Sean Moloughney10.01.10
Whether it’s aching knees, a bad back, a pounding migraine or the unrelenting effects of cancer, pain can be a debilitating quality of life issue that indiscriminately affects the physical and mental functioning of people from all walks of life.
According to the National Center for Health Statistics (NCHS), more than 76 million people in the U.S. suffer from chronic pain—more than who suffer from diabetes (24 million), heart disease (23 million) and cancer (11 million) combined.
An estimated 46 million adults in the U.S. report some form of doctor-diagnosed arthritis, rheumatoid arthritis, gout, lupus or fibromyalgia, according to the non-profit Arthritis Foundation. By 2030, that figure is projected to rise to about 67 million American adults. Interestingly, two-thirds of people who have doctor-diagnosed arthritis are under the age of 65.
The most common type of arthritis is osteoarthritis (OA), a degenerative joint disease characterized by the breakdown of the joint’s cartilage. This breakdown causes the bones to rub against each other, resulting in stiffness, pain and loss of movement in the joint. Nearly 27 million adults have OA, a number expected to increase with longer life expectancies, the obesity epidemic and the first of the more than 78 million Baby Boomers reaching retirement age in 2011.
Pain is not an isolated health condition. While half of all adults will develop symptomatic OA of the knee at some point in their lives, that risk increases to two of every three obese adults. Weight loss of as little as 11 pounds reduces the risk of developing OA of the knee among women by 50%.
In 2003, the total cost attributed to arthritis and other rheumatic conditions in the U.S. was $128 billion (more than the GDP of New Zealand), up from about $86 billion dollars in 1997, according to the Centers for Disease Control and Prevention (CDC). Those figures include $81 billion in medical expenditures (direct costs), up from $51 billion in 1997, and $47 billion in earnings losses (indirect costs), up from $35 billion in 1997.
According to a report from Business Insights, the global pain management market generated more than $46 billion in sales in 2007, a 12.5% increase over 2006. The most prevalent forms of neuropathic pain are neuralgia/fibromyalgia and lower back pain, with about 16 million cases for each condition during 2008. Analgesics (narcotics and non-narcotics) account for 43% of the global pain management market, with revenues of nearly $20 billion in 2007.
Citing a recent ABC News/USA Today/Stanford University Medical Center poll, Cheryl Myers, chief of scientific affairs and education for EuroPharma, Green Bay, WI, said more than half of Americans suffer from chronic or recurrent pain, and nearly half (46%) reported pain in the last two weeks. “That means the market for effective pain relief may be one out of every two Americans,” she noted.
Chris Haynes, director of sales, ESM Technologies, Carthage, MO, said there are plenty of opportunities in today’s market, which he believes is destined for future growth. “Pain is something everyone has at some level at certain points in their life. We can’t escape it. Showing consumers ways to get quick relief, naturally, with clinically proven results is the key to success.”
The Roots of Pain
As a warning signal following injury, inflammation and pain are normal. However, EuroPharma’s Ms. Myers said more consumers are realizing that chronic inflammation is not only a cause of pain and discomfort, but also a “root cause” of many serious, life-threatening illnesses, including cancer, heart disease, obesity, diabetes and arthritis. “Therefore, many individuals are looking for healthy alternatives to manage inflammation in their lives every day, whether they have pain or not.”
Inflammation is caused by the release of a hormone-like compound called prostaglandin (PGE1) and is sustained by the enzyme cyclooxygenase 2 (COX-2). Ideally, anti-inflammatory products would inhibit COX-2 without inhibiting COX-1, a good prostaglandin that protects blood vessels and the lining of the digestive tract.
Traditionally, non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin and ibuprofen have dominated the pain management category. However, while NSAIDs effectively inhibit COX-2, many also inhibit COX-1. So while they may offer an effective solution with short-term use, they may also cause serious side effects with prolonged use.
Alongside NSAIDs, acetaminophen is one of the most commonly used drugs in the U.S. for treating pain and fever. According to FDA, in 2005, consumers purchased more than 28 billion doses of products containing acetaminophen, and the hydrocodone–acetaminophen combination product has been the most frequently prescribed drug since 1997.
Acknowledging risks of liver damage and death from high doses of acetaminophen, the FDA’s Drug Safety and Risk Management Advisory Committee voted in June of 2009 to recommend a ban on two of the most popular prescription painkillers, Vicodin (hydrocodone and acetaminophen) and Percocet (oxycodone and acetaminophen). Vicodin and its generic equivalents are prescribed more than 100 million times a year in the U.S. The problem is, patients taking opioids over a long period of time typically build a tolerance, requiring higher doses to achieve the same effect.
To reduce the risk of liver damage, the committee also recommended that FDA lower the maximum daily dose of acetaminophen to less than 4 grams and the maximum single dose from 1000 mg to 650 mg.
Dean Mosca, president, Proprietary Nutritionals Inc. (PNI), Kearny, NJ, said concern regarding NSAIDs, as well as products containing acetaminophen, and their side effects has led to growing focus on preventative care, which positively impacts the dietary supplement market. “Pain management, overall, is growing tremendously. As one example, many chiropractors are extending their services to include therapeutic pain-management techniques. Pharmaceutical companies continue to launch and market all manner of pain-lessening drugs, and even yoga centers teach mental and physical exercise techniques to help the body adapt to and overcome pain.”
For example, in August the New England Journal of Medicine published a study that concluded the ancient Chinese practice of tai chi might be an effective therapy for fibromyalgia, a complex condition that affects 5 million Americans, mostly women, according to the CDC. After 12 weeks of tai chi, patients with fibromyalgia performed significantly better in measurements of pain, fatigue, physical functioning, sleeplessness and depression than a comparable group given stretching exercises and wellness education. Tai chi patients were also more likely to sustain improvement three months later.
In light of side effects associated with conventional NSAIDs and pain medications, Lakshmi Prakash, vice president of innovation and business development, Sabinsa Corporation, East Windsor, NJ, said, “Interest in natural approaches will continue to grow both in the human and pet supplement segments. Both nutritional and topical approaches will receive attention.”
Mr. Mosca agreed, noting that his company offers Celadrin, a proprietary blend of cetylated fatty acid esters and other active synergists, as a topical solution or oral supplement. “The topical form provides quick relief, in as few as 30 minutes, while the oral form provides more long-term joint support,” he said. “We see dietary supplements that address discomfort growing in the market as a non-invasive and non-side-effect-inducing part of an overall pain management strategy.”
Additionally, a clinical study of patients with knee pain showed PNI’s Perluxan, a hops extract, had a fast-acting effect on relieving discomfort—and significant improvement over placebo—after two hours following the first dose. Another pilot study demonstrated that Perluxan was comparable to ibuprofen in reducing pain-causing inflammatory enzymes, said Mr. Mosca.
Spelling Relief
With more consumers focused on general health and wellness goals, demand for post-exercise recovery products has gained significant strength, according to ESM’s Mr. Haynes. “Aging population demographics are obvious and in front of us every day,” he said. “A natural extension of an aging population is more people are looking to maintain a healthy lifestyle by exercising later into their lives. With this exercise there is going to be more pain and stiffness related symptoms. Workout regimens are getting more intense. Pain and soreness levels become standard, but workout enthusiasts are looking for quicker recovery times so they can get back in the gym.” Consumers are also more educated about their options, he added. “The ingredients or products with the best scientific results—that can market those results—win.”
As established stars of the natural pain relief market, glucosamine and chondroitin have gained support from clinical evidence that confirms their efficacy in combating osteoarthritis. U.S. consumer sales of glucosamine/chondroitin in 2009 totaled $800 million, down 4% from the previous year, according to Nutrition Business Journal (NBJ), Boulder, CO.
Glucosamine is a natural compound that is found in healthy cartilage. Glucosamine sulfate is a normal constituent of glycosaminoglycans in cartilage matrix and synovial fluid. According to the Natural Standard monograph for glucosamine, “Available evidence from randomized controlled trials supports the use of glucosamine sulfate in the treatment of osteoarthritis, particularly of the knee. It is believed that the sulfate moiety provides clinical benefit in the synovial fluid by strengthening cartilage and aiding glycosaminoglycan synthesis. If this hypothesis is confirmed, it would mean that only the glucosamine sulfate form is effective and non-sulfated glucosamine forms are not effective.”
Glucosamine is commonly taken in combination with chondroitin, a glycosaminoglycan derived from articular cartilage. But glucosamine may also treat OA in combination with other nutritional ingredients, such as omega 3 fatty acids, which have been recognized for their ability to combat inflammation.
Research published in Advances in Therapy in September 2009 studied a total of 177 patients with moderate to severe hip or knee OA who were tested during a period of 26 weeks in a two-center, two-armed, randomized, double-blind, comparison study. Researchers aimed to see if a combination of glucosamine sulfate (1500 mg/day) and the omega 3 polyunsaturated fatty acids EPA and DHA would be more effective than glucosamine sulfate alone.
Pain, stiffness and function were evaluated using the Western Ontario and McMaster Universities Arthritis index (WOMAC) score. Results indicated a therapeutic and statistical superiority for the combination product of glucosamine sulfate and omega 3 fatty acids in patients who complied with the study protocol.
Ben Winters, director of Christchurch-based Aroma New Zealand, said green lipped mussel powder is rich in omega 3 fatty acids, glucosamine sulfate and glycosaminoglycans, which reduce inflammation, pain and increase joint mobility.
“Our GlycOmega greenshell mussel powder is sourced from New Zealand greenshell mussel meat, Perna canaliculus, which is native to New Zealand and one of the most sustainable omega 3 fatty acid products in the world. We have been manufacturing and exporting GlycOmega for over 25 years into the joint care market and sales continue to increase every year as the positive pain relief effects take place. Joint pain is the biggest market for GlycOmega, for both humans and animals, as it provides natural anti-inflammatory activity.”
Research results for natural pain relief products have not always been positive. For example, glucosamine and chondroitin may have suffered somewhat of a setback following the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT). Results were published in the New England Journal of Medicine (NEJM) in February 2006.
The six-month study funded by the National Institutes of Health (NIH) involved nearly 1600 OA patients who were given a placebo or daily doses of 1500 mg of glucosamine hydrochloride and/or 1200 mg of chondroitin sulfate or 200 mg of the common NSAID celecoxib (Celebrex).
Overall, those taking celecoxib experienced statistically significant pain relief versus placebo—about 70% of those taking celecoxib had a 20% or greater reduction in pain versus about 60% for placebo. There were no significant differences between the other treatments tested and placebo, according to researchers.
However, for a subset of participants with moderate to severe pain, glucosamine combined with chondroitin sulfate provided statistically significant pain relief compared with placebo—about 79% had a 20% or greater reduction in pain versus about 54% for placebo. These findings prompted an ancillary GAIT study that later investigated whether these dietary supplements could diminish structural damage from OA of the knee.
In the ancillary study, interested GAIT patients were offered the opportunity to continue their original study treatment for an additional 18 months, for a total of 2 years. At the end of the study, the team had gathered data on 581 knees. After assessing X-ray data, researchers concluded glucosamine and chondroitin sulfate, together or alone, appeared to fare no better than placebo in slowing the loss of cartilage in OA of the knee. Interpreting the study results was complicated, however, because participants taking placebo had a smaller loss of cartilage, or joint space width, than predicted. Results were published in Arthritis & Rheumatism in October 2008.
A Matter of Lifestyle
Despite the results of GAIT, glucosamine and chondroitin remain popular alternatives to prescription and over-the-counter drugs, as consumers continue to look for joint health products that “fit their active lifestyles,” said Micah Osborne, president, ESM Technologies.
“They are asking for supplements that work faster and require a lower dose,” he continued. “You can see an example of this in a leading pain relief manufacturer’s new marketing campaign touting fewer pills per day for the same results as its leading competitor. The same holds true for supplements; consumers want the same or better results in fewer and smaller dosages and with the safety of natural products. They are also asking for more convenient dosage forms. This would include beverages, bars or chews, which fit their active lifestyles.”
Sabinsa’s Dr. Prakash, agreed, saying, “As functional foods become more accepted, premixed beverages, granules, candies and other food forms are becoming popular for a variety of health conditions.”
Mr. Osborne reiterated that consumers are asking for convenient joint health products that offer results in less time with smaller doses. “Products made with NEM (Natural Eggshell Membrane) not only have been proven to be efficacious for improving joint comfort and flexibility in as little as 7 to 10 days, but they also come in a very convenient dosage of one small, 500 mg pill per day.”
Consumers are also looking for controlled clinical studies or comparisons with known analgesics, said Dr. Prakash. “Current trends favor supplements supported by sound clinical studies and safety information.” Pet care supplements in this category are also gaining attention, she added.
Referring to several natural ingredients supported by clinical evidence, Dr. Prakash said a recent clinical study showed ginger may support pain management in muscle injury after exercise, “offering athletes a natural option.” Ginger extract has also been shown to offer support in managing migraines and joint inflammation.
“Earlier studies established the healthful role of Boswellia serrata extract (Indian frankincense) in supporting the management of symptoms of osteoarthritis, including pain,” she added.
Sabinsa offers a proprietary, sustained release blend comprising Boswellin (Boswellia serrata extract), Curcumin C3 Complex (turmeric root extract), glucosamine and Bioperine (black pepper extract, a nutrient bioavailability enhancer), which showed significant improvement in subjects with knee OA, and reduced pain and swelling scores. “These are examples of supplements that function like NSAIDs without the associated gastrointestinal side effects,” said Dr. Prakash. “They are also suitable for topical use.”
In addition, capsaicinoids (from hot chili peppers) are often used to provide topical pain relief in over-the-counter creams, she noted. “Several botanical oils soothe and offer pain management support (e.g., celery seed oil, clove oil, lavender oil, olibanum oil and others). White willow bark, devil’s claw and other materials with a history of traditional use and scientific data, and nutritional approaches such as magnesium salts and omega 3 fatty acids, appear in supplements as well.”
Curcumin, a compound derived from the popular Indian spice turmeric, inhibits multiple inflammation pathways in the body, according to Europharma. Some of the benefits associated with curcumin include immune system modulation, protection from oxidative stress and support for the body’s natural anti-inflammatory response. According to NBJ, sales of turmeric were up 38% in 2009 to $60 million.
EuroPharma’s Curamin combines BCM-95 bioavailable curcumin, “which has seven to 10 times the absorption of plain curcumin,” said the company’s Ms. Myers. “Known for its ability to balance the body’s natural inflammatory response, BCM-95 has been proven in published clinical studies to provide consistent, long-lasting effects. Curamin also contains a potent form of the anti-inflammatory herb boswellia, as well as Dl-phenylalanine (DLPA) for its ability to sustain endorphins and enkephalins in the brain, and the enzyme nattokinase, which supports healthy circulation so that important nutrients can be better carried to the areas of need, and waste materials more efficiently removed.”
Studies also indicate collagen can play a role in relieving pain associated with OA. According to BioCell Technology LLC, Newport Beach, CA, a new human study involving 80 patients supports previous evidence that its BioCell Collagen II improves various physical activities of subjects suffering from joint conditions associated with OA, including pain, stiffness, mobility and overall quality of life. The multicenter, double-blind, placebo-controlled trial indicated that a significant portion of OA patients experienced substantial improvement of their joint conditions, as measured by VAS and WOMAC scores.
Other popular joint pain ingredients include MSM (methylsulfonylmethane), which brought in $90 million in U.S. sales for 2009, according to NBJ. However, that figure is down 10% from the previous year. SAMe (S-adenosyl methionine), which was recently shown to help depressed patients who don’t respond to prescription antidepressant treatment, also helps reduce the pain associated with OA. SAMe generated $120 million in sales in 2009, up 11%.
Larry Kolb, president, U.S. operations, TSI Health Sciences, Inc., Missoula, MT, said he believes the most sought after indication areas will continue to include joint pain, headaches, lower back pain and muscle pain. However, he acknowledged a lack of innovation that has kept category growth down. “It’s a crowded marketplace with multiple brands and little innovation in terms of new ingredients that are proven. I believe the category will continue to grow in the single digits over the next five years, but it has matured and the large growth rates will not come until alternative ingredients bring innovation to the category.”
According to the National Center for Health Statistics (NCHS), more than 76 million people in the U.S. suffer from chronic pain—more than who suffer from diabetes (24 million), heart disease (23 million) and cancer (11 million) combined.
An estimated 46 million adults in the U.S. report some form of doctor-diagnosed arthritis, rheumatoid arthritis, gout, lupus or fibromyalgia, according to the non-profit Arthritis Foundation. By 2030, that figure is projected to rise to about 67 million American adults. Interestingly, two-thirds of people who have doctor-diagnosed arthritis are under the age of 65.
The most common type of arthritis is osteoarthritis (OA), a degenerative joint disease characterized by the breakdown of the joint’s cartilage. This breakdown causes the bones to rub against each other, resulting in stiffness, pain and loss of movement in the joint. Nearly 27 million adults have OA, a number expected to increase with longer life expectancies, the obesity epidemic and the first of the more than 78 million Baby Boomers reaching retirement age in 2011.
Pain is not an isolated health condition. While half of all adults will develop symptomatic OA of the knee at some point in their lives, that risk increases to two of every three obese adults. Weight loss of as little as 11 pounds reduces the risk of developing OA of the knee among women by 50%.
In 2003, the total cost attributed to arthritis and other rheumatic conditions in the U.S. was $128 billion (more than the GDP of New Zealand), up from about $86 billion dollars in 1997, according to the Centers for Disease Control and Prevention (CDC). Those figures include $81 billion in medical expenditures (direct costs), up from $51 billion in 1997, and $47 billion in earnings losses (indirect costs), up from $35 billion in 1997.
According to a report from Business Insights, the global pain management market generated more than $46 billion in sales in 2007, a 12.5% increase over 2006. The most prevalent forms of neuropathic pain are neuralgia/fibromyalgia and lower back pain, with about 16 million cases for each condition during 2008. Analgesics (narcotics and non-narcotics) account for 43% of the global pain management market, with revenues of nearly $20 billion in 2007.
Citing a recent ABC News/USA Today/Stanford University Medical Center poll, Cheryl Myers, chief of scientific affairs and education for EuroPharma, Green Bay, WI, said more than half of Americans suffer from chronic or recurrent pain, and nearly half (46%) reported pain in the last two weeks. “That means the market for effective pain relief may be one out of every two Americans,” she noted.
Chris Haynes, director of sales, ESM Technologies, Carthage, MO, said there are plenty of opportunities in today’s market, which he believes is destined for future growth. “Pain is something everyone has at some level at certain points in their life. We can’t escape it. Showing consumers ways to get quick relief, naturally, with clinically proven results is the key to success.”
The Roots of Pain
As a warning signal following injury, inflammation and pain are normal. However, EuroPharma’s Ms. Myers said more consumers are realizing that chronic inflammation is not only a cause of pain and discomfort, but also a “root cause” of many serious, life-threatening illnesses, including cancer, heart disease, obesity, diabetes and arthritis. “Therefore, many individuals are looking for healthy alternatives to manage inflammation in their lives every day, whether they have pain or not.”
Inflammation is caused by the release of a hormone-like compound called prostaglandin (PGE1) and is sustained by the enzyme cyclooxygenase 2 (COX-2). Ideally, anti-inflammatory products would inhibit COX-2 without inhibiting COX-1, a good prostaglandin that protects blood vessels and the lining of the digestive tract.
Traditionally, non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin and ibuprofen have dominated the pain management category. However, while NSAIDs effectively inhibit COX-2, many also inhibit COX-1. So while they may offer an effective solution with short-term use, they may also cause serious side effects with prolonged use.
Alongside NSAIDs, acetaminophen is one of the most commonly used drugs in the U.S. for treating pain and fever. According to FDA, in 2005, consumers purchased more than 28 billion doses of products containing acetaminophen, and the hydrocodone–acetaminophen combination product has been the most frequently prescribed drug since 1997.
Acknowledging risks of liver damage and death from high doses of acetaminophen, the FDA’s Drug Safety and Risk Management Advisory Committee voted in June of 2009 to recommend a ban on two of the most popular prescription painkillers, Vicodin (hydrocodone and acetaminophen) and Percocet (oxycodone and acetaminophen). Vicodin and its generic equivalents are prescribed more than 100 million times a year in the U.S. The problem is, patients taking opioids over a long period of time typically build a tolerance, requiring higher doses to achieve the same effect.
To reduce the risk of liver damage, the committee also recommended that FDA lower the maximum daily dose of acetaminophen to less than 4 grams and the maximum single dose from 1000 mg to 650 mg.
Dean Mosca, president, Proprietary Nutritionals Inc. (PNI), Kearny, NJ, said concern regarding NSAIDs, as well as products containing acetaminophen, and their side effects has led to growing focus on preventative care, which positively impacts the dietary supplement market. “Pain management, overall, is growing tremendously. As one example, many chiropractors are extending their services to include therapeutic pain-management techniques. Pharmaceutical companies continue to launch and market all manner of pain-lessening drugs, and even yoga centers teach mental and physical exercise techniques to help the body adapt to and overcome pain.”
For example, in August the New England Journal of Medicine published a study that concluded the ancient Chinese practice of tai chi might be an effective therapy for fibromyalgia, a complex condition that affects 5 million Americans, mostly women, according to the CDC. After 12 weeks of tai chi, patients with fibromyalgia performed significantly better in measurements of pain, fatigue, physical functioning, sleeplessness and depression than a comparable group given stretching exercises and wellness education. Tai chi patients were also more likely to sustain improvement three months later.
In light of side effects associated with conventional NSAIDs and pain medications, Lakshmi Prakash, vice president of innovation and business development, Sabinsa Corporation, East Windsor, NJ, said, “Interest in natural approaches will continue to grow both in the human and pet supplement segments. Both nutritional and topical approaches will receive attention.”
Mr. Mosca agreed, noting that his company offers Celadrin, a proprietary blend of cetylated fatty acid esters and other active synergists, as a topical solution or oral supplement. “The topical form provides quick relief, in as few as 30 minutes, while the oral form provides more long-term joint support,” he said. “We see dietary supplements that address discomfort growing in the market as a non-invasive and non-side-effect-inducing part of an overall pain management strategy.”
Additionally, a clinical study of patients with knee pain showed PNI’s Perluxan, a hops extract, had a fast-acting effect on relieving discomfort—and significant improvement over placebo—after two hours following the first dose. Another pilot study demonstrated that Perluxan was comparable to ibuprofen in reducing pain-causing inflammatory enzymes, said Mr. Mosca.
Spelling Relief
With more consumers focused on general health and wellness goals, demand for post-exercise recovery products has gained significant strength, according to ESM’s Mr. Haynes. “Aging population demographics are obvious and in front of us every day,” he said. “A natural extension of an aging population is more people are looking to maintain a healthy lifestyle by exercising later into their lives. With this exercise there is going to be more pain and stiffness related symptoms. Workout regimens are getting more intense. Pain and soreness levels become standard, but workout enthusiasts are looking for quicker recovery times so they can get back in the gym.” Consumers are also more educated about their options, he added. “The ingredients or products with the best scientific results—that can market those results—win.”
As established stars of the natural pain relief market, glucosamine and chondroitin have gained support from clinical evidence that confirms their efficacy in combating osteoarthritis. U.S. consumer sales of glucosamine/chondroitin in 2009 totaled $800 million, down 4% from the previous year, according to Nutrition Business Journal (NBJ), Boulder, CO.
Glucosamine is a natural compound that is found in healthy cartilage. Glucosamine sulfate is a normal constituent of glycosaminoglycans in cartilage matrix and synovial fluid. According to the Natural Standard monograph for glucosamine, “Available evidence from randomized controlled trials supports the use of glucosamine sulfate in the treatment of osteoarthritis, particularly of the knee. It is believed that the sulfate moiety provides clinical benefit in the synovial fluid by strengthening cartilage and aiding glycosaminoglycan synthesis. If this hypothesis is confirmed, it would mean that only the glucosamine sulfate form is effective and non-sulfated glucosamine forms are not effective.”
Glucosamine is commonly taken in combination with chondroitin, a glycosaminoglycan derived from articular cartilage. But glucosamine may also treat OA in combination with other nutritional ingredients, such as omega 3 fatty acids, which have been recognized for their ability to combat inflammation.
Research published in Advances in Therapy in September 2009 studied a total of 177 patients with moderate to severe hip or knee OA who were tested during a period of 26 weeks in a two-center, two-armed, randomized, double-blind, comparison study. Researchers aimed to see if a combination of glucosamine sulfate (1500 mg/day) and the omega 3 polyunsaturated fatty acids EPA and DHA would be more effective than glucosamine sulfate alone.
Pain, stiffness and function were evaluated using the Western Ontario and McMaster Universities Arthritis index (WOMAC) score. Results indicated a therapeutic and statistical superiority for the combination product of glucosamine sulfate and omega 3 fatty acids in patients who complied with the study protocol.
Ben Winters, director of Christchurch-based Aroma New Zealand, said green lipped mussel powder is rich in omega 3 fatty acids, glucosamine sulfate and glycosaminoglycans, which reduce inflammation, pain and increase joint mobility.
“Our GlycOmega greenshell mussel powder is sourced from New Zealand greenshell mussel meat, Perna canaliculus, which is native to New Zealand and one of the most sustainable omega 3 fatty acid products in the world. We have been manufacturing and exporting GlycOmega for over 25 years into the joint care market and sales continue to increase every year as the positive pain relief effects take place. Joint pain is the biggest market for GlycOmega, for both humans and animals, as it provides natural anti-inflammatory activity.”
Research results for natural pain relief products have not always been positive. For example, glucosamine and chondroitin may have suffered somewhat of a setback following the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT). Results were published in the New England Journal of Medicine (NEJM) in February 2006.
The six-month study funded by the National Institutes of Health (NIH) involved nearly 1600 OA patients who were given a placebo or daily doses of 1500 mg of glucosamine hydrochloride and/or 1200 mg of chondroitin sulfate or 200 mg of the common NSAID celecoxib (Celebrex).
Overall, those taking celecoxib experienced statistically significant pain relief versus placebo—about 70% of those taking celecoxib had a 20% or greater reduction in pain versus about 60% for placebo. There were no significant differences between the other treatments tested and placebo, according to researchers.
However, for a subset of participants with moderate to severe pain, glucosamine combined with chondroitin sulfate provided statistically significant pain relief compared with placebo—about 79% had a 20% or greater reduction in pain versus about 54% for placebo. These findings prompted an ancillary GAIT study that later investigated whether these dietary supplements could diminish structural damage from OA of the knee.
In the ancillary study, interested GAIT patients were offered the opportunity to continue their original study treatment for an additional 18 months, for a total of 2 years. At the end of the study, the team had gathered data on 581 knees. After assessing X-ray data, researchers concluded glucosamine and chondroitin sulfate, together or alone, appeared to fare no better than placebo in slowing the loss of cartilage in OA of the knee. Interpreting the study results was complicated, however, because participants taking placebo had a smaller loss of cartilage, or joint space width, than predicted. Results were published in Arthritis & Rheumatism in October 2008.
A Matter of Lifestyle
Despite the results of GAIT, glucosamine and chondroitin remain popular alternatives to prescription and over-the-counter drugs, as consumers continue to look for joint health products that “fit their active lifestyles,” said Micah Osborne, president, ESM Technologies.
“They are asking for supplements that work faster and require a lower dose,” he continued. “You can see an example of this in a leading pain relief manufacturer’s new marketing campaign touting fewer pills per day for the same results as its leading competitor. The same holds true for supplements; consumers want the same or better results in fewer and smaller dosages and with the safety of natural products. They are also asking for more convenient dosage forms. This would include beverages, bars or chews, which fit their active lifestyles.”
Sabinsa’s Dr. Prakash, agreed, saying, “As functional foods become more accepted, premixed beverages, granules, candies and other food forms are becoming popular for a variety of health conditions.”
Mr. Osborne reiterated that consumers are asking for convenient joint health products that offer results in less time with smaller doses. “Products made with NEM (Natural Eggshell Membrane) not only have been proven to be efficacious for improving joint comfort and flexibility in as little as 7 to 10 days, but they also come in a very convenient dosage of one small, 500 mg pill per day.”
Consumers are also looking for controlled clinical studies or comparisons with known analgesics, said Dr. Prakash. “Current trends favor supplements supported by sound clinical studies and safety information.” Pet care supplements in this category are also gaining attention, she added.
Referring to several natural ingredients supported by clinical evidence, Dr. Prakash said a recent clinical study showed ginger may support pain management in muscle injury after exercise, “offering athletes a natural option.” Ginger extract has also been shown to offer support in managing migraines and joint inflammation.
“Earlier studies established the healthful role of Boswellia serrata extract (Indian frankincense) in supporting the management of symptoms of osteoarthritis, including pain,” she added.
Sabinsa offers a proprietary, sustained release blend comprising Boswellin (Boswellia serrata extract), Curcumin C3 Complex (turmeric root extract), glucosamine and Bioperine (black pepper extract, a nutrient bioavailability enhancer), which showed significant improvement in subjects with knee OA, and reduced pain and swelling scores. “These are examples of supplements that function like NSAIDs without the associated gastrointestinal side effects,” said Dr. Prakash. “They are also suitable for topical use.”
In addition, capsaicinoids (from hot chili peppers) are often used to provide topical pain relief in over-the-counter creams, she noted. “Several botanical oils soothe and offer pain management support (e.g., celery seed oil, clove oil, lavender oil, olibanum oil and others). White willow bark, devil’s claw and other materials with a history of traditional use and scientific data, and nutritional approaches such as magnesium salts and omega 3 fatty acids, appear in supplements as well.”
Curcumin, a compound derived from the popular Indian spice turmeric, inhibits multiple inflammation pathways in the body, according to Europharma. Some of the benefits associated with curcumin include immune system modulation, protection from oxidative stress and support for the body’s natural anti-inflammatory response. According to NBJ, sales of turmeric were up 38% in 2009 to $60 million.
EuroPharma’s Curamin combines BCM-95 bioavailable curcumin, “which has seven to 10 times the absorption of plain curcumin,” said the company’s Ms. Myers. “Known for its ability to balance the body’s natural inflammatory response, BCM-95 has been proven in published clinical studies to provide consistent, long-lasting effects. Curamin also contains a potent form of the anti-inflammatory herb boswellia, as well as Dl-phenylalanine (DLPA) for its ability to sustain endorphins and enkephalins in the brain, and the enzyme nattokinase, which supports healthy circulation so that important nutrients can be better carried to the areas of need, and waste materials more efficiently removed.”
Studies also indicate collagen can play a role in relieving pain associated with OA. According to BioCell Technology LLC, Newport Beach, CA, a new human study involving 80 patients supports previous evidence that its BioCell Collagen II improves various physical activities of subjects suffering from joint conditions associated with OA, including pain, stiffness, mobility and overall quality of life. The multicenter, double-blind, placebo-controlled trial indicated that a significant portion of OA patients experienced substantial improvement of their joint conditions, as measured by VAS and WOMAC scores.
Other popular joint pain ingredients include MSM (methylsulfonylmethane), which brought in $90 million in U.S. sales for 2009, according to NBJ. However, that figure is down 10% from the previous year. SAMe (S-adenosyl methionine), which was recently shown to help depressed patients who don’t respond to prescription antidepressant treatment, also helps reduce the pain associated with OA. SAMe generated $120 million in sales in 2009, up 11%.
Larry Kolb, president, U.S. operations, TSI Health Sciences, Inc., Missoula, MT, said he believes the most sought after indication areas will continue to include joint pain, headaches, lower back pain and muscle pain. However, he acknowledged a lack of innovation that has kept category growth down. “It’s a crowded marketplace with multiple brands and little innovation in terms of new ingredients that are proven. I believe the category will continue to grow in the single digits over the next five years, but it has matured and the large growth rates will not come until alternative ingredients bring innovation to the category.”
