Prince Edward Island became the first province in Canada to extend its publicly funded school-based HPV vaccination program to boys. The program will use GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine], the only HPV vaccine indicated and recommended for boys and men. In 2007, The National Advisory Committee on Immunization (NACI) recommended the quadrivalent HPV vaccine to protect Canadian girls and women aged 9 to 26 against a broad spectrum of HPV-related diseases. In 2012, NACI updated and strengthened its statement related to the use of HPV vaccines and recommended the use of the quadrivalent HPV vaccine in males between 9 to 26 years of age. A national survey conducted in March 2011 by Ipsos Reid, commissioned by Merck, showed that 85% of parents of males would allow their son to get vaccinated against HPV if it was offered through a publicly-funded program at his school, 88% of parents support the assertion that boys should be vaccinated against HPV in the same program as girls, and 91% of parents agree that vaccinating both boys and girls against HPV would provide greater protection than vaccinating girls alone.
Seroyal complying with Heath Canada’s NHPD Regulations
In 2004, Health Canada introduced The Natural Health Products Directorate (NHPD) as the regulating authority for natural health products in Canada. As per the Regulations, manufacturers were granted 10 years to secure mandatory product licenses and site licenses. For the last 10 years, Seroyal has worked closely with Health Canada to secure these licenses. As of May 2013, 100% of Seroyal’s sites have been licensed and 99.3% of their 1,688 products have secured Natural Health Product numbers (NHPs) and Homeopatic Medicine Numbers (DIN- HM). Seroyal will achieve 100% compliance well in advance of the September 2014 date set by Health Canada. As leaders in the natural health product industry, Seroyal is committed to providing practitioners with safe, effective products that they can trust. Seroyal’s commitment to Good Manufacturing Practices and the highest quality assurance standards sets them apart as an industry leader.
Vitality provides Business Update
Vitality attended and exhibited at the 2013 Canadian Health Food Association (CHFA) West Conference and Trade Show at the Vancouver Convention Centre, West Building, Vancouver, BC. The Company is a member of CHFA, Canada’s largest trade association dedicated to natural health and organic products. CHFA West is one of Canada’s largest trade shows for the natural health and organics industry. According to CHFA, the natural health product industry contributes $3 billion, and the organics product industry contributes $2 billion, to the Canadian economy. The Company had the opportunity to meet with retailers and provide information regarding select Vitality products and the Company’s new branding was unveiled. The Company is currently investigating opportunities to market and distribute its 90 products, including products with time release vitamins and minerals formulations.
World’s First Treatment of Local Prostrate Cancer
Research facilitated by Lawson Health Research Institute at the London Health Sciences Centre (LHSC) has resulted in a new minimally invasive treatment option for patients with localized prostate cancer. Transurethral magnetic resonance (MR) guided ultrasound ablation treatment uses a new ablation device that uses thermal ultrasound therapy with real-time MR image guidance to eliminate cancer cells in the prostate gland. It provides physicians with a 360 degree viewing angle that allows the whole prostate gland to be treated in one session and with great accuracy. This reduces the significant long-term complications that normally accompany conventional treatments and also benefits patients with a smaller amount of cancer that is less likely to spread. The first procedure was done as part of a clinical trial approved by Health Canada and sponsored by Profound Medical Inc. with subsequent treatments performed in an experimental setting. An upcoming clinical trial will treat 30 patients with localized prostate cancer and follow their progress for the course of a year.
BD Announces Launch of BD UltraSafe PLUSTM Passive Needle Guard
BD Medical, a segment of the leading global medical technology company, announced the commercial launch of a new passive needle guard technology, BD UltraSafe PLUSTM. The BD UltraSafe PLUSTM Passive Needle Guard has received 510(k) clearance as an anti-needlestick safety device. This product, in addition to offering needlestick safety in an easy-to-use one- handed device, is enhanced with ergonomic features designed to facilitate comfort and support for healthcare providers and patients. In addition, this safety device is designed to meet increasingly complex biotechnology drug requirements, including higher viscosity. The BD UltraSafe PLUSTM Passive Needle Guard provides many advanced features including a robust plunger rod to help support injection of viscous drugs, a larger drug inspection window to improve drug visibility, extended built-in finger flanges and an enhanced plunger head for improved injection support and stability. These ergonomic improvements provide support for all users, including patients with diminished manual dexterity. BD recently conducted a clinical focus group with patients who had reduced dexterity and also suffered from rheumatoid arthritis and multiple sclerosis. Subjects reported that the BD UltraSafe PLUSTM Passive Needle Guard provided ease of use with 100% of injections executed successfully.
Health Canada Approves Genestra Brands® Health Claims for IBS Relief and Post Antibiotic Therapy
Genestra Brands® announced today that Health Canada has approved two significant claims related to its proprietary Human Micro Flora (“HMF”) probiotics – “Signicant reduction in the symptoms of irritable bowel syndrome (“IBS”)” and Effective supplementation of normal intestinal microbiota following antibiotic therapy”. Based on these claims, HMF IBS ReliefTM and HMF Antibiotic CareTM were recently launched in Canada. “Considering that few products in the market target these specific conditions, we are pleased to receive Health Canada’s approval for the two claims related to the treatment of IBS and to post- antibiotic recovery. This is another example of our ongoing commitment to incorporate safe and effective formulas that reflect the latest evidence- based research. Under the direction of Dr. Nigel Plummer, Genestra Brands® HMF strains were meticulously selected and diligently tested in double- blind placebo controlled clinical trials” said Yves Yau, President as Seroyal.
Farid Wassef, BSc Pharm, RPh
Bridging the gap
Farid Wassef is a second generation pharmacist born and raised in the Stouffville, Ontario area. The pharmacy was first opened by Farid’s father in 1974, which Farid undertook management of in 1989. In 2006, Farid felt it appropriate to merge with the local IGA pharmacy team, and has been partnered with them since. Farid tells a tale that is familiar to IHP readers, of an interest in something other than conventional medicine from an early stage of training, his personal interest leading him to seminars hosted by the likes of Wright and Gaby, and culminating in the decision to offer services of integrative medicine very early on in his career. The very unique twist to this story is that Farid is offering these services as a pharmacist, not the designation(s) we are accustomed to as a provider of integrative medicine.
Farid Wassef is a second generation pharmacist who has worked and lived in Stouffville, Ontario for over 40 years. The family pharmacy was owned by Farid’s father Lou in 1974, which Farid took over in 1989 upon graduation. In 1993, Farid opened a patient consultation practice, which involved integrating lifestyle changes, nutrition, and natural health products with pharmaceutical care. In 2006, Farid merged his pharmacy with his colleague’s at Stouffville IDA Pharmacy, where Farid continues to practice integrative medicine. Farid graduated from the prestigious Massachusetts College of Pharmacy in 1989 and quickly undertook the role of management of the family pharmacy. By 1993, Farid had built an office within the pharmacy and was actively seeing patients.
“I was very frustrated by a model that only allowed a couple of minutes to interact with a patient at the pharmacy counter” describes Farid. “That doesn’t provide the opportunity for any sort of counselling whatsoever!” It was surprising to hear this familiar story from a pharmacist! I was personally unaware of how a pharmacist would justify the practice of integrative medicine under the license of a pharmacist… Farid was eager to clarify. “Within the scope of practice of pharmacy, a pharmacist is permitted to counsel on prevention and treatment of disease, counsel on diet, lifestyle, nutritional/ nutraceutical supplements, botanical medicines, and of course pharmaceutical drugs. While pharmacist may not be permitted the act of diagnosis, I found many MD’s in the Stouffville and surrounding area eager to collaborate with an objective and evidence- based person providing good information on natural medicines. Through these collaborations we were able to offer patients a broad array of integrative diagnostic techniques in addition to standard laboratory procedures.”
Farid was not satisfied with his role as pharmacist and practitioner… He was driven to spread the word to other pharmacists, MD’s, and anyone else who would listen as to the power of diet and lifestyle in health promotion, disease prevention, and disease treatment, and eager to educate his fellow pharmacists as to the role they can and should be playing in their patients care. Working with the Institute of Functional Medicine (whom Farid credits with providing most of the training he relies upon as a practitioner of integrative medicine), Farid created a continuing education curriculum for pharmacists to receive training in integrative medicine. He has likewise lectured across North America to predominantly pharmacists and MD’s regarding application of integrative medicine, and methods through which integrative minded pharmacists can successfully collaborate with MD’s in their community. His immense efforts to move the discipline of integrative medicine forward earned him the 2006 award for Canadian Pharmacist of the Year.
While juggling the roles of a pharmacy manager, seeing 80+ patients per week, authoring over 200 articles, CE courses, and books (including Breaking the Age Barrier – Strategies for Optimal Health, Longevity, and Energy published by Penguin in 2003), and his ongoing industry consulting and speaking engagements, yet another intriguing path caught Farid’s eye; politics. The idea of impacting healthcare from a “top down” approach made a lot of sense to him! Farid slowly moulded his career to be able to take on the workload politics would entail; he sold ownership of the pharmacy and merged with the local IDA team, where he maintains an office and his practice to this day… He cut back on time with patients, yet maintains an important practice within the Stouffville IDA pharmacy, and continues to welcome public speaking arrangements, although at a reduced rate than in the past. It was 2009 when Farid first actively participated in a political role, attempting to block proposed cuts to the healthcare system (that subsequently came into effect in 2010). The final straw that brought Farid to action was the interpretation that the $1.2 billion e-health scandal is what necessitated healthcare cuts in the first place!

“I was very frustrated by a model that only allowed a couple of minutes to interact with a patient at the pharmacy counter”
The PC party of Ontario approached Farid in 2010 after witnessing his passion and determination to effect change, and in 2011 he secured his nomination as the PC candidate for the riding of Stouffville, Markham, Richmond Hill, and King townships. He lost the 2011 election to the incumbent Liberal candidate. Farid Wassef has been re-nominated and will stand in the next general election as the PC Candidate of Oak Ridges-Markham for Member of Provincial Parliament. Farid is determined to improve our healthcare system, which he believes should focus more on disease prevention and extending an individual’s functional health span.
It was a special experience to visit the Stouffville IDA where Farid continues to base himself and see patients. The pharmacy runs as any conventional pharmacy can be expected to run, yet adjacent to where the pharmacists operate is a segregated office area where Farid conducts patient visits. In the absence of Farid’s influence over the years, the pharmacy team likely would have little to zero interest in integrative medicine. Yet through years of observation of Farid’s practice, the entire pharmacy team at Stouffville IDA has a unique, welldeveloped, intrigue/ interest in the role of integrative medicine in today’s healthcare system. Also of tremendous interest were the unique offerings of natural health products by the pharmacy. Brands not typically associated with pharmacy were made available for the public, clearly guided by Farid over the years yet managed by the conventionally practicing pharmacists of the facility. Also, and near to my heart, the current owner of the facility is a fan of history of medicine. His pharmacy is lined with paraphernalia and artifacts from generations of pharmacists, including tincture bottles that must be over 100 years old, historical instruments of the profession, and photos of a graduating class of pharmacists from the very early 1900’s.
Apparently the individual who founded the first ever pharmacy in Stouffville is pictured in the photo. IHP is grateful to Farid Wasef and the entire Stouffville IDA team for taking the time to allow us to showcase their efforts to you. Farid may not have the expected credentials of a practitioner of integrative medicine, yet he delivers the service at a level equal to and beyond that of anyone in the field. Like so many professionals IHP has had the privilege of showcasing, the practice of integrative medicine begins, grows, and thrives through one common seed; passion! Passion to help others, to solve mysteries common- place answers simply don’t make sense for, and ultimately to achieve maximal positive impact for people using the least invasive strategy available. Farid has educated thousands of healthcare providers in this area. He has now turned his attention to the political arena, in hopes of bringing further change through legislation, hopeful the clinical aspect of thing resides in good hands. We wish you much success Farid in helping to bring healthcare reform we at IHP agree is desperately required.
Mill Creek Botanicals
Mill Creek Botanicals
For any new venture, 38 years in business is hard to fathom. Getting to that point with an all-star product line backed by extremely consistent quality and delivery makes the task seem even more difficult. For Mill Creek Botanicals CEO Panch Prasad, building the Mill Creek brand into one of the most recognized in the natural health field has been a journey of passion.
When Prasad purchased Mill Creek in early 2000, he had big plans. The trained chemist and natural product advocate had spent 10 years representing the brand as an independent broker. He personally used many of the products himself and thought there was still potential to grow the brand’s lineup and expand its market share. Today, Mill Creek is a global brand found in more than 45 countries that enjoys a high level of brand awareness in the natural products industry.
While Mill Creek had a complete product line a decade ago, Prasad’s drive for innovation and growth has helped it grow to more than 100 SKU’s. The company also introduced Mill Creek Baby, a collection of proprietary tear-free formulations for moisturizing, cleansing and relieving sensitive skin without harmful additives. The idea for a baby line came to Prasad from personal experience. He has two grandchildren and a new baby of his own and found so many formulas weren’t as clean and natural as they claimed. Mill Creek could do better he thought. And it did.
“Babies are so innocent, and it can be so frustrating when you see their skin become irritated because a formulation isn’t as natural as it says it is on the bottle,” Prasad says.
Prasad’s drive to add more unique proprietary formulations also led to his creating another Mill Creek sub-category, Novacell, a new Plant Stem Cell rejuvenating solution. Using advanced natraceutical technology, this product is formulated with mung bean plant stem cells, peptides and antioxidants. The line’s daily cleanser, facial serum, eye balm, night cream and day lotion are created with the unique characteristic to self-regenerate as a complete & functional entity to fight aging while maintaining natural integrity and the environment.
“I love growing a company, but it’s important to me that we do it right. We still continue to search for the best, purest ingredients that can be used in a way that is respectful of the environment from which they came,” Prasad says.
With its many unique and proprietary formulations, Mill Creek also adheres to strict PETA (People for the Ethical Treatment of Animals) guidelines with all their products. Above all, Prasad says Mill Creek has been able to separate itself from the competition for two reasons – quality and price.
“Great health and great natural products should not only be for the upper class.” Prasad adds, “our greatest challenge in this industry is creating the best products at a price everyone can afford. I’m proud of the fact that Mill Creek has been doing that for quite some time.”
Started in 1975, Mill Creek has gained its share of industry recognition. Most recently in 2013 it won Delicious Livings best beauty and body award; in 2009 and 2010 it won the Best of Beauty Award from Better Nutrition Magazine. In 2003, it won a Natural Products Showcase Award for best packaging and its environmentally sensitive practices at the Natural Product Expo. Once again, in 2011 & 2012, Mill Creek won Natural Choice Awards from Whole Foods Magazine.
With its global reach to more than 45 countries, including Asia, Europe and South America, the Nevada-based company is a prominent U.S. exporter. In 2007, Prasad was recognized with the “Exporter of the Year” award from the U.S. Department of Commerce.
Prasad believes the company has an obligation to give back to its community. Mill Creek supports the Mayo Clinic for its Cancer and Parkinson’s disease research and is involved with Vitamin Angels, a global initiative that helps undernourished children achieve better health with natural supplements. Mill Creek also donates to local Nevada charities. IHR
Remembering A Health Food Pioneer: Willie Pelzer
Remembering A Health Food Pioneer
Willie Pelzer
1934-2013
By Lio Perron
The life story of the man affectionately known as the “Granola King” is a compelling one. Born in a German family from Lemberg, Poland, Withold Pelzer sailed across the Atlantic to chart a new life in North America after the end of the Second World War. Unfazed by his lack of post-secondary education, his rudimentary English and the backlash against German immigrants at the time, the hard-working 17-year-old found work in the sugar beet fields of Lethbridge, Alberta. A few years later, he moved to Saskatchewan to work on a grain farm. In 1961, after a decade in Western Canada, Pelzer and his young bride moved to Ontario to find new opportunities.
Five decades later, through sheer willpower, Pelzer went on to invent granola in his kitchen. He built a sizable fortune and had an unprecedented impact on Canada’s natural food industry with a string of innovative food products. Today, Sunny Crunch Foods Ltd. has a staff of 100 employees producing an impressive range of products, including granola cereal, nutrition bars, meal replacement bars, sports nutrition bars, energy bars, snack bars, protein powders and herbal capsules. The company’s products are sold in Canada and around the world under different labels.
“It all goes back to grandma’s recipe. She would take oats, sweeten them with honey and served them warm for dessert. Kids just loved it. No artificial preservatives, just whole grain goodness and organic honey,” explains his son Richard Pelzer who has succeeded his father as company president.
The self-made millionaire gambled his life on a simple family recipe in an industry that was struggling to gain acceptance and recognition in the late 1960s. On Sunny Crunch’s website, Pelzer is quoted as saying “Porridge was one of the only foods I knew of that used rolled oats and I wanted to come up with a new kind of food that would make use of rolled oats and other healthy grains in an attractive new way.”
However, the road to riches was a rocky one. “Dominion was the dominant chain back then. He would visit the personal buyer of each store and try to convince them to sell his granola cereal, but the answer was always the same. This is bird seeds, this is not a product for consumers. They’ll never eat this. No thanks, please go away,” says Richard Pelzer.
The Birth of Canada’s Natural Health Product Industry
Despite repeated setbacks, Willie Pelzer took it all in stride. The dream within his heart was too intense for him to quit in the face of temporary defeat. In 1964, Pelzer, Bill Cooper, Walt Zimmerman, Al Smith, Lionel Pasen and other like-minded health food pioneers banded together to create the Canadian Health Food Association.
“Willie’s talent was getting rid of all the clutter. He saw the basic problem. Very often we would all get lost in the minutiae that doesn’t count. He got rid of all that and got down to the bare facts. It was a pleasure working with him,” explains industry veteran Lionel Pasen, founder of the Toronto-based company, Natural Products Consulting Corp.
The CHFA now represents over 1,000 businesses across Canada. It’s the country’s largest trade association dedicated to natural health and organic products. Members include manufacturers, retailers, wholesalers, distributors, and importers of natural and organic products. These can include foods, vitamin and mineral supplements, herbal products, homeopathics, sports nutrition products, and health and beauty aids.
Since its creation, the CHFA has played a pivotal role in educating the public about its members’ products. It has also successfully lobbied governments to help grow and protect the industry. Today the natural health product industry is worth $3 billion annually to the Canadian economy. However, in the early days the CHFA remained wary of unsolicited government interference. For example, in the 1970s the Ontario government toyed with the idea of restricting the sale of vitamins to pharmacies alone. It’s a move both Pasen and Pelzer were determined to prevent.
“We met with Dr Allan Dyer who was a senior civil servant representing the Ontario government. Willie and I walked out of the meeting saying ‘Dr. Dyer, you’ll request the next meeting with us’. We went down to a restaurant and I said to Willie, what are we going to do?” says Pasen with a chuckle. “We started a letter campaign. Fortunately, there was a postal strike at the time. By the time the strike was over we had collected 40,000 signatures and the government backed off.”
Willie Pelzer’s life was intricately linked to the Canadian Health Food Association. He presided over the CHFA from 1969 to 1971, and again from 1991 to 1997. “Willie Pelzer assumed the presidency of the CHFA for a second time at a critical juncture in its history. His energy and personal generosity provided a stable financial platform that allowed the Association to grow into the dynamic organization it is today,” says William Gall, past CHFA Board Chair.
By the early 1990s, the industry wanted its own regulation. With the support of health food stores, they launched another letter campaign. The CHFA lobbied federal Health Minister Allan Rock, whose wife was a natural health aficionado. The government accepted all 53 recommendations put forward by the industry and created a new directorate at Health Canada to regulate the industry.
A Recipe for Success
While Pelzer’s commitment to the CHFA was never in doubt, making granola a mainstream food item remained his overriding priority. In the late 1960s and early 1970s health food stores were few and far between. In order to reach the largest number of customers, Pelzer and his wife set their sights on big retailers.
“We would make stands in grocery stores and shopping malls and handout granola for people to taste and tell them where they can buy it,” explains his wife, Joy Pelzer. These forays into large supermarkets fueled his desire to achieve success despite his inability to capture the imagination of big grocery chain buyers.
Not one to take no for an answer, Pelzer kept going back to meet the same buyers over and over again.
“One day, he got to the last buyer and of course he said ‘no’ because that’s what they all said,” explains Richard. “As he was walking out of the office, for whatever reason, he got an inspiration and turned around. For the next 20 minutes, he preached a sermon to the buyer. He doesn’t know where it came from, he can’t recall what he said. For 20 minutes, he pointed his finger at the buyer telling him he’s making a mistake. The buyer said, Willie I want you to do a demonstration at my store for one weekend and we’ll take it from there.”
It was a daunting task. If Pelzer had failed to capture people’s imagination, it likely would have been a fatal blow to his dream. Just like a “clutch” athlete, Pelzer had an uncanny ability to perform above expectations in high-pressure situations. When the time came, he loaded the front seat, the back seat and the trunk of his car and drove to the supermarket to set up a booth in the cereal aisle. By the end of the weekend he had sold out.
In one weekend, Pelzer had won over customers. The growing popularity of granola wasn’t lost on Dominion buyers. One by one, they started ordering his granola cereal in much larger quantities.
Despite their early success, he and Joy kept reinvesting every penny back into the business when they first launched Sunny Crunch Foods Ltd. “We worked day and night,” says Joy. “We would start at eight in the morning and go until two in the morning when we first opened our little factory. We were baking and packaging for delivery the next day. We took jobs cleaning offices to make extra money. We had to do this for about ten years.”
They eventually found success, but it didn’t change Pelzer, according to those closest to him. He remained generous towards the CHFA and gregarious toward his employees.
“When you make a mistake, bosses usually get upset and it might be cause for dismissal,” says Vasco Rego, who has been plant manager at Sunny Crunch Foods Ltd for the past 36 years. “He saw mistakes as a positive because he felt people usually learn from them.”
Through his street-smarts, resourcefulness, stubbornness and hard work, Pelzer created a health food giant out of nothing. At the time of his death, he was at the top of the food chain as one of the richest and most successful entrepreneurs in Canada’s health food industry.
Willie Pelzer passed away at the Mackenzie Health hospital in Richmond Hill on Friday, May 17 with his family at his side. He was 79 years old. IHR
Insomnia
Insomnia
Role for acupuncture and melatonin
Abstract
“Sleep may be the price you pay so your brain can be plastic the next day,” is an intriguing statement by Cirelli and Tononi (Cirelli 2008). The 2002 Canadian Community Health Survey (CCHS) showed that as many as 18% of participants averaged less than five hours of sleep per night (Shields 2005). Sleep is a vital and recurrent function in daily life. It is thought to be an essential component of good health and hypothesized to have the following functions: energy conservation, memory consolidation, regeneration of substrates, and rest. Lack of sleep can have a negative impact on a person’s career, physical activity level, social interaction, mental aptitude and quality of life. There can be a severe economic burden caused by lack of sleep related to motor vehicle accidents, decreased workplace productivity, absenteeism from commitments and health-care costs from co-morbidities. Melatonin and acupuncture are two natural therapies with large bodies of evidence supporting their use in the management of insomnia.
Features of Sleep and Insomnia
Insomnia is defined as a state of insufficient sleep; it can include difficulties in falling asleep, staying asleep or a combination of both (Balch 2006). Acute insomnia is thought to last less than one to three months on average and consists of difficulty getting to sleep, continuing sleep, and/or sleep is poor quality; resulting in compromised daytime function (AASM 2005). Chronic insomnia can be defined as a failure to get a full night’s sleep on the majority of days in a month. The deleterious impact of insomnia must be considered as an issue on its own and/or as a sign of an underlying major medical diagnoses. There is a plethora of evidence from cognitive, endocrine, neurological, and behavioral disciplines that links insomnia to stress and that attributes insomnia to a state of hyper-arousal and receptor imbalance. Risk factors associated with insomnia include female gender, widowed or single status, low education or income, being unemployed, smoking status, stress, chronic disease, pain, restriction of activity and health dissatisfaction (Sutton 2001).
Sleep is divided into two types: rapid eye movement (REM) and non REM sleep (NREM) with four associated stages, of which the first three are NREM. The four stages of sleep are as follows: Stage one consists of light sleep where one is easily awakened, while stage two consists of theta activity and alpha waves interrupted by k complexes and sleep spindles. Stage three is a deep sleep that consists of slow brain waves, known as delta waves, accompanied by a lack of reaction to environmental stimuli. Stage four consists of the deepest sleep (REM), without major muscle movements (Dement 1975). It is also noted that in this phase, electroencephalogram (EEG) waves are similar to those of an awakened individual.
The Etiology and Physiology of Insomnia
The etiological basis for insomnia includes but is not limited to disturbances in circadian rhythms, stress, genetic conditions, other co-morbid diagnoses, drugs, alcohol, medications and hormonal imbalances. Physiological mechanisms of insomnia include theories that involve the central and autonomic nervous systems (CNS, and ANS respectively). People with insomnia and poor sleep are found to be more alert on daytime alertness tests, such as the multiple sleep latency test (MSLT) (Bonnet 1995, Seidel 1984). They are thought to have altered electroencephalographic (EEG) activity, (beta/gamma) waves at night (Krystal 2002).
Neurological imaging diagnostics such as single photon emission computed tomography (SPECT), positron emission tomography (PET), or proton magnetic resonance spectroscopy (MRS) have shown that insomniacs may have selective hyperactive brain coordinates (Nofzinger 2004, Smith 2002, Winkelman 2008). A highly active ANS that is found in insomniacs coincides with higher metabolic rates, body temperatures, and heart rates (Freedman 1982). There is a reinforced activation of the hypothalamic-pituitaryadrenal (HPA) axis by corticotrophin-releasing hormone (CRH) (Vgontzas 2001). Additionally, high cortisol levels maintain an increased sympathetic tone. Overall, these explanations suggest that therapeutics designed to restore the balance between the ANS and CNS, by mediating sympathetic and parasympathetic tone, could improve insomnia and optimize sleep quality.
Beyond pharmacotherapy, there are a large number of natural therapeutic options available to patients with insomnia such as melatonin, passionflower, 5-hydroxy tryptophan, L-theanine and acupuncture. It has been suggested that benzodiazepine, melatonin and histamine receptor antagonist activity have all been theoretically linked to insomnia. Supplements should be chosen with the associated mechanisms of action in mind, given the variation in pharmacokinetics. In addition to nutritional applications of treatment, eastern therapeutic strategies such as Traditional Chinese Medicine (TCM) methods have also been efficacious.
Eastern Perspectives in Insomnia
TCM etiologies of insomnia include but are not limited to anger, worry, overwork, excessive sexual activity, irregular diet, and a term known as gall bladder timid and residual heat (Maciocia 2008). It is thought that abnormal yin organs are unable to house essence, thereby causing the person to be restless and awake. The state of the mind and the ethereal soul are crucial to proper sleep. Additionally, internal organ disharmony disrupts essence and essence disrupts the mind; essence and Qi are the roots of the mind and without proper rooting of the mind, insomnia could result (Maciocia 2008). Sleep is contingent on normal functioning of the heart/mind, liver/ethereal soul and the kidneys/will power.
TCM theories are based on organ pair and meridian associated diagnoses resulting from either “full-excess” or “empty-deficiency” conditions. The deficiency or excess conditions are a result of imbalance in the connection between the body and the mind. The full conditions are: liver fire blazing, heart fire blazing, phlegm heat harassing the mind, heart Qi stagnation, heart blood stasis, residual heat in the diaphragm and retention of food (Maciocia 2008). The empty conditions are: heart and spleen blood deficiency, heart yin deficiency, heart and kidneys not harmonized, heart and gall bladder deficiency and liver yin deficiency (Maciocia 2008). The intent is to drain in excess conditions and support/ tonify in deficiency.
TCM strategies of acupuncture and herbal medications are individualized depending on what type of excess or deficient condition the person has. For instance, the diagnosis of insomnia as heart fire blazing is treated by needling points such as bladder 15, 44, spleen 6, Ren 15 and Du 19, with a herbal remedy known as XieXin Tang that collectively clears the heart and calms the mind (Maciocia 2008).
Evidence for the Role of Acupuncture in Insomnia
There is a large body of evidence that has shown the efficacy of acupuncture in reducing insomnia by itself or as part of a disease complex. It is effective as an independent therapy or in conjunction with other treatments. One study utilized the Pittsburgh Sleep Quality Index (PSQI) to compare acupuncture to Zolpidem (10mg) in a psychosomatic clinic of 33 patients with primary insomnia. There were significant improvements in both groups: regression analysis showed the results as a baseline PSQI score of 4.13 (p<0.001), the second score 1.32 (p=0.005), and the third 1.49 (p=0.03), confirming that acupuncture was just as effective as the medication (Tu 2012).
One systematic review examined 33 trials with 2293 patients aged 15 to 98 years of age to assess the safety and efficacy of acupuncture for insomnia alone and with other diagnoses, such as stroke, end-stage renal disease, perimenopause, pregnancy and psychiatric diagnoses. They evaluated needle, electro or magnetic acupuncture and pressure. Compared with no treatment (2 studies, 280 participants) or placebo (2 studies, 112 participants), acupressure resulted in more people with improvement in sleep quality (compared to no treatment: OR 13.08, 95% confidence interval (CI) 1.79 to 95.59; compared to placebo: OR 6.62, 95% CI 1.78 to 24.55) (Cheuk 2012). Compared with other treatment alone, acupuncture combined with other treatment was shown to marginally increase the percentage of people with improved sleep quality (13 studies, 883 participants, OR 3.08, 95% CI 1.93 to 4.90) (Cheuk 2012). Overall, needle acupuncture showed the highest efficacy out of all the subgroups. Another systematic review demonstrated through the measurement of subjective sleep outcomes that acupuncture reduced sleep latency, increased sleep and wake ratio (sleep efficiency), resulted in better sleep duration/quality, and minimal insomnia symptoms (Huang 2009).
One interesting, randomized, double blind, placebo controlled trial showed that in postmenopausal women aged 50-67 years old who had insomnia, (as measured by polysomnography exam (PSG) and questionnaires (WHOQOLBREF, Beck Depression Inventory and PSQI)), the acupuncture group had significantly lower scores on the PSQI and improved WHOQOL outcomes after five weeks; confirming that acupuncture improved sleep quality and quality of life in postmenopausal women with insomnia (Hachu 2013). Collectively, the variety of type of studies demonstrate that acupuncture has a measurable improvement on subjective and objective sleep criteria, and that this could potentially be applied to designing individualized treatment strategies for insomnia patients.
Evidence for the Role of Melatonin in Insomnia
Melatonin is a hormone secreted by the pineal gland that regulates circadian rhythm and signals conditions for sleep in the body (Fritz 2009). Administration of exogenous melatonin, typically between 1-5mg under the tongue half an hour before bed, has been shown to decrease sleep latency, increase sleep duration, and increase REM sleep (Brzezinski 2005, Buscemi 2005). Melatonin has also been demonstrated to assist in the discontinuation of benzodiazepine sleeping medications (Garfinkel1999, Kunz 2012). In a randomized controlled trial, 19 of 24 patients who discontinued benzodiazepines using melatonin continued to have good quality sleep six months later (Garkinkel 1999). Another analysis found that after receiving a prescription for melatonin, one third of patients discontinued use of benzodiazepines (Kunz 2012). Melatonin has been studied in several populations including shift workers, patients on benzodiazepines, patients with idiopathic insomnia, patients with schizophrenia, the elderly including patients with Alzheimer’s and Parkinsons, as well as children, including children with neurodevelopment conditions such as Asperger’s, epilepsy, and ADHD (Fritz 2009). Melatonin has an excellent safety profile, with the exception of concurrent use with calcium channel blockers (CCBs), a blood pressure medication; one study found a small decrease in the effect of CCBs when combined with melatonin (Grossman 2006).
Conclusion
Insomnia by itself or in association with other diagnoses can immensely decrease quality of life, as well as be an increased economic burden on the healthcare system and society. Mechanisms of action thought to be targeted are abnormal melatonin production and receptor function, as well as HPA axis imbalance. Melatonin and acupuncture have shown immense potential in insomnia management and are well supported by a large body of evidence. Melatonin has been shown in many studies to improve sleep quality and latency, morning alertness and quality of life at a dose range of 2-4 mg for approximately three weeks. Acupuncture has been shown in several studies to improve sleep efficiency, quality and overall quality of life, and even in some studies enabled patients to reduce medication, especially with individualized protocols. Collectively, these effective natural treatments in addition to targeting the root cause of disease have shown promise in reducing insomnia associated morbidity, and increasing overall wellbeing.
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