Eggshell membrane: A possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies

Background: Natural Eggshell Membrane (NEM) is a novel dietary supplement that contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joint and connective tissues. Two single center, open-label human clinical studies were conducted to evaluate the efficacy and safety of NEM as a treatment for pain and inflexibility associated with joint and connective tissue disorders.
Methods: Eleven (single-arm trial) and 28 (double-arm trial) patients received oral NEM 500mg once daily for four weeks. The primary outcome measure was to evaluate the change in general pain associated with the treatment joints/areas (both studies). In the single-arm trial, range of motion (ROM) and related ROM-associated pain was also evaluated. The primary treatment response endpoints were at seven and 30 days. Both clinical assessments were performed on the intent-to- treat (ITT) population within each study. Results: Single-arm trial: Supplementation with NEM produced a significant treatment response at seven days for flexibility (27.8% increase: P=0.038) and at 30 days for general pain (72.5% reduction: P=0.007), flexibility (43.7% increase; P=0.006), and ROM-associated pain (75.9% reduction; P=0.021). Double-arm trial: Supplementation with NEM produced a significant treatment response for pain at seven days for both treatment arms (X: 18.4% reduction; P=0.021, Y: 31.3% reduction; P=0.014). There was no clinically meaningful difference between treatment arms at seven days, so the Y arm crossed over to the X formulation for the remainder of the study. The significant treatment response continued through 30 days for pain (30.2% reduction; P=0.0001). There were no adverse events reported during either study and the treatment was reported to be well tolerated by study participants.
Conclusions: Natural Eggshell Membrane (NEM) is a possible new effective and safe therapeutic option for the treatment of pain and inflexiblity associated with joint and connective tissue (JCT) disorders. Supplementation with NEM, 500mg taken once daily, significantly reduced pain, both rapidly (seven days) and continuously (30 days). It also showed clinically meaningful results from a brief responder analysis, demonstrating that significant proportions of treated patients for these trials are; NCT00750230 and NCT00750854.



比較対象を置かない単一群試験11人とdouble-arm試験28人の被験者は、1日1回NEM 500mgを4週間経口摂取した。主要評価項目は(両研究とも)関節及びその周辺のこの処置に関連した一般的な痛みの変化を評価することだった。単一群試験では可動範囲(ROM)とROMに関連した痛みの範囲も評価された。主要な処置反応の終了点は、7日間及び30日間だった。いずれの臨床評価もそれぞれの研究の中でintent-to-treat(ITT)解析で行なわれた。