups at 12 months. More limited evidence suggests that these improvements can be maintained over the 12 months after the end of treatments and that there are few harms with behavioral interventions. Two medications combined with behavioral interventions resulted in small (0.85 kg/m 2 for orlistat) or moderate (2.6 kg/m 2 for sibutramine) BMI reduction in obese adolescents on active medication; however, no studies followed weight changes after medication use ended. Potential adverse effects were greater than for behavioral interventions alone and varied in severity. Only 1 medication (orlistat) has been approved by the US Food and Drug Administration for prescription use in those aged Ն12 years. CONCLUSIONS:Over the past several years, research into weight management in obese children and adolescents has improved in quality and quantity. Despite important gaps, available research supports at least short-term benefits of comprehensive medium-to high-intensity behavioral interventions in obese children and adolescents. Pediatrics 2010;125:e396-e418 In 2005, the US Preventive Services Task Force (USPSTF) found insufficient evidence to recommend for or against routine primary care screening for overweight in children and adolescents as a means of preventing adverse health outcomes (an "I" recommendation). 1,2 The USPSTF concluded that, although there was fair evidence that overweight adolescents and children aged Ն8 years are at increased risk for becoming obese adults, the efficacy of behavioral counseling or other primary care-relevant interventions for treating overweight children and adolescents was uncertain.Given the findings in a recently published systematic review on weightmanagement programs for children and adolescents, 3 the USPSTF decided to update its recommendation, focusing on the critical evidence gap concerning treatment efficacy at the time of the last review. Thus, for this targeted systematic revi...
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