Efficacy and Safety of Natural Eggshell Membrane (NEM) in Patients with Grade 2/3 Knee Osteoarthritis: A Multi-Center, Randomized, Doubleblind, Placebo-Controlled, Single-crossover Clinical Study

Abstract

Objective: To evaluate the efficacy and safety of NEM® (natural eggshell membrane), in patients with grades 2 and 3 knee osteoarthritis (OA) having significant joint pain and stiffness, in a large, multi-center clinical trial. Subjects and methods: This study was a randomized, double-blind, placebo-controlled, multi-center, single-crossover design. One-hundred sixty subjects (male, 32; females, 134; age ≥ 40 years) with grade 2 or 3 knee OA for 1-5 years were randomized to either NEM (n=83) 500 mg once daily or placebo (n=83) for 30 days. Osteoarthritis was evaluated using the Western Ontario and McMaster Universities OA index. NEM and placebo groups were compared at baseline, day 7, and day 30. After 30 days on placebo, the placebo group crossed over while remaining blinded and was provided with NEM (500 mg) for an additional 60 days. Results: In NEM-treated subjects, WOMAC-stiffness was reduced at day 7 (P=0.034 vs. placebo), and WOMAC-total (P=0.004), WOMAC-pain (P=0.023), WOMAC-stiffness (P=0.001), and WOMAC-function (P=0.001) were reduced at day 30 (vs. placebo). The number of subjects experiencing greater decreases (≥ 20%) in WOMAC-pain was significantly greater in the 90-day NEM group (48%, P=0.022), compared to the 60-day NEM group (30%). No serious adverse events (AE) were observed in the NEM group, and there was no significant between-group difference in the total number of AEs reported (NEM, n=8; placebo, n=15). Conclusion: In this large, multi-center study in subjects with grade 2 and 3 knee OA, NEM reduced pain and stiffness within 7-30 days, and these clinically meaningful benefits persisted for 90 days. NEM can be considered as a safe, natural intervention for inclusion as part of a comprehensive clinical protocol in the management of knee OA.