NEM® open label human clinical trials
26. May, 2010 
3 Comments
ESM Technologies’ NEM® (Natural Eggshell Membrane) is a proven ingredient for the joint health market that delivers fast results. Two 30-day open label human clinical trials were conducted to evaluate NEM® (500mg once daily) as a treatment for various joint and connective tissue disorders.
Effect of NEM® on Joint Pain
The results of the studies showed that supplementation with
NEM® produced an average 25% reduction in pain (both Study 1 & Study 2) in just 7 days. By the end of the 30-day trial, patients in Study 1 had an average reduction in pain of more than 72% (See graph) and nearly half of these patients reported that they were completely pain-free by the end of the study. Patients in Study 2 experienced more moderate relief with an average 30% reduction in pain at the completion of the trial, however about one-third of them experienced more than 50% reduction in pain. No side effects were reported by study participants in either trial.
Effect of NEM® on Range of Motion
Supplementation with NEM® also produced an average 28% increase in flexibility in just 7 days for patients in Study 1. Flexibility had improved by an average 44% by the end of the study (See graph left) with more than half of the patients experiencing greater than 50% improvement in flexibility by day 30. NEM® not only improved joint flexibility, it also reduced the pain patients experienced while flexing the affected joint in a range of motion (ROM) evaluation. At day 7, patients had 43% less pain while flexing, and by day 30, this had improved to 76% less pain while flexing. Again, no side effects were reported by study participants.
Supplementation with NEM® produced a significant treatment response at:
- 7 days for flexibility (27.8% increase, P = 0.038)
- 30 days for general pain (72.5% reduction, P = 0.007)
- 30 days for flexibility (43.7% increase, P = 0.006)
- 30 days for ROM-associated pain (75.9% reduction, P = 0.021)
Supplementation with NEM® produced a significant treatment response for pain at 7 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 7 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)
Ruff, K.J., DeVore, D.P., Leu, M.D., and Robinson, M.A. Eggshell Membrane A Possible New Natural Therapeutic For Joint & Connective Tissue Disorders: Results From Two Open-label Human Clinical Studies. Clin Interv Aging, (2009) 4:235-240. >>
Clinical White Paper >>
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Dear ladies and sirs,
the study may be a good hint of a possible effectiveness of your product in the treatment of joint pain. But – what kind of pain was it? ligament derived or due to osteoarthritis? To say more about the effectivitie of your product it is essential to have an – even small – RCT due to the fact that the placebo effect in pain trails is sometimes enormous. Do you plan an RCT?
Best regards
Heribert Hoebler
Our two open label clinical trials allowed patients with diverse types of pain and many different affected joints. We enrolled patients with neck, shoulder, back, hip, hand, elbow, & knee pain, and even some with fibromyalgia-related pain. While this could have confounded the trial results, in the end it was a great positive as we saw significant responders from all types of pain. Ultimately, we can’t say with any precision whether they suffered from ligament pain, tendon pain, or joint pain. However efficacy was quite generally seen throughout the various affected joints. As these were (open label) pilot studies, we did follow them up with a randomized controlled trial (RCT) as you suggested. This trial included pain, stiffness, & function evaluation using the WOMAC questionnaire. The results were quite good for an arthritis study and were published in Clinical Rheumatology (for more info, see http://www.esmingredients.com/main-feed/double-blind-placebo-controlled-study-confirms-rapid-10-day-results-seen-in-previous-human-trials/ ).”
This published article on the NEM® open label studies has been the most read article in Clinical Interventions in Aging for the last 5 years and holding. Over 1 Million people have visited the Clinical Interventions in Aging webpage!