Effect of High-Dose vs Standard-Dose Wintertime Vitamin D Supplementation on Viral Upper Respiratory Tract Infections in Young Healthy Children

Question  Does high-dose vitamin D supplementation (2000 IU/d) help to prevent wintertime viral upper respiratory tract infections compared with standard-dose vitamin D supplementation (400 IU/d) among preschool children?

Findings  In this multisite randomized clinical trial that included 703 children, the number of wintertime laboratory-confirmed viral upper respiratory tract infections was higher in the high-dose group than the standard-dose group, not a statistically significant difference.

Meaning  Vitamin D dosing higher than 400 IU/d may not be indicated for preventing wintertime viral upper respiratory tract infections in children.

Reference: JAMA. 2017;318(3):245-254.

The Effect of Nursing Quality Improvement and Mobile Health Interventions on Infant Sleep Practices

Question  Will 2 separate, complementary interventions (nursing quality improvement intervention and mobile health intervention) promote safe infant sleep practices?

Findings  In a 4-group cluster randomized clinical trial with 1263 families, mothers who received a mobile health intervention with regular text or email messages and videos reported statistically significantly higher rates of placing their infants supine to sleep compared with mothers who received control interventions (adjusted prevalence, 89.1% vs 80.2%, respectively), room sharing without bed sharing (82.8% vs 70.4%), no soft bedding use (79.4% vs 67.6%), and any pacifier use (68.5% vs 59.8%). A nursing quality improvement intervention did not influence infant safe sleep practices.

Meaning  A mobile health intervention improved adherence with infant safe sleep practices. Whether widespread use of this type of intervention is feasible and reduces sudden and unexpected infant death rates remains to be studied.

Reference: JAMA. 2017;318(4):351-359.

Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain. The Mint Randomized Clinical Trials

Question  What is the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain?

Findings  In 3 randomized clinical trials including 681 participants with chronic low back pain originating from the facet joints, sacroiliac joints, or a combination of these or the intervertebral disks, radiofrequency denervation combined with exercise compared with exercise alone resulted in either no significant difference in pain intensity, or a difference smaller than the prespecified minimal clinically important difference after 3 months.

Meaning  The study findings do not support the use of radiofrequency denervation for chronic low back pain originating from these sources.

Reference: JAMA. 2017;318(1):68-81.

Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes The SWITCH 2 Randomized Clinical Trial

Question  Is the rate of hypoglycemia lower with insulin degludec vs insulin glargine U100 in insulin-treated patients with type 2 diabetes?

Findings  In this randomized crossover clinical trial of 721 patients, insulin degludec resulted in a significantly lower rate of overall symptomatic hypoglycemic episodes over a 16-week maintenance period compared with insulin glargine U100 (186 vs 265 episodes per 100 patient-years of exposure, respectively).

Meaning  Patients with type 2 diabetes treated with insulin degludec compared with insulin glargine U100 had a reduced risk of overall symptomatic hypoglycemia.

Reference: JAMA. 2017;318(1):45-56.

Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes The SWITCH 1 Randomized Clinical Trial

Question  Is the rate of hypoglycemia noninferior or lower with insulin degludec vs insulin glargine U100 in insulin-treated patients with type 1 diabetes?

Findings  In this randomized crossover trial of 501 patients, insulin degludec compared with insulin glargine U100 resulted in a significantly lower rate of overall symptomatic hypoglycemic episodes over a 16-week maintenance period (2201 vs 2463 episodes per 100 patient-years of exposure).

Meaning  Patients with type 1 diabetes treated with insulin degludec, compared with insulin glargine U100, had a reduced risk of overall symptomatic hypoglycemia.

Reference: JAMA. 2017;318(1):33-44.

Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women

Question  Does an internet-based weight loss program promote long-term weight loss in low-income postpartum women in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program)?

Findings  In this cluster randomized trial including 371 low-income postpartum women, an internet-based program plus the WIC program produced significantly greater weight loss over 12 months compared with the WIC program alone (3.2 kg vs 0.9 kg).

Meaning  Among low-income postpartum women, an internet-based weight loss program plus the WIC program compared with the WIC program alone resulted in significantly greater weight loss over 12 months. Future research is needed to determine cost-effectiveness.

Reference: JAMA. 2017;317(23):2381-2391.

Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence

Question  Is electroacupuncture involving the lumbosacral region effective in reducing urine leakage for women with stress urinary incontinence?

Findings  In this randomized clinical trial that included 504 women, the mean decrease in urine leakage, measured by the 1-hour pad test from baseline to week 6, was 9.9 g with electroacupuncture vs 2.6 g with sham electroacupuncture, a significant difference.

Meaning  Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks.

Reference: JAMA. 2017;317(24):2493-2501.