Effect of Early High-Dose Vitamin D3 Repletion on Cognitive Outcomes in Critically Ill Adults.

BACKGROUND: Long-term cognitive impairment frequently occurs after critical illness; no treatments are known to improve long-term cognition. RESEARCH QUESTION: Does a single high-dose (540,000 International Units) enteral treatment of vitamin D3 given shortly after hospital admission in critically ill patients who are vitamin D deficient improve long-term global cognition or executive function? STUDY DESIGN AND METHODS: This study evaluated long-term cognitive outcomes among patients enrolled in a multicenter, blinded, randomized clinical trial comparing vitamin D3 treatment vs placebo in critically ill adults with vitamin D deficiency. Global cognition was measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Executive function was measured with a composite score derived from three Delis-Kaplan Executive Function System subscales. Outcomes were assessed at a median of 443 days (interquartile range, 390-482 days) after randomization and were compared using multivariate proportional odds regression. Adjusted ORs of > 1.0 would indicate better outcomes in the vitamin D3 group compared with the placebo group. RESULTS: Ninety-five patients were enrolled, including 47 patients randomized to vitamin D3 treatment and 48 patients randomized to placebo. The adjusted median RBANS score at follow-up was 79.6 (95% CI, 73.0-84.0) in the vitamin D3 group and 82.1 (95% CI, 74.7-84.6) in the placebo group (adjusted OR, 0.83; 95% CI, 0.50-1.38). The adjusted median executive function composite scores were 8.1 (95% CI, 6.8-9.0) and 8.7 (95% CI, 7.4-9.3), respectively (adjusted OR, 0.72; 95% CI, 0.36-1.42). INTERPRETATION: In vitamin D-deficient, critically-ill adults, a large dose of enteral vitamin D3 did not improve long-term global cognition or executive function. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03733418; URL: www.clinicaltrials.gov.

Auricular Acupuncture to Facilitate Outpatient Opioid Weaning: A Randomized Pilot Study.

Objective: The purpose of this study was to integrate acupuncture within the standard of care during outpatient opioid tapering and assess impact of this treatment on cumulative withdrawal symptoms, psychologic distress, and pain. Methods: This prospective randomized controlled pilot study administered the National Acupuncture Detoxification Association protocol following monthly opioid tapering. A total of 9 participants were randomized into the intervention group and compared with 6 participants who underwent the standard of care for outpatient opioid tapering. All providers prescribing medication management to both groups were blinded. Psychologic distress was evaluated using the hospital anxiety and depression scale (HADS). The clinical institute narcotic assessment (CINA) measured subjective withdrawal symptoms and pain was assessed using the numerical rating scale (NRS). Results: Overall anxiety appeared slightly higher in the acupuncture group (HADS 7.0 compared with 6.5), however, depression was lower when compared with the standard of care group (HADS 4.0 compared with 6.5). The standard of care group reported more intense withdrawal symptoms (CINA 9.0 compared with 3.5) as well as higher pain scores (NRS 6.5 compared with 5.0). There were no statistically significant differences among the standard of care and acupuncture groups. Conclusions: This study suggests that auricular acupuncture may be implemented within the standard of care for patients undergoing outpatient opioid weaning regimens. Although results were not statistically significant, they support future research and reveal a promising expansion of treatment options for patients physically dependent on opioid medication. Clinical Trials.gov ID: NCT02882048.