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Efficacy and Safety of Natural Eggshell Membrane (NEM )

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Efficacy and Safety of Natural Eggshell Membrane (NEM ) al of Arth rn ri u ti o s J Eskiyurt et al., J Arthritis 2019, 8: Journal of Arthritis ISSN: 2167-7921 Research Article Open Access Efficacy and Safety of Natural Eggshell Membrane (NEM) in Patients with Grade 2/3 Knee Osteoarthritis: A Multi-Center, Randomized, Double- blind, Placebo-Controlled, Single-crossover Clinical Study Nurten Eskiyurt1, Merih Saridoğan2, Kazim Senel3, Rezzan Günaydin4, Akin Erdal3, Elif Özyiğit3, ÜlKü Akarırmak2, Ömer Faruk Şendur5, Kayra Barut5, Gülseren Akyüz6, Tuğba Özsoy6, Tiraje Tuncer7, Özlem Karataş7, Jale İrdesel8, Ayşegül Ketenci1 and Cem Aydogan9* 1Physical Treatment and Rehabilitation Department, Istanbul School of Medicine, Istanbul University, Istanbul, Turkey 2Physical Treatment and Rehabilitation Department, Cerrahpaşa School of Medicine, Istanbul University, Istanbul Turkey 3Author deceased; Former affiliation: Ataturk University School of Medicine, Physical Treatment and Rehabilitation Department, Erzurum, Turkey +Physical Treatment and Rehabilitation Department, Ordu University School of Medicine, Ordu, Turkey 5University Physical Treatment and Rehabilitation Department, School of Medicine, Adnan Menderes, Aydın, Turkey 6Physical Treatment and Rehabilitation Department, School of Medicine, Pendik Training and Research Hospital, Marmara University, Istanbul, Turkey 7Physical Treatment and Rehabilitation Department, School of Medicine, Akdeniz University, Antalya, Turkey 8Physical Treatment and Rehabilitation Department, School of Medicine, Uludag University, Bursa, Turkey 9Phytonet AG, Schindellegi-Feusisberg, Switzerland 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. Keywords: Arthritis; Complementary therapy; Nutraceuticals; Pain; For these reasons, there is an increasing interest in studies WOMAC focusing on the treatment of OA [4]. The main goal of OA treatment is to relieve the pain and other symptoms of patients, and to enhance Abbreviations: AE(s): Adverse Events(s); NEM: Natural Eggshell their functional capacities. There are a variety of prescription drugs Membrane; OA: Osteoarthritis; RCT: Randomized Controlled Trial; and biologicals approved for use for OA, but these options are often ROM: Range of Motion; WOMAC: Western Ontario and McMaster associated with significant side effects and are costly. Traditional Universities Osteoarthritis Index pharmacological therapies include analgesics (e.g. paracetamol, oxycodone, propoxyphene, etc.) and/or non-steroidal anti- Introduction inflammatory drugs (NSAIDs) (e.g. ibuprofen, diclofenac, celecoxib), Joint and connective tissue disorders are among the most common either alone or in combination [5-7]. However, these treatments are and important chronic diseases that unfavorably influence the quality frequently associated with adverse health concerns including cardiac of life of those afflicted. In 2010, it was estimated that osteoarthritis (OA) and rheumatoid arthritis (RA), the two most prevalent chronic rheumatic diseases, affected 3.8% and 0.24% of the global population, *Corresponding author: Cem Aydogan, MD, PhD, Phytonet AG Untere respectively [1]. This equates to more than 290 million people combined Paulistrasse 51 8834, Schindellegi-Feusisberg, Switzerland, Tel: +41 43 477 94 worldwide. 75; E-mail: [email protected] Received September 16, 2019; Accepted November 15, 2019; Published Symptomatic knee OA including knee pain and stiffness, occurs to November 22, 2019 a greater degree in females and in individuals over the age of 50 years. Citation: Eskiyurt N, Saridoğan M, Senel K, Günaydin R, Erdal A, et al. (2019) The incidence of OA increases with age and 50% of those 60 years Efficacy and Safety of Natural Eggshell Membrane (NEM®) in Patients with Grade and older report having chronic knee pain [2]. A gradual increase is 2/3 Knee Osteoarthritis: A Multi-Center, Randomized, Double-blind, Placebo- expected in the future prevalence of OA due to the increasing elderly Controlled, Single-crossover Clinical Study. J Arthritis 8: 285. population and obesity rates throughout the world. A recent study of Copyright: © 2019 Eskiyurt N, et al. This is an open-access article distributed the prevalence of symptomatic knee OA in the Izmir region in Turkey under the terms of the Creative Commons Attribution License, which permits found that 20.9% of those aged 40 and over were afflicted [3]. unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. J Arthritis, an open access journal ISSN: 2167-7921 Volume 8 • Issue • 1000285 Citation: Eskiyurt N, Saridoğan M, Senel K, Günaydin R, Erdal A, et al. (2019) Efficacy and Safety of Natural Eggshell Membrane (NEM®) in Patients with Grade 2/3 Knee Osteoarthritis: A Multi-Center, Randomized, Double-blind, Placebo-Controlled, Single-crossover Clinical Study. J Arthritis 8: 285. Page 2 of 7 risks [8,9], gastrointestinal problems [10,11], and addiction issues criteria, and had grade 2 or grade 3 knee OA according to the Kellgren associated with long-term use of pain-relieving narcotics [12,13]. and Lawrence classification [27]. For OA (and many other conditions), natural, non-prescription The following were the main exclusion criteria for this study: BMI interventions (i.e. integrative approaches including nutraceuticals, > 35 kg/m2; diagnosed inflammatory syndromes such as rheumatoid dietary supplements, functional foods) are preferred by many patients arthritis, gout, pseudogout, Paget’s disease, or chronic pain syndrome; due to their reduced potential for side effects and generally lower cost. severe chronic joint pain lasting for at least 3 months with a score of The most intensively investigated natural products in the context of OA ≥ 80 according to the Western Ontario and McMaster Universities are glucosamine and chondroitin sulfate [14,15]. Although less costly Osteoarthritis (WOMAC 3.1) Index [28]; known allergy to eggs or egg and having an improved side effect profile compared to prescription products; prior enrollment in any clinical study for the treatment of therapies, their overall efficacy is mild with borderline clinical joint and/or connective tissue disorders in the previous 6 months; those significance. Clearly, there remains an unmet need for additional safe who received any new study product in the previous 30 days; pregnant and efficacious non-prescription treatment options. women or breastfeeding women. Patients who agreed to participate in the study but were receiving exclusionary drugs were deemed eligible Natural eggshell membrane [NEM; commercially available in to be included in the study following a 7-day wash-out period for the USA as NEM®] is a non-prescription, natural source of immune- analgesics and NSAIDs, and a 90-day wash-out period for steroids and modulating bioactives [16,17]. NEM has demonstrated safety and nutraceuticals used for the treatment of joint and connective tissue efficacy in multiple, clinical trials in relieving joint pain and stiffness in disorders (e.g. glucosamine, chondroitin, methylsulfonylmethane, etc.). individuals with OA [18-21]. In addition, NEM has also been reported Only paracetamol was allowed for pain use during the study and was efficacious in various animal species, including rat models of OA and provided and tracked in the same manner as treatment capsules. All RA [17,22-26]. The current study was performed to confirm the efficacy other pain treatments were excluded during the study period. and safety of NEM in a large, multi-center trial in a new geographic population of subjects with diagnosed grades 2 and 3 OA of the knee. Randomization Subjects and Methods The patients were randomly assigned to either the NEM or placebo groups, and were randomized centrally, according to their registration Study design order, using a permuted-block randomization
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