MON-366 Improvement In Clinical Symptoms And Steroid Hormones: Results Of An Open-label Uncontrolled Pilot Study Of An Oral Supplement For Post-traumatic Stress Disorder And Associated Fibromyalga

Abstract

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/m2. 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.