title: Eggshell membrane: a possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies.
abstract: 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 500 mg 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 inflexibility associated with joint and connective tissue (JCT) disorders. Supplementation with NEM, 500 mg 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 may be helped considerably from NEM supplementation. The Clinical Trial Registration numbers for these trials are: NCT00750230 and NCT00750854.
authors: ESM Technologies, LLC, Carthage, MO 64836, USA. kruff@esmingredients.com
authors: Kevin J
authors: KJ
authors: Ruff
authors: Dale P
authors: DP
authors: DeVore
authors: Michael D
authors: MD
authors: Leu
authors: Mark A
authors: MA
authors: Robinson
mesh_terms: D000529:Complementary Therapies; D003240:Connective Tissue Diseases / Q000188:drug therapy*; D004527:Egg Proteins / Q000008:administration & dosage* / Q000494:pharmacology; D005260:Female; D006801:Humans; D007592:Joint Diseases / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D010146:Pain / Q000188:drug therapy; D016059:Range of Motion, Articular
chemical_list: D004527:Egg Proteins