AB0762 Fficacy and Safety of Nemartro(Nem®-Stratum Nutrition) Brand Eggshell Membrane in Patients with Knee Osteoarthritis Accompanying with Joint Pain and Stiffness. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Background

Traditional treatments for pain and stiffness in osteoarthritis attempt to address only the symptoms associated with the diseases.

Objectives

To investigate the efficacy and safety of natural eggshell membrane Natural Eggshell Membrane (NEM) in patients with knee osteoarthritis having joint pain and stiffness.

Methods

This study is a Efficacy and Safety of NEM®ARTRO(NEM®-Stratum Nutrition) Brand Eggshell Membrane in Patients With Knee Osteoarthritis Accompanying With Joint Pain and Stiffness. A Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study. This study was planned to include 200 female or male patients, however a total of 166 patients were screened and all the 166 patients were enrolled to the study. Median age of the medication group was 53 and in the placebo group was 57. The study was conducted as a multicenter, randomized, double blind, placebo controlled and crossover study. Patients aged ≥40 years having osteoarthritis complaints for 1–5 years and grade 2 or 3 knee osteoarthritis were included as 166 patients in total (32 male and 134 female). They were randomly assigned to receive either Natural Eggshell Membrane (NEM®) (drug group) or placebo (placebo group) for 30 days. After the evaluations on day 30, the placebo group was also initiated to Natural Eggshell Membrane (NEM®). Thus, at the end of 90 days, two groups (the 60-day and 90-day Natural Eggshell Membrane (NEM®) treatment groups) were evaluated. For pain and stiffness in patients, VAS and WOMAC scales and for quality of life SF-36 scale was used. The degree of pain and stiffness was evaluated at baseline and days 7, 30, and 90. Quality of life scales were evaluated in the baseline and in the end of treatment.

Results

There was no difference between the drug (n=83) and placebo (n=83) groups regarding demographics, baseline clinical findings, and pain (VAS, WOMAC) and stiffness (WOMAC) scores. At the end of 7- and 30-day treatment, the pain and stiffness scores were significantly lower in the drug group than in the placebo group. A total of 8 adverse events in the medication group and 15 adverse events in placebo group were observed. It was seen that none of the conditions in medication group are serious. WOMAC pain score has decreased 30% in the first month and 40% in the third month for medication group. VAS score was decreased 22% in the first month and 42% in the third month for medication group. WOMAC stiffness score has decreased 34% in the first month and same in the third month for medication group. SF-36 score was 39 for the first month and 46 for the third month for medication group.

Conclusions

In the treatment of patients with knee osteoarthritis, Natural Eggshell Membrane (NEM®) reduces pain and stiffness in early period and provides a significant progress in quality of life and maintains its efficacy in long-term.

Acknowledgement

This study is sponsored by Generica.

Disclosure of Interest

N. Eskiyurt Grant/research support from: Investigator payment from Generica for the study, M. Saridogan Grant/research support from: Investigator payment from Generica for the study, K. Senel Grant/research support from: Investigator payment from Generica for the study, R. Gunaydin Grant/research support from: Investigator payment from Generica for the study, A. Erdal Grant/research support from: Investigator payment from Generica for the study, U. Akarirmak: None declared, O. Sendur Grant/research support from: Investigator payment from Generica for the study, K. Barut: None declared, G. Akyuz Grant/research support from: Investigator payment from Generica for the study, T. Ozsoy: None declared, T. Tuncer: None declared, O. Karatas Grant/research support from: Investigator payment from Generica for the study, J. Irdesel Grant/research support from: Investigator payment from Generica for the study, A. Ketenci: None declared, C. Aydagan Consultant for: Food Supplement Consultant of Generica