New research on the buying habits of the Millennial generation has led to some surprising discoveries; and retailers may have to change some marketing focus to capture this generation of consumers.

Like their grandparents (aka Baby Boomers) the Millennials are a very large demographic, but one of the main differences is their diversity of needs and spending habits. As revealed in the consumer survey conducted by global management consulting firm L.E.K. Consulting, Millennials share some buying habits with previous generations of younger consumers, yet they have also diverged from “the norm” in that within this demographic are several “sub-groups” of consumers.

According to Rob Haslehurst, Managing Director of L.E.K.’s Consumer Products and Retail practice and co-author of the report, “Retailers Play the Generation Game: Lessons from Adapting to Millennials,” these consumers “are sometimes treated as a monolithic group, although they’re not, and it’s often assumed that they behave the way young consumers have always behaved, which is a half-truth at best.”

L.E.K.’s survey of 3,800 American consumers included 2,200 Millennials and 200 teenagers at the threshold of the next generation “Gen Z.” They explored the preferences and behaviours of the unique Millennial sub-groups, and compared these to how Gen X and Baby Boomer consumers behaved when they were the same age.

The largest differences were seen in the Millennials with kids, and the ones without, although differences in education level also weighed in. Perhaps not so surprising, L.E.K.’s survey found that Millennials with children and at least a college education spent considerably more than average in several categories. Most notable of these were in purchases for the home (a whopping 68 % more) but also in footwear (56 % more), electronics (52 %), and for apparel and personal care (49 % each). In the U.S.A. research has shown that Millennials spend 1.2 trillion dollars annually, so these percentages are eye-opening.

What else did they find that was helpful to retailers?

1. Millennials will spend more on convenience than previous generations, such as prepared foods, while cutting costs through ride sharing, or buying when free shipping is included. A creative retailer should focus on “value-added” purchase incentives.
2. They spend far more time researching purchases—one hour more than Baby Boomers in most cases! For retailers, this means a concise, user-friendly online shopping experience is essential to attract more of these buyers.
3. They are more socially conscious. Therefore, they prefer to buy a brand that is honestly authentic as well as “kind to the environment” or the community. Promotional tie-ins to non-profit businesses or that otherwise aid minorities or the community are more attractive to them.

In summary, retailers have always had to adjust to changing generations, but in the case of the Millennials they should also consider targeting their sub-groups, not just the age group, and to utilize technology to personalize the targeting of Millennials by using location-based marketing, social media and other apps which also may add convenience to the Millennial buyer.

Although Canada adopted formal organic standards federally in 2009, Ontario, its largest province has lagged behind in regulating organic food and agriculture. All that may soon change, however.

Bill 153 had its first reading carried in Ontario’s Legislative Assembly last month and seeks to enact the Organic Products Act, 2017. The Act specifically “prohibits the marketing and labelling of products as ‘organic’ unless they have been certified as organic in accordance with the Act. It also requires that the Minister assigned the administration of the Act create a register of all products that are certified as organic, and that the Minister periodically update the register.”

Once this bill becomes law, producers and distributors of organic foods and products to be sold in Ontario will have to comply with regulations for farming or manufacturing practices to be able to claim their goods are organic (biologique in French). This should be well-received by Ontario consumers who buy many foods and products labelled “organic”, yet without consistent regulation there’s more opportunity for consumer fraud or confusion when buying organic. Ontario’s organic market is the largest of all and continues to grow by 10% each year.

The introduction of this bill is good news for the Organic Council of Canada which called out Ontario for not regulating its organics industry in a report as recently as July of this year, while also praising Quebec’s leadership.

Other Canadian provinces already adopted the federal standards, notably British Columbia (1993 voluntarily, 2016-2018 by act), Manitoba (2013), New Brunswick (2014) and Nova Scotia (2015). Quebec enacted its first act in 1996 and regulated its organic industry by 2006 and its system is considered to be one of the strongest. So far, the rest of the provinces and territories do not regulate organics.

The Organic Council of Canada states on their web site; “Organic regulation will create a more level playing field for organic businesses in Ontario and protect consumers.”

The Council also urges all provinces and territories to adopt two more recommendations in addition to regulation; to create an improved data collections system for organics, and to increase organic policies and programs across all jurisdictions.

A pilot study was recently published which claims that increased physical activity helped boost breast cancer survivors’ cognitive function.

It’s known that increased physical activity improves cognition in cognitively impaired or even healthy adults, but the benefits for cancer survivors were undetermined. Many breast cancer survivors report poor memory or reduced ability to concentrate after treatments indicating a decline in brain function.

The study was conducted by a team of 9 physicians and specialists and was designed to examine the effect of a 12-week program of increased physical activity on half of the group of women, compared with a control group of the other half, who were given articles for reading that addressed nutrition, women’s health and cerebral health. The randomized trials selected physical activities for each participant based on individual interests and capabilities while having them wear devices such as the Fitbit One activity tracker to record minutes of activity.

Researchers sent the data collected to extract activity levels for analysis while also providing encouragement to participants through phone calls and emails. Results concluded that engaging in at least 150 minutes of moderate-to-vigorous physical activity weekly showed more than double the improvements in brain processing speed compared to the control group. Further, women who were two years or less from cancer diagnosis were four times more likely to show improvement in how fast the brain could process information after exercise.

One of the lead researchers is Sheri Hartman, PhD, assistant professor in the Department of Family and Preventive Medicine, and co-director of the diet and physical activity shared resource at UC San Diego Moores Cancer Center. She stated, “The women who participated in the physical activity intervention experienced a significant improvement in cognitive processing speed and some improvements in their perceived mental abilities. This study supports the idea that exercise could be a way to help improve cognition among breast cancer survivors.”

This initial study was conducted on just 87 predominantly well-educated, non-Hispanic white women and researchers have stated that greater diversity in the cancer population is needed for more conclusive results.

In a move that was expected, and some say welcomed, Metro, the Quebec-based grocery chain and Jean Coutu, Quebec’s largest pharmacy retailer announced their merger. It was expected because of increased competition in Canadian grocery and pharmacy retail markets by chains like Walmart and Costco. While the takeover by Loblaw Companies Ltd. of Shoppers Drug Mart in 2014, which operates as Pharmaprix in Quebec may have strengthened Metro’s resolve to respond to competition through corporate growth.

Some say the deal will be welcomed by Quebecer’s who will be happy the merger is within the province, unlike what happened to Rona, purchased by American-owned Lowes, or St. Hubert’s Chicken bought by Ontario-based Cara, owners of long-time rival Swiss Chalet and several other restaurant chains.

The pharmacy chain will operate as a separate division of Metro and is expected to be headed by its current CEO Francois Coutu who, along with his father and founder Jean Coutu, have both repeatedly rebuffed suggestions that the family-owned company was for sale in the past. But at the recent news conference announcing the merger, Jean Coutu said, “Sometimes you have to forget your ego and try to combine with a real friend.”

Metro CEO Eric La Fleche said, “We need this size to have economies of scale and efficiency to fight with the large players that we currently face,” likely referring to their major competitors and Amazon’s recent entry into the grocery retail business with its takeover of Whole Foods Market.

The $4.5-billion merger of Metro’s grocery stores in Ontario and Quebec, and Jean Coutu’s pharmacies mostly in Quebec, with a few stores in Ontario and New Brunswick, will certainly strengthen their collective footprint in the province’s grocery and pharmacy markets. The total number of stores will rise to 1300+, and employ nearly 90,000 workers with annual earnings expected to be about $16-billion.

The merger will still require regulatory approval and assent from at least two-thirds of the shareholders of Jean Coutu Group. A special meeting will be held in November to vote on the deal, but the Coutu family and senior directors collectively hold about 93% of the vote and have all stated they will support the sale to Metro.

According to the Financial Post, after the merger announcement “Jean Coutu’s shares ended the day 6.3 per cent higher and Metro’s spiked close to 8.8 per cent.” The merger will likely conclude in early 2018.

Natural health enthusiasts for years have hailed the benefits of drinking various teas for weight loss but now scientific research not only supports that claim, it explains exactly how that can happen.

A study published in the European Journal of Nutrition has discovered that both black and green tea influenced the ratio of gut bacteria in animals. Specifically, the percentage of intestinal bacteria associated with obesity decreased, while bacteria associated with lean body mass increased.

Previous research showed that the polyphenols in green tea improved energy, but this new study reveals that black tea polyphenols stimulate the growth of certain gut bacteria and the formation of short-chain fatty acids, a type of bacterial metabolite known to influence energy metabolism in the liver which can lead to weight loss.

Susanne Henning, the study’s lead author and adjunct professor at the UCLA Center for Human Nutrition said, “Our new findings suggest that black tea, through a specific mechanism through the gut microbiome, may also contribute to good health and weight loss in humans. The results suggest that both green and black teas are prebiotics, substances that induce the growth of good microorganisms that contribute to a person’s well-being.”

The study was conducted on four different groups of mice, all of which were given a high-sugar diet. One group was also given a low-fat diet, a second a high-fat diet, a third high-fat and green tea extract and the fourth group was given a high-fat diet and a black tea extract. After four weeks the mice were weighed and the ones given either green or black tea had weight that dropped to the same levels as those given just a low-fat diet, high-sugar.

After collecting samples from the mice’s large intestines (to measure bacteria content) and liver tissues (to measure fat deposits) researchers found that the mice that consumed either type of tea extract had less of the type of bacteria associated with obesity and more of the bacteria associated with lean body mass.

However, only the mice that consumed black tea extract had an increase in a type of bacteria called Pseudobutyrivibrio which showed that the weight loss benefits were different than for green tea. Green tea is easily absorbed in the stomach and small intestine and can more directly influence the liver. Black tea molecules are too large to be absorbed in this way and instead remain in the intestine where they appear to boost the growth of “friendly” gut bacteria (probiotics) and help form metabolites that control liver energy metabolism.

Although the research has only been conducted so far on rodents, this is exciting news for proponents of natural health alternatives for human weight loss, and also shows that both green and black tea have far more than just antioxidant benefits.

With 20 years of experience in sales and customer development, Joanne Hillion has been named the senior vice-president of customer development for Acosta Canada. With senior level roles for companies like Energizer and Mars Food Division, Hillion will bring her expertise to Acosta’s grocery customer development team with great promise.

“Joanne has led large sales teams and successfully and consistently delivered growth and profit performance in a challenging marketplace,” says president Brent Scowen. “Her multi-category and capability-building experience will be great assets to our organization. We are very excited to have her on board to elevate our high-performance customer teams in driving remarkable results for our clients.”

In addition, Warren Paisley has been appointed as the vice-president of customer development for the company. Like Hillion, Paisley has acquired over 20 years of experience in brand-building and multiple executive roles for companies like Mosiac’s Labatt Integrated Team, Paisley will bring great knowledge with his extensive marketing background that Scowen is excited to tap into for Acosta’s growth.

“Warren is super passionate about building brands and people. He has had a remarkable track record of success in serving clients with breakthrough integrated campaigns that have engaged and inspired shoppers and realized remarkable results for clients. With his marking and shopper expertise and strong financial acumen he will bring lots of value-add to our clients’ businesses,” shares Scowen.

Legislation recently released a statement that will name Ontario as the first province to require the full disclosure of companies that make payments to doctors.

According to Eric Hoskins, the Minister of Health and Long-Term Care, the public disclosure will enable patients with more information in order to make better, and more informed, decisions when it comes to their health care. “We are the first jurisdiction in Canada to undertake this, so I think that leadership by Ontario is important on an issue that I think resonates with all Canadians,” says Hoskins.

Payments such as paid meals, engagement fees, and travel expenses will all be subject to disclosure, that will be available via an online database to be accessible for all.

Earlier this year, many pharmaceutical companies released data that showed payments of almost $50 million to health-care organizations, which can cause concerns about the promotion of drugs. However, Hoskins ensures that these conflicts aren’t negative. “What we want to do is want to…present information so that patients and health providers and the industry can have a better understanding of the nature of the transactions that are taking place.”

While doctors are not allowed to accept payments in exchange for meetings or gifts, they are allowed to accept teaching support that can aid their patients.

In terms of the minimum payment that will require disclosure, regulations are still being put forward to decide on a fair number.

“We had a substantial consultation over the course of the summer and there was clear and broad support for the direction that we’re taking and the support for this proposed legislation. We’ll have that opportunity as we go forward…to continue the dialogue and continue the consultation and learn from other jurisdictions, but also hear from stakeholders. (Ambien) ”

Ontario will be following countries like the USA and Australia who have already been providing the transparency for patients.

According to a study published by The North American Menopause Society (NAMS), research that discusses the benefits of hormone therapy for women experiencing hearing loss, especially for those experiencing menopause, no longer holds any merit—suggesting that hormone therapy negatively effects hearing.

About 48 million Americans experience hearing loss—a number that will continue to rise as people age. As estrogen and progestogen levels decrease for women as they age, as well as their hearing, many have suggested hormone therapy as a beneficial aid.

After analyzing 80,972 women who claimed to have hearing problems, researchers have noted a higher risk of hearing loss for those using oral hormone therapy.

“The finding from this observational study that women who underwent menopause at a later age and used oral hormone therapy had greater hearing loss was unexpected but should lead to more testing in a randomized, clinical trial,” says executive director Dr. JoAnn Pinkerton.  “Information about the potential effect on hearing is important to include in a discussion regarding the risks and benefits of hormone therapy for symptomatic menopausal women.”

Results from a Six Center, Open Label Clinical Study
Ulrich Danesch1*, Marion Seybold1, Reiner Rittinghausen1, Walter Treibel2 and Norman Bitterlich3

1Weber and Weber GmbH and Co. KG, Biological Medicinal Products, Herrschinger Str. 33, D-82266 Inning/Ammersee, Germany
2Orthopedic Practice, Maxhofstr. 9a, 81475 Munich, Germany

3Medizin and Service GmbH, Boettcherstr. 10, 09117 Chemnitz, Germany

Objective:
NEM® brand eggshell membrane is a novel dietary supplement ingredient that contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joints. A six center, open label clinical study was conducted to evaluate the efficacy and safety of NEM® as a treatment for pain and inflexibility associated with osteoarthritis of the knee and/or hip in a European population.

Methods:
Forty-four subjects received oral NEM® 500 mg once daily for eight weeks. The primary outcome measure was to evaluate the mean effectiveness of NEM® in relieving general pain associated with moderate osteoarthritis of the knee and/or hip at 10,30 and 60 days utilizing a 10-question abbreviated questionnaire based on the WOMAC osteoarthritis questionnaire.

Results:
Supplementation with NEM® produced a significant treatment response from baseline at 10 days (Q1-6 and Q9) (8.6% to 18.1% improvement) and at 30 and 60 days for all nine pain-related questions evaluated (22.4% to 35.6% improvement) and at 30 and 60 days for stiffness (Q10) (27.4% to 29.3% improvement). In a Patient’s Global Assessment, greater than 59% of patients rated the efficacy of NEM® as good or very good following 60 days of supplementation. Physicians also rated the treatment effective in subjects, with greater than 75% having moderate or significant improvement from baseline after 60 days. There were no serious adverse events reported during the study and the treatment was reported to be well tolerated.

Conclusions:

Supplementation with NEM® significantly reduced pain, both rapidly (10 days) and continuously (60 days) demonstrating that it is a safe and effective therapeutic option for the treatment of pain associated with osteoarthritis of the knee and/or hip. Results from previous clinical studies on NEM® can likely be extended to the broader European population.

Introduction:

Estimates of the prevalence of osteoarthritis (OA) in European populations vary widely, however a recent study [1] from a region in Spain places the prevalence of knee OA at 12.2% and that of hip OA at 7.4%. The pain associated with these maladies can be quite debilitating and few treatment options exist outside of easing symptoms. This usually involves the use of analgesics (i.e. acetaminophen, oxycodone, propoxyphene) or non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen, diclofenac, celecoxib), alone or in combination. Most of these treatments have shown limited effectiveness in randomized controlled clinical trials (RCTs) [2-5] or are known to have significant and sometimes severe side effects. NEM® brand eggshell membrane has previously demonstrated good efficacy in relieving pain and stiffness associated with OA of the knee in an RCT [6] and has shown similar efficacy in limited trials for other affected joints [7].

Eggshell membrane is primarily composed of fibrous proteins such as Collagen Type I [8]. However, eggshell membranes have also been shown to contain other bioactive components, namely glycosaminoglycans (i.e. dermatan sulfate, chondroitin sulfate and hyaluronic acid and keratan sulfate) [9-11]. A number of these constituents have been shown previously to be beneficial in the treatment of OA [12,13]. Eggshell membrane itself has been shown both in vitro [14] and in vivo [15] to reduce various pro-inflammatory cytokines, including interleukin-1 beta (IL-1β) and tumor necrosis factor alpha (TNF-a), two primary mediators of inflammation. A U.S. company, ESM Technologies, LLC (Carthage, MO USA), has developed methods to efficiently and effectively separate eggshell membrane from eggshells on a commercial metric-ton scale. The isolated membrane is then partially hydrolyzed using a proprietary process and dry-blended to produce NEM® brand eggshell membrane. Compositional analysis of NEM® conducted by the manufacturer has identified a high content of protein and moderate quantities of glucosamine (up to 1% by dry weight), chondroitin sulfate (up to 1%), hyaluronic acid (up to 2%), and collagen (Type I, up to 5%).

The multi-center trial reported herein was designed to evaluate the acceptability of this natural arthritis treatment with European orthopedic surgeons and patients. Success of this trial would also validate the extension of the body of clinical evidence for NEM® from the United States to a European population. Therefore, a 2-month open-label study was conducted at six different clinical sites throughout Germany to evaluate the efficacy and tolerability of NEM® for the relief of the pain and discomfort associated with osteoarthritis of the knee and/or hip.

Materials and Methods Study Design

The study was conducted according to a prospective, multi-center, open label design and was conducted in Germany in accordance with the International Conference on Harmonization guideline for the principles of Good Clinical Practice (ICH E6) and the Declaration of Helsinki to ensure protection of human subjects. Patients provided their written informed consent to participate. Neither the clinical investigators nor the patients were blinded to treatment (open label design). Treatment consisted once daily orally of Atrosia® (Weber and Weber, GmbH and Co. KG, Germany) providing 500mg of NEM® in vegetarian capsules that were stored in closed containers at ambient temperature. Clinic visits were scheduled for subjects at study initiation and at 60 days following the onset of treatment. Treatment compliance was checked at clinic visits by patient interview and by counting the number of unused doses of the study medications. Analgesics (i.e. acetaminophen) were allowed for rescue pain relief. However, subjects recorded the time and amount of analgesic taken in patient diaries so that overall analgesic use could be evaluated as part of the study.

Patients

All subjects 18 years of age or older who were seeking relief of mild to moderate pain due to osteoarthritis of the knee and/or hip were considered for enrollment in the study. In order to be eligible, subjects must have had moderate persistent pain in the knee and/or hip associated with osteoarthritis and must have had baseline scores within the range of 4-7 on the first three questions dealing with joint pain. Subjects that were currently taking analgesic medications or NSAIDs every day, currently taking glucosamine, chondroitin sulfate, MSM, or collagen were ineligible to participate in the study. Patients were excluded if they were currently receiving remission-inducing drugs such as methotrexate or immunosuppressive medications or had received them within the past 3 months. Other exclusionary criteria were: a known allergy to eggs or egg products, or pregnant or breastfeeding women. Subjects participating in any other research study involving an investigational product (drug, device, or biologic) or a new application of an approved product, within 30 days of screening were also excluded from participating in the trials.

Treatment response

The primary outcome measure of this study was to evaluate the mean effectiveness of NEM® in relieving general pain associated with moderate osteoarthritis of the knee and/or hip (Questions 1-9). Additional outcome measures were to evaluate general stiffness (Question 10) and analgesic use during the study. e primary treatment response endpoints were the 10-, 30-, and 60-day patient assessments utilizing a 10-question ‘Short Form’ questionnaire derived from the Western Ontario and McMasters Universities Osteoarthritis Index questionnaire (WOMAC), which has some precedence [16,17]. Each question included a zero to 10 analog Likert-scale, with zero equating to no pain (or no stiffness) and 10 equating to most severe pain (or most severe stiffness). Patients were asked to mark a number corresponding to the perceived pain (or stiffness) from the affected treatment joint(s). Endpoints were then compared to pretreatment assessments. At the conclusion of the study, subjects were asked to provide a Patient’s Global Assessment of treatment efficacy (4 categories-very good/good/moderate/poor) and tolerability (same 4 categories). Clinical investigators were also asked to provide a Physician’s Global Assessment of treatment efficacy (5 categories- symptom-free/significant improvement/moderate improvement/ unchanged/impaired).

Adverse events

A secondary objective of this study was to evaluate tolerability and any adverse reactions associated with supplementation with NEM®. The subject’s self-assessment diaries were reviewed and any discomfort or other adverse events were recorded and reported in accordance with applicable ICH Guidelines. Adverse events and serious adverse events were assessed by the clinical investigator at each study visit and followed until resolution, as necessary. Serious adverse events were required to be reported to the clinical monitor immediately.

Statistical analysis

As this was an open-label study, a simple single group sample size estimate [18] was performed for statistical power determination for a continuous variable. In previous trials with NEM® [6,7], the standard deviation for the study subjects for pain (within the inclusion range of this study) averaged 34.6%. We hoped to be able to detect a 1.5 point difference from baseline within the 10-point Likert scale. us a minimum of 43 subjects would need to be enrolled to have a 95% likelihood of detecting the expected improvement with a statistical power of 80%. Comparisons of demographic data from the six clinical sites were made with a Kruskal-Wallis test for multiple independent samples at baseline. Statistical significance was accepted at p<0.05. Post-baseline statistical analyses were done as repeated measures Analysis of Variance (rm-ANOVA) with a Greenhouse-Geisser correction. Items found to have statistical significance with rm-ANOVA were then compared using a Wilcoxon test for dependent samples. Statistical significance was accepted at p<0.05. Analysis of the primary outcome measure (the change from baseline in general pain levels) was conducted in the per protocol population. SPSS Statistics V19.0 was used for all statistical analyses [19].

Results

Patient recruitment began in March 2012 at six clinical sites in Germany and the final follow-up was conducted in July 2012. A total of forty-four subjects between the ages of 32 and 95 were enrolled with osteoarthritis of the knee and/or hip. Of these subjects, twenty-seven (61%) were female and seventeen (39%) were male. e treated joints consisted of knee (39), hip (14), ankle (3), both either knee and hip (10), or both knee and ankle (2). Of the thirty-nine subjects with knee OA, sixteen (40.0%) had bilateral incidence. Of the fourteen subjects with hip OA, seven (50.0%) had bilateral incidence. Patient demographics are reported in Table 1. All forty-four subjects completed baseline evaluations. Thirty-seven (84%) of the forty-four subjects completed the two-month study per the protocol. Compliance with the study treatment regimen was good.

Patient data was initially evaluated between sites to exclude site bias (not shown). As there were no abnormalities in these evaluations, the data were pooled for all subsequent analyses. A clinical comparison of valid subjects was carried out to obtain a mean baseline score for each of the ten questions from the patient questionnaire (Table 2). Statistical analysis of the primary outcome measure revealed that supplementation with NEM® produced a significant treatment response from baseline at 10 days (Q1-6 and Q9) (8.6% to 18.1% improvement) and at 30 and 60 days for all nine pain-related questions evaluated (22.4% to 35.6% improvement) (Table 3). Treatment response fell just shy of statistical significance at 10 days for Questions 7 and 8 (p=0.056 and p=0.064, respectively). Supplementation with NEM® produced a significant treatment response from baseline at 30 and 60 days for stiffness (Q10) (27.4% to 29.3% improvement). Greater than 59% of patients rated the efficacy of NEM® as good or very good (Table 4) following 60 days of supplementation. Physicians also rated the treatment effective in subjects, with greater than 75% having moderate or significant improvement from baseline after 60 days (Table 5). For the 30 days prior to study commencement, patients consumed on average 7.0 ± 6.0 doses of acetaminophen. Analgesic use had dropped considerably to 2.43 ± 2.69 doses (per 30 days) at 30 days of supplementation with NEM®. Analgesic use rebounded slightly to 3.59 ± 3.86 doses (per 30 days) by the end of the study at day 60. There were two adverse events reported during the study. One was a scratchy throat and was believed to be related to antibiotic use. e other was stomach discomfort which was believed to be related to the study material. ere were no serious adverse events reported during the study. The treatment was reported to be well tolerated by study participants with greater than 86% of patients rating NEM® tolerability as good or very good.

Discussion:

Joint and connective tissue disorders are quite common in Westernized countries [1,20] and result in significant costs, both financial [21] and quality-of-life [22], for those that suffer from the debilitating diseases. This open-label clinical trial was designed to evaluate the acceptability of this natural arthritis treatment with European orthopedic surgeons and patients and to validate the extension of the body of clinical evidence for NEM® from the United States to a European population through the evaluation of the efficacy, safety, and tolerability of NEM® brand eggshell membrane as a treatment option for osteoarthritis of the knee and/or hip. Results of the study indeed suggest that NEM® is both effective and safe for treating pain associated with osteoarthritis of the knee and/or hip in a European population.

Patients experienced relatively rapid (10 days) responses for pain- related questions with a mean response of approximately 14%. By the end of the follow-up period (60 days) the mean response for pain- related questions had more than doubled to approximately 33%. A brief responder analysis of the data provides a number of clinically relevant highlights. On average, nearly one-fourth of the subjects experienced a 30% improvement in pain-related questions within 10 days (Figure 1). And almost 20% of the study population experienced a 50% improvement in pain-related questions by the end of the study (60 days) (not shown). These results align well with results from previous clinical studies of NEM® that were conducted in the U.S. [6,7].

The safety pro le for NEM® is also of significance as this is the h clinical trial to date in which there have been no reports of serious adverse events associated with treatment. No side effects from consuming NEM® have thus far been identified, excluding the obvious egg allergy concern. This is of obvious importance in a condition such as osteoarthritis that requires long-term treatment.

e trial had a limited initial enrollment (44 subjects), however there was a relatively low drop-out rate (16%) and good treatment compliance. As the trial was also open label, there is the obvious issue of the placebo effect. The inclusion of a placebo control would have provided greater clinical meaning; however, it would have required a significantly larger study population.

Conclusions:

With so many people suffering from osteoarthritis of the knee and hip in Western populations, it is important for patients to have treatment options that are both safe and effective. The reporting of the results from this six center, open label German clinical study demonstrates that NEM® brand eggshell membrane may be a viable treatment option for the management of osteoarthritis of the knee and/or hip in the broader European population. In this clinical study, NEM®, 500mg taken once daily, significantly reduced pain, both rapidly (10 days) and continuously (60 days). It also showed clinically meaningful results from a brief responder analysis, demonstrating that a significant proportion of treated patients will bene t from NEM® supplementation.

Acknowledgement:

The study sponsor was Weber and Weber GmbH and Co. KG. UD, MS and RR are employed by the sponsor. WT and NB have no competing interests. The authors would like to acknowledge ESM Technologies, LLC for providing the powdered NEM® ingredient used to produce the study capsules for this trial.

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