Ruff Kevin J, Kopp Kenneth J, Von Behrens Pamela, Lux Mark, Mahn Matthew, Back Matthew
ESM Technologies LLC, Carthage,
Kopp Veterinary Consulting, St Louis.
Vet Med (Auckl). 2016 Aug 18;7:113-121. doi: 10.2147/VMRR.S101842. eCollection 2016.
Sub-optimal joint function is extremely prevalent in dogs. Therefore, a 6-week, prospective, randomized, double-blind, placebo-controlled study was conducted at eight different veterinary clinics to evaluate the efficacy, safety, and tolerability of NEM brand eggshell membrane (EM), a novel dietary supplement shown in other species to help maintain healthy joints and connective tissues.
Fifty-one dogs received oral EM ~13.5 mg/kg (6 mg/lb) or placebo (excipients) once daily for 6 weeks. The primary outcome measure of this study was to evaluate the change in mean joint function following 1 week and 6 weeks of supplementation as determined via the Canine Brief Pain Inventory (CBPI) questionnaire (Q#5-10) in the treatment group versus the placebo group. Secondary outcome measures were for changes in mean CBPI pain and CBPI quality of life, and mean joint pain, mobility and lameness via Veterinary Canine Scoring Assessments (VCSA). A final secondary outcome measure was for a change in serum levels of the cartilage degradation biomarker, c-terminal cross-linked telopeptide of type-II collagen (CTX-II).
Supplementation with EM produced a significant treatment response versus placebo at 1 week (20.5% improvement, =0.028), but fell shy of significance at 6 weeks post-treatment (22.5% improvement) for the primary outcome measure (CBPI Function), despite a sizeable treatment effect. Similarly, there was also a significant treatment response versus placebo at 1 week for CBPI Pain (19.4% improvement, =0.010), but fell just shy of significance at 6 weeks (22.5% improvement), again despite a sizeable treatment effect. Results were not significant versus placebo at 1 week for CBPI quality of life (14.0% improvement), but produced a significant treatment response by the end of the 6-week study (26.8% improvement, =0.033). Additionally, EM produced a significant treatment response versus placebo at 6 weeks for VCSA pain (23.6% improvement, =0.012), but fell shy of significance for VCSA mobility and VCSA lameness (walking & trotting). Serum CTX-II levels in EM-supplemented dogs was significantly improved versus placebo at 6 weeks (47.9% improvement, =0.018). There were no serious adverse events reported during the study and subject dog owners reported that EM was well tolerated by their pets.
Supplementation with EM, ~13.5 mg/kg (6 mg/lb) taken once daily, significantly reduced joint pain and improved joint function rapidly (CBPI 1 week) and demonstrated a lasting improvement in joint pain (VCSA 6 weeks) leading to an improved quality of life (CBPI 6 weeks). Moreover, a profound chondroprotective effect was demonstrated following 6 weeks of supplementation with EM (CTX-II).
关节功能欠佳在犬类中极为普遍。因此，在八家不同的兽医诊所开展了一项为期6周的前瞻性、随机、双盲、安慰剂对照研究，以评估NEM品牌蛋壳膜（EM）的疗效、安全性和耐受性。NEM是一种新型膳食补充剂，在其他物种中已显示有助于维持关节和结缔组织的健康。
51只犬每天口服一次EM，剂量约为13.5毫克/千克（6毫克/磅）或安慰剂（辅料），持续6周。本研究的主要结局指标是通过犬类简短疼痛量表（CBPI）问卷（问题5 - 10）评估治疗组与安慰剂组在补充1周和6周后平均关节功能的变化。次要结局指标包括CBPI疼痛和CBPI生活质量的平均变化，以及通过兽医犬类评分评估（VCSA）得出的平均关节疼痛、活动能力和跛行情况。最后一项次要结局指标是软骨降解生物标志物II型胶原C末端交联端肽（CTX-II）血清水平的变化。
在1周时，与安慰剂相比，补充EM产生了显著的治疗反应（改善20.5%，P = 0.028），但在治疗后6周，主要结局指标（CBPI功能）虽有可观的治疗效果，却未达到显著水平（改善22.5%）。同样，在1周时，与安慰剂相比，CBPI疼痛也有显著的治疗反应（改善19.4%，P = 0.010），但在6周时同样未达到显著水平（改善22.5%），尽管治疗效果显著。在1周时，与安慰剂相比，CBPI生活质量未达到显著水平（改善14.0%），但在为期6周的研究结束时产生了显著的治疗反应（改善26.8%，P = 0.033）。此外，在6周时，与安慰剂相比，EM对VCSA疼痛产生了显著的治疗反应（改善23.6%，P = 0.012），但对VCSA活动能力和VCSA跛行（行走和小跑）未达到显著水平。在6周时，补充EM的犬血清CTX-II水平与安慰剂相比有显著改善（改善47.9%，P = 0.018）。研究期间未报告严重不良事件，受试犬的主人报告称其宠物对EM耐受性良好。
每天一次口服约13.5毫克/千克（6毫克/磅）的EM，能显著减轻关节疼痛并迅速改善关节功能（CBPI 1周），并在关节疼痛方面显示出持续改善（VCSA 6周），从而提高生活质量（CBPI 6周）。此外，补充EM 6周后显示出显著的软骨保护作用（CTX-II）。
