Introduction: The purpose of this prospective study was to determine the impact of obtaining blood specimens in the prehospital setting versus drawing specimens in-hospital. Variables examined were length of time from arrival to laboratory result availability; specimen quality; and emergency department length of stay. Methods: A total of 101 patients were enrolled in the study and assigned to either prehospital group (n = 58) or the in-hospital group (n = 43). Clinical laboratory personnel were blinded to the study groups. Results: Patients in the experimental group had door-to-results times for complete blood cell counts of 26 min shorter than the control group (p < .004). Doorto-results times for serum chemistry studies were 28 min faster than controls (p < .02). There was no significant difference between groups for hemolysis. Conclusions: Collecting samples in the prehospital setting significantly shortens time to results, is not associated with an increase in hemolysis, and may decrease overall emergency department lengths of stay. Key words: divert, door-to-laboratory results availability, length of stay, hemolysis, prehospital lab draw, throughput T HE GOAL of every emergency department (ED) is to see and treat patients in a timely manner. Patient and employee
Post-traumatic stress disorder (PTSD) and fibromyalgia (FM) are multisystem disorders with endocrine features including low levels of steroid hormones and insulin resistance. Dysregulation of neuroendocrine pathways is implicated in the pathogenesis of PTSD and FM. Zadiol(TM) is an orally administered investigational dietary supplement containing 3 active ingredients (isoflavones from the Red Clover plant, [R+] alpha lipoic acid, and L-DOPA derived from the legume Mucuna pruriens ) that are hypothesized to normalize steroid hormone signaling. We investigated the effects of the supplement on clinical symptoms and hormones in adults with treatment-resistant PTSD or PTSD and FM (PTSD+FM). This was a single-center, open-label, uncontrolled pilot study. Eligible adults (18-70 years) received the supplement orally once daily for 3 months. The primary outcomes were the change from baseline to endpoint (3 months) in PTSD and FM symptoms, assessed with the self-report questionnaires: PTSD checklist for DSM-5 (PCL-5; range 0-80) and Revised Fibromyalgia Impact Questionnaire (FIQR; range 0-100). Additional endpoints included the change from baseline to endpoint in sleep quality measured by actigraphy, steroid hormones, insulin, Perceived Stress Scale (PSS; range 0-40), and adverse events. For all questionnaires, higher score indicates greater symptom severity. Fasting blood samples were collected in the AM. The study included 10 individuals with PTSD; 5 also had FM. The majority were female (7/10) with mean age 65 years and BMI 32 kg/m 2 . After 3 months of treatment, mean±SD PCL-5 score was 26±19, an improvement from the baseline score of 48±14 (p<0.001). The change was similar for individuals with PTSD and PTSD+FM (both p<0.05). In individuals with PTSD+FM, baseline FIQR score was 48±22 (indicating presence of FM symptoms) and 11±6 at endpoint, indicating improved FM symptoms (p<0.01). In females, mean estradiol was increased from baseline (p<0.01) and there was a trend for decreased testosterone (p=0.06). In males and females, mean cortisol was normal at baseline (9±4 µg/dL) and was unchanged at endpoint. Insulin was reduced from baseline (18±13 µIU/mL) to endpoint (6±3 µIU/mL, p<0.05). There was a nonsignificant improvement in PSS score from 20±8 at baseline to 15±9 at endpoint, as well as nonsignificant decreases in the number of awakenings and mean time during awakenings. There was also a trend for reduced diastolic and systolic blood pressure. The supplement was well tolerated; no adverse events were reported. The results of this pilot study in individuals with treatment-resistant PTSD and FM suggest the supplement resulted in an improvement in PTSD and FM symptoms as well as improvements in gonadal steroids and insulin. Further investigation of the efficacy and mechanism of action of Zadiol is warranted. The study was funded by Bioimmunity, Inc.
Fibromyalgia is a chronic pain sensitivity disorder that affects approximately 3-8% of the general population with symptoms that include fatigue and widespread musculoskeletal pain. Psychological and physical stressors are frequent drivers of fibromyalgia, and additional lockdown-associated stressors may worsen symptoms. Reduced production of human growth hormone (hGH) is evident in approximately 30% of individuals with fibromyalgia, which is hypothesized to contribute to common fibromyalgia symptoms. An orally administered amino acid supplement has been previously shown to improve endogenous hGH status in adults. We investigated if daily administration of the supplement would increase levels of endogenous insulin-like growth factor 1 (IGF-1), a surrogate marker of the body's hGH levels, and improve symptoms related to low-normal hGH production in a cohort of 84 individuals being treated for fibromyalgia. This is the full-cohort analysis of an open-label, single-arm study that investigated the effects of 24 weeks of daily oral administration of the supplement in individuals with low-normal hGH production. The primary endpoint was the change from baseline to endpoint (Week 24) in serum IGF-1. Additional endpoints included the change in body weight, clinical symptoms (assessed with the Revised Fibromyalgia Impact Questionnaire [FIQR], range 0-100, and Perceived Stress Scale [PSS], range 0-40), fasting cardiometabolic markers, tolerability, and safety. Participants continued to receive standard care. The study enrolled 84 fibromyalgia patients with low-normal age-adjusted IGF-1 serum levels. High mean±SD baseline FIQR and PSS scores of 76±16 and 32±5, respectively, indicated poor to moderate symptom management with standard care. All individuals completed 24 weeks of treatment. Serum IGF-1 levels increased with a Week 24 mean±SE change of 28.4±3.0 ng/mL (paired t-test p<0.001). Body weight was reduced with a Week 24 mean±SE change of -5.5±0.3 kg (p<0.001). The change from baseline in FIQR and PSS scores were -29.1±1.1 and -20.0±0.8, respectively (both p<0.001), indicating a substantial improvement. Statistically significant improvements from baseline were also observed for systolic and diastolic blood pressure, HbA1c, LDL and HDL cholesterol, and triglycerides (all p<0.001). The supplement was well tolerated; no adverse events were reported. Sustained augmentation of IGF-1 with the supplement may represent a unique method of improving clinical symptoms of fibromyalgia in individuals with low-normal hGH production. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.
SeroVital is an orally-administered amino acid supplement that promotes hGH secretion via suppression of somatostatin. We investigated if daily administration of the supplement would increase levels of endogenous insulin-like growth factor 1 (IGF-1), a primary mediator of the effects of hGH, and improve symptoms related to low-normal hGH production in a cohort of individuals being treated for fibromyalgia, a complicated condition associated with endocrine features including low or low-normal hGH. This open-label, single-arm study investigated the effects of 24 weeks of daily oral administration of the supplement in individuals with low-normal hGH production (between the 15th and 50th percentile for age-appropriate levels of IGF-1). The primary endpoint was the change from baseline to endpoint (Week 24) in serum IGF-1. Additional endpoints included the change in body weight, clinical symptoms (assessed with the Revised Fibromyalgia Impact Questionnaire [FIQR], range 0-100, and Perceived Stress Scale [PSS], range 0-40), fasting cardiometabolic markers, tolerability, and safety. Participants continued to receive standard care. The study enrolled 45 adults with mean baseline age (mean±SD) 67±11 years, 67% female, BMI 31±7 kg/m2, and IGF-1 107±28 ng/mL. High mean±SD baseline FIQR and PSS scores of 82±14 and 35±3, respectively, indicated poor to moderate control of fibromyalgia with standard care. All individuals completed 24 weeks of treatment. There was an increase in serum IGF-1 levels at Week 12 that was sustained to endpoint, resulting in a mean±SE Week 24 change of 32.1±2.8 ng/mL (paired t-test p<0.001). IGF binding protein-3 (IGFBP-3) levels were unchanged from baseline (p=ns), indicating no change in IGF-1 sensitivity. There was a steady reduction in body weight that resulted in Week 24 mean±SE change of -6.4±0.4 kg (p<0.001). The change from baseline in FIQR and PSS scores were -25.6±1.6 and -21.5±0.5, respectively (both p<0.001), indicating a substantial improvement. Statistically significant improvements from baseline were also observed for systolic and diastolic blood pressure, HbA1c, LDL and HDL cholesterol, and triglycerides (all p<0.001). The supplement was well tolerated; no adverse events were reported. In patients being treated for fibromyalgia with low-normal hGH production, daily addition of the hGH-enhancing supplement for 24 weeks produced an increase in IGF-1 with associated weight loss and improvements in cardiometabolic markers and clinical symptoms. Sustained augmentation of IGF-1 with the supplement may represent a unique method of improving clinical symptoms in individuals with low-normal hGH, including otherwise healthy adults exhibiting low-normal hGH production.This was an independent investigator-initiated study. Sierra Research Group provided some samples of the supplement.
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