Balancing steroidal hormone cascade in treatment-resistant veteran soldiers with PTSD using a fermented soy product (FSWW08): a pilot study

Introduction : A clinical study was conducted to determine steroidal hormone cascade in the blood to relate them to mental performance with the Clinician-Administered PTSD scale (CAPS), serum lipid concentrations, and steroidal hormones, particularly cortisol, testosterone, estradiol, dehydroepiandrosterone (DHEA), and pregnenolone, in treatment-resistant male veterans with combat-related chronic posttraumatic stress disorder (PTSD) before and after consumption of a special fermented soy formulation (FSWW08). Admitted veterans in the study were resistant to conventional psychological and pharmacological therapies. Method: Ten treatment-resistant soldiers with combatrelated PTSD (according to the International Classifi cation of Diseases, 10th Revision code) for <= 1.5 years were enrolled in this study. A specially formulated fermented soy product, FSWW08, was given to the veterans for 3 months and then extended to 6 months. CAPS was used to assess the severity of PTSD. Immunologic cytokines, triglycerides, and 16 steroidal hormones were also determined from the blood of the PTSD patients before, during, and after consumption of the FSWW08. Results: FSWW08 increased blood levels of steroids, such as testosterone, estradiol, and particularly the adrenal hormones cortisol and androstenediol. Decreased steroidal hormones from the upper part of the hormone cascade, such as cholesterol, DHEA, and pregnenolone were experienced. The arteriosclerotic risk was reduced (cholesterol, 280 +/- 35 to 205 +/- 22 mmol/L, p < 0.001; triglycerides, 645 +/- 267 to 161 +/- 22 mg/dL, p < 0.001; very-low-density lipoprotein cholesterol, 312 +/- 112 to 151 +/- 20 mg/dL, p < 0.001; homocysteine in serum (i. s.), 26 +/- 4 to 11.8 +/- 2.1 mu mol/L, p < 0.001). High-density lipoprotein cholesterol concentration was signifi cantly lower after consumption of FSWW08 (51 +/- 15 to 89 +/- 7.8 mg/dL, p < 0.001). FSWW08 signifi cantly reduced mental symptoms according to CAPS after 7 days throughout the 6-month study. Insomnia (estradiol increased from 53 +/- 24 to 88 +/- 41 pg/L), breathing disorders (may be related to increased aldosterone) are hormone dependent and were corrected in those with insomnia. The increase in testosterone and decrease in prolactin was corroborated by an increase in sex drive and improved partner relationships. Common immunity disorders of the veterans, such as increased herpes labialis, flu-like syndromes, and stomach pain were resolved in all veterans and was corroborated by signifi cant improvements in immunologic cyto kines: tumor necrosis factor alpha was reduced (from 13.5 +/- 0.4 to 9.0 +/- 1.4 pg/mL, p < 0.001) and interleukin beta (from 7.0 +/- 0.5 to 4.5 +/- 1.8 pg/mL) and interferon gamma (from 10.4 +/- 2.4 to 6.3 +/- 1.5 pg/mL, p < 0.001) were also detected. PTSD is associated with clinically elevated leukocytes and lymphocytes, which are reduced by FSWW08 as well. Conclusion: It is the fi rst time that the normalization of the whole steroidal hormone cascade in the blood could be correlated with improvements in mental and physical parameters (especially metabolic and immunologic disorders) in veterans with combat-related and treatment-resistant PTSD. Studies of FSWW08 in larger cohorts and over longer periods of time, as well as dosing effects, have to be conducted to validate these results.