Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical trial.

STUDY OBJECTIVES: The purpose of this study was to evaluate the efficacy and safety/tolerability of bilateral high-frequency tonic motor activation (TOMAC) in patients with medication-refractory restless legs syndrome (RLS). METHODS: RESTFUL was a multicenter, randomized, double-blind, sham-controlled trial in adults with medication-refractory moderate-to-severe primary RLS. Participants were randomized 1:1 to active or sham TOMAC for a double-blind, 4-week stage 1 and all received active TOMAC during open-label, 4-week stage 2. The primary endpoint was the Clinical Global Impressions-Improvement (CGI-I) responder rate at the end of stage 1. Key secondary endpoints included change to International RLS Study Group (IRLS) total score from study entry to the end of stage 1. RESULTS: A total of 133 participants were enrolled. CGI-I responder rate at the end of stage 1 was significantly greater for the active versus sham group (45% vs. 16%; Difference = 28%; 95% CI 14% to 43%; p = .00011). At the end of stage 2, CGI-I responder rate further increased to 61% for the active group. IRLS change at the end of stage 1 improved for the active versus sham group (-7.2 vs. -3.8; difference = -3.4; 95% CI -1.4 to -5.4; p = .00093). There were no severe or serious device-related adverse events (AEs). The most common AEs were mild discomfort and mild administration site irritation which resolved rapidly and reduced in prevalence over time. CONCLUSIONS: TOMAC was safe, well tolerated, and reduced symptoms of RLS in medication-refractory patients. TOMAC is a promising new treatment for this population. CLINICAL TRIAL: Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study); clinicaltrials.gov/ct2/show/NCT04874155; Registered at ClinicalTrials.gov with the identifier number NCT04874155.

Comparison of Clinical Features in a Population of Basic Military Trainees Versus the General Department of Defense Beneficiary Population Presenting With Influenza.

INTRODUCTION: Upper respiratory tract infection (URI) is a well-documented cause of morbidity, extra expense, and lost training time among basic military trainees (BMTs). The goal of this study was to characterize the clinical presentation of influenza in the BMT population and to better understand how this presentation differs from that of the general Department of Defense (DoD) beneficiary population (non-BMTs). MATERIALS AND METHODS: Clinical and demographic data were collected in a prospective study that enrolled DoD beneficiaries presenting to medical treatment facilities in San Antonio, Texas, with URI symptoms between January 2005 and March 2011. Vital signs and symptom duration were collected at the time of enrollment along with basic demographic information. RESULTS: Among 4,448 participants enrolled, 466 (10.5%) tested positive for influenza: 198 of 3,103 BMTs (6.4%) vs. 268 of 1,345 non-BMTs (20%) (p < 0.01); 412 of 466 had complete data for nine symptom-related variables. BMTs were more likely to be Caucasian males and younger than non-BMTs. BMTs had a higher temperature at the time of presentation (101.5°F vs. 100.5°F, p < 0.01). BMTs presented less frequently than non-BMTs with chills (79.7% vs. 94.4%, p < 0.01), malaise (62.1% vs. 87.0%, p < 0.01), nausea (30.2% vs. 43.0%, p < 0.01), and vomiting (12.1% vs. 21.7%, p = 0.01). Multiple logistic regression analysis showed that BMTs were less likely to have the four symptoms compared to non-BMTs even after controlling for gender and age (chills: odds ratio [OR] = 0.3, 95% confidence interval [CI] = 0.1-0.6, p < 0.01; malaise: OR = 0.5, 95% CI = 0.3-0.8, p < 0.01; nausea: OR = 0.5, 95% CI = 0.3-0.8, p < 0.01; vomiting: OR = 0.4, 95% CI = 0.2-0.8, p < 0.01). Although there was no difference in the frequency of subjective fever between the two groups, reported duration of fever was significantly shorter in BMTs than non-BMTs: median of 1 day (range 0-10) vs. 2 days (range 0-8) (p < 0.01). BMTs presented with a composite symptom index mean of 6.2 (standard deviation = 1.4) symptoms, whereas non-BMTs presented with a mean of 6.9 (standard deviation = 1.3) symptoms (p < 0.01). CONCLUSIONS: The pretest probability of a BMT presenting with URI symptoms having influenza is significantly lower than that for the general DoD beneficiary population. BMTs with influenza presented sooner, with higher fever, and with fewer overall symptoms than the general DoD beneficiary population. These differences are likely attributable to early reporting and response bias and less likely attributed to age. Military efforts to identify BMTs with suspected influenza infection early and to refer them for treatment promptly are efficacious.

Comparison of diagnostic test performance in a population of high risk young adults versus a general population presenting with influenza.

BACKGROUND: Upper respiratory tract infection (URI) is a well-documented cause of morbidity, extra expense and lost training time among basic military trainees (BMTs). OBJECTIVES: The goal of this study is to better understand how influenza diagnostic tests perform in the BMT population, and how this performance differs from the general population. STUDY DESIGN: Laboratory test data was collected in a prospective study that enrolled Department of Defense beneficiaries presenting to medical facilities in San Antonio, TX with URI symptoms between January 2005 and March 2011. Three laboratory tests for influenza were performed during the study period: polymerase chain reaction (PCR), enzyme immunoassay (EIA), and viral culture. Patients were grouped into BMT and non-BMT populations and the tests from each of these populations were compared for statistical differences. Similar comparisons were made with various sub-groups to include: influenza A versus influenza B, and influenza A subtypes: (H1N1) versus (H3N2) versus (H1N1)pdm09. RESULTS: Among 4448 participants enrolled, 466 (10.5%) tested positive for influenza. Sensitivity of viral culture differed between BMTs and non-BMTs: 63% versus 41% (p<0.01). There was no difference in the sensitivity of PCR or EIA between the two populations. The sensitivities of viral culture, EIA and PCR were higher in those infected with influenza A than in those infected with influenza B. The sensitivity of viral culture was significantly higher in (H1N1)pdm09 subtype cases. CONCLUSIONS: Viral culture performed better in BMTs than in non-BMTs. These differences are likely attributable to the younger age of the BMTs.

Catechin and caffeine content of green tea dietary supplements and correlation with antioxidant capacity.

The health benefits associated with tea consumption have resulted in the wide inclusion of green tea extracts in botanical dietary supplements, which are widely consumed as adjuvants for complementary and alternative medicines. Tea contains polyphenols such as catechins or flavan-3-ols including epicatechin, epigallocatechin, epicatechin gallate, and epigallocatechin gallate (EGCG), as well as the alkaloid, caffeine. Polyphenols are antioxidants, and EGCG, due to its high levels, is widely accepted as the major antioxidant in green tea. Therefore, commercial green tea dietary supplements (GTDS) may be chemically standardized to EGCG levels and/or biologically standardized to antioxidant capacity. However, label claims on GTDS may not correlate with actual phytochemical content or antioxidant capacity nor provide information about the presence and levels of caffeine. In the current study, 19 commonly available GTDS were evaluated for catechin and caffeine content (using high-performance liquid chromatography) and for antioxidative activity [using trolox equivalent antioxidant capacity (TEAC) and oxygen radical antioxidant capacity (ORAC) assays]. Product labels varied in the information provided and were inconsistent with actual phytochemical contents. Only seven of the GTDS studied made label claims of caffeine content, 11 made claims of EGCG content, and five specified total polyphenol content. Caffeine, EGCG, and total polyphenol contents in the GTDS varied from 28 to 183, 12-143, and 14-36% tablet or capsule weight, respectively. TEAC and ORAC values for GTDS ranged from 187 to 15340 and from 166 to 13690 mumol Trolox/g for tablet or capsule, respectively. The antioxidant activities for GTDS determined by TEAC and ORAC were well-correlated with each other and with the total polyphenol content. Reliable labeling information and standardized manufacturing practices, based on both chemical standardization and biological assays, are recommended for the quality control of botanical dietary supplements.