Effects of an Extract of Salmon Milt on Symptoms and Serum TNF and Substance P in Patients With Fibromyalgia Syndrome

• Published in: Clinical therapeutics 2019-08, Vol.41 (8), p.1564-1574.e2
• Main Authors: Tsilioni, Irene, PhD, Pipis, Haralambos, DMD, Freitag, Manuela Sagrario Cabrera, MD, Izquierdo, Maria Dolores Carrillo, PhD, Freitag, Karin, MD, Theoharides, Theoharis C., MS, MPhil, PhD, MD
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Animals; Blood; Blood levels; Comorbidity; Control methods; Dietary Supplements; Enzyme-linked immunosorbent assay; Family medical history; Fatigue; Fatigue - blood; Fatigue - diet therapy; Fatigue tests; Female; Fibromyalgia; Fibromyalgia - blood; Fibromyalgia - diet therapy; Humans; Inflammation; Internal Medicine; Levels; Male; Medical Education; Medical treatment; Middle Aged; milt; Morning; Musculoskeletal diseases; Pain; Pain - blood; Pain - diet therapy; Patients; Polyamines; Questionnaires; Rheumatology; Salmon; Semen; Serum levels; Signs and symptoms; Sperm; Spermine; Substance P; Substance P - blood; TNF; Tumor necrosis factor; Tumor Necrosis Factor-alpha - blood; Variance analysis; Womens health; Young Adult
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2019.05.019

AbstractPurposeThe aim of this study was to evaluate the effects of a dietary supplement containing primarily an extract of salmon's milt (semen) on symptoms and blood levels of proinflammatory molecules in patients with fibromyalgia syndrome (FMS), a chronic, painful musculoskeletal disease without a distinct pathogenesis or treatment. We recently reported increased serum levels of the proinflammatory molecules substance P (SP) and tumor necrosis factor (TNF) in patients with FMS as compared to those in normal controls. MethodsThis prospective, open-label study was conducted in patients with FMS (n = 87; 80 women, 7 men; age range, 18–80 years) selected from 2 clinical centers in Spain. Patients were administered the supplement and were evaluated at weeks 1 (before treatment), 4, 8, and 12 (end of treatment) for clinical parameters of functioning, fatigue, and pain, as well as overall impression. Patients were directed to take 1 capsule per day in the morning for the first 4 weeks, followed by 1 capsule in the morning and 1 capsule in the evening for the remaining 8 weeks. Differences in symptom scores in patients with FMS between weeks 1 and weeks 4, 8, and 12 were evaluated using ANOVA. Blood was obtained and serum separated in patients with FMS at 1 and 12 weeks and in a separate population of healthy controls (n = 20; 15 women, 5 men; age range, 25–65 years). Serum levels of SP and TNF were measured in patients with FMS at 1 and 12 weeks and in healthy controls by ELISA. TNF and SP levels in patients with FMS were compared between weeks 1 and 12, as well as between patients with FMS and untreated controls, using the Mann–Whitney U test. FindingsClinical parameters of functioning, fatigue, and pain, as well as overall impression, were improved significantly at 4 weeks as compared to 1 week and remained unchanged for the duration of the study (all, P