IHP Magazine - April 2012

IHP APRIL/MAY 2012 | $14.95 PUBLICATIONS MAIL 40678000 | 60 BLOOR STREET WEST SUITE 1106 | TORONTO ONTARIO, M4W 3B8

Saturated Fat

Automated Breast Ultrasound

Low Back Pain in Pregnancy

By William R Ware, PhD

By Chris Habib, ND and Tina Ureten, MD, RDMS, RDCS

By Jennifer Nash, DC

EXCL US

Dr. Richard Nahas, MD

IVE!

Seekers Centre for Integrative Medicine

Continuing Education: Antiviral effects of Green Tea

By Elizabeth Cherevaty, ND

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Support For the maintenance of good health,1 maintains cardiovascular health2 and helps support cognitive and brain function.3 Also supports the development of the brain, eyes and nerves in children up to 12 years old.4 Help to promote healthy mood balance and reduce serum triglycerides.5

2,800-3,000 mg EPA + DHA per day containing a ratio of EPA:DHA between 0.5:1 and 2:1, in conjunction with conventional therapy, helps to reduce the pain of rheumatoid arthritis in adults.6 Note: Combined EPA + DHA levels should not exceed 3,000 mg/day unless otherwise directed by your healthcare practitioner.

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1. Health Canada. Natural Health Product Monograph - Fish Oil, 2009. [internet] [Accessed February 22, 2012]. Available at: http:// www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_fish_oil_huile_poisson-eng.php.

2. Health Canada 2009.

3. Health Canada 2009.

4. Health Canada 2009.

5. Health Canada 2009.

6. Health Canada 2009.

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2,800-3,000 mg EPA + DHA per day containing a ratio of EPA:DHA between 0.5:1 and 2:1, in conjunction with conventional therapy, helps to reduce the pain of rheumatoid arthritis in adults.8 Note: Combined EPA + DHA levels should not exceed 3,000 mg/day unless otherwise directed by a healthcare practitioner.

Parts per million (ppm)

PC

Bs

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Note: Includes congeners PCB 28, PCB 52, PCB101, PCB 138 and PCB 180.

Heavy Metal Test Maximum Allowable Limit

0.10 0.08 0.06 0.04

Seroyal Results

0.02

≤0.01

≤0.01

≤0.01

Le ad

Co nt en t

0.00 Co nt en t

Help to promote healthy mood balance and reduce serum triglycerides.7

Seroyal Results ≤0.015

0.02

iu m

For the maintenance of good health,3 maintains cardiovascular health4 and helps support cognitive and brain function.5 Also supports the development of the brain, eyes and nerves in children up to 12 years old.6

0.04

Ca dm

1 capsule (800mg EPA + DHA)

0.06

yC on te nt

Support

Maximum Allowable Limit

0.08

er cu r

Amount

0.10

M

Cardiovascular and neurological support

Polychlorinated Biphenyls (PCBs) Test

Parts per million (ppm)

Omega 800 is a unique blend of fish oils from sardine and anchovy to specifically assist in promoting healthy mood balance and to maintain overall cardiovascular health in reducing high serum triglycerides/triacylglycerols levels.2 Omega 800 is naturally flavoured with essential oil of orange and does not have a fishy aftertaste.

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Pesticides Test - FDA PAM 304 Multi-Residue Screen 0.5 Parts per million (ppm)

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Typical Seroyal Sardine & Anchovy Oil Analysis

Maximum Allowable Limit

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Seroyal Results ≤0.01 DD T

0.0

1. NHPD Monograph on Fish Oil. March 2009.

2. NHPD Monograph on Fish Oil. March 2009.

3. Health Canada. Natural Health Product Monograph - Fish Oil, 2009. [internet] [Accessed February 22, 2012].

Available at: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_fish_oil_huile_poisson-eng.php.

4. Health Canada 2009.

5. Health Canada 2009.

6. Health Canada 2009.

7. Health Canada 2009.

8. Health Canada 2009.

This information is for practitioner use only and is not meant to diagnose, treat, cure, prevent any disease or replace traditional treatment, and has not been evaluated by Health Canada.

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Note: Multiple pesticides are tested (only DDT is shown).

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4/5/12 2:09:22 PM

PUBLISHERS LETTER

Natural Health Products Directorate A gentler hand...

As many of you may be aware, the austerity measures of Canada’s government directly impact the operations of the Natural Health Products Directorate (NHPD). As a result, Health Canada has said it will ease up the process for companies requesting NPN’s. Is this good or bad for the industry?

As frustrated as companies have been over the past seven years trying to meet NHPD requirements for receiving NPN’s, I have witnessed the process transform the natural health products industry in Canada. Practitioners across Canada and internationally have a heightened respect and trust for the current state of the market in Canada, and seem to view it as an example that should be copied globally.

I am hopeful that the changes to occur at the NHPD do not see a return of the industry to what I call “the wild west”, where companies felt free to make claims of quality and efficacy that were unfounded.

The NHPD forced the industry to pay much more attention to concepts of safety and efficacy. In doing so companies became much more interested in the science behind their products. The result may have forced top quality products to become a bit pricier, but a more educated public is seeking such evidence-based products and is willing to pay for them.

Practitioners in Canada need to be the leaders in the evolution of the industry towards more science-based offerings. How often do practitioners contact the companies they dispense and demand confirmation of quality assurance information? What percentage of “professional” combination products have research on the specific offering? It really is a simple formula... If the practitioners demand the information, the industry will provide it... If the practitioners select research proven products, the industry will conduct more research.

SJagota­

www.facebook.com/IHPMag

www.twitter.com/IHPMag TM

Photograph by Scott Jordan

Sanjiv Jagota Publisher

4 | IHP April/May 2012 } ihpmagazine.com

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ISSN 1920-4302 | APRIL/MAY 2012 Volume 5 • Issue 2

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 | Robert Murdoch Art Intern | Stacey Rosenblum Contributors Angela MacNeil, MSc, ND Christopher Habib, ND Michael Heitsu, OAND Director of Policy Christopher Knee, MSc, ND (Cand.)

Esther Konigsberg, MD Jennifer V. Nash, DC Philip Rouchotas, MSc, ND Tina I. Ureten, MD, RDMS, RDCS William R. Ware, PhD

President | Olivier Felicio - ext. 6107

Cal-Mag + 1000 IU Vitamin D3 Liquid answers the needs of many practitioners who have been seeking a highly efficacious calcium, magnesium, Vitamin D3 combination that is easy to administer to many patient sub-populations.

Controller & Operations | Melanie Seth - ext. 6114 Finance Administrator | Henry Fonseca Advertising Information Sanjiv Jagota Telephone: (416) 203-7900 ext 6125 Email: sanjiv@ihpmagazine.com

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Circulation Garth Atkinson | Publication Partners 345 Kingston Rd., Suite 101 Pickering, Ontario, L1V 1A1 Telephone: 1-877-547-2246 Fax: 905-509-0735 Email: ihp@publicationpartners.com 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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AOR Curcumin - Product Monograph Exclusively available in Canada by AOR Curcumin: not turmeric! Curcumin is one of three curcuminoids found in turmeric root. Turmeric root generally contains less than 2% curcumin. While 95% curcumin products are far better therapeutically, curcumin is renowned for being poorly absorbed, and therefore large amounts need to be consumed in order to achieve therapeutic benefits.

One three-month study on patients with potentially cancerous lesions attempted to determine a toxicity threshold for curcumin (Cheng et al., 2001). Patients could not tolerate 12g/day of curcumin only because of the bulky dosing, but good compliance, safety and tolerability were observed with up to 8g of regular curcumin. Another dose-escalating study found trace amounts of curcumin in the blood with 10g and 12g with no toxicity symptoms (Lao et al., 2006). A toxicity level for curcumin has still not been defined, but we know that very high doses have been used with few side effects.

Although many different high-bioavailability curcumin products are now available to the natural health industry, the clinical studies behind Longvida® curcumin by far show the most promising results. Longvida® curcumin is a patented brand of curcumin developed by the University of California and is available exclusively in Canada from AOR. The clinical studies behind Longvida® are compelling and the results are extraordinary.

Longvida® curcumin demonstrated at least a 100-fold increase in bioavailability compared to regular curcumin (Gota et al., 2010). This safety study reported no adverse events to a maximal dose of 1200mg of Longvida® curcumin, the same dose provided in 9 capsules of Curcumin Active, in both healthy volunteers and patients with osteosarcoma. The results of this study were significant relief of pain and inflammation and improved quality of life and sense of well-being.

Curcumin has been seen as a very promising compound in the treatment and prevention of Alzheimer’s disease, based on in vitro work, but bioavailability problems have prevented clinical application (extensively reviewed in Belkacemi et al. 2011). The incredible increase in bioavailability of Longvida® curcumin compared to normal curcumin has made it possible to study the effect of curcumin on Alzheimer s disease in vivo. A human study using the equivalent of 400-600mg of Longvida® curcumin on Alzheimer s patients is underway (Belkacemi et al., 2011). A completed study that has not yet been published led by Dr. DiSilvestro at the University of Ohio found increased beta-amyloid clearance in Alzheimer s patients after only 1 month at a dose of 80mg of Longvida® curcumin! Imagine the potential results of longer-term supplementation!

Turmeric vs. Curcumin vs. Curcumin Active Turmeric root supplements absolutely do not offer the same benefits as those containing isolated curcumin. Curcumin is the most potent component of the turmeric root. Unfortunately, turmeric root contains less than 2% of curcumin making it ineffective for any health benefits. In addition, over 95% of all clinical studies have been conducted using isolated curcumin and NOT with turmeric root. Even 750mg of a 10:1 ratio extract of turmeric will deliver no more than 150mg of the active curcumin. One study found only trace amounts of curcumin in the blood in a dose-escalating study of up to 12g of pure curcumin (Lao et al., 2006). This means that in order to achieve trace amounts in the blood which can then transport the curcumin to the target site for therapeutic effect, more than 12g need to be consumed.

Curcumin s benefits have been promising in numerous in vitro studies, but its lack of bioavailability has veiled its efficacy as a nutraceutical. Over the last ten years there has been much research to develop formulations that can deliver more of the active ingredient curcumin without resorting to large doses that patients have difficulty complying with. Curcumin Active is based on the results of this extensive research and delivers the most highly bioavailable curcumin supplement on the market: Longvida® Curcumin – with the latest research showing a greater than 100-fold increase in bioavailability compared to traditional curcumin supplements. Just one capsule of Curcumin Active delivers an effective dose of curcumin, the equivalent of over 13g of 95% extract (Gota et al., 2010). This would require taking 30 capsules of regular 95% curcumin extract, or more than 100 capsules of 750mg turmeric root extract!

Bioavailability Mechanism Longvida Curcumin® consists of Solid Lipid Particles™ (SLP) which are tiny nano-sized (1 billionth of a meter) particles that have a protective layer providing a phenomenal increase in stability, potency and effectiveness. Unlike regular curcumin that is easily broken down by the basic pH of the intestines, these solid lipid curcumin particles are resistant to breakdown. What is even more important is the fact that these tiny particles are absorbed very rapidly through the intestinal lining thanks to the protective layer. Once they are absorbed, the particle coating protects the curcumin from phase II detoxification processes, which usually eliminates curcumin and other “foreign” particles quickly from the body; this is the fate of regular curcumin and turmeric supplements. Finally, the tiny size of the nanoparticle allows it to be taken up into the body’s cells quickly to be put to use. This means that they deliver all of the health benefits of curcumin, including pain relief, reduced inflammation, antioxidant properties and other effects much more efficiently than any other curcumin product.

In the study that showed a 100-fold increase in absorption compared to regular curcumin, plasma curcumin concentrations did not appear to follow the same dose-dependent curve for all individuals (Gota et al., 2010); this may indicate a range of effective dosing that is dependent on individual biochemistry and physiology. Curcumin Active dosing suggests 9 capsules per day, however this is a maximum, and results can be seen with a much smaller dosage. The Alzheimer’s study mentioned above used less than the equivalent of one capsule of Curcumin Active per day.

Therapeutic Potentials Curcumin is well known for its anti-inflammatory and pain relieving properties, which are well supported by clinical studies. These studies have shown that curcumin is highly effective for improving joint mobility and for reducing stiffness, swelling and pain. Inflammation is gaining recognition for being at the root of most degenerative conditions, and NF-κB signaling is becoming notorious for inducing most inflammation-related processes in the human body. Curcumin’s main mechanism of action as an anti-inflammatory is through modulating NFκB signaling. Studies have found positive results when examining curcumin and NF-κB in human tendon cells (Buhrmann et al., 2011), diabetic mice (Yekollu et al., 2011), and rats with autoimmune myocarditis (Mito et al., 2011).

Additional recent studies have found that curcumin may be beneficial in inhibiting HIV-1 replication (Gandapu et al., 2011), protecting the liver in chronic liver disease (Bischt et al., 2011), and there is even interest in its therapeutic potential for MS (Xie et al., 2011). As mentioned above, curcumin has an emerging potential in clearing beta-amyloid plaque from the brain in Alzheimer’s patients. Curcumin is also a potent antioxidant and anti-microbial, and is cardioprotective. Still, the abundance of research points towards curcumin’s therapeutic potential in cancer, where it has been found to inhibit TNF-α, angiogenesis, metastasis, encourage cancer cell apoptosis and shrink tumors in some patients, help prevent relapse, and it has been used as adjunct therapy with radiation and certain forms of chemotherapy.

Curcumin Active is Safe & Effective Curcumin is therapeutically beneficial in many degenerative diseases. Longvida® curcumin has a phenomenal safety profile in both healthy individuals as well as in fragile populations such as cancer patients. Curcumin Active by AOR delivers a high dose of Longvida® curcumin, the most bioavailable curcumin on the market that is efficient in relieving pain and inflammation and protective against inflammatory-based conditions.

References: Begum AN, Jones MR, Lim GP, Morihara T, Kim P, Heath DD, et al. Curcumin structure-function, bioavailability, and efficacy in models of neuroinflammation and Alzheimer’s disease. J Pharmacol Exp Ther. 2008 Jul;326(1):196-208.

Frautschy, SA et al. Omega 3 DHA and a bioavailable curcumin formulation synergize for Alzheimer prevention. 39th Annual Meeting of the Society of Neuroscience , Chicago, IL October 2009.

Belkacemi, A, Doggui S, Dao L, Ramassamy C. Challenges associated with curcumin therapy in Alzheimer disease. Expet Rev Mol Med. 2011 Nov; 13(e34):1-15.

Frautschy, SA et al. Efficacy of Longvida® in relation to systemic availability in the brain. 39th Annual Meeting of the Society of Neuroscience , Chicago, IL October 2009.

Bisht S, Khan MA, Bekhit M, Bai H, Cornish T, Mizuma M, et al. A polymeric nanoparticle formulation of curcumin (NanoCurc™) ameliorates CCl4-induced hepatic injury and fibrosis through reduction of pro-inflammatory cytokines and stellate cell activation. Lab Invest. 2011 Sep;91(9):1383-95.

Gandapu U, Chaitanya RK, Kishore G, Reddy RC, Kondapi AK. Curcumin-loaded apotransferrin nanoparticles provide efficient cellular uptake and effectively inhibit HIV-1 replication in vitro.

PLoS One. 2011 6(8):e23388.

Buhrmann C, Mobasheri A, Busch F, Aldinger C, Stahlmann R, Montaseri A, Shakibaei M. Curcumin modulates nuclear factor kappaB (NF-kappaB)-mediated inflammation in human tenocytes in vitro: role of the phosphatidylinositol 3-kinase/Akt pathway. J Biol Chem. 2011 Aug 12;286(32):28556-66.

Cheng AL, Hsu CH, Lin JK, Hsu MM, Ho YF, Shen TS, et al. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. Anticancer Res. 2001 Jul-Aug;21(4B):2895-900.

Dadhaniya P, Patel C, Muchhara J, Bhadja N, Mathuria N, Vachhani K, Soni MG. Safety assessment of a solid lipid curcumin particle preparation: acute and subchronic toxicity studies.

Food Chem Toxicol. 2011 Aug;49(8):1834-42.

Frautschy, SA. Bioavailability, brain concentrations, activity and dose-response of Longvida® SLCP. 38th Annual Meeting of the Society of Neuroscience , Washington DC, November 15, 2008.

IHPAPR2012_9493_AOR_Curcumin_Active_FP.indd 2

Gota VS, Maru GB, Soni TG, Gandhi TR, Kochar N, Agarwal MG. Safety and pharmacokinetics of a solid lipid curcumin particle formulation in osteosarcoma patients and healthy volunteers. J Agric Food Chem. 2010 Feb 24;58(4):2095-9.

Lao CD, Ruffin MT, Normolle D, Heath DD, Murray SI, Bailey JM et al. Dose escalation of a curcuminoid formulation. BMC Complement Altern Med. 2006 Mar 17;6:10.

Mito S, Watanabe K, Harima M, Thandavarayan RA, Veeraveedu PT, Sukumaran V, et al.

Curcumin ameliorates cardiac inflammation in rats with autoimmune myocarditis. Biol Pharm Bull. 2011 34(7):974-9.

Xie L, Li XK, Takahara S. Curcumin has bright prospects for the treatment of multiple sclerosis. Int Immunopharmacol. 2011 Mar;11(3):323-30.

Yekollu SK, Thomas R, O’Sullivan B. Targeting curcusomes to inflammatory dendritic cells inhibits NF-κB and improves insulin resistance in obese mice. Diabetes. 2011 Nov;60(11):2928-38.

4/5/12 1:09:36 PM

February 27, 2012

LETTER TO THE EDITOR Integrated Healthcare Practitioners Magazine 60 Bloor Street West, Suite 1106 FebruaryON 27, 2012 Toronto, M4W 3B8 Dear Sir, Re: Letter to the Editor On behalf ofHealthcare the transitional Council of the College of Naturopaths of Ontario, it is my pleasure to submit Integrated Practitioners Magazine this Letter to the Editor to provide clarity and transparency surrounding the transition of the profession of 60 Bloor Street West, Suite 1106 naturopathic medicine in Ontario from the current Drugless Practitioners Act (DPA) to the Registered Toronto, ON M4W 3B8 Health Professions Act, 1991 (RHPA). In particular I would like to clarify several of the inaccuracies in the editorial by the Editor-in-Chief contained in the February/March 2012 edition of Integrated Healthcare Dear Sir, Practitioner.

Re: Letter to the Editor The RHPA continues to be a model of self-governance that other jurisdictions seek to follow across the country. Within the RHPA and the Naturopathy Act, 2007, there are statutory obligations to regulate the On behalf of the transitional Council of the College of Naturopaths of Ontario, it is my pleasure to submit profession of the naturopathy in the public Section 3(2) of the Health Code, this Letter to Editor to provide clarityinterest. and transparency surrounding theProfessions transition of Procedural the profession of

In carrying out its objects, the College has a duty to serve naturopathic medicine in Ontario from the current Drugless Practitioners Act (DPA) to the Registeredand

While public protection is the objective of the current DPA model, it does not Health Professions Act, 1991 (RHPA). In particular I would like to clarify several of the inaccuracies in the contain robust set of publiccontained protectioninmechanisms that are 2012 outlined as requirements the RHPA. editorialthe by the Editor-in-Chief the February/March edition of Integratedwithin Healthcare This means that the members of the transitional Council and its Committees must make decisions that Practitioner. serve the public interest - placing patient interest above professional interests. Public protection is protecting from and disrespect, from poor quality from sexualthe The RHPAindividuals continues from to beharm, a model of dishonesty self-governance that other jurisdictions seek care, to follow across abuse, from breach of laws and from ineffective care. country. Within the RHPA and the Naturopathy Act, 2007, there are statutory obligations to regulate the profession of naturopathy in the public interest. Section 3(2) of the Health Professions Procedural Code, Within the RHPA framework the scope of practice of the has been practised Ontario

In carrying out profession its objects,as theit College has a duty toinserve and has been maintained and in fact expanded in some areas.

While public protection is the objective of the current DPA model, it does not

contain the robust set of public protection mechanisms that are outlined as requirements within the RHPA. The is comprised of membersCouncil of the naturopathic profession This transitional means thatCouncil the members of the transitional and its Committees must(which makecurrently decisionsincludes that one PT certified ND) in addition to representatives from the general public, all of whom are appointed by serve the public interest - placing patient interest above professional interests. Public protection is the Lieutenant Governor in Council. They are responsible for establishing the College of Naturopaths of protecting individuals from harm, from dishonesty and disrespect, from poor quality care, from sexual Ontario to allow for the self-regulation of Naturopathic Doctors within the framework of the RHPA and the abuse, from breach of laws and from ineffective care.

Naturopathy Act, 2007. Irrespective of whether they come from the profession or the public, Council members expected to develop policies, guidelines, and addition in to Ontario making Within theare RHPA framework the scope of practice of thestandards profession asregulations it has beeninpractised decisions that are consistent with the legislative framework to ensure that the public receives safe, ethical has been maintained and in fact expanded in some areas. and competent naturopathic care from qualified individuals. To be perfectly clear, the transitional Council as a body has no decision making authority to appoint, re-appoint or remove a member of the Council.

The transitional Council is comprised of members of the naturopathic profession (which currently includes one PT certified ND) in addition to representatives from the general public, all of whom are appointed by If you, or any person, areininterested putting name forward for consideration of appointment to aof the Lieutenant Governor Council. in They are your responsible for establishing the College of Naturopaths provincial agency, board or commission, including the transitional Council of the College of Naturopaths Ontario to allow for the self-regulation of Naturopathic Doctors within the framework of the RHPA and the of Ontario, submit an application to the Public Appointments Secretariat (PAS) via their website at Naturopathy Act, 2007.

Irrespective of whether they come from the profession or the public, Council www.pas.gov.on.ca. members are expected to develop policies, guidelines, standards and regulations in addition to making decisions are consistent with the legislative framework that that the public receives safe, ethical There hasthat been a great deal of information circulated about to theensure decisions the transitional Council has and competent naturopathic care from qualified individuals.

To be perfectly clear, the transitional Council th made and their impact upon163 theQueen profession.

The transitional Council recommends that members of the Street East, 4 Floor, Toronto,ON M5A 1S1 as a body has no decision authority to appoint, re-appoint or remove member of the Council. profession ensure they are making fully informed prior to making any assumptions or acoming to any conclusions.

To assist members of the profession and all stakeholders, a series of Fact Sheets as well as the draft If you, or anyand person, are interested in putting your forward for consideration of on appointment to a Regulations the Submission Overviews sent to name the Ministry have been published the transitional provincial agency, board or commission, including the transitional Council of the College of Naturopaths Council website located at www.collegeofnaturopaths.on.ca. I also invite you to contact us directly with of Ontario, submit application the Public Appointments Secretariat (PAS) via their website at your questions andan comments at to info@collegeofnaturopaths.on.ca. www.pas.gov.on.ca.

Sincerely, th

163 Queen Street East, 4 Floor, Toronto,ON M5A 1S1

Mary-Ellen McKenna, ND President transitional Council of the College of Naturopaths of Ontario 10 | IHP April/May 2012 } ihpmagazine.com

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EDITORS LETTER

Editors reply to the transition Counsel of the College of Naturopaths of Ontario The clarification from transitional Council is appreciated, though it does not address the fundamental concerns expressed in my editorial in the February/March edition of IHP.

I don’t think you will find any Naturopathic Doctors who disagree with the transitional Council acting in the public interest. The needed debate is about what the real public interest is. If I had one question, it would be this – what is the public interest in leaving Ontario as one of the most restrictive places to practice? My patients want me to be able to use all my skills and training in providing safe and effective medicine. Your Letter to the Editor outlines six aspects of public protection. I feel one important aspect that is potentially being overlooked is the mandate to protect the public from ineffective care. Restricting naturopathic doctors from the ability to practice to their full scope and training fails to protect the public from ineffective care.

I do acknowledge that there are many positive aspects to moving under the Naturopathy Act, and there will be a time to focus on these later. Right now, though, the sense of urgency in my editorial is about the importance of getting the new rules right.

Providing the profession of naturopathic medicine the opportunity to meet with Transition Counsel members on March 31, 2012 was an appreciated action. Sadly, Counsel waited until after their draft regulations were submitted for review by the government to address the profession in any organized fashion. I, and I am confident the other 200 ND’s in the room, would have felt their views are being heard and at least considered had we been paid the respect of a consultation prior to submission of the draft regulations.

I thank Counsel for taking the time to submit their Letter to the Editor, and hope that moving forward Counsel considers more frequent, and timely, consultation with the profession. Over 1000 welleducated, passionate people, who devote their lives to public safety, interest, and wellbeing, are eager to help you in the immense undertaking of drafting the laws of our profession.

Best regards,

Philip Rouchotas, MSc, ND Editor-in-Chief

hotas

uc P Ro

We invite questions or comments. philip@ihpmagazine.com

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My Life. My Own.

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My life is defined by my heart and mind. They are my most prized possessions, quite literally. That means I do my best to keep them healthy. Omega3s help maintain cardiovascular health and help focus, concentration and mental acuity. So taking a supplement tailored to my needs makes more sense than leaving it to chance.

Progressive OmegEssential Fish Oil is made with select ingredients from nature, balanced by a real naturopathic doctor for my needs.

I want to keep my heart and mind working well for a long time, so I treat them right.

For details, write #104 on Free Info Page, page 92.

My Progressive.

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IHPFEB2012_Omega_BodyPlus_OmegEssential_FP_Monograph REV02.pdf

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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.

These inhibitors is arearesponsible for relieving associated with hereditary Progressive OmegEssential™ high potency blend ofsymptoms cold water, wild caught, purifiedAGA. fish oil along with a family of strategic support One of the primary causes of hair loss is a high level of the male hormone dihydrotestosterone (DHT) within the hair follicle (Vierhapper, 2001). nutrients.

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 of the Maintenance of Good Health which binds to the receptor five-fold more avidly than the parent compound (Sinclair 1998). conversion 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 function and cardiovascular health (NHPD Monograph: Fish Oil).

Fontani, et al (2005) conducted a study to evaluate the effect of omega-3 supplementation on cognitive performance in 33 normal healthy men and women (aged 22 – 51 years) during a 35-day period. Tests involving different types of attention were used, along with the Profile of Mood States (POMS). Results showed a mood profile with increased vigour and reduced anger, anxiety and depression states after omega-3.

Furthermore, findings indicated that omega-3 supplementation is associated with an improvement of attentional and physiological functions, particularly those involved in complex cortical processing.

Higher consumption of fish and omega-3 fatty acids has been associated with a lower risk of coronary heart disease (CHD). Hu, et al (2002) examined the association between fish and omega-3 fatty acid consumption and risk of CHD in women. Dietary consumption and follow-up data from 84,688 female nurses (aged 34 to 59 years) free from cardiovascular disease and cancer were compared from validated questionnaires. The outcomes indicated that women who consumed more fish and fish oil (omega-3 fatty acids) significantly reduced their risk of heart disease (particularly CHD deaths) by 30%, compared to women who rarely ate fish.

Similarly, a prospective, nested case-control analysis was performed among apparently healthy men, who had no evidence of prior heart disease by Albert, et al (2002) to address the hypothesis that long-chain omega-3 fatty acids found in fish are associated with a reduced risk of sudden death from cardiac causes. The fatty-acid composition of whole blood in 184 men was compared with the previously collected blood of 94 men, in whom sudden death occurred as the first manifestation of cardiovascular disease. The study reported that men who consumed long-chain omega-3 fatty acids had a significantly reduced risk of sudden death.

Dosage Indication: Fish Oil Supplement. Helps support cardiovascular health, brain function and healthy mood balance.

Adults ( 19 years) Dosage Softgels: Take 2 softgels with breakfast and 2 softgel with dinner for a total of 4 softgels per day.

Liquid: Take 1 tsp (5ml) daily with food.

Interactions Omega-3 fatty acids may increase the risk of bleeding when taken with anticoagulants, aspirin, ginkgo biloba or ginseng (Mason, 2001).

Therefore, medical supervision is required.

Based on human studies, fish oils may lower blood pressure when taken in certain doses and have additive effects in patients treated with anti-hypertensives (Prisco, et al, 1998). Use with caution.

Quality Assurance Parameter Microbial Total Count Yeast & Mold Escherichia coli Salmonella spp Staphylococcus aureus Heavy Metal Arsenic Cadmium Lead Total Mercury

References Test

Specifications

USP USP USP USP USP

Less than 1,000 cfu/g Less than 100 cfu/g Negative Negative Negative

USEPA USEPA USEPA USEPA

Less than 0.25 ppm Less than 0.25 ppm Less than 0.25 ppm Less than 0.25 ppm

Albert C, et al (2002). Blood Levels of Long-Chain n-3 Fatty Acids and the Risk of Sudden Death. The New England Journal of Medicine, Vol. 346 No. 15: 1113-1118, April 11.

Fontani G, et al (2005). Cognitive and physiological effects of Omega-3 polyunsaturated fatty acid supplementation in healthy subjects. European Journal of Clinical Investigation, 35: 691-699.

Hu F, et al (2002). Fish and Omega-3 Fatty Acid Intake and Risk of Coronary Heart Disease in Women. The Journal of the American Medical Association, Vol. 287 No. 14, April 10.

Jellin JM, et al (2006). Pharmacist’s Letter/Prescriber’s Letter th Natural Medicines Comprehensive Database.8 ed. Stockton, CA: Therapeutic Research Faculty.

Mason P. Dietary Supplements. 2nd ed. London: Pharmaceutical Press; 2001.

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

Prisco D, et al (1998). Effect of medium-term supplementation with a moderate dose of n-3 polyunsaturated fatty acids on blood pressure in mild hypertensive patients. Thromb Res. 1:105-12.

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CONTENTS

44

contents APR IL/MAY 2012 VOLUME 5 – ISSUE 2

ARTICLES 44. Cover Story: Dr. Richard Nahas, MD

Seekers Centre for Integrative Medicine

52. Clinic Profile: Fredericton Naturopathic Clinic 56. Company Profile: Metagenics The Metagenics Difference

FEATURES 58. Automated Breast Ultrasound (ABUS)

Making Mammography Obsolete

63. Low Back Pain and Pelvic Girdle Pain in Pregnancy

Assessment and management

68. Saturated Fat

Friend, foe, or simply neutral

74. Cold-Fx

A review of evidence

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CONTENTS

68

COMING NEXT Issue

• Iron in the pathogenesis of Parkinson’s Disease • Chronic venous insufficiencymanagement strategies • Endocrine disruptors in the environment- impact to human health?

52 departments 4. Publisher’s Letter 11. Editor’s Letter 18. Invited Commentary 21. Peer Review Board 25. Research News 34. Industry News 41. Product Profiles 82. Continuing Education: Green Tea

25

Antiviral Effects

90. Calendar/Events

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St. John’s Wort Oil (Hypericum perforatum)...

Macerated in the golden light of the sun.

Dampening the Deeper Pain of Skin Wounds and Injuries Analgesic

Anti-neuralgic

Anti-inflammatory

Vulnerary

INGREDIENTS: Fresh, Sun-macerated, Certified Organic St. John’s Wort (Hypericum perforatum) Certified Organic Gargano Gold® extra-virgin olive oil

Available in Bulk Sizes

Made from the flowering tops of St. John’s Wort sun-macerated in extra-virgin olive oil, this herbal oil has long been regarded as a first-rate topical treatment for burns, bruises, inflammations, haemorrhoids, varicose veins, skin injuries, and muscle pain, not to mention earaches. Called “arnica for the nerves”, the keynote of St. John’s Wort oil is its special usefulness for painful, neuralgic injuries, a feature so evident that it was noted by physicians like Hippocrates and Theophrastus even way back in classical antiquity.

Our St. John’s Wort Oil can be used both internally and externally. While there is much research yet to be done on the therapeutic qualities of this outstanding herbal oil, for the present Health Canada has officially endorsed the following uses: • Traditionally used in Herbal Medicine as an antiseptic and/or antimicrobial to help treat and heal minor skin wounds, cuts, burns and bruises.

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Health Canada Site License 300242

For details, write #105 on Free Info Page, page 92.

…the keynote of St. John’s Wort oil is its special usefulness for painful, neuralgic injuries…

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St. John’s Wort Oil (Hypericum perforatum)

Product Monograph for IHP March 2012

By Terry Vanderheyden, ND

Pain

As naturopathic doctors, we learned that Hypericum perforatum plays the same role for nerve tissues that Arnica montana does for muscle injuries.

St. John’s wort is indeed a potent analgesic. Its topical uses for nerve injuries and inflammation and other painful wounds like burns are well founded.

An in-vivo trial determined that St. John’s wort has “profound analgesic activity”, twice the analgesic effect, in fact, of ibuprofen. Furthermore, in 2004, Bukahri and co-authors determined that, unlike ibuprofen, analgesia resulted from both central and peripheral actions. The herb’s action on peripheral afferent nerves resembled the analgesia effected

by ASA or ibuprofen, whereas its centrally-acting analgesia was more akin to that of the narcotic analgesics. Note that doses of an extract (0.3% Hypericin and 5% Hyperforin) were administered intraperitoneally at 30, 70 and 100 mg per kg. Compared to controls, percentage reduction in pain was highly significant (p<0.001) at all doses tested. Positive control (ibuprofen) was significant (p<0.01) at 100 mg/kg.

St. John’s wort oil is thus ideally suited for neuralgic conditions like sciatica, neuropathy, herpes zoster, and pains or injuries involving nerve-rich areas such as fingers and toes.

Healing Burns and Hemorrhoids, Varicose Veins and Wounds In addition to its analgesic properties, St. John’s wort has also been traditionally used as a vulnerary for wound healing. Hippocrates, Theophrastus, Dioscorides, and Galen all extolled St. John’s wort as an external treatment for burns, hemorrhoids, and skin injuries (Blumenthal et al 2000).

Eclectic physicians like Harvey Wickes Felter M.D. prescribed St. John’s wort oil to treat bruises, contusions, sprains, lacerations, swellings, and ecchymoses (Felter 1922). “St. John’s Wort,” he relates, “is valued by many practitioners as a vulnerary, much as arnica is employed.”

Herbalist David Hoffmann (2003) emphasizes that the externally applied oil speeds the healing of wounds, burns, bruises and varicose veins, adding that, “The oil is especially useful for the healing of sunburn.”

A clinical trial (Lavagna et al. 2001) using a mix of infused oils at a ratio of 70% St. John’s wort and 30% calendula for wound healing after caesarean section found wound-healing time to be almost half that of a control group given wheat germ oil.

Oral and Rectal Use: Ulcers and Inflammatory Bowel Diseases The late Dr. Rudolf Weiss, herbalist and physician (1988), remarks that the oil can be taken orally for stomach ulcers and as a retention enema for inflammatory bowel diseases such as colitis.

Earaches

A clinical trial (Sarell et al) compared ear oil comprised of a mixture of St. John’s wort, mullein, garlic and calendula with a standard anodynal drug preparation for ear pain associated with acute otitis media. The authors found a statistically significant benefit for pain with both treatments, relating that there was no difference of note between groups.

The research team reinforced their findings in another trial conducted two years later.

Contra-indications and Cautions:

Increased photosensitivity has been observed in fair-skinned individuals.

Note that our sun-infused oil is made from fresh flowers. The quality of this superior product is evident in its deep red colour.

For more information, please visit the website at www.stfrancisherbfarm.com.

IHPAPR2012_9272_St_Johns_Wort_Oil_AD_V2_FP.indd 2

Terry Vanderheyden, ND Research Consultant

References: 1. Bukahri IA, Dar A and Khan RA. Antinociceptive Activity of Methanolic Extracts of St. John’s Wort (Hypericum perforatum) Preparation. Pakistan Journal of Pharmaceutical Sciences July 2004; 17(2): 13-19.

2. Mark Blumenthal et al. ed., Expanded Commission E Monographs, Newton, MA: Integrative Medicine Communications, 2000, pp. 359-366.

3. HW Felter, The Eclectic Materia Medica, Pharmacology and Therapeutics, Portland, OR: Eclectic Medical Publications; 1985. Reprinted from original 1922 edition, p. 424.

4. David Hoffmann, Medical Herbalism, Rochester, VT: Healing Arts Press, 2003, p. 559.

5. Lavagna SM et al. Efficacy of Hypericum and Calendula oils in the epithelial reconstruction of surgical wounds in childbirth with caesarean section. Il Farmaco 2001; 56: 365-371.

6. Rudolf Fritz Weiss, Herbal Medicine. 6th edition, Gothenburg (Sweden): AB Arcanum; 1988, p. 296.

7. EM Sarrell et al., “Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media.” Arch Pediatr Adolesc Med. 2001;155(7):796-9.

8. EM Sarrell et al., “Naturopathic Treatment for Ear Pain in Children.” Pediatrics 2003;111;574-9.

Products Professionals Prefer® Contact us today to place an order.

1.866.562.9131 | Fax: 866-353-0427 info@stfrancisherbfarm.com www.stfrancisherbfarm.com

4/5/12 1:46:34 PM

INVITED COMMENTARY

Preparing for a new future of naturopathic medicine in Ontario The process of Transition

By Michael Heitsu, OAND Director of Policy

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INVITED COMMENTARY

Getting the New Rules Right

The Naturopathy Act and a new College for the naturopathic profession in Ontario is about much more than a change in who regulates naturopathic medicine in Ontario. The vision of the profession extending back to the 1980’s, and a major focus for OAND efforts and resources, has been to have a new foundation in legislation that helps to create new opportunities for collaboration, and contributes to the growing respect and understanding of the value of naturopathic medicine.

That is why the naturopathic profession is concerned that the government-appointed Transitional Council is having a challenge in developing the new rules for the profession under the Naturopathy Act. The goal is for these new rules to be approved and the new regulatory College in place by March, 2013.

When Transitional Council consulted on the draft regulations last fall, there was a clear consensus in the profession that the proposed new rules did not properly capture the scope of practice of the profession, and would create barriers to collaboration and integration of NDs that would both impact patient care, and limit the potential contribution of NDs to the healthcare system.

This profession’s view builds on the new scope of the profession in British Columbia. Jason Boxtart ND, the Chair of the Canadian Association of Naturopathic Doctors, said “The CAND supports legislation and regulations that ensure naturopathic doctors can practice to the full extent of their education and training. The professional associations, regulators and educational institutions in Canada, through the Canadian Naturopathic Coordinating Council (Chaired by the CAND) recognize the Scope of Practice and regulations in place in British Columbia as a “national scope of practice” for use in all jurisdictions. The CAND supports the OAND and all other provincial associations in their efforts to obtain effective and appropriate regulations for NDs in line with the BC model.”

Despite a widespread consensus in the profession that the proposed approach would needlessly leave Ontario as one of the most restrictive places to practice naturopathic medicine, Transitional Council chose to make no substantive changes. Council did issue a series of “Fact Sheets” intended to provide a rationale for their recommendations, but these lacked reference to any evidence

about safety or training concerns, impacts on patient care, what is permitted in other jurisdictions, or broader health policy considerations.

The OAND and the profession remain engaged in efforts to work with the Ontario government to help identify needed changes to the draft regulations. At the same time, the OAND remains determined to build a stronger working relationship with Transitional Council, in keeping with best practices for a self-regulating health profession.

Getting transition right creates the potential for NDs to more fully emerge as a primary care profession. Particularly for patients interested in a more natural approach to health, it is important that NDs be able to use all their skills and training like they can in other jurisdictions, and be able to fully take their place as a collaborative and integrated profession.

Why a new foundation?

Ontario’s 1200 Naturopathic Doctors have been regulated since the 1920s under the Drugless Practitioners Act. Being the only health profession outside of the Regulated Health Professions Act has created many barriers to collaboration with other health professions and integration into the health care system. Antiquated legislation also makes it difficult for Ontario NDs to use all their skills and training, and to be able to introduce new therapies that are being safely and effectively used by NDs in places with more modern rules.

The 2007 Naturopathy Act moves the profession into the same regulatory framework as all other professions, and for the first time provides the profession with a clear scope and six controlled acts: diagnosis, prescribing, administering a substance, examinations and treatment beyond the openings of the body, blood draws, and manipulation. The Act also provides patients with proper confidence that there are the same mechanisms as other professions to allow complaints and discipline to be addressed fairly and effectively.

Ultimately, this new foundation recognizes the choice of naturopathic medicine as part of the mainstream of healthcare and provides the basis for more understanding and respect for the profession and practitioners, and helps NDs to more fully emerge as a primary care profession in the eyes of the public. ihpmagazine.com { April/May 2012 IHP | 19

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INVITED COMMENTARY

This new foundation for the profession comes at a time when Ontario’s health care system is facing major challenges.

stomach ulcers (Globe and Mail 2010). In fact drug costs are a particular impact for Ontario, where benefits are some of the most generous in the country (TD Economics 2010).

The growing cost of the health care system is clearly threatening its sustainability. Today, 43% of Ontario revenue is going to health care (Conference Board of Canada 2011). Unless new approaches are taken, health care costs will consume 80% of Ontario spending by 2030, taking resources away from all other provincial priorities (TD Economics 2010).

There is increasing recognition that NDs offer solutions to many of the biggest challenges in health care. The profession has been building awareness that NDs are clinically trained to play a larger role in the delivery of primary care, and to ensure that NDs are recognized for their unique expertise in wellness and addressing preventable risk factors, including chronic diseases.

Little can be done about cost pressures resulting from population growth, inflation, and an aging population. But other cost drivers can be limited through new approaches. Most chronic diseases, from diabetes to cancer, are the product of modifiable health risks.

The enrichment factor, including drug costs, new technologies and changing patients’ expectations can also be shifted (Ontario Ministry of Finance 2010). Changes in these areas are critical to sustaining the health care system.

The care provided by NDs contributes to managing major cost drivers in the public system through several avenues; NDs are experts in addressing prevention and modifiable risk factors, provide patients with alternatives to pharmaceuticals, provide a more personalized approach to medicine that is increasingly in demand, and provide access to primary care in particular for those wanting an alternative to conventional medicine.

NDs and the Health Care System

New Approaches are Needed

Disease prevention is widely recognized as key to savings in the health care system (Toronto Star 2011). 80% of Ontarians over the age of 45 have a chronic disease (Ontario Ministry of Health and Long Term Care 2007). Over a million Ontarians have been diagnosed with diabetes, and this number is expected to increase by more than 60% over the next decade (Canadian Diabetes Association 2010). 80% of Canadians aged 20 to 59 have at least one of five major modifiable health risks, including hypertension, elevated cholesterol, and obesity (Makrides 2010).

Pharmaceutical costs are rising fast, and recently overtook physicians as the second largest area of health spending in Ontario (TD Economics 2010). Nearly one third of drug costs are for conditions that are the result of modifiable health risks, including high cholesterol, high blood pressure, diabetes and

With the clear challenges to the sustainability of the health care system, it is important that NDs be able to use all of their skills and training to provide patients with the care they want. Patients of ND’s are inherently proactive with their health thereby creating savings for the public healthcare system.

Other professions are also making changes to respond to increasing patient expectations that their health care choices will be respected.

The new CPSO policy on Complementary/Alternative Medicine recognizes and supports patient-centred care, including respect for preferences, to incorporate non-allopathic approaches from their MD and other practitioners. Recognizing the legitimacy of non-allopathic therapies for primary or secondary care helps to foster a culture of respect for patient choice and for health care professionals practicing complementary medicine, and provides another foundation for improved collaboration. •

References Canadian Diabetes Association, Cost of Diabetes in Ontario, 2010 Conference Board of Canada, 2011 Budget: Controlling Growth in Health-Care Spending is Key to Budget Commitment to Balance the Books, website.

Globe and Mail, Insurers Focus on Prevention, January 3, 2010 Makrides L, Sawatzky C, Petrie J, Veinot P. Modifiable health risks in Atlantic Canadian employees: a 5-year report. Health Promot Int. 2010 Dec;25(4):384-93.

Ontario Ministry of Finance, Ontario’s Long Term Report on the Economy, 2010, Chapter 3.

Ontario Ministry of Health and Long Term Care, Preventing and Managing Chronic Disease – A Framework, 2007, p.3 TD Economics: Charting a Path to a Sustainable Health Care System, 2010, Pages 4-11.

Toronto Star, Illness Prevention Will Save Taxpayers Money: McGuinty, May 9, 2011.

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PEER REVIEW

Peer Review Board Members Aoife Earls, MSc, ND Trafalgar Ridge Chiropractic and Acupuncture 2387 Trafalgar Rd, Unit 7A Oakville, Ontario L6H 6K7 aearlsnd@gmail.com Berchman Wong, ND 718 - 33 Canniff St Toronto, Ontario M6K 3M5 berchman.nd@gmail.com Betty Rozendaal, BES, MA, ND Thornhill Naturopathic Health Clinic 12A Centre Street Thornhill, Ontario L4J 1E9 rozendaal@sympatico.ca Carol Morley, ND Zawada Health 201 City Centre Drive Suite 404 Mississauga, Ontario L5B 2G6 info@zawadahealth.com Daniel Watters, BSc, ND Rosedale Wellness Centre 365 Bloor St East Toronto, Ontario M4W 3L4 wattersdaniel@hotmail.com David Miller, BSc, ND 60 Albert Street

Southampton, Ontario NOH 2L0 davidjmillernd@gmail.com Elizabeth Cherevaty, BSc, ND Healing Foundations Naturopathic Clinic 111 Norfolk St., 2nd Floor Guelph, Ontario N1H 4J7 drliz@guelphnaturopathic.com Erin Psota, BSc, ND 626 King St West, Suite 201 Toronto, Ontario M5V 1M7 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 M2K 1E2 hfritz@ccnm.edu Jacob Scheer, DC, ND, MHSc 2100 Finch Ave. W. #206 North York, Ontario M3N 2Z9 Jacob.Scheer@utoronto.ca ihpmagazine.com { April/May 2012 IHP | 21

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PEER REVIEW Jiselle Griffith, BSc, ND The Health Hub Integrated Clinic 35 Hayden St, Suite 109 Toronto, Ontario M4Y 3C3 info@jisellegriffith.ca

Raza Shah, BSc, ND St. Jacobs Naturopathic 1-9 Parkside Drive St. Jacobs, Ontario N0B 2NO stjacobs.nd@gmail.com

Jordan Robertson, BSc, ND Lakeshore Clinic 2159 Lakeshore Road Burlington, Ontario L7R 1A5 jordanrobertsonnd@gmail.com

Sarah Vadeboncoeur, ND Ottawa Integrative Health Centre 1129 Carling Ave Ottawa, Ontario K1Y 4G6 sarahmvadeboncoeur@gmail.com

Kelly Brown, BSc, ND Healthview Therapy Centre 5118 Roblin Blvd Winnepeg, Manitoba R3R 0G9 drkbrownnd@gmail.com Leigh Arseneau, ND The Naturopathic Institute of Advanced Medicine 122 Simcoe St North Oshawa, Ontario L1G 4S4 docleigh@gmail.com Lindsay Bast, BSc, ND Greenwood Wellness Clinic PO Box 189 1400 Greenwood Hill Rd. Wellesley, ON N0B 2T0

Scott Clack, ND Touchstone Naturopathic Centre 950 Southdown Rd, Unit B5 Mississauga, Ontario L5J 2Y4 sclack.nd@touchstonecentre.com Shawna Clark, ND Forces of Nature Naturopathic Clinic 2447 1/2 Yonge St Toronto, Ontario M4P 2E7 info@shawnaclarknd.com Stephanie Swinkles, DDS Elmsdale Dental Clinic 4-269 Highway 214 Elmsdale, Nova Scotia N2S 1K1 steph_moroze@hotmail.com

Louise Wilson, BSc, ND 320 Queen St S Bolton, Ontario L7E 4Z9 Dr.louisewilsonnd@gmail.com

Susan Coulter, BSc, ND Roots of Health 2-497 Laurier Ave Milton, ON L9T 3K8 scoulter@rootsofhealth.ca

Mandana Edalati, BA, ND Wellness Naturopathic Centre Suite 213-1940 Lonsdale Ave North Vancouver, British Columbia V7M 2K2 dredalati@gmail.com

Sylvi Martin, BScN, ND Fusion Chiropractic and Integrative Health 735 Danforth Avenue Toronto, Ontario M4J 1L2 martin.sylvi@gmail.com

Melanie DesChatelets, BSc, ND True Health Studio 200-4255 Arbutus St Vancouver, British Columbia V6J 4R1 melanie@drdeschat.com

Tanya Lee, BSc, ND The Health Centre of Milton 400 Main St East Suite 210 Milton, Ontario L9T 1P7 tanyalee.nd@gmail.com

Nicole Egenberger, BSc, ND Remede Naturopathics 214 Sullivan Street Suite 3B New York, New York 10012 info@remedenaturopathics.com

Terry Vanderheyden, ND Bayside Naturopathic Medicine 118 Bay Street Barryâ&#x20AC;&#x2122;s Bay, Ontario KOJ 1B0 doctrv@gmail.com

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HairGrow Tech IHP FullPg.qxp:Educational ad

3/30/12

2:34 PM

Page 1

reductase activity – the enzyme responsible for converting excess testosterone to DHT (which is the primary molecule that causes hair loss). The SDG from flax lignans in both formulas also decreases excess cholesterol the building block of testosterone. Based on new research on the rate of metabolism of SDG in flax lignans (8-12 hours on average), the dosage in both products has been revised from once a day to twice a day for optimum results.

Twice the Strength! Double the Power!

Hair Grow Technology’s Bio-Fen® product line is continually moving forward! We are introducing our two latest versions; Bio-Fen® Plus for Men and Bio-Fen® Plus for Women. These products have been assigned Natural Product Numbers (NPN’s) by the Natural Health Products Directorate (NHPD) of Health Canada.

We recognize that both men and women experience androgenic alopecia (AGA, or male / female pattern baldness) and have made some improvements to the original formulation based on the latest science to address their specific needs. You will notice that we now have additional complementary (Health Canada Approved) health claims on each product.

What causes hereditary hair loss?

For details, write #106 on Free Info Page, page 92.

Each hair grows from a pocket in the skin called the hair follicle.

During its growing phase the follicle has a bulb-shaped bottom, the center of which is called the dermal papilla. The paplla is fed by very small blood vessels, which bring it food, oxygen and remove wastes.

The papilla is highly sensitive to hormones and chemicals secreted by the body (or ingested as a medicine) which impacts hair growth It is believed that some individuals have a genetic predisposition to a receding hairline (most common in men) or hair (follicle) thinning over larger areas of the scalp (more common in women). These conditions result from hormonal changes caused by an enzyme in the dermal papilla called 5-alpha-reductase. This enzyme breaks down the hormone testosterone into dihyrotestosterone (DHT). Over a period of time, an over abundance of DHT causes the hair follicle to degrade and shortens the active phase of the hair, eventually leading to thinner hair and eventual hair loss.

How does Bio-Fen® PLUS work?

We are bringing you two new products with double the number of capsules and triple the number of health claims for men and four times the number of health claims for women, As in the previous formulation, the fenugreek seed extract in both new formulas reduces excess blood lipid levels (hyperlipidemia). Fenugreek contains β-sitosterol, an active plant sterol, which has been shown to inhibit 5-alpha-

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Bio-Fen® Plus for Women will also help to: • Reduce elevated blood lipid levels/hyperlipidemia • Prevent iron deficiency.

• Metabolize carbohydrates, fats and proteins.

Bio-Fen® Plus for Men:

How long must I use Bio-Fen® Plus?

The mechanism that causes AGA in men follows the same pathway that results in benign prostatic hyperplasia (BPH). For example, the prescription drug finasteride also works by blocking the enzyme 5αreductase and is used as a treatment for both BPH and AGA. For AGA it is marketed under the brand name of Propecia, but the exact same molecule for BPH is sold under the name of Proscar.

Bio-Fen® Plus for Men capsules are usually effective at stopping hair loss within the first two months. However, since healthy hair grows only about 1 cm each month, it may take up to three months before you notice that hair growth is increased or the rate of hair loss is decreased. Anyone experiencing new growth should see it within four months. In some people the original pigmentation may come back.

Once you stop completely your hair growth pattern will slowly go back to the point where you started. However, some people may be able to go with a lower maintenance dose.

As before, the saw palmetto extract inhibits the enzyme 5-alpha reductase, and this action slows down the conversion of testosterone to dihydrotestosterone (or DHT) – the overabundance of which causes the miniaturization of hair follicles. This activity of the saw palmetto also helps to relieve the urinary symptoms of mild to moderate BPH for men.

The saw palmetto that originally was an extract standardized to 45% free fatty acids, esters, and sterols while the new formula is a 4:1 extract to support the BPH claim. The product still contains these molecules for hair loss, but they are now at proprietary amounts based on our research so that the competition cannot duplicate our formula.

Bio-Fen® Plus for Men will also help to: • Relieve the urologic symptoms associated with mild to moderate benign prostatic hyperplasia - BPH (e.g. weak urine flow, incomplete voiding, frequent daytime and night time urination).

• Reduce elevated blood lipid levels / hyperlipidemia.

Bio-Fen® Plus for Women: The women’s formula is almost the same as the men’s formula. The mechanisms and results for the women formula is the same. The only difference is it contains silicon and iron instead of saw palmetto.

Silicon has been shown to contribute to hair shaft strength and thus healthy hair growth. It also contains iron which helps prevent iron deficiency. A number of studies have related sub-clinical iron deficiency in women to diffuse hair loss/alopecia.

The increased amount of SDG and other revisions to the regulations allow us to make some additional health claims for Bio-Fen® Plus for Women.

Available at Health Food Stores and Independent Pharmacies

Why has the recommended dose doubled?

Based on new research on the rate of metabolism of SDG in flax lignans (8-12 hours on average), the dosage in both products has been increased to twice a day for optimum results. The flax lignan extract in the original formulation was 100 mg standardized to 20% SDG x 1 capsule per day, which equaled to 20 mg/day of SDG. The new formulations have 200 mg per capsule of flax lignan extract standardized to 50% SDG x 2 caps/day equals 200 mg/day of SDG. As such, one is getting 10 times the amount of SDG per day!.

How safe is Bio-Fen® Plus?

The ingredient combination in Bio-Fen® Plus is generally safe for most adults. However, the following cautions are advised: For Men: Consult a health care practitioner prior to use to exclude a diagnosis of prostate cancer, or if you have diabetes. For BPH or elevated blood lipid levels, consult a health care practitioner if symptoms persist or worsen. People sensitive to niacin may experience flushing of the skin that is generally mild and transient. Discontinue use if you experience hypersensitivity to flax, such as an allergy (may occur in rare cases).

For Women: Consult a health care practitioner prior to use if you are pregnant or if you have diabetes. Consult a health care practitioner if elevated blood lipid levels persist or worsen. People sensitive to niacin may experience flushing of the skin that is generally mild and transient.

Discontinue use if you experience hypersensitivity to flax, such as an allergy (may occur in rare cases). Because of the iron content, some people may experience constipation, diarrhea and/or vomiting. Keep out of the reach of children. There is enough iron in this package to seriously harm a child.

4/5/12 1:18:02 PM

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 for in many men and women (Sinclair 1998). Bio-Fen Plus contains extracts BIO-FEN Menaffected and Women 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. are responsible for relieving symptoms associated withPlus hereditary AGA. Bio-Fen represents aThese line of inhibitors products approved

by Health Canada for hair growth and restoration.

Bio-Fen for Men and Bio-Fen Plus for Women are both oral natural health One of the primary causes hair loss is and a high level of hereditary the maleandrogenic hormonealopecia dihydrotestosterone (DHT) within the hair follicle (Vierhapper, 2001). products (NHPs) which support hairofgrowth in men women with (AGA), or female/male pattern baldness.

Bio-Fen contains a combination of herb extracts andwith vitamins & minerals that are known inhibit the enzymeof 5 androgen -reductase (5AR), a keyto pathway in the progression of AGA. catalyzes the enzymatic For people AGA, their follicles have atogreater number receptors whichimplicated DHT attaches.

5-α-reductase conversion of testosterone to dihydrotestosterone, which binds to the receptor five-fold more avidly than the parent compound (Sinclair 1998).

AGA Pathophysiology One of the primary causes of hair loss is a high level of the male hormone, dihydrotestosterone (DHT) within the hair follicle (Hoffmann 2002). DHT is produced from Saw palmetto repens) testosterone in the(Serenoa testes (males), the adrenal glands, and the follicle. After a period of time, anVitamins over abundance of DHT causes the hair follicle to degrade and shortens the active phase of the hair,(lipophillic) eventually leading to thinning hairbeen and eventual Thereinhibitor is a familial In tendency forstudy stepwise the hair follicle and an increase in the calcium ratio a Polish of miniaturization 46 women whoof had symptoms of diffuse alopecia, Standardized Serenoa extract has found tohair be loss. a potent of of telogen (resting phase) to anagen (growthtissue phase)DHT. hairs, which is promoteddose by systemic effects of was androgens.

Althou gh everyone thosemg with pantothenate orally administered twiceproduces a day inDHT, dosesonly of 100 fora four to 5α-reductase, resulting in decreased An open-label, responseand local higher of androgen in their binding sitesof fora DHT, and greater five androgen sensitivity experience hairinjected loss (Prager 5AR forrepeated the 30 days and months, and vitamin B6 was every2002). day for 20istoresponsible studynumber was conducted onreceptors 42 healthy maleshair to follicles, determine the effect combination conversion of testosterone to dihydrotestosterone, binds to the sameon androgen but with five-fold greater(Brzezińska-Wcisło affinity. (Hoffmann 2001).

2002, Trueb again after six months It was2002) determined that vitamin of carotenoid astaxanthin and saw palmettowhich berry lipid extract DHT receptor, and

testosterone levels (Angwafor 2008). The men were divided into two groups:

B6 administered parenterally for a few weeks induces improvement in the hair

Flax condition in subset women and Flax reduces hair are loss. onelignans groupinhibit received 800 mg/day of the combination supplement the other Flax the enzyme 5AR, thus balancing formation of the maleand hormones that are responsible fora hair lossof(Evans 1995). lignans converted by the body to group received 2000 mg/daywith of the supplement for 14 days.

ANOVA-RM enterolactones, which compete estrogen and testosterone for receptor binding,showed and increase sex hormone binding globulin (SHBG), resulting in lower levels of free (ie active) significant within-group increases in serum testeosterone significant estrogen and testosterone.

Flaxseed has been shown total to reduce serum levelsand of 17-beta-estradiol and estrone sulfate (Hutchins 2001), and results in a shift in estrogen metabolism to Medicinal Ingredients Dose Per Capsule decreases serum DHT baseline in both favor the lessin biologically activefrom estrogens (Brooks 2004).dose groups (P=0.05). There

was no significant difference between dose groups with regard to the increase of

Fenugreek (Trigonella foenum graecum)

Fenugreek 260 mg testeosterone or the decrease of DHT; therefore both doses were effective (Angwafor seed extract 4:1 Fenugreek 2008). has been used traditionally as an oral and topical treatment for hair loss. Plant sterols contained in fenugreek such as -sitosterol have been shown to block DHT receptor sites (Prager 2002, see below).

Saw palmetto berry extract containing

160 mg

Another study tested liposterolic extract of Serenoa repens (LSESr) and beta45% free fatty acids Saw Palmetto (men’s product) sitosterol inextract the treatment of males (23-64 of age)resulting with mild to moderate AGA. Saw palmetto is a potent inhibitor of 5 years -reductase, in decreased tissue DHT (Prager 2002). In a pilot study of 26 men with mild to moderate AGA, treatment with Flax lignans, standardized toblinded 20% assessors (Prager 2002). In a meta Six of 10 (60%) subjectssaw were rated asextract improved at and the beta-sitosterol final visit, thus50mg establishing a combination of lipophilic palmetto 200mg improved symptoms by up to 60%, as scored by 100 mg diglucoside the effectiveness of 5α-reductase inhibitors AGA (Prager 2002). Chronic analysis by the Cochrane group, saw palmetto hasagainst also been found to be effective as a treatment secoisolariciresinol for symptoms of BPH (Wilt 2002). (SDG) inflammation of the hair follicle is considered to be a contributing factor for AGA. A

D-calcium pantothenate (Vitamin B5) 10.40 mg Silica (women’s product) study

by Chittur et al sought to determine whether blockade of inflammation using Silica is a and tracetwo mineral that has been found to increase hydroxyproline in connective tissue (Barel 2005). In a randomized, double blind, placebo controlled study, 50 LSESr anti-inflammatory agents (carnitine and thiocticconcentration acid) could alter Niacinamide (Vitamin B3) 10.25 mg women with damaged skin weremarkers treated orally with 10mg silica as orthosilicic the expression of molecular of inflammation (Chittur 2009). It acid was (OSA) found daily for 20 weeks. The treatment group reported a significant decrease in visual analog scale ratings of hair brittleness (Barel 2005). A second randomized, double blind, placebo controlled trial conducted in 50 women with brittle hair found that 10mg silica as OSA Pyridoxine HCl (Vitamin B6) 2 mg that the combination suppressed lipopolysaccharide-activated gene expression of for 9 months significantly improved hair elasticity, breakage, and diameter (thickness) (Wickett 2007). chemokines associated with pathways involved in inflammation and apoptosis.

Riboflavin (Vitamin B2)

1.58 mg

Folic acid

0.095 mg

study thatcell 5-alpha inhibitors in combination withmetabolism.

B The vitamins are concluded support healthy growthreductase and division, and facilitate optimal hormone

blockade of inflammatory processes could represent a new two-pronged approach Medicinal ingredients per capsule in both the men’s and women’s: in the treatment of AGA.

Fenugreek (Trigonella foenum graecum) seed extract 4:1 ....................................................260 mg Biotin 400 mcg equiv 1040mg) Fenugreek (dry Seeds Flax lignans, standardized to 5% 50%to SDG ...............................................................................100 mg Non-Medicinal Ingredients Fenugreek seeds contain 30% protein, steroid saponins, sterols, flavonoids d-calcium pantothenate (Vitamin B5) ..................................................................................10.4 mg and alkaloids (notably trigonelline and choline). Steroid saponins bind and Niacinamide (Vitamin B3) ...................................................................................................10.3 mg Inert microcrystalline cellulose and vegetable-based magnesium eliminateHCl extra cholesterol and hormones in the body; DHT is made from mg Pyridoxine (Vitamin B6) ...............................................................................................2.0 stearate in a veggie-based capsule testosterone, which is in turn is made from cholesterol.

Therefore, when excess Riboflavin (Vitamin B2) .......................................................................................................1.6 mg cholesterol is eliminated, less DHT can be made (Stark 1993).

In a study of 20 Folic acid ..............................................................................................................................95 mcg Recommended adult dose: One capsule per day adults....................................................................................................................................250 who consumed 12.5g and 18.0g of germinated fenugreek seed powder for Biotin mcg

one month, higher levels of consumption resulted in a significant reduction in total

Men’s also has: cholesterol and low-density lipoprotein (LDL) levels (Sowmya 1999).

Saw palmetto berry extract 4:1 .............................................................................................125 mg (dry equiv. 500 mg) Flax lignans

Flax reduces the amount of DHT produced by reducing cholesterol levels in the

Women’s also has: body.(silicon A meta-analysis of 28 studies between 1990 and 2008 showed that flaxseed mg Silicon dioxide) ........................................................................................................40 significantly reduces circulating total and LDL-cholesterol concentrations (Pan mg Iron (ferric citrate) ................................................................................................................20

2009). Flaxseed interventions reduced total and LDL cholesterol by 0.10 mmol/L

Recommended use:0.00 one mmol/L) capsule twice capsules perCI: bottle).

Bio-Fen® Plus capsules are usually effective (95% CI: -0.20, and daily 0.08 (60 mmol/L (95% -0.16, 0.00 mmol/L), at respectively. stopping hair Significant loss within the first two were months.

Anyonewith experiencing new growth reductions observed whole flaxseed (-0.21should and see it within four months.

Once Bio-Fen is stopped, the hairand growth pattern will and slowly return to its original point, however some people may -0.16 mmol/L, respectively) lignan (-0.28 -0.16 mmol/L, respectively) besupplements able to continue with a lower maintenance dose.

(Pan 2009).

Bio-Fen has been approved by Health Canada and has received a unique NPN number. In addition to being approved for hair growth applications, Bio-Fen has been approved for additional health benefits.

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.

Contraindications: The ingredient combination in Bio-Fen Plus for Men/Women is generally safe for most adults.

Bio-Fen should not be used by patients withB6 diabetes, or known hypersensitivity to any ingredients.

Brzezińska-Wcisło L. Evaluation of vitamin 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.

References 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 Brooks JD, et al.

Am J Clin Complement Alternat Med Nutr.

2009. 2004 Feb;79(2):318-25.

Evans BA, et al. 1995 Nov;147(2):295-302.

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.

Hoffmann R. Clin Exp Dermatol. 2002 Jul;27(5):373-82.

2001;39(1):58-65.

Hutchins AM,et al.

Nutr Cancer.

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 Prager N, etof al.androgenetic 2002 Apr;8(2):143-52. treatment alopecia. J Altern Complement Med 2002;8:143-52.

Trüeb RM. Exp Gerontol. 2002 Aug-Sep;37(8-9):981-90.

Serenoa repens monograph. Alternative Medicine Review 1998;3:227-9.

Wickett RR, et al Arch Dermatol Res. 2007 Dec;299(10):499-505.

Wilt T et al.

Database Syst Rev. 2002;(3):CD001423.

Sinclair R. Cochrane 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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RESEARCH NEWS

A vegan or vegetarian diet substantially alters the human colonic fecal microbiota

Plasma antioxidant capacity is reduced in Asperger syndrome

The influence of regular diets on intestinal microbiota is widely unknown. The current study examined fecal samples of vegetarians (n=144), vegans (n=105), and an equal number of control subjects consuming an omnivorous diet who were matched for age and gender. Classical bacteriological isolation was utilized and the main aerobic and anaerobic bacterial genera were identified and enumerated. Absolute and relative numbers were computed and compared between groups. Total counts of Bacteroides spp., Bifidobacterium spp., Escherichia coli and Enterobacteriaceae spp. were significantly lower (P=0.001, P=0.002, P=0.006 and P=0.008, respectively) in vegan samples than in controls, whereas others (E. coli biovars, Klebsiella spp., Enterobacter spp., other Enterobacteriaceae, Enterococcus spp., Lactobacillus spp., Citrobacter spp. and Clostridium spp.) were not. The total microbial count did not differ between the groups. In addition, subjects on a vegan or vegetarian diet showed significantly (P=0.0001) lower stool pH than did controls and stool pH and counts of E. coli and Enterobacteriaceae were significantly correlated across all subgroups. The authors concluded that maintaining a vegan or vegetarian diet results in a significant shift in the microbiota while total cell numbers remain unaltered. Eur J Clin Nutr. 2012 Jan;66(1):53-60. PMID: 21811294

Recent evidence suggests that children with autism may have an impaired detoxification capacity and suffer from chronic oxidative stress; however, the oxidative metabolism specifically in Asperger syndrome has not been studied. The current study investigated the oxidative status of a group of adolescent patients with Asperger syndrome, a group of adolescents with a first episode of psychosis, and a group of healthy controls. Total antioxidant status (TAOS), non-enzymatic (glutathione and homocysteine) and enzymatic (catalase, superoxide dismutase, and glutathione peroxidase) antioxidants, and lipid peroxidation were measured in plasma or erythrocyte lysates at baseline, 8 to 12 weeks, and one year. TAOS was found to be reduced in Asperger individuals compared with healthy controls and psychosis patients after covarying by age and antipsychotic treatment. This reduced antioxidant capacity did not depend on any of the individual antioxidant variables measured. Psychosis patients had increased homocysteine levels in plasma and decreased copper and ceruloplasmin at baseline. No impaired detoxifying capacity was found in the first year of illness in the group of adolescents with a first episode of psychosis. The authors concluded that Asperger patients seem to have a chronic low detoxifying capacity. J Psychiatr Res. 2012 Jan 4. PMID: 22225920

C-reactive protein is an independent predictor for carotid artery thickness progression This study was conducted to investigate the association of high sensitivity c-reactive protein (hsCRP) on early carotid atherosclerosis progression in a large, population-based cohort study. The study cohort included 839 young adults (aged 24 to 43 years, 70% white, 42% men) enrolled in the Bogalusa Heart Study, who underwent baseline examinations in 2001-2002 for measurements of cardiovascular disease risk factors. Progression of carotid artery intima-media thickness (IMT) was assessed during a mean follow-up of 2.4 years.

Carotid artery IMT progression rates were as follows: composite carotid artery = 9.2 +/- 52 um/y, common carotid artery = 0.0 +/- 51 um/y, carotid bulb = 8.8 +/- 103 um/y, and internal carotid artery = 18.9 +/- 81 um/y. Elevated baseline hsCRP revealed an independent association with composite carotid artery IMT progression. Increased age, systolic blood pressure, fasting glucose, LDL cholesterol, and current smoking were also found to increase risk of carotid artery IMT progression in young adults. The authors concluded that this study underlines the importance of assesssing hsCRP levels along with smoking and traditional cardiovascular disease risk factor profiles in asymptomatic young adults. BMC Cardiovasc Disord. 2011 Dec 30;11(1):78. PMID: 22208681

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RESEARCH NEWS

Savings from the use of probiotics in the prophylaxis of antibiotic-associated diarrhea Antibiotic-associated diarrhea (AAD) and Clostridium difficileassociated diarrhea (CDAD) are the most common causes of healthcare-associated infectious diarrhea. Results from a doubleblind, dose-response, placebo-controlled trial of the probiotic formula, Bio-K+ (i.e., containing Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R) published in 2010 revealed that the incidence of AAD and CDAD were lower for patients assigned to the probiotic formula compared to placebo.

This study aimed to estimate the savings in direct medical costs that might result from the use of two different doses of the probiotic formula versus placebo. Economic analyses showed that the use of the probiotic formula would result in estimated mean per patient savings of US$1968 and US$2661 for the single and double dose, respectively, compared with placebo if used an average of 13 days by all patients at risk of developing AAD and CDAD. Using this product in the prophylaxis of AAD and CDAD could lead to estimated savings in direct medical costs that would substantially offset its acquisition cost. Treating 1000 hospitalized patients on antibiotics with the double dose of this product compared to current practice would save a single payer system over $2.5M. J Med Econ. 2012;15(1):53-60. PMID: 22023067

Intakes of lignans are associated with clinical breast tumor characteristics The current study investigated usual dietary intakes of total and specific lignans with tumor characteristics. Dietary lignan intakes were calculated from food frequency questionnaires in 683 women with breast cancer and 611 healthy women without breast cancer enrolled in the Data Bank and BioRepository at Roswell Park Cancer Institute (RPCI). Clinicopathologic data were abstracted from the RPCI breast cancer database. Women in the highest versus the lowest tertile of total lignan intakes had a 40–50% lower odds of breast cancer regardless of menopausal status and substantially reduced odds of an invasive tumor, especially among premenopausal women (OR 0.48; 95% CI 0.26–0.86). Lignan intakes were inversely associated with the odds of grade three tumors among premenopausal women and with the risk of estrogen receptor (ER) negative (ER−) breast cancer among premenopausal women (OR 0.16; 95% CI 0.03–0.44) and particularly triple negative tumors (ER−, progesterone receptor negative, HER2 negative; OR 0.16; 95% CI 0.04–0.62). Significant differences in the contribution to these effects by specific lignans were found, especially matairesinol and lariciresinol. The authors concluded that higher lignan intakes were associated with lower risks of breast cancer with more favorable prognostic characteristics. J Nutr. 2012 Jan;142(1):91-8. PMID: 22113872

Body dissatisfaction is found among adolescents with severe dysmenorrhea This cross-sectional study aimed to determine whether adolescent girls with severe dysmenorrhea (SD) have different psychological characteristics from their peers. Subjects included a nationally representative sample of 16 to 20 year old adolescents attending post-mandatory education in Switzerland (n = 7548; 3340 females). Subjects were administered an anonymous survey consisting of 565 items on four main topics, including sociodemographic determinants of health, health status, health behaviors, and health care use. A total of 12.4% (95% CI 11.0-14) of the subjects declared SD. Compared to their peers, subjects with SD were more likely to report depressive symptoms [adjusted odds ratio (AOR) 1.73; 95% CI 1.38-2.15], have a higher gynecological age (AOR 1.13; 95% CI 1.05-1.20), and attend vocational school (AOR 1.33; 95% CI 1.00-1.76). Moreover, the proportion of those reporting dissatisfaction with body appearance was higher (AOR 1.50; 95% CI 1.02-2.22). Patients with SD not only show a different profile from their peers in terms of mental health academic track and gynecological age but they are also more dissatisfied with their body appearance. Therefore, clinicians should offer patients with SD a global evaluation, bearing in mind what factors can be associated with SD. J Pediatr Adolesc Gynecol. 2012 Feb;25(1):19-22. PMID: 22217652

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METAGENICS PHYTOMULTI PhytoMulti by Metagenics is a robust multivitamin fortified with over 20 phytonutrient extracts, including lutein, greet tea extract, and resveratrol. As such, PhytoMulti is an ideal product for use in adults in order to optimize vitamin and mineral status, in lieu of poor dietary intake or increased physiological requirements, but also provides a broad spectrum of plant nutrients in order to mimic the many health effects of a plant-based diet. The USDA MyPlate recommendations include between 9-10 servings of fruits and vegetables per day, but less than 10% of adults achieve this target (Murphy 2011).

The Mediterranean dietary pattern is an example of a well-researched diet that is very high in phytonutrients. The Mediterranean diet is associated with markedly lower risk of several chronic diseases, including cardiovascular disease and diabetes (Eustruch 2006, Interact Consortium 2011, Nordmann 2011), and a high fruit and vegetable diet has been shown to reduce risk of cancer (Block 1992), in large part due to high amounts of combined phytonutrients. Phytonutrients have been shown to confer beneficial health effects through numerous mechanisms, including modulation of signal transduction pathways, antioxidant properties, and through hormonal effects. PhytoMulti contains over 20 of these plant substances, including: lutein, zeaxanthin, acacia nilotica, and extracts of artichoke leaf, grape seed extract, green coffee, green tea, citrus bioflavonoids, resveratrol, prune skin, watercress, rosemary, pomegranate, lycopene, cinnamon, bitter melon, and blueberry.

Multivitamin supplementation has been shown to benefit a variety of physical and cognitive parameters particularly in children, pregnant women or women who may become pregnant, individuals under increased stress, individuals with poor absorption, and the elderly. In pregnancy, supplementation with a folic acid containing multivitamin has been shown to reduce risk of complications such as placental abruption, preeclampsia, in addition to decreasing risk of congenital defects including neural tube defects, anencephaly, myelomeningocele, meningocele, oral facial cleft, structural heart defects, limb defects, urinary tract anomaly, and hydrocephalus when used prior to conception and during the first trimester (Wilson 2007).

Periconceptional multivitamin use in lean women has been shown to decrease the risk of small-for-gestational-age (SGA) under the 5th percentile by up to 46% compared to non-users (OR=0.54, 95% CI), and has been associated with a 71% reduction in preeclampsia risk (OR=0.29, 95% CI) in lean women, users versus non-users (Catov 2007; Bodnar 2006). Periconceptional multivitamin use has also been associated with reduced risk of several pediatric cancers, including leukemia (OR=0.61) (39% reduced risk); pediatric brain tumors (OR=0.73) (27% reduced risk); and neuroblastoma (OR=0.53) (47% reduced risk) in a recent metaanalysis (Goh 2007).

In patients under high levels of psychological stress, use of a multivitamin has been shown improve perceived levels of stress and psychometric parameters.

Gruenwald et al (2002) found that use of a multivitamin for 6 months resulted in a 40.7% overall improvement in self rated stress levels using a psychologicalneurological questionnaire to assess “psycho-organic, central vegetative, and somatic discomforts.” Other outcomes included a 29% decrease in frequency of infections and 91% decrease in gastrointestinal discomfort. Schlebusch et al (2000) found similar benefit on various psychometric parameters in a 30 day trial (1997), and Harris found that multivitamin supplementation can improve measures of mood, stress, and alertness in older men (2011). Importantly, supplementation with a spectrum of B vitamins has also been shown to reduce ratings of workplace stress (Stough 2011).

Several trials have shown increased cognitive performance in children taking a multivitamin supplement. Benton et al (1988) found a significant increase in nonverbal intelligence in children taking a multi versus those taking placebo after 8 months’ intervention. In a 14 month study of 608 children, Vazir et al (2006) found a significant increase in attention-concentration increment scores in those supplemented with a micronutrient-fortified beverage versus those receiving placebo.

Additional benefits demonstrated in children include a reduced mean duration (5.0 versus 7.5 days, supplement versus placebo) of several common childhood illnesses including such as fever, cough and cold, diarrhea, and ear infections (Sarma 2006).

In the elderly, multivitamin supplementation has been shown to significantly improve status of such nutrients as vitamin D, vitamin B6, vitamin B12, folate, vitamin C, vitamin E, zinc, and selenium (McKay 2000; Girodon 1997). In addition, supplementation has also been found to significantly reduce rates of infection in the elderly, as found a trial in 81 subjects given various supplemental combinations of micronutrients and followed over a 2 year period (Girodon 1997).

PhytoMulti: Active Ingredients* (per 1 tablet) Ingredient Vitamin A as retinyl acetate Vitamin A as carotenoids Vitamin E d-alpha tocopherol Vitamin C ascorbic acid Vitamin D3 cholecalciferol Vitamin K phytonadione Thiamine mononitrate

Dose 2500 2500 50 60 500 60 12.50

Unit IU IU IU mg IU mcg mg

Riboflavin 7.50 mg Niacin 6.25 mg Niacinamide 18.75 mg Pantothenic acid 37.5 mg Vitamin B6 pyridoxine HCl 12.50 mg Calcium L-Mefolinate 400 mcg Vitamin B12 cyanocobalamin 120 mcg Biotin 250 mg Magnesium citrate 20 mg Chromium polynicotinate 100 mcg Copper citrate 500 mcg Iodine potassium iodide 75 mcg Manganese citrate 250 mcg Molybdenum aspartate 25 mcg Selenium aspartate 50 mcg Zinc citrate 7.50 mg * In addition to extracts of over 20 phytonutrients.

IHPAPR20112_9311_Metagenics_Phyto_Multi_FP.indd 2

References Benton D, Roberts G. Lancet. 1988 Jan 23;1(8578):140-3.

Block G, et al. Fruit, vegetables, and cancer prevention: a review of the epidemiological evidence. Nutrition and cancer 1992;18(1):1-29.

Bodnar LM, Tang G, Ness RB, Harger G, Roberts JM. Am J Epidemiol. 2006 Sep 1;164(5):470-7. Epub 2006 Jun 13.

Catov JM, Bodnar LM, Ness RB, Markovic N, Roberts JM. Am J Epidemiol. 2007 Aug 1;166(3):296-303.

Epub 2007 May 11.

Chavarro JE, Rich-Edwards JW, Rosner BA, Willett WC. Fertil Steril. 2008 Mar;89(3):668-76. Epub 2007 Jul 10.

Eustruch R, Martínez-González MA, Corella D, et al. Ann Intern Med. 2006 Jul 4;145(1):1-11 Girodon F, Lombard M, Galan P, Brunet-Lecomte P, Monget AL, Arnaud J, Preziosi P, Hercberg S. Ann Nutr Metab. 1997;41(2):98-107.

Goh YI, Bollano E, Einarson TR, Koren G. Clin Pharmacol Ther. 2007 May;81(5):685-91. Epub 2007 Feb 21.

Grieger JA, Nowson CA, Jarman HF, Malon R, Ackland LM. Eur J Clin Nutr. 2007 Nov 28.

Gruenwald J, Graubaum HJ, Harde A. Adv Ther. 2002 May-Jun;19(3):141-50.

Harris E, Kirk J, Rowsell R, Vitetta L, Sali A, Scholey AB, Pipingas A. Hum Psychopharmacol. 2011 Dec;26(8):560-7.

InterAct Consortium. Diabetes Care. 2011 Sep;34(9):1913-8.

McKay DL, Perrone G, Rasmussen H, Dallal G, Hartman W, Cao G, Prior RL, Roubenoff R, Blumberg JB. J Am Coll Nutr. 2000 Oct;19(5):613-21.

Murphy MM, et al. Journal of the American Dietetic Association 2011:in press.

Nilsen RM, Vollset SE, Rasmussen SA, Ueland PM, Daltveit AK. Am J Epidemiol. 2008 Apr 1;167(7):867-74. Epub 2008 Jan 10.

Nordmann AJ, Suter-Zimmermann K, Bucher HC, et al. Am J Med. 2011 Sep;124(9):841-51.e2.

Ribeiro ML, Arçari DP, Squassoni AC, Pedrazzoli J Jr. Mech Ageing Dev. 2007 Oct;128(10):577-80. Epub 2007 Aug 15.

Sarma KV, Udaykumar P, Balakrishna N, Vijayaraghavan K, Sivakumar B. Nutrition. 2006 Jan;22(1 Suppl):S8-14.

Schlebusch L, Bosch BA, Polglase G, Kleinschmidt I, Pillay BJ, Cassimjee MH. S Afr Med J. 2000 Dec;90(12):1216-23.

Stough C, Scholey A, Lloyd J, Spong J, Myers S, Downey LA. Hum Psychopharmacol. 2011 Oct;26(7):470-6.

Tanvetyanon T, Bepler G. Cancer. 2008 Jul 1;113(1):150-7.

Vazir S, Nagalla B, Thangiah V, Kamasamudram V, Bhattiprolu S. Nutrition. 2006 Jan;22(1 Suppl):S2632.

Wilson RD, et al. J Obstet Gynaecol Can. 2007 Dec;29(12):1003.

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RESEARCH NEWS

Food acceptance increases with parentadministered taste exposure and incentives

Probiotic supplementation during pregnancy affects childhood atopic eczema: a meta-analysis

Intervention studies have shown that encouraging children to eat healthily through incentives combined with taste exposure can increase both intake and liking. This randomized controlled trial was conducted to test the hypothesis that parent-administered repeated taste exposures to an initially disliked vegetable combined with reward will increase children’s liking and intake in a home setting. Families with children aged 3–4 years (n = 173) were randomly assigned to exposure + tangible reward (sticker), exposure + social reward (praise), or no-treatment control conditions after a pretest assessment in which a target vegetable was selected for each child. In the intervention groups, parents offered their children 12 daily tastes of the vegetable, giving either praise or a sticker for tasting. The exposure + tangible rewards group increased their intake (P = 0.001) and liking (P = 0.001) of their target vegetable significantly more than the control group. Differences were maintained at the three-month follow-up (intake: P = 0.005; liking: P = 0.001). No significant differences were found between the exposure + social reward and control groups. These findings support parental use of tangible rewards with repeated taste exposures to improve children’s diets.

Am J Clin Nutr. 2012 Jan;95(1):72-7. PMID: 22158728

In this study, a literature review and meta-analysis were conducted of randomized, double-blind, placebo-controlled trials that assessed the impact of probiotic intake during pregnancy on the development of eczema in children. A total of seven randomized, double-blind, placebo-controlled trials published between 2001 and 2009 were selected from the PubMed and Ovid databases for the meta-analysis. Study selection, quality appraisal, and data extraction were performed independently and in duplicate.

The development of atopic eczema in children whose mothers took probiotics during pregnancy was compared to placebo and results revealed a significant risk reduction for atopic eczema in children aged 2–7 years by the administration of probiotics during pregnancy (reduction 5.7 %; P = 0.022). However, this effect was only significant for lactobacilli (reduction 10.6 %; P = 0.045) and not for a mixture of various bacterial strains as probiotics (difference 3.06 %; P = 0.204). The authors concluded that the administration of lactobacilli during pregnancy prevents childhood atopic eczema but interestingly, a mixture of various bacterial strains does not affect the development of atopic eczema, independent of whether they contain lactobacilli or not. Br J Nutr.

2012 Jan;107(1):1-6. PMID: 21787448

Antioxidant supplementation after breast cancer diagnosis and mortality The current study examined the associations between antioxidant use after breast cancer (BC) diagnosis and BC outcomes in the Life After Cancer Epidemiology (LACE) cohort.

The cohort included 2264 women who were diagnosed with early stage primary BC from 1997 to 2000 who enrolled, on average, two years post-diagnosis. Antioxidant supplement use after diagnosis was reported by 81% of women. Among antioxidant users, frequent use of vitamin C and vitamin E was associated with a decreased risk of BC recurrence (vitamin C: HR 0.73; 95% CI 0.55-0.97; vitamin E: HR 0.71; 95% CI 0.54-0.94) and vitamin E use was associated with a decreased risk of all-cause mortality (HR 0.76; 95% CI 0.58-1.00).

Conversely, frequent use of combination carotenoids was associated with increased risk of death from BC (HR 2.07; 95% CI 1.21-3.56) and all-cause mortality (HR 1.75; 95% CI 1.13-2.71). Therefore, the effects of antioxidant supplement use after diagnosis likely differ by type of antioxidant; frequent use of vitamin C and vitamin E in the period after BC diagnosis may decrease the likelihood of recurrence, whereas frequent use of combination carotenoids may increase mortality. Cancer. 2011 Sep 27. PMID: 21953120

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RESEARCH NEWS

Ursodeoxycholic acid with vitamin E is a potential treatment for nonalcoholic steatohepatitis

Acupuncture improves pregnancy rates in women undergoing IVF: a systematic review and meta-analysis

Randomized controlled studies investigating the effect of ursodeoxycholic acid (UDCA) and vitamin E on nonalcoholic steatohepatitis (NASH) have produced inconsistent results. The long-term tolerability and efficacy of this therapeutic combination were investigated in this study. Subjects included adult patients (n = 101) with persistent elevation of serum aminotransferases (AST and ALT) and/or γ glutamyl-transferase (GGT), in whom a histological diagnosis of NASH was made between 1998 and 2009, and who were treated with a combination of UDCA and vitamin E. UDCA and vitamin E were well tolerated (5% withdrawal for side effects). Mean serum AST, ALT, and GGT levels (expressed as times of Upper Normal Limit) diminished significantly (1.39 ± 0.74 to 0.78 ± 0.34 for AST; 1.72 ± 0.92 to 0.91 ± 0.69 for AST; and 3.25 ± 2.85 to 1.30 ± 1.30 for GGT). AST, ALT, and GGT reached normal range in 80%, 70%, and 65% of the patients, respectively. From the ten patients who had a second liver biopsy during follow-up, NAFLD activity score improved in seven, and worsened in one. The combination of UDCA with vitamin E is well tolerated and seems to improve liver function tests. Clin Res Hepatol Gastroenterol. 2011 Dec 7. PMID: 22154224

The current systematic review and meta-analysis of 24 trials (n = 5807 participants) was conducted to evaluate the effect of acupuncture on in vitro fertilization (IVF) outcomes. Subjects included women undergoing IVF in randomized controlled trials who were evaluated for the effects of acupuncture on IVF outcomes. The intervention groups used manual, electrical, and laser acupuncture techniques and the control groups consisted of no, sham, and placebo acupuncture. The major outcomes were clinical pregnancy rate (CPR) and live birth rate (LBR). The pooled CPR (23 studies), but not the LBR (six studies) from the acupuncture groups was significantly greater than that from all of the control groups. The results differed with type of control used; the CPR and LBR differences between groups were more obvious and the LBR results tended to be significant when the acupuncture was performed around the time of oocyte aspiration or controlled ovarian hyperstimulation when the studies using the Streitberger control were ignored. The authors concluded that based on the results of studies that do not include the Streitberger control, acupuncture seems to improve CPR and LBR among women undergoing IVF. Fertil Steril. 2012 Jan 11. PMID: 22243605

Physical activity and performance at school: a systematic review The current study was conducted to describe the prospective relationship between physical activity and academic performance. Prospective studies reporting at least one physical activity or physical fitness measurement and at least one academic performance or cognition measure during childhood or adolescence were identified from searches in PubMed, PsycINFO, Cochrane Central, and Sportdiscus from 1990 through 2010. Titles and abstracts were screened for eligibility and the methodological quality of the studies was rated. Ten observational and four intervention studies were identified. The quality score of the studies ranged from 22% to 75% and two studies were scored as high quality.

Methodological quality scores were particularly low for the reliability and validity of the measurement instruments. Based on the results of the best-evidence synthesis, the authors found evidence of a significant longitudinal positive relationship between physical activity and academic performance and concluded that participation in physical activity is positively related to academic performance in children. Because only two high-quality studies were found, future high-quality studies should be conducted to confirm these findings. These studies should thoroughly examine the dose-response relationship between physical activity and academic performance and provide explanatory mechanisms for this relationship. Arch Pediatr Adolesc Med. 2012 Jan;166(1):49-55. PMID: 22213750 30 | IHP April/May 2012 } ihpmagazine.com

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Osteo Basics Monograph SISU Osteo Basics is a calcium and trace mineral formula intended to support bone health.

Each tablet contains:

calcium (from calcium citrate and calcium malate) 300 mg magnesium (from magnesium citrate and magnesium malate) 50 mg vitamin D3 200 IU zinc citrate 5 mg copper citrate 1 mg

Calcium, trace minerals and bone health

Supplementation with calcium and trace minerals has been found to help preserve spinal bone density in postmenopausal women.

Vitamin D is involved in calcium absorption and helps maintain the health of bones. Magnesium is involved in the metabolism of calcium and vitamin D as well as the secretion and activity of parathyroid hormone (PTH) which, when elevated (increase in PTH commonly occurs with age) can lead to loss of bone minerals. Magnesium supplementation has been shown to suppress PTH and decrease markers of bone turnover. Magnesium is also required for the proper hydroxylation of vitamin D to its active form. Zinc and copper are essential cofactors in the synthesis of the bone matrix, partially due to their importance in collagen formation.

Doses and directions: 3 tablets per day

Purity

Quality Assurance Total aerobic count

<3,000 cfu/g

Escherichia coli

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Salmonella

Negative

Staphylococcus aureus

Negative

Total Yeast & Mold Count

<300 cfu/g

Arsenic

<0.14 µg/kg b.w./day

Cadmium

<0.09 µg/kg b.w./day

Lead

<0.29 µg/kg b.w./day

Total Mercury

<0.29 µg/kg b.w./day

References Strause et al. Spinal bone loss in postmenopausal women supplemented with calcium and trace minerals.

J Nutr 1994;124:1060-64 Dimai et al. Daily oral magnesium supplementation suppresses bone turnover in young adult males.

J Endocrinol Metab 1998;83:2742-48) Aydin et al Short-term oral magnesium supplementation suppresses bone turnover in postmenopausal osteoporotic women.

Biol Trace Elem Res 2010 Feb;133(2):136-43. Epub 2009 Jun 2.

Lowe et al. Is there a potential therapeutic value of copper and zinc for osteoporosis?

Proc Nutr Soc. 2002 y;61(2):181-5.

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RESEARCH NEWS

Inappropriate food choices significantly contribute to the salt intake of eightmonth-old infants Excessive intake of sodium can lead to potential harmful effects on the developing kidneys and blood pressure in later life.

Sodium intakes were examined in infants in the current study to establish if inappropriate feeding practices are contributing to high intakes. Data were collected from a cohort of eightmonth-old infants (n = 1178) born in 1991 and 1992 participating in the Avon Longitudinal Study of Parents and Children, using three-day dietary records completed by their mothers. The majority of infants were first introduced to solids around 3–4 months, with plain baby rice, rusks, and other cereals being the first foods consumed. Seventy percent of infants consumed more than 400 mg sodium per day and the mean intake for the highest quartile was 1060 mg per day. Infants in this quartile were often consuming cows’ milk as a main drink, eating three times the amount of bread compared with the lowest quartile, and using salty flavorings such as yeast extract and gravy. Sodium intakes in this cohort of infants were higher than recommendations and clear and practical education is needed for mothers to highlight what foods to introduce and when. Eur J Clin Nutr. 2012 Jan;66(1):104-10. PMID: 21772314

Bariatric surgery reduces long-term cardiovascular events Although obesity is a risk factor for cardiovascular events, solid evidence regarding the protective role of weight loss is lacking.

The current study was conducted to investigate the association between bariatric surgery, weight loss, and cardiovascular events. The Swedish Obese Subjects (SOS) study is an ongoing, nonrandomized, prospective, controlled study. Conducted at 25 public surgical departments and 480 primary health care centers in Sweden, it includes 2010 obese participants (body mass index of at least 34 in men and at least 38 in women) who underwent bariatric surgery and 2037 contemporaneously matched obese controls who received usual care. Bariatric surgery was associated with a reduced number of cardiovascular deaths (28 events in the surgery group versus 49 events in the control group; adjusted hazard ratio [HR] 0.47; 95% CI 0.29-0.76; P = 0.002). The number of total first time (fatal or nonfatal) cardiovascular events (myocardial infarction or stroke, whichever came first) was lower in the surgery group (adjusted HR 0.67; 95% CI 0.54-0.83; P < 0.001). The authors concluded that compared with usual care, bariatric surgery was associated with reduced number of cardiovascular deaths and lower incidence of cardiovascular events in obese adults. JAMA. 2012 Jan 4;307(1):56-65. PMID: 22215166

Calcium and vitamin D supplementation is associated with decreased abdominal visceral adipose tissue in overweight and obese adult This study investigated the effect of calcium and vitamin D (CaD)-supplemented orange juice (OJ) on weight loss and reduction of visceral adipose tissue (VAT) in overweight and obese adults (n = 171). Two parallel, double-blind, placebocontrolled trials were conducted with either regular or reduced-energy (lite) OJ. Participants were randomly assigned to one of two groups; the treatment groups consumed three 240-mL glasses of OJ (regular or lite) fortified with 350 mg calcium and 100 IU vitamin D per serving and the control groups consumed either unfortified regular or lite OJ. Computed tomography scans of VAT and subcutaneous adipose tissue were performed by imaging a single cut at the lumbar four level. After 16 weeks, average weight loss (~2.45 kg) did not differ significantly between groups. The reduction of VAT was significantly greater in both the regular (P = 0.024) and lite (P = 0.039) OJ trials in the CaD group compared to the control group.

The effect of CaD on VAT remained significant when the results of the two trials were combined (P = 0.007). These findings suggest that calcium and/or vitamin D supplementation contributes to a beneficial reduction of VAT. Am J Clin Nutr. 2012 Jan;95(1):101-8.

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INDUSTRY NEWS Harper government invests in personalized medicine The Harper Government announced an important investment that will help Canadians receive more effective treatments and make the healthcare system more sustainable through personalized medicine.

Healthcare will evolve from a reactive “one-size-fits-all” system towards a system of predictive, preventive, and precision care.

Areas in which personalized approaches are particularly promising include oncology, cardiovascular diseases, neurodegenerative diseases, psychiatric disorders, diabetes and obesity, arthritis, pain, and Alzheimer’s disease. In all of these fields, and others, a personalized molecular medicine approach is expected to lead to better health outcomes, improved treatments, and reduction in toxicity due to variable or adverse drug responses. In addition to saving on the costs of expensive drug treatments, this personalized treatment would prevent a great deal of suffering, while identifying and initiating earlier treatments that would be more effective.

First patient dosed with oral AFN-1252 in a Phase 2 clinical trial Affinium Pharmaceuticals announced the commencement of a multi-center Phase 2 clinical trial evaluating oral AFN-1252 in acute bacterial skin & skin structure infections (“ABSSSI”). This trial is the first human efficacy study conducted with this new class of antibiotic and follows the recently completed Phase 1 trials which demonstrated excellent safety, tolerability, and pharmacokinetics of AFN-1252 in single and multiple ascending oral dosages. The Phase 2 study will confirm efficacy and tolerability of 200 mg of oral AFN-1252 dosed twice daily for 5 to 14 days in patients with staphylococcal skin infections. The trial will also evaluate both the traditional endpoints at end of treatment and early endpoints currently recommended by the FDA. “We’re on the cusp of delivering human proof-of-concept data for our antibiotic, AFN-1252, with its truly new mechanism of action and unique selective spectrum. Preclinical

animal data indicates AFN-1252 has mg/ kg efficacy that is significantly improved compared to linezolid; and both single and multiple dose Phase 1 data indicate an excellent safety and tolerability profile.

We are confident that the Phase 2 trial will confirm AFN-1252 as a potent and well tolerated anti-Staph antibiotic” commented Dr. Hafkin, Chief Medical Officer of Affinium Pharmaceuticals.

CMCC and UOIT create new professional pathway for qualified students A new articulation agreement between the Canadian Memorial Chiropractic College (CMCC) and the University of Ontario Institute of Technology (UOIT) will enable qualified students to complete a Bachelor of Health Sciences (Honours) in Kinesiology degree and a Doctor of Chiropractic degree in seven years, instead of eight. For individuals who identify their career path early, this agreement seamlessly bridges a foundational degree into a professional degree in chiropractic.

“UOIT and CMCC share a commitment to innovation in education,” said UOIT President Tim McTiernan, PhD. “This accelerated pathway will enable our students to further their education in less time so they can take an active role in helping others. In addition, cross appointments between our two institutions will enable the sharing of expertise and knowledge resources, allowing us to fully leverage the academic excellence resident at both institutions.” Acceptance into the CMCC-UOIT Bridging Program will begin in September 2012.

Atrium Innovations announces continued growth and record results in 2011 Atrium Innovations Inc., a globally recognized leader in the development, manufacturing, and commercialization of innovative, science-based dietary supplements, released its 2011 revenue results. For the fiscal year ended December 31, 2011, Atrium recorded revenues of $414.7 million representing an increase of 16.3% compared to revenues of $356.6 million in 2010. This increase is mainly

attributable to the acquisition of Seroyal, as well as to organic growth of North American branded business and to the favorable impact of exchange rates. “2011 proved to be a year of important changes for Atrium. After completing a series of strategic acquisitions in the last few years, the time was right to alter our management structure and thereby optimize our business platform with increased emphasis on organic growth. We appointed a Head of Operations in both North America and Europe, and welcomed new corporate executives. This team will provide us with a structure precisely tailored to maximize our synergies and build an effective platform.

Atrium’s new ERP system implementation will be central to the new platform in North America. In this era of enhanced regulation, Atrium is advantageously positioned to reap the benefits of an industry which is increasingly gaining legitimacy and credibility,” said President and Chief Executive Officer, Pierre Fitzgibbon.

Harper government invests in suicide prevention On January 12, 2012, Leona Aglukkaq, Minister of Health, and Peter Penashue, Minister of Intergovernmental Affairs, announced funding for an initiative that aims to prevent suicide by rapidly gathering the best research on suicide prevention and making it available to community members and leaders who can put this information swiftly into action. The initiative is being carried out through the Evidence on Tap program by the Canadian Institutes of Health Research (CIHR). Through a competitive, peer-reviewed process, CIHR will support teams of researchers that will review and analyze research evidence from across the globe on suicide prevention.

Teams will be asked to specifically examine research on school and community-based approaches to suicide prevention, the role of media in preventing suicide, and interventions that focus on people at high risk for suicide. The teams will have six months to carry their work. They will be required to submit a report to CIHR and to hold a workshop to share their findings with stakeholders.

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For details, write #109 on Free Info Page, page 92.

IHPAPR2012_9157_Seabuckthorn_FP.indd 1

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Product MonograPh Bio-Fen SBT SeaBuckThorn Single Source capSuleS Bio-Fen Plus is an oral natural health product used in the treatment of hereditary androgenic alopecia (AGA) for male or female pattern baldness. increasing concentrations of seabuckthorn seed oil. Seabuckthorn oil Seabuckthorn oil hasAGA a longishistory of useand for the treatment of Without treatment, progressive, causes social distress in many affected men and women (Sinclair 1998). Bio-Fen Plus contains seed extracts was also able significantly activity of inhibitors the antioxidant inflammatory conditions of the skin, respiratory, andspecific vitamins. of fenugreek seeds, saw palmetto berries and flaxgastrointenstinal, lignans, as well as Eachtoingredient is increase known to possess of theenzymes enzyme superoxide dismutase,AGA. catalase, glutathione peroxidase and glutathione reproductive systems, amongst others (Suryakumar 2011). Seabuckthorn 5α-reductase.

These inhibitors are responsible for relieving symptoms associated with hereditary reductase. Liver glutathione contentthe washair alsofollicle increased, whereas hepatic oil is of a rich ofcauses omega-3 alphaloss linolenic acidlevel (ALA), which One the source primary of hair is a high of the maleprovides hormone dihydrotestosterone (DHT) within (Vierhapper, 2001). malondialdehyde (a marker of lipid peroxidation) was reduced (Ting a basis for its application in the treatment chronicnumber inflammatory For people with AGA, their follicles haveofa greater of androgen receptors to which DHT attaches.

5-α-reductase catalyzes the enzymatic 2011).

Figure 1 shows a summary of the mechanisms of action 1998). attributed conditions as as the maintenance of good health,which including conversion of well testosterone to dihydrotestosterone, bindshealthy to the receptor five-fold more avidly than the parent compound (Sinclair to Seabuckthorn oil (adapted from Suryakumar 2011). skin and mucus membranes (Suryakumar 2011, Ting 2011).

Saw palmetto (Serenoa repens) Standardized (lipophillic) Serenoa extract has been found to be a potent inhibitor phytochemistry of 5α-reductase, resulting in decreased tissue DHT. An open-label, dose response Seabuckthorn, also known as Hippophae rhamnoides, is a shrub study on 42 healthy males and to determine the effect of2011). a combination nativewas toconducted cold arid regions of Europe Asia (Suryakumar A of carotenoid astaxanthin and saw palmetto berry lipid extract on DHT and wide spectrum of pharmacological effects have been reported for SBT, testosterone levels (Angwafor 2008). The men were divided into two groups: including antioxidant, immunomodulatory, anti-atherogenic, anti-stress, one group received 800 mg/day of the combination supplement and the other hepatoprotective, and tissuefor repair effects (Suryakumar group received 2000radioprotective mg/day of the supplement 14 days.

ANOVA-RM showed significant within-group increases serum testeosteronealland 2011). Chemical analyses of the in plant havetotal demonstrated partssignificant to be decreases in serumsubstances DHT from baseline vitamins in both dose (P=0.05). There rich in bioactive including A, C,groups E, K, riboflavin, was significant difference betweenlycopene); dose groups with regard(ergosterol, to the increase of folicnoacid; carotenoids (carotene, phytosterols testeosterone or the decrease of DHT; therefore both doses were effective (Angwafor stigmasterol, lansterol, amyrins); organic acids (malic acid, oxalic acid); 2008).

polyunsaturated fatty acids including omega-3s; and some essential amino

acids (Listudy 2007,tested Suryakumar 2011).

Oiloffrom the seed is particularly Another liposterolic extract Serenoa repens (LSESr) andhigh betasitosterol in the treatment of males (23-64 years age) ALA) with mild to moderate in linoleic (18:2 n-6) and α-linolenic (18:3ofn-3, acids, while theAGA. Six of 10 (60%) subjects wereacid rated(16:1 as improved final (Ting visit, thus establishing pulp is rich in palmitoleic n-7, upattothe50%) 2011). the effectiveness of 5α-reductase inhibitors against AGA (Prager 2002). Chronic inflammation of the hair follicle is considered to be a contributing factor for AGA. A antioxidant study

by Chitturcapacity et al sought to determine whether blockade of inflammation using Studiesand in two animals have shown that seabuckthorn oil has significant LSESr anti-inflammatory agents (carnitine andseed thioctic acid) could alter antioxidant In models of of carbon tetrachloride (CCl4)-induced the expressioneffects. of molecular markers inflammation (Chittur 2009). It was found that the combination suppressed oil lipopolysaccharide-activated gene radical expression of oxidative stress, seabuckthorn was able to improve DPPH chemokines with pathways involvedactivity, in inflammation apoptosis. scavengingassociated activity, ferrous ion chelating reducingand power and The study concluded that 5-alpha reductase inhibitors in combination with inhibition of lipid peroxidation activity, in a dose-dependent manner with blockade of inflammatory processes could represent a new two-pronged approach in the treatment of AGA.

Vitamins In a PolishTrials study of 46 women who had symptoms of diffuse alopecia, calcium clinical pantothenate was orally administered twice acontrolled day in doses of administration 100 mg for four to In a randomized, double blind, placebo trial, five months, and vitamin B6 was injected every day for 20 to 30 days and repeated of seabuckthorn oil was able to improve mucus membrane function, as again after six months (Brzezińska-Wcisło 2001). It was determined that vitamin demonstrated a significant in symptoms of dry eyes,inasthewell B6 administeredby parenterally for reduction a few weeks induces improvement hairas effects onintear film of hyperosmolarity, a key factor condition a subset women and reduces hair loss. in dry eye. One hundred

subjects between the ages of 20 and 75 years who were experiencing dry eye symptoms were given 2g (2 capsules) of seabuckthorn oil or a placebo Medicinal Ingredients dose Per capsule oil daily for 3 months from fall to winter. Over the course of the study, Fenugreek (Trigonella foenum graecum) there was a general increase in tear film osmolarity. with the 260Compared mg seed extract placebo group,4:1 this increase was significantly less in the seabuckthorn oil group (P = 0.04).berry Theextract maximum intensities of redness Saw palmetto containing 160 mgand burning also tended to be lower in the seabuckthorn oil group: P = 0.04 for redness, 45% free fatty acids and P = 0.05 for burning. Researchers concluded that seabuckthorn oil oil Flax lignans, standardized to 20% “attenuated the increase in tear film osmolarity 100 during mgthe cold season and secoisolariciresinol diglucoside (SDG) positively affected the dry eye symptoms” (Larmo 2010).

D-calcium pantothenate (Vitamin B5)

10.40 mg

Dosage Niacinamide (Vitamin B3) 10.25 mg Seabuckthorn oil should be supplemented at a dose of 2g (equivalent to HClday.

(Vitamin B6) 2 mg 2Pyridoxine capsules) per Seabuckthorn oil is generally well tolerated, with no known adverse effects.

Riboflavin (Vitamin B2) 1.58 mg Folic acid

0.095 mg

Biotin 400 mcg Figure 1. Seabuckthorn Mechanisms of Action Fenugreek Seeds non-Medicinal Ingredients Fenugreek seeds contain 5% to 30% protein, steroid saponins, sterols, flavonoids INCREASED and alkaloids (notably trigonelline and choline). Steroid saponins bind and ANGIOGENESIS 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 cholesterol is eliminated, less DHT can beUPREGULATED made (Stark 1993). In a study of 20 ENDOBENOUSANTIOXIDANTS Recommended adult AMPLIFIED dose: One capsule per day adults who consumed 12.5g and 18.0g of germinated fenugreek seed powder for COLLAGEN SYNTHESIS one month, higher levels of consumption resulted in a significant reduction in total cholesterol and low-density lipoprotein (LDL) levels (Sowmya 1999).

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 significantly reduces circulating total and LDL-cholesterol concentrations (Pan REDUCED 2009). Flaxseed interventions reduced total and LDL cholesterol by 0.10SBT mmol/L LEAF AQUEOUS (95% CI: -0.20, 0.00 mmol/L)ROSMEDIATED and 0.08 mmol/L (95% CI: -0.16, 0.00 mmol/L), EXTRACT respectively. Significant reductionsINJURY were observed with whole flaxseed LYOPHILIZED (-0.21 and -0.16 mmol/L, respectively) and lignan (-0.28 and -0.16 mmol/L, respectively) supplements (Pan 2009).

ENHANCED EXPRESSION OF MMP-2 & MMP-9

References 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.

ACCELERATED WOUND CONTRACTION

AUGMENTED ECM-STABILIZATION

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.

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 Complement Alternat Med 2009.

IMPROVED RE-EPITHELIALIZATION

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.

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 treatment of androgenetic alopecia. J Altern Complement Med 2002;8:143-52.

References Serenoa repens monograph. Alternative Medicine Review 1998;3:227-9.

Ting HC, Hsu YW, Tsai CF, Lu FJ, Chou MC, Chen WK. The in vitro and in vivo antioxidant properties of seabuckthorn (Hippophae rhamnoides L.) seed oil. Food Chemistry 125 (2011) 652–659.

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.

Larmo PS, Järvinen RL, Setälä NL, Yang B, Viitanen MH, Engblom JR, Tahvonen RL, Kallio HP. Oral sea buckthorn oil attenuates tear film osmolarity and symptoms in individuals with dry

Stark Madar Z.Aug;140(8):1462-8.

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. eye. JA, Nutr.

2010

Li T, Beveridge T, Drover J. Phytosterol content sea buckthorn rhamnoidesinL.) seed oil: andand identification.

Chemistry 101 (2007) 1633–1639.

Vierpper H, Nowotny P, Maier H, Waldhausl W. of Production rates (Hippophae of dihydrotestosterone healthy menExtraction and women in men with Food male pattern baldness: determination by stable isotope/ dilution and mass spectrometry. J Clin Endocrinol Metab 2001;86:5762-4.

Suryakumar G, Gupta A. Medicinal and therapeutic potential of Sea buckthorn (Hippophae rhamnoides L.). J Ethnopharmacol. 2011 Nov 18;138(2):268-78.

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INDUSTRY NEWS Canadian researchers to test the safety of a new HIV vaccine Many researchers have tried and failed to create an HIV vaccination but researchers from the University of Western Ontario have been working on a vaccine, dubbed SAV001 that takes a different approach.

Developed by Dr. Chil-Yong Kang and his team over the last ten years, this vaccine uses the whole HIV virus that has been genetically engineered to be non-pathogenic. The idea is that the vaccine will prime the body’s T-cells to destroy any cells that might become infected with HIV. This vaccine has been shown to stimulate a strong immune response in preliminary animal toxicology tests but it will be several years before researchers will know whether it is effective in humans. The research team announced that they have received approval from regulators with the U.S. Food and Drug Administration to begin testing the experimental vaccine on humans. The Phase I clinical trial will involve 40 volunteers with HIV to test the safety of the vaccine. If reported to be safe, the next phases of study would test whether the vaccine is actually effective.

The vaccine was developed with support from Sumagen Canada, a biotech company established in 2008 specifically to support clinical development of Kang’s vaccine.

directive, which can include restricting the use of feeding tubes and ventilators.

More than half of the surgeons surveyed reported that they would not operate if an advance directive limited what could be done to keep a patient alive after surgery.

The researchers said such instructions can cause tension between the surgeon and the patient because it shows the patient may be unwilling to accept the therapies that come with high-risk operations. Ann Surg. 2011 Dec 1. PMID: 22167006

CMA releases social media guidelines for doctors The Canadian Medical Association (CMA) Board of Directors has approved Canada’s first-ever national social media guidelines to help doctors safely, effectively, and responsibly use tools such as Facebook, Twitter, and other forms of social media as they care for patients. The CMA’s document Social media and Canadian physicians - Issues and rules of engagement (http://www.cma.ca/socialmedia) provides practical considerations and outlines the potential benefits and drawbacks of social media for physicians. The document states “The reality is that individual doctors and medical organizations have to consciously decide if, why and how to use the various social media platforms.”

Study reveals that many surgeons do not discuss end-of-life care

Generic version of Plavix® will save the Canadian healthcare system over one billion dollars

A new survey published in the Annals of Surgery reveals that many surgeons fail to discuss their patients’ wishes in case a risky operation goes awry and even more surgeons would not operate if patients limited what could be done to keep them alive. Margaret Schwarze, an assistant professor at the University of Wisconsin School of Medicine and Public Health, and her colleagues asked 912 surgeons who regularly perform risky operations 14 questions on how they discuss a patient’s advance directives. More than four out of every five surgeons discussed which forms of life support the patients would like to limit but only about half asked specifically about the patient’s advance

The Federal Court of Canada recently ruled in favour of Apotex, clearing the way to deliver their generic version of Plavix®, Apo-Clopidogrel, to the Canadian market.

Apotex challenged the Sanofi-aventis Plavix® patents for over eight years, through two Federal Court systems and multiple levels of judicial review, including the Supreme Court of Canada. “Apotex is proud to have been the only generic company in Canada to have successfully taken on enormous risk and lead the legal pursuit to deliver a cost saving alternative to Plavix® for Canadians” stated Mr. Jack Kay, Apotex President. The Clopidogrel market in Canada is valued at over $300 million in annual brand sales.

Apotex’s successful litigation of the Plavix® patents comes seven years prior to all patents expiring and this represents an accumulative savings of an estimated one billion dollars to the Canadian healthcare system.

FDA advisers suggest revising popular birth control labels U.S. health advisers recommended a revision of labels for the new generation of widely used birth control pills that contain the compound drospirenone (i.e., Yaz, Yasmin). Although all common birth control pills increase women’s chances of getting blood clots, data has been mounting that reveals a higher risk linked with these newer pills. Outside experts advising the Food and Drug Administration agreed that the current, rather complex label does not adequately help women and doctors understand the risks and benefits of such pills. “[The label] is incredibly hard for physicians to read and if we think that patients are reading these and understanding these before making their decisions, we’re delusional,” said panel member Dr. Peter Kaboli, associate professor of internal medicine at the University of Iowa Caver College of Medicine. An FDA study conducted in 2011 found that women taking Yasmin were about twice as likely to develop venous or arterial thrombotic events (VTEs and ATEs) than women on older birth control. This study also estimated that 10 in 10,000 women taking the newer drug would get a blood clot per year, compared with about six in 10,000 women taking older contraceptives.

Pfizer’s Lyrica helps restless legs syndrome study Pfizer reported that Lyrica benefited patients with Restless Legs Syndrome in a late-stage clinical study of more than 700 patients. Lyrica, which is one of Pfizer’s top-selling products, is approved to treat diabetic nerve pain, pain after shingles, and fibromyalgia, among other conditions.

Pfizer said it does not have plans at this time to seek regulatory approval for Lyrica to address Restless Legs Syndrome. ihpmagazine.com { April/May 2012 IHP | 37

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For Details, write #114 on Free Info Page, page 96.

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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 2 058.IHP NAHS mono.indd 1 IHPAPR2012_10055_North_American_Herb_and_Spice_FP.indd 2

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INDUSTRY NEWS The Food Stress Index (FSI) set a new record in 2011 VARIUM, a consulting firm in social marketing, released the results of a series of surveys that reveal a revolution in eating habits since 2004. A 2011 survey of 300 adults in Montreal measured changes in choice of food in relation to ten risks (i.e., trans fats, salt, etc.) and ten benefits (i.e., omega-3, dietary fiber, probiotics, etc.). The Food Stress Index (FSI) is the sum of decisions not to buy or not to eat some food when it is related to a risk or, conversely, decisions to buy or to eat some food when it is associated with one of the scale’s benefits. Between 2007 and 2011, the FSI increased significantly with 90% of respondents having changed their eating habits based on a risk or benefit of food. In 2011, 83.2% of those surveyed decided not to buy or not to consume a food because it was linked to at least one dietary risk compared to 77.5% in 2004. In contrast, 93.2% of respondents from 2011, against 87.0% in 2007, claimed to have purchased or consumed a food to enjoy its benefits.

CMAJ top achievements in health research awards The Canadian Institutes of Health Research (CIHR) and the Canadian Medical Association Journal (CMAJ) have revealed the six recipients of the 2011 CIHR-CMAJ: Top Achievements in Health Research Awards. For the third year, a peer-review panel of Canadian and international experts selected exceptional individuals based on the considerable health impact of their work to benefit Canadians and others worldwide.

Among the six outstanding achievements selected, two received special mentions for their highest-ranking successes. Recipients included: Dr. Daniel Drucker for his innovative work in improving the lives of patients with type 2 diabetes (Toronto, Ontario); Dr. Gideon Koren and colleagues for revolutionizing the area of medication safety in pregnancy (Toronto, Ontario); Dr. Marvin Fritzler for identifying novel autoantigens that resulted in new diagnostic testing and biomarkers for autoimmune diseases (Calgary, Alberta); Dr. Terry Klassen and colleagues for improving health outcomes of acutely ill and injured children

visiting pediatric emergency departments (across Canada); Drs. Anthony Tang and George Wells for helping reduce cardiac mortality rates with resynchronization therapy and implantable defibrillators in heart failure (Ottawa, Ontario); and Dr. Michael Hill and colleagues for the Calgary Stroke Program (Calgary, Alberta) that has changed the face of stroke care by thoroughly integrating research and clinical care .

Advance® Xtra Performance (XP) male sling system launched in Canada American Medical Systems (AMS), a leading provider of world-class devices and therapies for male and female pelvic health has announced the Canadian launch of AdVance XP, a minimally invasive implant for the treatment of male stress urinary incontinence (SUI). Male SUI is a common side effect of prostate cancer and benign prostatic hyperplasia treatments, such as radical prostatectomy and transurethral resection of the prostate. Built on the success of the AdVance platform, AdVance XP incorporates additional features that are designed to deliver Xtra Performance for improved ease-of-use and clinical outcomes.

Enhancements include a redesigned sling that incorporates a new mesh designed to improve procedural reproducibility, longer arms that are easier to use in larger patients, and distinct tissue anchors designed to increase holding power during the critical healing period, following implantation. This latest Health Canada licensing and launch brings AdVance XP to North America for the first time and increases the total number of countries to twelve where this latest AMS innovation is being supplied to physicians and their patients.

Panel: Some men can delay prostate cancer treatment An independent panel of experts convened by the U.S. National Institutes of Health (NIH) has reported that men with low-risk prostate cancer may want to wait to see if their disease progresses before receiving treatment. The panel backed the so-called active monitoring approach to prostate

cancer treatment as a way to help men avoid the potential health consequences of treatment, which can include impotence and incontinence. Several studies have suggested that men are over-screened and over-treated for prostate cancer. “It’s clear that many men would benefit from delaying treatment,” said Dr. Patricia Ganz, a cancer prevention expert at the University of California Los Angeles, who chaired the NIH’s state-of-the-science panel on prostate cancer. The problem, said Ganz, is that there is no consensus on the best strategies for monitoring the progress of prostate cancer or on the benchmarks that should be used to determine when treatment is needed.

“We need to standardize definitions, group patients by their risks and conduct additional research to determine the best protocols for managing low-risk disease,” she said in a statement. The panel urged NIH for more research to clarify this matter.

WHO is deeply concerned by mutated birdflu research The World Health Organization (WHO) issued a stern warning at the end of December 2011 to scientists who have engineered a highly pathogenic form of the deadly H5N1 bird flu virus, saying that their work carries significant risks and must be tightly controlled. WHO reported that it is “deeply concerned about the potential negative consequences” of work by two leading flu research teams who had said earlier in the month that they found ways to make H5N1 into an easily transmissable form capable of causing lethal human pandemics. In its first comment on the controversy, the WHO said: “While it is clear that conducting research to gain such knowledge must continue, it is also clear that certain research, and especially that which can generate more dangerous forms of the virus...has risks.” H5N1 bird flu is extremely deadly in people who are directly exposed to it from infected birds but so far it has not yet naturally mutated into a form that can pass easily from person to person. Scientists fear that this kind of mutation is likely to happen at some point and will constitute a major health threat if it does. •

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PRODUCT PROFILES

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1. Active Green Tea

3. Cyto-Matrix - Omega-D3 Liquid Forte

Active Green Tea is a potent, standardized extract of green tea with high levels of the key active ingredient, epigallocatechin gallate (EGCG). Studies have found that individuals who consume large amounts of green tea live longer, develop less cancer, and have better cardiovascular health. Green Tea has been shown to have antioxidant, anti-inflammatory and anti-cancer properties. In addition to this, green tea extracts have powerful antimicrobial effects and can help the body to fight off infections. Studies have found that to fully reap the health benefits of green tea, ten or more cups must be consumed per day. AOR’s Active Green Tea provides this dose in a convenient capsule form. For more information write 120 on page 92.

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. For more information write 122 on page 92.

2. Omega 800 Omega 800 is a unique blend of fish oils from sardine and anchovy to specifically assist in promoting healthy mood balance and to maintain overall cardiovascular health in reducing high serum triglycerides/triacylglycerols levels. Omega 800 yields 800 mg EPA (Eicosapentaenoic Acid) and DHA (Docosahexaenoic Acid) per capsule (525 mg EPA, 275 mg DHA). Omega 800 is naturally flavoured with essential oil of orange and does not have a fishy aftertaste. In addition, the fish gelatin capsule format offers less repeat. Omega 800 also contains naturally mixed tocopherols that protect against oxidation and thus enhance product freshness and stability. A great clean taste is maintained throughout the entire shelf life of the Omega 800. GENESTRA BRANDS™ Omega 800 is involved in stringent quality assurance protocols that independently test and certify products for proven quality, purity and label claims.

For more information write 121 on page 92.

4. Recovery SAP Intensive probiotic therapy for gastrointestinal recovery.

NFH’s Recovery SAP is a 50billion CFU probiotic specifically formulated for post-antibiotic recovery of healthy gastrointestinal flora. Its enteric-coated capsule ensures optimal delivery to the intestinal tract. Recovery SAP may also be used in the treatment of irritable bowel syndrome and inflammatory bowel diseases, or in cases of acute gastrointestinal distress. For more information write 123 on page 92.

5. Optimal Health Multi 1 & 2 Two unique products formulated in collaboration with doctors from InspireHealth Integrative Cancer Care Centre. SISU Optimal Health Multi 1 is a multi vitamin and mineral combination to support the body’s healing systems. Optimal Health Multi 2 is a powerful antioxidant formula to support the body’s immune system.

Both products provide therapeutic levels of ingredients, are safe for people with chronic disease and pose a low risk of drug interaction.

Visit sisu.com or call 800.663.4163 for more information. For more information write 124 on page 92. ihpmagazine.com { April/May 2012 IHP | 41

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1. QÜELL – Not just another fish oil QÜELL FISH OIL is a Supercritical CO2 triglyceride fish oil.

Unique among other fish oils for its critical extraction, purity, bioavailability and concentrations. Critical Concentration: The Supercritical CO2 process is able to create highly concentrated levels of EPA and DHA in triglyceride form. The result is a product that can deliver significant amounts of EPA and DHA in easy to swallow softgels. For more information write 125 on page 92.

2. XanthiTrim XanthiTrim reduces fatty liver, supports thermogenesis and the body’s natural ability to metabolize fat. What is XanthiTrim? A clinically researched patented combination of brown seaweed extract, fucoxanthin, pomegranate seed oil and GreenSelect® Phytosome.

Features 300 mg of clinically researched Xanthigen® and 150 mg of GreenSelect® Phytosome; Improves non alcoholic fatty liver and fat metabolism; Supports reaching a healthy weight; Enhances resting energy expenditure; A vegetarian, liquid-filled Caplique® Capsule.

For more information write 126 on page 92.

3. Cal Mag Raspberry Liquid Cal Mag Raspberry Liquid is a delicious, natural raspberry-flavoured comprehensive bone support formula that contains calcium and magnesium along with a therapeutic dosage of vitamin D. Calcium and magnesium are delivered in citrate form providing superior

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bioavailability and moderate protection from bone loss. Calcium intake, when combined with sufficient vitamin D, a healthy diet, and regular exercise, may reduce the risk of developing osteoporosis.

Magnesium helps in the development and maintenance of bones and teeth. For more information write 127 on page 92.

4. SISU To Go Ester-C® Energy Boost Bring your water to life with Ester-C® Energy Boost. A daily vitamin drink mix that mixes easily in water and provides a healthy, natural alternative to pre-bottled drinks. Each convenient packet contains 1,000 mg of clinically-proven Ester-C® and is enhanced with vitamins, minerals, and electrolytes. Available in natural orange or wildberry flavour. Visit sisu.com or call 800.663.4163 for more information. For more information write 128 on page 92.

5. greens+ O Introducing NEW greens+ O! Containing 75-80% organic ingredients, greens+ O is a great tasting, soy free, dairy free, gluten free, 100% Vegan formulation and like all greens+, is made with non-GMO ingredients. Genuine Health kept the foundation of the award-winning, research-proven greens+ formula, but replaced potential allergens with innovative ingredients, such as organic spirulina, broccoli sprouts, chia seeds, and sunflower lecithin. genuinehealth.com. For more information write 129 on page 92.

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PRODUCT PROFILES

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1. SafSlim SafSlim is a revolutionary breakthrough in targeted belly fat science, the first-ever solution to target the root causes of unsightly and health threatening belly fat. SafSlim’s unique ingredient has been shown in a major university study to reduce belly fat by up to 9.4%, in only 16 weeks, with NO changes in diet or exercise. SafSlim is the most effective way to transform your belly…naturally! For more information call 1.800.665.3414 or visit www.safslim.ca. For more information write 130 on page 92.

2. Alive Herbs “Nature’s Way has been North America’s Leader in herbal medicine for over 40 years. As the pre-eminent provider of health and healing through the power of nature, our commitment to quality reflects our commitment to you.” Our Standardized Extracts are guaranteed to contain the amount of active compound for targeted herbal therapies. Our Herbal Singles are made up of pure, potent plant supplements. And our Herbal Formula’s are used to target specific health concerns. That is why can always “Trust the Leaf ”! For more information write 131 on page 92.

3. 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

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Cellsper Capsule Enteric Coated Vegetarian Capsules Only 0.5 mg of FOS per Capsule Available in 60 and 100 capsule bottles. For more information write 132 on page 92.

4. PASCOFLAIR PASCOFLAIR is a unique preparation containing 425mg of Passionflower extract. As a widely used herb, Passionflower provides fast and effective relief. Studies have shown passionflower has anxiolytic effects equal to diazepam, oxazepam, and mexazolam with a better safety profile than these medications. Extracts from passionflower have also shown promise in the treatment of opiate, benzodiazepine, and nicotine withdrawal in mice and humans.

PASCOFLAIR won the 2009 “Apotheken-Award” for Natural Medicine – an honor chosen by German pharmacists each year for the best in natural medicine. For more information write 133 on page 92.

5. NAC NAC is N-Acetyl-L-Cysteine, a stable and easily absorbed form of the amino acid cysteine, which is used in the body to produce glutathione (GSH), a powerful and essential antioxidant in the body. NAC has also been shown to support cardiovascular health by lowering lipoprotein-a levels and preventing cholesterol oxidation.

NAC is also very effective for supporting optimal immune function and promoting healthy liver function and detoxification. Finally, clinical trials have demonstrated the benefits of NAC in various breathing disorders, including asthma and bronchitis. AOR’s NAC provides an effective dose of 500mg of this beneficial nutrient per capsule. For more information write 134 on page 92. ihpmagazine.com { April/May 2012 IHP | 43

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COVER STORY

Dr Richard Nahas, md Seekers Centre for Integrative Medicine

By Philip Rouchotas MSc, ND Photography by Brittany Veinot

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COVER STORY

From Left to Right; Ashleigh Harvey, Dr. Haider Zaidan, Catherine Larrivee, Shadi Nahas, Dr. Richard Nahas, Anouk Chaumont, Dr. Hamed Sattari, Johanna Lynn, Madeline Rodriguez

n downtown Ottawa operates an exceptional facility of integrative medicine, established by the husband and wife team of Dr Shadi Nahas, PhD, Director of Research, and Dr Richard Nahas, MD, Medical Director. Richardâ&#x20AC;&#x2122;s training and continued commitment as an ER physician may not seem to be a typical path upon which a physician comes to embrace integrative medicine, yet it is precisely this path that the doctor credits with driving his vision of the facility existing today.

Following an undergraduate degree in biochemistry from Ottawa University, Richard attended medical school at the University of Toronto, completing his training in 1998. Typical of conventionallytrained physicians who go on to embrace integrative medicine, Richard felt there were gaps in knowledge during his training. His interest in integrative medicine began in his teen years in relation to application of principles of clinical nutrition in performance enhancement, sports psychology, and the notion of training the mind along with the body. He chose medicine as his path eager to

learn the intricacies of the human body and was disappointed with the relative lack of knowledge academia was able to impart. The focus was on describing disease, with very poor understanding of the underlying causes of the diseases being studied.

He found himself gravitating towards emergency medicine, feeling it was what conventional medicine did best. Seeking an opportunity to learn a broader understanding of medicine, Richard began to travel the world delivering his ER skills to areas

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COVER STORY

that seemed to require them most. His travels included elective study in Egypt, clinical rotation in Gaza, as well as service with Doctors Without Borders taking him to Johannesburg, Africa and the Amazon of South America. These travels further spurred his interest in integrative medicine. He found conventional medicines helped people in these settings in the short term, but felt the people were better served by their local medicines in terms of long term feasibility as well as chronic disease management.

Travel experiences taught Richard that political/ economic factors are at the heart of healthcare issues in developing nations, as opposed to more medicine serving as a viable solution. Also, the experiences exposed Richard to a wide array of local, traditional healing systems that he found intriguing.

Richard returned to his home town of Ottawa resolved to serve his community with integrated systems of healing. While conventional medicine inarguably offers world- class care in emergency settings, Canada is entrenched in epidemics of chronic illness- the arena where integrative medicine demonstrates its greatest strength. Richardâ&#x20AC;&#x2122;s opinions and perspective on the integrative versus conventional medicine debate are certainly strong, however shortcomings of conventional models of care are not where he chooses to apply his focus. â&#x20AC;&#x153;I must balance my feelings of how much change is requiredâ&#x20AC;?, Richard describes. ihpmagazine.com { April/May 2012 IHP | 47

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COVER STORY

“There are many challenges that surface in operating an integrative practice, including lack of recognition and understanding from peers, the reality of practicing in isolation and an inability to consult with colleagues for direction on difficult cases, but this is typical of individuals who choose the path of a pioneer”.

So we pose the question to Richard that surely it would be easier to remain in ER practice... “When you believe in what you are doing, you see results, you know in your heart it is a better system of medicine... you don’t have a choice, you can’t go back”, he replied.

Being critical of conventional medicine does not improve the situation, and in fact serves little purpose other than to make things worse. An integrative physician truly hoping to impact the healthcare system must make effort to work with the system around them, regardless of obstacles that may present before them.

Richard describes one example that exemplifies the requirement for integrative practitioners to consider efforts of collaboration among their highest priorities: “The Seekers Centre of Integrative Medicine served as one centre for the TACT trial of chelation in secondary coronary prevention.

One patient wanted to join the trial, but their local cardiologist instructed them not to join, stating that he did not believe in chelation. The cardiologist ended up being the chief cardiologist at the Ottawa Heart Institute. I undertook the task of contacting the cardiologist to discuss the role of chelation and the outcomes I had already witnessed it achieve in terms of angina treatment. We have since ended up being collaborators in many areas, he referred 50-60 patients that ended up as participants in the trial, and we are discussing conducting a trial together to assess vascular compliance at the Ottawa Heart Institute”.

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The Seekers Centre for Integrative Medicine team: Richard Nahas, MD – Medical Director Shadi Nahas, PhD – Director of Research Catherine Larrivee – Executive Director Brian Bailey, MD – Clinician Hamed Sattari, MD (Iran) – Clinical trial coordinator, auricular acupuncture Haider Zaidan, MD (Iran) – Clinical trial coordinator, auricular acupuncture Johanna Lynn – Hypnotist Christine Garand – Ayurvedic nutritionist Ashleigh Donato – Administrative Associate Team Leader Madeline Rodriguez – Office Assistant

Richard accurately outlined an embarrassing shortcoming of the naturopathic community that deserves discussion. He finds there is lacking a forum for ND’s to meet or collaborate in Ottawa, and feels as though local ND’s “seem to protect their turf ”. Sadly Richard, this seems to occur far too frequently across the country.

Richard describes himself as having an abundance mentality; “the more success integrated practitioners have, the more awareness is created for integrative practices as a whole”... He finds the lack of sharing of techniques among integrative practitioners frustrating.

We at IHP sincerely agree Richard. ND’s need to share more, turf protect less.

Richard was eager to share his vision of healthcare... He sees an ND in every group and family clinic across the country; a sure fire way to improve patient outcomes and decrease healthcare costs.

He highlights that the more severe the case, the greater impact on outcomes and cost savings the ND is likely to deliver. We agree with you yet again, Richard.

With the Seekers Centre having “paid its dues” in the local community and reaching a state of success it and its associates are pleased with, Richard devotes further resources to the task of integration with local conventional institutions. Reaching conventional physicians, one-at-a-time in practice settings, en-mass through lectures at Ottawa University School of Medicine, Richard hopes to see integrated medical practices reaching all patients in all settings. He maintains rotations as an ER physician in further effort of maintaining relationships with conventional practitioners and institutions, “and I manage to squeak in a little integrative medicine with each patient, such as exercise and B vitamins for mental illness, probiotics and gluten avoidance in inflammatory bowel disease”...

The path of a pioneer is difficult indeed. Obstacles can too often cause such individuals to become jaded... They continue to deliver what they believe, yet retract from convention out of frustration. Richard showcases an infinitely more positive and productive strategy in facing such obstacles. Seeking, building, and maintaining relationships with established convention is the true key to disseminating the ideal you know to be best. One patient at a time, one physician at a time, knowledge spreads.

Physicians initially opposed to integrative medicine often do so out of lack of knowledge and a belief that integrative medicine is the horror stories they hear in the media. Being reached by a like- trained colleague who discusses strategies objectively at the very least establishes curiosity in doubters... Often, curiosity breeds investigation. Investigation uncovers a surprisingly welldeveloped evidence- base. And before you know it doubters are your colleagues. • ihpmagazine.com { April/May 2012 IHP | 49

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For details, write #111 on Free Info Page, page 92.

ITI Cortisol Manager ad for ETCanada.indd 1 IHPAPR2012_9656_Enzymatic_ITICortisol_Manager.indd 1

11/2/112:13:56 10:06 PM AM 4/5/12

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: · 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* 5

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.

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6.

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8.

9.

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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.

IHPAPR2012_9656_Enzymatic_ITICortisol_Manager.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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CLINIC PROFILE

Fredericton Naturopathic Clinic Excellence in naturopathic medicine delivered to an under-serviced community

By Angela MacNeil, MSc, ND Photography by Kandise Brown

IHP is striving to highlight clinics from across Canada, which brings us to the Fredericton Naturopathic Clinic in New Brunswick. Opened by Naturopathic Doctors Parissa and Judah Bunin in 2003, the clinic can be found in the Kchikhusis Centre, which is located on a First Nation’s reserve within the city of Fredericton, and is easily accessible from both the north and south sides of the beautiful Saint John River that runs through the city.

After becoming naturopathic doctors, this husband and wife team moved to Fredericton to open up their clinic because they felt a need to strengthen the profession in New Brunswick. At that time, the

population was very conservative regarding naturopathic medicine and relatively few naturopathic doctors focused on evidencebased medicine. Therefore, the Bunins considered themselves “pioneers” and decided to focus their treatment approach on those naturopathic therapies with the most scientific support. As the clinic has evolved, they have witnessed an evolution in the public’s perception of the profession. The clinic staff has been working hard to develop trust in their community. This trust continues to strengthen as evidenced by increasing numbers of referrals in recent years from medical doctors, pharmacists, physiotherapists, acupuncturists, and massage therapists, among others.

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CLINIC PROFILE In addition to being a naturopathic doctor, Parissa is also a registered massage therapist. Her strong background in physical medicine has influenced the modalities practiced at the clinic where physical modalities, such as ultrasound and electrical stimulation are employed frequently. The clinic also expanded to include another registered massage therapist, Emily Durling.

The Fredericton Naturopathic Clinic has seen a slow, steady growth over the past 11 years and currently, 40 to 50 patients are seen each week. Judah and Parissa are happy with this rate of growth because upon opening their practice, they agreed that they did not want the clinic to grow too big too quickly as they had young children and placed a great importance on family life and community involvement.

The small clinic is now at the point where it is advancing into different special areas of focus. Parissa recently completed a parenteral therapy course in Ontario, while Judah plans to focus more on oncology and recently attended the Oncology Association of Naturopathic Physician’s inaugural convention. Judah notes that no naturopathic doctors in the Fredericton area have expertise in oncology, so there is a void that needs to be filled.

The Fredericton Naturopathic Clinic is 850 square feet with two large treatment rooms, a reception area, and a dispensary. The dispensary carries a variety of different products that include both professional and retail lines, such as AOR, Thorne, Seroyal, Vitazan, St. Francis, Sisu, Natural Factors, and Trophic. The practitioners felt that it was necessary to carry retail lines in an effort to increase convenience for patients while also providing some affordable alternatives to potentially more expensive items.

Being cognizant of financial realities in Fredericton, a limited number of integrative tests are performed, such as food sensitivities, salivary hormones, urinary neurotransmitters, stool analyses, and finger-prick vitamin D from such laboratories as Rocky Mountain Analytical, Neuroscience, Doctor’s Data, and ZRT.

Judah and Parissa are registered with the Board of Directors of Drugless Therapy-Naturopathy (BDDT-N) in Ontario, since naturopathic medicine is unregulated in New Brunswick. They wanted to register with the BDDT-N as it provides assurance to the public that they have, in fact, received the necessary education and passed the board exams required of naturopathic doctors in regulated provinces. They are also actively involved with the New Brunswick Association of Naturopathic Doctors, where Parissa has served as Treasurer and Judah is the current President. This association is working hard to achieve the goal of regulating naturopathic medicine, which has required a significant investment of time and energy by the Bunins, but they are optimistic that regulation might be a reality within the next one to two years.

The Bunins also keep busy by teaching science-based courses at the Atlantic College of Therapeutic Massage. Judah teaches biology, physiology, pathology, nutrition, and research literacy, while Parissa teaches pharmacology, microbiology, and communications.

Judah also dedicates a few hours each week conducting research at the college. In fact, he is currently involved in a joint project with the Kinesiology Department at the University of New Brunswick to study the physiological effects of massage on circulation in fibromyalgia patients. As the research coordinator at the college, he was heavily involved in designing the study and writing the grant that ultimately awarded the research team $15 000 to conduct this research. The team has presented its findings at three different conferences, including last year’s Health Fusion in Calgary, and will soon be submitting a manuscript to a peer-reviewed journal.

IHP has great respect for practitioners who are trying to increase awareness and acceptance of evidence-based integrated therapeutics, so we commend the Fredericton Naturopathic Clinic for all of its efforts. We wish them much success and thank them for allowing us to draw attention to a successful naturopathic practice in an under-serviced province. •

The team at the Fredericton Naturopathic Clinic: Parissa Bunin, BSc, RMT, ND, DrAc Judah Bunin, BScH, MSc, ND, DrAc Emily Durling, RMT Erin Hamilton, Administrative Assistant

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METAGENICS NUTRAGEMS COQ10 300 NutraGems by Metagenics features chewable gels containing advanced, emulsified Coenzyme Q10 (CoQ10) designed to provide general support for cardiovascular health, energy production, antioxidant protection, and overall wellness and healthy aging.

CoQ10, also known as ubiquinone, is a fat-soluble substance present in most human cells, with the highest concentrations in the heart, liver, kidney, and pancreas (Aberg 1992). CoQ10 is synthesized in the human body and is also obtained from the diet. Meat, fish, nuts, and some oils are the main dietary sources of CoQ10 (Pravst 2010). CoQ10 is an essential cofactor in the synthesis of mitochondrial adenosine triphosphate (ATP) and therefore a key component of the mitochondrial respiratory chain (Ernster 1995). Since most cellular functions depend on adequate supply of ATP, CoQ10 is essential for the health of virtually all tissues and organs. CoQ10 as the reduced form is also an antioxidant, protecting membranes from oxidation (Mellors 1966), inhibiting the peroxidation of lipoprotein lipids (Stocker 1991), and may also have a role in regenerating other antioxidants such as vitamin E (Sohal 2004).

Due to its lipophilicity and high molecular weight, CoQ10 from oral supplementation is absorbed slowly from the gastrointestinal tract; the uptake mechanism is similar to that of vitamin E. Depending on the delivery forms of CoQ10, the Tmax is approximately 6 â&#x20AC;&#x201C; 8 h (Bhagavan 2006). CoQ10 is transported via the lymphatics to the circulation (Katayama 1972). The majority of CoQ10 is eliminated via biliary and fecal excretion. The elimination half-life is approximately 33 â&#x20AC;&#x201C; 34 h (Tomono 1986; Greenberg 1990).

Genetic CoQ10 deficiencies can occur as a result of defects of ubiquinone biosynthesis (primary deficiencies) or due to other causes (secondary deficiencies); major clinical phenotypes include encephalomyopathy, severe infantile multisystemic disease, cerebellar ataxia, isolated myopathy, and nephritic syndrome (Quinzii 2011). Various studies have shown that oral administration of CoQ10 improves signs and symptoms associated with CoQ10 deficiencies (Quinzii 2011).

Hydroxymethylglutaryl coenzyme A (HMG CoA) reductase inhibitors, or statins, inhibit the synthesis of cholesterol by inhibiting mevalonate, a main precursor of both cholesterol and CoQ10. Studies have shown that statin therapy reduced serum and muscle CoQ10 levels (Folkers 1990; Ghirlanda 1993; Watts 1993; Paiva 2005). It has been hypothesized that mitochondrial dysfunction through depletion of CoQ10 is one underlying pathophysiology of statin-induced myopathy (Thompson 2003). Preliminary clinical trials have found CoQ10 prevent or improve statin-associated myalgic symptoms (Thibault 1996; Kim 2001; Caso 2007).

Because of its bioenergetic role and antioxidant properties, CoQ10 has been investigated in numerous studies for its potential benefit for cardiovascular health. A recent meta-analysis based on 12 clinical trials found that CoQ10 had the potential to lower systolic and diastolic blood pressure in hypertensive patients (Rosenfeldt 2007); this effect is likely related to the improvement in endothelial function (Tiano 2007). Myocardial depletion of CoQ10 has been observed in heart failure and the severity of symptoms is associated with the severity of CoQ10 deficiency (Folkers 1985). At least 2 meta-analyses investigating CoQ10 supplementation in chronic heart failure reported improvement in stroke volume, ejection fraction, cardiac output, cardiac index, or end diastolic volume index (Soja 1997; Sander 2006). CoQ10 may be valuable as an adjunctive clinical therapy of cardiovascular disease (Greenberg 1990; Langsjoen 1999; Molyneux 2008). Health Canada Natural Health Product monograph states that CoQ10 helps maintain and/or support cardiovascular health (HealthCanada 2007).

Two clinical studies found that CoQ10 supplementation may be efficacious in preventing migraine headaches (Rozen 2002; Sandor 2005). One larger study found that CoQ10 deficiency may be common in pediatric and adolescent migraine, and CoQ10 supplementation may result in clinical improvement (Hershey 2007).

Health Canada Natural Health Product monograph states that CoQ10 helps reduce the frequency of migraine headaches and associated nausea and vomiting when taken as a prophylactic (HealthCanada 2007).

Mitochondrial respiratory chain dysfunction and oxidative stress are key features of some neurodegenerative disorders. Preliminary data from pilot clinical trials of high-dose CoQ10 for early-stage patients showed some potential benefit of CoQ10 in improving motor function, slowing progression, and improving some clinical symptoms (Beal 2002; Shults 2002; Horstink 2003). Large-scale controlled trials investigating CoQ10 and neurodegenerative health are currently underway.

Preliminary data also found that CoQ10 may improve semen quality, sperm count, or sperm motility in infertile men with idiopathic oligoasthenoteratospermia (Balercia 2009; Safarinejad 2009). There are other preliminary data indicating a potential benefit of CoQ10 in several other indications (Littarru 2010).

CoQ10 has an excellent safety record. It is well tolerated, with few potential drug interactions. Only minor adverse effects such as gastrointestinal upset and headache were reported (Rosenfeldt 2007).

NutraGems CoQ10 300 ingredients (per 1 chewable gel) Ingredient Dose Unit Calories 5 kcal Sugar alcohol 0.5 g Coenzyme Q10 300 mg

References

Aberg, F., E. L. Appelkvist, et al. (1992). Arch Biochem Biophys 295(2): 230-4.

Balercia, G., E. Buldreghini, et al. (2009). Fertil Steril 91(5): 1785-92.

Beal, M. F. (2002). Free Radic Res 36(4): 455-60.

Bhagavan, H. N. and R. K. Chopra (2006). Free Radic Res 40(5): 445-53.

Caso, G., P. Kelly, et al. (2007). Am J Cardiol 99(10): 1409-12.

Ernster, L. and G. Dallner (1995). Biochim Biophys Acta 1271(1): 195-204.

Folkers, K., P. Langsjoen, et al. (1990). Proc Natl Acad Sci U S A 87(22): 8931-4.

Folkers, K., S. Vadhanavikit, et al. (1985). Proc Natl Acad Sci U S A 82(3): 901-4.

Ghirlanda, G., A. Oradei, et al. (1993). J Clin Pharmacol 33(3): 226-9.

Greenberg, S. and W. H. Frishman (1990). J Clin Pharmacol 30(7): 596-608.

HealthCanada. (2007). "Natural Health Product Monographs: Coenzyme Q10." Retrieved March 5, 2012,

IHPAPR2012_9314_Metagenics_NaturaGems_CoQ10_FP.indd 2

from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licenprod/monograph/mono_coenz-q10-eng.php.

Hershey, A. D., S. W. Powers, et al. (2007). Headache 47(1): 73-80.

Horstink, M. W. and B. G. van Engelen (2003). Arch Neurol 60(8): 1170-2; author reply 1172-3.

Katayama, K. and T. Fujita (1972). Chem Pharm Bull (Tokyo) 20(12): 2585-92.

Kim, W. S., M. M. Kim, et al. (2001). Invest New Drugs 19(1): 81-3.

Langsjoen, P. H. and A. M. Langsjoen (1999). Biofactors 9(2-4): 273-84.

Littarru, G. P. and L. Tiano (2010). Nutrition 26(3): 250-4.

Mellors, A. and A. L. Tappel (1966). J Biol Chem 241(19): 4353-6.

Molyneux, S. L., J. M. Young, et al. (2008). Clin Biochem Rev 29(2): 71-82.

Paiva, H., K. M. Thelen, et al. (2005). Clin Pharmacol Ther 78(1): 60-8.

Pravst, I., K. Zmitek, et al. (2010). Crit Rev Food Sci Nutr 50(4): 269-80.

Quinzii, C. M. and M. Hirano (2011). Biofactors 37(5): 361-5.

Rosenfeldt, F. L., S. J. Haas, et al. (2007). J Hum Hypertens 21(4): 297-306.

Rozen, T. D., M. L. Oshinsky, et al. (2002). Cephalalgia 22(2): 137-41.

Safarinejad, M. R. (2009). J Urol 182(1): 237-48.

Sander, S., C. I. Coleman, et al. (2006). J Card Fail 12(6): 464-72.

Sandor, P. S., L. Di Clemente, et al. (2005). Neurology 64(4): 713-5.

Shults, C. W., D. Oakes, et al. (2002). Arch Neurol 59(10): 1541-50.

Sohal, R. S. (2004). Methods Enzymol 378: 146-51.

Soja, A. M. and S. A. Mortensen (1997). Mol Aspects Med 18 Suppl: S159-68.

Stocker, R., V. W. Bowry, et al. (1991). Proc Natl Acad Sci U S A 88(5): 164650.

Thibault, A., D. Samid, et al. (1996). Clin Cancer Res 2(3): 483-91.

Thompson, P. D., P. Clarkson, et al. (2003). JAMA 289(13): 1681-90.

Tiano, L., R. Belardinelli, et al. (2007). Eur Heart J 28(18): 2249-55.

Tomono, Y., J. Hasegawa, et al. (1986). Int J Clin Pharmacol Ther Toxicol 24(10): 536-41.

Watts, G. F., C. Castelluccio, et al. (1993). J Clin Pathol 46(11): 1055-7.

4/5/12 1:44:53 PM

COMPANY PROFILE

The Metagenics Difference

By Mark Kaye, DC Metagenics Senior Manager of Technical Product Support

M

etagenics, Inc. is a nutrigenomics and lifestyle medicine company focused on reversing chronic illness and improving health. Founded in 1983, the company currently serves more than 75,000 healthcare providers worldwide to help their patients achieve a lifetime of good health through premium quality, science-based medical foods and nutritional formulas, as well as clinically demonstrated lifestyle therapy programs.

modulators (SKRMs). To confirm efficacy, these proprietary ingredients and formulations are carefully examined at the Functional Medicine Research Center®, an onsite clinical research facility that evaluates hundreds of patients each year in clinical trials and case management studies. The company’s substantial scientific investment has produced more than 80 articles in peer-reviewed journals and 230-plus patents awarded or pending.

Metagenics continues to shape the future of the nutraceutical industry and patient-centered care with innovations that have raised the bar for quality and effectiveness:

Innovative Products and Programs

Breakthrough Science

Metagenics has established a higher caliber of science for better quality research and formulation with one of the largest scientific staffs and technologically advanced facilities in the industry.

Expert phytochemists, biochemists, MDs, and other scientists at MetaProteomics® utilize advanced genomic and proteomic research technologies to identify plant-based nutrients that positively influence health in uniquely effective ways, such as the discovery of plant derivatives that act as selective kinase response

Metagenics turns nutrigenomic discoveries into readily available clinical approaches that offer a higher degree of safety, effectiveness, and reliability to help patients achieve their best health possible.

A wide product array includes clinically tested medical foods and nutraceuticals that feature proprietary plant derivatives and patented nutrient combinations, as well as time-honored botanicals and other novel ingredient discoveries from research scientists around the globe. The groundbreaking FirstLine Therapy® system facilitates clinical implementation of therapeutic lifestyle changes—including diet, nutrition, exercise, and stress reduction—to help patients at increased risk for cardiovascular disease, diabetes, and other chronic conditions.

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COMPANY PROFILE

Unsurpassed Quality

Each formula is designed with sound research then monitored at every production stage to deliver products that live up to their scientific promise. Metagenics exceeds recognized quality standards of the industry—and the competition—with resources devoted to verify ingredient safety, ensure proper ingredient form/ identity, and test for purity and quality at multiple steps. In fact, Metagenics is one of the first companies in its industry niche to achieve three certifications for Good Manufacturing Practices (GMP) for its state-of-the-art manufacturing facility. Cutting corners on quality can have long-reaching health effects, especially if a product contains the wrong ingredient form or potentially harmful contaminants—or if the ingredients aren’t absorbed properly. That’s why Metagenics remains one of the most trusted names in professional nutritional formulas.

Professional Education

Metagenics University, the company’s educational arm, collaborates with renowned health and medical experts to deliver more than 200 events each year to keep practitioners on the leading edge of clinical applications of nutrigenomics and lifestyle medicine. The industry’s

largest offering of seminars and workshops, held throughout North America and abroad, is complemented by webinar events for live or on-demand viewing to help healthcare professionals stay informed no matter where they practice. And only Metagenics offers certification in administering clinically effective lifestyle medicine protocols with the FirstLine Therapy system.

Metagenics maintains its corporate headquarters in San Clemente, California; with R&D headquarters in Gig Harbor, Washington; and operating subsidiaries in Brussels, Belgium and Brisbane, Australia. • ihpmagazine.com { April/May 2012 IHP | 57

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Feature Automated Breast Ultrasound

Christopher Habib, ND Research Resident Canadian College of Naturopathic Medicine 1255 Sheppard Avenue East Toronto, Ontario M2K 1E2 chabib@ccnm.edu

Tina I Ureten, MD, RDMS, RDCS President of VIP Breast Imaging 525 University Ave. Toronto, Ontario M5G 2L3 tina@vipbreastimaging.com

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Feature Automated Breast Ultrasound

Automated Breast Ultrasound (ABUS) Making Mammography Obsolete Christopher Habib, ND and Tina I Ureten, MD, RDMS, RDCS

Abstract

There is a growing body of evidence that suggests the harms associated with standard breast cancer screening exams (mammography, breast self-examinations, and clinical breast exams) may outweigh the benefits. These harms include false-positive results, over-diagnosis, and over-treatment. Automated breast ultrasound (ABUS) is one of the latest technological breakthroughs that have been proposed as a suitable alternative for breast cancer screening. ABUS is a safe, painless, radiation-free, and non-invasive technology. It is a 3D ultrasound technology that is specifically developed for whole breast imaging and allows for images of high-resolution to be produced. Although somewhat limited, the currently available evidence is reviewed and appears to support the use of ABUS as a valuable screening tool, especially when considering the risks and benefits of the available alternatives. ABUS

has also been studied in comparison to mammography, hand-held ultrasound, and MRI. In all studies, ABUS appears to provide additional value in terms of its sensitivity and specificity. ABUS appears to have high accuracy in determining preoperative cancer lesions and appears to be accurate in analyzing all types of histological subgroups.

The main limitation in the studies that have been conducted is that they included a higher proportion of malignant lesions or breast masses than would be found in the screening population. Other limitations are that interpreting ABUS data requires a learning curve and that ABUS may be less valuable when it comes to examining the axillary regions or when examining the vascularity and elasticity of breast lesions. Largerscale research will need to be conducted on this exciting technology to determine its exact role in breast cancer screening, but ABUS will likely prove to be a cost-effective alternative.

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Feature Automated Breast Ultrasound

In Canada, regular screening for breast cancer occurs with mammography, breast self-examinations, and clinical breast exams (Shields 2009). Currently, there exists controversy over exactly which screening tools should be utilized for particular patient populations. These three screening exams are recommended to reduce mortality due to breast cancer, but there is a growing body of evidence that suggests that the harms associated with these exams may outweigh the benefits (Canadian Task Force 2011). These harms include false-positive results, over-diagnosis, and over-treatment. In addition, positive results often cause emotional pain and anxiety for patients that can be severe and have long-term implications (Montgomery 2010). As such, there is a high demand for an alternative that reduces these harms and yet provides clinically useful information.

Automated breast ultrasound (ABUS) is one of the latest technological breakthroughs that have been proposed as a suitable alternative for breast cancer screening (Wenkel 2008). ABUS is a safe, painless, radiation-free, and non-invasive technology. It is a 3D ultrasound technology that is specifically developed for whole breast imaging and allows for images of high-resolution to be produced (Lin 2011). It has also been referred to in the literature as automated breast volume scanning (ABVS), automated whole-breast ultrasound (AWBS), and sonographic tomography (Kelly 2010). In this article, it will only be referred to as ABUS for simplicity. Although somewhat limited, the currently available evidence appears to support the use of ABUS as a valuable screening tool, especially when considering the risks and benefits of the available alternatives. This article will review the studies that have been conducted and discuss the value of ABUS compared to other breast imaging methods.

A recent pilot study of ABUS was conducted to evaluate its ability to detect and classify breast lesions according to the Breast Imaging Reporting and Data System (BI-RADS) (Wenkel 2008). Thirty-five women who had unclear findings in breast diagnosis performed through palpation, sonography, or mammography were selected and received ABUS. Five radiologists independently evaluated the ABUS images and classified them according to BI-RADS. All breast cancers were found with the ABUS by all examiners and correctly classified in the BI-RADS. In this study, ABUS allowed detection of solid and cystic lesions and their BI-RADS classification with a high reliability. This study was not without limitations. The first limitation was that the selected patient group had a high number of lesions and thus did not reflect a screening population.

Another limitation was that some histological subgroups such as medullary carcinoma and ductal carcinoma in situ were not

present in the cohort and thus the researchers could not comment on the ability of ABUS to detect these subgroups. Finally, only the affected breast was scanned and analyzed, possibly resulting in a high degree of alertness by the radiologists.

Another recent study of ABUS was conducted to determine the accuracy of measuring preoperative cancer extent (Tozaki 2010). This retrospective study looked at forty patients with histopathologically confirmed breast cancer who underwent ABUS on the day prior to surgery. The age range of patients was 31-76 years old. The discrepancy of the tumor extent between ABUS and the histological examination was calculated. It was found that ABUS enabled visualization of the breast carcinomas in all patients. The histopathological diagnosis was ductal carcinoma in situ in seven patients and invasive ductal carcinoma in thirty-three patients. The accuracy of determination of the tumor extent with a deviation in length of less than 2cm was 98%.

This particular study helps fill gaps in the evidence to support the use of ABUS for these particular histological subgroups.

The same researchers have also studied the optimal scanning technique to cover the whole breast using ABUS (Tozaki 2010).

In this study, forty patients aged 23-68 years old underwent ABUS in the upper-outer, lower-outer, lower-inner, and upperinner breast regions. Three examiners were used. The researchers also compared ABUS to hand-held ultrasound (HHUS). In total, sixty-one lesions were detected by HHUS and this number was consistent with those found by ABUS. No comment could be made when comparing the diagnostic accuracy of ABUS due to the small number of histologically confirmed lesions. The total scanning time for ABUS ranged from 10-12 minutes, which is fairly reasonable. All four scanning techniques for the major segments of the breast were found to be operator-independent and feasible for performing ABUS. Some of the disadvantages for ABUS that were identified by this study included the difficulty in examining the axillary regions, as well as analyzing the vascularity and elasticity of the breast lesions. Overall, this study indicates that ABUS is comparable to HHUS with regards to scanning technique, but with the additional benefit of being operator-independent.

Breast cancer detection using mammography plus ABUS compared to mammography alone has been studied (Kelly 2010).

Twelve radiologists were blinded and provided with images of radiographically dense breasts. Half of the images were malignant. The radiologists first reviewed the mammograms and assessed their likelihood ratings based on BI-RADS and the Digital Mammographic Imaging Screenings Trial

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Feature Automated Breast Ultrasound

(DMIST). The radiologists then reviewed the mammograms with the ABUS data. Performance across screening techniques was compared using absolute callback, areas under the curve, and with figure of merit. With ABUS, true positives of cancer detection increased by 63% with only a 4% decrease in true negatives. The area under the curve average and the figure of merit were higher when mammography was paired with ABUS compared to mammography alone. Therefore, this study concluded that for dense-breasted women, incorporating ABUS with mammography adds significant clinical value.

The automated process for breast ultrasound eliminates operator variability, provides greater consistency, and ensures reproducibility of quality images. Similar to one of the studies that were discussed previously, one limitation of this study might have been that the radiologists could have been extremely vigilant by realizing that the test images had higher rates of lesions than in a normal population.

ABUS has also been compared to MRI in a retrospective analysis (Grady 2010). Forty-one women who were diagnosed with breast cancer had preoperative staging using ABUS. They subsequently underwent bilateral contrast-enhanced MRI prior to surgery to determine tumor extension and other information regarding the spread of the cancer. Both imaging techniques were compared for accuracy to pathologic truth. ABUS accurately staged breast cancer preoperatively in 68% of cases, while MRI only did so in 54% of cases. ABUS resulted in an overall improvement in accuracy of 14% and thus appears superior to contrast-enhanced bilateral breast MRI. A second more recent study has also compared ABUS to MRI and determined how closely their results match (Moon 2011). ABUS and MRI breast images were obtained from forty patients; bilaterally in twenty-seven patients and unilaterally in thirteen patients. Calculated values for percent density and breast volume were compared and found to be highly correlated.

These studies together appear to support ABUS as being equal to or superior to MRI. The diagnostic accuracy of ABUS, including its sensitivity and specificity has been studied (Wojcinski 2011). In one study, ABUS data sets from fifty patients were collected and a database was created containing twenty-three women who had no detectable lesions with conventional ultrasound, thirteen women with benign lesions, and fourteen women with known breast cancer. An independent examiner evaluated the ABUS data on a separate workstation without any prior knowledge of the patients. The diagnostic accuracy for the ABUS was 66.0%. All breast cancers were detected, resulting in a sensitivity of 100%.

However, due to the high number of requests for second-look ultrasounds, specificity was 52.8%. In this study, the researchers concluded that ABUS must still be regarded as an experimental technique. The main limitations identified in this study were that the design had a limited sample size and that the proportion of cases to controls was not representative of the whole population.

The difference between ABUS and HHUS in detecting and diagnosing breast lesions has been examined and has provided further data on its diagnostic value (Lin 2011). In this study, eighty-one patients were subjected to both examinations and the number of lesions detected was compared. Diagnostic accuracy and specificity were calculated. Ninety-five lesions were detected by both devices. Both exhibited a sensitivity of 100% and a high specificity (ABUS 95.0% and HHUS 85.0%). ABUS had a higher diagnostic accuracy (97.1%) than HHUS (91.4%) for breast neoplasms. ABUS was also capable of displaying the retraction phenomenon in coronal plane, which produced a high specificity (100.0%) and a high sensitivity (80.0%) in detecting breast cancer, while it also had a high accuracy (91.4%) in determining malignant from benign lesions. A second study also looked at the differences between ABUS and HHUS (Isobe 2011). Sixty patients underwent ABUS and HHUS and four segments were scanned. In fourteen of the fifteen patients with breast lesions under the nipple, the lesions were detectable with both HHUS and ABUS. In the other patient, the lesion was not detectable by HHUS but was detected by ABUS. Overall, these two studies show that ABUS likely has superior diagnostic accuracy when compared to HHUS. The inter-observer agreement of radiologists looking at breast masses that were detected by ABUS has been evaluated (Zhang 2011). In this study, 208 patients were subjected to ABUS and data were automatically sent to the ABUS workstation.

Two radiologists evaluated 234 breast masses (148 benign and 86 malignant). The reviewers were blinded to the patientâ&#x20AC;&#x2122;s mammographic images, medical history, and pathologic findings.

Substantial agreement was obtained for lesion shape, orientation, margin, echo pattern, posterior acoustic features, calcification, and final assessment. Fair agreement was obtained for retraction phenomenon and lesion boundary. This study provides evidence that inter-observer agreement for ABUS is high.

Researchers have retrospectively evaluated the detection of benign and malignant breast masses using ABUS data to determine which lesion variables affect detectability (Chang 2011). In this study, bilateral whole breast images were obtained using ABUS in sixtyseven consecutive women who were scheduled to undergo needle

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Feature Automated Breast Ultrasound

biopsy due to suspicious breast masses. Twenty-four invasive ductal cancers in twenty-three breasts, forty-six benign breast lesions in forty-four breasts, and thirty-eight normal breasts were included.

Three breast radiologists who did not perform the examinations and were blinded to the histology reviewed the ABUS data.

Sensitivities for benign mass detection ranged from 56.3% to 66.7% and for malignant masses ranged from 87.5% to 95.8%, indicating significantly higher sensitivity for malignant breast masses. The overall specificity was 79.5%. An analysis showed that mass size, surrounding tissue changes, and shape of the mass were the variables associated with detectability at ABUS. The lower detection rate for benign lesions was attributed to the fact that they only included solid breast lesions and not cystic lesions, which are easier to detect. This study was limited by the patient group that had a high number of lesions and did not represent a screening population. There also exists a learning curve in interpreting ABUS and these particular radiologists had little prior experience with ABUS, which may have affected the results.

In terms of financial cost, ABUS will probably prove cost-effective as a supplement to mammography for women with dense breasts (Feig 2010). Once radiologists have had practice with interpreting ABUS data and have progressed along the learning

References Canadian Task Force on Preventive Health Care, Tonelli M, Gorber SC, Joffres M, Dickinson J, Singh H, Lewin G, Birtwhistle R, Fitzpatrick-Lewis D, Hodgson N, Ciliska D, Gauld M, Liu YY. Recommendations on screening for breast cancer in average-risk women aged 40-74 years. CMAJ. 2011;183(17):1991-2001.

curve, it is likely that ABUS will provide clinicians with valuable diagnostic information. The ABUS system has an excellent safety profile and it is painless, radiation-free, and non-invasive.

The evidence available demonstrates that it is specifically developed for whole breast imaging, but that it may be less valuable when it comes to examining the axillary regions or when examining the vascularity and elasticity of breast lesions. Some of the other variables that may limit its ability to detect breast lesions also include mass size and shape as well as surrounding tissue changes. Even so, ABUS appears to have high accuracy in determining preoperative cancer lesions and appears to be accurate in analyzing all types of histological subgroups. The evidence available seems to suggest that ABUS performs better than mammography, MRI, and HHUS and that inter-rater agreement for ABUS data are high. Its sensitivity and specificity are both high, especially when comparing these values to those of alternative screening methods. Many of the studies that have been done included a higher proportion of malignant lesions or breast masses than would be found in the screening population, meaning that it is likely too early to recommend ABUS as an independent screening tool. Larger-scale research will need to be conducted on this exciting technology to determine its exact role in breast cancer screening. •

Montgomery M and McCrone SH. Psychological distress associated with the diagnostic phase for suspected breast cancer: systematic review. Journal of Advanced Nursing. 2010; 66(11), 2372–2390.

Moon WK, Shen YW, Huang CS, Luo SC, Kuzucan A, Chen JH, Chang RF. Comparative study of density analysis using automated whole breast ultrasound and MRI. Med Phys. 2011;38(1):382-9.

Chang JM, Moon WK, Cho N, Park JS, Kim SJ. Radiologists’ performance in the detection of benign and malignant masses with 3D automated breast ultrasound (ABUS). Eur J Radiol. 2011;78(1):99-103.

Shields M, Wilkins K. An update on mammography use in Canada. Health Rep. 2009;20(3):7-19.

Feig S. Cost-effectiveness of mammography, MRI, and ultrasonography for breast cancer screening. Radiol Clin North Am. 2010;48(5):879-91.

Tozaki M, Fukuma E. Accuracy of determining preoperative cancer extent measured by automated breast ultrasonography. Jpn J Radiol. 2010;28(10):771-3.

Grady I, Gorsuch-Rafferty H, Hansen P. Sonographic tomography for the preoperative staging of breast cancer prior to surgery. Journal of Ultrasound.

2010;13(2):41-45.

Tozaki M, Isobe S, Yamaquchi M, Ogawa Y, Kohara M, Joo C, Fukama E. Optimal scanning technique to cover the whole breast using an automated breast volume scanner. Jpn J Radiol. 2010;28(4):325-8.

Isobe S, Tozaki M, Yamaguchi M, Ogawa Y, Homma K, Satomi R, Saito M, Joo C, Fukuma E. Detectability of breast lesions under the nipple using an automated breast volume scanner: comparison with handheld ultrasonography. Jpn J Radiol.

2011;29(5):361-5.

Wenkel E, Heckmann M, Heinrich M, Schwab SA, Uder M, Schulz-Wendtland R, Bautz WA, Janka R. Automated breast ultrasound: lesion detection and BI-RADS classification—a pilot study. Rofo. 2008;180(9):804-8.

Kelly KM, Dean J, Lee SJ, Comulada WS. Breast cancer detection: radiologists’ performance using mammography with and without automated whole-breast ultrasound. Eur Radiol. 2010;20(11):2557-64.

Wojcinski S, Farrokh A, Hille U, Wiskirchen J, Gyapong S, Soliman AA, Degenhardt F, Hillemanns P. The Automated Breast Volume Scanner (ABVS): initial experiences in lesion detection compared with conventional handheld B-mode ultrasound: a pilot study of 50 cases. Int J Womens Health. 2011;3:337-46.

Lin X, Wang J, Han F, Fu J, Li A. Analysis of eighty-one cases with breast lesions using automated breast volume scanner and comparison with handheld ultrasound.

Eur J Radiol. 2011. doi:10.1016/j.ejrad.2011.02.038

Zhang J, Lai XJ, Zhu QL, Wang HY, Jiang YX, Liu H, Dai Q, You SS, Xiao MS, Sun Q. Interobserver agreement for sonograms of breast lesions obtained by an automated breast volume scanner. Eur J Radiol. 2011; doi:10.1016/j.ejrad.2011.06.043

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FEATURE LOW BACK PAIN IN PREGNANCY

Low Back Pain and Pelvic Girdle Pain in Assessment and management Jennifer V. Nash, DC

Abstract

Low back pain (LBP) and pelvic girdle pain (PGP) associated with pregnancy are common problems that may be under-reported and under-treated. These conditions have a significant impact on activities of daily living and may lead to chronic pain postpartum. While the exact etiology of LBP and PGP in pregnancy is not known, a combination of traumatic, hormonal and biomechanical mechanisms likely contribute to decreased integrity and stability in the back/pelvis during pregnancy. LBP and PGP can be differentiated based on the location of pain; specific pain provocation testing can be useful in the diagnosis of PGP. Exercise and acupuncture have been shown to reduce pain, improve functional ability and decrease disability in those with LBP and PGP associated with pregnancy; there is also some evidence for the use of spinal manipulative therapy and pelvic belts.

Jennifer V. Nash, DC Instructor and Co-Facilitator Faculty of Health Sciences McMaster University nashjv@mcmaster.ca

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Half to two-thirds of women experience pregnancy related low back pain (PLBP) and/or pregnancy related pelvic girdle pain (PPGP) (Skaggs 2007, Wu 2004) yet it often goes unreported and untreated, perhaps because there is an assumption that it is a “normal” part of pregnancy. A recent survey found that only 32% of women with PLBP reported their pain to their prenatal care giver and only 25% of prenatal care providers recommended treatment (Wang 2004).

PLBP and PPGP have been correlated with disturbances to daily activities such as standing for 30 minutes, sleep disturbances, and use of pain medication (Mens 1996, Skaggs 2007, Wang 2004).

It is therefore important for primary care practitioners to be knowledgeable and able to recommend effective treatment options.

Assessment and Diagnosis

Typically, PLBP is concentrated in the lumbar spine region, whereas PPGP is concentrated between the posterior iliac crests

and gluteal fold, particularly in the region of the sacroiliac joint; this can occur in conjunction with or separately from pain in the symphysis (Vleeming 2008). Women are more likely to experience PLBP and PPGP if they have a history of previous low back pain (LBP), history of PLBP and PPGP, and strenuous work (Wu 2004).

PPGP is diagnosed after other lumbar causes for the pain have been ruled out and when the pain is reproduced by specific clinical tests (Vleeming 2008). Pain provocation tests (Table 1) are useful in assessment and diagnosis of PPGP (Ronchetti 2008, Vleeming 2008).

Other serious causes of PLBP and PPGP must be ruled out with a thorough history and physical examination; differential diagnoses may include osteomyelitis, cauda equina syndrome, disc herniation, urinary tract infection, femoral vein thrombosis, or an obstetric complication.

Table 1. Pain Provocation Tests Test Name

Description

Sensitivity

Specificity

Reference

Posterior Pelvic Pain Provocation Test (P4 or thigh thrust)

With the patient lying supine, the hip is flexed to 90 degrees.

Downward pressure is applied to the flexed knee along the axis of the femur. The test is considered positive if pain is produced in the gluteal region.

0.84-0.93

0.98

Albert 2000

Patrick’s Fabere Test or Figure 4 Test

With the patient lying supine the patient’s hip is flexed, leg is externally rotated and abducted so that the ipsilateral heel rests on the opposite knee. If this manuoever produces pain in the ipsilateral joints of the pelvis then it is considered positive.

0.40-0.70

0.99

Albert 2000

Long Dorsal Sacroiliac Ligament Test

With the patient lying on their side with slight hip and knee flexion, the examiner palpates the long dorsal sacroiliac ligament. If pain lasts for greater than five seconds after the examiner removes their hand it is recorded as pain; if it lasts for less than five seconds it is recorded as tenderness.

0.11-0.49

1.00

Albert 2000

Active Straight Leg Raise Test

With the patient lying supine, both legs straight and approximately 20cm apart, the patient is asked to raise one leg at a time approximately 20cm off the table, keeping the knee straight. The degree of difficulty in performing this test is an indicator of severity.

0.87

0.94

Mens 2001

Pain with palpation of symphysis

With the patient lying supine the examiner palpates the pubic symphysis. If pain lasts for greater than five seconds after the examiner removes there hand it is recorded as pain; if it lasts for less than five seconds it is recorded as tenderness.

0.60-0.81

0.99

Albert 2000

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Feature Low Back Pain in Pregnancy

Prognosis

Typically PPGP resolves within a few weeks to months after delivery but 8-10% of women continue to have pain for one to two years postpartum (Albert 2001, Rost 2006).While PLBP and PPGP are two separate clinical conditions, they can also occur in combination.

Women who experience combined PLBP and PPGP appear more likely to experience LBP and pelvic girdle pain (PGP) during the post-partum period than those who experience just PLBP or PPGP (Gutke 2008, Turgut 1998). It is important to recognize that many non-pregnant women with chronic back pain identify pregnancy as the initial onset of their back pain (Mens 1996).

study by Mogren (2005) found that a higher number of years of regular leisure physical activity was associated with decreased risk of low back and pelvic pain during pregnancy (p=0.010).

A randomized control trial comparing a 12-week preventative exercise training program to usual care demonstrated positive results in a nulliparous pregnant population (Mørkved 2007). At 36 weeks gestation women in the training group were significantly less likely to report lumbopelvic pain (44% vs 56%; p=0.03) and had significantly higher scores of functional status on Disability Rating Index (DRI) (p=0.01) (Mørkved 2007).

Etiology

Education

The exact etiology of PLBP and PPGP is not clear and may in fact be multi-factorial.

Education as a stand-alone strategy has received little focus for the management of PLBP and PPGP, however many studies include education as a component of a comprehensive program (Elden 2005, Mens 2000, Stuge 2004). Education on relevant anatomy and biomechanics, advice regarding ergonomics of daily activities and reassurance are commonly included and may help to reduce anxiety and fear in women with PLBP and PPGP (Vleeming 2008).

Relaxin is a hormone that is produced in increased quantities during pregnancy and which leads to increased ligamentous laxity (MacLennan 1991).Women with PLBP and PPGP have been shown to have increased motion in their pelvic joints compared to healthy controls (Mens 2009). Smaller and flatter sacroiliac joints predicts an elevated risk of PLBP and PPGP; it has been hypothesized that as a result the loosening of the ligaments during pregnancy this joint becomes less stable (Vleeming 1990). Pain may result from increased shear forces across the sacroiliac joints.

Pregnancy also induces postural and biomechanical changes which could affect the stability of the lumbar spine and pelvis, thereby leading to pain. Increased abdominal muscle length (Fast 1990, Gilleard 1996) and altered angle of insertion have been noted for the rectus abdominus (RA) and have been correlated with the inability to stabilize the pelvis against resistance (Gilleard 1996).

Studies using ultrasound have identified increased cross-sectional area of the RA and decreased RA thickness following delivery and in comparison to nulliparous controls (Coldron 2008, Weiss 2009). Sihvonen (1998) also found that changes to the functioning of back extensor muscles were related to back pain in pregnancy.

It is possible that changes to the morphology of these muscles could reduce their ability to stabilize the spine and pelvis. Other contributing factors may include altered posture, muscle fatigue, muscle imbalance and previous trauma (Kristiansson 1996, Mens 1996, Perkins 1998).

Conservative Management Prevention

There is some evidence that exercise may play a role in preventing PLBP and PPGP (Mogren 2005, Mørkved 2007). A retrospective

Exercise

In the non-pregnant population alterations to the functioning of the deep abdominal musculature play a role in LBP and exercise programs targeting these muscles appear effective in treating LBP (Ferreira 2010, Hides 2010). Since changes to morphology and functioning of both abdominal and low back musculature have been identified during pregnancy, it is reasonable to consider exercises which target the core musculature as a possible treatment during pregnancy.

Interventions including stabilizing exercises have been shown to be effective in reducing pain and improving functional ability in women with PLBP and PPGP (Elden 2005, Kluge 2011, Stuge 2004). Kluge (2011) compared pain intensity and functional ability in pregnant women before and after either specific stabilizing exercise program or control intervention. Pain intensity decreased in the intervention group from 30.0 to 18.5 (p<0.01); there was also a significant difference in pain intensity between the two groups following the intervention (18.5 compared to 33.0; p<0.01).

The sitting pelvic tilt exercise has been found to be an effective treatment in the third trimester (Suputtitada 2002). Compared to a control group, those performing the exercise had significantly lower pain intensities as measured by visual analogue scale (VAS) after 56 days of performing the exercise (p<0.05) (Suputtitada 2002).

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Stuge (2004a) studied the role of exercise in treating PLBP and PPGP during the postpartum period. Physical therapy including ergonomics, massage, joint mobilization, manipulation, electrotherapy, and hot packs was compared to physical therapy plus exercises targeting the core musculature over a 20 week period. Exercise plus physical therapy resulted in statistically and clinically significant lower back pain intensity both in the morning (VAS; p=0.001) and evening (VAS; p<0.001) and lower disability as measured by Oswestry Disability Index (p<0.001) ) compared to those receiving physical therapy only. Differences between groups remained at one and two years postpartum (Stuge 2004b).

In a prospective trial pregnant women were randomized to watergymnastics or a control group; subjects in the water-gymnastics group participated in a once-weekly program for approximately 17-20 weeks. Significantly more women in the control group (17) versus water-gymnastics group (seven) were on sick-leave for back/ LBP after week 32-33 (p=0.031) (Kihlstrand 1999).

Overall exercise targeting the muscles that stabilize the back and pelvis and water gymnastics appear to be effective treatment options, however a few studies have found inconsistent results (Mens 2000, Nilsson-Wikmar 2005).

Spinal Manipulative Therapy

Spinal manipulative therapy (SMT) is an effective treatment for low back pain in the non-pregnant population (van Tulder 2006).

While SMT may be effective for treating PLBP and PPGP, most studies in pregnant populations have combined SMT with other interventions such as exercise and myofascial release making it difficult to determine the effect of individual treatment modalities (Lisi 2006, Skaggs 2005, Stuge 2004).

For example, Skaggs (2005) applied a multimodal treatment protocol including education, soft tissue mobilization, joint mobilization and manipulation and specific stabilization exercise to 170 patients. Patients were evaluated on the first and second visit using the Bournemouth Questionnaire; the average score on the first visit was 45 (SD=23) and second visit was 34 (SD=22). The difference in scores indicated significant improvement (p<0.01).

Retrospective case series have demonstrated that pregnant women with PLBP who underwent chiropractic care (including SMT) had clinically important improvement on Numerical Rating Scale pain score (Lisi 2005) and reported relief (Diakow 1991).

Acupuncture

Elden (2005) found acupuncture to be superior to standard treatment including information, advice, pelvic belt, and home exercise program targeted to abdominal and gluteal muscles. Following six weeks of twice per week acupuncture, the acupuncture and standard treatment groups differed in pain intensity in the morning (p<0.001) and in the evening (p<0.001) as measured on VAS (Elden 2005). Similar results were also found by Kvorning (2004).

Guerreiro da Silva (2004) compared conventional treatment (pharmacotherapy: paracetamol and hyoscine) to conventional treatment plus acupuncture. Women in the acupuncture group showed a greater reduction in average pain on a numerical rating scale 0-10 (-4.8 points) compared to the control group (-0.3 points; p<0.0001). In addition, use of paracetamol decreased more in the acupuncture group (2.0) versus the control group (0.0; p=0.005).

Pelvic Belts

There is some evidence that pelvic belts help stabilize the pelvis and may be useful in the diagnosis and treatment of PLBP and PPGP. Mens et al (2002) found that pelvic belts significantly decreased sacroiliac joint laxity (p<0.001) and are more effective when positioned directly below the anterior superior iliac spine rather than at the level of symphysis pubis (p=0.006). Use of a pelvic belt has also been correlated with decreased score on the active straight leg test (Mens 2006). Another study by Carr (2003) found a lumbrosacral orthosis to be helpful in reducing pain intensity and effect of pain on daily activities during pregnancy. Pelvic belts are often used in combination with other interventions as part of a comprehensive treatment program.

Other

Other non-conservative treatment options may include pharmacotherapy, prolotherapy, surgery and injection therapy, but are beyond the scope of this paper.

Conclusion

PLBP and PPGP are common problems which significantly impact the activities of daily living in pregnant women. While the etiology is not clear, and may in fact be multi-factorial, the ability to stabilize the lumbar spine and pelvis appears compromised during pregnancy. Exercise and acupuncture are effective conservative treatment options; education, pelvic belts, and spinal manipulative therapy also appear to be useful. Health care providers working with this population should educate patients and consider recommending conservative treatment options. â&#x20AC;˘

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Feature Low Back Pain in Pregnancy References Albert H, Godskesen M, Westergaard J. Prognosis in four syndromes of pregnancyrelated pelvic pain. Acta Obstet Gynecol Scand. 2001; 80: 505-511.

Mens, JMA, Vleeming MB, Stoeckart T, Stan HJ, Snijders CJ. Understanding peripartum pelvic pain. Implications of a patient survey. Spine. 1996; 21: 1363-1370.

Albert H, Godskesen M, Westergaard J. Evaluation of clinical tests used in classification procedures in pregnancy-related pelvic joint pain. Eur Spine J. 2000; 9: 161-166.

Mogren IM. Previous physical activity decreases the risk of low back pain and pelvic pain during pregnancy. Scand J Public Health. 2005; 33: 300-306.

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Skaggs CD, Gross G, Ducar D, Thompson PA, Nelson DM. A comprehensive musculoskeletal management program reduces pain and disability in pregnancy. J Chiropr Educ. 2005; 19: 31-2. (abstr)

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Mens JMA, Pool-Goudzwaard A, Stam HJ. Mobility of the Pelvic Joints in Pregnancy-Related Lumbopelvic Pain. Obstet Gynecol Surv. 2009; 64: 200-208.

Mens JMA, Damen L, Snijders CJ, Stam HJ. The mechanical effect of a pelvic belt in patients with pregnancy-related pelvic pain. Clin Biomech. 2006; 21(2): 122-127.

Mens, JM, Vleeming A, Snijders CJ, Koes BW, Stam HJ. Reliability and validity of the active straight leg raise test in posterior pelvic pain since pregnancy. Spine. 2001; 26(10): 1167-71.

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Saturated

Feature Saturated Fat

Fat Friend, foe, or simply neutral?

William R Ware, PhD

William R Ware, PhD Emeritus Professor, Faculty of Science University of Western Ontario London, Ontario, Canada N6G1R3 warewr@rogers.com

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Feature Saturated Fat

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Feature Saturated Fat Abstract

There is widespread belief that saturated fat (SF) is adversely associated with coronary heart disease (CHD) and cardiovascular disease (CVD). This hypothesis has been incorporated into practice and nutritional guidelines. Specific targets for maximum amounts of SF as a percentage of dietary energy are also a common aspect of guidelines. Historically total fat was viewed as the culprit, but when evidence was not forthcoming, the focus shifted to SF. Central to this subject is the syllogism, i.e. SF elevates LDL cholesterol, LDL cholesterol causes heart disease and therefore SF causes heart disease. This syllogism falls apart when one examines its two critical components. First, there is a remarkably poor correlation between SF intake and LDL cholesterol, especially in the range of low intake to that common in North America. As regards the second component of the syllogism, LDL cholesterol levels are not related to the prevalence of adult coronary atherosclerosis, independent of age, gender or ethnicity. For asymptomatic individuals, cholesterol

is not a significant CHD/CVD risk factor for women, the elderly, or men over about 50 years of age. For younger men, the association may be seriously confounded by issues associated with blood pressure reactivity and stress. Lowering LDL with statin drugs in asymptomatic individuals has a near negligible effect on acute event risk (approximately 1% absolute risk reduction) which may be due to pleiotropic effects, and no impact on mortality. Finally, the association between SF and CHD or CVD has come under intense attack in the past two years. The overall conclusion is that there is no significant evidence for concluding that dietary SF is associated with the risk of CHD or CVD. This conclusion was already evident in 1998 but ignored. In addition, many studies find that SF does not appear to be a risk factor for several common cancers, nor with the risk of type2 diabetes, and if there is a weak association with insulin resistance, it does not appear to carry over to type 2 diabetes risk.

The original suggestion that there was a connection between saturated fat (SF) consumption and the risk of coronary heart disease was made on the basis of ecological studies. Such studies are notoriously prone to pointing in the wrong direction. This was followed by the observation that it was possible to elevate cholesterol and LDL cholesterol by feeding individuals excess saturated fat. Thus the syllogism: SF raises LDL, LDL causes heart disease, and therefore SF causes heart disease. In a comment in 2001 on an article in the journal Science titled “The Soft Science of Dietary Fat” (Taubes 2001), Scott Grundy, a high profile academic advocate of the diet-cholesterol-heart disease hypothesis, stated that, contrary to Taubes’ critical view, SFs are the main dietary cause of coronary heart disease (CHD) (Grundy 2001). This is still the conventional wisdom today with a number of guidelines recommending low SF consumption, typically ≤ 7% of total energy intake, although as will be discussed, there are a growing number of sceptics and a remarkable lack of evidence.

philosophy raised their triglycerides and lowered their HDL, in fact to an extent that was vastly more risky than the danger attributed to the minor elevation in LDL.

Keeping SF intake low was part of the low-fat diet movement, which started some 30-40 years ago. With the backing of governments, professional nutritional and medical associations and the media, fat was demonized and there was a significant move to lower intake. Low-fat products appeared on the supermarket shelves in ever increasing numbers. The calorie deficit was, for most followers of the new path, made up by carbohydrates and the carbohydrates turned out to be mostly the rapidly digestible, high glycemic variety. It is now generally recognized that this mass hysteria over fat had unintended consequences. Excess carbohydrate stimulated excess insulin production and fat storage, obesity, insulin resistance and the risk of diabetes. It is also ironic that in order to avoid a minor elevation in LDL of debatable clinical significance, those following the low-fat

It is also important to recognize that nutritional studies which address the question of the association between dietary fat and various disorders present fundamental difficulties. If one macronutrient is decreased, then either it must be replaced by another macronutrient to maintain the same energy intake or the decrease in energy intake must be taken into account as a confounder. Either way, two critical variables are changed simultaneously. If the intake of A is reduced and B increased and benefit is observed with regard to, for example, the incidence of heart disease, this does not prove that the decrease in A was responsible or that A is a risk factor. In addition, randomized interventional nutrition studies, which are relied upon to produce definitive guidance, are frequently accompanied by failure to achieve the desired intakes, have poor long-term adherence to the study plan and frequently there is a convergence of the control and the intervention groups toward a common diet leading to non-significant results.

Hypotheses survive until falsified (to paraphrase Karl Popper).

One is reminded of the famous black swan example. The hypothesis that saturated fat causes heart disease is now coming under scrutiny due to a number of studies which appear to directly falsify it, followed by several new meta-analysis which simply add confirmation. Recent research will be reviewed in this article along with related issues such as the connection between saturated fat and other diseases. In fact, the so-called Great Fat Debate is heating up (Zelman 2011). A number of black swans have been sighted.

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Feature Saturated Fat

THE SYLLOGISM: QUESTIONS

Earlier articles by the author which have appeared in this publication (Ware 2011a, Ware 2011b) presented strong evidence that LDL is not a risk factor for the prevalence or progression of coronary atherosclerosis in either diabetics or non-diabetics, and is a weak or for many individuals a non-existent risk factor for acute cardiac events. Lowering LDL with drugs in asymptomatic individuals carries an absolute risk reduction of only around 1% for acute events and no impact on cardiac related mortality, and the number needed to treat to prevent one non-fatal event is about 100. This small impact may also be a pleiotropic effect and have no connection with lipid lowering. Thus, the above chain of reasoning that leads from SF to LDL elevation to heart disease risk appears seriously weakened for these reasons alone.

Critical to the case against SF is its alleged ability to elevate cholesterol and LDL to an extent that is clinically significant.

Based on a meta-analysis of metabolic ward studies, when 10% of energy intake from saturated fat was replaced by carbohydrates while keeping calorie intake constant, there was a decrease in LDL by 0.36 mmol/L (14 mg/dL) (Clarke 1997). Another meta-analysis, where 1% of energy from carbohydrates was replaced by various individual saturated fats keeping the total energy intake constant, found changes in LDL that ranged from 0.05 to -0.004 mmol/L (1.9 to -0.16 mg/dL) (Mensink 2003).

But using these numbers, even a 5% or 10% change in energy from SFs produces an LDL change that is of the same size as the normal variation of LDL levels in any given individual seen over short periods of time (Hegsted 1987). Furthermore, this ignores the huge individual variations. Thus one can question the clinical significance of these small changes. Furthermore, the above studies are inconsistent with more recent studies.

In a 2008 paper (Volek 2008), the authors present a scatter plot (Fig. 5) from a frequently cited paper used to support the claim that saturated fat intake increases serum cholesterol (Clarke 1997). If one examines just the part of the plot ranging from 5% to 25% saturated fat intake as a percentage of total energy, a range

that encompasses the intake of a majority of North Americans who on average consume about 14% of energy as SF, the correlation between SF intake and cholesterol is almost impossible to see, and if one looks at the range from 15% to 7%, approximately the change recommended by the current guidelines, the scatter is so great that this decrease in SF intake appears equally likely to raise as to lower total cholesterol. Volek and coauthors conclude that total cholesterol is not a strong predictor and find it hard to consider the cited figure as evidence of substantial benefit for reducing SF across the board.

These results alone are enough to generate justified skepticism, but they are strongly reinforced by two recent studies which also addressed the question of correlation between SF intake and LDL levels and found no association (Mirmiran 2009, Wood 2011).

Thus the syllogism presented above appears to have fatal flaws.

OBSERVATIONAL AND INTERVENTION STUDIES. SATURATED FAT AND CHD/CVD

Already in 1998 a lengthy and comprehensive systematic review appeared in the Journal of Clinical Epidemiology which examined the evidence for and against the hypothesis that SF intake was related to either CVD incidence or mortality (Ravnskov 1998). A very large number of ecological (population) studies, as well as cross-sectional (snapshot), case-control and cohort follow-up studies were examined. In addition autopsy studies that examined the relationship between saturated fat (animal fat) intake and the extent of atherosclerosis were reviewed. Ravnskov did not find any convincing evidence up to 1998 for the association.

The overall picture that emerged was one of inconsistency with more studies falsifying the hpothesis than supporting it, even when studies of comparable quality were compared in detail.

In 2005 a 20-year update on the famous Nursesâ&#x20AC;&#x2122; Health Study also looked at the association between dietary fat intake and CHD (Oh 2005). When the results of this prospective cohort study were corrected for confounding, there was no significant relation between the relative risk of coronary heart disease and saturated

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Feature Saturated Fat fat intake when the lowest vs. the highest quintile were compared.

The same was true for total fat intake, but polyunsaturated fat was found to be significantly protective and trans fats significantly harmful. This study involved the analysis of data from a lengthy follow-up study of over 78,000 female nurses.

A recent meta-analysis of 21 prospective epidemiologic studies and a pooled analysis of 11 cohort studies have recently appeared which have fueled the SF-heart disease debate. The pooled analysis (Jakobsen 2009) examined the impact on coronary events or CHD-related mortality associated with the various combinations of substitution of monounsaturated fatty acids (MUFAs), polyunsaturated fatty acids (PUFAs) or carbohydrates in place of SF. PUFA substitution was found to decrease the risk of both endpoints whereas carbohydrates were found to significantly increase the risk for coronary events but not mortality. MUFA substitution for SF was not associated with CHD risk. There was no effect modification by gender or age.

The second study, a meta-analysis of prospective studies (SiriTarino 2010a) examined the relationship between SF and cardiovascular disease (CVD). It was found that there was no significant evidence for concluding that dietary SF is associated with increased risk of CHD or CVD. The researchers comment that more data are needed to elucidate the question of CVD risks being associated with specific nutrients used to replace SF. Some would be satisfied at this point with the picture that has emerged.

In the introduction of the meta-analysis of Siri-Tarino et al, the authors point out that there are only a limited number of randomized clinical intervention trials that have examined the issue of saturated fat and CVD or CHD. The results have been inconsistent with some showing benefit, others none. Those what showed beneficial effects associated with reducing saturated fat intake replaced it with PUFAs. These positive results could have been due to simply an increase in PUFAs. The pooling study discussed above supports this conjecture.

THE ASSOCIATION OF SATURATED FAT WITH OTHER DISORDERS

Cancer. Interest in the potential association between cancer and dietary fat in general and saturated fat in particular has extended over more than two decades. Interest has focused on breast, prostate and colorectal cancer. For breast cancer, two recent very large meta-analyses did not support a positive independent association with either total fat or animal fat (Alexander 2010, Turner 2011). Meta-analyses for colorectal cancer were also negative (Alexander 2009, Liu 2011). Prospective studies failed to find a consistent association between fat and prostate cancer, but the risks associated with saturated fat are unclear (Dennis 2004). Reduction of consumption of processed meat may in

general decrease cancer risk. However, here the issue appears to be carcinogens rather than fat (Kushi 2002).

Diabetes and Insulin resistance. In the Nurses’ Health Study, total, saturated and monounsaturated fat were not associated with the risk of type 2 diabetes. Furthermore, polyunsaturated fat was protective and trans-fats increased risk (Salmeron 2001).

In the Health Professionals Follow-up, saturated fat was not associated with the risk of type 2 diabetes in men once the results were adjusted for BMI (van Dam 2002). As regards fat type and insulin resistance, if fat intake was high, no fat-type dependence was found. No changes in insulin resistance were found when fat composition was kept constant but total intake varied between 20% and 40% of energy. However, if fat intake is low there is some evidence that saturated fat may decrease insulin sensitivity, but this does not carry over to increased incidence of diabetes (Siri-Tarino 2010b).

Decades ago, the traditional diet for diabetics involved severe carbohydrate restriction. As the 20th century progressed this became less popular and then with the advent of the highly successful anti-fat campaign, diabetic patients were warned of the extreme dangers of substituting fat for carbohydrates. Dr. Robert Atkins was brought before a U.S. congressional committee to defend the accusation that by promoting a low-carbohydrate (and therefore elevated fat) diet, he was seriously endangering public health, an accusation proven false by a number of studies over the past decade. Today there are calls for a return to this traditional approach of treating type 2 diabetes, and the merits of carbohydrate restriction in the context of diabetes prevention and therapy have been pointed out repeatedly in the past few years (Accurso 2008, Volek 2005a, Volek 2005b, Volek 2008, Volek 2009). The success achieved by Richard K. Bernstein using carbohydrate restriction and carefully selected carbohydrates matched to the individual’s metabolism is now documented in several editions of his book Dr. Bernstein’s Diabetes Solution (Bernstein 2011). The HbA1c levels he achieves are vastly better than anything conventional medicine appears able to achieve, and this is accomplished with diet. Drugs or insulin are used only when absolutely necessary. Taken together, the journal literature and the evidence in this book should give cause for reflection among diabetologists.

CONCLUSIONS

The fat-is-bad notion is alive and well as evidenced by the recent move by Denmark to place a special tax, thought to be the world’s first ever, on foods high in saturated fat. Health authorities in Denmark claim it will save countless lives. The scientists advising the government presumably refused to give any weight to the contrary evidence, in fact the lack of evidence, in the literature and the associated numerous commentaries,

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Feature Saturated Fat and in addition, to studies regarding the danger of substituting high glycemic index carbohydrates for fat. Yet the natural human tendency is to do just that and in particular to increase refined carbohydrates. The saturated fat saga is an excellent example of the tendency among professionals to ignore vast amounts of literature that disagree with their long-held beliefs. Hypotheses that appear to have been conclusively falsified have a remarkably long lifetime and vitality.

A reasonable approach to the dietary fat issue is perhaps simply to avoid all trans-fats (Aronis 2011), severely limit processed meats (Micha 2010), make sure of an adequate intake of omega-3 fatty acids and in particular, the long-chain fatty acids found in fish (Mozaffarian 2007), use general calorie restriction rather than specific macronutrient restriction when trying to lose weight and consider carbohydrate restriction when attempting to control blood sugar levels (Feinman 2008, Omodei 2011). •

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Feature COLD-FX®

COLD-FX® A review of evidence

Christopher Knee MSc, ND (Cand.) and Esther Konigsberg, MD

Statement of conflict of interest: this article was written by Christopher Knee and reviewed by Dr. Esther Konigsberg, on behalf of Afexa Life Sciences, Inc, manufacturers and distributors of COLD-FX. Abstract

Upper respiratory tract infections (URTI), such as the common cold and flu, have long been labeled as self-limiting illnesses. However, the associated morbidity and mortality are hardly trivial, and evidence continues to mount suggesting that the overall burden of URTI may be underestimated. Estimates indicate that about 70% of all respiratoryrelated physician visits in Ontario are due to URTI, and that the frequency of visits is about three times higher during the winter months.

In Canada, the total financial costs related to respiratory disease are

Humans experience around 200 colds over a lifetime, resulting in about five years of congestion, coughing, headache, and sore throat (Ackerman 2010), and a full year spent in bed (Kirchberger 2007, Papadopoulos 2001). The common cold is a heterogenous group of illnesses collectively described as an acute upper respiratory tract infection (URTI) (Heikkinen 2003), and is typically characterized by rhinorrhea, nasal obstruction, cough and sore throat (Turner 2011). The rhinoviruses account for the majority (30-50%) of URTI cases, while other causative agents include coronaviruses (10-15%), influenza viruses (5-15%), adenoviruses (5-10%), respiratory syncytial virus (RSV) (5%), and parainfluenza viruses (5%) (Heikkinen 2003). Less than 10% of URTI’s are caused by bacteria (Fendrick 2003). URTI, often referred to as the common cold or flu, have long been labeled as self-limiting illnesses; however, the associated morbidity is hardly trivial, with an estimated

ranked sixth overall, at approximately $8.63 billion annually. Of more concern, costs due to lost productivity (workplace and school absences, presenteeism) are thought to be grossly underestimated. Clinically, URTI contribute to a category of respiratory disease that is ranked as the third highest cause of hospitalizations and deaths in Canada. This may be due to the unappreciated role URTI play in the predisposition and exacerbation of illnesses such as sinusitis, otitis media, chronic obstructive pulmonary disease (COPD), and asthma. The purpose of this review was to outline the prevalence, etiology, and extensive impact of URTI in several capacities, including health care costs, workplace productivity, and clinical implications. Evidence for COLD-FX®, a proprietary extract from North American ginseng plant, is also presented to demonstrate its potential use in the management of URTI, and in reducing the burden of illness.

median duration of 7.4 days, and up to 25% of non-influenza cases lasting two weeks (Fendrick 2003). Most importantly, the overall burden of URTI may be underestimated, as URTI cause significant morbidity and mortality in high-risk populations, may result in secondary infections, and have substantial socioeconomic Christopher Knee, MSc., ND (Cand.)

Health Care Professionals Resources Associate Afexa Life Sciences Inc., A Division of Valeant Pharmaceuticals International, Inc. Email: cknee@afexa.com Dr. Esther Konigsberg, MD, CCFP Integrative Medicine Consultants Inc., Burlington and Toronto Afexa Life Sciences Inc., Consultant (905) 333-1104

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Feature COLD-FX® impact through both health care costs and lost productivity. The purpose of this discussion is to outline the extensive impact of URTI in several capacities, and introduce evidence regarding the ability of COLD-FX® (Afexa Life Sciences) to impact the course of URTI. Prevalence of URTI

Accurate statistics on the prevalence of URTI are difficult to assimilate, mostly due to self-reporting bias through surveys, diagnostic limitations and variability, and underreporting of illness (Canadian Institute for Health Information 2001, Jefferson 2009, Stocks 2002). Results from the 1998-1999 National Population Health Survey indicate that approximately one third of Canadian adults (aged 15-64) will have a sore throat, cold or flu in a given month (34% females, 27% males) (Statistics Canada 2001). More recently, from 2001-2002, a study by the Institute of Clinical Evaluative Services (ICES) found that URTI accounted for about 70% of all respiratory-related physician visits in Ontario, and the frequency of visits was three times higher during winter-early spring compared to the summer months (Jaakkimainen 2006). In general, the incidence of URTI is inversely proportional to age, with children experiencing six to eight episodes annually, and adults two to four annually (Heikkinen 2003).

Health Care Costs of URTI

URTI can have both direct (hospital, physician, medication, research) and indirect (mortality, long-term disability) financial effects on the Canadian health care system. In 2000, direct and indirect costs for respiratory infections (ie. common cold, influenza, pneumonia) were about $2.4 billion and $552 million, respectively.

When combined with respiratory diseases (ie. COPD, asthma), the total financial cost ranked sixth overall – behind cardiovascular diseases, musculoskeletal diseases, injuries, malignant neoplasms, and neuropsychiatric conditions – at an estimated $8.63 billion annually (Public Health Agency of Canada 2007). In the US, the incidence of non-influenza-related viral URTI has been estimated at approximately 500 million episodes per year, with a total economic impact of almost $40 billion (Fendrick 2003).

The Impact of URTI on Workplace Productivity

URTI also result in significant economic burden through workplace absences and lost productivity. For example, in the month of November 2009 alone, about 1.5 million Canadians aged 15-69 (about 9.0% of workers in this age category) reported absences from work as a result of H1N1 or the seasonal flu (Statistics Canada 2010). In fact, annual costs due to lost productivity have been estimated at $1 billion (CBC 2009). In its most recent survey, the National Center for Health Statistics (NCHS) in the United States reported that roughly 22 million workdays and 20 million schooldays are lost annually due to the common cold (National Institute of Allergy and Infectious Disease 2011). Of larger

importance may be the hidden impact of presenteeism – almost 83% of survey respondents recently admitted to attending work or school while experiencing an influenza-like illness (Vugia 2004).

It has been estimated that employees who go to work while sick are about 33% less productive, on average, and can cost their employers twice as much in productivity losses than if they were to stay home (Bramley 2002). Therefore, practitioners are encouraged to educate patients on the importance of taking time off from work or school in order to reduce productivity losses, duration of illness, and the risk of transmission.

The Impact of URTI on Morbidity and Mortality

Some URTI, such as influenza and pneumonia, are a leading cause of death in Canada. From 2004-2005, ‘respiratory disease’ (influenza, pneumonia, COPD, asthma, and ‘other’) accounted for approximately 10.4% of all hospitalizations and 8.7% of all deaths in Canada – ranked third only to cardiovascular disease and cancer (Public Health Agency of Canada 2007). Bronchiolitis-associated infections and hospitalizations, of which respiratory syncytial virus (RSV) is the primary cause, have also increased recently, likely due to increases in the number of children placed in daytime child-care centers (Canadian Institute for Health Information 2001). Influenza (A) is typically associated with the highest morbidity and mortality – those at greatest risk of hospitalization and/or death include children aged six-23 months, those with chronic medical conditions, and the elderly (Canadian Institute for Health Information 2001).

Acute Exacerbations and Complications Due to URTI

There are a number of illnesses associated with co-infection of the respiratory tract. The most prominent research is centered on COPD and asthma, followed by acute otitis media (AOM), bronchitis, and sinusitis. According to a recent longitudinal study, about one in four individuals in Canada are likely to be diagnosed with COPD during their lifetime, and it is the fourth most common cause of death worldwide (Gershon 2011). The prevalence of COPD increases with age and is strongly linked with smoking in 80-90% of cases, as well as the number of childhood URTI (Public Health Agency of Canada 2007). The average COPD patient experiences about two acute exacerbations per year, leading to increased utilization of healthcare resources, accelerated decline in lung function, and increased mortality (O’Donnell 2008). Viral URTI are thought to be responsible for at least 50% of acute exacerbations of COPD (due to the ability of rhinoviruses to replicate in the lower airways), with the frequency of exacerbations being directly proportional to community outbreaks of URTI (Mallia 2006).

Researchers have also demonstrated viral URTI to be the primary risk factor for asthma exacerbations in 80-85% of cases (Edwards 2006), predominantly due to rhinoviruses as with COPD

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Feature COLD-FX® (Papadopoulos 2001). Virus-induced asthma exacerbations, which typically peak in the fall with the start of the school year (Johnston 2006), are often serious – if in the presence of respiratory allergies, the likelihood of respiratory emergency is substantially higher (Gern 1999).

Acute otitis media (AOM) is typically considered a bacterial illness, however viruses such as RSV, rhinovirus, and influenza also account for about 10% of cases (Leung 2008). Other estimates have noted at least 45% of AOM episodes to be preceded by a common cold (Papadopoulos 2001). Mechanistically, viral infections in the upper respiratory tract cause congestion of the nasopharynx and eustachian tube, leading to impaired drainage of middle ear secretions and subsequent bacterial accumulation (Greenberg 2003). Rhinoviruses also lead to a significant number of sinus infections (Leung 2008), as well as winter outbreaks of acute bronchitis (Walsh 2009). Undoubtedly, URTI have vast implications in the development of acute exacerbations and serious complications of a variety of other illnesses, which should not be overlooked.

Current Strategies for the Treatment of URTI

According to the National Population Health Survey, as many as 20% of Canadians purchase an over-the-counter (OTC) cough, cold, or flu medication in a given month – the second largest

category of OTC pharmaceutical products. In the same survey, 63% of Canadians who reported cold or flu symptoms in a given month said they attempted to treat the illness themselves, while 20% ignored their symptoms, and only 9% sought medical attention (Statistics Canada 2001). Unfortunately, URTI are mostly viral illnesses for which antibiotics are not effective, and conventional OTC medications provide only temporary symptomatic relief at best. Most importantly, even though OTC medications are so commonly used, there is limited evidence supporting their safety and efficacy; as a result, and in combination with reports of misuse, overdose, and adverse events, Health Canada has recently prohibited the use of OTC cough and cold medications in children under the age of six years (Health Canada 2008).

COLD-FX® for Reducing the Burden of URTI

COLD-FX is a proprietary extract (CVT-E002) from the root of Panax quinquefolius (North American ginseng). Two decades of research on COLD-FX has culminated in four pivotal human clinical trials (see Table 1). Administration of COLD-FX reproducibly demonstrates outcomes of reduced frequency, severity, and duration of URTI. Adult dosing for prevention is recommended at 200mg twice daily through the cold and flu season (September through April). For management of an acute URTI, dosing is recommended as 300mg twice daily at first sign of symptoms for 10 days.

Table 1. Summary of COLD-FX® Clinical Trials for Acute Respiratory Illness Author/ Publication Date

Study Design

Duration

Dosage

Results

Two study periods: eight and 12 weeks

200 mg COLD-FX twice daily or placebo

•

McElhaney 2004

198 healthy nursing home patients (90% received flu vaccination)

Predy 2005

279 healthy adults aged 18-65 (no flu vaccination)

Four months

400 mg COLD-FX once daily or placebo

McElhaney 2006

43 healthy adults aged 65+ (flu vaccination at week four)

Four months

400 mg COLD-FX once daily or placebo

McElhaney 2011

783 adults aged 65+ (all received flu vaccination before study)

Four months

400 mg or 800 mg COLD-FX once daily, or placebo

ARI = Acute Respiratory Illness

OR = Odds Ratio

89% relative risk reduction of ARI (laboratory-confirmed influenza and RSV) • NNT = 17 (eight weeks treatment) and 12 (12 weeks treatment), respectively •

26% reduction in number of Jackson-verified ARI 56% reduction of recurrent ARI (OR = 0.37, NNT = 7.8) • 31% reduction in symptom severity • 34% reduction in duration of ARI •

•

48% relative risk reduction of ARI (OR = 0.29, NNT = 3) • 55% reduction in duration of ARI (5.6 vs. 12.6 days) •

31% and 33% relative risk reduction of Jacksonconfirmed ARI for 400 and 800 mg, respectively • OR (NNT) = 0.62 (11.2) and 0.59 (10.5) for 400 and 800 mg vs. placebo, respectively

NNT = Number Needed To Treat

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Feature COLD-FX® The mechanism of action of COLD-FX has been studied in preclinical, animal, and human trials. The basic action of COLD-FX, as illustrated in Figure 1, is that of an immune modulator – it works in a highly unique manner by targeting an early warning system of Toll-like receptors (TLRs). COLD-FX has been shown to stimulate both macrophages and natural killer

cells to release inflammatory mediators and cytokines, which can directly attack the infectious agent (virus or bacteria) as well as activate T cells and B cells. Activation of the T and B cells results in both an immediate and long-term defense against infection, with a memory-immune response as well as the production of virus-specific antibodies (Predy 2006, Wang 2001, Wang 2004).

Figure 1. COLD-FX ® Mechanism of Action (based on preclinical investigation of mechanism of action, internal reports).

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Feature COLD-FXÂŽ

Reports of serious adverse events (SAEs) from taking COLD-FX in both clinical trials and post-marketing surveillance have been extremely low to date. The number of SAEs in clinical trials has not been significantly higher in subjects taking COLD-FX compared to placebo. As per the product monograph, COLD-FX should not be used by individuals with ginseng allergies, taking anti-coagulant medications, who are pregnant or breastfeeding, or those with impaired liver or kidney function. Individuals should avoid exceeding the recommended daily dose of COLD-FX (Barrett 2007). Laboratory studies have also demonstrated that COLD-FX does not affect major liver enzymes responsible for the metabolism of some drugs and herbs, including (but not limited to) cytochrome P450, monooxygenase, and conjugation enzymes (Ueng 2002).

COLD-FX has also recently been shown to be safe and tolerable in children aged 3-12 years (Vohra 2008), and is currently being studied for pediatric efficacy through the University of Alberta.

Conclusions

The absolute impact of URTI has long been underestimated,

and evidence continues to illuminate the extensive implications that URTI can have both socioeconomically and clinically.

URTI result in significant health care costs annually, and have been shown to increase the morbidity and mortality of several other illnesses. Current OTC medications fail to address the importance of preventing URTI and have modest benefit for symptom relief.

Since COLD-FX has not yet been tested in patients with co-morbidities such as asthma or COPD, additional studies are warranted to demonstrate whether these patients would benefit from any reduction in the frequency, severity, or duration of URTI as a result of taking COLD-FX daily. While other generic or crude ginseng extracts are available OTC to patients and consumers, they may vary in chemical composition and pharmacological activity, and often lack product-specific published research. COLD-FX offers practitioners with a safe, reliable option for not only reducing the frequency, severity, and duration of URTI, but for possibly limiting the far-reaching burden of illness presented above. â&#x20AC;˘

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Feature COLD-FX®

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Vohra S, Johnston BC, Laycock KL, Midodzi WK, Dhunnoo I, Harris E, Baydala L. Safety and Tolerability of North American Ginseng Extract in the Treatment of Pediatric Upper Respiratory Tract Infection: A Phase II Randomized, Controlled Trial of 2 Dosing Schedules. Pediatrics. 2008; 122: e402-e410.

Vugia D, Gershman K, Hadler JL, Segler S, Ryan PA, Lynfield R, Baumbach J, Bennett NM, Cieslak PR, Craig A, Perrotta D, Whitney C, McCoy SI, Zell E, Shay D, Rebmann C, Cowgill K. Experiences with Influenza-Like Illness and Attitudes Regarding Influenza Prevention – United States 2003-2004 Influenza Season. CDC Morbidity and Mortality Weekly Report. 2004; 53(49): 1156-1158.

Walsh EE. Acute Bronchitis. In: Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases, 7th ed. Chapter 61: Section C: Pleuropulmonary and Bronchial Infections: 873-876. Churchill Livingstone/Elsevier. 2009.

Wang M, Guilbert LJ, Ling L, Li J, Wu Y, Xu S, Pang P, Shan JJ. Immunomodulating activity of CVT-E002, a proprietary extract from North American ginseng (Panax quinquefolium). Journal of Pharmacy and Pharmacology. 2001; 53: 1515-1523.

Wang M, Guilbert LJ, Li J, Wi Y, Pang P, Basu TK, Shan JJ. A proprietary extract from North American ginseng (Panax quinquefolium) enhances IL-2 and IFN-γ productions in murine spleen cells induced by Con-A. International Immunopharmacology. 2004; 4: 311-315.

Figure 1 - COLD-FX® Mechanism of Action (Based on preclinical investigation of mechanism of action, internal reports).

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Integrated Healthcare Practitionersâ&#x20AC;&#x2122; Dietary and Nutritional Supplement, and Herbal Remedies Management Program Author: Elizabeth J Cherevaty, 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 botanical medicine and by the cnpbc ; one ce hour.

Green tea Antiviral effects

Abstract

Green tea (Camellia sinensis) and its extracts are well-recognized for their antioxidant content and associated human health benefits. In recent years, evidence from in vitro and human clinical trials has accumulated to indicate that green tea-derived antioxidants, including its chief catechin, epigallocatechin gallate (EGCG), may have potentially beneficial antimicrobial activity against various strains of pathogenic yeast, bacteria and viruses. This article aims to synthesize the available evidence concerning the use of green tea extracts in the prevention or treatment of human viral illnesses. The human viral illnesses on which the majority of the research is focused with respect to the use of green tea include viral upper respiratory tract infections (oral or buccal use), and human papilloma virus (HPV)-induced anogenital warts (topical use). Five human observational and randomized controlled trials support the use of green tea in the prophylaxis or treatment of influenza and/or the common cold. A recent systematic review and meta-analysis involving 1247 men and women found a proprietary green tea catechin formula to be effective in the topical treatment and prevention of recurrences of condylomata acuminata due to HPV. Introduction

Besides water, tea is the most commonly consumed beverage worldwide (Mazzanti 2009). Prepared from fresh Camellia sinensis leaves, green tea is dry-heated or steamed, then rolled, dried and roasted (Mazzanti 2009). Constituents of unfermented Camellia sinensis leaves include polyphenols (20%-45% of dry weight), caffeine (2%-5%), amino acids (4%), lignin (6.5%), organic acids (1.5%), protein (15%) and chlorophyll (0.5%) (Mazzanti 2009, Meltzer 2009, Sarma 2008, Schneider 2009).

EGCG ((-)-epigallocatechin gallate) is the most potent green tea antioxidant (Mazzanti 2009) and comprises 60%-80% of its catechin content (Schneider 2009).

Green Tea as an Antiviral Agent

In vitro and human evidence supports the potential antiviral prophylactic and treatment uses of green tea (Meltzer 2009, Rowe 2007, Schutz 2010). Green tea polyphenols, chiefly the catechins, are antioxidants to which a majority of the anti-microbial, anti-inflammatory, anti-tumor and immunostimulatory properties of green tea have been ascribed (Mazzanti 2009, Meltzer 2009,

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Schneider 2009). EGCG has direct in vitro viricidal, inhibitory and anti-infective properties against several viruses, including HIV (Hauber 2009, Nance 2009), herpes simplex virus (HSV-1) (Isaacs 2008), hepatitis A (Kuzuhara 2009) and B viruses (Xu 2008). Green tea catechin derivatives have been shown to have in vitro inhibitory effects on six influenza virus subtypes (Song 2007). EGCG is also highly anti-inflammatory and inhibits pro-inflammatory chemokines, prostaglandins and tumor necrosis factor (TNF), which contribute to symptom production during human viral infections (Rowe 2007).

Viral Upper Respiratory Tract Infections

A prospective cohort study reported influenza prophylaxis in nursing home residents who gargled with a green tea catechin solution. Seventy-six elderly nursing home residents in Japan gargled with a 200 Îźg/mL green tea catechin or control solution, three times daily for three months, while 48 age- and sex-matched Elizabeth J. Cherevaty, ND Healing Foundations Naturopathic Clinic 111 Norfolk St., Guelph, Ontario N1H 4J7 drliznd@healingfoundations.ca

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Green tea constituents were identified to reduce incidence of influenza in health care workers in a recent, randomized, double-blind trial (Matsumoto 2011). Participants (n=197) were randomized to receive six capsules daily containing either a total of 378 mg catechin and 210 mg theanine, or placebo throughout influenza season (five months). The incidences of clinicallydefined and laboratory-confirmed influenza infection and each individual’s symptom-free period were recorded. Treatment significantly decreased clinically-defined influenza (n=4, 4.1%) compared to placebo (n=13, 13%), (p=0.022). The incidence of laboratory-confirmed influenza was lower with treatment but did not significantly differ from control (p=0.112) (Matsumoto 2011). The high rate of influenza vaccination (92.9%) among all participants may have caused an underestimation of the prophylactic efficacy of catechin/theanine treatment and the need was suggested for further, large-scale randomized trials to confirm effects (Matsumoto 2011).

A large observational study reported an inverse relationship between green tea consumption and influenza infection in

children (Park 2011). Elementary school students (n=2050) completed a series of two questionnaires during Japan’s endemic influenza A season. The consumption of 1-5 cups (200 mL/cup) of green tea daily compared with <1 cup per day was associated with a significantly lower risk of developing influenza. The incidence of clinically- and laboratory-confirmed influenza infection was also inversely related to consumption of green tea almost daily (i.e. ≥6 days per week) compared with <3 days per week. In contrast, no associations were observed between influenza incidence and conventional preventive measures such as hand hygiene, use of facemasks, or seasonal influenza vaccination in these children (Park 2011).

Continuing Education Lesson

control participants gargled with a placebo solution. The catechin solution (60% EGCG) was approximately half the concentration of commercially available green tea beverages (Yamada 2006).

All participants had received the World Health Organization (WHO)-recommended seasonal influenza vaccine prior to enrollment. Influenza A and B rapid assay was performed on nasal secretions of any resident who presented with influenza-like illness. Significantly fewer residents developed influenza B with treatment (1.3%) than control (10%), (p=0.028). None of the residents developed influenza A infection. This relatively small study was limited by the lack of dose-response determination for the treatment and non-randomization, which allowed residents to choose whether they would receive catechin or control solutions at the outset of the study (Yamada 2006).

Rowe et al. (2007) conducted a randomized, double-blind, placebo-controlled study investigating whether a standardized green tea extract containing L-theanine and EGCG would prevent the development of influenza and common cold symptoms in healthy adults. Participants were randomized to receive either one treatment capsule containing a proprietary preparation of L-theanine and EGCG (ImmuneGuard; standardization not reported) (n=53), or placebo (n= 55) capsule twice daily with food. Participants were asked to log daily cold and flu symptoms, including fever, runny nose, sore throat, cough, headache, diarrhea and nausea during the 12-week study.

During the 12-week study period, there was a 32.1% lower rate of symptom development in the treatment group (43.2%) versus control (63.6%), (p=0.035). There were 33.3% fewer symptomatic days in the treatment group versus placebo (p<0.022). There was a 22.9% lower incidence of illness (p=0.092) in the treatment group during the study period, but no significant differences in illness incidence from month to month (February to May). In the same study, peripheral blood mononuclear cells (PBMC) obtained from all subjects at baseline and on study day 21 were cultured for 24 hours in either media containing ethylamine (a catabolic product of L-theanine and a γδ T cell antigen) or control media.

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Continuing Education Lesson

PBMC obtained from participants after 21 days of treatment secreted 26% more IFN-γ in response to ethylamine than those from the placebo group (p=0.046), supporting the hypothesis that L-theanine could prime human γδ T cells to secrete more antimicrobial IFN-γ ex vivo (Rowe 2007). Adverse effects were mild and transient, with similar rates between treatment and control groups. A limitation of this study was the self-reporting of symptoms, which precluded both objective clinical diagnosis and the ability to rule out causation of symptoms by other illnesses such as asthma, bronchitis or allergy (Rowe 2007).

Results of this study were consistent with previous work cited by the same authors, wherein PBMC obtained from subjects who had begun drinking five to six cups of green tea daily for one week secreted significantly more IFN-γ in response to γδ T cell antigens compared to baseline (Rowe 2007).

A multi-ingredient formulation containing green tea has been demonstrated to provide symptomatic benefits in the common cold (Schutz 2010). In a randomized, double-blind, placebocontrolled, multi-centre trial, participants with symptoms of a general feeling of sickness, headache and/or joint aches, sore throat and/or difficulty swallowing, hoarseness and/ or cough, and stuffy nose/sniffle were randomly assigned to receive either a polyphenol-rich beverage containing green tea extract (3g/L), grape skin extract (12 g/L), grape seed extract (0.5 g/L), shiitake mushroom extract (0.05 g/L) and vitamin C (0.3 g/L) or placebo beverage containing water, sugar, citric acid and flavour, twice daily for 10 days. Participants underwent a total of three clinical examinations during the study period and logged their symptoms daily. By the third scheduled clinical examination, 19 of 49 treatment patients (38.8%) and 4 of 47 placebo patients (8.3%) who completed the study were asymptomatic (p<0.001). By their own evaluations, 41.9% of treatment patients and 5.0% of placebo patients were complaint-free by day seven of the study (p<0.001). Significant differences in sleep disorders, disturbances of daily activities and tissue use were also reported with treatment beverage (Schutz 2010). Blinded patient and physician ratings of the efficacy of the beverages received supported the superiority

of the polyphenol treatment (Schutz 2010). Interestingly, the incidence of herpes labialis, a common concomitant symptom of the common cold, was significantly lower in the treatment group at the end of the study than that in the placebo group (Schutz 2010). The observed improvements in all common cold symptoms assessed suggested a general increase in defense and immunity rather than symptom-specific effects of the polyphenol beverage (Schutz 2010). This study supports the use of green tea extract in a multi-agent immunomodulatory approach to treatment of the common cold, although the presence of several antioxidant and immunomodulatory substances precludes the conclusion that the observed benefits could be solely attributed to green tea.

Human Papilloma Virus (HPV)

A recent meta-analysis demonstrated the efficacy of a Camellia sinensis leaf extract known as Polyphenon E (MediGene AG, Germany) in the topical treatment of anogenital warts (condylomata acuminata, HPV-6 and -11) (Tzellos 2011).

Polyphenon E contains > 80% green tea catechins (Stockfleth 2008), which appear to inhibit HPV viral transcription and binding to cell receptors; have antiproliferative effects; and promote apoptosis when applied topically (Tzellos 2011 citing others). Three randomized, double-blind, placebo-controlled, multicentre studies enrolling a total of 660 men and 587 women met inclusion criteria for the meta-analysis; all three studies used Polyphenon E 15% or 10% (green tea catechins) ointment for HPV-induced anogenital warts. Both Polyphenon E formulations were found to be efficacious for clearance of lesions in both men and women, and compared to conventional therapies showed a low recurrence rate (Tzellos 2011). The treatment was generally well tolerated in all trials, with mild local skin reactions peaking at weeks two to four of treatment being considered essential to achieving a clinical response (Tzellos 2011).

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Authors

Study Design

Participants

Treatment

Results

Yamada 2006

3-month, prospective cohort study

Nursing home residents (N=124) ≥ 65 yoa

Gargling with tea catechin solution (n=76) residents; 48 matched controls gargled without tea catechins

Significantly lower influenza incidence with treatment (1.3%, n=1) vs. control (10%, n=5).

Influenza

Matsumoto 2011

5-month, randomized, double-blind, 2-group parallel study

Healthcare workers ≥ 20 yoa

6 capsules daily: 378 mg catechins + 210 mg L_theanine) (n=98) or placebo (n=99)

Incidence of clinically-defined influenza was significantly lower with treatment (4.1%, n=4) vs. placebo (13.1%, n=13).

Influenza

Park 2011

4- month observational study

2050 elementary school students 6-13 yoa

Ad libitum consumption of green tea recorded in 2 questionnaires

1-5 cups (200-1000 mL) green tea daily was inversely associated with influenza incidence

Influenza

Influenza & Common cold

Common cold symptoms

HPV (Condylomata acuminata)

Rowe 2007

Randomized, double-blind, placebo-controlled, 12-week parallel study

Healthy women (n=72) and men (n=52), 21-70 yoa

ImmuneGuard (decaffeinated Camellia sinensis extract) or placebo, 1 capsule bid for 12 weeks

Treatment resulted in a 33.3% reduction in symptomatic days (p<0.002) and a 32.1% reduction in the experience of any cold or flu symptom compared to placebo (p=0.035)

Schutz 2010

Randomized, double-blind, placebo-controlled, multi-centre study

98 patients reporting common cold symptoms ≤24 hrs before beginning study intervention

Green tea polyphenolrich (n=49) or placebo beverage (n=49) bid for 10 days

Symptoms declined faster with polyphenol-rich beverage than placebo (p<0.001)

Systematic review & meta-analysis

Three studies involving 660 men, 587 women included in meta-analysis

Polyphenon 15% or 10% (catechins) applied by patients 3 times daily to anogenital warts for 12 weeks

Polyphenon 15% and 10% are effective in treatment and prevention of anogenital warts

Tzellos 2011

Safety

Green tea infusion has been widely consumed throughout the world, at typical intake levels of one to three cups per day in the U.S. and up to nine cups per day in Japan, with a low incidence of adverse effects in adults (Sarma 2008 citing Imai 1997) and children (Park 2011). The most common adverse effects of green tea are gastrointestinal upset and central nervous stimulation from caffeine (Schneider 2009). As of 2009, two systematic reviews had identified 34 cases of possible or probable hepatotoxicity following intake of green tea products (Mazzanti 2009, Sarma 2008).

Some of the case reports were confounded by the concomitant

Continuing Education Lesson

Viral Disease

use, or non-reporting of other potentially hepatotoxic substances (Mazzanti 2009). The mechanism of liver damage is theoretically ascribed to paradoxical pro-oxidant activities of EGCG when present in high concentrations (Mazzanti 2009). Oral bioavailability of catechins is generally low but increases with fasting and repeated administration (Mazzanti 2009). Therefore, green tea extracts should be consumed with food (Sarma 2008).

Extracts providing up to 690 mg total catechins and up to 150 mg caffeine per day are considered safe for adult use for up to 12 weeks; green tea extracts are contraindicated in individuals with liver disorders (Health Canada 2008).

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Continuing Education Lesson References Bruneton J. Pharmacognosy, phytochemistry, medicinal plants, 2nd ed. Lavoisier Publ, Paris. [As reviewed in Mazzanti et al. 2009].

Hauber I, Hohenberg H, Holstermann B, et al. The main green tea polyphenol epigallocatechin-3gallate counteracts semen-mediated enhancement of HIV infection. PNAS 2009;106(22):9033-9038.

Health Canada. Green tea extracts [monograph]. Natural Health Products Directorate (2008). Accessed electronically Dec. 12, 2011. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_greentea-thevert-eng.php Isaacs CE, Wen GY, Xu W, et al. Epigallocatechin gallate inactivates clinical isolates of herpes simplex virus. Antimicrobial Agents and Chemotherapy 2008;52(3):962-970.

Kuzuhara T, Iwai Y, Takahashi H, et al. Green tea catechins inhibit the endonuclease activity of influenza A virus RNA polymerase [Internet]. Version 128. PLoS Currents: Influenza. 2009 Oct 5 [revised 2009 Oct 13]:PMC2762814.

Matsumoto K, Yamada H, Takuma N, et al. Effects of green tea catechins and theanine on preventing influenza infection among healthcare workers: a randomized controlled trial. BMC Comp Alt Med 2011;11:15-21.

Park M, Yamada H, Matsushita K, et al. Green tea consumption is inversely associated with the incidence of influenza infection among schoolchildren in a tea plantation area of Japan. J Nutr 2011;141:1862-1870.

Rowe CA, Nantz MP, Bukowski JF, et al. Specific formulation of Camellia sinensis prevents cold and flu symptoms and enhances γδ T cell function: a randomized, double-blind, placebo-controlled study. J Am Coll Nutr 2007;26(5):445-452.

Sarma NS, Barret ML, Chavez ML, et al. Safety of green tea extracts: a systematic review by the US Pharmacopeia. Drug Safety 2008;31(5):469-484.

Schneider C, Segre T. Green tea: potential health benefits. Am Fam Physician 2009;79(7):591-594.

Schutz K, Sab M, de With A, et al. Immune-modulating efficacy of a polyphenol-rich beverage on symptoms associated with the common cold: a double-blind, randomized, placebo-controlled, multicentric clinical study. Br J Nutr 2010;104:156-1164.

Song JM, Park KD, Lee KH, et al. Biological evaluation of anti-influenza viral activity of semisynthetic catechin derivatives. Antivir Res 2007;76:178-185.

Stockfleth E, Beti H, Orasan R, et al. Topical Polyphenon® E in the treatment of external genital and perianal warts: a randomized controlled trial. Br J Dermatol 2008;158:1329-1338.

Mazzanti G, Menniti-Ippolito F, Moro PA, et al. Hepatotoxicity from green tea: a review of the literature and two unpublished cases. Eur J Clin Pharmacol 2009;65:331-341.

Tzellos TG, Sardeli C, Lallas A, et al. Efficacy, safety and tolerability of green tea catechins in the treatment of external anogenital warts: a systematic review and meta-analysis. JEADV 2011;25:345-353.

Meltzer SM, Bradley HM, Krishnansu ST. Green tea catechins for treatment of external genital warts.

Am J Obst Gyn 2009;233e1-233e7.

Xu J, Wang J, Deng F, et al. Green tea extract and its major component epigallocatechin gallate inhibits hepatitis B virus in vitro. Antivir Res 2008;78:242-249.

Nance CL, Siwak EB, Shearer WT. Preclinical development of the green tea catechin, epigallocatechin gallate, as an HIV-1 therapy. J Allerg Clin Immunol 2009:459-465.

Yamada H, Takuma N, Daimon T, et al. Gargling with green tea catechin extracts for the prevention of influenza infection in elderly nursing home residents: a prospective clinical study. J Alt Comp Med 2006;12(7) 669-672.

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1. Green tea catechins exhibit antiviral activity through which of the following mechanisms?

A) Direct viricidal activity B) Inhibition of the ability of a virus to infect a host cell C) Stimulate antibody production, with memory, protecting the host from future infection for up to a decade D) All of the above are correct E) A and B above are correct.

2. While demonstrating preclinical promise against herpes simplex virus, hepatitis A and hepatitis B viruses, green tea catechins have failed to demonstrate antiviral activity towards influenza viruses.

A) True B) False 3. Why do trials evaluating safety and efficacy of natural medicines in flu prevention and treatment recruit patients who have received the seasonal influenza vaccine?

A) It makes it harder to show efficacy of the natural medicine, thereby making it easier to continue with the status quo.

B) It controls for variation in participants previous exposures, or lack there of, to the influenza virus.

C) The vaccine is the current standard of care for flu prevention, and therefore a medicine needs to show benefit above and beyond the current standard to be considered useful.

D) There is no basis to recruit participants who have received the flu vaccine. It would be more appropriate to recruit patients who have not received the flu vaccine.

4. Human intervention trials have demonstrated efficacy of green tea administration for prevention and/ or treatment of flu among which of the following populations?

A) Elderly B) Health care workers C) Healthy adults D) Children 5. Human intervention trials have demonstrated administration of green tea preparations to be effective against which of the following viral infections?

A) Herpes simplex virus B) Influenza C) Human papilloma virus D) Hepatitis B

E) A and B are correct F) B and C are correct G) C and D are correct 6. Green tea as reviewed in this article has been shown to act as an antimicrobial agent when given via which routes of administration?

A) oral B) topical C) gargle D) intravenous E) A and B are correct F) B and D are correct G) A, B, and C, are correct 7. Intake of one to five cups of green tea per day (200-1000 mL) has been associated with lower incidence of influenza.

A) True B) False 8. Topical preparations with anti-HPV properties are of the following concentrations: A) 5% green tea catechins B) 15% green tea catechins C) 25% green tea catechins D) all of the above

Continuing Education Lesson

Questions

9. Green tea is generally well tolerated, however there have been 34 reports of liver damage associated with use of green tea products. Which of the following is true?

A) Use of other potentially hepatotoxic substances was ruled out as a potential contributing cause.

B) These patients had pre-existing liver diseases, increasing their risk for a negative reaction.

C) This is thought to be mediated by paradoxical pro-oxidant effects of green tea when it is present in high concentrations D) all of the above.

10. Products providing up to 690 mg total catechins and 150 mg caffeine per day are considered safe for adult use for up to 12 weeks, but green tea extracts should not be used in patients with liver disorders.

A) True B) False

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®

is a registered trademark licensed exclusively to PoliNat. International patents pending.

GreenSelect® Phytosome is a registered trademark of Indena.

Caplique® Capsule is a registered trademark used by Pure Encapsulations under license.

TO ORDER: 866.856.9954

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Uses For XanthiTrim Weight Management: XanthiTrim contains 300 mg of Xanthigen® per serving, a synergistic combination of fucoxanthin from brown seaweed and pomegranate seed oil. In a 16-week, randomized study, Xanthigen® supported healthy weight management and fat metabolism in volunteers. This was attributed in part to its ability to encourage resting energy expenditure and thermogenesis, the body’s natural ability to dissipate caloric energy as heat from the mitochondria of adipose tissue. This results in oxidation and utilization of fats rather than fat storage. In this study, Xanthigen® also maintained healthy liver fat metabolism and function, healthy inflammatory balance, and healthy triglyceride levels. Subjects were on a moderately calorie-restricted diet. GreenSelect® Phytosome is a proprietary, caffeinefree extract from green tea, that is 1 part GreenSelect® green tea to 2 parts phophatidylcholine. This allows for greater absorption of epigallocatechin gallate, or EGCG, one of the primary components known to support healthy metabolism. Green tea has demonstrated the ability to promote resting energy expenditure and thermogenesis in a number of clinical studies. A 90-day study involving GreenSelect® Phytosome revealed its ability to support healthy weight management and body composition in subjects following a calorie-restricted diet.*

What Is The Source?

Xanthigen® is derived from a proprietary blend of brown seaweed (Undaria pinnatifida and Laminaria japonica) standardized to provide a minimum of 1,275 mcg fucoxanthin, and pomegranate seed oil. GreenSelect® Phytosome is derived from green tea leaf extract (Camellia sinensis) standardized to contain 13% epigallocatechin gallate

(EGCG) and soy lecithin phospholipids. Medium chain triglycerides are derived from coconut and palm oil. ®

is a registered trademark licensed exclusively to PoliNat. International patents pending.

GreenSelect® Phytosome is a registered trademark of Indena.

Recommendations Pure Encapsulations recommends 2 capsules daily, in divided doses, with meals and 8 oz. water.

Are There Any Potential Side Effects Or Precautions?

Not to be taken by pregnant or lactating women. In rare cases, green tea can cause dizziness, insomnia, agitation or fatigue. Consult your physician for more information.

Are There Any Potential Drug Interactions?

Green tea may be contra-indicated with blood thinning medications. Green tea extract may also interfere with the absorption and effectiveness of a number of other medications, including certain heart, anti-diarrhea, cold and hay fever medications. Consult your physician for more information.

XanthiTrim one Caplique ™ Capsule contains

Xanthigen® proprietary blend ........................................................ 300 mg providing: brown seaweed (Undaria pinnatifida, Laminaria japonica) (providing 1,275 mcg fucoxanthin (min.)), pomegranate seed oil GreenSelect® Phytosome ................................................................ 150 mg providing: green tea (Camellia sinensis) extract (leaf) and soy lecithin phospholipids (standardized to contain 13% epigallocatechin gallate (EGCG)) Contains soy other ingredients: medium chain triglycerides

2 Caplique™ Capsules per day, in divided doses, with meals and 8 oz water.

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Among white of women and 20%and of years andwill older will experience a fragility fracture in their remaining lifetime (Sambrook, 2006). According tothere Keen, there 1.6 million hip fracmen 50 men years50 and older experience a fragility fracture in their remaining lifetime (Sambrook, 2006).

According to Keen, were 1.6were million hip fraccardiovascular disease (CVD).

Eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) are well-recognized for their anti-inflammatory, anti-arrhythmic, anticonversion of testosterone to dihydrotestosterone, which binds to the receptor five-fold more avidly than the parent compound (Sinclair tures per annum worldwide in 1990, and this number is projected at 6 million by 2050 (2003). Sequelae of fracture range from restricted mobility and loss of 1998).

tures per annum worldwide in 1990, andeffects, this number is projected at 6 million by 2050 (2003).

Sequelae of fracture range from mobility and loss events of hypertensive, and anti-atherosclerotic and have beenwithin shown to reduce riskhip of sudden cardiac death, stroke, and restricted secondary cardiovascular to dramatically increased mortality rates a year following fracture in particular (10-20%) (Sambrook, 2006).

Economic burden of(No authors independence to2011). dramatically increased mortality rates also within a year following hip fracture inD3 particular (10-20%) (Sambrook, 2006).of Economic burden of independence cardiovascular disease (Zhao 2012).

1999, Poudyal Recently published evidence suggests that adequate vitamin is important for the prevention Vitamins Saw palmetto (Serenoa repens) osteoporotic fractures amount to upwards of 20 billion USD in the US alone, and 30 billion USD in the EU (Sambrook, 2006). osteoporotic fractures amount to upwards of 20 billion USD in the US alone, and 30 billion USD in the EU (Sambrook, 2006).

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 Omega-3 fatty prevention Table 1:acids: Summary of Relevant Human pantothenate was orally administered twice a day in doses of 100 mg for four to of 5 -reductase, resulting in decreased tissue DHT. Studies An open-label, dose response Table 1: Summary ofPrimary Relevant Human Studies The HeartStudy Association recommends with EPA+DHA for five all patients aReferences constellation risk factors Dose Study des ign & isupplementation ption the effect Outcomes months,with and metabolic vitamin B6syndrome, wasReferences injected every day forof20cardiovascular to 30 days and repeated study was conducted on 42des healthy males todescr determine of a combination DoseAmerican ign & descr iption Outcomes including elevated triglycerides, blood pressure,berry and blood lowDHT HDL;and increased waist circumference (Grundyska-Wcisło 2005). Combined supplementation again after six months (Brzezi 2001). ItEPA+DHA was determined that vitamin of carotenoid astaxanthin and saw palmetto lipid glucose; extract on mg calcium andof RCT ofrisk calcium and vitamin D supplement of treatment group increased from atcause baseline to Diweeks Daniele et al.improvement Pharmacol B6 administered parenterally forDiofaDaniele few in Takaki the hair testosterone levels 2008).

The men divided intoofBMD two groups: has shown to (Angwafor improve these factors and slow the progression of atherosclerosis, the primary underlying cardiovascular disease (Cottin 2011, 500 been mg 500 calcium and RCT calcium and vitamin Dwere supplement BMD treatment group increased from 1.101 at1.101 baseline to N, et induces al.N, Pharmacol 200one IU Vitamin D mg/day versus ofplacebo in 1201800mg women over a 30 1.111 attherapy 30 condition months; BMD placebo group decreased Res. 2004;50(6):637-41. inweeks aofsubset ofdecreased women and reduces hair loss. one received combination and the other 2011).

In study, supplementation EPA day added to statin forof48 resulted in better pulse wave velocity (baPWV) 200 group IU Vitamin D 800 versus placebo inthewith 120 women oversupplement a per 30 1.111 g/cm2 atg/cm2 30 months; BMD placebo group Res.brachial-ankle 2004;50(6):637-41. group received 2000 mg/day of theofsupplement for 14 days.

ANOVA-RM (p=0.04) and stiffness parameter the carotid (p=0.02), both measures ofshowed atherosclerosis, compared to statin therapy alone (Takaki 2011). mcg Vitamin D3increases increase in lumbar spineofBMD 1.6% was observed in Baeksgaard L, et al. Osteoporos significant within-group in serum testeosterone andAnsignificant 2 year double blindtotal randomized, placebo14 mcg 14 Vitamin D3 2 year An increase in lumbar spine BMD 1.6% of was observed in Baeksgaard L, et al. Osteoporos double blind randomized, placeboMedicinal Ingredients Dose Per Capsule (=560 IU) DHT from baseline in both dose groups the treatment group after 2Inyears.

In the placebo group no Int. 1998;8(3):255-60. decreases in serum (P=0.05).

There (=560 IU) the treatment group after 2 years. the placebo group no Int. 1998;8(3):255-60. controlled onofeffect of a calcium and Secondary prevention controlled trial ontrial effect a calcium and significant changes were observed during the 2 years. was significant difference between groups with regard tointhe of significant changes wereoilobserved during(Trigonella the 2 disease years. foenum D dose supplement inhealthy 240 healthy Fenugreek graecum) Theno GISSI-Prevenzione trialvitamin was a groundbreaking theincrease area of fish and cardiovascular (No authors 1999). A total of 11,324 patients who vitamin D supplement in 240investigation 260 mg testeosterone the decrease of DHT; therefore both doses were (Angwafor 58-67 extractper 4:1 had survivedor a heart attack women within the previous months wereeffective randomized to either 1gseed EPA+DHA day, vitamin E 300mg per day, both, or none for 3.5 years. The women 58-67 years ofyears age. of3age.

2008).

Magnesium; 3 controlled human trials showing benefit on bone turnover primary endpoint measure was a combined measure of death, non-fatal myocardial infarction, and stroke.

After 3.5 years treatment with EPA+DHA, but not vitamin Magnesium; 3 controlled human trials showing benefit on bone turnover 250-750 mg magne31 osteoporotic post-menopausal women 71% of magnesium group hadincreases 1-8% increases in trabecular Volpe SL,Magnes et 160 al. Magnes Saw palmetto berry extract containing mg Res. This benefit 250-750 mg magne31 osteoporotic women 71% of risk magnesium group had 1-8% in trabecular Volpe SL, et al.

Res. E, significantly lowered the risk of thepost-menopausal primary endpoint (combined of death, second heart attack, or stroke), by 15%, RR 0.85 (95%CI 0.74-0.98). sium hydroxide 23 extract controls at250 least mgover BMD over 2All years.

All treatment subjects showed increased 1993;6(3):291-6.

Another study testedand liposterolic ofreceived Serenoa repens (LSESr) and beta45% freeand fatty acids siumattributable hydroxide 23 and controls received at least mg250 BMD 2 years. treatment subjects showed increased 1993;6(3):291-6. was to a decrease in the overall risk of death 20%, risk of cardiovascular death 30%, of sudden death 45%. According to Marchioli, the reduction for two years.

BMD after 2controls’ years; controls’ BMD risk decreased. sitosterol in the treatment offorMg/d males (23-64 years of age) with mildBMD to moderate AGA. Mg/d two years. after 2 years; BMD decreased. in sudden deathC; is due towere thestudy anti-arrhythmic effect of thesevisit, fish-derived omega-3 fatty Flax acidslignans, (2005). Importantly, these standardized to effects 20% were seen from the addition of fish oil 1 human suggesting tofinal BMD Six of 10Vitamin (60%) subjects rated as improved at the thus establishing Vitamin C; 1 human study suggesting benefit benefit to BMD 100 mg is not only safe to standard pharmacological therapies: beta blockers, lipid(Prager lowering drugs, diuretics,for aspirin, etc, demonstrating thatand thetotal combination ofetEPA+DHA 100 to 5,000 mg; 994 women from a community-based After adjusting age, body mass index (BMI), Morton al.Miner J Bone Miner secoisolariciresinol diglucoside (SDG) effectiveness of 5 the -reductase inhibitors against AGA 2002).

Chronic 100 to 5,000 mg; 994 women from a community-based After adjusting for age, body mass index (BMI), and total Morton DJ, et al.DJ, J Bone alongside these drugs, but can improve outcomes even in medicated patients. mean daily dose was cohort of whom 277 women were regular calcium intake, vitamin C users had BMD levels Res. 2001;16(1):135-40. inflammation of the follicle is considered to be were a contributing factor for AGA. vitamin A mean daily dose was hair cohort of whom 277 women regular calcium intake, C users had BMD levels Res. 2001;16(1):135-40.

D-calcium (Vitamin B5) 10.40 mg mg. et alvitamin C supplement approximately 3% at higher at thepantothenate midshaft study by745 Chittur soughtvitamin tosupplement determine whether blockade of approximately inflammation using 745 mg.

C users. users.

3% higher the midshaft radius, radius, femoralfemoral neck, and total hip.

Since the GISSI-Prevenzione trial, other studies have also reported significant reductions in incidence of atrial fibrillation by approximately 50% mg in patients undergoing neck, andcould total hip.

LSESr and two anti-inflammatory agents (carnitine and thioctic acid) alter Niacinamide (Vitamin B3) 10.25 Folic Acid; Vitamin B12; Vitamin B6 12005, controlled human trial suggesting benefit bone resorption and BMD coronary artery (CABG) Sorice 2011). the expression ofbypass molecular markers inflammation (Chittur 2009).

It was found Folic Acid; Vitamin B12;graft Vitamin B6of1(Calo controlled human trial suggesting benefit to boneto resorption and BMD 2.5 mg0.5 folate, Osteoporotic 0.5suppressed Osteoporotic subjects 55-82 Vitamin years)expression Vitamin treatment decreased biomarkers of bone B6) resorption Herrmann al. Clin Chem Pyridoxine HCl (Vitamin 2et mg that thefolate, combination lipopolysaccharide-activated gene of 2.5 mg subjects (n=47, (n=47, 55-82 years) treatment decreased biomarkers of bone resorption Herrmann M, et al.M, Clin Chem mg vitamin B12 and were treated with either a combination of by-13% after 8 and 12 months.

Hyperhomocysteinemia is a Lab Med. 2007;45(12):1785-92. mg vitamin and were with involved either a in combination of by-13% after 8 and 12 months. Hyperhomocysteinemia is a Lab Med. 2007;45(12):1785-92.

Vitamin DB12 chemokines associated withtreated pathways inflammation and apoptosis.

25 mg vitamin B6 B12, folate,and B12, and B6 or placebo.

BMD at new riskfor factor for osteoporosis.

Riboflavin (Vitamindisease B2) (Zhao 2012). Although1.58 mg mechanism 25 mg vitamin B6 folate, B6 or placebo.

BMD atassociated new risk factor osteoporosis.

The study concluded that 5-alpha reductase inhibitors combination with Observational evidence shows that spine low vitamin D levels areatin with increased risk of cardiovascular the precise lumbar and hip measured baseline In hyperhomocysteinemic subjects, B-vitamins increased lumbar spine and hip measured at baseline In hyperhomocysteinemic subjects, B-vitamins increased blockade of inflammatory processes could represent a new two-pronged approach is not well known, vitamin and D supplementation has been shown to improve blood and cholesterol (Goel Folic acid 0.095 2012). mg One study after 1 year. the pressure lumbar spine (t-score to 2011, -1.7), Pfeifer and 2011, Salehpour and after 1 year. atBMD the at lumbar spine (t-score -2.7 to -2.7 -1.7), and in the treatment of AGA. conducted in healthy premenopausal obese women found thatBMD supplementation with 25 bone mcg (1000 IU) vitamin decreased breakdown by 50%. D3 per day for 12 weeks resulted in significantly decreased markersmarkers of bone of breakdown by 50%.

Biotin 400 mcg improved HDL-cholesterol, apoA-I concentrations and LDL-cholesterol:apoB-100 ratio compared to placebo (Salehpour 2012). Pfeifer found that supplementation one controlled trial suggesting to calcium retention Boron; Boron; oneSeeds controlled human human trial suggesting benefit benefit to calcium retention Fenugreek with vitamin D3 800 IU decreased systolic blood pressure by 9.3% (p=0.02) (2001).

Vitamin D is of particular importance in Canadians because the prevalence of 3 mg Boron 167 day trial of 11 postmenopausal women, In subjects with low Mg intake, boron decreased the percentHunt CD, et al.J Clin Am of J Clin 3 mg Boron 167 day trial of 11 postmenopausal women, In subjects with low Mg intake, boron decreased the percentHunt CD, et al.

Am Non-Medicinal Ingredients Fenugreek containlatitudes 5%given to 30% protein, steroid saponins, sterols, supplements of 3mgB; 0mgB; 3mgB;age (0mg ageflavonoids of calcium dietary calcium losturine. in the urine.

Nutr. 1997;65(3):803-13. deficiency seeds in northern (Li 2011). given supplements of 0mgB; (0mg of dietary lost in the Nutr. 1997;65(3):803-13. and alkaloids (notably trigonelline and choline).

Steroid saponins bind and BMg); or Mg. 200mg Mg. Inert microcrystalline cellulose and vegetable-based magnesium BMg); or 200mg eliminate extra cholesterol and hormones in the body; DHT is benefit made from Zinc; Copper; Manganese; 1 controlled human trial suggesting Recommendations Zinc; Copper; Manganese; 1 controlled human trial suggesting benefit to BMDto BMD stearate in a veggie-based capsule testosterone, which is Mn, in turn is made from cholesterol.

Therefore, when excess 15mg 5mg post-menopausal randomized to All groups experienced loss ofBMD spinalover BMD over sourced intervention L, al. J Nutr.

15mgrecommended Zn, 5mgZn, Mn, 59 post-menopausal randomized to All groups experienced spinal intervention Strause L, etanchovy, al. etJ Nutr. o3mega triple strength + loss D3 of contains EPA and DHA fromStrause wild sardines and/ or mackerel.

The dose for59adults is onewomen softgelwomen per day. cholesterol is eliminated, less DHT can beZn, made (Stark 1993).

In acompared study compared ofto20baseline, 2.5mg Cu either1000mg Ca; 15mg Zn, 5mg Mn,period 2.5mg period to baseline, except for the Ca+Zn+Cu+Mn, 1994;124(7):1060-4.

2.5mg Cu either1000mg Ca; 15mg 5mg Mn, 2.5mg except for the Ca+Zn+Cu+Mn, 1994;124(7):1060-4. o3megawith triple strength + D3 contains no artificial colours, sweeteners, or preservatives, corn, dairy, egg, wheat, gluten, or yeast.

1000mg Ca Cu; of of thegerminated above; or placebo overseed 2had which hadfor an increase inofBMD Recommended adult dose: One capsule per day adults who consumed 12.5g and 18.0g fenugreek powder with 1000mg Ca Cu; both ofboth the above; or placebo over 2 which an increase in BMD 1.5%.of 1.5%.

References years. of consumption resulted in a significant reduction in total one month, higher levels years.

Calò L, Bianconi L, Colivicchi F, Lamberti F, Loricchio ML, de Ruvo E, Meo A, Pandozi C, Staibano M, Santini M. L-lysine; 1Each controlled human trial(LDL) suggesting benefit cholesterol low-density lipoprotein levels 1999).

Ingredients: enteric coated capsule contains: L-lysine; 1 and controlled human trial suggesting benefit to(Sowmya BMDto BMD Fatty acids for the prevention ofinatrial fibrillation after coronary artery et bypass surgery: a randomized, controlled Not specified 40 subjects 40 subjects with senile involutional osteoporosis There wasN-3amarked more marked increase in subjects Abate al. Minerva Not specified with senile involutional osteoporosis There was a more in BMD inBMD subjects Abate G, et al.G,Minerva Med. Med. trial. J Am Collincrease Cardiol. 2005 May 17;45(10):1723-8.

Fish oil concentrate ..............................................1409 randomized into carbocalcitonin ormg treated with arginine-lysine-lactose, a greater reduction in 1994;85(5):253-9.

Flax lignans randomized into carbocalcitonin alone oralone treated with arginine-lysine-lactose, a greater reduction ineffects 1994;85(5):253-9.

Cottin SC, Sanders TA, Hallreduction WL. The differential of EPA and DHA on cardiovascular risk factors. Proc Nutr carbocalcitonin association complex, withmg painful and greater of parathormone Flax reduces the amount ofacid DHT.......................................647 produced bycomplex, reducing cholesterol levels insymptoms, the EPA (eicosapentanoic carbocalcitonin association with painful symptoms, and greater reduction of parathormone Soc. 2011 May;70(2):215-31. and hydroxyprolinuria to improvement in body. A meta-analysisarginine-lysine-lactose. of 28 arginine-lysine-lactose. studies between 1990 and 2008 showed that flaxseed and hydroxyprolinuria levels, levels, due to due improvement in DHA (docosahexanoic acid) ....................................253 mg Goel RK, Lal H. Role of mediated vitamin d supplementation intestinal calcium absorption by lysine. in hypertension. Indian J Clin Biochem. 2011 Jan;26(1):88-90. significantly reduces circulating total and LDL-cholesterol concentrations (Pan intestinal calcium absorption mediated by lysine.

Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith Lycopene; 1 human observational study reduced risk of osteoporosis Vitamin (cholecalciferol) ..................................1000 IU 2009).

Flaxseed interventions reduced total andsuggesting LDL cholesterol 0.10 mmol/L Lycopene; 1D3 human observational study suggesting reduced risk ofby osteoporosis SC Jr, Spertus JA, Costa F;found American Heart Association; National Heart, Lung, Blood Institute.

Diagnosis and Dietary intakeCross-sectional Cross-sectional of 33 postmenopausal A serum higherlycopene serum lycopene wasto to be associated with a Rao et al and Osteoporos Dietary intake rangofstudy 33 postmenopausal A higher was besyndrome: associated a Rao LG, et alLG, Osteoporos Int.Lung,Int. (95% CI: -0.20, 0.00 rangmmol/L) and study 0.08 mmol/L (95% CI: -0.16, 0.00 mmol/L), management of found the metabolic an with American Heart Association/National Heart, and Blood Institute ing from 1.76 mg/d women aged 50-60 correlating dietary low NTx, a bone resorption marker.

Lycopene reduces bone 2007;18(1):109-15. ing from 1.76Significant mg/d women aged were 50-60observed correlating NTx, (-0.21 a bone and resorption marker.

Lycopene2005 reduces bone 2007;18(1):109-15. respectively. reductions withdietary whole low flaxseed Scientific Statement.

Circulation.

Oct 25;112(17):2735-52. to 7.35 mg/d. lycopenelycopene intake to markers blood markers ofturnover bone turnover in postmenopausal to 7.35mmol/L, mg/d. intake to blood of bone markersmarkers in postmenopausal women,women, and mayand be may be -0.16 respectively)turnover. and lignan (-0.28 and -0.16 mmol/L, respectively) LiinW, Green TJ,the Innisrisk SM,ofBarr SI, Whiting SJ, Shand A, von Dadelszen P. Suboptimal vitamin D levels in pregnant beneficial reducing osteoporosis. turnover. beneficial in reducing the risk of osteoporosis. supplements (Pan 2009). women despite supplement use. Can J Public Health. 2011 Jul-Aug;102(4):308-12.

Silicon;Silicon; animal animal studies studies Marchioli R, Levantesi Macchia A, Maggioni AP, Marfisi Silletta MG, L, Tognoni The ofeffect of ch-OSA supplementation days investigated on loss bone agedG,ovariectomized rats.RM, Calomme M,Tavazzi et al.

CalcifG, Valagussa F; The effect ch-OSA supplementation for 30 for days30investigated on bone in loss agedinovariectomized (OVX) (OVX) rats.

Calomme M,PUFA et and al. of n-3 theCalcif results of the GISSI-Prevenzione GISSI-Prevenzione Investigators. Antiarrhythmic mechanisms Supplementation at 1mg Si/kg significantly reversed the decrease in Ca excretion observed after OVX; reduced bone turnover; Tissue Int. 2006;78(4):227-32.

Supplementation at 1mg Si/kg significantly reversed the decrease in Ca excretion observed after Biol.

OVX; reduced bone turnover; Tissue Int. 2006;78(4):227-32. trial. J Membr 2005 Jul;206(2):117-28.

References and increased the femoral bone mineral content (BMC) in theregion distaland region and total femoral BMC. and increased the femoral bone mineral content (BMC) intothe distal BMC. supplementation Angwafor F III, Anderson ML. An open label, dose response study determine the effect oftotal a dietary supplement on dihydrotesto testosterone andand estradiol healthy males.

J Nofemoral authors.

Dietary with n-3 sterone, polyunsaturated fatty acids vitaminlevels E afterinmyocardial infarction: Selenium; animal and 1 human observational Int Soc Sports Nutr 2008;5:12. results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico.

Selenium; animal studies studies and 1 human observational study study Dietary intake Case-control study (n=1215) of Se intake and There was 73% decreased risk of hip fracture in the highest Zhang J, et al.

Am J Epidemiol.

Lancet. 1999 Augof7;354(9177):447-55.

Dietary intake ło L. Evaluation Case-control study of Se intake andeffectiveness There was 73% decreased risk hip and fracture in the highest Zhang J, et al. Am JofEpidemiol. ska-Wcis of vitamin B6(n=1215) and calcium on hair growth from clinical trichographic as pects for treatment diffuse alopecia in women. Wiad Brzezi risk of osteoporotic hippantothenate fracture.

Dataselenium from selenium intake quintile (OR 0.27).

2006;163(1):9-17.

Pfeifer M, Begerow B, Minne HW, Nachtigall D, Hansen C. Effects of a short-term vitamin D(3) and calcium Lek 2001;54:11-8. risk of osteoporotic hip fracture.

Data from intake quintile (OR 0.27).

2006;163(1):9-17.

1,215 subjects with history of hip fracture. supplementation on blood pressure and parathyroid hormone levels in elderly women.

J Clin Endocrinol Metab. 2001 1,215 subjects with history of hip fracture.

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 Apr;86(4):1633-7.

Complement Alternat Med 2009.

Morton DJ et al. JDiwan Bone Miner Res.L.2001 Jan;16(1):135-40.

References Poudyal Panchal V, 2001 Brown Omega-3 fatty acids and metabolic syndrome: effects and emerging Morton DJ H, et al.

J BoneSK, Miner Res. Jan;16(1):135-40.

References Prince RL etblood al. Arch Intern Med. 2006;166(8):869-75.

G et al. Minerva Med. 1994;85(5):253-9.

Pan A, G YuAbate W, Franco OH, Lin X. Meta-analysis of the effects of flaxseed interventions on lipids.

Am J Clin Nutr 2009;90:288-97. mechanisms action.

Prog Lipid Res. 2011 Oct;50(4):372-87.

Prince RL et al. of Arch Intern Med. 2006;166(8):869-75.

Abate etD,al.Demark-Wahnefried Minerva Med. 1994;85(5):253-9.

Rao LG et al. Osteoporos Int. 2007;18(1):109-15.

Baeksgaard L et al. Osteoporos Int. 1998;8(3):255-60.

RaoSalehpour LG et al. A, Osteoporos Int. 2007;18(1):109-15.

Baeksgaard L et al. Osteoporos Int. 1998;8(3):255-60.

Shidfar Hosseinpanah F, Vafa of M,botanically Razaghi M, derived Hoshiarrad A, Gohari Vitamin D3 and in thethe risk of Prager N,Calomme Bickett K, M French Marcovici A 2006;78(4):227-32. randomized, double-blind, placebo-controlled trial to determine inhibitors of M. 5-alpha-reductase Ruml LA etthe al.F,effectiveness Am J Ther. 1999;6(6):303-11. et al. N, Calcif Tissue G. Int. Ruml LA in et overweight al. Am J Ther.

1999;6(6):303-11.

Calomme M et al. Calcif Tissue Int. 2006;78(4):227-32.

CVD women: a randomised controlled trial. Br J Nutr. 2012 Feb 9:1-8. treatment of androgenetic alopecia.

J Altern Complement Med 2002;8:143-52.

Sambrook P etand al. obese Lancet.

2006;367(9527):2010-8.

Dimai HP et al. J Clin Endocrinol Metab.

1998;83(8):2742-8.

Sambrook P et al. Lancet. 2006;367(9527):2010-8.

Dimai HP et al. J Clin Endocrinol Metab. 1998;83(8):2742-8.

Strause L et J Nutr.C,1994 Jul;124(7):1060-4.

Di Daniele N et al. Pharmacol Res. 2004 Dec;50(6):637-41.

Sorice Tritto FP,al.Sordelli Gregorio R, Piazza L. N-3 polyunsaturated fatty acids reduces post-operative atrial Strause L M, et al.

J Nutr.

1994 Jul;124(7):1060-4.

Di Daniele N et monograph. al. PharmacolAlternative Res. 2004 Dec;50(6):637-41.

Serenoa repens Medicine Review 1998;3:227-9.

Tarantino U et al.patients Aging undergoing Clin Exp Res. 2007;19(4 Suppl):7-11.

Herrmann M et al. Clin Chem Lab Med. 2007;45(12):1785-92. fibrillation “on-pump” coronary artery bypass graft surgery. Monaldi Arch Chest Dis. Tarantino U etincidence al. AginginClin Exp Res. 2007;19(4 Suppl):7-11.

Herrmann M et al. Clin Chem Lab Med. 2007;45(12):1785-92.

Volpe SL et al. Magnes Res. 1993;6(3):291-6.

CD et al. androgenetic Am J Clin Nutr.

1997 Mar;65(3):803-13.

2011 Sinclair R.Hunt Male pattern alopecia.

BMJ 1998;317:865-9.

Volpe SLJun;76(2):93-8. et al. Magnes Res. 1993;6(3):291-6.

Hunt CD et al. Am J Clin Nutr. 1997 Mar;65(3):803-13.

Zhang J et al. Am J Epidemiol. 2006 Jan 1;163(1):9-17.

Keen RW et al. Curr Osteoporos Rep. 2003;1(2):66-70.

Zhang J etA, al.Umemoto Am J Epidemiol.

2006 Keen RW et al. Curr Osteoporos Rep. 2003;1(2):66-70.

Takaki S, Ono K, SekiJan K, 1;163(1):9-17.

Ryoke T, Fujii A, Itagaki T, Harada M, Tanaka M, Yonezawa T, Ogawa H, Sowmya P, Rajyalakshmi P. Hypocholesterolemic effect of germinated fenugreek seeds in human subjects. Plant Foods Hum Nutr 1999;53:359-65.

Matsuzaki M; ELIA study group. Add-on therapy of EPA reduces oxidative stress and inhibits the progression of aortic stiffness in on patients withabsorption coronary artery and statin therapy: a randomized controlled study. J Atheroscler Stark A, Madar Z. The effect of an ethanol extract derived from fenugreek (Trigonella foenum-graecum) bile acid anddisease cholesterol levels in rats, Br J Nutr 1993;69:277-87.

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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/ Zhao G, Ford ES, Li C, Croft JB. Serum 25-hydroxyvitamin D levels and all-cause and cardiovascular disease mortality dilution and mass spectrometry. J Clin Endocrinol Metab 2001;86:5762-4. among US adults with hypertension: the NHANES linked mortality study. J Hypertens. 2012 Feb;30(2):284-9.

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Trident SAP 65:10 PRODUCT MONOGRAPH

EPA FOR DEPRESSION

A study by Lespérance et al. (2010) was an 8-week trial examining the short-term efficacy of omega-3 fatty acids in patients with major depressive episodes (MDE).(2) Patients in the treatment group received 1050 mg/d of EPA and 150 mg/d DHA, with the control group receiving a placebo.(2) Researchers found that for patients with MDE, the omega-3 supplementation was superior to placebo for symptom improvement.(2) In patients with anxiety and MDE, the omega-3 supplementation was not found to be statistically significantly beneficial.(2) A study comparing omega-3 fatty acids, as monotherapy and in combination with fluoxetine, examined patients’ depressive symptoms and their cortisol levels.(3) Patients received either 1000 mg EPA, 20 mg fluoxetine, or both, for 8 weeks. Plasma cortisol levels decreased in all 3 treatment groups, without a significant difference between the 3 groups.(3) This suggests that the therapeutic effect of EPA may be exerted through its ability to lower cortisol levels.(3)

DEPRESSION IN THE ELDERLY

A placebo-controlled double-blinded study was performed for elderly women between 66–95 years of age with symptoms of depression.(4) Women were given either 1.67 g/d of EPA and 0.83 g/d of DHA or placebo.

Results were based on an improvement in depression symptoms based on the Geriatric Depression Scale after 8 weeks of treatment. Researchers concluded that the omega-3 supplementation was effective for improving symptoms of depression as well as quality of life in elderly female patients.(4)

DEPRESSION AND CARDIOVASCULAR DISEASE

The leading cause of mortality for patients with major depression is coronary heart disease.(5) Patients who have experienced a cardiovascular event are also more likely to experience major depression and an increased risk of mortality.(5) Researchers have proposed that a deficiency of omega-3 fatty acids plays a role in the pathology of both cardiovascular disease and major depression. After an acute coronary event (ACE), patients who developed depression had lower serum levels of omega-3 fatty acids than patients who did not experience depression after an ACE.(5) Prospective studies have found that the lower the dietary or membrane levels of EPA and DHA, the higher the risk for both major depression and cardiovascular disease.

This area needs further research but it does provide a strong amount of evidence to warrant exploring the effect of increasing the omega-3 status of patients with cardiovascular disease or major depression.(5)

EPA:DHA RATIO

A study by Carney et al. (2009) examined the effect of the combination of omega-3s and sertraline for treatment of patients with depression and coronary heart disease.(6) The study was a randomized, doubleblind study where all patients were given 50 mg/d sertaline, and either 2 g/day of omega-3—930 mg EPA and 750 mg DHA—for 10 weeks, or placebo.(6) Outcome was measured using the Beck Depression Inventory and the Hamilton Rating Scale for Depression. No significant differences were noted between the groups.(6) In a study using a 1:4 ratio of EPA (420 mg):DHA (1680 mg) per day for 6 weeks in women with perinatal depression, researchers found no benefit from the therapy for these women.(7) These studies suggest that supplementation of lower ratios of EPA:DHA is not effective for the treatment of depression, and highlights

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the importance of high-ratio EPA:DHA omega-3 supplementation in this population.

In a review article exploring the data of omega-3 supplementation and its benefit on depression, the authors investigated whether EPA or DHA or both are the beneficial component of the omega-3 supplement.(8) Of the 241 studies identified, only 28 met the inclusion criteria set out by researchers and were therefore included in the analysis. The summary of the meta-analysis found that EPA was likely more efficacious than DHA in the treatment of depression.(8) Researchers did express that further larger, well-designed, randomized controlled trials need to be conducted to confirm this finding.(8)

PERINATAL AND POSTPARTUM DEPRESSION

Depression during pregnancy is quite common and treatment can be challenging. As fetal demand of omega-3 fatty acids remains very high during pregnancy, the associated decrease in the mother may leave them prone to depression.(9) A study exploring monotherapy for the treatment of depression during pregnancy was performed.(9) The study was an 8-week double-blind, placebo-controlled comparing the treatment with 2.2 g/d EPA and 1.2 g/d DHA to placebo for major depressive disorder in pregnancy.(9) At the end of the study, subjects on the omega-3 treatment had significantly lower depressive symptoms than subjects composing the control group.(9) Also important to note was that the treatment was well tolerated and there were no adverse effects on either the women or newborns.(9) In a study in women with postpartum depression (PPD), subjects were given either 0.5 g, 1.4 g or 2.8 g/d of a 1.5:1 ratio EPA:DHA supplement for 8 weeks.(10) Women were assessed before and after treatment with the Edinburgh Postnatal Depression Scale and the Hamilton Rating Scale for Depression.(10) Before treatment, the mean scores were 18.1 and 19.1, while the after-treatment mean scores were 9.3 and 10.0.(10) The positive results that were seen in this small trial warrant the need for further research in this population group.(10) It has emerged in the scientific literature that oral supplementation of omega-3 fatty acids in higher ratios of EPA:DHA are more effective than lower ratios for the treatment of depression. While EPA:DHA ratio may not play as important a role in cardiovascular protection or the mitigation of inflammation, there is a need for this specificity in the treatment of depression, and possibly in other mental-emotional, psychological or psychiatric conditions.

REFERENCES 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001941/ • Viewed April 25, 2011 Lespérance, F., N. Frasure-Smith, E. St-André, et al. “The efficacy of omega-3 supplementation for major depression: A randomized controlled trial”. Journal of Clinical Psychiatry 72, No. 8 (2010): 1054–1062.

Jazayeri, S., S.A. Keshavarz, M. Tehrani-Doost, et al. “Effects of eicosapentaenoic acid and fluoxetine on plasma cortisol, serum interleukin-1β and interleukin-6 concentrations in patients with major depressive disorder”. Psychiatry Research 178, No. 1 (2010): 112–115.

Rondanelli, M., A. Giacosa, A. Opizzi, et al. “Effect of omega-3 fatty acids supplementation on depressive symptoms and on health-related quality of life in the treatment of elderly women with depression: a double-blind, placebo-controlled, randomized clinical trial”. Journal of the American College of Nutrition 29, No. 1 (2010): 55–64.

McNamara, R.K. “Membrane omega-3 fatty acid deficiency as a preventable risk factor for comorbid coronary heart disease in major depressive disorder”. Cardiovascular Psychiatry and Neurology 2009 (2009): 362795.

Carney, R.M., K.E. Freedland, E.H. Rubin, et al. “Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: A randomized controlled trial”. JAMA 302, No. 15 (2009): 1651–1657.

Rees, A.M., M.P. Austin, and G.B. Parker. “Omega-3 fatty acids as a treatment for perinatal depression: randomized double-blind placebo-controlled trial”. The Australian and New Zealand Journal of Psychiatry 42, No. 3 (2008): 199–205.

Martins, J.G. “EPA but not DHA appears to be responsible for the efficacy of omega-3 long chain polyunsaturated fatty acid supplementation in depression: Evidence from a metaanalysis of randomized controlled trials”. Journal of the American College of Nutrition 28, No. 5 (2009): 525–542.

Su, K.P., S.Y. Huang, T.H. Chiu, et al. “Omega-3 fatty acids for major depressive disorder during pregnancy: results from a randomized, double-blind, placebo-controlled trial”. Journal of Clinical Psychiatry 69, No. 4 (2008): 644–651.

Freeman, M.P., J.R. Hibbeln, K.L. Wisner, et al. “Randomized dose-ranging pilot trial of omega-3 fatty acids for postpartum depression”. Acta Psychiatrica Scandinavica 113, No. 1 (2006): 31–35.

© NFH Nutritional Fundamentals for Health 2012

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For details, write #115 on Free Info Page, page 92.

Depression is a condition that affects millions of people worldwide.

It can affect anyone from children and adults to the elderly. For major depression to be diagnosed, a patient must report a minimum of five depressive symptoms that have been lasting for at least two weeks.(1) The Beck Inventory, or other screening tests, may also be useful for making a diagnosis of depression as well as for monitoring treatment.(1) Several studies have determined that a higher ratio of EPA to DHA is actually the most effective for the treatment of depression.

Trident SAP 65:10

Science-based high-dose EPA for the treatment of depression Depression can affect people at any life stage. An individual suffering from depression can experience a variety of symptoms that may include: fatigue, difficulty concentrating, change in appetite, irritability, agitation, withdrawal, insomnia or excessive sleeping, and in some cases, thoughts of death.(1) The cause of depression is still unknown, but it is thought that imbalances in neurotransmitters or chemicals in the brain contribute to symptoms.(1) Several pharmaceutical agents can be used to treat depression; however, many of them possess unwanted, negative side effects. Fish oil, and more specifically EPA, has been extensively researched in the role it can play for the treatment of major depression, postpartum depression, as well as potentially for bipolar disorder.

Each softgel contains:

ACTIVE INGREDIENTS

Eicosapentaenoic acid (EPA) . . . . . . . . . . . . . . . . . . . . 650 mg Docosahexaenoic acid (DHA) . . . . . . . . . . . . . . . . . . . 100 mg

Contains no : preservative, artificial flavor or color, soy, corn, wheat, gluten or dairy.

Trident SAP 65:10 contains 60 or 120 softgels per bottle.

DOSAGE

Adults: Take 2 capsules daily with food or as directed by your health care practitioner.

INDICATIONS

Trident 65:10 can be used for the treatment of mild to moderate depression. ɶ Trident 65:10 can be used to help prevent and treat postpartum depression in women. ɶ Trident 65:10 may be helpful as an adjunctive treatment for patients with bipolar disorder. ɶ

SAFETY

For details, write #115 on Free Info Page, page 92.

EPA and DHA are essential fatty acids and are classified as GRAS. Studies to date have found no significant adverse effects.

PURITY AND CLEANLINESS

Third-party testing is performed on Trident 65:10 to ensure it is free of volatile organics, heavy metals, PCBs and other impurities.

Certificates of analysis report no detection of heavy metals or PCBs and are in accordance with the stringent purity limits established by the Council for Responsible Nutrition (CRN) and Pharmacopeia Europa (Ph. Eur.).

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

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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4/5/12 2:16:27 PM

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Visit us at genuinehealth.com 1. The American Heart Association recommends supplementation with EPA+DHA for all patients with metabolic syndrome, a constellation of cardiovascular risk factors including elevated triglycerides, blood pressure, and blood glucose; low HDL; increased waist circumference (Grundy 2005)

IHPAPR2012_9418_Genuine Health_FP.indd 1

For details, write #116 on Free Info Page, page 92.

900mg of EPA/DHA for cardiovascular support, and 1,000 IU of vitamin

4/5/12 1:33:08 PM