Objective: To test the hypothesis that calcium supplementation can prevent weight gain in persons who are overweight or obese.

Design: Randomized, placebo-controlled trial. Randomization was computer-generated, and allocation was assigned by pharmacy personnel who prepared intervention and placebo capsules. Participants, providers, and those who assessed outcomes were blinded to study group assignment.

Setting: Single research center.

Participants: 340 overweight (body mass index [BMI], 25 to <30 kg/m²) and obese (BMI ≥30 kg/m²) adults (mean age, 38.8 years [SD, 10.5]).

Intervention: Calcium carbonate (elemental calcium, 1500 mg/d) (n = 170) or placebo (n = 170) with meals for 2 years.

Measurements: Changes in body weight and fat mass (primary outcomes).

Results: Seventy-five percent of participants completed the trial (78% received calcium; 73% received placebo). There were no statistically or clinically significant differences between the calcium and placebo groups in change in body weight (difference, 0.02 kg [95% CI, –1.64 to 1.69 kg]; P = 0.98), BMI (difference, 0.32 kg/m² [CI, –0.41 to 1.02 kg/m²]; P = 0.39), or body fat mass (difference, 0.39 kg [CI, –1.04 to 1.92 kg]; P = 0.55). Parathyroid hormone concentrations decreased in the calcium group compared with the placebo group (difference, –0.71 pmol/L [CI, –1.28 to –0.13 pmol/L]).

Limitation: The study took place at a research center, and its sample was mostly women.

Conclusion: Dietary supplementation with elemental calcium, 1500 mg/d, for 2 years had no statistically or clinically significant effects on weight in overweight and obese adults. Calcium supplementation is unlikely to have clinically significant efficacy as a preventive measure against weight gain in such patients.

Primary Funding Source: Office of Dietary Supplements and Intramural Research Program of the National Institutes of Health.

Objective: To evaluate the effectiveness and tolerability of red yeast rice and therapeutic lifestyle change to treat dyslipidemia in patients who cannot tolerate statin therapy.

Design: Randomized, controlled trial.

Setting: Community-based cardiology practice.

Patients: 62 patients with dyslipidemia and history of discontinuation of statin therapy due to myalgias.

Intervention: Patients were assigned by random allocation software to receive red yeast rice, 1800 mg (31 patients), or placebo (31 patients) twice daily for 24 weeks. All patients were concomitantly enrolled in a 12-week therapeutic lifestyle change program.

Measurements: Primary outcome was LDL cholesterol level, measured at baseline, week 12, and week 24. Secondary outcomes included total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride, liver enzyme, and creatinine phosphokinase (CPK) levels; weight; and Brief Pain Inventory score.

Results: In the red yeast rice group, LDL cholesterol decreased by 1.11 mmol/L (43 mg/dL) from baseline at week 12 and by 0.90 mmol/L (35 mg/dL) at week 24. In the placebo group, LDL cholesterol decreased by 0.28 mmol/L (11 mg/dL) at week 12 and by 0.39 mmol/L (15 mg/dL) at week 24. Low-density lipoprotein cholesterol level was significantly lower in the red yeast rice group than in the placebo group at both weeks 12 (P < 0.001) and 24 (P = 0.011). Significant treatment effects were also observed for total cholesterol level at weeks 12 (P < 0.001) and 24 (P = 0.016). Levels of HDL cholesterol, triglyceride, liver enzyme, or CPK; weight loss; and pain severity scores did not significantly differ between groups at either week 12 or week 24.

Limitation: The study was small, was single-site, was of short duration, and focused on laboratory measures.

Conclusion: Red yeast rice and therapeutic lifestyle change decrease LDL cholesterol level without increasing CPK or pain levels and may be a treatment option for dyslipidemic patients who cannot tolerate statin therapy.

Primary Funding Source: Commonwealth of Pennsylvania.

Objective: To determine the efficacy and safety of stent placement in patients with ARAS and impaired renal function.

Design: Randomized clinical trial. Randomization was centralized and computer generated, and allocation was assigned by e-mail. Patients, providers, and persons who assessed outcomes were not blinded to treatment assignment.

Setting: 10 European medical centers.

Participants: 140 patients with creatinine clearance less than 80 mL/min per 1.73 m² and ARAS of 50% or greater.

Intervention: Stent placement and medical treatment (64 patients) or medical treatment only (76 patients). Medical treatment consisted of antihypertensive treatment, a statin, and aspirin.

Measurements: The primary end point was a 20% or greater decrease in creatinine clearance. Secondary end points included safety and cardiovascular morbidity and mortality.

Results: Forty-six of 64 patients assigned to stent placement had the procedure. Ten of the 64 patients (16%) in the stent placement group and 16 patients (22%) in the medication group reached the primary end point (hazard ratio, 0.73 [95% CI, 0.33 to 1.61]). Serious complications occurred in the stent group, including 2 procedure-related deaths (3%), 1 late death secondary to an infected hematoma, and 1 patient who required dialysis secondary to cholesterol embolism. The groups did not differ for other secondary end points.

Limitation: Many patients were falsely identified as having renal artery stenosis greater than 50% by noninvasive imaging and did not ultimately require stenting.

Conclusion: Stent placement with medical treatment had no clear effect on progression of impaired renal function but led to a small number of significant procedure-related complications. The study findings favor a conservative approach to patients with ARAS, focused on cardiovascular risk factor management and avoiding stenting.

Primary Funding Source: Dutch Kidney Foundation, Bayer, Cordis, and Pfizer.

Objective: To determine risk for adverse events after outpatient colonoscopy in elderly patients.

Design: Population-based, matched cohort study.

Setting: Surveillance, Epidemiology, and End Results cancer registry areas.

Patients: Random 5% sample of Medicare beneficiaries, age 66 to 95 years, who underwent outpatient colonoscopy between 1 July 2001 and 31 October 2005 (n = 53 220), matched with beneficiaries who did not have colonoscopy.

Measurements: Medicare claims were used to measure the rate of serious gastrointestinal events (bleeding and perforation), other gastrointestinal events, and cardiovascular events resulting in a hospitalization or emergency department visit within 30 days after colonoscopy compared with matched beneficiaries who did not have colonoscopy. Logistic regression was used to estimate adjusted predictive risks for adverse events and to assess whether these events varied by age, comorbid conditions, or type of colonoscopy.

Results: Persons undergoing colonoscopy had a higher risk for adverse gastrointestinal events than their matched group. Rates of adverse events after colonoscopy increased with age. Patients having polypectomy had higher risk for all adverse events compared with their matched group and with the screening and diagnostic colonoscopy groups. Comorbid conditions increased the risk for adverse events. Patients with a history of stroke, chronic obstructive pulmonary disease, atrial fibrillation, or congestive heart failure had significantly higher risk for serious gastrointestinal events.

Limitation: The analysis relied on the diagnosis and procedure codes recorded on the Medicare claims.

Conclusion: Risks for adverse events after outpatient colonoscopy among elderly Medicare beneficiaries were low; however, they increased with age with specific comorbid conditions and depending on whether polypectomy was done. These data may inform decisions on whether to perform colonoscopy in persons of advanced age or those with comorbid conditions.

Primary Funding Source: None.

Methods: The USPSTF performed a brief literature update, including a search for new and substantial evidence on the benefits and harms of screening pregnant women for hepatitis B virus infection.

Finding: The net benefit of screening continues to be well established.

Recommendation: Screen for hepatitis B virus infection in pregnant women at their first prenatal visit. (Grade A recommendation.)

Purpose: To search for large, high-quality studies related to hepatitis B screening in pregnancy that have been published since the 2004 USPSTF recommendation.

Data Sources: English-language studies indexed in PubMed and the Cochrane Database of Systematic Reviews and published between 1 January 2001 and 5 March 2008.

Study Selection: For benefits of screening and newborn prophylaxis, we included systematic reviews; meta-analyses; and randomized, controlled trials. For harms of screening, we included systematic reviews; meta-analyses; randomized, controlled trials; cohort studies; case–control studies; and case series of large, multisite databases. Abstracts and full articles were independently reviewed for inclusion by both reviewers.

Data Extraction: Data on the benefits of screening, including benefits of hepatitis B immune globulin and hepatitis B vaccine prophylaxis of newborns of hepatitis B surface antigen–positive mothers, were extracted by 1 reviewer.

Data Synthesis: No new studies met inclusion criteria. A 2006 systematic review of randomized, controlled trials found that newborn prophylaxis reduced perinatal transmission of HBV infection; all relevant trials were published in 1996 or earlier.

Limitation: The focused search strategy, which was restricted to English-language articles, may have missed some smaller studies or new research published in languages other than English.

Conclusion: No new evidence was found on the benefits or harms of screening for HBV infection in pregnant women. Previously published randomized trials support the 2004 USPSTF recommendation for screening.