IHP Magazine - November 2011 Issue by Rive Gauche Media

IHP NOVEMBER/DECEMBER 2011 | $14.95

Statins for patients with diabetes?

Original Research: Homeopathic preparation for patients with nervous disorders

Nutritional management of sarcopenia

By William R Ware, PhD

By Rompp B, Krick B, Weiss G

By Jordan Robertson, ND

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Integrative management of vectortransmitted illnesses

Continuing Education: Sodium: villain or biomarker? By Philip Rouchotas MSc, ND and Heidi Fritz MA, ND

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PUBLISHERS LETTER

Where has the time gone? Wow! Another year has come and gone and again everyone seems be asking themselves “where has the time gone”? It seems that with all the new technologies we adopt, the systems we establish in business, the support staff we bring on board to make our lives easier, we are still busier than ever! My new years resolution is to figure out where my time is going, and finding a way to have a little more of it for myself and my family. As I speak to people, from professionals to students, we all have the same feeling of “where did the time go”? I say it is time to step back and evaluate what is responsible for consuming so much of our time. If we begin to apply greater value to time, it is likely we will quickly find effective means of freeing more of it up. I would love to hear your feedback on what you may have found to be effective strategies for freeing up more of your time. I wish all of you happy holidays and great start to the New Year!

SJagota

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Photograph by Scott Jordan

Sanjiv Jagota Publisher

4 | IHP November/December 2011 } ihpmagazine.com

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Got the Winter Blues?

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For detailed information on effects and possible adverse effects read the leaflet or consult your doctor or pharmacist. For details, write #102 on Free Info Page, page 88.

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Product Information

NPN: 80025095 Each tablet contains: Dry extract (4.6-6.5:1) St. John’s Wort Dry extract (3.8-5.6:1) valerian root Dry extract (6.25-7.1:1) passionflower

60mg 28mg 32mg

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Detailed Information:

Figure1: Effect of NEURAPAS® balance on HAMD scores versus placebo

Clearly stress is becoming more and more common. People are feeling overwhelmed by the demand to balance pressures at work with responsibilities to home and society. Symptoms are wide-ranging and include sleep disturbances, anxiety, despondence, lack of drive, fatigue, lack of motivation, headache, lack of concentration. Stress and burnout can have more serious implications: a recent study found that workplace stress is associated with a 50% increase in risk for coronary heart disease1.

compared with placebo, as measured by the Hamilton Depression Scale3. This fast-acting relief is likely due to its effects on easing anxiety and promoting healthier sleeping patterns.

NEURAPAS® balance has a combination of ingredients which work synergistically to relieve the symptoms of burnout and stress, including imbalanced mood and sleep disturbances. Each ingredient has years of research supporting its effectiveness. In addition, studies have shown that Passionflower has a specific synergistic effect on St. John’s wort, which lowers the dose of St. John’s wort required for the same biological effect by 9/10ths, a very significant synergy2.

A 2006 study found that NEURAPAS® balance has a significant impact on normalizing sleep patterns as measured by sleep EEGs, as well as reducing objectivelymeasured duration of wake-time at night even in healthy patients7.

Several clinical studies have shown conclusively that NEURAPAS® balance has a clinically significant antidepressant effect3,4. In addition, because of the unique synergy--meaning smaller amounts of St. John’s wort achieve the same therapeutic effect-NEURAPAS® balance has been shown to have no effect on liver enzymes at therapeutic doses5. Therefore the concern for side effects traditionally observed with St. John’s wort is not a problem with NEURAPAS® balance. In the treatment of mild to moderate depression, NEURAPAS® balance has been shown to have a statistically-significant effect after only 2 weeks of treatment,

St. John’s wort has also been shown to have an effect on the hypothalamic-pituitary-adrenal (HPA) axis, regulating the production of cortisol without having to stimulate adrenal function to alleviate stress6.

Clearly, this well-balanced combination of St. John’s Wort, valerian and passionflower in NEURAPAS® balance has possitive effects on balancing mood and regulating sleep disorders caused by stress and agitation. For more information and full research, visit our website. References:

1. Kivimaki et al. (2006) Work stress in the etiology of coronary heart disease--a metaanalysis. Scand. J. Work Environ. Health. 32:431-42. 2. Fiebich et al. (2011) Pharmacological studies in an herbal drug combination of St. John’s wort (Hypericum perforatum) and passion flower (Passiflora incarnata): In vitro and in vivo evidence of synergy between Hypericum and Passiflora in antidepressant pharmacological models. Fitotherapia 82: 474-480. 3. Urlea-Schön et al. (2003) Efficacy of a triple herbal preparation in mild depressive disorders: results of a randomised placebo-controlled trial. Focus Compl. Alt. Therp. 4. Krick (2005) unpublished. 5. Pascoe Naturmedizin (2004) Neurapas: Measurement of cytochrome P450 induction on enzyme activity level in cryopreserved, plated human hepatocytes.T-08-2004. 6. Butterweck et al. (2004) Flavonoids of St. John’s wort reduce HPA axis function in the rat. Planta Med. 70:1008-11. 7. McGregor et al. (2006) Triple combination in NEURAPAS balance demonstrates a unique effect on sleep EEGs. Acta Biologica. 1:3-14.

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A novel solution for the prophylaxis of urinary tract infections (utis)

ISSN 1920-4302 | NOVEMBER/DECEMBER 2011 Volume 4 • Issue 6

Publisher | Sanjiv Jagota - ext. 6122 Editor-in-Chief | Philip Rouchotas, MSc, ND - ext. 6109 Associate Editor | Angela MacNeil, MSc, ND Art Director | Scott Jordan Design | Sarah Vincett Production | James Shotton Contributors William R. Ware, PhD Heidi Fritz, MA, ND Jordan Robertson, ND Birgit Rompp, PhD Bianka Krick Gabriele Weiss, DVM Elizabeth Stavros, BSc, ND(Cand.) Philip Rouchotas, MSc, ND

The perfect combination for keeping UTI producing E. coli bacteria away Highly concentrated Cranberry Extract (35:1) equivalent to 20 g fresh fruit/day combined with 1.6 g of natural D-Mannose at recommended daily dosage Ultra convenient vegetarian capsules allow for ease of use with even your most active patients

President | Olivier Felicio - ext. 6107 Controller & Operations | Melanie Seth - ext. 6114 Finance Administrator | Leslie Witol Multimedia Specialist | Matthew Pomepey Customer Service | Marsha Miller - ext. 6126 Advertising Information Sanjiv Jagota Telephone: (416) 203-7900 ext 6125 Email: sanjiv@ihpmagazine.com

Jeff Yamaguchi Telephone: (416) 203-7900 ext 6122 Email: jeff@gorgmgo.com

Paul Airut Telephone: (416) 203-7900 ext 6103 Email: paul@gorgmgo.com

Erin Poredos Telephone: (416) 203-7900 ext 6128 Email: erin@gorgmgo.com

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Cran-Mannose UTI™ A high potency combination for the treatment of acute recurrent urinary tract infections due to E. coli and the prophylaxis of recurrent infections.

Subscription Rates Canada $80 (gst included) for six issues | $120 International Published by

Canada Post Canadian Publication Mail Agreement Number 4067800 Th e publisher does not assume any responsibility for the contents of any advertisement and any and all representations or warranties made in such advertising are those of the advertiser and not of the publisher. Th e publisher is not liable to any advertiser for any misprints in advertising not the fault of the publisher and in such an event the limit of the publisher’s liability shall not exceed the amount of the publisher’s charge for such advertising. No portion of this publication may be reproduced, in all or part, without the express written permission of the publisher. ihp magazine is pleased to review unsolicited submissions for editorial consideration under the following conditions: all material submitted for editorial consideration (photographs, illustrations, written text in electronic or hard copy format) may be used by ihr Media Inc. and their affiliates for editorial purposes in any media (whether printed, electronic, internet, disc, etc.) without the consent of, or the payment of compensation to, the party providing such material. Please direct submissions to the Editor, ihp magazine.

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Pharma GABA®, the clinically proven form of GABA used in GABA-Pro™ chewable tablets and vegetarian capsules, is naturally manufactured via a fermentation process that utilizes a Lactobacillus sp. In clinical studies Pharma GABA® has been shown to: • Be absorbed easily and act peripherally to activate the parasympathetic nervous system • Increase the alpha to beta brain wave ratio within 5 minutes of ingestion as shown on EEG tracings • Prevent stress-induced alterations in body chemistry such as:

– Decreases in secretory IgA

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clinical highlight

Stress Management Stress is defined as any disturbance—for example, heat or cold, chemical toxin, microorganisms, physical trauma, strong emotional reaction—that can trigger the “stress response.” How an individual handles stress plays a significant role in determining their level of health. Comprehensive stress management involves a holistic approach designed to counteract the everyday stresses of life. Most often, the stress response is so mild it goes entirely unnoticed. However, if stress is extreme, unusual, or long-lasting, the stress response can be overwhelming and harmful to virtually any body system.

THe geNeRAL ADAPTATION SYNDROMe The stress response is part of a larger response known as the General Adaptation Syndrome (GAS), a term coined by the pioneering stress researcher Hans Selye. The GAS is composed of three phases: alarm, resistance, and exhaustion.1 These phases are largely controlled and regulated by the adrenal glands. The initial response to stress is the alarm reaction, which is often referred to as the fight-or-flight response. The fight-or-flight response is the result of the activation of the sympathetic nervous system and hypothalamic-pituitary-adrenal (HPA) axis. The fight-or-flight response is designed to counteract danger by mobilizing the body’s resources for immediate physical escape from danger. As a result: • The heart rate and force of contraction of the heart increases to provide blood to areas necessary for response to the stress situation • Blood is shunted away from the skin and internal organs, except the heart and lung, while the amount of blood supplying the required oxygen and glucose to the muscles and brain is increased • The rate of breathing rises to supply the necessary oxygen to the heart, brain, and exercising muscle • Sweat production increases to eliminate toxic compounds produced by the body and to lower body temperature • And blood sugar levels rise dramatically as the liver converts stored glycogen into glucose for release into the blood stream

The resistance reaction allows the body to continue fighting a stressor long after the effects of the fight-or-ﬂight response have worn off. Here, corticosteroids secreted by the adrenal cortex are largely responsible for the resistance reaction. For example, these hormones increase blood glucose levels and stimulate the conversion of protein to energy so that the body has a large supply of energy long after glucose stores are depleted. They also promote the retention of sodium to keep blood pressure elevated. As well as providing the necessary energy and circulatory changes required to deal effectively with stress, the resistance reaction provides the changes required to meet emotional crisis, perform strenuous tasks, and fight infection. The effects of adrenal cortex hormones are quite necessary when the body is faced with danger, but prolongation of the resistance reaction or continued stress increases the risk of significant disease (including diabetes, high blood pressure, and cancer) and results in the final stage of the GAS, exhaustion.

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Exhaustion may manifest as a partial or total collapse of a body function or specific organ. Two of the major causes of exhaustion are loss of potassium ions and depletion of adrenal glucocorticoid hormones like cortisone. Loss of potassium results in cellular dysfunction and, if severe, cell death.

THe CLINICAL APPROACH Whether currently aware of it or not, the patient has developed a pattern for coping with stress. Unfortunately, most people have found patterns and methods that ultimately do not support good health. Negative coping patterns must be identified and replaced with positive ways of coping. The clinician should try to identify any negative or destructive coping patterns that the patient may have developed, and should attempt to replace that pattern with more positive measures for dealing with stress. Stress management can be substantially improved by assisting the patient in the following six equally important areas: • Sleep • Techniques to calm the mind and promote a positive mental attitude • Lifestyle factors • Exercise • A healthful Mediterranean diet • Dietary and botanical supplements

The Importance of Sleep Sleep quality is one of the most important considerations in stress management. Insufficient sleep, poor sleep quality, or sleep deprivation can all significantly activate or exacerbate stress.2 Over the course of a year, over one-half of the US population will have difficulty falling asleep. About 33% of the population experiences insomnia on a regular basis. Even in the patient who does not exhibit insomnia, if their sleep is often disrupted or they do not spend sufficient time in the deeper stages of sleep, they will be affected in profound ways.

Calming the Mind and Body Learning to calm the mind and body is extremely important in relieving stress. Among the easiest methods for the patient to learn are relaxation exercises. The goal of a relaxation technique is to produce a physiologic response known as a relaxation response—a response that is the exact opposite of the stress response. Although an individual may relax by simply sleeping, watching television, or reading a book, relaxation techniques are designed specifically to produce the relaxation response. Relaxation response was a term coined by Harvard professor and cardiologist Herbert Benson in the early 1970s to describe a physiologic response that is just the opposite of the stress response. With the stress response, the sympathetic nervous system dominates. With the relaxation response, the parasympathetic nervous system dominates. While the sympathetic nervous system is designed to protect against immediate danger, the parasympathetic system is designed for repair, maintenance, and restoration of the body.

Lifestyle Factors A patient’s lifestyle is a major determinant of his or her stress levels. The two primary areas of concern (other than addressing

FOR PROFESSIONAL USE ONLY. This product is not intended to diagnose, treat, cure or prevent any disease. *All figures used with the permission of the rights holder. © All Rights Reserved Bioclinic Naturals™ 2011. September 2011. Head office Bioclinic Naturals™, 1550 United Boulevard, Coquitlam, BC, Canada V3K 6Y2 | U.S. Distribution office 1111 80th St. SW, Suite 100 Everett, WA 98203 customer service 1·877·433·9860 · fax 1·877·433·9862 · email customersupport@bioclinicnaturals.com · www.bioclinicnaturals.com

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Stress Management

Dietary Guidelines An individual suffering from stress or anxiety must support the biochemistry of the body by following some important dietary guidelines. Specifically, he or she must: • Eliminate or restrict the intake of caffeine • Eliminate or restrict the intake of alcohol • Eliminate refined carbohydrates from the diet eat a diverse range of whole foods • Increase the potassium-to-sodium ratio • Eat regular-planned meals in a relaxed environment • Control food allergies

According to Selye, whether or not stress is harmful depends on the strength of the system. From a purely physiologic perspective, it can be strongly argued that the delivery of high quality nutrition to the cells of the body is the critical factor in determining the strength of the system.

NUTRITIONAL AND BOTANICAL SUPPORT Nutritional and botanical support for the individual experiencing signs and symptoms of stress largely involves attempting to restore proper HPA function as well as adrenal responsiveness. An abnormal adrenal response—either deficient or excessive hormone release— significantly alters an individual’s response to stress. Often, the adrenals become “exhausted” as a result of the constant demands placed on them. An individual with adrenal exhaustion usually suffers from chronic fatigue and may complain of feeling “stressed out” or chronically anxious. He or she typically has a reduced resistance to allergies and infection.

Nutritional Supplements The nutrients especially important for supporting adrenal function are vitamin C, vitamin B6, zinc, magnesium, and pantothenic acid. Each of these nutrients plays a critical role in the health of the adrenal glands, and in the manufacture of adrenal hormones. During stress, the levels of these nutrients in the adrenals decrease substantially. Taking a high potency multiple vitamin and mineral formula is very important for providing necessary levels of these key anti-stress nutrients.

L-Theanine L-theanine is an amino acid found in tea leaves, particularly green tea (Camellia sinensis). Much like GABA, L-theanine exerts a profoundly relaxing, yet non-drowsy effect with noticeable effects within 5 to 15 minutes of ingestion. Clinical studies have demonstrated that L-theanine is an effective nutrient to help manage stress and promote mental calmness.5 These clinical effects are directly related to L-theanine’s ability to stimulate the production of alpha brain waves as well as reduce beta waves (associated with nervousness, scattered thoughts and hyperactivity). The clinicallyproven form of L-theanine is Suntheanine®, a pure and natural form produced via an enzymatic process. Although most individuals would achieve results with L-theanine, some people would respond better with GABA, especially during acute stressful situations.

Pharma GABA As a key neurotransmitter, GABA (gamma-aminobutyric acid) is an important regulator of proper neurological function. It appears that

many people with anxiety, insomnia, epilepsy, and other brain disorders do not manufacture sufficient levels of GABA. Since GABA does not cross the blood-brain barrier very well, virtually all of the GABA found in the brain is manufactured there. There has been some controversy regarding the transport of supplemental GABA across the blood-brain-barrier, yet supplementation with a natural form of GABA has shown clinical effects in activating the parasympathetic response, increasing alpha brain waves and promoting feelings of relaxation with greater mental focus and clarity.6,7 The mechanism of action appears to take place via a peripheral mechanism. The clinically-proven form is Pharma GABA, a special form of GABA naturally manufactured from Lactobacillus hilgardii—the bacteria used to ferment vegetables in the preparation of the traditional Korean dish known as kimchi. Pharma GABA has shown impressive results in combating stress, including showing an ability to lower cortisol levels and other markers of acute stress during exposure to stressful situations.8 The recommended dosage schedule for Pharma GABA is 100 to 200 mg up to six times daily.

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negative coping patterns) are time management and relationship issues. In addition, the importance of getting quality sleep cannot be overstated in a stress management program and regular physical exercise can produce a tremendous effect in terms of improving mood and the ability to handle stressful life situations.3,4

Water

L-theanine

GABA

Figure 1 Changes of alpha/beta waves ratio values after administration of water (control), L-theanine, and ß-aminobutyric acid (gABA) measured by electroencephalogram (eeg). Values are means ± SEM of alpha/beta ratio values of 3 measurements (at 0, 30, and 60 minutes after each administration). Values with different letters are signiﬁcantly different at P < 0.05.

RefeReNCeS 1. Selye H., “The General Adaptation Syndrome and the diseases of adaptation,” J Clin Endocrinol, 1946; 6(2): 117-230. 2. Roth T., Roehrs T., Pies R., “Insomnia: pathophysiology and implications for treatment,” Sleep Med Rev, 2007; 11(1): 71-79. 3. Chiesa A., Serretti A., “Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis,” J Altern Complement Med, 2009; 15(5): 593-600. 4. Tsatsoulis A., Fountoulakis S., “The protective role of exercise on stress system dysregulation and comorbidities,” Ann N Y Acad Sci, 2006; 1083: 196-213. 5. Owen G.N., Parnell H., De Bruin E.A., Rycroft J.A., “The combined effects of L-theanine and caffeine on cognitive performance and mood,”Nutr Neurosci, 2008 Aug; 11(4): 193-198. 6. Konagai C., Nakamura K., Koga Y., et al., “Effect of Pharma GABA on reduction of school child’s study stress effect,” Japanese Society Nutrition Food Science, 2008; 62: 1726. 7. Nakamura H., Takishima T., Komentani T., et al., “Psychological stress-reducing effect of chocolate enriched with gamma-aminobutyric acid (GABA) in humans. Assessment of stress using heart rate variability and salivary chromogranin A,” Int J Food Sci Nutr, 2009: in press. 8. Abdou A.M., Higashiguchi S., Horie K., Kim M., Hatta H., Yokogoshi H., “Relaxation and immunity enhancement effects of Aminobutyric acid (GABA) administration in humans,” Biofactors, 2006; 26(3): 201-208.

fIgUReS 1. Abdou A.M., Higashiguchi S., Horie K., Kim M., Hatta H., Yokogoshi H., “Relaxation and immunity enhancement effects of ß-Aminobutyric acid (GABA) administration in humans,” BioFactors, 2006 26(3): 204.

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EDITORS LETTER

When a standard of care doesnâ&#x20AC;&#x2122;t exist? The practice of medicine is made more difficult when a physician enters a paradigm that lacks an objective laboratory means of confirming a suspected diagnosis. Vector- transmitted illnesses cause debilitating symptoms yet for the most part go undiagnosed and untreated due to a lack of ability to objectively confirm infection. Dr Ben Boucher has established a subjective, questionnaire means of making such a diagnosis, setting the bar very high in that the diagnosis requires a large number of symptoms to be present, symptoms must cross multiple body systems, and symptoms need to be of an extreme magnitude. The result has been efficient delivery of relief for hundreds of patients formerly living with chronic, debilitating illness. Dr Boucherâ&#x20AC;&#x2122;s story is accompanied by a clinic profile of the Halifax Naturopathic Health Centre, a newer facility that has done an incredible job of assimilating itself into the local community and delivers an exceptional level of care to the patients it serves.

This issues continuing education article challenges the widely held notion of sodium as a causal factor of cardiovascular and all cause death. Dr William Ware continues his critical evaluation of the role of LDL in atherosclerosis with an eloquent review of the role of statins among patients with diabetes whom are asymptomatic for cardiovascular disease. We are likewise pleased to present a piece of original research, an open study determining the safety and efficacy of a homeopathic preparation for nervous disorders. Additional contributions include an article on protein prescription for prevention/ treatment of sarcopenia, and an overview of functional food/ nutraceutical/ essential nutrient/ botanical influences associated with prevention/ treatment of cervical dysplasia. Best regards,

Philip Rouchotas, MSc, ND Editor-in-Chief

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We invite questions or comments. philip@ihpmagazine.com

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Flora SAP

Science-based suppository probiotic for vaginal health Genito-urinay infections affect more than 1 billion women worldwide every year and are the most common reason a women will see a gynecologist.(1) These infections can be bacterial in nature (called bacterial vaginosis) or fungal in nature (called vulvovaginal candidiasis). The types of bacteria in the vaginal canal will fluctuate based on a variety of factors including hormone levels, diet, sexual contact and douching; however, the basic composition is Lactobacilli-dominant in healthy females.(1) It is the depletion of these healthy organisms that can leave a woman prone to urinary and vaginal infections.(1) There are probiotic bacteria that can help in modulating the immune system and displacing pathogens that can cause these infections.(2) A healthy vaginal canal should be colonized by Lactobacilli as the dominant bacterial species. Lactobacilli produce H2O2, which helps maintain a vaginal pH close to 4.0, which is essential for vaginal health.(3) Maintenance of a vaginal pH around 4.0 decreases a woman’s chances of developing vaginosis.(3)

Each capsule of Flora SAP contains:

ACTIVE INGREDIENTS

L. rhamnosus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 billion L. acidophilus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 billion L. fermentum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 billion L. casei . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 million L. thermophilus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 million Flora SAP contains no artificial flavours, colours, soy, gluten or preservatives. Contains 10 capsules/bottle and applicator. Please keep refrigerated.

ADULT DOSAGE

Use one capsule inserted vaginally per night for 10 days or as recommended by your health care practitioner

INDICATIONS

ɶ Flora SAP can help prevent and treat recurrent vulvovaginal candidiasis and bacterial vaginosis ɶ Flora SAP may help prevent growth of Group-B streptococci (GBS) during pregnancy ɶ Flora SAP can be used to help prevent spontaneous preterm delivery associated with intrauterine infection ɶ Flora SAP can be used to help prevent recurrent urinary tract infections

SAFETY

Lactobacilli are considered to be safe because they are components of the commensal human flora and due to the fact that they have been used for a long time in food industry and in douches, even by pregnant women, without harmful effects.(3)

Scientific Advisory Panel (SAP): adding nutraceutical research to achieve optimum health

PURITY, CLEANLINESS AND STABILITY

Third-party testing is performed on finished product to ensure Flora SAP is free of heavy metals, pesticides, volatile organics and other impurities.

Nutritional Fundamentals for Health • 3405 F.-X.-Tessier, Vaudreuil, QC J7V 5V5 • Tel. 1 866 510 3123 • Fax. 1 866 510 3130 • www.nfh.ca For details, write #104 on Free Info Page, page 88.

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Flora SAP

PRODUCT MONOGRAPH Vaginal infections—including bacterial vaginosis and vulvovaginal candidiasis—can cause symptoms including vaginal itching, discharge and discomfort. In recent years, there has been more research looking at the strains of bacteria that commonly colonize the vaginal canal and their ability to help prevent and eliminate other harmful bacteria or yeast from the region. The types of microbes in the vaginal canal will fluctuate but the basic composition is that Lactobacilli are the dominant species in healthy females.(1) Lactobacillus rhamnosus has proven to be effective at helping to restore and maintain a healthy vaginal canal.(1) The mechanism by which the bacteria work is not completely understood, but the possibilities include a reduction in pathogen ascension from the anus, modulation of host immunity, as well as being able to interfere with the colonization of pathogens.(1)

URINARY TRACT INFECTIONS

Urinary tract infections (UTIs) are extremely common in women and depletion of vaginal Lactobacilli is associated with an increased risk of UTI.(4) In a double-blind placebo-controlled study researchers randomized 100 women with a history of recurrent UTI who had received antimicrobials into either the treatment or control group.(4) Women in the treatment group used a vaginal suppository probiotic daily for 5 days then once weekly for 10 weeks. 15% of women in the treatment group had a reoccurrence of their UTI compared to 27% of women in the control group.(4) Researchers concluded that using a vaginal suppository probiotic after treatment for cystitis is associated with a reduced risk for a recurrent UTI.(4)

BACTERIAL VAGINOSIS

A study looked at the use of a probiotic suppository compared to using a suppository in combination with oral administration of Lactobacillus for the treatment of bacterial vaginosis.(5) 60 women with bacterial vaginosis were randomized into one of two groups. Group 1 was treated with a vaginal suppository containing Lactobacillus acidophilus; group 2 used the same vaginal suppositories and an oral probiotic. Patients were then examined at the end of 3 months of therapy and again 3 months after the end of treatment.(5) Both groups had a significant reduction in vaginal pH, improved sniff tests and decreased symptoms after the 3 months of treatment. Group 2 maintained these positive changes 3 months after treatment finished. (5) Researchers concluded that therapy with vaginal Lactobacillus is a successful treatment for bacterial vaginosis.(5) Also the combination of oral administration is useful for improving long-term results after treatment.(5) In another study, researchers looked at the use of long-term vaginal administration of Lactobacillus rhamnosus for the prevention of recurrence of bacterial vaginosis after treatment with metronidazole.(6) 49 women were randomized into 2 groups; both were treated with metronidazole for 1 week, but group 2 followed up the treatment with a weekly vaginal application of 40 mg of Lactobacillus rhamnosus for 6 months. At the 6-month followup, 96% of women in group 2 had a balanced vaginal ecosystem; follow-up testing at 12 months revealed no statistically significant difference in the vaginal ecosystem in this group from the 6-month follow-up.(6) Group 1, however, did have a significant number of women with abnormal flora over time.(6) The conclusion of this study was that vaginal administration of Lactobacillus rhamnosus reduces the recurrence of bacterial vaginosis and stabilizes the vaginal ecosystem.(6)

For more information visit: www.nfh.ca

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VAGINAL CANDIDIASIS

Vaginal candidiasis is most frequently caused by the species Candida albicans. In a study looking at Lactobacillus rhamnosus, researchers found that it has the ability to prevent adherence of Candida albicans and decrease the pathogen cell division rate.(7) In a separate review article, researchers found trials to support the use of Lactobacillus rhamnosus, Lactobacillus fermentum and Lactobacillus acidophilus for the prevention of colonization and infection of the vagina by Candida albicans.(8)

INTRAUTERINE INFECTIONS

In a study by Krauss-Silva et al. (2010), researchers found that in a vaginal canal that is colonized by Lactobacilli, a higher amount of H2O2 is produced. The quantity of lactic acid and H2O2 assists in maintaining a pH of close to 4.0 and is therefore protective against pathogenic bacteria and yeast.(3) Intrauterine inflammation appears to be the stimuli that contribute to the onset of preterm labour.(9) To examine the cause of the inflammation, researchers analyzed dried blood spots from 527 newborns delivered via caesarean section in 23–27 weeks gestation.(9) It was found mixed bacterial vaginosis organisms were associated with the proinflammatory pattern where Lactobacillus was associated with a low inflammatory response.(9) This study indicated that the microorganisms that colonize the placenta can provoke a distinctive inflammatory response and that Lactobacillus may suppress this response.(9)

GBS IN PREGNANCY

An in vitro study examined the use of 4 strains of Lactobacilli and their ability to block adherence of 3 urogential pathogens to vaginal epithelial cells.(10) Researchers found that 2 of the strains— Lactobacillus acidophilus and Lactobacillus paracasei—were able to inhibit the attachment of Group-B streptococci (GBS) to the vaginal epithelial cells via competition and exclusion.(10) Another study examined the effect of 10 clinical isolates of Lactobacilli on the growth of GBS.(11) They found seven of the isolates that had inhibitory effects on the growth of GBS were Lactobacillus rhamnosus.(11) Researchers postulated that the administration of certain strains of Lactobacilli may be a safe and less expensive alternative for the prevention of neonatal GBS infections.(11)

REFERENCES: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

Reid, G. “Probiotic Lactobacilli for urogenital health in women”. Journal of Clinical Gastroenterology 42, Suppl 3 Pt 2 (2008): S234–S236. Reid, G., J. Dols, and W. Miller. “Targeting the vaginal microbiota with probiotics as a means to counteract infections”. Current Opinion in Clinical Nutrition and Metabolic Care 12, No. 6 (2009): 583–587. Krauss-Silva, L., M.E. Moreira, M.B. Alves, et al. “Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol”. Reproductive Health 7 (2010): 14. Stapleton, A.E., M. Au-Yeung, T.M. Hooton, et al. “Randomized, placebo-controlled phase 2 trial of a Lactobacillus crispatus probiotic given intravaginally for prevention of recurrent urinary tract infection”. Clinical Infectious Diseases 52, No. 10 (2011): 1212–1217. Delia, A., G. Morgante, G. Rago, et al. “[Effectiveness of oral administration of Lactobacillus paracasei subsp. paracasei F19 in association with vaginal suppositories of Lactobacillus acidofilus in the treatment of vaginosis and in the prevention of recurrent vaginitis]”. Minerva Ginecologica 58, No. 3 (2006): 227–231. Marcone, V., G. Rocca, M. Lichtner, and E. Calzolari. “Long-term vaginal administration of Lactobacillus rhamnosus as a complementary approach to management of bacterial vaginosis”. International Journal of Gynaecology and Obstetrics 110, No. 3 (2010): 223–226. Coudeyras, S., G. Jugie, M. Vermerie, and C. Forestier. “Adhesion of human probiotic Lactobacillus rhamnosus to cervical and vaginal cells and interaction with vaginosis-associated pathogens”. Infectious Diseases in Obstetrics and Gynecology 2008 (2008): 549640. Falagas, M.E., G.I. Betsi, and S. Athanasiou. “Probiotics for prevention of recurrent vulvovaginal candidiasis: a review”. The Journal of Antimicrobial Chemotherapy 58, No. 2 (2006): 266–272. Fichorova, R.N., A.B. Onderdonk, H. Yamamoto, et al; Extremely Low Gestation Age Newborns (ELGAN) Study Investigators. “Maternal microbe-specific modulation of inflammatory response in extremely lowgestational-age newborns”. mBio 2, No. 1 (2011): e00280-10. Zárate, G. and M.E. Nader-Macias. “Influence of probiotic vaginal lactobacilli on in vitro adhesion of urogenital pathogens to vaginal epithelial cells”. Letters in Applied Microbiology 43, No. 2 (2006): 174–180. Açikgöz, Z.C., S. Gamberzade, S. Göçer, and P. Ceylan. “[Inhibitor effect of vaginal lactobacilli on group B streptococci”. Mikrobiyoloji Bülteni 39, No. 1 (2005): 17–23.

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contents NOVEMBER /DECEMBER 2011 VOLUME 4 â&#x20AC;&#x201C; ISSUE 6

ARTICLES 36. Cover Story: Dr. Ben Boucher, MD

Integrative management of vectortransmitted illness

44. Clinic Profile: Halifax Naturopathic Health Centre A centre of excellence

FEATURES 48. Statin prescription for patients with diabetes

Yeah or Nay?

55. Sarcopenia

Nutritional intervention for a quiet epidemic

62. Cervical dysplasia and human papilloma virus (HPV)

Nutritional therapeutic management

69. Effectiveness and safety of the homeopathic preparation Pasconal ÂŽ Nerventropfen in patients with nervous disorders

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62 COMING NEXT Issue

• Advanced Glycation End products (AGE’s) and diabetes; strategies for intervention • Homocysteine; a predictor of more than just stroke risk • Varicosities; effective management options

48 departments

4. Publisher’s Letter 11. Editor’s Letter 18. Peer Review Board 20. Research News 28. Industry News 32. Product Profiles 78. Continuing Education: Sodium and risk of death Villain or biomarker?

86. Calendar/Events

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For details, write #105 on Free Info Page, page 88. IHP.indd 1 ITI Cortisol Manager ad for ETCanada.indd 1

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Cortisol Manager Technical Data TM

DESCRIPTION: Cortisol Manager dietary supplement has been shown to reduce cortisol levels in human subjects.* The supplement combines an effective dose of phosphatidylserine with documented stress-reducing ingredients and cortisol-balancing botanicals to help relieve occasional sleeplessness at night while also providing all-day stress reduction.* Cortisol Manager promotes relaxation and supports a healthy sleep cycle without the use of habit forming ingredients.* This safe and natural formula increases the ability to fall asleep, stay asleep, and will not cause morning grogginess.* Cortisol Manager features: · Patented ingredients – Sensoril® brand Ashwagandha, US Patent 6,713,092 – Suntheanine® brand L-Theanine, US Patent Nos. 6,589,566 & 6,297,280 · Clinically effective level of phosphatidylserine20 · Fast acting formulation: Reduced cortisol levels after only 24 hours* †† · Safe and effective: No morning grogginess and no habit-forming ingredients* ††

When exposed to internal or external stress, the brain sends a message to the adrenal glands to increase cortisol secretion. The body responds by providing a surge in energy, increasing mental alertness, and raising blood pressure, thereby preparing the body for the “fight-or-flight” response.2 While this response provides an effective mechanism for coping with an acute stressor, increased or prolonged exposure to stress can lead to disruptions to normal cortisol levels. Disruptions in cortisol balance, in turn, can lead to changes in body chemistry, altering the balance of hormones and affecting the systems of the body. Research has shown that maintaining healthy cortisol levels can reduce stress, relieve occasional sleeplessness and fatigue, and optimize immune system and neurological function.*3,4,5 HOW IT WORKS: Cortisol Manager Study The effectiveness of Cortisol Manager dietary supplement was examined in a preliminary, open-label study involving 21 volunteers.6 The combination was taken each night, and results were assessed using salivary cortisol measurements as well as self-assessment questionnaires. According to the Zung Anxiety Self-Assessment, Cortisol Manager produced a statistically significant reduction in stress over the course of the 28-day study.* After 2 weeks scores reduced from from a baseline of 39.8 to 35.5 (p=0.04); after 4 weeks from 39.8 to 32.7 (p=0.005).5 Additionally, the participant survey revealed that:5 · 71% of participants felt more relaxed during the day* · 71% experienced improved sleep* · 64% achieved deeper sleep, while 57% felt they fell asleep more easily* · 57% felt their stress level was reduced* · 57% felt they were better able to handle stressful situations* CONCLUSION: Cortisol Manager dietary supplement has been shown to promote stress-relief and quality sleep by balancing levels of cortisol, the stress hormone.* This safe and natural formulation promotes relaxation with no habit-forming ingredients and no morning grogginess.* Cortisol Manager supports healthy cortisol levels, which in turn can help reduce stress, relieve occasional sleeplessness and fatigue, and optimize immune system and neurological function.* References:

3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21.

Hillier SG. Diamonds are forever: The cortisol legacy. J Endocrinol 2007;195:1-6. Papadimitriou A, Priftis KN. Regulation of the hypothalamic-pituitary-adrenal axis. Neuroimmunomodulation 2009;16(5):265-71. Epub 2009 Jun 29. Melamed S, Ugarten U, Shirom A, Kahana L, Lerman Y, Froom P. Chronic burnout, somatic arousal and elevated salivary cortisol levels. J Psychosom Res. 1999 Jun;46(6):591-8. Capaldi Ii VF, Handwerger K, Richardson E, Stroud LR. Associations between sleep and cortisol responses to stress in children and adolescents: a pilot study. Behav Sleep Med. 2005;3(4):177-92. Prinz PN, Bailey SL, Woods DL. Sleep impairments in healthy seniors: roles of stress, cortisol, and interleukin-1 beta. Chronobiol Int. 2000 May;17(3):391-404. An open label pilot study of the safety and effectiveness of a cortisol-reducing combination in healthy adults. 2006. Unpublished. Archana R, Namasiviayam A. Antistressor effect of withania somnifera. J Ethnopharm. 1999;64:91-93. Bhattacharya A. Anti-oxidant effect of Withania somnifera glycowithanolides in chronic footshock stress-induced perturbations of oxidative free radical scavenging enzymes and lipid peroxidation in rat frontal cortex and striatum. J Ethnopharmacol. 2001 Jan;74(1):1-6. Bhattacharya SK. Adaptogenic activity of Withania somnifera: an experimental study using a rat model of chronic stress. Pharmacol Biochem Behav. 2003 Jun;75(3):547-55. Ziauddin M. Studies on the immunomodulatory effects of Ashwagandha. J Ethnopharmacol. 1996;50:69-76. Ito K. Effect of l-theanine on the release of alpha-brain waves in human volunteers. Nippon Nogeikagaku Kaishi. 1998;72:153-157. Juneja LR, Chu DC, Okubo T, Nagato Y, Yokogoshi H. L-theanine - a unique amino acid of green tea and it’s relaxation effect in humans. Trends in Food Science & Technology. 1999;10:199-204. Yokogoshi H, Mochizuki M, Saitoh K. Theanine-induced reduction of brain serotonin concentration in rats. Biosci Biotechnol Biochem. 1998 Apr;62(4):816-7. Kuribara H. The anxiolytic effect of two oriental herbal drugs in Japan attributed to honokiol from magnolia bark. J Pharm Pharmacol. 2000 Nov;52(11):1425-9. Kuribara H, Stavinoha WB, Maruyama Y. Honokiol, a putative anxiolytic agent extracted from magnolia bark, has no diazepam-like side-effects in mice. J Pharm Pharmacol. 1999 Jan;51(1):97-103. Kuribara H, Stavinoha W, Maruyama Y. Behavioural pharmacological characteristics of honokiol, an anxiolytic agent present in extracts of Magnolia bark, evaluated by an elevated plus-maze test in mice. J Pharm Pharmacol 1998;50:819-26. Kalman D, Feldman S, Feldman, et al. Effect of a proprietary Magnolia and Phellodendron extract on stress levels in healthy women: a pilot, double-blind, placebo-controlled clinical trial. Nutrition Journal 2008;7:11:1-6. Pan Y, Wang FM, Qiang LQ, Zhang DM, Kong LD. Icariin attenuates chronic mild stress-induced dysregulation of the LHPA stress circuit in rats. Psychoneuroendocrinology. 2010 Feb;35(2):272-83. Epub 2009 Jul 23. Hellhammer J. Effects of soy lecithin phosphatidic acid and phosphatidylserine complex (PAS) on the endocrine and psychological responses to mental stress. Stress. 2004 Jun;7(2):119-26. Monteleone P. Effects of phosphatidylserine on the neuroendocrine response to physical stress in humans. Neuroendocrinology. 1990 Sep;52(3):243-8. Benton D. The influence of phosphatidylserine supplementation on mood and heart rate when faced with an acute stressor. Nutr Neurosci. 2001;4(3):169-78.

IHP.indd 2 ITI Cortisol Manager ad for ETCanada.indd 2

Benefit

Ingredient Ashwagandha (Withania somnifera)

Several studies have shown that ashwagandha enhances energy levels and stress resistance.*7-8 The herb reduces levels of corticosterone, a stress hormone closely related to cortisol.*9 Research has also documented ashwagandha’s moodenhancing effects.*9 In addition, ashwagandha helps promote healthy immune system function by increasing red and white blood cell counts and platelet counts*10

L-Theanine

L-theanine is an amino acid known to promote relaxation and stress reduction by inducing muscle relaxation, reducing occasional anxiety, and maintaining blood pressure already within normal limits.* L-theanine increases the activity of alpha brain waves— the type associated with increased feelings of relaxation.*11 It also increases the concentration of certain neurotransmitters, including serotonin and dopamine, which promote muscle relaxation and provide relief for occasional sleeplessness.*12,13

Magnolia (Magnolia officinalis)

Magnolol and honokiol extracts, derived from magnolia, have promoted relaxations in animal studies.*14–16 In a randomized, placebo controlled study supplementation with a combination of extracts of magnolia and phellodendron resulted in a decrease in transitory anxiety.17

In a preliminary open label study involving 21 volunteers.

BACKGROUND: The Cortisol Connection Cortisol, often referred to as the “stress hormone”, is produced by the adrenal cortex in response to stress. Cortisol is therefore intricately involved in many physiological functions, including the regulation of healthy blood sugar metabolism, maintenance of healthy blood pressure levels already within normal limits, establishment of healthy immune system function, and promotion of the body’s natural anti-inflammatory response.1

1. 2.

The following chart summarizes the benefits of each of the ingredients in Cortisol Manager

Epimedium Flavonoids in Epimedium koreanum has been shown in animals to (Epimedium koreanum) support a healthy response to stress by the hypothalamic-pituitaryadrenal axis.*18 Phosphatidylserine

Extracted from soy lecithin, phosphatidylserine has been clinically shown to significantly reduce serum adrenocorticotropin (ACTH) and cortisol levels and salivary cortisol levels following mental stress.*19 It also reduces plasma levels of epinephrine, norepinephrine, ACTH and cortisol after exposure to physical stress.*20 This phospholipid is a critical structural component of neuronal cells and helps promote a positive mood, by decreasing feelings of stress.*21

Supplement Facts Serving Size: 1 tablet Amount per tablet Sodium 5 mg Stress-Reducing Proprietary Blend* 250 mg ashwagandha (Withania somnifera) (Sensoril® brand) root and leaf extract and L-theanine (Suntheanine® brand) Cortisol-Reducing Proprietary Blend* 225 mg magnolia (Magnolia officinalis) bark extract standardized to contain 2% honokiol and 1% magnolol and epimedium (Epimedium koreanum) aerial part extract Phosphatidylserine 50 mg

%DV*** <1%*** **

***Percent Daily Values (DV) are based on a 2,000 calorie diet. **Daily Value not established.

Other ingredients: dextrose, cellulose, modified cellulose gum, modified cellulose, magnesium stearate, stearic acid, titanium dioxide color, soy lecithin, and carnauba wax. Warnings: If pregnant, nursing, taking prescription drugs, or if you suffer with chronic insomnia, consult your healthcare practitioner prior to use. Keep out of reach of children. Contains no sugar, yeast, wheat, gluten, corn, dairy products, artificial flavoring, preservatives, or ingredients of animal origin. All colors used are from natural sources. Sensoril® is protected under U.S. Patent 6,713,092 and is a trademark of Natreon, Inc. Suntheanine®, a patented form of L-Theanine, is a trademark of Taiyo International, Inc.

Cortisol Manager 30ct Integrative Therapeutics - 70453

Cortisol Manager 90ct Integrative Therapeutics – 70459

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PEER REVIEW

Peer Review Board Members Aoife Earls, MSc, ND River Oaks Naturopathic and Wellness Centre 478 Dundas St West Oakville, Ontario L6H6Y3 aearlsnd@gmail.com Berchman Wong, ND Toronto, Ontario berchman.nd@gmail.com Carol Morley, ND Zawada Health 201 City Centre Drive Suite 404 Mississauga, Ontario L5B2G6 info@zawadahealth.com Daniel Watters, ND Rosedale Wellness Centre 365 Bloor St East Toronto, Ontario M4W 3L4 wattersdaniel@hotmail.com Elizabeth Cherevaty, ND Meridian Wellness Centre 329 Woolwich St Guelph, Ontario N1H3W4 drliz@guelphnaturopathic.com

Erin Psota, ND 626 King St West, Suite 201 Toronto, Ontario M5V1M7 drpsota@gmail.com Faryal Luhar, ND Healthwise Wellness 4250 Weston Rd Toronto, Ontario M9L1W9 ndluhar@hotmail.com Heidi Fritz, MA, ND Research Fellow Canadian College of Naturopathic Medicine 1255 Sheppard Ave East Toronto, Ontario M2K1E2 hfritz@ccnm.edu Jacob Scheer, DC, ND, MHSc 2100 Finch Ave. W. #206 North York, Ontario M3N2Z9 Jacob.Scheer@utoronto.ca Jiselle Griffith, ND The Bloor St Neighbourhood Condos 35 Hayden St, Suite 109 Toronto, Ontario M4Y3C3 info@jisellegriffith.ca

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PEER REVIEW

Jordan Robertson, ND Lakeshore Clinic 2159 Lakeshore Road Burlington, Ontario L7R1A5 jordanrobertsonnd@gmail.com

Shawna Clark, ND Forces of Nature Naturopathic Clinic 2447 1/2 Yonge St Toronto, Ontario M4P2E7 info@shawnaclarknd.com

Leigh Arseneau, ND The Naturopathic Institute of Advanced Medicine 122 Simcoe St North Oshawa, Ontario L1G4S4 docleigh@gmail.com

Shehab El-Hashemy, MBChB, ND Associate Dean of Academic Delivery Canadian College of Naturopathic Medicine 1255 Sheppard Ave East Toronto, Ontario M2K1E2 selhashemy@ccnm.edu

Louise Wilson, ND 320 Queen St S Bolton, Ontario L7E4Z9 Dr.louisewilsonnd@gmail.com Mandana Edalati Wellness Naturopathic Centre Suite 213-1940 Lonsdale Ave North Vancouver, British Columbia V7M2K2 dredalati@gmail.com Melanie DesChatelets, ND True Health Studio 200-4255 Arbutus St Vancouver, British Columbia V6J4R1 melanie@drdeschat.com Nicole Egenberger, ND Remede Naturopathics 214 Sullivan Street Suite 3B New York, New York 10012 info@remedenaturopathics.com Sarah Vadeboncoeur, ND Ottawa Integrative Health Centre 1129 Carling Ave Ottawa, Ontario K1Y4G6 sarahmvadeboncoeur@gmail.com Scott Clack, ND Touchstone Naturopathic Centre 950 Southdown Rd, Unit B5 Mississauga, Ontario L5J2Y4 sclack.nd@touchstonecentre.com

Stephanie Swinkles, DDS Elmsdale Dental Clinic 4-269 Highway 214 Elmsdale, Nova Scotia N2S1K1 steph_moroze@hotmail.com Sylvi Martin, ND College of Physicians and Surgeons Investigator 80 College St Toronto, Ontario martin.sylvi@gmail.com Tanya Lee, ND The Health Centre of Milton 400 Main St East Suite 210 Milton, Ontario L9T1P7 tanyalee.nd@gmail.com Terry Vanderheyden, ND Bayside Naturopathic Medicine 118 Bay Street Barryâ&#x20AC;&#x2122;s Bay, Ontario KOJ1B0 doctrv@gmail.com Tracey Teasdale, ND, CISSN Thompson Chiropractic 12 Fairview Road, Suite 105 Barrie, Ontario info@nd-sportsmed.com

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RESEARCH NEWS

Essential amino acid supplementation improves quality of life in elderly patients The current study was undertaken to assess the efficacy of supplemented essential amino acids (EAA) on depressive symptoms, nutrition, muscle function, daily physical activity, and health-related quality of life (HRQoL) in institutionalized elderly patients. Forty-one patients (58.5% women; mean age 79.8 years) with sequelae of coronary artery disease (73%) and femoral fracture (34%) were randomly assigned to receive oral EAA (4 grams 2 times a day) or an isocaloric placebo for eight weeks. Before randomization and eight weeks after the protocol started, the following variables were measured: depressive symptoms (Geriatric Depression Scale, GDS), nutritional panel (Mini Nutritional Assessment, MNA; serum albumin and prealbumin levels), muscle strength (Hand Grip, HG), Activity Daily Life (ADL), Quality of Life (SF-36, HRQoL), and amino acid profile. Compared with the placebo group, EAA patients experienced improved nutrition (MNA score p < 0. 04, albumin p < 0.01), GDS (< 0.001), HG (p = 0.001), ADL (p < 0.04), and both physical and mental components of SF-36 (p < 0.002). The authors concluded that oral supplementation with EAA improved several determinants of quality of life in institutionalized elderly patients, including depressive symptoms, nutrition, muscle function, and daily life activity. Clin Nutr. 2011 May 31. PMID: 21636183

Prenatal smoking exposure is related to the use of psychotropic medication up to young adulthood This study was conducted to determine the relationship between prenatal smoking exposure and the use of psychotropic medication up to young adulthood. Population-based longitudinal register data consisting of all singletons born in Finland from 1987 to 1989 (n = 175 869) was assessed. Information on maternal smoking was determined during antenatal care and received from the Finnish Medical Birth Register. Information on the children’s psychotropic medication (1994–2007) was received from the Drug Prescription Register and the children’s psychiatric diagnoses related to outpatient (1998–2007) and inpatient (1987–2007) care were derived from the Finnish Hospital Discharge Register. A total of 15.3% of the children were exposed to prenatal smoking. The incidence of psychotropic medication use was 8.3% in unexposed children, 11.3% in children exposed to <10 cigarettes per day (95% CI: 1.29-1.43), and 13.6% in children exposed to >10 cigarettes per day (95% CI: 1.53-1.74). The exposure was significantly associated with the risk for all medication use and for both singleand multiple-drug consumption even after adjustment for possible confounders. These findings show that exposure to smoking during pregnancy is linked to both mild and severe psychiatric morbidity. Am J Epidemiol. 2011 Sep 15;174(6):681-90. PMID: 21821539

Estradiol transdermal system versus oral estrogenonly hormone therapy on the impact of venous thromboembolism The aim of the current study was to quantify the magnitude of risk reduction for venous thromboembolism events associated with an estradiol transdermal system relative to oral estrogen-only hormone therapy agents. A claims analysis was conducted using the Thomson Reuters MarketScan database from January 2002 to October 2009. Participants included women aged 35 years or older who were newly using an estradiol transdermal system or an oral estrogen-only hormone therapy with two or more dispensings. Venous thromboembolism was defined as one or more diagnosis codes for deep vein thrombosis or pulmonary embolism. Cohorts of estradiol transdermal system and oral estrogen-only hormone therapy were matched. Among the matched estradiol transdermal system and oral estrogen-only hormone therapy users (27 018 women in each group), the mean age of the cohorts was 48.9 years; in each cohort, 6044 (22.4%) and 1788 (6.6%) participants had a hysterectomy and an oophorectomy at baseline, respectively. The incidence of venous thromboembolism was significantly lower in participants receiving an estradiol transdermal system compared to estrogen-only hormone users (unadjusted incidence rate ratio: 0.72; 95% CI: 0.57-0.91; P = 0.006) and this effect remained after adjustment for confounding factors. Menopause. 2011 Oct;18(10):1052-9. PMID: 21775912 20 | IHP November/December 2011 } ihpmagazine.com

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RESEARCH NEWS

Positive association between chronic cerebrospinal venous insufficiency and multiple sclerosis: a meta-analysis

Use of non-aspirin nonsteroidal antiinflammatory drugs increases the risk of spontaneous abortion

It has been proposed that multiple sclerosis (MS) is caused by chronic cerebrospinal venous insufficiency (CCSVI), a term that describes ultrasound-detectable abnormalities in the anatomy and flow of intra- and extracerebral veins. This meta-analysis was conducted of studies published on MEDLINE and EMBASE that reported the frequency of CCSVI among patients with and without MS. Eight eligible studies were identified; all included healthy controls, and four of them also included a control group of patients with neurologic diseases other than MS. CCSVI was more frequent among patients with MS than among the healthy controls (OR: 13.5; 95% CI: 2.6-71.4) but there was extensive unexplained heterogeneity among the studies. The association remained significant in the most conservative sensitivity analysis (OR: 3.7; 95% CI: 1.2-11.0). Although CCSVI was also more frequent among patients with MS than among controls with other neurologic diseases (OR: 32.5; 95% CI: 0.6–1775.7), the association was not statistically significant and the 95% CI was wide. The authors concluded that these findings reveal a positive association between CCSVI and MS but that poor reporting of the success of blinding and marked heterogeneity among the studies preclude definitive conclusions. CMAJ. 2011 Oct 3. PMID: 21969411

The association between the use of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy and the risk of spontaneous abortion remains unclear. The current study was conducted to assess the association between having a spontaneous abortion and types and dosages of non-aspirin NSAIDs in a cohort of pregnant women. Using a nested case–control design, data was obtained from the Quebec Pregnancy Registry for 4705 women who had a spontaneous abortion. Ten controls were randomly selected for each case and were matched by date of the spontaneous abortion and gestational age. Adjusting for potential confounders, the use of non-aspirin NSAIDs during pregnancy was significantly associated with the risk of spontaneous abortion (OR: 2.43; 95% CI: 2.12–2.79). Specifically, use of diclofenac (OR: 3.09; 95% CI: 1.96–4.87), naproxen (OR: 2.64; 95% CI: 2.13–3.28), celecoxib (OR: 2.21; 95% CI: 1.42–3.45), ibuprofen (OR: 2.19; 95% CI: 1.61–2.96), and rofecoxib (OR: 1.83; 95% CI: 1.24–2.70) alone, and combinations thereof (OR: 2.64; 95% CI: 1.59–4.39), were all associated with increased risk of spontaneous abortion. No dose–response effect was seen. The authors concluded that these drugs should be used with caution during pregnancy. CMAJ. 2011 Sep 6. PMID: 21896698

Yoga therapy is an effective adjunctive treatment for schizophrenia In a randomized, controlled pilot study, 18 clinically stable patients (12 men and 6 women) with schizophrenia (mean age 42±13.5) in a state psychiatric facility were randomized to an eight-week Yoga Therapy program (YT) and a Waitlist group (WL). YT intervention included yoga postures, breathing exercises, and relaxation. At baseline and at eight weeks, symptomatology was measured using the Positive and Negative Syndrome Scale (PANSS). Secondary efficacy outcomes were measured with the World Health Organization Quality of Life BREF questionnaire (WHOQOL-BREF). The YT group obtained significant improvements in positive and negative symptoms of schizophrenia symptoms compared to WL, including PANSS scores on positive syndrome (p=0.02), negative syndrome (p<0.01), general psychopathology (p<0.00), activation (p<0.04), paranoia (p<0.01), and depression subscales (p<0.02). PANSS total scores also decreased for the YT group (p<0.00). YT had improved perceived quality of life in physical (p<0.04) and psychologic domains (p<0.01). The authors concluded that adults with schizophrenia who participated in an eight-week therapeutic yoga program showed significant improvements in psychopathology and quality of life compared with controls and that these findings should be confirmed in larger, more sufficiently powered studies with active control groups. J Altern Complement Med. 2011 Jul;17(7):601-7. PMID: 21711202 ihpmagazine.com { November/December 2011 IHP | 21

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RESEARCH NEWS

Dietary folate and vitamin B6 intake reduce the risk of breast cancer

Association between smoking and risk of bladder cancer among men and women

The objective of the current study was to examine the associations between dietary folate, vitamin B6, vitamin B12, and methionine intake and the risk of breast cancer by estrogen receptor (ER) and progesterone receptor (PR) status among Chinese women. A hospital-based case–control study was conducted from June 2007 to August 2008, with 438 cases and 438 age (five-year interval)- and residence (rural/urban)-matched controls. Dietary intake information was assessed using a validated food frequency questionnaire administered through an interview. A significant inverse association was found between dietary folate and vitamin B6 intake and breast cancer risk. The adjusted odds ratio of the highest versus the lowest quartile was 0.32 (95 % CI: 0.21-0.49; P< 0.001) for dietary folate and 0.46 (95 % CI: 0.30-0.69; P< 0.001) for vitamin B6. No associations were observed for vitamin B12 and methionine intake. A significant inverse association between dietary folate intake and breast cancer risk was observed in all subtypes of ER and PR status. These findings suggest that dietary folate and vitamin B6 intakes were inversely associated with breast cancer risk but this inverse association did not differ by ER and/or PR status. Br J Nutr. 2011 Sep;106(6):936-43. PMID: 21736840

The current study was conducted to evaluate the association between tobacco smoking and bladder cancer. Men (n = 281 394) and women (n = 186 134) of the National Institutes of Health-AARP (NIH-AARP) Diet and Health Study cohort completed a lifestyle questionnaire and were followed up between the years of 1995 and 2006. Previous prospective cohort studies of smoking and incident bladder cancer were identified by systematic review. Former smokers [hazard ratios (HR): 2.22; 95% CI: 2.03-2.44; number needed to harm (NNH): 1250) and current smokers (HR: 4.06; 95% CI: 3.66-4.50; NNH: 727) had higher risks of bladder cancer than never smokers. In contrast, the summary risk estimate for current smoking in seven previous studies (initiated between 1963 and 1987) was 2.94 (95% CI: 2.45-3.54). The population attributable risk (PAR) for ever smoking in this study was 0.50 (95% CI: 0.45-0.54) in men and 0.52 (95% CI: 0.45-0.59) in women. Compared with a pooled estimate of US data from cohorts initiated between 1963 and 1987, relative risks for smoking in the more recent NIH-AARP Diet and Health Study cohort were higher, with PARs for women comparable with those for men. JAMA. 2011 Aug 17;306(7):737-45. PMID: 21846855

β-glucan intake decreases blood cholesterol levels: a meta-analysis A meta-analysis was performed on epidemiologic studies to assess the relationship between β-glucan consumption from oats and barley on blood cholesterol level, triglyceride/ triacylglycerol (TGL/TAG) level, and blood glucose level (BGL) in humans. Thirty research articles were analyzed that evaluated the effect of different exposure levels of β-glucan on blood cholesterol and BGL, yielding 126 clinical studies. A significant inverse relation in total cholesterol (TC) (−0.60 mmol/L; 95% CI: −0.85 to −0.34), low-density lipoprotein (LDL) (−0.66 mmol/L; 95% CI: −0.96 to −0.36), and TGL/TAG (−0.04 mmol/L; 95% CI: −0.15 to 0.07) was found after consumption of β-glucan. In contrast, an increase in high-density lipoprotein cholesterol (HDL) was noted (0.03 mmol/L; 95% CI: −0.06 to 0.13) with a random-effect model. The analysis also showed a significant change in BGL (−2.58 mmol/L; 95% CI: −3.22 to −1.84) but since there was high heterogeneity among studies, the authors concluded that the effect of β-glucan on BGL is still inconclusive. A fixed-effect model showed a significant change in TC, LDL, and BGL but no significant changes in HDL and TGL/TAG. The dose–response model showed that a 3g/day dose of oat or barley β-glucan was sufficient to decrease TC. Nutrition. 2011 Oct;27(10):1008-16. PMID: 21470820

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RESEARCH NEWS

Dried plum improves bone mineral density in postmenopausal women

Parental smoking increases the risk of middle ear disease in children

Dried plum is effective in both preventing and reversing bone loss. This study was conducted to examine the extent to which dried plum reverses bone loss in osteopenic postmenopausal women. Subjects included 160 women who were 1–10 years postmenopausal and were not on hormone replacement therapy or any other prescribed medication known to influence bone metabolism. Subjects were randomly assigned to receive either dried plum (100 g/d) or dried apple (comparative control) and they also received 500 mg calcium plus 400 IU (10 μg) vitamin D daily. Bone mineral density (BMD) of lumbar spine, forearm, hip and whole body was assessed at baseline and at the end of the study using dual-energy X-ray absorptiometry. Blood samples were collected at baseline, 3, 6, and 12 months to assess bone biomarkers. Dried plum significantly increased BMD of ulna and spine compared to dried apple and compared to corresponding baseline values, only dried plum significantly decreased serum levels of bone turnover markers, including bone-specific alkaline phosphatase and tartrate-resistant acid phosphatase-5b. These findings confirm the ability of dried plum to improve BMD in postmenopausal women in part due to suppressing the rate of bone turnover. Br J Nutr. 2011 Sep;106(6):923-30. PMID: 21736808

A systematic review and meta-analysis was conducted of studies investigating the association between secondhand tobacco smoke (SHTS) and middle ear disease (MED) in children. MEDLINE, EMBASE, and CAB abstracts (through December 2010) and reference lists were searched. Sixty-one epidemiological studies of children assessing the effect of SHTS on outcomes of MED were included. Articles were reviewed and the data were extracted and synthesized by two researchers. Living with a smoker was associated with an increased risk of MED in children by an odds ratio (OR) of 1.62 (95% CI: 1.33-1.97) for maternal postnatal smoking and by 1.37 (95% CI: 1.25-1.50) for any household member smoking. Prenatal maternal smoking (OR: 1.11; 95% CI: 0.93-1.31) and paternal smoking (OR: 1.24; 95% CI: 0.98-1.57) were associated with a nonsignificant increase in the risk of MED. The strongest effect was on the risk of surgery for MED, where maternal postnatal smoking increased the risk by an OR of 1.86 (95% CI: 1.31-2.63) and paternal smoking by 1.83 (95% CI: 1.61-2.07). The authors concluded that exposure to SHTS, particularly to smoking by the mother, significantly increases the risk of MED in childhood. Arch Pediatr Adolesc Med. 2011 Sep 5. PMID: 21893640

High testosterone is associated with reduced risk of cardiovascular events in men Low serum testosterone is associated with increased adiposity, an adverse metabolic risk profile, and atherosclerosis while polymorphisms in the sex hormone–binding globulin (SHBG) gene are associated with the risk of type 2 diabetes. However, few studies have addressed whether endogenous testosterone or SHBG are predictors of cardiovascular (CV) events. In this prospective population-based Swedish study (2416 men; aged 69 to 81 years), gas chromatography/mass spectrometry was used to analyze baseline levels of testosterone and SHBG was measured by immunoradiometric assay. During a median five-year follow-up, 485 CV events occurred. Both total testosterone and SHBG levels were inversely associated with the risk of CV events (p = 0.009 and p = 0.012, respectively). Men in the highest quartile of testosterone (≥550 ng/dl) had a lower risk of CV events compared with men in the three lower quartiles (hazard ratio: 0.70; 95% CI: 0.56-0.88). This association remained after adjustment for traditional CV risk factors and was not changed in the analyses excluding men with known CV disease at baseline. The authors concluded that high serum testosterone predicted a reduced five-year risk of CV events in elderly men. J Am Coll Cardiol. 2011 Oct 11;58(16):1674-81. PMID: 21982312

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RESEARCH NEWS

High maternal trans fatty acid intake increases fetal growth

Association between sleep duration and bone mineral density in Chinese women

The current study was conducted to examine the association between maternal trans fatty acid intake during pregnancy and fetal growth. A prospective cohort study of pregnant women and their offspring were studied, including 1369 mother-child pairs. Trans fatty acid consumption was assessed using a validated semi-quantitative food-frequency questionnaire in each of the first and second trimesters of pregnancy. Fetal growth was estimated as the birth-weight-for-gestational-age (BW/GA) z value in infants born at term. No associations between first-trimester trans fatty acid consumption and fetal growth were observed. Total trans fatty acid consumption during the second trimester, on the other hand, was positively associated with the fetal growth z score (0.29 units; 95% CI: 0.07-0.51 units) for each 1% increment in energy from trans fatty acids as a replacement for carbohydrates. The associations were limited to the trans fatty acids 16:1t (0.12 units; 95% CI: 0.02-0.22 units) and 18:2tc (0.53 units; 95% CI: 0.09-0.96 units). The authors concluded that a higher maternal intake of trans fatty acids, especially 16:1t and 18:2tc, during the second trimester of pregnancy was associated with greater fetal growth. Am J Clin Nutr. 2011 Sep 14. PMID: 21918217

Short sleep duration is related to several endocrine and metabolic dysfunctions but evidence of the association between insufficient sleep and bone health is limited. The current study examined the relationship between sleep duration and bone mineral density (BMD). Subjects included 602 Chinese women aged 18â&#x20AC;&#x201C;80 years. Sleep duration was collapsed to form categories of five hours or less, six hours, seven hours, eight hours, and nine hours or more. Total and regional BMD were measured using dual-energy X-ray absorptiometry. Women with a short sleeping duration were more likely to have lower total and all body regional BMD after adjusting for potential covariates (all p values < 0.05). Compared to those who slept eight hours, individuals who slept five hours or less and six hours had significantly lower total and regional BMD (all p < 0.05). Upon dividing women into 18â&#x20AC;&#x201C;44 years old and 45 years or older groups and repeating the regression models, the significant associations between BMD and sleep duration were only observed in the 45 years or older group. These findings may lead to the development of better preventive approaches to osteoporosis. Bone. 2011 Aug 12. PMID: 21864732

The effect of grape seed extract on cardiovascular risk markers: a systematic review This systematic review was conducted to assess the effect of grape seed extract on changes in blood pressure (BP), heart rate (HR), lipid levels, and C-reactive protein (CRP) levels. MEDLINE (1950 to 2010), Agricola (1970 to 2010), Scopus (1996 to 2010), and the Cochrane Central Register of Controlled Trials (through 2010) were searched for human randomized controlled trials of grape seed extract reporting efficacy data on at least one of the following end points: systolic or diastolic BP, HR, total cholesterol, low-density or high-density lipoprotein cholesterol, triglycerides, or CRP. Nine randomized, controlled trials (n=390) met the inclusion criteria and a meta-analysis was conducted. Upon meta-analysis, grape seed extract significantly lowered systolic BP (95% CI: -2.85 to -0.22, P=0.02]) and HR (95% CI: -2.50 to -0.34, P=0.01). No significant effect on diastolic BP, lipid levels, or CRP was found. The authors concluded that based on the currently available literature, grape seed extract appears to significantly lower systolic BP and HR, with no effect on lipid or CRP levels. Larger randomized, double-blinded trials evaluating different dosages of grape seed extract and for longer follow-up durations are needed. J Am Diet Assoc. 2011 Aug;111(8):1173-81. PMID: 21802563

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Have a happy flu season! Your patients will feel better faster with...

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• Potent combination of Ester-C®, echinacea, andrographis, and NAC Take the SISU Ester-C® Challenge and you could win a trip to your “Happy Place”!

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• Reduces the severity of symptoms, shortens the duration of colds and flu

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SISU Cold and Flu Rescue Monograph SISU Cold & Flu Rescue

Active constituents: Each vegetarian capsule contains: 300 mg Ester C® brand vitamin C, 200 mg N-acetyl-L-cysteine (NAC), 200 mg Andrographis (extract, standardized to 10% andrographolides), 45 mg Echinacea angustifolia (5:1 extract standardized to 4% echinacosides), 60 mg Echinacea purpurea (4:1 extract).

General information:

Andrographis: In a systematic review of 4 clinical trials, Poolsup et al (2004) concluded that the evidence is substantial for the ability of Andrographis to reduce symptoms of upper respiratory tract infection (URTI). Significant symptomatic improvement when using Andrographis products has been reported in particular for the following: headache, throat and nasal symptoms (including sinusitis) ( Gabrielian et al) myalgia, fever and cough (Melchior et al). N-acetyl-L-cysteine: In a randomized, double-blind, placebo controlled, multicentre clinical trial, 262 patients received either NAC or placebo during “cold and flu” season. Although rates of exposure and infection with influenza virus (as demonstrated by seroconversion) did not vary significantly between active and placebo groups, the incidence of clinical illness did. The NAC group had a significantly lower incidence of clinical signs and symptoms of illness when compared to placebo (29 vs. 51%). The beneficial and protective effects of NAC are likely due to its role as a glutathione (GSH) precursor. Nencioni et al (2003) have demonstrated that GSH content of a cell contributes to its ability to down-regulate the replication of influenza virus. Vitamin C: This nutrient is highly concentrated in white blood cells and supports proper function of these cells. Although there has been ongoing controversy over whether vitamin C is helpful in the prevention of the common cold, the overall evidence suggests a benefit in reducing the duration and severity of symptoms and that those under stress (particularly significant physical stresses such as those associated with competitive sports) may reduce their risk of common cold by as much as 50% when vitamin C is used preventatively. In a randomized, placebo-controlled clinical trial, Ester C® at a dose of 1000 mg per day for 60 days was found to significantly reduce the incidence and duration of common cold symptoms vs. placebo. Echinacea : This herbal medicine has a long history of traditional use in the treatment of URTI.

Doses and directions: 2 capsules, 3 times per day, begin taking within 72 hours of symptom onset or as directed by a health care practitioner.

Therapeutic effects: Helps to shorten the severity and duration of cold and flu symptoms.

Quality Assurance

Purity Identity & Potency (per capsule)

Method

Test

Test Parameters

Tolerances

SPC

USP<2021>/MFHPB<18>

<5,000

Escherichia coli

USP<2022>/MFHPB<19>

Negative

Salmonella

USP<2022>/MFLP<75>

Negative

Staphylococcus aureus

USP<2022>/MFHPB<21>

Negative

Total Mold & Yeast

USP<2021>/MFHPB<22>

<1,000

cfu/g

Arsenic

ICP / AA

<0.14

μg/kg b.w./day

Cadmium

ICP / AA

<0.09

μg/kg b.w./day

Lead

ICP / AA

<0.29

μg/kg b.w./day

Total Mercury

ICP / AA

<0.29

μg/kg b.w./day

Solvent Residues

GC/GC-MS

Conforms to USP/ICH tolerance limits

Pesticides

USP<561>

N-acetyl-L-cysteine (NAC)

Identity

HPLC

Conforms to reference material

Quantity

HPLC

200mg

Identity

TLC / HPLC

Conforms to reference material

Echinacosides

HPLC

1.8mg

(80 – 120%)

Quantity

Input

45mg

(95 – 105%)

Purple coneflower 4:1 extract (Echinacea purpurea)

Identity

TLC / HPLC

Conforms to reference material

Quantity

Input

60mg

Andrographis extract (Andrographis paniculata)

Identity

HPLC

Conforms to reference material

Narrow-leaf echinaecea 5:1 extract (Echinacea angustifolia)

Vitamin C (Calcium ascorbate)

cfu/g

Conforms to USP tolerance limits (80 – 120%)

(95 – 105%)

Andrographolides HPLC

20mg

(80 – 120%)

Quantity

Input

200mg

(95 – 105%)

Identity

Titrimetry / HPLC

Conforms to reference material

Quantity

Titrimetry / HPLC

300mg

(90 – 150%)

References Flora et al., “Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment.” Eur J Resp.1997;10:1535-1541.

Nencioni et al.,”Influenza A virus replication is dependent on an antioxidant pathway that involves GSH and Bcl-2.” FASEB (online), Feb 19 2003.

Gabrielian et al., “A double-blind, placebo-controlled study of Andrographis paniculata fixed combination Kan Jang in the treatment of acute upper respiratory tract infections including sinusitis.” Phytomedicine, 2002;9:589-597.

Poolsup et al.,”Andrographis paniculata in the symptomatic treatment of uncomplicated upper respiratory tract infections: systematic review of randomized controlled trials.” J Clin Pharm Ther.,2004;29:37-45.

Kelly, Greg S., “Clinical applications of N-acetylcysteine.” Alt Med Rev.1998;3(2):114-127.

Van Straten et al.,”Preventing the common cold with a vitamin C supplement: a double blind, placebo controlled survey.” Advances in Therapy,2002 May;19(3):151-159.

Lindenmuth and Lindenmuth, “The efficacy of echinacea compound herbal tea preparation on the severity and duration of upper respiratory and flu symptoms: a randomized, double-blind placebo-controlled study.” J Alt Compl Med.2000;6(4):327-334. Melchior et al.,”Double-blind, placebo-controlled pilot and Phase III study of activity of standardized Andrographis paniculata,Herba Nees extract fixed combination (Kan jang) in the treatment of uncomplicated upper-respiratory tract infection.” Phytomedicine,2000;7(5):341-350.

sisu.com

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Saxena RC, Singh R, Kumar P, Yadav SC, Negi MP, Saxena VS, Joshua AJ, Vijayabalaji V, Goudar KS, Venkateshwarlu K, Amit A, “A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection.” Phytomedicine, 2010 Mar;17(3-4):178-85. Epub 2010 Jan 25.

1.800.663.4163

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RESEARCH NEWS

Homocysteine and reclassification of cardiovascular disease risk

Breastfeeding is associated with improved child cognitive development

A post hoc analysis was performed of the MESA (Multi-Ethnic Study of Atherosclerosis) and NHANES III (National Health and Nutrition Examination Survey III) datasets to examine whether adding homocysteine (Hcy) to a model based on traditional cardiovascular disease (CVD) risk factors improves risk classification. Reclassification of coronary heart disease (CHD) events was performed using a net reclassification improvement (NRI) index with a Framingham risk score (FRS) model with and without Hcy. Hcy level (>15 μmol/l) significantly predicted CVD (p = 0.006) and CHD events (p = 0.01) in the MESA trial and CVD (p < 0.001) and CHD mortality (p < 0.001) in the NHANES III after adjustments for traditional risk factors and C-reactive protein. The level of Hcy, when added to FRS, significantly reclassified 12.9% and 18.3% of the overall and 21.2% and 19.2% of the intermediate-risk population from the MESA and NHANES cohorts, respectively. The NRI also showed significant reclassification in both MESA (p < 0.001) and NHANES III (p < 0.001) datasets. Therefore, the addition of Hcy level to FRS significantly improved risk prediction, especially in individuals at intermediate risk for CHD events. J Am Coll Cardiol. 2011 Aug 30;58(10):1025-33. PMID: 21867837

The current study was conducted to assess the association between breastfeeding and child cognitive development in term and preterm children. Data on white singleton children from the United Kingdom Millennium Cohort Study was analyzed and children were grouped according to breastfeeding duration. Results were stratified by gestational age at birth: 37 to 42 weeks (term, n = 11 101) and 28 to 36 weeks (preterm, n = 778). British Ability Scales tests were administered at age five years (naming vocabulary, pattern construction, and picture similarities subscales). The mean scores for all subscales increased with breastfeeding duration. After adjusting for confounders, there was a significant difference in mean score between children who were breastfed and children who were never breastfed: in term children, a two-point increase in score for picture similarities (when breastfed ≥4 months) and naming vocabulary (when breastfed ≥6 months); in preterm children, a four-point increase for naming vocabulary (when breastfed ≥4 months) and picture similarities (when breastfed ≥2 months) and a six-point increase for pattern construction (when breastfed ≥2 months). These differences suggest that breastfed children will be one to six months ahead of children who were never breastfed. J Pediatr. 2011 Aug 10. PMID: 21839469

Fecal assays detect hypersensitivity to cow’s milk protein and gluten in adults with irritable bowel syndrome The current study determined the frequency of food hypersensitivity (FH) among patients with symptoms of irritable bowel syndrome (IBS) and the ability of fecal assays for tryptase, eosinophil cationic protein (ECP), or calprotectin to diagnose FH. Subjects included 160 patients with IBS, 40 patients with other gastrointestinal diseases, and 50 healthy individuals (controls). At baseline, patients completed a symptom severity questionnaire, fecal samples were assayed, and levels of specific immunoglobulin E were measured. Patients were observed and placed on an elimination diet (without cow’s milk or derivatives, or wheat, egg, tomato, or chocolate) for four weeks. Those reporting improvements after the elimination diet period were then diagnosed with FH, based on the results of a doubleblind, placebo-controlled, oral food challenge (with cow’s milk proteins and then with wheat proteins). Twenty-five percent of IBS patients had FH. Levels of fecal ECP and tryptase were significantly higher among patients with IBS and FH than those without FH. The ECP assay was the most accurate assay for diagnosis of FH, showing 65% sensitivity and 91% specificity. The authors concluded that fecal assays for ECP could be used to identify FH in patients with IBS. Clin Gastroenterol Hepatol. 2011 Aug 11. PMID: 21839707

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INDUSTRY NEWS USDA launched the latest release of nutrient database The USDA has provided access to Release 24 of the USDA National Nutrient Database for Standard Reference. Information on more than 7900 different foods is now available. You can either view the data on the website (http://www.ars. usda.gov/ba/bhnrc/ndl) or download the data files and documentation in several different formats for use on your computer. The Mission of the Nutrient Data Laboratory is “To develop authoritative food composition databases and state of the art methods to acquire, evaluate, compile and disseminate composition data on foods and dietary supplements available in the United States.”

World Tuberculosis cases decline for first time ever The World Health Organization reported on October 11, 2011 that the number of people getting sick with tuberculosis (TB) declined last year for the first time and the death toll reached its lowest level in a decade. In 2010, 8.8 million people fell ill with TB and 1.4 million died, marking notable declines compared to years prior according to the 2011 Global Tuberculosis Control Report released by the United Nations (UN). Globally, the TB death rate dropped 40% in 2010 compared to 1990 and all regions except Africa were on track to reach a 50%

mortality decline by 2015. “This is major progress. But it is no cause for complacency,” UN Secretary-General Ban Ki-moon said in a statement. “Too many millions still develop TB each year, and too many die. I urge serious and sustained support for TB prevention and care, especially for the world’s poorest and most vulnerable people.”

Integrated cancer care centre opens in Victoria Cancer patients on Vancouver Island and the Gulf Islands now have access to a new integrated cancer care service. InspireHealth has operated a Vancouver centre since 1997 and it has expanded its services to Victoria. The InspireHealth Victoria regional centre opening followed an expansion announcement in Vancouver, where it was stated that other offices will be opened in Victoria, Abbotsford, Kelowna, and Prince George, as well as a virtual program to support rural and remote communities. Integrated cancer care combines diet, activity, and stress management with standard cancer treatments to promote an overall healthier lifestyle, which can lead to better patient outcomes and cancer survival rates. InspireHealth is funded through contributions from the Ministry of Health, along with a mix of physician salaries, patient-pay-membership fees, and private donations.

PregVit® and PregVit folic 5® prenatal multivitamins are in compliance with Passover requirements Duchesnay, the first Canadian pharmaceutical company to have been granted Kosher certification from the Kashruth Council of Canada (COR) for its prenatal multivitamins PregVit® and PregVit folic 5®, has received confirmation that the two products are chometz free and in full compliance with Passover requirements. A new Chometz-free symbol has been provided to Duchesnay and will appear on the revised PregVit® and PregVit folic 5® packaging before next Passover. In the meantime, Canadian women using the current PregVit®and PregVit folic 5® packaging can rest assured that their prenatal/postpartum multivitamins are suitable for Passover.

Doctors should consider ADHD starting at age four The American Academy of Pediatrics recently expanded its guidelines for diagnosing and treating kids with attentiondeficit hyperactivity disorder (ADHD), recommending that doctors evaluate all patients age four to 18 that show signs of the condition. These new guidelines update the previous recommendations that focused on diagnosing and managing ADHD in kids age six to 12. Drafted by a 14-member committee, the new recommendations say

Carlson Labs founder passes away John R. Carlson, the co-founder and president of Carlson Laboratories, passed away October 1, 2011 at the age of 77 years. Carlson retired last fall from his post at the company and was serving as Director Emeritus. For 45 years, Carlson was dedicated to the natural products industry, serving as an active member of such industry organizations as the American Academy of AntiAging Medicine, Natural Products Association (NPA), National Institute of Nutritional Education, and Mid-American Health Organization. He was also a founding member of Citizens for Health. The industry has recognized his service on many occasions; John was the recipient of the National Nutritional Food Association’s Crusader Award in 2001 and received the first Board of Directors Award in 1985 from the National Institute of Nutritional Education. John also received the Emeritus Director award from Citizens for Health in 1996. John Carlson was a true pioneer and he was a powerful example of the true nature and soul of the natural products Industry.

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INDUSTRY NEWS pediatricians should consult with parents, teachers, and other adults in the community about kids’ behavior or school-related problems because affected children may not always show symptoms in the doctor’s office. The authors recommend that parents of fourand five-year olds with ADHD be trained in techniques to help manage kids’ behavior and only when that does not work, and moderate or severe ADHD persists, should young kids be put on medication. In school-aged kids, teachers or parents can also provide behavior therapy but some children may require special education plans. Stimulant medications (i.e., Ritalin) have also been shown to be effective alone or alongside therapy in this age group. The authors suggest that implementing both medication and behavior therapy will probably be the most effective in school-aged kids and adolescents. Lastly, medication and individual behavior therapy are recommended for teens with ADHD and the authors emphasize that doctors need to keep their eyes open for any signs of drug or alcohol abuse in this group.

WHO reports that air pollution is threatening health quality According to an unprecedented compilation of air quality data released on September 29, 2011 by the World Health Organization (WHO), air pollution is reaching levels that threaten people’s health in many cities. This information includes data from nearly 1100 cities across 91 countries. The WHO estimates that more than 2 000 000 people die every year from breathing in tiny particles present in indoor and outdoor air pollution. PM10 particles, which are particles of 10 micrometers or less that can penetrate into the lungs and may enter the bloodstream, can cause heart disease, lung cancer, asthma, and acute lower respiratory infections. The WHO air quality guidelines for PM10 is 20 µg/m3 as an annual average but the data released shows that average PM10 in some cities has reached up to 300 µg/m3. WHO is calling for greater awareness of health risks caused by urban air pollution, implementation of effective policies, and close monitoring of the situation

in cities. A reduction from an average of 70 µg/m3 of PM10 to an annual average of 20 µg/m3 of PM10 is expected to yield a 15% reduction in mortality, which would be considered a major public health gain.

World’s first malaria vaccine works in major trial An experimental vaccine from GlaxoSmithKline (GSK) has been reported to decrease the risk of malaria by half in African children aged five to 17-months old in final-stage trial data of a major clinical trial. Researchers who analyzed data from the first 6000 children in this ongoing trial found that after 12 months of follow-up, three doses of RTS,S (or Mosquirix) reduced the risk of children experiencing clinical malaria and severe malaria by 56% and 47%, respectively. Results in babies aged six to 12 weeks are expected within a year and, if all goes well, GSK believes the vaccine could reach the market in 2015. While hailing an unprecedented achievement, experts stress that the vaccine is no quick fix for eradicating malaria. The new vaccine is less effective against malaria than other vaccines are against common infections such as polio and measles. “We would have wished that we could wipe it out, but I think this is going to contribute to the control of malaria rather than wiping it out,” said Tsiri Agbenyega, a principal investigator in the RTS,S trials in Ghana.

Carlson Laboratories wins Better Nutrition Magazine’s “Best of Supplements Awards 2011” Carlson Laboratories is one of the recipients of Better Nutrition Magazine’s 4th Annual Best of Supplements Awards for their newest formulation, Nutra-Support Energy, which contains a special blend of vitamins, omega-3s, and other nutrients intended to boost energy levels naturally. Winning products were chosen based on a wide range of qualifications, including quality and type of ingredients, product uniqueness in the marketplace, popularity of product, reader feedback on products and reviews, as well as expert feedback on products.

Canada unveils larger, graphic anti-smoking labels Canada unveiled some of the world’s largest and most graphic anti-smoking labels on the grounds that smokers were starting to ignore existing warnings on cigarette packs. Some of the labels include pictures of a woman dying of lung cancer in a hospital bed, a man with a hole in this throat after surgery for smoking-related larynx cancer, and a close-up shot of a diseased and cancerous tongue. “We want to make the images larger and more noticeable and more understandable ... The images are pretty gross. They can be a little bit scary as well, but that is the reality of smoking,” said federal Health Minister Leona Aglukkaq. “Over time, people get used to seeing the old pictures so we want to grab people’s attention once again,” she said. Existing anti-smoking labels cover 50% of a pack but the new labels will have to cover 75% of the front and back of each pack of cigarettes and small cigars. Tobacco manufacturers and importers will have until March 21, 2012 to switch over to the new labels and retailers must only carry packs with the bigger warnings by June 19, 2012.

Bastyr University announces new campus in San Diego Bastyr University announced that its new campus will be located in San Diego, California with plans for the first class to begin in Fall 2012.”We are thrilled to secure a location for our Southern California campus,” said Bastyr University President Daniel K. Church, PhD. “To become the first regionally accredited naturopathic medical institution in California is a tremendous honor and we look forward to providing the same quality education as our Kenmore, Washington, campus does.” San Diego was selected because of its strategic proximity to a significant number of prospective students, faculty, and patients in Southern California who are interested in the natural health arts and sciences. The Doctor of Naturopathic Medicine degree program will be offered when the school first opens and other degree programs are expected to be offered in the future.

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INDUSTRY NEWS Medistick available at Source for Sports Medistik, the sports medicine pain relief stick, has announced that it will be available in participating stores at Source for Sports across Canada. “We are excited to have Source for Sports offering our products,” says Ruza Jelinkova, managing director for Medistik. “Source for Sports is a leading Canadian retailer and gives us access to a broader group of people that will benefit from the use of our product. We have had great success with the growth of MEDISTIK™ due to its higher levels of active ingredients compared to other leading sport analgesics.” Medistik is used to provide pain relief for stiff and sore muscles, tendinitis, and arthritic pain. It provides athletes faster recovery, quicker return to training and better performance. Medistik is free of banned substances as defined by the Canadian Centre for Ethics in Sports and the World Anti-Doping Association.

Research centre for seniors will be built at the University of Waterloo On August 29, 2011 the Schlegel-UW Research Institute for Aging (RIA) was part of an exciting announcement involving an ambitious partnership between the Ontario government, University of Waterloo, Conestoga College, and the Schlegel Villages to develop a centre of excellence for research, training, and innovation in senior health care. The new centre will be located at the University of Waterloo, including a 192-bed Long Term Care (LTC) home, a specialized building for staff and students to work and learn with residents and staff from the adjacent LTC home. Future developments include assisted living and independent living for seniors as well as a primary care health centre to create a full continuum of care.

Drug shortages to be posted A survey of Canadian pharmacists conducted last year revealed that drug shortages are becoming more common. More than 90% of respondents said they experienced trouble tracking down

a medication in the previous week and almost all respondents said they had seen deterioration in the previous year. To address this serious issue, pharmaceutical companies have agreed to pool information on drug shortages and pending shortages, and then post the details on two existing public websites. They also pledged to build a more comprehensive one-stop website that will become a permanent, reliable source of information about drug shortages, as long as Health Canada helps with funding.

Parents delaying or skipping recommended vaccines More than one in 10 parents use an “alternative” vaccination schedule for their young children, including refusing vaccines altogether, according to a new cross-sectional, internet-based survey of a nationally representative sample of parents (n = 748) of children six months to six years of age. The study found that of the 13% of parents who reported following an alternative vaccination schedule, most refused only certain vaccines (53%) and/or delayed some vaccines until the child was older (55%) but 2% of parents refused any vaccination altogether. Even among parents who did follow the recommended schedule, about one-quarter said they thought that delaying vaccines would be safer or that the expert-backed schedule was not the best one to follow (Pediatrics. 2011 Oct 3. PMID: PMID: 21969290). The study’s lead author, Dr. Amanda Dempsey, said “It’s really quite worrisome to me. Vaccine refusal and delay is not likely to go away anytime soon, and is likely to get significantly worse over time. We may just be seeing the tip of the iceberg right now.”

Clinpro 5000 1.1% sodium fluoride anti-cavity toothpaste now available in Canada Clinpro 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste (NPN 80012416) is now available at Shoppers Drug Mart stores nationwide, in addition to the product’s previous availability through dental professionals. Clinpro 5000 features an advanced formula containing fluoride,

calcium, and phosphate, which are components naturally found in saliva. “At 3M ESPE, we’re proud to have offered Clinpro 5000 toothpaste to dental professionals since May 2010,” said Lisa Citton-Battel, Business Manager with 3M ESPE. “Now, patients can further benefit from the many enhancements this toothpaste provides since it’s readily available at Shoppers Drug Mart stores across Canada.” Some of the many benefits of using Clinpro 5000 anti-cavity toothpaste include: strengthened teeth, reversed signs of early lesions, increased fluoride delivery to teeth, and gentle cleaning and whitening. For more information, visit www.3MESPE.ca.

Major international vaccine centre to open in Saskatchewan The Vaccine and Infectious Disease Organization (VIDO) and the University of Saskatchewan have opened the International Vaccine Centre (InterVac), one of the world’s most advanced containment facilities. InterVac’s state of-the-art vaccine development will help to address global health issues by contributing to the next generation of innovative vaccines. It will also keep Canada at the forefront of innovative science by training scientists and students from around the world and build upon our national legacy in vaccine development that stretches over a century.

Challenge to accelerate clinical value using technology Canada Health Infoway (Infoway) has launched its ImagineNation Outcomes Challenge, which will accelerate the use of innovative IT solutions with the potential to improve healthcare quality and the patient experience. “The ImagineNation Outcomes Challenge taps into the desire of Canadians and their clinicians to develop and spread innovations that improve healthcare,” said Richard Alvarez, President and CEO, Canada Health Infoway. The Outcomes Challenge offers more than $1 000 000 in awards to teams whose solutions are used most and those with the strongest growth in users in any of the

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INDUSTRY NEWS four Challenge categories: 1) e-scheduling; 2) patient access to health information; 3) medication reconciliation; and 4) clinical synoptic reporting. Challenges are a good way of eliciting and spreading innovation. Infoway has committed to engage in open challenges to encourage broader innovation in a cost-effective and timely way, while fostering a community of innovators across the country. To learn more, visit http:// www.imaginenationchallenge.ca.

MD Physician Services responds to Healthscreen client requests MD Physician Services Software announced that it is introducing an electronic medical record (EMR) Migration Support Program in Ontario to financially assist physicians transitioning from their current EMR system to PS Suite® EMR. MD is waiving migration fees and will not be charging upfront licence fees. Migration will include all clinical and demographic data ensuring minimal impact to physicians’ practices and patient care. In addition, MD is providing free clinical workflow consulting and system assessment. The EMR Migration Support Program is available until December 31, 2011. Ontario physicians interested in participating can contact MD at 1-800361-9151 or visit md.cma.ca/emr.

Crib bumper pads a risk for sleeping babies Once thought to protect babies from injury, bumper pads on cribs may lead to suffocation, according to new guidelines for sleeping babies released by the American Academy of Pediatrics. They caution against lining cribs with the protective cushion, saying that there is no evidence that bumper pads prevent injuries. The guidelines also recommend soft objects and loose bedding, such as quilts and pillows, not be kept in cribs and that babies should sleep on a firm surface and should sleep in the same room as parents, but not in the same bed. In addition, the guidelines state that infants should not regularly have routine sleep time in sitting devices such

as car seats and strollers and should not sleep in a bed where they might suffocate. A series of 18 recommendations from the academy are intended to help guide parents, health care providers, and others who care for infants following an increase in sleeprelated deaths over the last few years. The expanded recommendations aim to reduce the risk of sudden infant death syndrome, suffocation, entrapment, and asphyxia.

Bayshore Home Health launches monthly e-newsletter aimed at seniors’ health Bayshore Home Health officially launched the first edition of its new monthly e-newsletter, Eye on Health. The newsletter is designed to support families and informal caregivers in caring for their elderly loved ones. Each month, Eye on Health will feature a new theme related to seniors’ health and well-being, and offer tips and solutions to help manage health issues and alleviate the stresses associated with caregiving. In the not so distant future, seniors will comprise 13% of the Canadian population, with Statistics Canada predicting that by 2026 this will increase to 21%. As seniors become a greater proportion of the Canadian population, arthritis and other common diseases will become more prevalent if the necessary preventative steps are not taken. To access and subscribe to editions of Eye on Health, please visit www.bayshore.ca.

Canada’s future physicians make choices to ensure personal -professional life balance Data released from the medical student and resident component of the 2010 National Physician Survey (NPS) shows Canada’s future physicians want to work smarter to meet the growing and increasingly complex health care needs of Canadians. Of the nearly 5600 medical students and residents who responded to the 2010 NPS, 53% identified a balance between personal and professional life as the most important factor for a satisfying practice.

NPS is Canada’s largest census survey of physicians and physicians-in-training and the data provide meaningful information on attitudes among the country’s present and future physicians toward a wide range of critical issues. For more information and to see the NPS 2010 data and highlights of the results, please go to www. nationalphysiciansurvey.ca.

A universal CPAP compliance monitoring solution is now available Umbian Inc. has announced U-Sleep, which is the first commercially available, universal CPAP compliance monitoring solution. U-Sleep monitors CPAP device usage, providing critical daily feedback to CPAP users and sleep specialists. The monitoring of CPAP device usage encourages regular use and subsequently improves the effectiveness of therapy. The current release of U-Sleep supports CPAP devices from multiple leading manufacturers and U-Sleep’s flexible design allows usage data to be submitted via multiple methods. Once data is submitted, U-Sleep quickly assesses individual compliance and provides immediate notification of compliance outcomes via email, phone, or text message. For more information on U-Sleep, please visit www.u-sleep.com.

Pfizer Canada is proud to be one of Canada’s top 100 employers Pfizer Canada Inc. has been selected as one of Canada’s Top 100 Employers for 2012 in a list announced in The Globe and Mail newspaper. Canada’s Top 100 Employers list is based on research conducted by Mediacorp Canada Inc., a publisher specializing in employment-related issues. The competition is based on two main criteria: an organization must be a leader in its industry in attracting and retaining quality employees and that it offers reasonable employment prospects. The editors of the contest reviewed the recruitment histories of more than 75 000 employers across Canada and invited 500 of these to participate in the extensive application process. •

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PRODUCT PROFILES

3 4

1. SISU Vitamin D

4. NEW Probiotic 50 Billion (soy and dairy free)

Are your patients D-prived? It is estimated the economic burden of vitamin D deficiency in Canada is approximately $14.4 billion per year. Vitamin D is essential for bone health and the prevention of many chronic health conditions. SISU Vitamin D is fast-dissolving, sublingual tablets of vitamin D3 1000 IU, and are available in bottles of 90, 200 and a new 400 tablet size. Also available: SISU Kids 400 IU.

Probiotic 50B provides 50 billion CFU per capsule of the beneficial bacteria Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium longum and Bifidobacterium lactis. Probiotic 50B is offered in a new acid-resistant capsule with pH targeted release. These capsules are designed to resist disintegration in an acidic environment (i.e. stomach) and dissolve in more alkaline environments (i.e. small and large intestine). This technology helps to protect the organisms from stomach acid, delivering the maximal viable organisms to the GI tract. This blend of lactobacilli and bifidobacteria is designed to promote healthy intestinal ecology to support gastrointestinal and immune health.

2. cal : mag berry liquid+ Helps in the development & maintenance of healthy bones, and when combined with a nutritious diet and regular exercise, it may help reduce the risk of developing osteoporosis. Comprehensive bone support: Calcium, Magnesium, Vitamins A, D, K and Boron; Deliciously smooth natural blueberry taste; Citrate formula for easy absorption.

3. Digest-ProGD™ Digest-ProGD is a broad spectrum proprietary enzyme blend, providing unique support for the digestion of gluten and dairy proteins. The formula contains amylase, glucoamylase and alphagalactosidase which support the digestion of lactose, carbohydrates, proteins and fats. Suitable for vegetarians and useful for gluten and casein free diets.

5. Wobenzym PS For over 60 years, Wobenzym® has been a trusted name for systemic enzyme supplementation. Developed by leading scientists and used by millions of people worldwide, Wobenzym® PS exclusively available to healthcare professionals, is clinically supported to help maintain healthy joint function. Wobenzym® PS is delivered in a unique enteric-coated tablet and provides a specific formulation of both plant and animal enzymes to help maintain optimal immune function, balance inflammation as well as improve wound healing.

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PRODUCT PROFILES

1. PASCOFEMIN® PASCOFEMIN® is a well-tolerated, effective solution for physical and emotional symptoms of menopause such as hot flashes, headaches, mood swings and sleep disturbances. In one study of women who had tried other therapies to control menopause symptoms without success, significant effectiveness was found in 71% of patients. Even more impressive, after patients left the study and had to purchase it on their own, 80% were satisfied enough to continue using PASCOFEMIN®. There are no known side effects or contraindications.

2. Cyto-Matrix - Omega-D3 Liquid Forte Evidence based dosages for all indications; High safety profile; Molecularly distilled, ultra-pure fish oil; Easy to administer for maximum patient adherence; No fishy aftertaste, light citrus flavour. Each teaspoon (5 mls) contains: Fish Oil Concentrate - 4,377 mg; Omega-3 Fatty Acids - 2,845 mg, EPA (Eicosapentaenoic acid) - 1,750 mg; DHA (Docosahexaenoic acid) - 875 mg; Vitamin D3 -1000 IU.

3. Designed with you in mind. Progressive Complete Calcium for Women 50+ has been formulated for mature women to aggressively defend against all forms of calcium

depletion while providing high quality calcium at an optimal dose. Also available for Adult Women, Adult Men and Kids.

4. Another Innovation from Cyto-Matrix Includes the strain L. salivarius, a strain known for its ability to effectively upregulate the secretion of the anti-inflammatory cytokine IL-10. Low levels of IL-10 are associated with the signs and symptoms of the inflammatory bowel diseases such as Crohn’s disease and Ulcerative colitis. Includes a broad range of strain specific probiotics with well researched effects on balancing the immune system. Advanced Probiotic Formula 11 Strains 11 Billion Live Probiotic; Cellsper Capsule Enteric Coated Vegetarian Capsules Only 0.5 mg of FOS; per Capsule Available in 60 and 100 capsule bottles.

5. Introducing sleep+ time release The innovative, non-habit forming formula helps you to fall asleep faster, stay asleep longer and wake up feeling refreshed. Phase I releases passionflower to relax the body and mind to help falling asleep. Phase II provides time-released melatonin to support the body’s natural rhythm helping you to stay asleep all night long. genuinehealth.com ihpmagazine.com { November/December 2011 IHP | 33

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PRODUCT PROFILES

1. CogniCare PQQ-10™ PQQ and CoQ10 are synergistic nutrients which modulate cellular signalling pathways, neutralize reactive oxygen species and support optimal mitochondrial function. Mitochondrial dysfunction plays a role in an ever increasing range of conditions and is thought to play an important role in age related decline.

2. New! fast arthritis relief+ Targets the pain and inflammation of osteoarthritis, while rebuilding cartilage and lost joint space. A powerful formula containing: Natural Eggshell Membrane, research proven to help build and repair joints, AvoVida® proven to increase the joint space lost in OA, and Bromelain, a natural enzyme with anti-inflammatory properties. www. genuinehealth.com. * Clinical Intervention in Aging 2009; 4:235-40 **NEM (Natural Eggshell Membrane) a patented, research-proven ingredient containing naturally occurring ingredients, including glucosamine, chondroitin and hyaluronic acid and Type 1 collagen – all essential nutrients for proper joint health and flexibility.

3. pharMAX™heal Trans-dermal wound healing cream Traditionally used in herbal medicine to aid in wound healing; to help relieve skin inflammation and irritation. Contains natural oils and extracts that work synergistically for maximum effect: Calendula (Calendula officinalis L.) flower extract: Contains water-soluble flavonoids; Rutin: Water-soluble bioflavonoid found in plants; Manuka (Leptospermum scoparium) branch/leaf oil: Appears to involve a post-synaptic spasmolytic effect that functions through a cAMP directed pathway; Sea buckthorn (Hippophae rhamnoides) seed oil: Rich in linoleic and linolenic acid (1:1) ratio; Porphyridium cruentum extract: Contains copper sulphate.

4. SISU Cold & Flu Rescue with Ester-C Reduce the severity of symptoms and shorten the duration of colds or flu with SISU Cold & Flu Rescue with Ester-C®. Cold & Flu Rescue is a potent combination of Ester-C®, echinacea, andrographis, and NAC to effectively relieve cold and flu symptoms and respiratory tract infections – without the side effects that are common with over-the-counter drugs. Visit sisu.com or call 800.663.4163 for more information.

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DESCRIPTION Wobenzym® PS is clinically supported to help maintain healthy joint function and is exclusively available to healthcare professionals. Wobenzym PS is offered in the form of enteric-coated tablets and provides a specific formulation of enzymes to the body to help maintain optimal immune function, and wound healing as well as muscle and tendon structure. FUNCTIONS For over 60 years, Wobenzym® has been a trusted name for systemic enzyme supplementation. Developed by leading scientists and used by millions of people worldwide, the family of Wobenzym® products has proven to be safe and useful for overall immune support. Wobenzym PS in particular has numerous clinical studies that link its use to maintaining optimal joint health. In the human body, hundreds of chemical reactions occur during the course of normal metabolic processes. Many chemical reactions require significant energy in order to take place, and therefore need a catalyst to allow the reaction to proceed. The catalyst acts to lower the energy needed for the reaction to move forward. In the body, enzymes play the role of the catalyst and allow reactions to take place that otherwise would not occur. The enzyme itself is not consumed in this process and can be utilized again and again. Enzymes are relatively unique to each reaction and different enzymes will catalyze different reactions. Structurally, enzymes are complex molecules that are comprised of amino acid chains and can sometimes include co-factors which assist the enzyme in the chemical reaction. Some enzymes are sensitive to changes in pH and temperature and can be destroyed if exposed to less than ideal conditions. Wobenzym® PS is a systemic enzyme formulation that contains a unique blend of enzymes from both plants and animals that have been clinically studied for supporting numerous processes in the body. Systemic enzyme supplements work directly in the body after they are absorbed in the small intestine, and are not intended to aid in digestion. Consequently, these enzymes can be utilized to assist the body’s various regulatory and communications systems. After the enzymes are absorbed, protease molecules can bind with molecules found within the blood including -2-macroglobulin, resulting in the formulation of an -2-macroglobulinprotease complex. This newly formed complex alters the molecular configuration of the -2-macroglobulin molecule which results in a change in its affinity to bind certain cytokines. Once a cytokine is bound to the protease, the entire complex is able to be eliminated from the body, allowing normal cytokine balance and immune function to be maintained.

Wobenzym® PS can help to support healthy joints and muscles, and support the immune system as well as normal wound healing processes. Wobenzym® PS tablets are enteric coated to ensure that the enzymes are protected and are not broken down in the stomach. This allows the enzymes to reach the small intestine where absorption can occur. INDICATIONS Wobenzym® PS may be a useful natural health product for individuals wishing to support healthy joint, immune and circulatory function. 3 Enteric Coated Tablets Contain: Ananas comosus Bromelain 1350 FIP unit* ..............................270 mg Sophora japonica Rutoside trihydrate (Rutin) .............................300 mg Sus scrofa Trypsin 4320 FIP unit* (pancreas) .................144 mg Other ingredients: microcrystalline cellulose, calcium phosphate, hydroxypropyl cellulose, vegetable-based enteric-coating, vegetable stearate, silica, natural vanilla flavour and purified water. * FIP is the measurement of enzyme activity according to the methods of the Internationale Phamaceutique Federation.

SUGGESTED USE Adults take 3 tablets 2 times daily at least 45 minutes before meals or as directed by your healthcare professional. SIDE EFFECTS Warning: If you are pregnant or breastfeeding, suffering from bleeding disorders or liver damage, or if you are taking anticoagulant drugs (such as warfarin), consult a healthcare professional before using this product.

For details, write #120 on Free Info Page, page 88.

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Dr Ben Boucher, MD, was born and raised in the Havre Boucher region (Antigonish County) of Nova Scotia. He is quick to highlight his Aboriginal and Acadian ancestry, which he traces back to the 1700’s, as a driving force in his lifelong self- image of individualism- an individual who finds himself COVER STORY having spent a lifetime at odds with the status quo. Physicians who fully embrace the tenants of individualized, holistic medicine seem to share this sense of “being different”, and Dr Boucher is no exception. Every healthcare provider tells a story of when in their lives they felt compelled to pursue their respective career path. Ben describes his choice was made at the age of five, when he was called upon by his father to tend to an ailing relative. His formal training began in 1974 at Dalhousie Medical School, preceded by an honours undergraduate degree in biology from St Francis Xavier University. His interest in integrative medicine was established by the time he arrived at medical school. Ben described his medical training as “frustrating”, with “excessive competitiveness”, and a lack of interest in anything outside of established norms. He wrote a paper in his second year of medical school that assimilated evidence of vascular outcomes associated with vitamin E supplementation, and suffered scrutiny from professors for his efforts.He opened his first practice on Cape Breton Island in 1979, where he had spent many summers working as the Warden for the Cape Breton Island National Park. He had a strong desire to “be where he was needed”, and Cape Breton seemed a perfect fit as the family physician of the community had passed away in 1949. Eventually Ben moved his practice to Port Hawksbury where he has been for the past 17 years. An extremely influential experience in Ben’s life occurred in 1990 when he attended an ACAM conference and chelation workshop. He was fascinated to learn concepts of oxidant/ antioxidant chemistry, the impact of heavy metals on human health, and the ability of chelation therapy to effectively treat vascular disease. He quickly implemented chelation therapy in his private practice, and since 2007 has served as a site for the ongoing TACT trial of chelation therapy for secondary prevention of cardiovascular disease. Shortly after implementing chelation therapy in private practice, Ben witnessed the therapy spare an elderly patient from amputation of a limb deemed necessary as a complication of diabetes. In 1991, one year after offering patients chelation, and on the heels of the one incredible case described above, the Provincial Medical Board of Nova Scotia (PMBNS) banned chelation therapy. Ben found this puzzling as he was the only physician in Nova Scotia offering the therapy at the time. Ben set into motion a cleaver series of events; the patient who had been spared from amputation and continued to receive regular chelation treatments had an attorney write the PMBNS and threaten to sue. The letter read to the effect of: “the treatment has been effective for me, has spared me amputation, and your actions threaten to make the treatment unavailable”. The PMBNS was quick to reverse their “chelation ban”. In 2008 Ben began treating Lyme related illness. Again, the impetus stemmed from a desire to do what was needed. He no longer considers the paradigm as Lyme- related, preferring to apply a broader term he has coined; “vector transmitted illnesses”. While most public health effort in the area focuses on Lyme, Ben is quick to highlight a long list of vectors capable of transmitting illness, including bartonellosis, babesiosis, erlilria, anaplasma, and others. The basis for the present lack of understanding of these illnesses, and the poor definitions of treatment strategies primarily stem from the extreme difficulty in making an objective diagnosis. Sensitivity and specificity of testing methods, especially in cases where the infection is months to years old, are horrifically poor. To overcome this obstacle, Ben relies primarily on the patient’s symptomatic presentation to base the diagnosis. Ben’s approach to diagnosis relies on a thorough review of symptoms questionnaire, where patients are requested to rank the severity of each symptom they report. Ben suspects vector transmitted illness when a patient reports multiple symptoms (15+) that span multiple body systems, and that are of a very severe magnitude. Objective evaluation has ruled out more commonly suspected causes, leaving vector transmitted illness as the most likely cause. Ben has set the bar very high to suspect such illness, evidenced by the extreme magnitude of debility patients present with to be considered for the diagnosis. The treatment approach is aggressive, and long term. Antibiotics are the mainstay, but true to Ben’s holistic application of healthcare, the implementation takes on unique characteristics. First and foremost, patients are counselled to improve diet quality, and as treatment progresses to adopt physical activity. Initially, herbal antibiotics take the place of prescriptions; Ben has found that prescription antibiotics work better when herbal antibiotics are used first for a period of a couple of months. He uses the Byron White herbal formulas, commonly observing symptom picture severity improve from scores of 8-9/10 to scores of 3-4/10 within a couple of months, but then the patient plateaus. Prescription antibiotics are then introduced to “finish the job”, which again often requires several months of therapy to achieve.Ben is eager to share his experiences in the realm of vector transmitted illnesses due to what he describes as an unacceptable negligence of the commonality of the problem. He sees himself as one of only a handful of physicians across Canada treating patients for this underlying cause of significant debility. As such, patients are referred to his care from across Canada. As impressive as Ben’s achievements as a physician is his commitment to his community and his own health. Ben ran for political office in two separate elections during the 1980’s as an NDP candidate. He envisioned utilizing the web as a means of operating elections and national referendums, a strategy he felt would achieve greater involvement from the public in the process of politics, and reduce public apathy. As a patient role model, Ben lives the life he requests patients to follow, most evident in his personal fitness regime that includes pedal biking, swimming, kayaking, snow snowing, and power walking.IHP is grateful to Dr Rouchotas Ben Boucher forND allowing us to present his work to you. He is a member of the rare club of physicians who have been blazing a path for By Philip MSc, future waves of integrative healthcare providers to follow long before the concepts were household in nature. He does not treat what is most convenient, Photography by Michelle Campbell but what is most pressing. In recent years he has found himself operating in an obscure field of medicine; instead of being intimidated in this arena of poor objective evaluation, his tireless efforts have produced the standard of care for it. Dr Ben Boucher, MD, was born and raised in the Havre Boucher region (Antigonish County) of Nova Scotia. He is quick to highlight his Aboriginal and Acadian ancestry, which he traces back to the 1700’s, as a driving force in his lifelong self- image of individualism- an individual who finds himself having spent a lifetime at odds with the status quo. Physicians who fully embrace the tenants of individualized, holistic medicine seem to share this sense of “being different”, and Dr Boucher is no exception. Every healthcare provider tells a story of when in their lives they felt compelled to pursue their respective career path. Ben describes his choice was made at the age of five, when he was called upon by his father to tend to an ailing relative. His formal training began in 1974 at Dalhousie Medical School, preceded by an honours undergraduate degree in biology from St Francis Xavier University. His interest in integrative medicine was established by the time he arrived at medical school. Ben described his medical training as “frustrating”, with “excessive competitiveness”, and a lack of interest in anything outside of established norms. He wrote a paper in his second year of medical school that assimilated evidence of vascular outcomes associated with vitamin E supplementation, and suffered scrutiny from professors for his efforts.He opened his first practice on Cape Breton Island in 1979, where he had spent many summers working as the Warden for the Cape Breton Island National Park. He had a strong desire to “be where he was needed”, and Cape Breton seemed a perfect fit as the family physician of the community had passed away in 1949. Eventually Ben moved his practice to Port Hawksbury where he 36 | IHP November/December 2011 } ihpmagazine.com h a s been for the past 17 years. An extremely influential experience in Ben’s life occurred in 1990

Dr Ben Boucher,MD Integrative management of vectortransmitted illness

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COVER STORY

r Ben Boucher, MD, was born and raised in the Havre Boucher region (Antigonish County) of Nova Scotia. He is quick to highlight his Aboriginal and Acadian ancestry, which he traces back to the 1700’s, as a driving force in his lifelong self- image of individualism- an individual who finds himself having spent a lifetime at odds with the status quo. Physicians who fully embrace the tenants of individualized, holistic medicine seem to share this sense of “being different”, and Dr Boucher is no exception. Every healthcare provider tells a story of when in their lives they felt compelled to pursue their respective career path. Ben describes his choice was made at the age of five, when he was called upon by his father to tend to an ailing relative. His formal training began in 1974 at Dalhousie Medical School, preceded by an honours undergraduate degree in biology from St Francis Xavier University. His interest in integrative medicine was established by the time he arrived at medical school. Ben described his medical training as “frustrating”, with “excessive competitiveness”, and a lack of interest in anything outside of established norms. He discussed a paper in his second year of medical school that assimilated evidence of vascular outcomes

associated with vitamin E supplementation, and experienced scrutiny from professors for his efforts. He opened his first practice on Cape Breton Island in 1979, where he spent a wonderful summer working as the Warden for the Cape Breton Highlands National Park. He had a strong desire to “be where he was needed”, and Cape Breton seemed a perfect fit as the family physician of the community had passed away in 1949. Eventually Ben moved his practice to Port Hawksbury where he has been for the past 17 years. An extremely influential experience in Ben’s life occurred in 1990 when he attended an ACAM conference and chelation workshop. He was fascinated to learn concepts of oxidant/ antioxidant chemistry, the impact of heavy metals on human health, and the ability of chelation therapy to effectively treat vascular disease. He quickly implemented chelation therapy in his private practice, and since 2007 has served as a site for the ongoing TACT trial of chelation therapy for secondary prevention of cardiovascular disease. Shortly after implementing chelation therapy in private practice, Ben witnessed the therapy spare an elderly patient from amputation of a limb deemed necessary as a complication of diabetes.

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COVER STORY

“Ben has found that prescription antibiotics work better when herbal antibiotics are used first for a period of a couple of months.”

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COVER STORY

In 1991, three months after offering patients chelation, and on the heels of the one incredible case described above, the Provincial Medical Board of Nova Scotia (PMBNS) banned chelation therapy for vascular disease. Ben found this puzzling as he was the only physician in Nova Scotia offering the therapy at the time. Ben set into motion a cleaver series of events; the patient who had been spared from amputation and continued to receive regular chelation treatments had an attorney write the PMBNS and threaten to sue. The letter read to the effect of: “the treatment has been effective for me, has spared me amputation, and your actions threaten to make the treatment unavailable”. The PMBNS did not question future treatments. In 2008 Ben began treating Lyme related illness. Again, the impetus stemmed from a desire to do what was needed. He no longer considers the paradigm as Lyme- related, preferring to apply a broader term he has coined; “vector transmitted infection”. While most public health effort in the area focuses on Lyme, Ben is quick to highlight a long list of vectors capable of transmitting illness, including bartonella, babesia, erlichia, anaplasma, and others. The basis for the present lack of understanding of these infections, and the poor definitions of treatment strategies primarily stem from the extreme difficulty in making an objective diagnosis. Sensitivity and specificity of testing methods, especially in cases where the infection is months to years old, are horrifically poor. To overcome this obstacle, Ben relies primarily on the patient’s symptomatic presentation to base the diagnosis. Ben’s approach to diagnosis relies on a thorough review of symptoms questionnaire, where patients are requested to rank the severity of each symptom they report. Ben suspects vector transmitted illness when a patient reports multiple symptoms (15+) that span multiple body systems, and that are of a very severe magnitude. Objective evaluation has ruled out more commonly suspected causes, leaving vector transmitted illness as the most likely cause. Ben has set the bar very high to suspect such illness, evidenced by the extreme magnitude of debility patients present with to be considered for the diagnosis. The treatment approach is aggressive, and long term. Antibiotics

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COVER STORY

are the mainstay, but true to Ben’s holistic application of healthcare, the implementation takes on unique characteristics. First and foremost, patients are counselled to improve diet quality, and as treatment progresses to adopt physical activity. Initially, herbal antibiotics take the place of prescriptions; Ben has found that prescription antibiotics work better when herbal antibiotics are used first for a period of a couple of months. He uses the Byron White and other herbal formulas, commonly observing symptom picture severity improve from scores of 8-9/10 to scores of 3-4/10 within a couple of months, but then the patient plateaus. Prescription antibiotics are then introduced to “finish the job”, which again often requires several months of therapy to achieve. Ben is eager to share his experiences in the realm of vector transmitted infections due to what he describes as an unacceptable negligence of the commonality of the problem. He sees himself as one of only a handful of physicians across Canada treating patients for this underlying cause of significant debility. As such, patients are referred to his care from across Canada. As impressive as Ben’s achievements as a physician is his commitment to his community and his own health. Ben ran for political office in two separate elections during the 1980’s as an NDP candidate. He envisioned utilizing the web as a means of operating elections and national referendums, a strategy he felt would achieve greater involvement from the public in the process of politics, and reduce public apathy. As a patient role model, Ben lives the life he requests patients to follow, most evident in his personal fitness regime that includes pedal biking, swimming, kayaking, snow shoeing, and power walking. IHP is grateful to Dr Ben Boucher for allowing us to present his work to you. He is a member of the rare club of physicians who have been blazing a path for future waves of integrative healthcare providers to follow long before the concepts were household in nature. He does not treat what is most convenient, but what is most pressing. In recent years he has found himself operating in an obscure field of medicine; instead of being intimidated in this arena of poor objective evaluation, his tireless efforts have produced the standard of care for it. •

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Product MonograPh Bio-Fen Bio-Fen Plus is an oral natural health product used in the treatment of hereditary androgenic alopecia (AGA) for male or female pattern baldness. Without treatment, AGA is progressive, and causes social distress in many affected men and women (Sinclair 1998). Bio-Fen Plus contains extracts PROGRESSIVE NUTRITIONAL THERAPIES OMEGESSENTIAL™ of fenugreek seeds, saw palmetto berries and flax lignans, as well as specific vitamins. Each ingredient is known to possess inhibitors of the enzyme 5α-reductase.OmegEssential™ These inhibitors are for relieving symptoms associated with hereditary Progressive is responsible a high potency blend of cold water, wild caught, purified AGA. fish oil along with a family of strategic support nutrients. One of the primary causes of hair loss is a high level of the male hormone dihydrotestosterone (DHT) within the hair follicle (Vierhapper, 2001). For people with AGA, their follicles have a greater number of androgen receptors to which DHT attaches. 5-α-reductase catalyzes the enzymatic Fish Oils for the Maintenance of Good Health which binds to the receptor five-fold more avidly than the parent compound (Sinclair 1998). conversion of testosterone to dihydrotestosterone, As a source of omega-3 fatty acids, namely EPA and DHA, fish oils aid in the maintenance of good health, help support cognitive health/brain Vitamins Saw palmetto repens) health (NHPD Monograph: Fish Oil). function and (Serenoa cardiovascular In a Polish study of 46 women who had symptoms of diffuse alopecia, calcium Standardized (lipophillic) Serenoa extract has been found to be a potent inhibitor was orally twice a day inindoses of 100 mg for four to of 5α-reductase, resultingconducted in decreasedatissue An open-label, doseof response on administered cognitive performance 33 normal healthy men Fontani, et al (2005) studyDHT. to evaluate the effect omega-3pantothenate supplementation months,types and vitamin B6 waswere injected everyalong day forwith 20 tothe 30 Profile days andofrepeated studywomen was conducted malesduring to determine the effect of aTests combination and (agedon 2242– healthy 51 years) a 35-day period. involvingfive different of attention used, Mood six months (Brzezińska-Wcisło 2001). It wasstates determined vitamin of carotenoid astaxanthin andshowed saw palmetto berryprofile lipid extract on DHT and States (POMS). Results a mood with increased vigour again and after reduced anger, anxiety and depression afterthat omega-3. B6 administered parenterally forofa attentional few weeks induces improvement functions, in the hair testosterone levels (Angwafor 2008). that The omega-3 men were supplementation divided into two groups: Furthermore, findings indicated is associated with an improvement and physiological condition in a subset of women and reduces hair loss. one group received mg/day the combination supplement and the other particularly those 800 involved in of complex cortical processing. group received 2000 mg/day of the supplement for 14 days. ANOVA-RM showed significant within-groupofincreases serum total testeosterone significant Higher consumption fish andin omega-3 fatty acids hasand been associated Medicinal with a lower risk of coronary heart diseasedose (CHD). et al (2002) Ingredients PerHu, capsule decreases in serum DHT from baseline in both dose groups (P=0.05). There examined the association between fish and omega-3 fatty acid consumption and risk of CHD in women. Dietary consumption and follow-up was no significant difference between dose groups with regard to the increase of Fenugreek (Trigonella graecum) diseasefoenum and cancer were compared data from 84,688 female nurses (aged 34 to 59 years) free from cardiovascular 260 mg from validated testeosterone or the decrease of DHT; therefore both doses were effective (Angwafor extract questionnaires. The outcomes indicated that women who consumed more seed fish and fish 4:1 oil (omega-3 fatty acids) significantly reduced their risk 2008). of heart disease (particularly CHD deaths) by 30%, compared to women who rarely ate fish. Saw palmetto berry extract containing 160 mg Another study tested liposterolic extract of Serenoa repens (LSESr) and beta45% free fatty acids Similarly, a prospective, nested case-control analysis was performed among apparently healthy men, who had no evidence of prior heart sitosterol in the treatment of males (23-64 years of age) with mild to moderate AGA. disease by Albert, et al (2002) to improved address atthe that long-chain omega-3 fatty acids found intofish are associated with a reduced risk of Flax lignans, standardized 20% Six of 10 (60%) subjects were rated as thehypothesis final visit, thus establishing 100 mgcollected blood of sudden death from cardiac causes. fatty-acid composition of whole blood in 184 men wasdiglucoside compared(SDG) with the previously secoisolariciresinol the effectiveness of 5α-reductase inhibitorsThe against AGA (Prager 2002). Chronic in whom sudden death occurred as the first manifestation of cardiovascular disease. The study reported that men who consumed 94 men, inflammation of the hair follicle is considered to be a contributing factor for AGA. A D-calcium pantothenate (Vitamin B5) 10.40 mg long-chain omega-3 fattytoacids had whether a significantly risk of using sudden death. study by Chittur et al sought determine blockadereduced of inflammation LSESr and two anti-inflammatory agents (carnitine and thioctic acid) could alter Niacinamide (Vitamin B3) 10.25 mg Dosage the expression of molecular markers of inflammation (Chittur 2009). It was found Pyridoxine HCl (Vitamin B6) 2 mg that the combination suppressed lipopolysaccharide-activated gene expression of brain Indication: Fish Oil Supplement. Helps support cardiovascular health, function and healthy mood balance. chemokines associated with pathways involved in inflammation and apoptosis. Adults 19 years)that 5-alpha Dosage Riboflavin (Vitamin B2) 1.58 mg The study( concluded reductase inhibitors in combination with Takea2new softgels with breakfast 2 softgel with dinner for a total of 4 softgels per day. blockade of inflammatory processesSoftgels: could represent two-pronged approach and Folic acid 0.095 mg Liquid: Take 1 tsp (5ml) daily with food. in the treatment of AGA.

Biotin 400 mcg Interactions Fenugreek Seeds non-Medicinal Ingredients Fenugreek seeds to increase 30% protein, saponins, sterols, flavonoids Omega-3 fattycontain acids 5% may thesteroid risk of bleeding when taken with anticoagulants, aspirin, ginkgo biloba or ginseng (Mason, 2001). and alkaloids (notably trigonelline and choline). Steroid saponins bind and Therefore, medical supervision is required. Inert microcrystalline cellulose and vegetable-based magnesium eliminate extra cholesterol and hormones in the body; DHT is made from stearate in a veggie-based capsule testosterone, which is in turn is made from cholesterol. Therefore, when excess Based on human studies, fish oils may lower blood pressure when taken in certain doses and have additive effects in patients treated with cholesterol is eliminated, less DHT can be made (Stark 1993). In a study of 20 anti-hypertensives (Prisco, et al, 1998). Use with caution. Recommended adult dose: One capsule per day adults who consumed 12.5g and 18.0g of germinated fenugreek seed powder for one month, higher levels of consumption resulted in a significant reduction in total cholesterol and low-density lipoprotein (LDL) levels (Sowmya 1999). Quality Assurance References

Flax lignans Parameter Albert C, et al (2002). Blood Levels of Long-Chain n-3 Fatty Acids Test Specifications Flax reduces the amount of DHT produced by reducing cholesterol levels in the and the Risk of Sudden Death. The New England Journal of Microbial body. A meta-analysis of 28 studies between 1990 and 2008 showed that flaxseed Medicine, Vol. 346 No. 15: 1113-1118, April 11. Total Count USP Less than 1,000 cfu/g significantly reduces circulating total and LDL-cholesterol concentrations (Pan Yeast & Mold USP Less than 100 cfu/g Fontani G, et al (2005). Cognitive and physiological effects of 2009). Flaxseed interventions reduced total and LDL cholesterol by 0.10 mmol/L coli USP (95%Negative Omega-3 polyunsaturated fatty acid supplementation in healthy (95%Escherichia CI: -0.20, 0.00 mmol/L) and 0.08 mmol/L CI: -0.16, 0.00 mmol/L), Salmonella spp reductions were observed USP with Negative subjects. European Journal of Clinical Investigation, 35: 691-699. respectively. Significant whole flaxseed (-0.21 and aureus USPand -0.16 Negative -0.16 Staphylococcus mmol/L, respectively) and lignan (-0.28 mmol/L, respectively) Hu F, et al (2002). Fish and Omega-3 Fatty Acid Intake and Risk Heavy Metal supplements (Pan 2009). of Coronary Heart Disease in Women. The Journal of the Arsenic USEPA Less than 0.25 ppm American Medical Association, Vol. 287 No. 14, April 10. Cadmium USEPA Less than 0.25 ppm Lead USEPA Less than 0.25 ppm References Jellin JM, et al (2006). Pharmacist’s Letter/Prescriber’s Letter Angwafor F III, Anderson ML. An open label, dose response study to determine the effect on dihydrotestosterone, testosterone and estradiol levelsthin healthy males. J Total Mercury USEPA Less than 0.25 ppmof a dietary supplement Natural Medicines Comprehensive Database.8 ed. Stockton, Int Soc Sports Nutr 2008;5:12. CA: Therapeutic Research Faculty. Brzezińska-Wcisło L. Evaluation of vitamin B6 and calcium pantothenate effectiveness on hair growth from clinical and trichographic aspects for treatment of diffuse alopecia in women. Wiad Lek 2001;54:11-8.

Mason P. Dietary Supplements. 2nd ed. London: Pharmaceutical

Chittur S, Parr B, Marcovici G. Inhibition of inflammatory gene expression in keratinocytes using a composition containing carnitine, thioctic acid and saw palmetto extract. Evid Based Press; 2001. Complement Alternat Med 2009.

NHPD Monograph. (2006). Fish Oil, August 8.

Pan A, Yu D, Demark-Wahnefried W, Franco OH, Lin X. Meta-analysis of the effects of flaxseed interventions on blood lipids. Am J Clin Nutr 2009;90:288-97.

Prisco the D,effectiveness et al (1998). Effectderived of medium-term supplementation Prager N, Bickett K, French N, Marcovici G. A randomized, double-blind, placebo-controlled trial to determine of botanically inhibitors of 5-alpha-reductase in the treatment of androgenetic alopecia. J Altern Complement Med 2002;8:143-52. with a moderate dose of n-3 polyunsaturated fatty acids on blood Serenoa repens monograph. Alternative Medicine Review 1998;3:227-9.

pressure in mild hypertensive patients. Thromb Res. 1:105-12.

Sinclair R. Male pattern androgenetic alopecia. BMJ 1998;317:865-9. Sowmya P, Rajyalakshmi P. Hypocholesterolemic effect of germinated fenugreek seeds in human subjects. Plant Foods Hum Nutr 1999;53:359-65. Stark A, Madar Z. The effect of an ethanol extract derived from fenugreek (Trigonella foenum-graecum) on bile acid absorption and cholesterol levels in rats, Br J Nutr 1993;69:277-87. Vierpper H, Nowotny P, Maier H, Waldhausl W. Production rates of dihydrotestosterone in healthy men and women and in men with male pattern baldness: determination by stable isotope/ dilution and mass spectrometry. J Clin Endocrinol Metab 2001;86:5762-4.

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CLINIC PROFILE

Halifax Naturopathic Health Centre

A centre of excellence

By Angela MacNeil, MSc, ND â&#x20AC;˘ Photography by Chris Gallant

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CLINIC PROFILE

he Halifax Naturopathic Health Centre opened its doors not even 18 months ago, yet it has seen itself swell to a facility boasting up to 250 patient visits per week, and has already fostered impressive referral networks with physicians across the province of Nova Scotia and across North America. The vision of two driven and passionate ND’s, Craig Herrington and Rosalyn Hayman, the Halifax Naturopathic Health Centre embodies the true essence of a modern facility of world class, evidencebased integrative healthcare that has caught the eye of the entire province. The clinic’s founders set out with a series of clearly defined goals. They wanted to be the largest naturopathic facility in the province, and they successfully achieved this in the epicentre of the city of Halifax. They recognized the need for respectability and sought to bring on board a well- tenured local naturopathic physician to help achieve this; Dr Sarah Baillie, ND was inspired by the teams vision and joined the team in time for its opening, an ND who had been practicing in Halifax since 1999. The team demanded of itself delivery of best medical practices, choosing to implement evidencebased approaches afforded to the naturopathic profession. Eloquently executed marketing initiatives and professional networking programs quickly allowed the team

to achieve its vision of a naturopathic facility integrated into the community and working hand- in- hand with an array of local conventional physicians. The facility has five treatment rooms, a blood lab, and an IV room. Jackie Batog, RN, has joined the team and manages all blood and injection services. Jackie runs all conventional and integrative diagnostic tests, performs injections, and sets up IV’s. The facility also boasts a highly diverse dispensary. Like many of the most successful clinics IHP interviews, the team carries a small number of items from each of a very large number of companies, as opposed to relying on two or three companies to stock their dispensary. “The best each company has to offer” governs the manner in which the dispensary is built. St Francis Herb Farm and Naturally Nova Scotia are the two botanical companies called upon to supply tinctures. NFH, Thorne, Cytomatrix, and a selection of Halifax Naturopathic Health Centre private label offerings comprise the nutraceutical companies most heavily relied upon. The facility is truly eclectic in terms of the types of patients attracted. It has established an excellent reputation in terms of cancer care, with physicians from across the city and province referring patients for this purpose. High dose vitamin C,

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CLINIC PROFILE

low dose naltrexone, and an anti cachexia drip are commonly employed treatments for cancer, in addition to intense dietary counseling and an assortment of orally administered essential nutrients, botanical medicines, nutraceutical and functional food interventions. The facility also boats well- developed programs for women’s health, endocrine abnormalities, weight loss, and others. In addition to the cachexia drip, the facility has pioneered a fibromyalgia drip featuring B complex vitamins, vitamin C, MSM, and glutathione. For patients with chronic pain, neurotherapy and prolotherapy are commonly employed. Chelation therapy for cardiovascular disease is another important offering of the facility, utilizing EDTA and/ or plaquex (a phosphatidylcholine solution). Jackie Batog, RN, has introduced unique and cutting- edge diagnostic options, notably an advanced cardiovascular risk panel that includes assessment of Apo-E, LDL subclasses, oxidized LDL, etc... The team has effectively implemented a round table approach to patient care. Frequent meetings are held to review tough cases. An environment devoid of competition has successfully been created. Patients are frequently seen by multiple ND’s within the same facility, coinciding with the evolution of the specific case and the requirements of the next stage of care. The team has found that the minds of four ND’s working together deliver superior patient outcomes relative to what any one of the ND’s could achieve alone. Some simple themes emerge as the team describes what they perceive as the keys to the success of the Halifax Naturopathic Health Centre. Locating in an under-serviced area of Canada meant a population eager for effective holistic treatments

was awaiting their arrival. A commitment to an evidencebased practice resonated well not only with patients but with surrounding conventional physicians the team intended on achieving collaboration with. A simple but well- executed marketing plan that included bringing an experienced and respected ND on board, networking with local physicians, and lectures to groups that included corporate seminars as well as a local women’s and children’s hospital. IHP is grateful to the Halifax Naturopathic Health Centre for allowing us to showcase their work to you. Their diligence, hard work, and commitment to excellence in naturopathic medicine has allowed for a quick and impressive magnitude of integration with the surrounding community. Their decision to apply effort to integrate with local physicians has proven invaluable. The number of conventional physicians open to sound delivery of integrative medicine is growing at an exponential pace. We wish the team continued success in delivering an exceptional standard of care to an under- serviced region of the country. •

The Halifax Naturopathic Health Centre Team At A Glance: Dr Sarah Baillie, ND Dr Rosalyn Hayman, ND Dr Craig Herrington, ND Dr Maggie Pattillo, ND Jackie Batog, RN Sarah Bing, R.Ac Nicole Hynes Tara Patriquin

Naturopathic doctor Naturopathic doctor Naturopathic doctor Naturopathic doctor Registered nurse Acupuncturist Office manager Administrative assistant

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Feature Diabetes Cholesterol

Statin prescription for patients with diabetes Yeah or Nay?

By William R Ware, PhD Introduction

In 2011, the American Diabetes Association (ADA) published their view of the standard of medical care for diabetes (American Diabetes Association 2011). Central to prevention and management of cardiovascular complications is the focus on LDL cholesterol and the recommendation of statin use by a significant fraction of all individuals with diabetes. Is this position consistent with the evidence available?

LDL and Coronary Atherosclerosis. The Absence of an Association Among Individuals with Diabetes A number of studies have been published recently regarding coronary artery calcium, a marker for atherosclerosis associated coronary plaque, in patients with type II diabetes free of symptomatic cardiovascular disease. All find LDL is not a factor in the prevalence of coronary artery calcium (CAC) (Elkeles 2004, Godsland 2006, Kobayashi 2008, Martin 2009, Mazzone 2007, Wolfe 2002). This conclusion was mostly based on multivariate risk factor analysis that failed to point to LDL as significant. Rather, age, systolic blood pressure or hypertension, gender and race were the important factors for prevalence. These studies, which all involved both genders and a wide range of age and ethnic background, raise a serious issue concerning the total lack of evidence for LDL as a target for therapy associated with coronary atherosclerosis in asymptomatic patients with diabetes. This is important because coronary atherosclerosis is almost always a prerequisite precursor for acute coronary events. These results are consistent with those found in a large number of studies of non-diabetic individuals free of symptomatic heart disease (Ware 2009).

Coronary Artery Calcification. Progression Studies Among Individuals with Diabetes When coronary calcification is present, it almost always progresses and this is associated with increasing risk of acute cardiac events. LDL also does not appear associated with the

risk of progression of CAC among individuals with type II diabetes. Consider the following studies involving subjects free of coronary heart disease (CHD). • A substudy of the Veterans Affairs Diabetes Trial examined the progression of CAC in 189 individuals with type II diabetes (Saremi 2010). CAC progression was found in > 75% of subjects but was not influenced by standard risk factors and in particular, blood lipids. The albumin to creatinine ratio predicted progression independent of adjustment for age or other traditional risk factors. • A recent study examined CAC progression in a group of 398 individuals with type II diabetes (Anand 2007). In the final multivariate analysis, odds ratios (OR) for independent factors for progression of CAC were; elevated baseline CAC (OR = 6.38), HbA1c > 7 (OR =1.95), and statin use (OR = 2.27), but not hyperlipidemia or smoking status. It is noteworthy that the researchers found statin therapy failed to inhibit progression of CAC but rather appeared to accelerate it. The increase in risk of progression was 212% for statin-treated patients (38-50%) with LDL < 2.6 mmol/L compared to those untreated. An earlier study from the same group found that 53% of a cohort of individuals with diabetes had subclinical CAC. One-third of these had progression during 2.5 years follow-up (Anand 2006). • Progression of atherosclerosis over four years measured by CAC was also addressed as part of the PREDICT study (Elkeles 2008). The rate of change was strongly related to the baseline coronary artery calcium score (CACS) and also, independent of CACS, correlated positively with waist to hip ratio, male gender, the use of antihypertensive drugs or statins and the albumin to creatinine ratio. There was no relationship with traditional lipid risk factors. • Compared to the above, somewhat different results have been reported (Budoff 2005). The study excluded individuals with cardiac symptoms or known CAD including revascularization, stroke or peripheral vascular disease. Two CT calcium scans were done with ihpmagazine.com { November/December 2011 IHP | 49

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Feature Diabetes Cholesterol Table 1. Primary prevention trials of statins among patients with diabetes Trail

ARR

NNT

RRR

UTER

ASCOT (Sever 2005)

0.6%

166

16%

1.4%

ASPEN (Knopp 2006)

0.7%

142

27%

3.6%

CARDS (Colhoun 2004)

1.9%

36%

3.6%

ARR - absolute percent risk reduction

NNT - number needed to treat

a mean of 27 months between. Hypercholesterolemia, defined as using cholesterol-lowering drugs or having total cholesterol (TC) â&#x2030;Ľ 240 mg/dL, was not found to be a significant risk factor for progression. For the statin non-users, progression was at a median annual rate of 20% (4% to 44%) whereas for statin treated patients it was 10% (4% to 25%) No statistical analysis was included, but the reported ranges are very large. â&#x20AC;˘ It is well known that depression is associated with diabetes and depressive symptoms are a risk factor for CHD (Campayo 2011). A recent report documented this in midlife women in the SWAN Heart Study, where depressive symptoms were independently associated with progression of CAC (Janssen 2011). In a multivariate analysis, the only other predictors of significance for progression were systolic blood pressure and a low level of education but not cholesterol levels. â&#x20AC;˘ Insulin resistance has been independently associated with the progression of CAC. A CAC progression study based on the Kaiser Permanente of Northern California database addressed this issue (Lee 2009). In the univariate analysis TC, LDL, HDL and triglycerides (TGs) were not even close to being significantly associated with progression over two years of follow-up. In multivariate analysis, progression was associated with age, female gender, African American decent, diabetes, fasting insulin, dyslipidemia (presumably high TGs plus low HDL), hypertension, diastolic BP and pulse pressure but not with lipid lowering medication.

RRR - relative risk reduction

UTER - untreated event rate

individuals with diabetes (Anand 2006, van Dieren 2011). A recent review even suggested that type 2 diabetes should not be considered a true risk equivalent for CHD (Riche 2007). The consistent finding of no association between TC or LDL cholesterol and the extent or progression of subclinical coronary atherosclerosis is consistent with studies in cohorts of individuals free of diabetes (Ware 2009). Given this, why are LDL targets and lipid lowering with statins central to primary prevention of adverse cardiac events in patients with diabetes? Intervention trials are thus of interest.

Primary and Secondary Prevention of Diabetic Complications with Statins If one examines the 2011 ADA standard of care (American Diabetes Association 2011), three primary prevention lipid lowering studies are cited where it is possible to stratify both by diabetes and the presence or absence of CHD and CVD, thus obtaining information on the role of statins in risk reduction in the context of primary prevention of acute CHD events in type 2 diabetes. Their Table 11 indicates endpoint restriction to fatal CHD and non-fatal heart attack, but it is extrapolated to 10-year risk. It is thus of interest to look at the individual primary prevention trials. The results were as follows for absolute percent risk reduction (ARR) the numbers needed to treat to prevent one event (NNT), the relative risk reduction (RRR) and the untreated event rate (UTER) for the endpoint of fatal and non-fatal heart attack over 4-5 years (calculated from reported events over the study period). See Table 1.

In some of these studies, 30-50% of the subjects were on statin therapy at baseline. It is thus curious that statin use also turns up in multivariate analysis in some of these studies to be a positive risk factor. It has been suggested that the positive associations may have been caused by these studies enrolling a high percentage of individuals who had been given statins because they were perceived to be at the greatest risk (Elkeles 2010).

The HPS (MRC/BHF) trial (Collins 2003) is omitted because for the endpoint in question, the study included in the diabetic group individuals with arterial disease, including 33% with previous heart attack or other CHD and 18% with other occlusive artery disease. HPS only stratifies individuals with diabetes by prior CHD when the endpoint includes coronary events, all strokes, and coronary and non-coronary revascularization, which inflates the benefit.

Recently published observational studies, including one that looked at event-free survival, find no association between LDL and cardiovascular/coronary heart disease (CVD/CHD) events among

The very small absolute risk reduction (average 1.1%) with large NNT seen in the above table was also found in studies of cohorts where diabetes is present in only a small fraction or absent. When

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Feature Diabetes Cholesterol meta-analyses were rigorously restricted to primary prevention statin trials (Wright 2010), absolute risk reduction for major CHD events was 1.0% (11 studies) and the NNT 100. There was no significant impact on mortality. The similarity to cohorts of individuals with diabetes is noteworthy. The largest meta-analysis of statin trials where both diabetes and primary vs. secondary prevention were stratified is the Cholesterol Treatment Trialists’ Collaborators (CCT) study. The results are summarized below for the composite endpoint of MI, coronary deaths, stroke, or coronary revascularization over 4-5 years, calculated from reported event numbers (Cholesterol Treatment Trialists’ (CTT) Collaborators 2008). See Table 2. Most participants in these trials were at elevated risk of adverse CVD events. These results illustrate the greater impact of statins in secondary prevention. The result for individuals with diabetes with no vascular disease is somewhat higher than in CARDS, ASPEN and ASCOT discussed above, presumably because of the expanded endpoint which increases event rates. The results for no diabetes and no vascular disease are slightly higher than those reported above (Wright 2010), again for the same reason. The CCT results tabulated above which include the NNT should be viewed with some caution since the combined studies average over somewhat different populations. The NNT as it is being used to illustrate clinical utility can only be applied for comparisons when the baseline absolute risks are similar. Also, the NNT decreases dramatically with the duration of studies (Breau 2009, Citrome 2011, McAlister 2008). In the CCT results, duration probably does not confuse the issue. There is growing suspicion that a significant and perhaps major part of the action of statin drugs involves non lipid lowering (pleiotropic) effects, of which there is a long and impressive list containing actions that can influence acute events but have nothing to do with lower circulating cholesterol (Liao 2005, Mihos 2010,

Sadowitz 2010). This significantly impacts the use of LDL lowering trials to prove that LDL is a causative factor. Some might argue that for secondary prevention it does not matter what the statin mechanism is as long as there is a modest (5%) absolute benefit. Then there are the statin adverse effects. For liver dysfunction, cataracts and myopathy, the number needed to treat to harm one patient with statin therapy has been estimated for men at 142, 52 and 91 and for women 136, 33 and 259, respectively (Hippisley-Cox 2010). It is doubtful that cataracts disappear if statin therapy is terminated. It is also strongly suspected that adverse events are significantly under-reported, downplayed or prevalence data suppressed. The point at which the ARR is large enough and the adverse side effects small enough to justify treatment is of course debatable, and the attitudes of both patient and physician highly variable. Conservative clinicians might conclude that the treatment is not justified in general for very small ARRs, especially in the absence of symptomatic heart disease (Wright 2010).

Conclusions Thus the obvious question. Does targeting LDL among individuals with diabetes free of cardiovascular disease make any sense when it rarely appears as significant if one examines correlations with the prevalence or progression of silent coronary atherosclerosis or coronary event free survival, or when one takes into account the very small absolute benefits seen in true primary prevention statin intervention trials? Furthermore, optimum LDL targets associated with guideline recommendations for diabetics have been described as not evidence based (Rutter 2011). LDL is universally regarded as the “bad” cholesterol. If it is so bad, why is it consistently absent as a factor in studies of the risk of prevalence and progression of silent atherosclerosis, the prerequisite precursor of acute events? Statins are ineffective in this context for individuals free from diabetes (Henein 2010, Ware 2009), and individuals with diabetes as discussed above. Why does low or very low LDL characterize half of hospital admissions for

Table 2. Summary of outcomes from the Cholesterol Treatment Trialists’ Collaborators 2008 Category

ARR

NNT

RRR

UTER

Diabetes and no vascular disease

2.6%

27%

11.8%

Diabetes with vascular disease

5.3%

20%

31.6%

No diabetes and no vascular disease

1.6%

22%

8.3%

No diabetes with vascular disease

5.0%

21%

23.5%

ARR - absolute percent risk reduction

NNT - number needed to treat

RRR - relative risk reduction

UTER - untreated event rate

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Feature Diabetes Cholesterol

The focus on relative rather than absolute risk reduction has resulted in widespread inflated perceptions of benefit, confused the risk/benefit analysis and produced a false sense of security among

the millions of statin users. Note the disconnect between ARR and RRR in the above tables. A 20-30% relative risk reduction is impressive and strongly influences therapeutic decisions, but it can be associated with a 1%-2% or even smaller absolute event risk reduction. Patients need to be advised on the basis of absolute risk reductions. A strong case for this was made by Professor Peter Sawicki MD, PhD, from Köln in an invited lecture during a symposium on the cholesterol hypothesis (co-chaired by the author of this review) at the annual meeting of the European Association for the Study of Diabetes recently held in Lisbon, Portugal. •

References Al-Mallah,M.H., Hatahet,H., Cavalcante,J.L. and Khanal,S. Low admission LDLcholesterol is associated with increased 3-year all-cause mortality in patients with non ST segment elevation myocardial infarction. Cardiol. J 2009; 16(3): 227-233. American Diabetes Association Standards of medical care in diabetes--2011. Diabetes Care 2011; 34 Suppl 1: S11-S61. Anand,D.V., Lim,E., Darko,D., Bassett,P., Hopkins,D., Lipkin,D., Corder,R. and Lahiri,A. Determinants of progression of coronary artery calcification in type 2 diabetes role of glycemic control and inflammatory/vascular calcification markers. J Am Coll Cardiol. 2007; 50(23): 2218-2225. Anand,D.V., Lim,E., Hopkins,D., Corder,R., Shaw,L.J., Sharp,P., Lipkin,D. and Lahiri,A. Risk stratification in uncomplicated type 2 diabetes: prospective evaluation of the combined use of coronary artery calcium imaging and selective myocardial perfusion scintigraphy. Eur Heart J 2006; 27(6): 713-721. Breau,R.H., Fergusson,D. and Dahm,P. Evidence-based urology in practice: number needed to treat. BJU Int 2009; 104(1): 6-8. Budoff,M.J., Yu,D., Nasir,K., Mehrotra,R., Chen,L., Takasu,J., Agrawal,N., Liu,S.T. and Blumenthal,R.S. Diabetes and progression of coronary calcium under the influence of statin therapy. American Heart Journal 2005; 149(4): 695-700. Campayo,A., Gomez-Biel,C. and Lobo,A. Diabetes and Depression. Current Psychiatry Reports 2011; 13(1): 26-30. Cholesterol Treatment Trialists’ (CTT) Collaborators Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. The Lancet 2008; 371(9607): 117-125. Citrome,L. Number needed to treat: what it is and what it isn’t, and why every clinician should know how to calculate it. J Clin Psychiatry 2011; 72(3): 412-413. Colhoun,H.M., Betteridge,D.J., Durrington,P.N., Hitman,G.A., Neil,H.A., Livingstone,S.J., Thomason,M.J., Mackness,M.I., Charlton-Menys,V. and Fuller,J.H. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebocontrolled trial. Lancet 2004; 364(9435): 685-696. Collins,R., Armitage,J., Parish,S., Sleigh,P. and Peto,R. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet 2003; 361(9374): 2005-2016. de Lorgeril,M. Disappointing recent cholesterol-lowering drug trials: is it not time for a full reappraisal of the cholesterol theory? http://michel. delorgeril. info/dwnl/wrnd/ DisappointingCholDrugTrials_wrnd2009. pdf). World Rev Nutr Diet 2009; 100: 80-89. Elkeles,R.S. Coronary artery calcium and cardiovascular risk in diabetes. Atherosclerosis 2010; 210(2): 331-336. Elkeles,R.S., Feher,M.D., Flather,M.D., Godsland,I.F., Nugara,F., Richmond,W., Rubens,M.B. and Wang,D. The association of coronary calcium score and conventional cardiovascular risk factors in Type 2 diabetic subjects asymptomatic for coronary heart disease (The PREDICT Study). Diabet. Med 2004; 21(10): 1129-1134. Elkeles,R.S., Godsland,I.F., Rubens,M.B., Feher,M.D., Nugara,F. and Flather,M.D. The progress of coronary heart disease in Type 2 diabetes as measured by coronary calcium score from electron beam computed tomography (EBCT): the PREDICT study. Atherosclerosis 2008; 197(2): 777-783. Godsland,I.F., Elkeles,R.S., Feher,M.D., Nugara,F., Rubens,M.B., Richmond,W., Khan,M., Donovan,J., Anyaoku,V. and Flather,M.D. Coronary calcification, homocysteine, C-reactive protein and the metabolic syndrome in Type 2 diabetes: the Prospective Evaluation of Diabetic Ischaemic Heart Disease by Coronary Tomography (PREDICT) Study. Diabet. Med 2006; 23(11): 1192-1200. Henein,M.Y. and Owen,A. Statins moderate coronary stenoses but not coronary calcification: Results from meta-analyses. Int J Cardiol. 2010; Published ahead of print, September 4, 2010. Hippisley-Cox,J. and Coupland,C. Individualising the risks of statins in men and women in England and Wales: population-based cohort study. Heart 2010; 96(12): 939-947. Janssen,I., Powell,L.H., Matthews,K.A., Cursio,J.F., Hollenberg,S.M., Sutton-Tyrrell,K., Bromberger,J.T. and Everson-Rose,S.A. Depressive symptoms are related to progression of coronary calcium in midlife women: The Study of Women’s Health Across the Nation (SWAN) Heart Study. Am Heart J 2011; 161(6): 1186-1191. Knopp,R.H., d’Emden,M., Smilde,J.G. and Pocock,S.J. Efficacy and safety of

atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in non-insulin-dependent diabetes mellitus (ASPEN). Diabetes Care 2006; 29(7): 1478-1485. Kobayashi,S., Oka,M., Maesato,K., Ikee,R., Mano,T., Hidekazu,M. and Ohtake,T. Coronary Artery Calcification, ADMA, and Insulin Resistance in CKD Patients. Clinical Journal of the American Society of Nephrology 2008; 3(5): 1289-1295. Krumholz,H.M. and Hayward,R.A. Shifting views on lipid lowering therapy. BMJ 2010; 341: c3531. Lee,K.K., Fortmann,S.P., Fair,J.M., Iribarren,C., Rubin,G.D., Varady,A., Go,A.S., Quertermous,T. and Hlatky,M.A. Insulin resistance independently predicts the progression of coronary artery calcification. American Heart Journal 2009; 157(5): 939-945. Liao,J.K. and Laufs,U. Pleiotropic effects of statins. Annu Rev Pharmacol Toxicol 2005; 45: 89-118. Martin,S.S., Qasim,A.N., Mehta,N.N., Wolfe,M., Terembula,K., Schwartz,S., Iqbal,N., Schutta,M., Bagheri,R. and Reilly,M.P. Apolipoprotein B but not LDL cholesterol is associated with coronary artery calcification in type 2 diabetic whites. Diabetes 2009; 58(8): 1887-1892. Mazzone,T., Meyer,P.M., Kondos,G.T., Davidson,M.H., Feinstein,S.B., D’Agostino,R.B., Sr., Perez,A. and Haffner,S.M. Relationship of traditional and nontraditional cardiovascular risk factors to coronary artery calcium in type 2 diabetes. Diabetes 2007; 56(3): 849-855. McAlister,F.A. The “number needed to treat” turns 20--and continues to be used and misused. CMAJ 2008; 179(6): 549-553. Mihos,C.G., Salas,M.J. and Santana,O. The pleiotropic effects of the hydroxy-methylglutaryl-CoA reductase inhibitors in cardiovascular disease: a comprehensive review. Cardiol. Rev 2010; 18(6): 298-304. Ravnskov,U. and McCully,K.S. Review and Hypothesis: Vulnerable plaque formation from obstruction of Vasa vasorum by homocysteinylated and oxidized lipoprotein aggregates complexed with microbial remnants and LDL autoantibodies. Ann Clin Lab Sci 2009; 39(1): 3-16. Riche,D.M. and McClendon,K.S. Role of statins for the primary prevention of cardiovascular disease in patients with type 2 diabetes mellitus. Am J Health Syst. Pharm. 2007; 64(15): 1603-1610. Rosch,P.J. Cholesterol does not cause coronary heart disease in contrast to stress. Scand Cardiovasc J 2008; 42(4): 244-249. Rutter,M.K. and Nesto,R.W. Blood pressure, lipids and glucose in type 2 diabetes: how low should we go? Re-discovering personalized care. Eur Heart J 2011. Sadowitz,B., Maier,K.G. and Gahtan,V. Basic science review: Statin therapy--Part I: The pleiotropic effects of statins in cardiovascular disease. Vasc Endovascular. Surg 2010; 44(4): 241-251. Saremi,A., Moritz,T.E., Anderson,R.J., Abraira,C., Duckworth,W.C. and Reaven,P.D. Rates and determinants of coronary and abdominal aortic artery calcium progression in the Veterans Affairs Diabetes Trial (VADT). Diabetes Care 2010; 33(12): 2642-2647. Sever,P.S., Poulter,N.R., Dahlof,B., Wedel,H., Collins,R., Beevers,G., Caulfield,M., Kjeldsen,S.E., Kristinsson,A., McInnes,G.T., Mehlsen,J., Nieminen,M., O’Brien,E. and Ostergren,J. Reduction in cardiovascular events with atorvastatin in 2,532 patients with type 2 diabetes: Anglo-Scandinavian Cardiac Outcomes Trial--lipid-lowering arm (ASCOT-LLA). Diabetes Care 2005; 28(5): 1151-1157. van Dieren,S., Nothlings,U., Van der Schouw,Y.T., Spijkerman,A.M., Rutten,G.E., van der,A.D., Sluik,D., Weikert,C., Joost,H.G., Boeing,H. and Beulens,J.W. Non-fasting lipids and risk of cardiovascular disease in patients with diabetes mellitus. Diabetologia 2011; 54(1): 73-77. Ware,W.R. The mainstream hypothesis that LDL cholesterol drives atherosclerosis may have been falsified by non-invasive imaging of coronary artery plaque burden and progression. Med Hypotheses 2009; 73(4): 596-600. Wolfe,M.L., Iqbal,N., Gefter,W., Mohler,E.R., III, Rader,D.J. and Reilly,M.P. Coronary artery calcification at electron beam computed tomography is increased in asymptomatic type 2 diabetics independent of traditional risk factors. J Cardiovasc Risk 2002; 9(6): 369-376. Wright,J. Do statins have a role in primary prevention? An update. Theraeutics Initative (Theraputics Letter) 2010; 77(March-April 2010, http://ti.ubc.ca/letter77).

heart attack (Al-Mallah 2009)? Why do the non-statin drugs that lower LDL not reduce the event risk, even in secondary prevention (Krumholz 2010)? The simple answer is that the association between heart disease and cholesterol is very much weaker than the conventional wisdom has led us to believe. A new paradigm is needed (de Lorgeril 2009, Ravnskov 2009, Rosch 2008).

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Feature Sarcopenia

arcopenia Nutritional intervention for a quiet epidemic Jordan Robertson, ND

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Jordan Robertson, ND Associate Faculty Bachelor of Health Sciences Program, McMaster University

Lakeshore Clinic 2159 Lakeshore Road Burlington, Ontario 905.333.1104 jordanrobertsonnd@gmail.com

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Feature Sarcopenia

arcopenia is a complex, age related process that occurs in every aging adult patient and is virtually untreatable by pharmaceutical interventions. This article will explain the lack of available treatment and provide evidence for the use of supplemented protein to prevent and reverse muscle loss in elderly patients. Sarcopenia research has been poor to date due to inconsistencies in diagnostic criteria and the difficulty in isolating the condition from other atrophic diseases such as cachexia and disuse atrophy. Measuring muscle with imaging has proven to be an inaccurate surrogate for muscle strength and power, the factors that account for the morbidity and mortality associated with sarcopenia (Brass 2011). Given these limitations to the research, and the known complexity of the disease, the development of therapeutic interventions has been challenging. Early theories on the mechanisms behind age related muscle atrophy focused on increased muscle catabolism as a principle cause, however more recent evidence has shown that muscle breakdown in the elderly appears to occur at similar rates to younger cohorts (Koopman 2011). Evidence has shown that the most marked changes in the aging skeletal muscle lays in the anabolic processes responsible for increasing muscle mass in response to nutrition and exercise. The term anabolic resistance was coined to describe these processes, which include: decreasing insulin sensitivity, decreased protein synthesis in response to dietary essential amino acids (EAA) and decreased protein synthesis response to exercise. Sarcopenia differs in both mechanism and clinical presentation from cachexia. Unlike cachexia, sarcopenia has a relative preservation of fat mass, which may cause weight loss to be masked in many patients. Evidence has shown that weight stable elderly patients should still be considered for treatment of sarcopenia (Gallagher 2000). Drug trials have focused on increasing anabolic hormones that decline with age (testosterone and other androgens), and improving blood flow to atrophic muscles. Testosterone supplementation to hypogonadal men has shown some benefit, however given the increased risk of cardiovascular events (Basaria 2010), focus has shifted to Selective Androgen Receptor Modulators (SARMs) (Rolland 2011). Growth hormone, ghrenlin, estrogen and myostatin inhibitors have all been investigated for the treatment of sarcopenia without substantial gains in muscle mass (Rolland 2011). ACE inhibitors show promise for the treatment of muscle loss after studies found that patients treated for hypertension with ACEI were found to have a stabilization of muscle atrophy. This benefit is suspected to be due to improved blood flow to peripheral tissues (Brass 2011). Nutritional supplementation for elderly patients must improve overall under-nutrition with a particular focus on protein intake.

Improving caloric intake alone has been shown to offer no benefit to muscle mass or function in the elderly (Milne 2009). Outlined below is the current evidence for using protein supplements for the prevention of sarcopenia as well as for treatment of reduced muscle mass. When considering protein supplementation in elderly patients factors to account for include: dose, %EAA, protein source, and timing of protein intake relative to other foods. Current recommendations for protein intake in the elderly (0.8g/ kg/d) offer little benefit to sarcopenic patients (Morley 2010). Reviews have shown that many elderly patients do not consume the recommended 0.8g/kg/d (Kerstetter 2003, Rousset 2003) and patients who do consume this dosage are only modestly protected against muscle loss (Genaro 2010, Morley 2010). The Healthy Aging and Body Composition study demonstrated that elderly patients in the highest quartile (protein intake 1.1g/kg/d) lost 40% less appendicular lean mass than patients in the lowest quartile (0.7g/kg/d) (Houston 2008). In a recent review, Morley and colleagues discussed the evidence for increasing the recommended daily dosage of protein for aging adults to 1.0-1.6g/kg/d based on data that shows that 1.0g/kg/d is the minimum dosage required to prevent muscle loss with dosages ranging up to 1.6g/kg/d showing improvements in muscle mass (Morley 2010). Conflicting studies exist for the timing of protein intake throughout the day as well as the positive or negative impact of combining protein intake with carbohydrates. Arnal et al (Arnal 1999) found that elderly women who consumed the majority of their protein intake at the midday meal had 80% greater protein retention than the control group as calculated by a more positive nitrogen balance. However, in a randomized controlled trial in 2009, Symons et al found that a bolous of 90 grams of animal protein (lean beef) was no more beneficial than a 30 gram bolous through direct examination of protein synthesis through vastus lateralus biopsy (Symons 2009). This more recent study suggests that an upper limit per meal is reached in patients around 30 grams. This study also provides more conclusive evidence given the direct observation of protein synthesis (through uptake of radiolabeled phenylalanine in muscle biopsy) versus calculated protein use based on nitrogen balance. Research has also suggested supplementation of elderly patients with protein between meals to prevent supplementation from replacing calories and nutrients consumed during regular meals (Fiatarone 1994). The current information on whether to combine protein with carbohydrates requires further research before conclusions can be drawn. Studies on patients assigned to bed-rest have shown that a mixed meal of 16.5g of EAA with 30g of carbohydrates reduced muscle loss, with controls having a more pronounced loss of muscles strength (Paddon-Jones 2004). Volpi and colleagues concluded that combining a protein bolous with carbohydrates impaired protein synthesis in elderly subjects compared to a protein

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Feature Sarcopenia bolus alone (Volpi 2000). Reviews on the subject have concluded that the presence of carbohydrates in modest doses (<30g) do not impair muscle protein synthesis in the elderly however larger doses may negatively influence insulin levels and lower protein synthesis (Kim 2010, Koopman 2011). STUDY FINDINGS Protein Dose per day

•

1.1g/kg/d has 40% less muscle mass loss than 0.7g/kg/d (Houston 2008)

•

1.0-1.6g/kg/d adequate dose for improving muscle mass (Morley 2010)

•

1.05g/kg/d in pulsed or spread meals increased protein synthesis in elderly (Arnal, 1999)

Protein Source

• Animal

protein superior to vegetarian

sourced protein (Pannemans 1998) •

Whey protein superior to casinates for stimulating protein synthesis (Pennings 2011)

Essential Amino Acids

• EAA

Leucine

•

responsible for protein synthesis.

Mixed protein sources offer no more benefit than EAA alone (Volpi 2003) Stimulates insulin release and protein synthesis in muscle tissue (Nicastro 2011) •

2.8 grams of leucine required to overcome anabolic resistance in elderly (Katsanos 2006, PaddonJones 2004b)

Meal planning and food combining

• No

more than 30g protein in one

meal (Symons 2009) • Combining

amino acid supplement

with carbohydrates impairs muscle protein synthesis (Volpi 2000) • Amino

acid supplements should

be given between regular meals (Fiatarone 1994) to ensure sufficient calories in patients with low BMI. • AA

supplements between meals

improves glycemic control in diabetic patients with sarcopenia (Solerte 2008)

Combining protein with exercise

• Protein

supplements immediately

following resistance exercise increases protein synthesis (Drummond 2008) • Combined

protein and carbohydrate

meals following exercise increases protein synthesis (Koopman 2008) • Intact

protein meals consumed 60

minutes before exercise increase protein synthesis by 108% (Symons 2011)

Differing protein sources and amino acid ratios produce varying results, illustrating the need for attention and detail when prescribing protein supplements to this population. Protein sources vary in the relative percentages of EAA as well as the speed at which they are digested and increase plasma levels. Whey protein isolates have shown benefit over casein protein mixtures in both the rate of availability of EAA in plasma and in the ability to stimulate protein synthesis in muscle cells (Pennings 2011). However, in a second 2011 study, Dideriksen et al showed no difference in muscle protein synthesis between whey and caseinate ingested after resistance training in the elderly (Dideriksen 2011). Current evidence shows that animal protein improves lean muscle tissue better than vegetarian sourced protein (Pannemans 1998) and that amino acid supplements containing only essential amino acids (EAA) confer better results than mixed, or non-EAA supplements. A small trial looked at the administration of an EAA only meal to healthy older adults who do not perform exercise on a regular basis (Volpi 2003). Although the size of the trial is a significant limitation, the results clearly indicated that a meal containing 18g of EAA stimulated muscle protein synthesis to the same degree as a 40g meal containing 18g of EAA and 22g of non-essential amino acids. Of greatest interest, leucine, a branched chain EAA, appears to regulate protein synthesis via multiple processes. Nicastro et al concluded in a 2011 review that leucine stimulates insulin release and is a regulatory molecule for skeletal muscle protein synthesis. Leucine also appears to influence cellular proteolytic processes, which may slow muscle loss (Nicastro 2011). Human controlled trials have shown that leucine enriched meals can improve muscle protein synthesis in the elderly at a dose of 2.8g of leucine in a mixed EAA meal (Katsanos 2006, Paddon-Jones 2004b). There are currently no dose-response trials on leucine supplementation, however the Katsanos trial (Katsanos 2006) was a follow up to a previous study (Katsanos 2005) that found that 1.7g of leucine did not stimulate protein synthesis in elderly subjects compared to younger controls when delivered in a 6.7g mixed protein meal. This possibly indicates a decrease in leucine sensitivity in the elderly with a threshold dose of approximately 2.8g needed to stimulate anabolism. The apparent decrease in leucine sensitivity may be due to age related alterations in first pass metabolism of leucine and other essential amino acids demonstrated by Volpi et al (Volpi 1999). Much of the research on the adverse outcomes of leucine supplementation has been derived from animal models. The research on possible adverse effects, which include appetite suppression (Nicastro 2011) and imbalances in other branched chain amino acids (Verhoeven 2009) should be considered with caution given the differing needs in individual amino acids from humans to rats and the relatively low dosage of leucine needed in

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Feature Sarcopenia humans to cause a response in skeletal muscle (Nicastro 2011). Trappe et al reported no adverse effects after the administration of 3.6g of leucine in combination with other branched chain amino acids after 60 days (Trappe 2008) to prevent muscle loss during bedrest. In addition, a review by Fernstrom (Fernstrom 2005) found no reported adverse outcomes for supra-physiologic doses of branched chain amino acids in over 20 trials. The timing of protein intake with respect to resistance exercise has been suggested as a possible treatment option to increase amino acid incorporation into skeletal muscle. In 2011, Pennings et al demonstrated for the first time that de novo protein synthesis is increased in elderly patients who combine protein and exercise versus protein ingestion alone. Subjects completed 30 minutes of stationary bike plus 2 leg resistance exercise before consuming 20g of protein (Pennings 2011b). Although the mechanism behind sarcopenia was thought to include anabolic resistance to exercise, studies have started to show that protein synthesis is increased in the elderly when protein and carbohydrates are ingested following exercise (Koopman 2008), and that the effect of protein ingestion, is delayed, not absent, when compared to younger controls (Drummond 2008).

in a 30-60 minute window post exercise (Symons 2011). Negative studies on protein and exercise have shown no additional benefit to adding exercise to protein intake but either have included subjects who consume >1.0g/kg/d of protein on a regular basis or have used large doses or protein, EAA or leucine over longer periods of time (Koopman 2008, Koopman 2011, Verdijk 2009). This research may suggest that the timing of protein intake with respect to exercise is most valuable as a treatment option in elderly patients who do not consume adequate protein at presentation, but that the benefits of timed doses cease as protein adequacy is reached. Very few studies have examined protein intake and functional endpoints such as strength. It appears that protein intake is more closely linked to the prevention of appendicular lean mass than muscle strength however more studies are needed to confirm these findings (Scott 2010). One uncontrolled trial examined the use of an EAA+argenine mixture containing 3.95g of leucine and 1.10g of argenine on functional endpoints such as gait speed and maximal leg strength. The study employed only 12 participants but showed significant gains in muscle mass and all functional endpoints measured (Borsheim 2008).

In a 2011 study by Symons, the discrepancies in the research on the topic of protein and exercise are adequately addressed. In this study, participants were given a large dose of protein (90g) in an intact meal of lean ground beef 60 minutes before exercise. This resulted in a 108% increase in protein synthesis in elderly patients as well as younger controls (Symons 2011). It appears that the timing of protein ingestion should vary, depending on whether patients are consuming intact protein meals (beef, poultry) or quickly digested protein isolates or EAA only supplements. Full meals containing protein require up to 100 minutes to reach peak plasma levels, while protein supplements may elevate plasma AA levels in as little as 15-30 minutes. Timing of exercise and protein prescriptions are thus dependent on the type of protein ingested with intact meals consumed 60 minutes prior to exercise and protein supplements

The understanding of sarcopenia will undoubtedly continue to evolve, as already, the use of the term anabolic resistance has begun to shift to account for new research. Recent evidence shows that elderly patients respond to exercise as well as younger controls (Pennings 2011b, Symons 2011) and that the elderly respond similarly to the young after an EAA bolous that exceeds normal dietary intakes (Volpi 1999). It is clear that protein adequacy with a focus on EAA and leucine can prevent muscle wasting and restore muscle mass. Further research into the benefits of protein and sarcopenia are required to determine the effects of carbohydrates and exercise on protein synthesis and functional endpoints such as muscle strength. Sarcopenia is present in the majority of elderly patients and is a condition that can be prevented and possibly treated with careful, specific treatment planning including protein supplementation. â&#x20AC;˘

References Arnal MA, Mosoni L, Boirie Y, Houlier ML, Morin L, Verdier E, Ritz P, Antoine JM, Prugnaud J, Beaufrere B, Mirand PP. Protein pulse feeding improves protein retention in elderly women. Am J Clin Nutr. 1999 Jun;69(6):1202-8.

Dideriksen KJ, Reitelseder S, Petersen SG, Hjort M, Helmark IC, Kjaer M, Holm L. Stimulation of muscle protein synthesis by whey and caseinate ingestion after resistance exercise in elderly individuals. Scand J Med Sci Sports. 2011 Apr 28.

Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, HedeBrierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. Borsheim E, Bui QU, Tissier S, Kobayashi H, Ferrando AA, Wolfe RR. Effect of amino acid supplementation on muscle mass, strength and physical function in elderly. Clin Nutr. 2008 Apr;27(2):189-95. Brass EP, Sietsema KE. Considerations in the development of drugs to treat sarcopenia. J Am Geriatr Soc. 2011 Mar;59(3):530-5.

Drummond MJ, Dreyer HC, Pennings B, Fry CS, Dhanani S, Dillon EL, SheffieldMoore M, Volpi E, Rasmussen BB. Skeletal muscle protein anabolic response to resistance exercise and essential amino acids is delayed with aging. J Appl Physiol. 2008 May;104(5):1452-61. Fernstrom JD. Branched-chain amino acids and brain function. J Nutr. 2005 Jun;135(6 Suppl):1539S-46S. Fiatarone MA, Oâ&#x20AC;&#x2122;Neill EF, Ryan ND, Clements KM, Solares GR, Nelson ME, Roberts SB, Kehayias JJ, Lipsitz LA, Evans WJ. Exercise training and nutritional supplementation for physical frailty in very elderly people. N Engl J Med. 1994 Jun 23;330(25):1769-75.

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FEATURE SARCOPENIA Gallagher D, Ruts E, Visser M, Heshka S, Baumgartner RN, Wang J, Pierson RN, Pi-Sunyer FX, Heymsfield SB. Weight stability masks sarcopenia in elderly men and women. Am J Physiol Endocrinol Metab. 2000 Aug;279(2):E366-75. Genaro Pde S, Martini LA. Effect of protein intake on bone and muscle mass in the elderly. Nutr Rev. 2010 Oct;68(10):616-23. Houston DK, Nicklas BJ, Ding J, Harris TB, Tylavsky FA, Newman AB, Lee JS, Sahyoun NR, Visser M, Kritchevsky SB; Health ABC Study. Dietary protein intake is associated with lean mass change in older, community-dwelling adults: the Health, Aging, and Body Composition (Health ABC) Study. Am J Clin Nutr. 2008 Jan;87(1):150-5. Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. Aging is associated with diminished accretion of muscle proteins after the ingestion of a small bolus of essential amino acids. Am J Clin Nutr. 2005 Nov;82(5):1065-73. Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. A high proportion of leucine is required for optimal stimulation of the rate of muscle protein synthesis by essential amino acids in the elderly. Am J Physiol Endocrinol Metab. 2006 Aug;291(2):E381-7. Kerstetter JE, Oâ&#x20AC;&#x2122;Brien KO, Insogna KL. Low protein intake: the impact on calcium and bone homeostasis in humans. J Nutr. 2003 Mar;133(3):855S-861S. Kim JS, Wilson JM, Lee SR. Dietary implications on mechanisms of sarcopenia: roles of protein, amino acids and antioxidants. J Nutr Biochem. 2010 Jan;21(1):1-13. Koopman R. Dietary protein and exercise training in ageing. Proc Nutr Soc. 2011 Feb;70(1):104-13. Koopman R, Verdijk LB, Beelen M, Gorselink M, Kruseman AN, Wagenmakers AJ, Kuipers H, van Loon LJ. Co-ingestion of leucine with protein does not further augment post-exercise muscle protein synthesis rates in elderly men. Br J Nutr. 2008 Mar;99(3):571-80. Milne AC, Potter J, Vivanti A, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003288. Morley JE, Argiles JM, Evans WJ, Bhasin S, Cella D, Deutz NE, Doehner W, Fearon KC, Ferrucci L, Hellerstein MK, Kalantar-Zadeh K, Lochs H, MacDonald N, Mulligan K, Muscaritoli M, Ponikowski P, Posthauer ME, Rossi Fanelli F, Schambelan M, Schols AM, Schuster MW, Anker SD; Society for Sarcopenia, Cachexia, and Wasting Disease. Nutritional recommendations for the management of sarcopenia. J Am Med Dir Assoc. 2010 Jul;11(6):391-6. Nicastro H, Artioli GG, Costa Ados S, Solis MY, da Luz CR, Blachier F, Lancha AH Jr. An overview of the therapeutic effects of leucine supplementation on skeletal muscle under atrophic conditions. Amino Acids. 2011 Feb;40(2):287-300. Paddon-Jones D, Sheffeild-Moore M, Urban R, Sanford A, Aarsland A, Wolfe R, Ferrando A. Essential Amino Acid and Carbohydrate Supplmentation Ameliorates Muscle Protein Loss in Humans During 28 Days Bedrest. The Journal of Clinical Endorinology and Metabolism. 2004 89(9):4351-4358. Paddon-Jones D, Sheffield-Moore M, Zhang XJ, Volpi E, Wolf SE, Aarsland A, Ferrando AA, Wolfe RR. Amino acid ingestion improves muscle protein synthesis in the young and elderly. Am J Physiol Endocrinol Metab. 2004b Mar;286(3):E321-8.

Pennings B, Koopman R, Beelen M, Senden JM, Saris WH, van Loon LJ. Exercising before protein intake allows for greater use of dietary protein-derived amino acids for de novo muscle protein synthesis in both young and elderly men. Am J Clin Nutr. 2011b Feb;93(2):322-31. Rolland Y, Dupuy C, Abellan van Kan G, Gillette S, Vellas B. Treatment strategies for sarcopenia and frailty. Med Clin North Am. 2011 May;95(3):427-38, ix. Rousset S, Patureau Mirand P, Brandolini M, Martin JF, Boirie Y. Daily protein intakes and eating patterns in young and elderly French. Br J Nutr. 2003 Dec;90(6):1107-15. Scott D, Blizzard L, Fell J, Giles G, Jones G. Associations between dietary nutrient intake and muscle mass and strength in community-dwelling older adults: the Tasmanian Older Adult Cohort Study. J Am Geriatr Soc. 2010 Nov;58(11):2129-34. Solerte SB, Fioravanti M, Locatelli E, Bonacasa R, Zamboni M, Basso C, Mazzoleni A, Mansi V, Geroutis N, Gazzaruso C. Improvement of blood glucose control and insulin sensitivity during a long-term (60 weeks) randomized study with amino acid dietary supplements in elderly subjects with type 2 diabetes mellitus. Am J Cardiol. 2008 Jun 2;101(11A):82E-88E. Symons TB, Sheffield-Moore M, Mamerow MM, Wolfe RR, Paddon-Jones D. The anabolic response to resistance exercise and a protein-rich meal is not diminished by age. J Nutr Health Aging. 2011 May;15(5):376-81. Symons TB, Sheffield-Moore M, Wolfe RR, Paddon-Jones D. A moderate serving of high-quality protein maximally stimulates skeletal muscle protein synthesis in young and elderly subjects. J Am Diet Assoc. 2009 Sep;109(9):1582-6. Trappe S, Creer A, Minchev K, Slivka D, Louis E, Luden N, Trappe T. Human soleus single muscle fiber function with exercise or nutrition countermeasures during 60 days of bed rest. Am J Physiol Regul Integr Comp Physiol. 2008 Mar;294(3):R939-47. Trappe TA, Carroll CC, Dickinson JM, LeMoine JK, Haus JM, Sullivan BE, Lee JD, Jemiolo B, Weinheimer EM, Hollon CJ. Influence of acetaminophen and ibuprofen on skeletal muscle adaptations to resistance exercise in older adults. Am J Physiol Regul Integr Comp Physiol. 2011 Mar;300(3):R655-62. Trappe TA, White F, Lambert CP, Cesar D, Hellerstein M, Evans WJ. Effect of ibuprofen and acetaminophen on postexercise muscle protein synthesis. Am J Physiol Endocrinol Metab. 2002 Mar;282(3):E551-6. Verdijk LB, Jonkers RA, Gleeson BG, Beelen M, Meijer K, Savelberg HH, Wodzig WK, Dendale P, van Loon LJ. Protein supplementation before and after exercise does not further augment skeletal muscle hypertrophy after resistance training in elderly men. Am J Clin Nutr. 2009 Feb;89(2):608-16. Verhoeven S, Vanschoonbeek K, Verdijk LB, Koopman R, Wodzig WK, Dendale P, van Loon LJ. Long-term leucine supplementation does not increase muscle mass or strength in healthy elderly men. Am J Clin Nutr. 2009 May;89(5):1468-75. Vinciguerra M, Musaro A, Rosenthal N. Regulation of muscle atrophy in aging and disease. Adv Exp Med Biol. 2010;694:211-33. Volpi E, Kobayashi H, Sheffield-Moore M, Mittendorfer B, Wolfe RR. Essential amino acids are primarily responsible for the amino acid stimulation of muscle protein anabolism in healthy elderly adults. Am J Clin Nutr. 2003 Aug;78(2):250-8.

Pannemans DL, Wagenmakers AJ, Westerterp KR, Schaafsma G, Halliday D. Effect of protein source and quantity on protein metabolism in elderly women. Am J Clin Nutr. 1998 Dec;68(6):1228-35.

Volpi E, Mittendorfer B, Rasmussen BB, Wolfe RR. The response of muscle protein anabolism to combined hyperaminoacidemia and glucose-induced hyperinsulinemia is impaired in the elderly. J Clin Endocrinol Metab. 2000 Dec;85(12):4481-90.

Pennings B, Boirie Y, Senden JM, Gijsen AP, Kuipers H, van Loon LJ. Whey protein stimulates postprandial muscle protein accretion more effectively than do casein and casein hydrolysate in older men. Am J Clin Nutr. 2011 May;93(5):997-1005.

Volpi E, Mittendorfer B, Wolf SE, Wolfe RR. Oral amino acids stimulate muscle protein anabolism in the elderly despite higher first-pass splanchnic extraction. Am J Physiol. 1999 Sep;277(3 Pt 1):E513-20.

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Product MonograPh Bio-Fen Bio-Fen Plus is an oral natural health product used in the treatment of hereditary androgenic alopecia (AGA) for male or female pattern baldness. ® in many affected men and women (Sinclair 1998). Bio-Fen Plus contains extracts Without treatment, AGA is progressive, and causes social distress SUPER OMEGA-3 GEMS : CARLSON FISH OIL CONCENTRATE of fenugreek seeds, saw palmetto berries and flax lignans, as well as specific vitamins. Each ingredient is known to possess inhibitors of the enzyme 5α-reductase. These inhibitors are responsible for relieving symptoms associated with hereditary AGA. One of the primary causes of hair loss is a high level of the male hormone dihydrotestosterone (DHT) within the hair follicle (Vierhapper, 2001). Carlson Omega-3 Gems provides a concentrated source receptors reduces fastingDHT TG attaches. 25-30%5-α-reductase and increasescatalyzes HDL cholesterol For peopleSuper with AGA, their follicles have a greater number of androgen to which the enzymatic conversion of testosterone to dihydrotestosterone, whichacids binds(LCto the receptor five-fold more1997). avidly Through than the parent compound (Sinclair of the omega-3 long-chain polyunsaturated fatty 1-3% (Harris this mechanism, higher1998). doses

PUFAs) EPA and DHA in a 3:2 ratio. These fish derived LC-

Saw palmetto (Serenoa repens) PUFAs are(lipophillic) well known forextract their has anti-inflammatory effects, and Standardized Serenoa been found to be a potent inhibitor of 5α-reductase, resulting in decreased tissue DHT. An open-label, dose response have been the subject of extensive scientific research for their study was conducted on 42 healthy males to determine the effect of a combination impact on cardiovascular health, mood cognitive of carotenoid astaxanthin and saw palmetto berryand lipid extract onfunction, DHT and testosterone (Angwafor The men wereconditions divided intoincluding two groups: as well as levels a broad range 2008). of inflammatory one group received 800 mg/day of the combination supplement and the other arthritis, inflammatory diseasefor (IBD), liver disease group received 2000 mg/day ofbowel the supplement 14 days.and ANOVA-RM showed significant within-group increases in serum total testeosterone significant (Wall 2010). Arguably the most important of these and is the effect decreases in serum DHT from baseline in both dose groups (P=0.05). There of combined EPA + DHA on cardiovascular health. was no significant difference between dose groups with regard to the increase of testeosterone or the decrease of DHT; therefore both doses were effective (Angwafor 2008).

Fish oil has been demonstrated to reduce the risk of sudden coronary death, estimates to 45% reduced Another study testedwith liposterolic extractofofupSerenoa repens (LSESr)risk and betasitosterol the treatment malesrecently (23-64 years of age) with mild toattack moderate AGA. amonginpatients whoofhad survived a heart Six of 10 (60%) subjects were rated as improved at the final visit, thus establishing (Marchioli The Gissi Prevenzione trial(Prager conducted the effectiveness2002). of 5α-reductase inhibitors against AGA 2002). Chronic inflammation the hair follicle is considered be a contributing factor of for AGA. A in over 11 ofthousand patients foundtothat 850 mg daily study by Chittur et al sought to determine whether blockade of inflammation using EPA+DHA for two years reduced the riskandofthioctic sudden coronary LSESr and two anti-inflammatory agents (carnitine acid) could alter the expression of molecular markers risk of inflammation (Chittur It was found death by 45% and reduced of all cause death2009). by 25% that the combination suppressed lipopolysaccharide-activated gene expression of (Valagusaassociated 1999, Marchioli scientists chemokines with pathways2002). involved Other in inflammation andsuggest apoptosis. The 5-alpha reductase in combination with thatstudy dosesconcluded as low asthat 250 mg per day ofinhibitors combined EPA+DHA blockade of inflammatory processes could represent a new two-pronged approach may be sufficient to obtain comparable outcomes (Mozaffarian in the treatment of AGA. 2006). Fenugreek Seeds Fenugreek seeds contain 5% to 30% protein, steroid saponins, sterols, flavonoids Higher doses of EPA+DHA however, in order and alkaloids (notably trigonelline are andrequired, choline). Steroid saponins bind and eliminate extra cholesterol and hormones in the body; DHT is made from to obtain a reduction of cholesterol, in particular triglyceride testosterone, which is in turn is made from cholesterol. Therefore, when excess (TG). A isdose of 2000 4000 of combined EPA+DHA cholesterol eliminated, less to DHT canmg be made (Stark 1993). In a study of 20 adults who consumed 12.5g and 18.0g of germinated fenugreek seed powder for one month, higher levels of consumption resulted in a significant reduction in total cholesterol and low-density lipoprotein (LDL) levels (Sowmya 1999).

of fish oil yield added benefits to cardiovascular health. EPA

Vitamins has also been to reduce thesymptoms inflammatory In a Polish study shown of 46 women who had of diffuseactivity alopecia, of calcium pantothenate was orally administered twice a day in doses of 100 mg for four to atherosclerotic plaques when incorporated into these arterial five months, and vitamin B6 was injected every day for 20 to 30 days and repeated lesions, slowing their progression 2010). again after thus six months (Brzezińska-Wcisło 2001). (Cawood It was determined that vitamin B6 administered parenterally for a few weeks induces improvement in the hair condition in a subset of women and reduces hair loss.

In addition to effects on cardiovascular health, supplementation with EPA+DHA has been shown to improve other Medicinal Ingredients dosemany Per capsule chronic inflammatory conditions, including liver damage Fenugreek (Trigonella foenum graecum) 260 mg inseed non-alcoholic extract 4:1 steatohepatitis (Tanaka 2008); clinical improvement of ulcerative colitis and improvement of Saw palmetto berry extract containing 160 mg joint andacids plasma markers of inflammation in patients 45% pain, free fatty with IBD (Aslan 1992, Brunborg 2008); and symptomatic Flax lignans, standardized to 20% 100 mg secoisolariciresinol diglucoside (SDG) improvements in autoimmune arthritis (Madland 2006) and osteoarthritis (Gruenwald 2009). D-calcium pantothenate (Vitamin B5) 10.40 mg Niacinamide (Vitamin B3) Supplement Facts Pyridoxine HCl (Vitamin B6)

10.25 mg Serving Size 1 Soft Gel mgGel Amount Per 2Soft % DV

Calories Riboflavin (Vitamin B2) Calories from Fat

9 1.58 mg 9

Total Fat

2% ✩

Vitamin Biotin E Natural (d-Alpha Tocopherol)

10 400 IU mcg

33%

Total Omega-3 Fatty Acids (From Fish Oil)*

600 mg

✝

300 mg

✝

Folic acid

non-Medicinal Ingredients EPA (Eicosapentaenoic)

0.095 mg

Inert microcrystalline cellulose and vegetable-based magnesium DHA (Docosahexaenoic) 200 mg ✝ stearate a veggie-based capsule ✩ PercentinDaily Values are based on a 2,000 calorie diet. ✝ Daily value (DV) not established.

Recommended adult dose: One capsule per day

*Reported as glyceride units.

Flax lignans Flax reduces the amount of DHT produced by reducing cholesterol levels in the body. A meta-analysis of 28 studies between 1990 and 2008 showed that flaxseed References significantly reduces circulating andsupplementation LDL-cholesterol concentrations (Pan a double-blind, placebo-controlled, crossover study. Am J Gastroenterol. 1992 Apr;87(4):432-7. Aslan A, Triadafilopoulos G. Fish oil total fatty acid in active ulcerative colitis: 2009). Flaxseed interventions reduced total and LDL cholesterol by 0.10 mmol/L Brunborg Madland TM, Lind and RA, 0.08 Arslanmmol/L G, Berstad A, Frøyland L. Effects of short-term oral administration of dietary marine oils in patients with inflammatory bowel disease and (95% CI: LA, -0.20, 0.00 mmol/L) (95% CI: -0.16, 0.00 mmol/L), joint pain: a pilot study comparing sealwere oil and cod liverwith oil. Clin Nutr. 2008 Aug;27(4):614-22. respectively. Significant reductions observed whole flaxseed (-0.21 and -0.16 mmol/L, and lignan andJA,-0.16 respectively) Cawood AL, Dingrespectively) R, Napper FL, Young RH,(-0.28 Williams Ward mmol/L, MJ, Gudmundsen O, Vige R, Payne SP, Ye S, Shearman CP, Gallagher PJ, Grimble RF, Calder PC. Eicosapentaenoic supplements (Pan 2009). acid (EPA) from highly concentrated n-3 fatty acid ethyl esters is incorporated into advanced atherosclerotic plaques and higher plaque EPA is associated with decreased plaque inflammation and increased stability. Atherosclerosis. 2010 Sep;212(1):252-9.

For details, write #111 on Free Info Page, page 88.

Gruenwald J, Petzold E, Busch R, Petzold HP, Graubaum HJ. Effect of glucosamine sulfate with or without omega-3 fatty acids in patients with osteoarthritis. Adv Ther. 2009 References Sep;26(9):858-71. Angwafor F III, Anderson ML. An open label, dose response study to determine the effect of a dietary supplement on dihydrotestosterone, testosterone and estradiol levels in healthy males. J Int Soc Sports Nutr 2008;5:12. Harris WS. n-3 fatty acids and serum lipoproteins: human studies. Am J Clin Nutr. 1997 May;65(5 Suppl):1645S-1654S. Brzezińska-Wcisło L. Evaluation of vitamin and calcium pantothenate on hair growth from clinical and aspectsafter for short-term treatment oforal diffuse alopecia in women. Madland TM, Björkkjaer T, Brunborg LA,B6 Fröyland L, Berstad A, Bruneffectiveness JG. Subjective improvement in patients withtrichographic psoriatic arthritis treatment with seal oil. Wiad A Lek pilot2001;54:11-8. study with double blind comparison to soy oil. J Rheumatol. 2006 Feb;33(2):307-10. Chittur S, Parr B, Marcovici G.E,Inhibition of inflammatory gene expressionEarly in keratinocytes using asudden composition carnitine, thioctic and sawmyocardial palmetto extract. Evidtime-course Based Marchioli R, Barzi F, Bomba et al; GISSI-Prevenzione Investigators. protection against deathcontaining by n-3 polyunsaturated fattyacid acids after infarction: Complement Alternat Med 2009.

analysis of the results of the Gruppo Italiano per lo Studio della Sopravvivenza

Pan A, Yu D, Demark-Wahnefried W, Franco OH, Lin X. Meta-analysis of the effects of flaxseed interventions on blood lipids. Am J Clin Nutr 2009;90:288-97.

nell’Infarto Miocardico (GISSI)-Prevenzione. Circulation. 2002 Apr 23;105(16):1897-903.

Prager N, Bickett K, French N, Marcovici G. A randomized, double-blind, placebo-controlled trial to determine the effectiveness of botanically derived inhibitors of 5-alpha-reductase in the Mozaffarian D, Rimm EB. Fish intake, contaminants, human health: evaluating the risks and the benefits. JAMA. 2006 Oct 18;296(15):1885-99. treatment of androgenetic alopecia. J Altern Complementand Med 2002;8:143-52.

Tanaka repens N, Sano K, Horiuchi A, TanakaMedicine E, Kiyosawa K, 1998;3:227-9. Aoyama T. Highly purified eicosapentaenoic acid treatment improves nonalcoholic steatohepatitis. J Clin Gastroenterol. 2008 Serenoa monograph. Alternative Review Apr;42(4):413-8.

Sinclair R. Male pattern androgenetic alopecia. BMJ 1998;317:865-9.

Valagusa, et al. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo

Sowmya P, Rajyalakshmi P. Hypocholesterolemic effect of germinated fenugreek seeds in human subjects. Plant Foods Hum Nutr 1999;53:359-65. Studio della Sopravvivenza nell’Infarto miocardico. Lancet. 1999 Aug 7;354(9177):447-55.

Stark Z.Fitzgerald The effectGF, of an ethanolC.extract from fenugreek (Trigonella foenum-graecum) on bile acidomega-3 absorption cholesterol levels in rats, Br J Nutr 1993;69:277-87. Wall A, R, Madar Ross RP, Stanton Fatty derived acids from fish: the anti-inflammatory potential of long-chain fattyand acids. Nutr Rev. 2010 May;68(5):280-9. Vierpper H, Nowotny P, Maier H, Waldhausl W. Production rates of dihydrotestosterone in healthy men and women and in men with male pattern baldness: determination by stable isotope/ dilution and mass spectrometry. J Clin Endocrinol Metab 2001;86:5762-4.

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Cer vical dysplasia and human

papilloma virus (HPV)

Nutritional therapeutic management By Elizabeth Stavros, ND (cand.) and Philip Rouchotas, MSc, ND

There are 15 known oncogenic strains of HPV that cause virtually all cases of cervical cancer and cervical dysplasia (Wheeler 2007). Strain 16 and 18 are the high- risk types most commonly detected by cytologic screening. Cervical cancer is the second major cause of cancer deaths among women worldwide, and ranks fourteenth amongst leading causes of cancer in women in the US (Marianne 2010). Certain cofactors affecting the progression of cervical dysplasia to cancer include; long term use of oral contraceptives, multiple sexual partners, poor nutritional status and smoking. All of these factors alter epithelial differentiation, cell growth and apoptosis of tumor cells (Gariglio 2009). Addressing the risk factors of cervical cancer broadens the spectrum of treatment

Philip Rouchotas MSc, ND Integrated Healthcare Practitioners Editor- in- Chief philip@ihpmagazine.com

Elizabeth Stavros ND (cand.) elizabeth.stavros@gmail.com

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Feature Cervical Dysplasia options available. This article focuses on various nutrient intervention options, and their safety and efficacy based on human trials as well as biological plausibility. Nutritional Intervention - when to begin

When a Pap test comes back with minor histologic or cytologic abnormalities, such as atypical squamous cells of undetermined significance (ASCUS), grade 1 cervical intraepithelial neoplasia (CIN1) or low-grade squamous intraepithelial lesion (LSIL), conventional medicine suggests to watch, wait, and repeat the Pap smear. Most of these cytologic changes are associated with HPV infection. It is during this time that nutritional interventions would be appropriate, supporting the immune system to reverse the low-grade cervical cell abnormalities and/or eliminate the associated HPV infection. Nutritional Medicines

Carotenoids Carotenoids include beta-carotene, alpha-carotene, cryptoxanthin, gamma-carotene, zeaxanthin, lutein, and lycopene. Studies have shown that beta-carotene deficiency in the cervical cells plays an etiologic role in the development of cervical dysplasia (Palan 1992). In addition, a significant decrease in plasma beta-carotene levels is found in women with either cervical dysplasia or cervical cancer (VanEenwyk 1991). Carotenoids like lycopene, found in tomatoes, are believed to be more responsible for an improvement in dysplasia than is betacarotene (Palan 1992). A case control trial including 235 women compared healthy controls to women with histopathological diagnosis of cervical intraepithelial neoplasia (CIN) or cervical cancer (Palan 2006). Cases were demonstrated to possess significantly lower plasma levels of lycopene, retinol, cantaxanthin, α-tocopherol and γ-tocopherol. These antioxidants have been shown to protect DNA from oxidative damage and obviate genotypic mutations linked to cancer (Davidson 1992, Witz 1991). Lycopene acts as a quencher of singlet oxygen (Di Mascio 1989). Results of a Japanese group study on HPV (Nagata 1999) show that the highest tertile of serum lycopene was correlated with decreased risk of cervical dysplasia after observation of blood samples and cervical cells from 156 women. Women with higher plasma cis-lycopene levels were found to have 56% reduction in HPV persistence when compared to women with low levels. Indole-3-Carbinol (I3C) and 3-3’Diindolylmethane (DIM) Glucosinolates are compounds that are present in all members of the cruciferous vegetable family, including cabbage, broccoli, brussels sprouts, cauliflower, and kale. They are hydrolyzed by the plant enzyme myrosinase to yield isothiocyanates, which

then break down to the metabolites indole-3-carbinol (I3C) and sulphoraphane (Higdon 2007). Research indicates that I3C has the potential to prevent and may treat a number of common cancers, particularly those that are estrogen related (Aubron 2003). Most animal and human studies using I3C to treat cancer show a chemoprotective effect. In a double-blind, placebo-controlled study, 30 patients with biopsy-confirmed CIN II-III were randomized to receive placebo or 200 or 400 mg oral I3C daily for 12 weeks. Four of eight patients in the 200 mg/day group and four of nine in the 400 mg/day group had complete regression of CIN while none in placebo group experienced regression (Bell 2000). The results of I3C on cervical dysplasia are promising, however safety data from animal models demonstrate that I3C can both inhibit and promote carcinogenesis depending on the species, carcinogen, target organ, and exposure (Reed 2006). Several animal studies have shown a tumor-promoting effect of I3C in the liver, thyroid and endometrium (Kim 1997, Stoner 2002). Additionally, undesirable side effects of I3C include dizziness, unsteady gait and symptoms of nervous system toxicity at only two to three times the normal dose (Rosen 1998). DIM supplementation, a dimer of I3C, is considered a promising alternative to I3C for its chemoprotective properties and excellent safety profile. However, in 2010, an RCT was conducted on 64 Patients diagnosed with CIN II or CIN III randomized in a 2:1 manner to receive DIM orally at 2mg/kg/day or placebo for 12 weeks. There was no statistically significant difference in any outcome measure between the DIM intervention group and control after six months of regular follow-up (Del Priore 2010). Dietary intervention with three to five servings of cruciferous vegetables daily is a safe alternative to intervention with I3C. Broccoli sprouts are a rich source of inducers of enzymes that protect against carcinogens, and they have been found to contain 10–100 times more inducer activity than mature cruciferous vegetables (Fahey 1997). Folic acid (Vitamin B9) Although studies have revealed folate deficiency as a risk factor for cervical dysplasia, clinical trials with oral folic acid supplements have demonstrated conflicting results. Three hundred and thirty one women with biopsy proven atypia, mild CIN or moderate CIN were randomized to receive either 5 mg of folic acid or placebo orally per day for six months. Colposcopy, Pap smear and serum vitamin levels were monitored every three months. At the end of treatment, there was no significant difference between the treatment group and the control, suggesting that folic acid supplementation does not induce regression of early epithelial cervical abnormalities

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Feature Cervical Dysplasia

(Flately 2009). Similar observation was made by Zarcone et al (1996) from a study involving 154 patients with CIN I and CIN II who were randomized to 10 mg of folic acid or placebo for six months orally. After treatment, dysplasia status, biopsy status and prevalence of HPV 16 infection did not differ significantly which suggests that folic acid supplements do not alter the course of established disease. Hernandez et al (2003) demonstrated that folate from food and supplements have inverse dose-response associations with squamous intraepithelial lesions of the cervix (SIL), in a case control study with 271 controls and 214 women confirmed for high and low grade SIL. Tong et al (2011) found that low serum folate concentration among individuals with methylenetetrahydrofolate reductase variants was coupled with high risk of cervical cancer. It remains unclear whether folic acid is an effective intervention of cervical dysplasia or whether it simply serves as a biomarker of intake of leafy green vegetables. Vitamin B12 Vitamin B12 studies on HPV persistence and cervical neoplasia have yielded conflicting results. A study comprising 91 low income Hispanic women showed no association between vitamin B12 and risk of HPV persistence (Sedjo 2003). However, lower vitamin B12 levels combined with polymorphisms in the methylenetetrahydrofolate reductase gene were associated with higher risk of cervical cancer (Sedjo 2002). Vitamin B12 is an essential vitamin involved in methylation reactions, fatty acid metabolism, DNA and RNA synthesis. A diet rich in vitamin B12 containing foods or supplemental vitamin B12 may be protective against HPV persistence. Vitamin C A randomized study administered 500 mg vitamin C daily (oral) to 141 women confirmed for CIN or squamous atypia (Mackerras 1999). The authors concluded that vitamin C supplements are unlikely to increase the regression or decrease the progression of minor atypia and CIN I. A group of 169 participants with 87 confirmed cervical cancer patients and 82 controls were administered 80 mg and 107 mg of vitamin C respectively. This study demonstrated a ten-fold increase in risk of cervical dysplasia when the intake of vitamin C was 50% less than the recommended daily allowance (Wassertheil-Smoller 1981). A study by Giuliano et al (2003) showed that risk of type-specific persistent HPV infection was lower among women whose intake of vitamin C is higher compared to those in the lowest quartile. Similar results have been reproduced elsewhere (VanEenwyk 1991). Although conflicting reports on vitamin C supplementation exist, it is evident that low vitamin C status is consistently associated with cervical cancer and its precursors.

Vitamin E Vitamin E exists in eight different forms, four tocopherols and four tocotrienols. with Îą-tocopherol being the form of vitamin E that is preferentially absorbed and stored in humans. Îą-tocopherol in a vitamin E rich diet behaves as peroxy radical scavenger with chain breaking properties, inhibiting induced neoplastic transformation of cells (Rigotti 2007). Serum tocopherol levels were found to be low in patients with HPV persistence in a study done with 405 Brazilian women (Siegel 2007). Prostaglandins are often related to carcinogenic events on account of their ability to suppress the immune system. Vitamin E inhibits prostaglandin action by reducing the adenylate cyclase response to prostaglandins (Stoll 1994). In a study involving American Indian women with biopsy proven CIN I or CIN II/III and same population controls, Yeo et al (2000) reported that low serum Îą-tocopherol was associated with increased CIN I/III, but the adjusted odds ratio was not significant. Further large cohort studies are needed to assess the role of vitamin E in HPV infection. Green tea extract (Camelia sinensis) The FDA approved a topical herbal drug (Polyphenol E) comprised of catechins from green tea leaves to treat genital warts caused by low risk HPV, strains 6 and 11. The efficacy and safety of Polyphenon E was confirmed by a randomized trial on 397 adults with HPV genital warts. Subjects who applied the treatment three times a day had complete clearance of warts in 16 weeks (Stockfleth 2008). Ahn et al (2003) reviewed the clinical efficacy of green tea extracts in the form of ointment or capsules in treating patients with HPV infected cervical lesions. A cohort of 51 patients with cervical lesions was divided into 4 groups and 39 patients were untreated controls. A 69% response was observed for treatment with green tea extract compared to a 10% response in untreated controls, suggesting that green tea extract can serve as a potential therapy for patients with HPV associated cervical lesions. Curcuma longa Curcumin, a yellow pigment from rhizomes of turmeric has been observed to have anticancer properties. Maher et al (2011) analyzed the effects of curcumin on HPV pathways involved in the development of cervical cancer. Curcumin was found to inhibit the transcription of HPV 16, restore the expression of tumor suppressor protein P53, and suppress the growth of cervical cancer cells. A study by Cheng et al (2001) demonstrated that curcumin is not toxic to humans at doses up to 8000 mg/day when administered orally for three months. This study also showed that curcumin

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Table 1: Summary of interventions for HPV infection and cervical dysplasia Nutrient

Source

Mechanism of Action

Recommended daily dose

Carotenoids

Carrots, squash, spinach, cabbage, radish, broccoli

Quencher of singlet oxygen and scavenge peroxy radicals

Mixed carotenes 15000 - 25000 IU

Epigallocatechin-3gallate

Green tea leaves

Antioxidant activity

300 mg

Glucosinolates

Broccoli sprouts

Controls estrogen levels

200 - 400 mg

Curcumin

Curcuma longa (Turmeric)

Antiviral and antitumor activity 400 mg - 3 g

Reishi

Ganoderma lucidum

Enhances immune response

400 mg – 3 g

Folic acid

Leafy vegetables, cereals

DNA methylation

0.8 - 2.4 mg

Vitamin B12

Beef, eggs, chicken, milk

DNA methylation

1 mg

Vitamin C

Strawberries, sprouts, papaya, Antioxidant activity tomatoes, broccoli

1000 - 2000 mg

Vitamin E

Green leafy vegetables, olive oil, soybeans, wheat germ

70 - 150 IU

led to histologic improvement in patients with CIN and other premalignant lesions, suggesting a biologic effect of curcumin in the chemoprevention of cervical cancer (Maher 2011). Ganoderma Lucidum Ganoderma lucidum, known by its common name Reishi mushroom, is traditionally used in Chinese medicine for inflammation and immunity. Preclinical studies by Gao et al (2003) suggested that the Ganoderma lucidum polysaccharides (GLPS) are responsible for the immune-stimulating effects of the herb. They investigated the effects of GLPS on the immune function of 34 advanced-stage cancer patients. These patients were treated with 1800 mg, three times/day orally for 12 weeks. Th irty patients after 12 weeks of treatment were assessed for immune function and found to have increased plasma concentrations of IL-2, IL-6 and Interferon gamma and decreased IL-1 and Tumor necrosis factor (TNF) concentrations. The study also found increased NK cell activity after 12 weeks of treatment, indicating that Ganoderma lucidum polysaccharides enhanced the immune response of patients with advanced cancer. Trametes Versicolor (Previously known as Coriolus versicolor) Trametes is a mushroom commonly used in Asia for boosting the immune system. Most of the research on this mushroom has

Inhibits prostaglandins

focused on its immune-enhancing properties in cancer patients undergoing chemotherapy. Recently, it has been studied for its immunomodulating effects on HPV. A study by J. Silva Couto (2006) examined women with CIN I associated with HPV. Half of the women were given 3g/day of Coriolus for a year and the other half received no supplementation. The study found that Coriolus versicolor supplementation over a period of one year substantially increased regression of dysplasia (regression rate 72% vs 47.5%) and induced clearance of the high-risk subtypes of the HPV virus (regression rate 90% vs 8.5%). Conclusion

Nutritional therapeutic interventions can restore balance to the immune system, tune up the body’s defense against infection and correct nutrient deficiencies. Nutrient supplementation is an alternative approach to the conventional “watch and wait” approach in response to cervical dysplasia and HPV infection. Supplementation is most effective in people with low baseline status of nutritional adequacy. Evidence from human clinical trials suggests that achieving nutrient adequacy exerts a protective effect against persistent HPV infection and that dietary and nutritional interventions may prevent the development of cervical dysplasia, or reverse existing histopathological abnormality. •

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References Ahn WS, Yoo J, Huh SW, Kim CK, Lee JM, Namkoong SE, Bae SM, Lee IP. Protective effects of green tea extracts (polyphenon E and EGCG) on human cervical lesions. Eur J Cancer Prev. 2003 Oct;12(5):383-90. Auborn KJ, Fan S, Rosen EM, Goodwin L, Chandraskaren A, Williams DE, Chen D, Carter TH. Indole-3-carbinol is a negative regulator of estrogen. J Nutr. 2003 Jul;133(7 Suppl):2470S-2475S. Bell MC, Crowley-Nowick P, Bradlow HL, Sepkovic DW, Schmidt-Grimminger D, Howell P, Mayeaux EJ, Tucker A, Turbat-Herrera EA, Mathis JM. Placebocontrolled trial of indole-3-carbinol in the treatment of CIN. Gynecol Oncol. 2000 Aug;78(2):123-9. Cheng AL, Hsu CH, Lin JK, Hsu MM, Ho YF, Shen TS, Ko JY, Lin JT, Lin BR, MingShiang W, Yu HS, Jee SH, Chen GS, Chen TM, Chen CA, Lai MK, Pu YS, Pan MH, Wang YJ, Tsai CC, Hsieh CY. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. Anticancer Res. 2001 JulAug;21(4B):2895-900. Couto JS. Evaluation of Coriolus versicolor supplementation in LSIL HPV patients. Townsend Letter: The Examiner of Alternative Medicine. Nov issue 2006. Davidson SE, West CM, Hunter RD. Lack of association between in vitro clonogenic growth of human cervical carcinoma and tumour stage, differentiation, patient age, host cell infiltration or patient survival. Int J Cancer. 1992 Jan 2;50(1):10-4. Del Priore G, Gudipudi DK, Montemarano N, Restivo AM, Malanowska-Stega J, Arslan AA. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol. 2010 Mar;116(3):464-7. Di Mascio P, Kaiser S, Sies H. Lycopene as the most efficient biological carotenoid singlet oxygen quencher. Arch Biochem Biophys. 1989 Nov 1;274(2):532-8. Fahey JW, Zhang Y, and Talalay P. Broccoli sprouts: An exceptionally rich source of inducers of enzymes that protect against chemical carcinogens. Proc Natl Acad Sci USA. 1997 Sept; 94(19): 10367–10372. Flatley JE, McNeir K, Balasubramani L, Tidy J, Stuart EL, Young TA, Powers HJ. Folate status and aberrant DNA methylation are associated with HPV infection and cervical pathogenesis. Cancer Epidemiol Biomarkers Prev. 2009 Oct;18(10):2782-9. Gao Y, Zhou S, Jiang W, Huang M, Dai X. Effects of ganopoly (a Ganoderma lucidum polysaccharide extract) on the immune functions in advanced-stage cancer patients. Immunol Invest. 2003 Aug;32(3):201-15. Gariglio P, Gutierrez J, Cortes E, Vazquez J. The role of retinoid deficiency and estrogens as cofactors in cervical cancer. Arch Med Res. 2009 Aug;40(6):449-65. Hernandez BY, McDuffie K, Wilkens LR, Kamemoto L, Goodman MT. Diet and premalignant lesions of the cervix: evidence of a protective role for folate, riboflavin, thiamin, and vitamin B12. Cancer Causes Control. 2003 Nov;14(9):859-70. Higdon JV, Delage B, Williams DE, Dashwood RH. Cruciferous vegetables and human cancer risk: epidemiologic evidence and mechanistic basis. Pharmacol Res. 2007 Mar;55(3):224-36. Kim DJ. Enhancement by indole-3-carbinol of liver and thyroid gland neoplastic development in a rat medium-term multiorgan carcinogenesis model. Carcinogenesis. 1997. 18 (2): 377-381. Mackerras D, Irwig L, Simpson JM, Weisberg E, Cardona M, Webster F, Walton L, Ghersi D. Randomized double-blind trial of beta-carotene and vitamin C in women with minor cervical abnormalities. Br J Cancer. 1999 Mar;79(9-10):1448-53. Maher DM, Bell MC, O’Donnell EA, Gupta BK, Jaggi M, Chauhan SC. Curcumin suppresses human papillomavirus oncoproteins, restores p53, Rb, and PTPN13 proteins and inhibits benzo[a]pyrene-induced upregulation of HPV E7. Mol Carcinog. 2011 Jan;50(1):47-57.

vitamins and risk of cervical dysplasia from a case-control study in Japan. Br J Cancer. 1999 Dec;81(7):1234-7. Palan PR, Mikhail MS, Basu J, Romney SL. Beta-carotene levels in exfoliated cervicovaginal epithelial cells in cervical intraepithelial neoplasia and cervical cancer. Am J Obstet Gynecol. 1992 Dec;167(6):1899-903. Palan PR, Mikhail MS, Goldberg GL, Basu J, Runowicz CD, Romney SL. Plasma levels of beta-carotene, lycopene, canthaxanthin, retinol, and alpha- and tautocopherol in cervical intraepithelial neoplasia and cancer. Clin Cancer Res. 1996 Jan;2(1):181-5. Reed GA, Arneson DW, Putnam WC, Smith HJ, Gray JC, Sullivan DK, Mayo MS, Crowell JA, Hurwitz A. Single-dose and multiple-dose administration of indole3-carbinol to women: pharmacokinetics based on 3,3’-diindolylmethane. Cancer Epidemiol Biomarkers Prev. 2006 Dec;15(12):2477-81. Rigotti A. Absorption, transport, and tissue delivery of vitamin E. Mol Aspects Med. 2007 Oct-Dec;28(5-6):423-36. Rosen CA, Woodson GE, Thompson JW, Hengesteg AP, Bradlow HL. Preliminary results of the use of indole-3-carbinol for recurrent respiratory papillomatosis. Otolaryngol Head Neck Surg. 1998 Jun;118(6):810-5. Sedjo RL, Fowler BM, Schneider A, Henning SM, Hatch K, Giuliano AR. Folate, vitamin B12, and homocysteine status. findings of no relation between human papillomavirus persistence and cervical dysplasia. Nutrition. 2003 Jun;19(6):497-502. Sedjo RL, Inserra P, Abrahamsen M, Harris RB, Roe DJ, Baldwin S, Giuliano AR. Human papillomavirus persistence and nutrients involved in the methylation pathway among a cohort of young women. Cancer Epidemiol Biomarkers Prev. 2002 Apr;11(4):353-9. Siegel EM, Craft NE, Duarte-Franco E, Villa LL, Franco EL, Giuliano AR. Associations between serum carotenoids and tocopherols and type-specific HPV persistence: the Ludwig-McGill cohort study. Int J Cancer. 2007 Feb 1;120(3):672-80. Stoll KE, Ottino P, Duncan JR. Interrelationship of ascorbate, arachidonic acid and prostaglandin E2 in B16 melanoma cells. Prostaglandins Leukot Essent Fatty Acids. 1994 Mar;50(3):123-31. Stockfleth E, Beti H, Orasan R, Grigorian F, Mescheder A, Tawfik H, Thielert C. Topical Polyphenon E in the treatment of external genital and perianal warts: a randomized controlled trial. Br J Dermatol. 2008 Jun;158(6):1329-38. Stoner G, Casto B, Ralston S, Roebuck B, Pereira C, Bailey G. Development of a multi-organ rat model for evaluating chemopreventive agents: efficacy of indole-3carbinol. Carcinogenesis. 2002 Feb;23(2):265-72. Tong SY, Lee JM, Song ES, Lee KB, Kim MK, Yun YM, Lee JK, Son SK, Lee JP, Kim JH, Hur SY, Kwon YI. The effects of polymorphisms in methylenetetrahydrofolate reductase (MTHFR), methionine synthase (MTR), and methionine synthase reductase (MTRR) on the risk of cervical intraepithelial neoplasia and cervical cancer in Korean women. Cancer Causes Control. 2010 Jan;21(1):23-30. VanEenwyk J, Davis FG, Bowen PE. Dietary and serum carotenoids and cervical intraepithelial neoplasia. Int J Cancer. 1991 Apr 22;48(1):34-8. Wassertheil-Smoller S, Romney SL, Wylie-Rosett J, Slagle S, Miller G, Lucido D, Duttagupta C, Palan PR. Dietary vitamin C and uterine cervical dysplasia. Am J Epidemiol. 1981 Nov;114(5):714-24. Wheeler C. Advances in primary and secondary interventions for cervical cancer: prophylactic human papillomavirus vaccines and testing. Nat Clin Pract Oncol. 2007 Apr: 4(4):224-235. Witz G. Active oxygen species as factors in multistage carcinogenesis. Proc Soc Exp Biol Med. 1991 Nov;198(2):675-82.

Marianne M. Management of cervical dysplasia and human papillomavirus. Townsend Letter, April issue. 2010.

Yeo AS, Schiff MA, Montoya G, Masuk M, van Asselt-King L, Becker TM. Serum micronutrients and cervical dysplasia in Southwestern American Indian women. Nutr Cancer. 2000;38(2):141-50.

Nagata C, Shimizu H, Yoshikawa H, Noda K, Nozawa S, Yajima A, Sekiya S, Sugimori H, Hirai Y, Kanazawa K, Sugase M, Kawana T. Serum carotenoids and

Zarcone R, Bellini P, Carfora E, Vicinanza G, Raucci F. [Folic acid and cervix dysplasia]. Minerva Ginecol. 1996 Oct;48(10):397-400.

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PRODUCT mOnOgRaPh

PRODUCT MONOGRAPH OIL OF OREGANO

Oil of Oregano is a hydrophobic extract of Origanum vulgare leaf. Major active constituents include the monoterpene phenolic compounds carvacrol and thymol. Carvacrol and thymol are potent antimicrobials with synergistic bactericidal, fungicidal, and antihelminthic activity.

Human studies

Oil of Mediterranean Oregano had antihelminthic effects when given at 600 mg emulsified oil per day in 14 adults who had tested positive for enteric parasites Blastocystis hominis, Entamoeba hartmanni, and Endolimax nana. After 6 weeks of treatment, there was complete resolution of parasitic infection in 8 cases, while Blastocystis hominis scores decreased in three more cases; gastrointestinal symptoms improved in 7 of the 11 subjects who had presented with Blastocystis hominis infection. (Force 2000)

Animal and In vitro studies

Carvacrol for oral candidiasis in immunocompromised rats was found to be as effective as treatment with Nystatin, reducing the number of colony forming units (CFU’s) and completely clearing hyphae from oral surfaces when given for 8 days (Chami 2004). In vitro, carvacrol was determined to exert an inhibitory effect against 6 different strains of Candida species primarily due to extensive lesion of the plasma membrane (Salgueiro 2003). Carvacrol has potent antimicrobial activity against several microbial species, including Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Psuedomonas aeruginosa, Candida albicans, and Aspergillus niger; out of these, Candida albicans has been found most susceptible (Santoyo 2006). Carvacrol and thymol are thought to exert an additive effect by disrupting bacterial membrane integrity (Lambert 2001). Oregano has been shown to inhibit Methicillin resistant strains of Staph.

Figure 1: Structure of Carvacrol (left) and Thymol (right)

aureus and epidermis, and attenuates biofilm formation in vitro (Nostra 2004; 2007).

Toxicology

Essential oil extracts are categorically known to be toxic in high doses, and are therefore typically given in drop doses; essential oils should not be used internally by pregnant or breastfeeding women. Animal studies to date, however, indicate relative safety of Oregano oil. Carvacrol was shown to be hepatoprotective against ischemia and reperfusion injury in rats; both carvacrol and silymarin had similar beneficial effects on AST and ALT levels (Canbek 2007). Carvacrol also increased liver regeneration rate in rats after partial hepatectomy (Uyanoglu 2008). Mutagenicity studies of carvacrol show only weak activity; carvacrol is excreted in urine after 24 hours in large quantities, unchanged or as glucoronide and sulphate conjugates (De Vincenzi 2004).

References

Canbek M, Uyanoglu M, Bayramoglu G, Senturk H, Erkasap N, Koken T, Uslu S, Demirustu C, Aral E, Husnu Can Baser K. Effects of carvacrol on defects of ischemia-reperfusion in the rat liver. Phytomedicine. 2008 Jan. De Vincenzia M et al. Constituents of aromatic plants: carvacrol. Fitoterapia 2004; 75(7-8): 801-804. Force M et al. Inhibition of enteric parasites by emulsified oil of oregano in vivo. Phytother Res. 2000 May;14(3):213-4. Lambert RJ, Skandamis PN, Coote PJ, Nychas GJ. A study of the minimum inhibitory concentration and mode of action of oregano essential oil, thymol and carvacrol. J Appl Microbiol. 2001 Sep;91(3):453-62. Nostro A, Roccaro AS, Bisignano G, Marino A, Cannatelli MA, Pizzimenti FC, Cioni PL, Procopio F, Blanco AR. Effects of oregano, carvacrol and thymol on Staphylococcus aureus and Staphylococcus epidermidis biofilms. J Med Microbiol. 2007;56(Pt 4):519-23. Nostro A et al. Susceptibility of methicillin-resistant staphylococci to oregano essential oil, carvacrol and thymol. FEMS Microbiol Lett. 2004;230(2):191-5. Salgueiro LR et al. Chemical composition and antifungal activity of the essential oil of Origanum virens on Candida species. Planta Med. 2003 Sep;69(9):871-4. Santoyo S, Cavero S, Jaime L, Ibañez E, Señoráns FJ, Reglero G. Supercritical carbon dioxide extraction of compounds with antimicrobial activity from Origanum vulgare L.: determination of optimal extraction parameters. J Food Prot. 2006;69(2):369-75. Uyanoglu M, Canbed M, Aral E, Husnu Can Baser K. Effects of carvacrol upon the liver of rats undergoing partial hepatectomy. Phytomedicine 2008; 15(3): 226-9. ihpSept10_NAHS_Ad.indd 2 IHP NAHS.indd 2 058.IHP NAHS mono.indd 1

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ORIGINAL RESEARCH

Effectiveness and safety of the homeopathic preparation Pasconal® Nerventropfen in patients with nervous disorders By Birgit Rompp PhD, Bianka Krick, Gabriele Weiss DVM

ABSTRACT Objective:

We investigated the safety and effectiveness of a homoeopathic combination preparation in patients suffering from nervousness and sleep disorders. Methods:

In this observational study, 325 patients suffering from nervous disturbances and sleep disorders were treated for about four weeks with a homeopathic combination preparation containing Avena sativa, Valeriana, Ignatia and Tarantula. The effectiveness and safety was assessed by a questionnaire filled out by the therapists. Results:

Patients without concomitant medication and therapy duration over four weeks responded better to the therapy with the homeopathic preparation. A clear reduction in the symptom severity could be observed for all 12 analyzed symptoms. In patients who did not receive concomitant medication due to the

inclusion diagnosis, a comparatively more positive and significant (p < 0.05) effect on the symptoms nervousness/restlessness and irritability/eccentricity was observed. The effect of PASCONAL® NERVENTROPFEN on five individual symptoms (nervousness/ restlessness, irritability/eccentricity, sleep disorders, fitful sleep, and hyperactivity) was more pronounced in patients who were treated for four weeks or more than in patients with a shorter treatment period. All p-values for comparison between the two subgroups were < 0.05. The therapy was well-tolerated. Conclusion:

This observational study indicates that the homoeopathic combination preparation is an effective and well-tolerated alternative to pharmaceuticals for the treatment of nervous disturbances and sleep disorders. Keywords:

nervousness, sleep disorders, homeopathic combination preparation, Avena sativa, Valeriana, Ignatia, Tarantula

Dr. Birgit Römpp Department of Clinical Research PASCOE pharmazeutische Präparate GmbH Schiffenberger Weg 55 D-35394 Giessen, Germany birgit.roempp@pascoe.de

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INTRODUCTION Stress dominates the lives of many people, frequently leading to undesirable health consequences, including nervousness, tension and sleep disorders. Stress often arises as a response to current circumstances of life, such as job-related, school, or private stress; rising workload or academic demands; overstimulation; inability to relax; burdening living conditions; and personal disappointments or losses. Psychiatric disorders such as sleep disturbances, psychosomatic complaints, states of anxiety and depression occur far more often than is widely believed (Kraft 2007). The spectrum of interventions for nervousness, restlessness, and sleep disturbances is broad, and treatments range from benzodiazepines and anxiolytics to relaxations techniques (Hankey 2006) and homoeopathic preparations (Kumar 2005). Traditional allopathic medicine is the most common mode of treatment for stress-related conditions but because side effects, interactions, and the potential for pharmaceutical dependence do not allow long-term treatment (Rosenberg 2006, Tan 2010), alternative

therapies are increasingly employed (Barnes 2004, Schneider 2004). Positive results have been reported for the treatment of sleep disorders (Coholic 2005, Waldschutz 2008), mild nervous disorders (Meerschaut 2007), and mental trauma (Ventegodt 2006) with complementary therapies. Given the superior tolerability of complementary and alternative therapy over conventional drug therapy, phytotherapeutic and homoeopathic remedies represent a potentially valuable treatment avenue in the management of sleep disorders, mild panic attacks, psychovegetative complaints, and depression. These alternative treatment methods can be used concomitantly with specific therapies addressing the underlying disease along with additional measures such as sleep hygiene, autogenic training, sports, identification of psychosocial burdens and appropriate psychotherapy (Kraft 2010). The current observational study was undertaken to evaluate the safety and effectiveness of PASCONAL® NERVENTROPFEN on these nervous conditions in both adults and children.

METHODS Study Design

Treatment

This prospective, non-interventional, non-randomised, cohort study was conducted between 1st May and 31st August 2010 by 71 physicians. Male and female patients aged 1 to 89 years suffering from nervous disturbances and sleep disorders were treated with the homoeopathic combination product PASCONAL® NERVENTROPFEN (PASCOE pharmazeutische Praeparate GmbH, Giessen, Germany) in everyday practise. Treatment and dosage were decided by the therapist. No specific inclusion and exclusion criteria were defined due to the character of a non-interventional study. Data assessment included a physiciancompleted questionnaire on three occasions: at baseline (beginning of the observation period; visit one), approximately two weeks later (visit two) and approximately four weeks later (end of the observation period; visit three).

The patients were treated with the homoeopathic combination product PASCONAL® NERVENTROPFEN (ingredients listed in Table 1-Components of PASCONAL® NERVENTROPFEN and their dilutions). This product is indicated for the use in sleep disorders due to nervous restlessness according to its active ingredients (as listed in Felter´s Eclectic Materia Medica). Dose and duration of treatment were left to the respective physician’s discretion.

The study was registered with the Protocol Registration System ClinicalTrials.gov (NCT01125605). All participants and their parents gave written, informed consent.

Outcome measures and Analyses

The data presented in this study are based on the data collected from the physician-completed questionnaires. The data were documented on at least two visits or on three visits at best. At the first visit, demographic data (sex, age, body height, body weight) were collected, as well as data on the duration of disease, previous therapies of the inclusion diagnosis, effectiveness and tolerability of previous therapies, relevant concomitant diseases/medication and the severity of symptoms. At visits two and three, dosage

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ORIGINAL RESEARCH

of the study medication and/or other medications, severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure), and effectiveness and tolerability of the study medication were recorded. If the study was completed on visit two, the effectiveness of PASCONAL® NERVENTROPFEN and adverse drug reactions were documented. Otherwise, these data were collected on visit three. The severity of symptoms was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints). The change from baseline to the end of the observation was calculated for the individual symptom scores and for the sum score of all 12 individual symptom scores (0 - 36). Additionally, the improvement of the symptoms versus baseline was assessed at the end of the observation on a scale that ranged from improved, to no change, to deteriorated. Statistics

Due to the character of an observational study, no hypotheses were specified and all conclusions were drawn from descriptive data analysis. The following values were computed, depending on the type of parameter: frequency data (absolute and relative frequencies), proportionally scaled measured values (median, 25% and 75% quartile, arithmetic mean, standard deviation, variance, minimum, maximum, number of valid data and number of missing data), and pre- / post-comparisons for data concerning symptoms. Additionally, the main efficacy variables were analysed by explorative statistics. Parameters for analysis included the sum

score of 12 clinical symptoms as well as the five individual symptoms nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, and hyperactivity. Explorative statistical analysis was based on the change of the sum score between baseline (visit one) and the last documented visit (visit two or visit three), according to the LOCF (Last observation carried forward) principle. The change was calculated as “value pre minus value post”, which means that positive values indicate a decrease of the score (corresponding to an improvement). The sum score was also analysed with respect to age, gender, concomitant medication and treatment duration (< 4 weeks versus ≥ 4 weeks). The one-sample t-test (two-sided) was used to test the null hypothesis that the changes from baseline were equal to zero. This analysis was performed for the total population and for each of the considered strata (age, gender, concomitant medication, treatment duration). Analysis of covariance (ANCOVA) was applied to investigate the differences in the changes of the sum score between the various subgroups. The GLM (Generalized Linear Model) procedure of the SAS® system (with type III sums of squares) was used after including the baseline value of the sum score as a covariate in the underlying statistical model. With respect to age, two types of analysis were carried out: 1) all four subgroups (1 to 6 years, 7 to 11 years, 12 to 17 years and ≥ 18 years); and 2) < 18 years and ≥ 18 years. In order to show the results when baseline adjustment is omitted, the two-sample t-test (two-sided) was performed in addition to ANCOVA (only for pair-wise comparison).

Table 1 Components of PASCONAL® NERVENTROPFEN and Their Dilutions Component Avena sativa Valeriana Ignatia Tarantula

Common Name Common oats Common valerian Ignatius bean Tarantula

Dilution mother tincture mother tincture D4 D5

g in 10 g 2.5 2.5 2.5 0.25

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ORIGINAL RESEARCH

RESULTS A total of 325 patients were enrolled in the study and their treatment was documented during the observational study by 71 physicians. Baseline characteristics are summarised in Table 2. The inclusion diagnosis was made an average of two years ago and female patients suffered longer from nervousness than male patients (2.3 years versus 1.3 years). Two hundred forty five patients reported receiving previous therapies due to the inclusion diagnosis (11.1% only drug therapy; 24% only physical therapy/ other therapy; 40.3% drug therapy and physical therapy/other

therapy). The effectiveness of these previous therapies was mostly rated as “moderate” (58.4%) or “with no effect” (17.6%), while only 22.4% judged the effectiveness as “good” or “very good”. The tolerability of the previous therapies was rated as “very well” in 73.1% and only 4.5% stated poor tolerability. 70 patients continued their concomitant medication (92 medications in total) due to the inclusion diagnosis. It is shown that most of these continued drugs (43,5%) were all kinds of psychopharmaceuticals followed by all kinds of hypnotics/sedatives (40.2%).

Table 2 Baseline Characteristics

Parameter

Value

mean age (years ± SD) Age < 18 years (%) Women (%) Weight (kg ± SD) No concomitant medication (%) Duration of disease years (years ± SD) Subchronic/chronic* state of inclusion diagnosis (% patients) No previous treatment of inclusion diagnosis (%)

38.9 ± 22 22.2 70.5 65.5 ± 22.7 54.2 2.0 ± 3.8 79.1 24.6

* Duration of symptoms > 2 months

The patients were treated with a mean daily dosage of three times a day 10 gtt PASCONAL® NERVENTROPFEN. The majority of patients were treated within the dosage recommendation as described in the SPC of PASCONAL® NERVENTROPFEN and the remaining patients were treated above the dosage recommendation. In total, 12 different symptoms were observed during the time of the study, namely nervousness/restlessness, irritability/ eccentricity, sleep disorders, hyperactivity, fitful sleep, nocturnal anxiety, lack of concentration/forgetfulness, tiredness, listlessness,

discontent, gastrointestinal problems, and headache/head pressure. The change in the severity of each symptom between the start and end of the observation period is shown in Table 3. For the symptoms of nervousness/restlessness, irritability/ eccentricity, sleep disorders, and fitful sleep, the majority of patients stated moderate or strong complaints (75.4%, 63.7%, 70.5% and 69.2%, respectively) at the start of the observation. These symptoms improved during the course of the study, with 87.7%, 88.9%, 84% and 87.4% of the patients, respectively, stating that they had no complaints anymore or only suffered from mild complaints.

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ORIGINAL RESEARCH

Table 3: Symptom Severity at Start and End of the Observation in all patients Severity Severity Symptoms Nervousness/ restlessness Irritability/ eccentricity Sleep disorders Hyperactivity Fitful sleep Nocturnal activity Lack of concentration/ forgetfulness Tiredness Listlessness Discontent Gastrointestinal problems Headache/ pressure

not present [%] mild [%] moderate [%] strong [%] start of end of start of end of start of end of start of end of observation observation observation observation observation observation observation observation 5.2 29.5 19.4 58.2 51.1 8.9 24.3 3.4 9.8

45.2

26.5

43.7

43.1

8.3

20.6

2.8

7.7 32.3 8.9 38.8 24.6

36.9 64.4 47.1 77.2 52.6

21.8 32.6 21.8 29.8 39.7

47.1 27.1 40.3 17.8 40.9

42.2 25.5 44.6 22.5 26.8

12.6 4.6 10.5 3.4 5.2

28.3 9.6 24.6 8.9 8.9

3.4 0.9 2.2 1.5 1.2

19.1 27.7 37.8 60.6

55.7 66.8 73.6 81.8

37.8 37.8 31.1 23.1

33.8 24.3 20.9 15.1

28.6 24.9 26.2 11.4

8.6 7.4 5.2 1.8

14.5 9.5 4.9 4.9

1.8 0.9 0.3 1.2

44.9

74.2

32.9

20.9

16.6

4.6

5.5

0.3

The other symptoms were less pronounced; for example, only 16.3% and 22.1% of the patients suffered from moderate and strong gastrointestinal problems and headache/pressure, respectively.

Nevertheless, an improvement in at least 65% of the patients was observed for each symptom at the end of the observational study (Figure 1). In all symptoms less than 3% deterioration was seen.

Figure 1: Change of all symptoms in comparison to the pre-value (visit 1)

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ORIGINAL RESEARCH

All symptoms were summarised to one “sum score”. The value decreased from and initial score of 15.8 to a score of 6.2 at the end of the study (Figure 2). The explorative analysis of the sum score was carried out with respect to age, gender, concomitant medication, and treatment duration. The difference between males and females in the mean decreases of the sum score (9.3 vs. 9.7) was not significant (p = 0.6115). The global test for differences between the four age groups did not show a significant result

(p=0.0960). For a more robust analysis, all patients <18 years were combined into one age group. The mean baseline values of the sum score for the two resulting groups were 13.5 (<18 years) and 16.4 (≥18 years), respectively. Although the difference in the mean decreases was only 0.3 points, ANCOVA with baseline adjustment produced a significant result (p= 0.0238). The result of the analyses showed that the baseline value of the scan had a significant impact (p<0.0001) on the observed change.

Figure 2: Sum Score

Although the mean baseline values were comparable between patients who received concomitant medication due to the inclusion diagnosis and patients who did not (15.9 vs. 15.7), the decrease of the sum score was considerably more pronounced in the latter group (8.2 vs. 9.9). The difference between both subgroups of patients was significant (p = 0.0033). Patients who received PASCONAL® NERVENTROPFEN for less than four weeks showed a considerably lower decrease of the sum score than patients who had been treated for four weeks or more (6.9 vs. 10.2). The difference between both subgroups of patients was significant (p = 0.0002). The five individual symptoms, nervousness/restlessness, irritability/ eccentricity, sleep disorders, fitful sleep, and hyperactivity, were analysed with respect to the direction of change between

baseline and the last documented visit by means of the categories “improved”, “unchanged” and “worsened”. Differences between subgroups were analysed with Fisher’s exact test (two-sided) for stratification by age (<18 years vs. ≥ 18 years), concomitant medication (due to inclusion diagnosis), and duration of treatment with PASCONAL® NERVENTROPFEN. The age of the patients had no significant effect on the five selected symptoms. In patients who did not receive concomitant medication due to the inclusion diagnosis, a comparatively more positive and significant (p < 0.05) effect on the symptoms nervousness/restlessness and irritability/ eccentricity was observed. The corresponding p-values for the remaining three symptoms were > 0.05. The effect of PASCONAL® NERVENTROPFEN on all five individual symptoms was more pronounced in patients who were treated for four weeks or more than in patients with a shorter treatment period. All p-values for comparison between the two subgroups were < 0.05.

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ORIGINAL RESEARCH

Overall, PASCONAL速 NERVENTROPFEN was well tolerated by 96.0% of the patients in the first observation interval and by 92.9% in the second observation interval. Fifteen patients reported moderate or poor tolerability of PASCONAL速 NERVENTROPFEN. Seven adverse events were reported with possible relationship to study treatment (2x nausea, 2x headache, 2x tiredness and 1x tachycardia/acid reflux ), four with probable

relationship (2x gastrointestinal disorders, 1 x severe tiredness and 1 x heartburn), two events with relationship unlikely (1 x aggressivity, 1 x stomach ache,) and only one with a certain relationship to the treatment (tongue and mucosa under tongue affected by alcohol concentration of the drops). In one case the relationship was not assessable. None of the adverse events required additional medical treatment.

DISCUSSION The results of this observational study reveal that the homoeopathic combination preparation, PASCONAL速 NERVENTROPFEN, is effective in the symptomatic treatment of sleep disorders due to nervous restlessness. The baseline data revealed that the majority of patients suffered from nervousness/restlessness, irritability/eccentricity, sleep disorders, and fitful sleep. The majority of patients had already received therapies due to the inclusion diagnosis and half of those therapies were pharmaceuticals. Astonishingly, over 75% of the patients who used previous therapies reported either no effect or moderate effectiveness of these therapies. After treatment with the homoeopathic combination preparation, a clear reduction in the symptom severity was observed for all analysed symptoms. Most patients experienced more than a 50% reduction in moderate and strong symptoms. Upon analysis of the sum score, it can be concluded that from start until the end of the observation, a reduction by 9.6 points could be observed, which corresponds to a decrease by 60%. The explorative analysis showed a connection between the sum score and age groups, concomitant medication and therapy duration, respectively. Patients over 18 years of age had a significant reduction of the mean sum score compared with the group of patients less than 18 years. However, it is important to point out that both age groups differ in the number of patients (72 under 18 years versus 253 patients over 18 years).

Patients who did not take any concomitant medication due to the inclusion diagnosis showed a higher decrease in the mean value of the sum score at the end of the observation. Compared with the group of patients who received concomitant medication, this result was significant. Therapy duration influenced the sum score value: patients who had been treated for four weeks and more showed a considerably higher decrease of the sum score than patients who received the homeopathic combination preparation less for than four weeks. The difference between both subgroups of patients was significant. Age had no influence on the direction of change (improved, unchanged or worsened) between baseline (visit 1) and the last documented visit of the five symptoms (nervousness/ restlessness, irritability/eccentricity, sleep disorders, fitful sleep and hyperactivity). However, patients who did not receive concomitant medication showed a significant effect on the direction of change in nervousness/restlessness and irritability/ eccentricity. For the remaining three symptoms, no significant effect could be observed. Interestingly, an effect on all five symptoms could be shown in patients who were treated four weeks or more. The therapy was well tolerated, which was to be expected based on the experience gained in pharmacovigilance surveillance of the product.

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ORIGINAL RESEARCH

LIMITATIONS

AUTHORS’ CONTRIBUTIONS

Observational studies have several limitations (Black 1996), including the absence of a placebo group. This can create bias and can also mask cause and effect relationships or suggest correlations where there are none. Therefore, no definite conclusions can be extrapolated from these studies.

Financial support for the analysis was provided by PASCOE pharmazeutische Präparate GmbH, Germany. The sponsor had influence on the conduct of the analysis in so far as the management and evaluation of the data was conducted in the department of Clinical Research of PASCOE pharmazeutische Präparate GmbH. The explorative statistics were done by D. Schremmer, GKM Gesellschaft für Therapieforschung mbH, Germany.

LITERATURE Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use among adults: United States, 2002. Adv Data 2004; (343): 1-19.

Meerschaut Lvd, Andrea S. The Homeopathic Preparation Nervoheel N can Offer an Alternative to Lorazepam Therapy for Mild Nervous Disorders. eCAM. 2007

Berger H, Fritz U. Medication in acute psychiatric treatment. Psychiatr Prax. 2004; 31 (2): 68-73.

Rosenberg RP. Sleep maintenance insomnia: strengths and weaknesses of current pharmacologic therapies. Ann. Clin. Psychiatry. 2006; 18: 49-56.

Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ. 1996; 312(7040): 1215-8. Coholic D. The Helpfulness of Spiritually Influenced Group Work in Developing Self-Awareness and Self-Esteem: A Preliminary Investigation.” The Scientific World Journal. 2005; 5: 789–802. Hankey A. CAM and Post-Traumatic Stress Disorder. eCAM. 2006 Kraft K. Schlaf- und psychische Störungen im Kindesalter. Z Phytotherapie. 2007; 28: 235-7. Kraft K. Depressionen und depressive Verstimmungszustände. MMW Fortschr Med. 2010;152(8): 20-21. Kumar S, Anupam S. Anti-anxiety Activity Studies on Homoeopathic Formulations of Turnera phrodisiaca Ward. eCAM. 2005; 2 2(1): 117-119.

Schneider B, Hanisch J, Weiser M. Complementary medicine prescription patterns in Germany. Ann Pharmacother. 2004; 38: 502–507. Tan KR, Brown M, Labouebe G, Yvon C, Creton C, Fritschy JM, Rudolph U, Luscher C. Neural bases for addictive properties of benzodiazepines. Nature. 2010; 463: 769-774. Ventegodt S, Clausen B, Merrick J. Clinical Holistic Medicine: The Case Story of Anna. I. Long-Term Effect of Childhood Sexual Abuse and Incest with a Treatment Approach. The Scientific World Journal. 2006; 6: 1965-1976. Waldschutz R, Klein P. The homeopathic preparation Neurexan vs. valerian for the treatment of insomnia: an observational study. Scientific World Journal. 2008; 8: 411-20.

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Integrated Healthcare Practitionersâ&#x20AC;&#x2122; Dietary and Nutritional Supplement, and Herbal Remedies Management Program Author: Philip Rouchotas, MSc, ND and Heidi Fritz, MA, ND successful completion of the questions at the end of this paper has been approved for continuing education by the bddt-n ; 1.0 credit nutritional medicine and by the cnpbc ; one ce hour.

Sodium and risk of death: Villain or biomarker?

Introduction A large body of evidence has linked higher intake of sodium with increased risk of chronic disease, most notably stroke and cardiovascular disease, and all cause death (Yang 2011). In recognition of this association, many initiatives have been launched globally to reduce dietary sodium intake most notably though the reduction of sodium content of processed foods (Henney 2010, van Vliet 2011, Webster 2011). This article examines the evidence around sodium as a risk factor for cardiovascular disease and death, drawing on lessons learned from the beta carotene experience. In Europe, the current leader in sodium reduction initiatives, national programs have been launched in 19 countries, with reductions of up to 25% in sodium content of key foods, yielding reductions of approximately 1-3 g per day in per capita sodium intake (from a baseline of between 8-12 g per day) (Webster 2011). This has been paralleled by documented reductions of up to 60-80% in coronary artery disease and stroke mortality in Finland and Japan respectively: Finland launched a comprehensive cardiovascular disease prevention program in the 1970s and experienced a 65% decrease in cardiovascular mortality by 1995 (He 2009, Laatikainen 2006, Puska 1998, Webster 2011). Likewise, according to the World Action on Salt and Health organization, Japan documented an 80% reduction in mortality in the wake of its salt reduction program (Iso 1999, WASH). Currently, sodium recommendations for healthy individuals (adequate intake) in Canada and the US are 1500 mg per day (van Vliet 2011), with a tolerable upper limit of 2300 mg (Henney 2010), based on reference values set by the Institute of Medicine

in 2005 (Henney 2010). The American Heart Association further recommends a limit of no more than 1500 mg per day (AHA 2011). Actual average daily intake during 2003â&#x20AC;&#x201C;2006, estimated by the Institute of Medicine, was 3,614 mg/d (Henney 2010).

Sodium and Risk of Death: Observational Evidence NHANES III, the third National Health and Nutrition Examination Survey (1988-2006) was a prospective cohort study of a nationally representative sample of US adults; Yang et al studied data from a subset of 12,267 subjects with available data for associations between sodium intake and mortality from all-causes, cardiovascular, and ischemic heart (IHD) disease (2011). Higher sodium intake was associated with significantly increased risk of all-cause mortality, hazard ratio HR 1.20 (95% confidence interval CI 1.03-1.41 per every 1000 mg/d increase), whereas higher potassium intake was associated with lower mortality risk (HR 0.80, 95% CI 0.67-0.94 per 1000 mg/d). Philip Rouchotas MSc, ND Integrated Healthcare Practitioners Editor- in- Chief philip@ihpmagazine.com Heidi Fritz MA, ND Research Fellow Canadian College of Naturopathic Medicine 1255 Sheppard Avenue East Toronto, Ontario, Canada M2K1E2 hfritz@ccnm.edu

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Similar findings were reported based on data from the first NHANES study (He 1999). A total of 14,407 subjects were included, and dietary sodium and energy intake were estimated at baseline using a single 24-hour dietary recall method. Among overweight persons with an average energy intake of 7452 kJ (~1781 calories), a 100 mmol higher sodium intake was associated with a 32% increase (relative risk RR 1.32, 95% CI 1.07-1.64, P = .01) in stroke incidence; an 89% increase (RR 1.89, 95% CI 1.31-2.74, P<.001) in stroke mortality; a 61% increase (RR 1.61, 95% CI 1.32-1.96, P<.001) in cardiovascular disease mortality; and a 39% increase (RR 1.39, 95% CI, 1.23-1.58, P<.001) in mortality from all causes. However, in this study dietary sodium intake was not significantly associated with cardiovascular disease risk in non-overweight persons. Such studies have also been conducted in Japan. Nagata et al (2004) investigated sodium intake and risk of death from stroke among 13,355 men and 15 724 women in Takayama City, Japan. In men, the highest compared with the lowest tertile of sodium intake was significantly positively associated with death from stroke (total from ischemic and hemorrhagic) after controlling for covariates, HR 2.33 ( 95% CI 1.23 -4.45). Significant positive associations were also observed between sodium intake and death from ischemic stroke (HR 3.22, 95% CI 1.22-8.53) as well as death from intracerebral hemorrhage (HR 3.85, 95% CI 1.16 -12.7). In women, a non significant association between sodium intake and death from stroke was found : HR 1.70, 95% CI, 0.96 -3.02 and HR 2.10, 95% CI 0.96 - 4.62, respectively. Takachi et al (2010) investigated the relationship between consumption of sodium and cancer and cardiovascular disease. Between 1995-1998, a total of 77,500 men and women aged 45-74 years were enrolled, and followed until the end of 2004; 4476 cases of cancer and 2066 cases of cardiovascular disease (CVD) were identified. Results showed that higher consumption of sodium was associated with a higher risk of CVD but not with the risk of total cancer: multivariate HR for the highest compared with lowest quintiles of intake were 1.19 (95% CI 1.01-1.40; P trend 0.06) for CVD and 1.04 (95% CI 0.93-1.16; P trend: 0.63) for total cancer. Umesawa et al (Umesawa 2008) report a Japanese population study conducted between 1988 -1990 among 58,730 Japanese subjects aged 40-79 y with no history of stroke, coronary heart

disease, or cancer. After 745,161 person-years of follow-up, 986 deaths from stroke (153 subarachnoid hemorrhages, 227 intraparenchymal hemorrhages, and 510 ischemic strokes) and 424 deaths from coronary heart disease were documented. Sodium intake was associated with mortality from total stroke, ischemic stroke, and total cardiovascular disease. The multivariable HR for the highest versus the lowest quintiles of sodium intake after adjustment for age, sex, and cardiovascular disease risk factors was 1.55 (95% CI 1.21- 2.00; P trend < 0.001) for total stroke; 2.04 (95% CI 1.41- 2.94; P for trend < 0.001) for ischemic stroke; and 1.42 (95% CI 1.20- 1.69; P for trend < 0.001) for total cardiovascular disease. As with NHANES III, this study also found an inverse relationship between potassium intake and risk of death. Strazzullo et al conducted a meta-analysis of 19 prospective cohorts examining the association between sodium intake and risk of stroke or cardiovascular disease (2009). The analysis included 177,025 participants with follow-up between 3.5-19 years, and over 11,000 vascular events. Higher salt intake was associated with increased risk of stroke (relative risk RR 1.23, 95% CI 1.06 -1.43; P=0.007) and cardiovascular disease (1.14, 0.99 - 1.32; P=0.07). For cardiovascular disease, sensitivity analysis showed that the exclusion of a single study led to a significant result: RR 1.17 (1.02 - 1.34; P=0.02). The associations observed were greater the larger the difference in sodium intake and the longer the follow-up. The authors concluded: “high salt intake is associated with significantly increased risk of stroke and total cardiovascular disease. Because of imprecision in measurement of salt intake, these effect sizes are likely to be underestimated. These results support the role of a substantial population reduction in salt intake for the prevention of cardiovascular disease.”

Continuing Education Lesson

Furthermore, those in the highest quartile sodium-potassium intake ratio compared to the lowest quartile also had significantly elevated risk: HR 1.46 (95% CI 1.27-1.67) for all-cause mortality; HR 1.46 (95% CI 1.11-1.92) for CVD mortality; and HR 2.15 (95% CI 1.48-3.12) for IHD mortality.

The Beta Carotene Experience: A Harsh Lesson Learned in the Concept of Biomarker With the emergence of well- constructed theories of the role of oxidant stress in the initiation of atherosclerosis (Ross 1993) and cancer (Cerutti 1991) came an explosion of research into the potential for a handful of antioxidant nutrients to prevent and treat “the big two” chronic degenerative diseases. The landmark Basel study for many confirmed suspicions of the powerful ability of antioxidants to prevent such diseases; in an observational cohort of 4858 men followed for 12 years, Basel researchers found individuals in the lowest quintile of plasma beta carotene were at a 60% increased risk of developing cancer relative to individuals in the highest quintile of plasma beta carotene (Stahelin 1991). The stage was set for large, multicentre, randomized control trials of intervention with antioxidant nutrients for the prevention and treatment of heart disease and cancer. ihpmagazine.com { November/December 2011 IHP | 79

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Continuing Education Lesson

Figure 1: Sodium Sources • Processed foods are the main source of the sodium Canadians consume, as they make up over 70% of average daily sodium intake. • Only about 15% of our sodium intake comes from salt added during cooking or at the table. • Unprocessed whole foods such as fruits, vegetables and fresh cuts of meat contain very little sodium. The sodium “naturally” present in foods accounts for only 10-15% of our daily intake. Adapted from the Canadian Stoke Network, www.sodium101.ca

An understatement is to call the outcomes of these intervention trials “disappointing”. Cochrane recently summarized 67 trials of antioxidant nutrients with 232,550 participants collectively (Bjelakovic 2008). The reviewers found a 16% increased risk in all cause death from vitamin A supplementation (RR 1.16, 95% CI 1.10 to 1.24), a 7% increased risk in all cause death from beta carotene supplementation (RR 1.07, 95% CI 1.02-1.11), and a 4% increased risk in all cause death from vitamin E supplementation (RR 1.04, 95% CI 0.94-1.20). The mechanistic basis upon which oxidant stress contributes to initiation and progression of heart disease and cancer remains sound. So what accounts for the lack of benefit, and marked detriment, from intervention with this selection of antioxidant nutrients? The concept of biomarker was quickly identified. Plasma determination of any one antioxidant nutrient does a poor job of providing insight into the biological impact of that specific nutrient. Instead, plasma determination of an antioxidant serves as an accurate biomarker of exposure to fruit and vegetables. The collective conscious of nutritional scientists was quick to incorporate this important fact in interpretation of relevant evidence moving forward, and what has emerged is a new era of research into whole foods and intervention trials focused on diet modification as opposed to single nutrient intervention. Modern trials that intervene with diet counseling have come to rely on plasma determination of beta carotene for an important task; serving as an accurate marker of fruit and vegetable intake, assessment of plasma beta carotene objectively confirms compliance or lack thereof with diet instructions of the trial. A simple example is the use of beta carotene assessment by WHEL investigators, an intervention trial in 3088 breast cancer survivors with a mean follow- up of 7.3 years examining the impact of diet and lifestyle counseling on cancer- free survival, invasive breast cancer events, and all cause mortality (Pierce 2007).

Is Sodium a Biomarker? Very little sodium occurs naturally in foods, and it is widely recognized that processed foods are the major source of sodium in the Standard American Diet (SAD). In addition to sodium chloride, table salt, sodium may be added to food as the flavour enhancer monosodium glutamate, sodium benzoate, sodium bicarbonate, sodium citrate, sodium nitrite, and sodium acid pyrophosphate (Fischer 2009). The Canadian Stroke Network’s website www.sodium101.ca states that over 70% of dietary sodium comes from processed foods (Figure 1). In view of the beta carotene experience, the undeniable link between sodium intake and risk of death, and the fact that upwards of 70% of dietary sodium originates from processed foods, we posit that sodium intake may in fact function as a biomarker of the effect of processed foods. Since processed foods represent by far the predominant source of dietary sodium, the link between sodium intake and risk of death in these population studies may actually represent the relationship between intake of processed foods and death/ disease. Besides sodium, processed foods contain several other harmful substances such as nitrates,

Figure 2. Relative Contributions to Daily Dietary Sodium Intake

77% - Processed and restaurant foods 12% - Naturally Occurring 6% - While eating 5% - Home cooking Source: Center for Disease Control, Salt: Sodium and Food Sources, 2010. Adapted from: Mattes, RD, Donnelly, D. Relative contributions of dietary sodium sources. Journal of the American College of Nutrition. 1991 Aug;10(4):383-393.

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Table 1. Sodium content of processed versus non-processed foods Description

Sodium Content (mmol/100g)

Beef

Topside, roast, lean and fat

2.1

Corned beef, canned

41.3

Bran, wheat

1.2

Bran flakes

43.5

Hard cheese, average

27.0

Processed cheese

57.4

Dried, boiled in unsalted water

0.2

Canned, re-heated, drained

9.6

Boiled

16.1

Canned

23.6

Cod, in batter, fried in blended oil

4.3

Fish fingers, fried in blended oil

15.2

Raw, boiled in unsalted water

0.4

Canned, re-heated, drained

10.9

Plain

0.1

Dry-roasted

34.3

Roasted and salted

17.4

Raw, boiled in unsalted water

Trace

Canned, re-heated, drained

10.9

Homemade, fried in blended oil

0.5

Oven chips, frozen, baked

2.3

Raw, steamed

4.8

Canned

24.8

Smoked

81.7

On-the-cob, whole, boiled in unsalted water

Trace

Kernels, canned, reheated, drained

11.7

Raw

2.0

Canned in oil, drained

12.6

Canned in brine, drainted

13.9

Bran

Cheese

Chick peas

Crab

Cod

New potatoes

Peanuts

Peas

Potato chips (fries)

Salmon

Sweet corn

Tuna

saturated and trans fats, (sodium) benzoate, MSG, many other preservatives and flavoring agents, as well as possible byproducts of processing that are as yet unidentified. Processed foods are also typically quite calorie-dense, thus promoting obesity and its health consequences. Furthermore, high intake of processed foods is typically accompanied by low intake of fruit and vegetables, the primary source of dietary potassium, and this may help explain the additional predictive power of sodium: potassium ratio and mortality, as shown in the studies cited above.

Continuing Education Lesson

Food Item

A recent Cochrane review examining the effect of intervention with low-sodium diets lends further support to this hypothesis (Taylor 2011). After pooling seven RCTs including 6489 participants with follow up of between seven months to 12.7 years, Taylor et al found no â&#x20AC;&#x153;strong benefitâ&#x20AC;? from sodium restriction on mortality and cardiovascular morbidity (2011). Among patients who were normotensive, relative risk for all cause mortality at the end of the trial was RR 0.67 (95% CI 0.40-1.12, 60 deaths), and after the longest follow up, risk was RR 0.90 (95% CI 0.58-1.40, 79 deaths). ihpmagazine.com { November/December 2011 IHP | 81

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Continuing Education Lesson

Among hypertensive subjects, risk at the end of trial was RR 0.97 (95% CI 0.83-1.13, 513 deaths), and after the longest follow up, risk was RR 0.96 (95% CI 0.83-1.11, 565 deaths) showing no strong evidence of any effect of salt reduction. Cardiovascular morbidity in people with normal blood pressure or raised blood pressure at baseline showed no strong evidence of benefit from salt restriction. Conversely, salt restriction increased the risk of all-cause death in those with congestive heart failure (end of trial RR 2.59, 95% 1.04-6.44, 21 deaths). Taylor’s paper raised a great deal of controversy. He et al (2011) have argued that the pooled analysis had insufficient statistical power, and that this is the reason for null results. Nonetheless, it raises important questions as to the true role of sodium as an agent of cardiovascular disease.

Exceptions Our hypothesis pertains to the population as a whole. We wish to point out that reduced sodium intake is a critical factor in a subset of hypertensive patients who are sodium-sensitive, as well as in patients with chronic renal disease.

Conclusion There is a well- established link between dietary sodium intake and risk of death, in particular cardiovascular mortality. As illustrated by the beta carotene experience, however, sodium may function as a biomarker rather than as the causative agent. Since the major source of dietary sodium in the Standard American Diet is processed foods, measurement of sodium intake may actually reflect consumption of processed foods and the complex combination of food chemicals and/ byproducts contained therein. We suggest that sodium has been unfairly vilified as an agent of harm, and that in fact harm is due to the complex, disease-promoting constituents of processed foods. References AHA (American Heart Association). 2011 Dietary and Lifestyle Recommendations. Updated 2011. http://www.heart.org/HEARTORG/GettingHealthy/NutritionCenter/HealthyDietGoals/Dictionary-of-Nutrition_UCM_305855_Article.jsp. Accessed 8 October 2011. Bjelakovic G, Nikolova D, Gluud LL, Simonetti RG, Gluud C. Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD007176.

Fischer PW, Vigneault M, Huang R, Arvaniti K, Roach P. Sodium food sources in the Canadian diet. Appl Physiol Nutr Metab. 2009 Oct;34(5):884-92. He J, Ogden LG, Vupputuri S, Bazzano LA, Loria C, Whelton PK. Dietary sodium intake and subsequent risk of cardiovascular disease in overweight adults. JAMA. 1999 Dec 1;282(21):2027-34. He FJ, MacGregor GA. A comprehensive review on salt and health and current experience of worldwide salt reduction programmes. J Hum Hypertens 2009; 23:363 – 384. He FJ, MacGregor GA. Salt reduction lowers cardiovascular risk: meta-analysis of outcome trials. Lancet. 2011 Jul 30;378(9789):380-2. Institute of Medicine (US) Committee on Strategies to Reduce Sodium Intake; Henney JE, Taylor CL, Boon CS, editors. Strategies to Reduce Sodium Intake in the United States. Washington (DC): National Academies Press (US); 2010. Iso H, Shimamoto T, Yokota K, Ohki M, Sankai T, Kudo M, Harada M, Wakabayashi Y, Inagawa M, Kitamura A, Sato S, Imano H, Iida M, Komachi Y. [Changes in 24-hour urinary excretion of sodium and potassium in a community-based heath education program on salt reduction]. Nihon Koshu Eisei Zasshi. 1999 Oct;46(10):894-903. Laatikainen T, Pietinen P, Valsta L, Sundvall J, Reinivuo H, Tuomilehto J. Sodium in the Finnish diet: 20-year trends in urinary sodium excretion among the adult population. Eur J Clin Nutr 2006; 60:965 – 970. Mattes, RD, Donnelly, D. Relative contributions of dietary sodium sources. Journal of the American College of Nutrition. 1991 Aug;10(4):383-393. Nagata C, Takatsuka N, Shimizu N, Shimizu H. Sodium intake and risk of death from stroke in Japanese men and women. Stroke. 2004 Jul;35(7):1543-7. Ni Mhurchu C, Capelin C, Dunford EK, Webster JL, Neal BC, Jebb SA. Sodium content of processed foods in the United Kingdom: analysis of 44,000 foods purchased by 21,000 households. Am J Clin Nutr. 2011 Mar;93(3):594-600. Pierce JP, Natarajan L, Caan BJ, Parker BA, Greenberg ER, Flatt SW, Rock CL, Kealey S, Al-Delaimy WK, Bardwell WA, Carlson RW, Emond JA, Faerber S, Gold EB, Hajek RA, Hollenbach K, Jones LA, Karanja N, Madlensky L, Marshall J, Newman VA, Ritenbaugh C, Thomson CA, Wasserman L, Stefanick ML. Influence of a diet very high in vegetables, fruit, and fiber and low in fat on prognosis following treatment for breast cancer: the Women’s Healthy Eating and Living (WHEL) randomized trial. JAMA. 2007 Jul 18;298(3):289-98. Puska P, Vartiainen E, Tuomilehto J, Salomaa V, Nissinen A. Changes in premature deaths in Finland: successful long-term prevention of cardiovascular diseases. Bull World Health Organization 1998; 76:419–425. Ross R. The pathogenesis of atherosclerosis: a perspective for the 1990s. Nature. 1993 Apr 29;362(6423):801-9. Stahelin HB, Gey KF, Eichholzer M, Ludin E, Bernasconi F, Thurneysen J, Brubacher G. Plasma antioxidant vitamins and subsequent cancer mortality in the 12-year follow-up of the prospective Basel Study. Am J Epidemiol. 1991 Apr 15;133(8):766-75. Strazzullo P, D’Elia L, Kandala NB, Cappuccio FP. Salt intake, stroke, and cardiovascular disease: meta-analysis of prospective studies. BMJ. 2009 Nov 24;339:b4567. Takachi R, Inoue M, Shimazu T, Sasazuki S, Ishihara J, Sawada N, Yamaji T, Iwasaki M, Iso H, Tsubono Y, Tsugane S; Japan Public Health Center-based Prospective Study Group. Consumption of sodium and salted foods in relation to cancer and cardiovascular disease: the Japan Public Health Center-based Prospective Study. Am J Clin Nutr. 2010 Feb;91(2):456-64. Taylor RS, Ashton KE, Moxham T, Hooper L, Ebrahim S. Reduced dietary salt for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD009217. Umesawa M, Iso H, Date C, Yamamoto A, Toyoshima H, Watanabe Y, Kikuchi S, Koizumi A, Kondo T, Inaba Y, Tanabe N, Tamakoshi A; JACC Study Group. Relations between dietary sodium and potassium intakes and mortality from cardiovascular disease: the Japan Collaborative Cohort Study for Evaluation of Cancer Risks. Am J Clin Nutr. 2008 Jul;88(1):195-202. Van Vliet BN, Campbell NR; Canadian Hypertension Education Program. Efforts to reduce sodium intake in Canada: why, what, and when? Can J Cardiol. 2011 Jul-Aug;27(4):437-45. Webster JL, Dunford EK, Hawkes C, Neal BC. Salt reduction initiatives around the world. J Hypertens. 2011 Jun;29(6):1043-50.

Brown IJ, Tzoulaki I, Candeias V, Elliott P. Salt intakes around the world: implications for public health. Int J Epidemiol. 2009 Jun;38(3):791-813.

WASH (World Action on Salt and Health). Evidence: Population Studies http:// www.worldactiononsalt.com. Accessed 8 October 2011.

Cerutti PA, Trump BF. Inflammation and oxidative stress in carcinogenesis. Cancer Cells. 1991 Jan;3(1):1-7.

Yang Q , Liu T, Kuklina EV, Flanders WD, Hong Y, Gillespie C, Chang MH, Gwinn M, Dowling N, Khoury MJ, Hu FB. Sodium and potassium intake and mortality among US adults: prospective data from the Third National Health and Nutrition Examination Survey. Arch Intern Med. 2011 Jul 11;171(13):1183-91.

CDC (Center for Disease Control). Salt: Sodium and Food Sources. Updated 10 February 2010. http://www.cdc.gov/salt/food.htm Accessed 8 October 2011.

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1) Sodium has been linked to increased risk of several chronic disease. Several national and international initiatives have been implemented to reduce intake of sodium at a population level. Achievements include: a. European initiative in 19 countries that achieved the reduced sodium content of key foods by up to 25%; b. A comprehensive lifestyle and diet program in Finland incorporated sodium reduction as one of its goals, achieving 65% reductions in cardiovascular mortality; c. A Japanese program that has been attributed with a 80% reduction in mortality; d. All of the above 2) Current sodium recommendations for healthy individuals are set at 1500 mg per day. a. True b. False 3) The following is true about the large NHANES III population based cohort study: a. Higher sodium intake was associated with 20% increased risk of all-cause mortality per every 1000 mg/d increase; b. Higher potassium intake was also associated with higher mortality risk c. Higher sodium-potassium intake ratio compared to the lowest quartile had an 80% increased risk of death; d. All of the above 4) The first NHANES study found that among overweight persons 100 mmol higher sodium intake was associated with: a. 32% increase in stroke incidence; b. 89% increase in stroke mortality; c. 39% increase in death from all causes; d. All of the above 5) Strazzulloâ&#x20AC;&#x2122;s meta analysis found the following overall results: a. Higher salt intake was associated with significantly increased risk of stroke (23%); b. Higher salt intake was assoicated with significantly increased risk of cardiovascular disease (14%); c. Higher salt intake was associated with significantly increased risk of chronic renal disease (21%); d. A and B

6) The Basel study was a landmark study in antioxidant research. It found that individuals with the lowest quintile of plasma beta carotene were at a 60% increased risk of developing cancer relative to individuals with the highest plasma beta carotene. a. True b. False 7) After several unsuccessful intervention trials using antioxidants for the prevention of cancer and cardiovascular disease, scientists realized: a. The oxidative stress hypothesis as a cause of chronic disease was false. b. The true value of an antioxidant should be determined through in vitro assays such as ORAC; c. Plasma determination of an antioxidant serves as an accurate biomarker of exposure to fruit and vegetables; d. A and C 8) Over 70% of dietary sodium in the standard American diet comes from processed foods. a. True b. False 9) In addition to table salt, sodium may be added to food as: a. Monosodium glutamate b. Sodium bicarbonate c. Sodium benzoate d. Sodium acid pyrophosphate e. All of the above

Continuing Education Lesson

Questions

10) Since processed foods represent by far the predominant source of dietary sodium, sodium may actually be acting as a biomarker of other harmful substances in processed foods. These include: a. Nitrates; b. Saturated and trans fats; c. As yet unidentified byproducts of processing; d. Deficiency of fruits and vegetables; e. All of the above

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Uses For Probiotic 50B G.I. Health: Probiotics have been shown to promote healthy cytokine production in the colon and maintain healthy GI barrier function, in part by supporting intestinal epithelial integrity. Several trials have also revealed that mixed probiotic supplementation helps maintain intestinal flora, support healthy yeast balance, and promote GI comfort. Immune Cell Function: Clinical studies indicate that Lactobacilli and Bifidobacteria supplementation supports healthy immune response and inflammatory balance. Probiotics may enhance B cell, T cell and NK cell function, phagocytic capacity and activity, and healthy cytokine production.

What Is The Source? Lactobacillus plantarum (Lp-115), Lactobacillus acidophilus (DDS-1), Lactobacillus rhamnosus (Lr-32), Bifidobacterium lactis (Bl-04) and Bifidobacterium longum (Bl-05) are grown on a dairy-free soy-free medium. Pure Encapsulations probiotic products contain a unique form of rice starch produced through a natural enzymatic process. This proprietary starch has been extensively tested and is added to protect the viability of the probiotic organisms. Gellan gum is derived from Pseudomonas elodea.

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Calendar Events

November November 17–20 Firstline Therapy Course Organized by: Metagenics Inc. New York, New York For more information, visit http://www. metagenics.com November 17 Interventions for Individuals at Risk for Suicide - Current Progress and Future Possibilities Organized by: Family and Community Medicine, University of Toronto Toronto, Ontario For more information, visit http://events. cepdtoronto.ca/website/index/PSR1128 November 18-20 OAND Convention & Tradeshow Organized by: Ontario Association of Naturopathic Doctors Toronto, Ontario For more information, visit www.oand.org November 18-20 Cranio-Sacral Therapy II Organized by: Bastyr University Kenmore, Washington For more information, visit http://www. bastyr.edu/continuinged/calendar.asp November 19-20 and December 3-4 Birth Doula Skills Workshop Organized by: Simkin Center for Allied Birth Vocations Kenmore, Washington For more information, visit http://www. seattlemidwifery.org/simkin-school/ simkin-schedule.html November 20 Endothelial Cell Pathology in the Context of Cardiovascular Disease Organized by: Boucher Institute of Naturopathic Medicine New Westminster, British Columbia For more information, visit http://binmce. org/calendar

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November 26-27 American Heart Association’s Cardiovascular Life Support Course Organized by: Boucher Institute of Naturopathic Medicine New Westminster, British Columbia For more information, visit http://binmce. org/calendar November 26-27 Integrative Health Strategies and Contemporary Acupuncture for Stress and Women’s Health Problems Organized by: McMaster University Hamilton, Ontario For more information, visit www. contemporaryacupuncture.com November 27 Pathology and Lab Refresher Series: Women’s Reproductive System Organized by: Boucher Institute of Naturopathic Medicine New Westminster, British Columbia For more information, visit http://binmce. org/calendar Nov 29 BDDT-N Record Keeping Course Organized by: BDDT-N Toronto, Ontario For more information, visit http://www. boardofnaturopathicmedicine.on.ca/ events.html

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How does BIO-FEN PLUSTM work?

Specific compounds within the herbal extracts inhibit the 5-alpha-reductase (and therefore reduce DHT) to prevent or slow down the rate of hair loss. This process is the principle by which the prescription drugs such as Propecia (finasteride) work. However, BIO-FEN PLUSTM also contains additional compounds which remove excess cholesterol and testosterone – the building blocks of DHT. BIO-FEN PLUSTM also contains vitamins to increase blood flow to the small capillaries that feed the hair roots, to deliver the active herbal compounds and remove waste. Therefore, BIO-FEN PLUSTM provides a natural, safer alternative to expensive drugs, and/or expensive & painful hair transplants.

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December 9-10 Heart & Stroke Clinical Update Organized by: Heart & Stroke Foundation of Canada Toronto, Ontario For more information, visit http://www. heartandstroke.on.ca/ December 10 Pharmacy Workshops: 101 Steroidal Anti-inflammatory Drugs Organized by: Boucher Institute of Naturopathic Medicine New Westminster, British Columbia For more information, visit http://binmce. org/calendar

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greens+ bone builder Product Monograph

Change in Protein Thiols (%)

Ophelia please update header and product names. Use bold lower case to match the brand. GREENS+ BUILDER 2007). Among white populations, 50% of women and 20% of Osteoporosis affects one in three women and one in eight men over the age BONE of 50 (Tarantino, Ophelia please update header and product names. Usewhite bold lower case to match the brand. Osteoporosis affects in three women and aone in eight men over the age of 50 (Tarantino, Among of women andrestricted 20% of men 50 yearsloss and of older men 50 years andone older will experience fragility fracture in their remaining lifetime 2007). (Sambrook, 2006). populations, Sequelae of50% fracture include mobility, GREENS+ BONE BUILDER will experience a fragility fracture in their remaining (Sambrook, 2006). Sequelae fracture include restricted mobility, loss Recent of independence, and marked increased in that independence, and marked increased in risk oflifetime death within a year following hip of fracture (10-20%) (Sambrook, 2006). studies have shown, however, oneininfact three women (10-20%) and eight menfemoral over theRecent age ofstudies 50 (Tarantino, 2007). Among white populations, 50% ofremodelling women 20% the of men risk of Osteoporosis death withindrugs aaffects year may following hipincrease fracture (Sambrook, 2006). havebecause shown, however, that bisphosphonate in factand increase risk 50 of years and older bisphosphonate the one risk in of atypical fractures, in part these drugs inhibit normaldrugs bonemay (Rizzoli 2011). experience a fragility fracture these in their remaining lifetimebone (Sambrook, 2006). Sequelae of fracture include restricted mobility, loss of independence, and marked increased in atypicalwill femoral fractures, in part because drugs inhibit normal remodelling (Rizzoli 2011). risk bone of death within combines a year following hip fracture (10-20%) (Sambrook, 2006).rich Recent studies have shown, however, thatwith bisphosphonate drugs may fact increase the risk of greens+ builder the health benefits of a greens concentrate in phytonutrients and antioxidants essential vitamins andinminerals specific atypical femoral fractures, in health part because inhibit normal bone remodelling 2011).forumulation Greens+ Bone Builder combines the benefitsthese of a drugs greens concentrate rich in phytonutrients and complete antioxidants with essentialincreased vitamins and minerals specific capacity to bone health. A to bone health. A recent randomized, double blind, placebo controlled trial found that (Rizzoli this serum antioxidant (p<0.05), recent randomized,cellular double protein blind, placebo controlled trial (p<0.05) found thatperoxidation this complete among forumulation increased serum antioxidant capacity (p<0.05), and1). decreased cellular proteinis a and decreased (p<0.001) and lipid 60 post-menopausal women (Kang 2011) (Figure Since osteoporosis (p<0.001) and lipid (p<0.05) among 60(Zhang post-menopausal women (Kang rich 2011) 1). Since osteoporosis is awith chronic disease mediated oxidative stress (Zhang Greens+ Bone Builderperoxidation combines the health benefits of a greens concentrate in (Figure phytonutrients and antioxidants essential vitamins andbyminerals specific to bone health. A chronic disease mediated by oxidative stress 2011), this antioxidant effect is a crucial component to modifying the disease course. In addition, greens+ 2011), this antioxidant effect is a crucial component to modifying the disease course. In addition, Greens+increased Bone Builder contains a complete array of vitamins and minerals thatin protein randomized, blind,array placebo controlled trialminerals found that this complete forumulation antioxidant capacity (p<0.05), and decreased cellular bone recent builder contains adouble complete of vitamins and that have been scientifically shown toserum benefit bone health; an evidence summary is listed have shown to benefit bone health; an evidence summary is listed in (Kang Table 1. (p<0.001) and lipid (p<0.05) peroxidation among 60 post-menopausal women 2011) (Figure 1). Since osteoporosis is a chronic disease mediated by oxidative stress (Zhang Tablebeen 1. scientifically 2011), this antioxidant effect is a crucial component to modifying the disease course. In addition, Greens+ Bone Builder contains a complete array of vitamins and minerals that scientifically shown benefit bone health; an evidence is listed in Table 1. Figurehave 1. a)been Effect of Greens+ BonetoBuilder on lipid peroxidation andsummary b) protein oxidation. Figure 1. a) Effect ofof Greens+ Bone Builder on lipid peroxidation and b) protein oxidation. Table 1: Summary Relevant Human Studies

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Calcium + 1: VitSummary D; 27+19of controlled demonstrating benefit to BMD Table Relevanthuman Humantrials Studies 500mgDose calcium + Double-blind of calcium supplement BMD of treatment group from 1.101 at baseline to 1.111 g/cm2 at 30 months; Di Daniele Ref Studycontrolled design & trial description Effect and magnitude of effect 200 IU Vitamin D versus placebo in 120 women over a 30 month BMD of placebo group decreased from 1.102 at baseline to 1.098 g/cm2 at 30 2004 Calcium + Vit treatment D; 27+19period. controlled human trials demonstrating benefit to BMD months. 500mg calcium + Double-blind controlled trial of calcium supplement BMD of treatment group from 1.101 at baseline to 1.111 g/cm2 at 30 months; 800mg calcium Double blinded controlled trial of 63 postmenopausal L2-L4 bone density: no change during calcium treatment (+ 1.03% after two Ruml 1999 Di Daniele D versus placebo of placebo group decreased from 1.102 at baseline to 1.098 g/cm2 at 30 2004 citrate 200 IU Vitaminwomen over 1-2 years. in 120 women over a 30 month years), butBMD decline of -2.38% on placebo. treatment months. Magnesium; 3 controlled human trialsperiod. showing benefit on bone turnover 800mg Double blinded controlledwomen trial ofand 63 23 postmenopausal L2-L4 bone density: no change during calcium treatment (+21.03% after two 1993 Ruml 1999 250-750mg Mgcalcium31 osteoporotic post-menopausal 71% of magnesium group had 1-8% increases in trabecular BMD over Volpe citrate over butsubjects decline showed of -2.38% on placebo. hydroxide controlswomen receiving Mg1-2 foryears. two years. years. Allyears), treatment increased BMD after 2 years; controlsâ&#x20AC;&#x2122; Magnesium; 3 controlled human trials showing benefit on bone turnover BMD decreased. 250-750mg Mg study suggesting 31 osteoporotic post-menopausal women and 23 71% of magnesium group had 1-8% increases in trabecular BMD over 2 Volpe 1993 Vitamin C; 1 human benefit to BMD hydroxide controls Mg for twocohort years.of years. for Allage, treatment subjects showed BMD after 2 years; controlsâ&#x20AC;&#x2122; Mean daily dose 994 women fromreceiving a community-based After adjusting body mass index (BMI),increased and total calcium intake, Morton was 745mg. whom 277 women were regular vitamin C vitamin CBMD users decreased. had BMD levels approximately 3% higher at the midshaft 2001 supplement users. radius, femoral neck, and total hip. Vitamin C; 1 human study suggesting benefit to BMD Folic Acid, B12, Vitamin B6; 1 controlled human trial showing to bone resorption MeanVitamin daily dose 994 women from a community-based cohort benefit of After adjustingand for BMD age, body mass index (BMI), and total calcium intake, Morton (n=47, 55-82 years)vitamin given aC Vitamin treatment of bone resorption by-13% at 12 at the midshaft 2.5mg was folate, Herrmann 2001 745mg. Osteoporotic whomsubjects 277 women were regular vitamin Cdecreased users hadmarkers BMD levels approximately 3% higher combination of folate, B12, and B6 or placebo. months. In hyperhomocysteinemic 0.5mg Vit B12, 2007 supplement users. radius, femoral neck, and subjects, total hip.B-vitamins increased BMD at the lumbar spine (t-score -2.7 to -1.7), decreased markers of bone 25mg Vit B6Acid, Vitamin B12, Vitamin B6; 1 controlled human trial showing Folic benefit to bone resorption andand BMD by 50%. 2.5mg folate, Osteoporotic subjects (n=47, 55-82 years) given breakdown a Vitamin treatment decreased markers of bone resorption by-13% at 12 Herrmann Boron;0.5mg one controlled trials suggesting benefit calcium Vit B12, human combination of folate, B12,toand B6 or retention placebo. months. In hyperhomocysteinemic subjects, B-vitamins increased BMD at 2007 3 mg Boron In subjects low spine Mg intake, supplemental boron 25mg Vit B6 167 day trial of 11 postmenopausal women given thewith lumbar (t-score -2.7 to -1.7), and decreased decreasedthe markers of bone Hunt 1997 supplements of boron and/ or magnesium. percentage of dietary by calcium breakdown 50%.lost in the urine. Zinc, Copper, Manganese; 1 controlled human trial showing to BMD Boron; one controlled human trials suggesting benefitbenefit to calcium retention 15mg Zn, 5mg randomized to women givenAll groupsInexperienced loss of spinal BMDsupplemental over intervention period 3 mg Boron 59 post-menopausal 167 day trialwomen of 11 postmenopausal subjects with low Mg intake, boron decreased the Strause Hunt 1997 Mn, 2.5mg Cu, either1000mg Ca; 15mg Zn, 5mg 2.5mg Cu; comparedpercentage to baseline,ofexcept forcalcium the Ca+Zn+Cu+Mn, which had an increase 1994 supplements of boron and/Mn, or magnesium. dietary lost in the urine. 1000mg Ca both of the above; or placebo over 2y. in BMD of 1.5%. Zinc, Copper, Manganese; 1 controlled human trial showing benefit to BMD L-lysine; 1 controlled human trial suggesting benefit to BMD 15mg Zn, 5mg 59 post-menopausal women randomized to All groups experienced loss of spinal BMD over intervention period Strause Not specified 40 subjects with senile involutional osteoporosis There was a more marked increase in BMD in subjects treated with arginineAbate 1994 Mn, 2.5mg Cu, either1000mg Ca; 15mg Zn, 5mg Mn, 2.5mg Cu; compared to baseline, except for the Ca+Zn+Cu+Mn, which had an increase 1994 given carbocalcitonin alone or carbocalcitonin lysine-lactose, due to improvement in intestinal calcium absorption mediated 1000mg Ca both of the above; or placebo over 2y. in BMD of 1.5%. association complex, with arginine-lysine-lactose. by lysine. L-lysine; 1 controlled human trial suggesting benefit to BMD Lycopene; 1 human observational study suggesting reduced risk of osteoporosis Not specified 40 subjects with senile involutional osteoporosis There was a more marked increase in BMD in subjects treated with arginineAbate 1994 Range: 1.76 to Cross-sectional study of 33 postmenopausal women Higher serum lycopene was associated with a low NTx, a bone resorption Rao 2007 given carbocalcitonin or carbocalcitonin lysine-lactose, due to improvement in intestinal calcium absorption 7.35 mg/d. aged 50-60 correlating dietary alone lycopene intake to marker. Lycopene reduces bone turnover markers in postmenopausal women, mediated association complex, with arginine-lysine-lactose. by beneficial lysine. in reducing the risk of osteoporosis. blood markers of bone turnover. and may be 1 human observational study suggesting reduced risk of osteoporosis Silicon;Lycopene; animal studies Range: 1.76 to supplementation Cross-sectional studyinvestigated of 33 postmenopausal Higher serum lycopene was associated with a low NTx, a bone resorption The effect of ch-OSA for 30 days on bone losswomen in aged ovariectomized (OVX) rats. Supplementation at 1mg Si/kg significantly Calomme Rao 2007 7.35 aged 50-60 correlating dietary lycopene to and increased marker.the Lycopene bone content turnover(BMC). markers in postmenopausal women, reversed themg/d. decrease in Ca excretion observed after OVX; reduced boneintake turnover; femoral reduces bone mineral 2006 markers of bone turnover. and may be beneficial in reducing the risk of osteoporosis. Selenium; animal studies andblood 1 human observational study studies DietarySilicon; intake animalCase-control study (n=1215) of Se intake and risk of There was 73% decreased risk of hip fracture in the highest selenium intake Zhang 2006 The effect of ch-OSA supplementation loss in (OR aged0.27). ovariectomized (OVX) rats. Supplementation at 1mg Si/kg significantly Calomme osteoporotic hip fracture.for 30 days investigated on bonequintile reversed the decrease in Ca excretion observed after OVX; reduced bone turnover; and increased the femoral bone mineral content (BMC). 2006 References: Selenium; animal and 1 3human observational studyspace? References Ophelia, couldstudies these go into columnw to pick up some Abate G, et al. Minerva Med. 1994 May;85(5):253-9. Prince RL, et al. Arch Intern Med. 2006 Apr 24;166(8):869-75. Prince RL, et al. decreased Arch Internrisk Med. 2006fracture Apr 24;166(8):869-75. Abate G,Dietary et al. Minerva May;85(5):253-9. intake Med. 1994 Case-control study (n=1215) of Se intake and risk of There was 73% of hip in the highest selenium intake Zhang 2006 Calomme M, et al. Calcif Tissue Int. 2006 Apr;78(4):227-32. Rao LG, et al. Osteoporos Int. 2007 Jan;18(1):109-15. Rao LG,(OR et al.0.27). Osteoporos Int. 2007 Jan;18(1):109-15. Calomme M, et al. Calcif Tissueosteoporotic Int. 2006 Apr;78(4):227-32. hip fracture. quintile Dimai HP, et al. J Clin Endocrinol Metab. 1998 Aug;83(8):2742-8. Rizzoli R, et al. Osteoporos Int. 2011 Feb;22(2):373-90. Rizzoli R, et al. Osteoporos Int. 2011 Feb;22(2):373-90. Dimai HP, et al. J Clin Endocrinol Metab. 1998 Aug;83(8):2742-8. Di Daniele N, et al. Pharmacol Res. 2004 Dec;50(6):637-41. Ruml LA, et al. Am J Ther. 1999 Nov;6(6):303-11. Ruml LA, et al. Am J Ther. 1999 Nov;6(6):303-11. Di Daniele N, et al. Pharmacol Res. 2004 Dec;50(6):637-41. References Ophelia, could these go into 3 columnw to pick up some space? Sambrook Herrmann M, et al. Clin Chem Lab Med. 2007;45(12):1785-92. P, et al. Lancet. 2006 Jun 17;367(9527):2010-8. SambrookPrince P, et al. Lancet. Jun 17;367(9527):2010-8. Herrmann M,G, et al. Clin Chem Lab Med. 2007;45(12):1785-92. RL, et al. 2006 Arch Intern Med. 2006 Apr 24;166(8):869-75. Abate et al. Minerva Med. 1994 May;85(5):253-9. Hunt CD, et al. Am J Clin Nutr. 1997 Mar;65(3):803-13. Strause L, et al. J Nutr. 1994 Jul;124(7):1060-4. Strause L, et al.LG, J Nutr. Jul;124(7):1060-4. Hunt CD, et al. Am 1997 Mar;65(3):803-13. et al.1994 Osteoporos Int. 2007 Jan;18(1):109-15. Calomme M,JetClin al. Nutr. CalcifSan Tissue Int.Sept 20062011. Apr;78(4):227-32. Kang N, et al. ASBMR Meeting, Diego, Tarantino U,Rao et al. Magnes Res. 1993 Sep;6(3):291-6. Tarantino U, et al.R, Magnes Res. 1993 Sep;6(3):291-6. Kang N, et al. ASBMR San Diego, Sept 2011. et al. Osteoporos 2011 Feb;22(2):373-90. al. Meeting, J Miner Clin Endocrinol Metab. 1998 Aug;83(8):2742-8. MortonDimai DJ, etHP, al. JetBone Res. 2001 Jan;16(1):135-40. Zhang J, etRizzoli al. Am J Epidemiol. 2006 JanInt. 1;163(1):9-17. Zhang J, et al. Am J Epidemiol. Jan 1;163(1):9-17. MortonDi DJ, et al. J N, Bone Miner Res. 2001 al. Am J 2006 Ther. 1999 Nov;6(6):303-11. Daniele et al. Pharmacol Res.Jan;16(1):135-40. 2004 Dec;50(6):637-41. Zhang YB, Ruml et al. JLA, SurgetRes. 2011 Jul;169(1):e37-4. Sambrook P, et al. Lancet. 2006 Jun 17;367(9527):2010-8. Herrmann M, et al. Clin Chem Lab Med. 2007;45(12):1785-92. Strause L, et al. J Nutr. 1994 Jul;124(7):1060-4. Hunt CD, et al. Am J Clin Nutr. 1997 Mar;65(3):803-13. Tarantino U, et al. Magnes Res. 1993 Sep;6(3):291-6. Kang N, et al. ASBMR Meeting, San Diego, Sept 2011. Zhang J, et al. Am J Epidemiol. 2006 Jan 1;163(1):9-17. Morton DJ, et al. J Bone Miner Res. 2001 Jan;16(1):135-40.

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Prostate SAP

Science-based support for prostate health The average male will experience a concern with their prostate at some point during their lifetime. The condition known as benign prostatic hypertrophy (BPH) becomes increasing prevalent in men as they age, with 50% of men experiencing BPH by the age of 60, and 90% of men by the age of 85.(1) This condition can cause a multitude of symptoms including difficulty starting the flow of urine, discomfort with urination, increased risk of urinary tract infections due to urine stagnation in the bladder, which may potentially lead to kidney damage.(2) BPH can interfere with activities of daily living and have a serious impact in a male’s life. Several herbs and nutrients have been studied that demonstrate the ability to prevent and treat BPH, and in many cases eliminate symptoms entirely.(3, 5) Prostate cancer will affect 1 in 7 men in their lifetime and is the most common form of cancer detected in males.(19)

ACTIVE INGREDIENTS

Each capsule contains: Certified organic borage oil (Borago officinalis) . . . . . . . . . . . . . 280 mg Certified organic pumpkin seed oil (Cucurbita pepo) . . . . . . . . 200 mg Saw palmetto (Serenoa repens fruit liposterolic extract) . . . . . . . . . . . . . . . . . . . . 185 mg Stinging nettle extract (Urtica dioica) . . . . . . . . . . . . . . . . . . . . . . . . 120 mg Rye flower pollen extracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 mg Free plant sterols (from Glycine max) . . . . . . . . . . . . . . . . . . . . . . . . 100 mg Providing 40 mg beta-sitosterol, 20 mg campesterol and 20 mg stigmasterol Cranberry (Vaccinium macrocarpon) (4.5% proanthocyanidins) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mg Mixed tocopherol concentrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37.5 mg Vitamin B6 (pyridoxal 5-phosphate). . . . . . . . . . . . . . . . . . . . . . . . . . . 25 mg Tomato extract (Solanum lycopersicum) (10% lycopene). . . . . . . . 15 mg Zinc (from zinc citrate). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 mg Selenium (from selenomethionine) . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mcg Non-medicinal ingredients: Certified organic extra virgin olive oil (100 mg) in a shell made of glycerin, purified water and gelatin. Contains no: Preservatives, artificial flavour or colour, sugar, dairy, starch, wheat, gluten, yeast, citrus or egg.

ADULT DOSAGE

Take 1 softgel twice daily or as directed by your health care practitioner. Take with food to minimize gastric disturbance. Take a few hours before or after taking other medications.

INDICATION

Prostate SAP is targeted as treatment and preventative therapy for any male over the age of 40 to help maintain a healthy prostate and urinary tract system. Prostate SAP can be used to help reduce benign prostatic hypertrophy. Prostate SAP may also be protective against the development of prostate cancer.(12)

Scientific Advisory Panel (SAP): adding nutraceutical research to achieve optimum health

PURITY AND STABILITY

Third-party testing is performed on the finished product to ensure Prostate SAP is free of heavy metals, solvents, pesticides and other impurities.

Nutritional Fundamentals for Health • 3405 F.-X.-Tessier, Vaudreuil, QC J7V 5V5 • Tel. 1 866 510 3123 • Fax. 1 866 510 3130 • www.nfh.ca

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Prostate SAP PRODUCT MONOGRAPH

Lower urinary tract symptoms, benign prostate hypertrophy (BPH), bladder outlet obstruction and prostate cancer have become increasingly common in the aging male population.(4) BPH affects more than 90% of men by the time they reach 90 years of age.(1) The precise cause of BPH has not yet to be determined but inflammation does play a pivotal role and is the target of many pharmaceuticals designed to treat BPH.(3) Growth of the prostate gland is controlled by the endocrine system, but the precise way each hormone affects the prostate gland is not well understood. During puberty, testosterone is thought to act to enlarge the prostate, but as men age their testosterone levels decline, and this is when the prostate growth often becomes problematic. There is some thought that the ratio between free testosterone and estrogen contributes to prostate enlargement, but this has not to date been demonstrated in the literature. There are several natural compounds that have demonstrated the ability to reduce symptoms caused by BPH.

SAW PALMETTO (Serenoa repens)

Saw palmetto is one of the most common herbs used for the treatment of lower urinary tract symptoms in males due to BPH. Researchers have determined that saw palmetto has several different mechanisms of action including the inhibition of 5‑alpha‑reductase, as well as anti‑androgenic, anti‑proliferative and anti‑inflammatory effects.(5) Two active components of saw palmetto are oleic and lauric acids: It has been demonstrated that they bind to alpha(1) adrenergic, muscarinic and 1,4‑DHP receptors and have the ability to inhibit 5‑alpha‑reductase.(5) These mechanisms may lead to the therapeutic effect seen in cases of BPH that result in fewer urinary‑tract symptoms.(5)

A review article exploring the efficacy of saw palmetto compared to placebo for urinary tract symptoms in men found that there was a statistically significant improvement in urinary flow and urinary symptom scores in subjects using saw palmetto.(6) Researchers concluded that saw palmetto was a well‑tolerated treatment that provided mild to moderate improvement in urinary symptoms and flow.(6) The efficacy of saw palmetto was also compared to finasteride, a commonly prescribed pharmaceutical for BPH, and was found to have similar improvements in urinary symptom scores with fewer adverse effects.(6) Research has also been conducted exploring the role of saw palmetto in prostate cancer. Saw palmetto has been found to have the ability to selectively induce apoptosis in prostate cancer cells through the intrinsic pathway, via activation of the mitochondrial permeability transition pore.(7)

PUMPKIN SEED OIL (Cucurbita pepo)

A double‑blind, placebo‑controlled study was performed over a 12 month period with patients who had BPH with an international prostate symptom score over 88. The international prostate symptom score measures quality of life, serum prostate‑specific antigen, prostate volume and maximal urinary flow rate. The groups receiving 320 mg/day of pumpkin seed oil (group B), 320 mg/day saw palmetto (group C) and the group receiving both (group D) all demonstrated an improvement in their score by 3 months.(8) Group D was the only group that had a reduction in serum PSA levels after 3 months.(8) The results of this trial indicated that pumpkin seed oil and saw palmetto oil are clinically safe and may be an effective treatment for BPH, particularly in combination.(8)

RYE FLOWER POLLEN EXTRACT

Clinically, rye flower pollen extract has been shown to improve symptoms of BPH. Testing exploring the mechanism of action has found that rye flower pollen most likely exhibits its positive effects by inhibiting cyclo‑oxygenase and the 5‑lipoxygenase activity resulting in an anti‑inflammatory effect.(9) The fat‑soluble portion of rye flower pollen also has effects on prostaglandins and leukotrienes and therefore may also have an antiproliferative effect, but this requires further research to be confirmed.(9)

STINGING NETTLE (Urtica dioica)

A double blind, placebo‑controlled study exploring the use of stinging nettle for BPH was conducted using 620 patients.(10) Following the 6‑month trial, 81% of patients in the stinging nettle group reported an improvement in lower urinary tract symptoms compared to 16% of controls.(10) The treatment group had an average improvement in their international prostate symptom score from 19.8 to 11.8 compared to a change of 19.2 to 17.7 in the placebo group.(10) Peak flow rates improved on average by 8.2 mL/s in the treatment group compared to 3.4 mL/s in the placebo group.(10) No change was observed in serum PSA or testosterone in either group. There were also no side effects identified in either group.(10) This study’s authors concluded that symptomatic BPH could have beneficial effects from treatment with stinging nettle.(10)

FREE PLANT STEROLS

Plant sterols or phytosterols may be beneficial for the treatment of abacterial prostatitis.(11) A

study found that the proliferation of chronic prostatitis was decreased in the group receiving phytosterols. Researchers found that phytosterols were able to reduce serum levels of IL‑1β and TNF‑α, and also reduced the expression of prostate COX‑2 and 5‑LOX.(11) The results demonstrated that phytosterols have a positive therapeutic effect on abacterial prostatitis.(11)

LYCOPENE

There are several pathways that have been identified as playing a role the development of prostate cancer.(12) Free radicals produced from inflammatory processes can potentially lead to oxidative DNA damage, which if unrepaired can become mutagenic.(12) The cytokines IL‑6 and IL‑4 as well as growth factor signaling pathways have all been identified

For more information visit: www.nfh.ca

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as contributors to prostate growth.(12) Lycopene modulates several of these pathways; it can reduce inflammatory signals, prevent oxidative damage and modulate the activity of androgen signaling and the growth factor axis. These are likely the mechanisms that result in cell growth inhibition and apoptosis that are seen with the use of lycopene.(12)

BORAGE OIL (Borago officinalis)

The omega‑6 fatty acid, gamma‑linolenic acid (GLA), found in borage oil has been shown to suppress tumor growth in vitro.(13) Researchers then tested the use of dietary GLA in rats with prostatic adenocarcinomas. Results revealed that the group of rats receiving the GLA had a decrease in prostate growth compared to controls. The control group was also found to have a significant increase in 5‑hydroxyeicosatetraenoic acid and prostaglandin E2 compared to the treatment group.(13) The researchers concluded that a GLA‑enriched diet reduces prostate cancer development in rats and could serve as a non‑toxic adjunctive treatment for human prostate cancer.(13)

ZINC CITRATE

The prostate gland usually contains a high concentration of zinc; however, levels are dramatically reduced in cases of prostate cancer.(14) Researchers explored the antiproliferative effects of zinc in BPH cells as well as in prostate cancer cells.(14) Both prostate cancer cells and BPH cells were treated with zinc and cell growth, viability and apoptosis were examined.(14) The BPH cells were found to be more sensitive to the antiproliferative effects of zinc when compared to the prostate cancer cells.(14) The variation in response to zinc in the prostate cancer and BPH cells does suggest that zinc may play an important role in the regulation of both cell growth and apoptosis in hyperplastic and prostate cancer cells.(14)

SELENIUM AND VITAMIN E

Selenium can play an important role in prostate health, as it helps to maximize the activity of glutathione peroxidase and is a powerful antioxidant in the body.(15) A trial using healthy middle‑aged men taking 200 µg of selenium for 6 weeks found that supplementation raised the activity of both erythrocyte and plasma glutathione peroxidase and lowered values of plasma prostate‑specific antigen.(15) This effect was not seen in the placebo treatment group. The study indicates that the average male in the US does not consume an adequate amount of selenium in their diet.(15) In a separate study researchers looked at a deficiency of trace elements and the link to PSA values.(16) Results showed that serum selenium, zinc and vitamin E were significantly lower in the prostate cancer patients.(16) Researchers concluded that a deficiency of vitamin E, zinc and selenium may be risk factors for the development of prostate cancer.(16)

VITAMIN B6 (PYRIDOXAL-5-PHOSPHATE)

Researchers have found that vitamin B6 deficiency results in a significant increase in the uptake of testosterone by the prostate gland.(17) This suggests that B6 has a function in the action of testosterone and potentially other steroid hormones whereby it either reduces the rate of synthesis of testosterone or increases the metabolic clearance.(17) This may play an important role in the health of the male prostate gland.

CRANBERRY EXTRACT (Vaccinium macrocarpon)

Cranberries are a fruit rich in phytochemicals and polyphenolic compounds. Flavonoids have been shown to induce apoptosis in human prostate tumor cells.(18) Researchers found that the induction of apoptosis in cells occurred with treatment of whole cranberry through caspase‑8–mediated cleavage of Bid protein.(18) These findings indicate that cranberry phytochemicals can induce apoptosis in prostate cancer cells in vitro, so further research is warranted to examine the role of cranberry as an anti‑prostate cancer agent.(18) Prostate health is concern for all men. Supplementation of these herbs and nutrients in combination may aid in the protection the prostate gland from developing BPH or prostate cancer and can be used as a treatment for symptoms of BPH.

REFERENCES 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19.

WebMD http://www.webmd.com/prostate-cancer/enlarged-prostate • Viewed Jan 14, 2011 Merck Manual Online. http://www.merckmanuals.com/home/sec21/ch239/ch239b.html • Viewed Jan 14, 2011 Bonvissuto, G., L. Minutoli, G. Morgia, et al. “Effect of Serenoa repens, lycopene, and selenium on proinflammatory phenotype activation: an in vitro and in vivo comparison study”. Urology 77, No. 1 (2011): 248.e9–16. Roehrborn, C.G. “Male lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH)”. The Medical clinics of North America 95, No. 1 (2011): 87–100. Abe, M., Y. Ito, A. Suzuki, et al. “Isolation and pharmacological characterization of fatty acids from saw palmetto extract”. Analytical sciences 25, No. 4 (2009): 553–557. Tacklind, J., R. MacDonald, I. Rutks, and T.J. Wilts. “Serenoa repens for benign prostatic hyperplasia”. Cochrane Database Systematic Reviews 2 (2009): CD001423. Baron, A., M. Mancini, E. Caldwell, et al. “Serenoa repens extract targets mitochondria and activates the intrinsic apoptotic pathway in human prostate cancer cells”. BJU International 103, No. 9 (2009): 1275–1283. Hong H, Kim CS, Maeng S. “Effects of pumpkin seed oil and saw palmetto oil in Korean men with symptomatic benign prostatic hyperplasia”. Nutrition Research And Practice 3, No. 4 (2009): 323–327. Loschen, G. and L. Ebeling. “Inhibition of arachidonic acid cascade by extract of rye pollen”. Arzneimittel-Forschung 41, No. 2 (1991): 162–167. Safarinejad, M.R. “Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebocontrolled, crossover study”. Journal of herbal pharmacotherapy 5, No. 4 (2005): 1–11. Shi, H., L. Cheng, X. Zheng, and L. Tu. “Study of effects and mechanism of phytosterols on chronic abacterial prostatitis”. Zhongguo Zhong Yao Za Zhi 35, No. 22 (2010): 3033–3037. Wertz, K. “Lycopene effects contributing to prostate health”. Nutrition and cancer 61, No. 6 (2009): 775–783. Pham, H., K. Vang, and V.A. Ziboh. “Dietary gamma-linolenate attenuates tumor growth in a rodent model of prostatic adenocarcinoma via suppression of elevated generation of PGE(2) and 5S-HETE”. Prostaglandins, leukotrienes, and essential fatty acids 74, No. 4 (2006): 271–282. Yan, M., K. Hardin, and E. Ho. “Differential response to zinc-induced apoptosis in benign prostate hyperplasia and prostate cancer cells”. The Journal of nutritional biochemistry 21, No. 8 (2010): 687–694. Zhang, W., E. Joseph, C. Hitchcock, and R.A. DiSilvestro. “Selenium glycinate supplementation increases blood glutathione peroxidase activities and decreases prostate-specific antigen readings in middle-aged US men”. Nutrition research (New York, N.Y.) 31, No. 2 (2011): 165–168. Adaramoye, O.A., O. Akinloye, and I.K. Olatunji. “Trace elements and vitamin E status in Nigerian patients with prostate cancer”. African health sciences 10, No. 1 (2010): 2–8. Symes, E.K., D.A. Bender, J.F. Bowden, and W.F. Coulson. “Increased target tissue uptake of, and sensitivity to, testosterone in the vitamin B6-deficient rat”. Journal of steroid biochemistry 20, No. 5 (1984): 1089–1093. MacLean, M.A., B.E. Scott, B.A. Deziel, et al. “North American cranberry (Vaccinium macrocarpon) stimulates apoptotic pathways in DU145 human prostate cancer cells in vitro”. Nutrition and cancer 63, No. 1 (2011): 109–120. http://www.cancer.ca/Canada • Viewed May 19, 2011

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Research-proven to build stronger bones - naturally Are your patients looking for a natural alternative to bisphosphonate drugs? Recommend greens+ bone builder, a research-proven formula.

greens+ bone builder’s unique formula: • Is proven to positively influence bone-forming cells (osteoblasts) and stimulate bone mineralization1 • Contains proven bone-building nutrients including Lycopene, Magnesium, Vitamin D, Copper and Manganese2 • Provides highly absorbable3 forms of Calcium, including Calcium formate, citrate-malate and bisglycinate • Provides naturally occurring Vitamin K, critical for proper Calcium absorption • Increases overall health and energy4 Just one serving daily helps build and protect bones for reduced risk for osteoporosis, while increasing overall health and energy.

Also available in convenient bone builder capsules and tablets. Learn more about greens+ bone builder, including its research-proven ingredients and formula. Go to: www.genuinehealth.com

The Bone-Building Solution by Sam Grac with Dr. Carolyn DeMarco MD and Dr. Leticia Rao PhD.

DA I LY E S S E N TI AL S 1. Dr. Leticia Rao, et al. University of Toronto. 2. Rao, et al. J Med Food 2003; Tucker. Curr Pharm Des 2003; Holick M. Mayo Clin Proc 2006; Branca and Valtunena. Public Health Nutr 2001. 3. Graci, et al. The Bone-Building Solution 2006. 4. Canadian Journal of Dietetic Practice and Research 2004;65(2):66-71. 5. Kang N, et al. ASBMR Meeting, San Diego, Sept 2011 Abstract #MO0448

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Our Total Quality Obligation guarantees your satisfaction – or your money back. 1 877 500-7888 www.genuinehealth.com

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