title: Lipid extract from hard-shelled mussel (Mytilus coruscus) improves clinical conditions of patients with rheumatoid arthritis: a randomized controlled trial.
abstract: Studies have suggested a lipid extract from hard-shelled mussel (Mytilus coruscus) (HMLE) possessed strong anti-inflammatory activity in arthritis model of rats. This study investigated whether HMLE could improve clinical conditions of rheumatoid arthritis patients. Fifty rheumatoid arthritis patients (28-75 years) were randomly assigned to receive HMLE capsules or receive placebo capsules for 6 months. Forty-two subjects and 50 subjects were included in per-protocol and intention-to-treat analysis, respectively. Significant differences in changes on disease activity score (DAS28) and clinical disease activity index (CDAI) after 6-month intervention (p < 0.01) were observed in both analyses with more evident efficacy shown in per-protocol population (∆DAS28 = 0.47; ∆CDAI = 4.17), which favored the benefits of the HMLE group. TNF-α (tumor necrosis factor α), interleukin (IL)-1β and PGE2 (prostaglandin E2) but not IL-6, were significantly decreased in both groups, and the decrements were much larger in the HMLE group for TNF-α and PGE2 after 6 months from baseline (p < 0.05). IL-10 was significantly increased in both groups and the change was much more evident in the HMLE group (p < 0.05). In conclusion, HMLE exhibited benefits for the clinical conditions of rheumatoid patients in relation to improvement in the balance between pro- and anti-inflammatory factors, which indicated its potential to serve as adjunctive treatment for rheumatoid arthritis. (ClinicalTrials.gov NCT02173587).
authors.affiliation: Department of Food Science and Nutrition, Zhejiang University, Hangzhou 310058, China. fuyuanqing@163.com.
authors.forename: Yuanqing
authors.initials: Y
authors.lastname: Fu
authors.affiliation: Department of Food Science and Nutrition, Zhejiang University, Hangzhou 310058, China. guipuli@aliyun.com.
authors.forename: Guipu
authors.initials: G
authors.lastname: Li
authors.affiliation: Department of Rheumatology, Zhejiang Sir Run Run Shaw Hospital, Hangzhou 310058, China. singwar@163.com.
authors.forename: Xinhua
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Orthopaedic Surgery, The General Hospital of Chinese People's Army Police Force, Beijing 100039, China. xgy7766@263.net.
authors.forename: Gengyan
authors.initials: G
authors.lastname: Xing
authors.affiliation: College of Life Science, Linyi University, Linyi 276005, China. xjhuhz@126.com.
authors.forename: Xiaojie
authors.initials: X
authors.lastname: Hu
authors.affiliation: Ningbo College of Health Sciences, Ningbo 315100, China. lifeng_yang@126.com.
authors.forename: Lifeng
authors.initials: L
authors.lastname: Yang
authors.affiliation: Department of Food Science and Nutrition, Zhejiang University, Hangzhou 310058, China. duoli@zju.edu.cn.
authors.forename: Duo
authors.initials: D
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004041:Dietary Fats / Q000008:administration & dosage*; D015232:Dinoprostone / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016753:Interleukin-10 / Q000097:blood; D053583:Interleukin-1beta / Q000097:blood; D015850:Interleukin-6 / Q000097:blood; D007668:Kidney / Q000187:drug effects / Q000378:metabolism; D008099:Liver / Q000187:drug effects / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D049878:Mytilus / Q000737:chemistry; D017747:Seafood; D014409:Tumor Necrosis Factor-alpha / Q000097:blood
chemical_list: D000893:Anti-Inflammatory Agents; D004041:Dietary Fats; D053583:Interleukin-1beta; D015850:Interleukin-6; D014409:Tumor Necrosis Factor-alpha; D016753:Interleukin-10; D015232:Dinoprostone