SAFETY FIRST

DISPELLING MYTHS ABOUT

COMPLEMENTARY THERAPIES

Published in 2014 by The Ontario Society of Physicians for

Complementary Medicine
Available online at Peoples Right to Integrative Medicine (PRIM) www.peoplesrim.org

SAFETY FIRST: DISPELLING MYTHS ABOUT COMPLEMENTARY THERAPIES

CONTENTS

Introduction (Robert Kidd) ..1

Prescribing of drugs (Steven Herr and David Carmichael) ...2

Nutritional counselling (Barbara Powell) ..5

Herbal therapy (Barbara Powell) ...9

Acupuncture (Linda Rapson) 12

Homeopathy (Parul Sanduja and Jozef Krop) .....................16

Manual medicine (Craig Appleyard) 19

Neural therapy (Robert Kidd) 21

Prolotherapy (Robert Banner) ..24

Environmental medicine (Jennifer Armstrong) ..28

Intravenous chelation therapy (Richard Nahas) 32

Bio-identical hormone replacement therapy (Robert Banner) .35

Introduction
In Canada, the safety of nonconventional medicine is frequently called into question by regulatory
authorities. In response to these concerns, this publication gathers together a collection of articles
outlining the safety aspects of a variety of medical practices that fall into what is commonly called
complementary, alternative or integrative medicine. Also included is one article (the first) about
the safety aspects of conventional or standard medicine as usually practised by physicians in
Ontario. The author of each article is an Ontario physician recognized by his or her peers as
having significant expertise in the subject being discussed.
The Hippocratic oath includes the promise to abstain from doing harm. This promise reflects the
reality that medical treatment has always included some measure of risk to the patient. The
history of medicine is replete with examples of treatments that were administered in good faith but
turned out, in most cases, to do more harm than good (for example, blood-letting and
administration of toxic metals). Is it possible that the widespread use of industrial pharmaceuticals
in our time has put todays medical profession into a similar situation?
All of the authors represented in this volume have been searching for ways to treat their patients
both effectively and safely. Often this dual purpose means deviating from the standard of care,
which in Ontario currently centres on pharmaceuticals. None of us objects to the use of
pharmaceuticals when the benefit-to-risk ratio is positive. However, safe and effective alternatives
are often available, many of them based on sound, well-accepted science.
The College of Physicians and Surgeons of Ontario (CPSO) frowns upon deviation from what it
considers to be the standard of care. In fact, the CPSO policy on complementary/alternative
medicine (http://cpso.on.ca/policies-publications/policy/complementary-alternative-medicine) is
written with the assumption that nonconventional medicine is at best ineffective and at worst
dangerous.
This suspicion of the unknown is perhaps understandable. Medicine, like all other fields of study,
is being overwhelmed by more information than it can process. New discoveries are constantly
being made around the worldsome within the CPSOs understanding of conventional medicine
and others outside of that understanding. The task of evaluating all this information is an
impossible burden for the CPSO and, in our view, should not even be attempted.
However, we believe there is a place for professional regulation. The public needs to know that
the services physicians are offering have been evaluated for safety and that the risks of accepting
these treatments are outweighed by the potential benefits.
This task could be accomplished by the CPSO if it concentrated on ensuring safety rather than
the impossible task of upholding standards that are changing by the day in response to new
knowledge. In fact, this approach should hold true for conventional medicine as well as for
complementary medicine. As documented in the article on the safety of conventional medicine (or
lack thereof), there is much room for improvement.
Our purpose in publishing this work is to demonstrate that those medical practices considered to
be complementary are at least as safe as, or safer than, the standard of care. It is also intended
to demonstrate that the physicians who utilize these methods are well aware of the associated
risks and that they take these risks into account when offering such services to their patients. It is
our hope that this publication will be a constructive contribution to the search for safer care for our
patients.
Robert F. Kidd, MD, CM

Safety considerations in the prescribing of drugs

What is the role of pharmaceuticals in the modern health care system?
Modern health care increasingly relies on the use of pharmaceuticals, especially prescription
drugs, for the treatment of acute and chronic health conditions. The cost of these drugs is a major
driving force behind the rapidly rising cost of health care in Canada. This trend has important
implications in terms of both the countrys financial situation and the safety of individual patients.
Health care costs already account for an enormous proportion of provincial government
expenditures. For example, in Ontario, 46 cents of every dollar collected by the provincial
government in taxes and received through federal transfer payments is devoted to health care, a
proportion that the Ontario Chamber of Commerce projects will increase to 80% by 2030.1 The
Canadian Institute for Health Information reports that prescription drug costs for the country as a
whole have more than tripled recently, from $10 billion in 1990 to $31 billion in 2010. On a per
capita basis, the only country that spent more on prescription drugs in 2007 was the United
States.2
What are the risks of using prescription drugs?
As doctors prescribe more drugs for a growing number of diagnosable health conditions,
particularly chronic illnesses, disorders and diseases, there is less assurance that the drugs are
safe. In fact, Lazarou et al.3 estimated that in 1994, adverse drug reactions (ADRs) represented
the fourth leading cause of death, behind heart disease, cancer and stroke.
More specifically, these researchers, analyzing data from 1966 to 1996, estimated that 6.7% of
hospitalized patients in the United States experienced a serious ADR, with the incidence rate of
fatal ADRs being 0.32%.3 In absolute terms, the estimated number of serious ADRs among
hospitalized patients for 1994 was 2,216,000, with over 106,000 deaths, making ADRs in
hospitals the fourth leading cause of death, ahead of pulmonary disease, diabetes, pneumonia
and accidents.3 In fact, one of every five injuries or deaths each year is considered to be the
result of an ADR,4 and ADRs are considered the leading cause of death among patients who are
receiving some form of mental health care.5
According to analysis by the Institute for Safe Medication Practices (US) of data reported to the
US Food and Drug Administration, the number of deaths from ADRs continues to increase by 5%
to 10% each year.6 With less than 5% of serious adverse events from prescription drug use being
reported,7 it is reasonable to conclude that ADRs could rank even higher than the fourth leading
cause of death.
In addition to the deaths they cause, ADRs have an enormous economic impact. In the United
States, the cost of treating prescription druginduced injuries is estimated to exceed the money
spent on the medications in the first place (US$259 billion in 2010).8 The annual cost of drugrelated morbidity and mortality was estimated at $177 billion in 2000.9
Why are prescription drugs so risky?
One of the major reasons why prescription drugs are so risky relates to irresponsible behaviour
on the part of the pharmaceutical industry. In his 2012 book Pharmageddon,5 Dr. David Healy
states, [W]here once the pharmaceutical industry made its money from drugs that cured, the big
money now lies in marketing chronic diseases for which the current best-selling drugs in medicine
offer little benefit. We are quite literally taking pills to save the lives of companies who have a
greater interest in the vitality of the diseases they market for than in our well-being.
This strategy of the pharmaceutical industry to market chronic diseases has led to the fraudulent
promotion and unnecessary prescribing of many prescription drugs, which have in turn
contributed to the rapidly rising number of ADRs. Public Citizen, a not-for-profit watchdog
organization in the United States, now considers the pharmaceutical industry the biggest

defrauder of governments, on the basis of payments made for violations of the False Claims Act.
More specifically, between 1991 and 2010, pharmaceutical companies paid $20 billion in state
and federal government penalties.10
From falsifying clinical trial data to hiring scientists to put their names to research articles that are
actually written by drug company staff (a practice called ghostwriting), there is little doubt that
pharmaceutical companies are not providing doctors with the truth about the effectiveness and
risks of prescription drugs. This has impeded the ability of doctors to accurately and effectively
treat illnesses, disorders and diseases.
What can be done to help ensure the safety of prescription drugs?
If pharmaceutical companies cannot be trusted to share with doctors truthful information about
the effectiveness and potential risks of prescription drugs, patients will have to take a more active
role in researching the benefits and side effects of the drugs prescribed for them.
Pharmacists working in drugstores can provide information about adverse effects, and patients
may wish to purchase their own reference books on this subject. Online databases containing this
type of information are also available. One example is www.RxISK.org, an independent website
that provides information about the side effects of more than 35,000 prescription drugs from 103
countries. People who are experiencing adverse effects that may be related to prescription drug
therapy may also request a RxISK Report about the drug and its effects that can be taken to their
doctor to facilitate a more informed conversation about treatment.

Steven Herr, BScH, MD, CCFP(EM), FCFP, MPLc

102348 Muskoka Road 3 N
Huntsville ON P1H 1H8
E-mail: steven@herr.ca
Websites: www.herr.ca www.MuskokaWay.org

David Carmichael, MA
Media relations officer, RxISK.org
Development officer, Peoples Right to Integrative Medicine (PRIM)
9255 Woodbine Avenue, PO Box 4038
Markham, ON L6C 1Y0
Telephone: 905-847-9368
Email: david@peoplesrim.org
Website: www.peoplesrim.org

References
1. Business advocacy: health care. Toronto (ON): Ontario Chamber of Commerce; [cited 2013
May 1]. Available from: http://occ.on.ca/advocacy/issues/health-care/
2. Drivers of prescription drug spending in Canada. Report of the Canadian Institute for Health
Information. Ottawa (ON): Canadian Institute for Health Information; 2011.
3. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized
patients: a meta-analysis of prescriptive studies. JAMA 1998;279(15):1200-5.
4. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, et al. Incidence of
adverse events and negligence in hospitalized patients. Results of the Harvard Medical
Practice Study I. N Engl J Med 1991;324(6):370-6.
5. Healy D. Pharmageddon. Berkeley (CA): University of California Press; 2012.
6. QuarterWatch: 2009 quarters 13. Did a cold remedy cause thousands to lose their sense of
smell? Horsham (PA): Institute for Safe Medication Practices; 2010 [cited 2013 May 2].
Available from: www.ismp.org/quarterwatch/pdfs/2009Q3.pdf
7. Heinrich J. Testimony before the US Senate Committee on Health, Education, Labor, and
Pensions. Adverse drug events: substantial problem but magnitude uncertain. Report
GAO/T-HEHS-00-53. Washington (DC): US General Accounting Office; 2000.
8. Bordet R, Gautier S, Le Louet H, Dupuis B, Caron J. Analysis of the direct cost of adverse
drug reactions in hospitalised patients. Eur J Clin Pharmacol 2001;56(12):935-41.
9. Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: updating the cost-of-illness
model. J Am Pharm Assoc (Wash) 2001;41(2):192-9.
10. Almashat S, Preston C, Waterman T, Wolfe S. Rapidly increasing criminal and civil
monetary penalties against the pharmaceutical industry: 1991 to 2010. Report of the Public
Citizen Health Research Group. Washington (DC): Public Citizen Health Research Group;
2010.

Safety considerations in nutritional counselling

Let food be thy medicine and medicine be thy food.
Hippocrates (460377 BC)
What is nutritional counselling?
Various aspects of nutrition have been observed and investigated for thousands of years. Such
study has led to our current understanding of metabolism and the components of food, including
proteins, carbohydrates, fats and micronutrients. Physicians may counsel their patients about
what and how much to eat. The goal of such counselling is to help individuals to make and
maintain dietary changes that treat or prevent illness and optimize health.
Who needs nutritional counselling?
According to a recent Health Canada report, many adult Canadians do not meet their nutrient
requirements through food intake alone.1 Magnesium, calcium, vitamin A and vitamin D are the
nutrients with the highest prevalence of inadequate intake. There is also inadequacy of potassium
intake, although no conclusions can be drawn from this finding. Conversely, for 50% of women
and 70% of men, energy intake exceeds energy needs.1 Scientists have also recognized that
many people (20% or more) carry genetic polymorphisms that will respond to nutrient fortification
or supplementation to prevent disease.2 These data indicate a widespread need for nutritional
counselling.
What is known about the safety of particular diet plans?
The risks of diet-related therapy are much lower than the risks of other forms of medical care,
such as drug therapy, which has been listed as the fourth leading cause of death in the United
States.3-5 Deaths linked to a particular diet are extremely rare, and those that have occurred were
linked to the ketogenic diet.6 Nonetheless, the use of some diets does entail a few concerns and
precautions, as described below.
Low-carbohydrate diets
Low-carbohydrate diets, used primarily for weight loss and anti-inflammatory purposes, are
defined as diets in which only 30%40% of calories are obtained from carbohydrates.
In a systematic review of the efficacy and safety of low-carbohydrate diets, Bravata et al.7 found
no evidence of adverse effects on serum lipids, fasting serum glucose, serum insulin or blood
pressure, and subsequent studies have confirmed these findings.8,9 In particular, no deaths have
been directly linked to a low-carbohydrate diet.
Both Shai et al.8 and Sharman et al.9 concluded that low-carbohydrate diets have some benefits
beyond weight reduction. However, Noto et al.10 suggested that large-scale trials on the complex
interactions between low-carbohydrate diets and long-term outcomes are needed. Furthermore,
people with kidney failure should not use low-carbohydrate, high-protein diets.11
There is also concern for people taking the anticoagulant warfarin, as a low-carbohydrate diet
may reduce the drugs effectiveness, leading to the need for a higher dose. Conversely, if and
when the patient stops eating the low-carbohydrate diet, the requirement for warfarin may go
down. As such, Beatty et al.12 suggested close monitoring of the international normalized ratio in
these patients.

Ketogenic diet
The ketogenic diet is a high-fat, low-carbohydrate, adequate-protein diet that is used by highly
trained physicians to reduce the frequency of seizures in patients with refractory epilepsy. In
patients with other conditions, its use is experimental. Despite the positive effects of a ketogenic
diet in most patients and recent literature supporting its safety,13 there are potential adverse
effects. Two complications are selenium deficiency, which has been associated with impairment
of myocardial function, and QT prolongation, as documented on electrocardiography. Sudden
death is possible but rare.14,15 Adding calcium and selenium to the ketogenic diet seems to
eliminate QT prolongation.13 The ketogenic diet is contraindicated in patients with pyruvate
carboxylase deficiency, porphyria and other rare genetic disorders of fat metabolism. In these
settings, there would be a risk of ketoacidosis and death.16
Very low fat diets
In very low fat diets, no more than 15% of total calories is derived from fat.17 The fat calories are
distributed about equally among saturated, monounsaturated and polyunsaturated fatty acids.
Approximately 15% of total daily calories consumed are derived from protein, and the remaining
calories (up to 70%, depending on the exact proportion of fat) from carbohydrates. This type of
diet may lead to nutrient deficiencies in particular subgroups, such as pregnant women, elderly
patients and anyone who adheres to the diet for a long period. Very low fat diets are not
advocated for young children.17
Very low energy diets
Very low energy diets are used in the treatment of obesity. If such a diet is used without medical
supervision, it is considered unsafe.18
What is known about the safety of supplementation with natural health products?
The safety, purity and potency of all natural health products in Canada are regulated by the
Canadian Natural Health Products Regulations,19 which have been in effect since January 1,
2004. Strict enforcement of the regulations by Health Canada ensures that Canadians have
access to safe, high-quality products. Under these regulations, any product claims must be
substantiated by traditional and/or scientific evidence and must be approved by the Natural
Health Products Directorate before a licence for manufacture and distribution is granted.
The supplements industry has an unmatched safety record. According to the 2010 annual report
of the National Poison Data System of the American Association of Poison Control Centers, only
2 of 1,146 deaths in that year that were judged to be related to a toxic drug or substance were
linked to (though not necessarily caused by) a natural health product.20 The UK-based
international campaign group, the Alliance for Natural Health International, recently revealed data
showing that a person is about 900 times more likely to die from food poisoning than from
supplements and nearly 300,000 times more likely to die from a preventable medical injury during
a stay in a UK hospital.21 The data also show that adverse reactions to pharmaceutical drugs are
62,000 times more likely to result in death than food supplements and 7,750 times more likely to
cause death than herbal remedies.
These comparative data, collected from official sources in both the United Kingdom and the
European Union, demonstrate that the risk of death from consuming supplements and herbs is
1 in 10 million.
Despite this safety record, there are some considerations with the use of supplements and
natural health products. In particular, quality and purity are assured only if the products are
purchased from a reputable company. Also, some natural health products have so-called soundalike names, which may lead to confusion (e.g., niacinamide and niacin). When there is a
possibility of such confusion, it is prudent for the physician to take extra care in advising the
patient, for example, by writing out the supplement name or supplying a handout.

Conclusion
Nutritional counselling, which may include counselling on the use of supplements and natural
health products, is very safe.
Barbara Powell, MD, CCFP, FCFP
PO Box 72099
Kanata North Postal Station
Kanata ON K2K 1W8
Telephone: 613-591-3942
Email: dr.barbara.powell@gmail.com
Website: www.celiacbrain.blogspot.com
References
1. Do Canadian adults meet their nutrient requirements through food intake alone? Ottawa
(ON): Health Canada; 2012 [cited 2013 Jan 30]. Cat. no. H164-112/3-2012E-PDF. Available
from: www.hc-sc.gc.ca/fn-an/surveill/nutrition/commun/art-nutr-adult-eng.php
2. Gray N. Expert outlines case for folate fortification in Europe. In: NutraIngredients.com
[newsletter]. Montpellier (France): William Reed Business Media SAS; 2013 [cited 2013 Jul
31]. Available from: www.nutraingredients.com/Regulation/Expert-outlines-case-for-folatefortification-in-Europe
3. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized
patients: a meta-analysis of prospective studies. JAMA 1998;279(15):1200-5.
4. Kohn LT, Corrigan JM, Donaldson MS, editors; Institute of Medicine, Committee on Quality
of Health Care in America. To err is human: building a safer health system. Washington
(DC): National Academy Press; 1999.
5. Starfield B. Is US health really the best in the world? JAMA 2000;284(4):483-5.
6. Keene DL. A systematic review of the use of the ketogenic diet in childhood epilepsy. Pediatr
Neurol 2006;35(1):1-5.
7. Bravata DM, Sanders L, Huang J, Krumholz HM, Olkin I, Gardner CD, et al. Efficacy and
safety of low-carbohydrate diets: a systematic review. JAMA 2003;289(14):1837-50.
8. Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, et al.; Dietary
Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a lowcarbohydrate, Mediterranean, or low-fat diet. N Engl J Med 2008;359(3):229-41. Erratum: N
Engl J Med 2009;361(27):2681.
9. Sharman MJ, Gmez AL, Kraemer WJ, Volek JS. Very low-carbohydrate and low-fat diets
affect fasting lipids and postprandial lipemia differently in overweight men. J
Nutr 2004;134(4):880-5.
10. Noto H, Goto A, Tsujimoto T, Noda M. Low-carbohydrate diets and all-cause mortality: a
systematic review and meta-analysis of observational studies. PloS One 2013;8(1):e55030.
11. Knight EL, Stampfer MJ, Hankinson SE, Spiegelman D, Curhan GC. The impact of protein
intake on renal function decline in women with normal renal function or mild renal
insufficiency. Ann Intern Med 2003;138(6):460-7.
12. Beatty SJ, Mehta BH, Rodis JL. Decreased warfarin effect after initiation of high-protein, lowcarbohydrate diets. Ann Pharmacother 2005;39(4):744-7.
13. Sharma S, Gulati S. The ketogenic diet and the QT interval. J Clin Neurosci 2012;19(1):1812.
14. Bank IM, Shemie SD, Rosenblatt B, Bernard C, Mackie AS. Sudden cardiac death in
association with the ketogenic diet. Pediatr Neurol 2008;39(6):429-31.
15. Stewart WA, Gordon K, Camfield P. Acute pancreatitis causing death in a child on the
ketogenic diet. J Child Neurol 2001;16(9):682.
16. Kossoff EH, Zupec-Kania BA, Amark PE, Ballaban-Gil KR, Bergqvist AG, Blackford R, et
al. Optimal clinical management of children receiving the ketogenic diet: recommendations
of the International Ketogenic Diet Study Group. Epilepsia 2009;50(2):304-17.
17. Lichtenstein AH, Van Horn L; Nutrition Committee. AHA science advisory: very low fat diets.
Circulation 1998;98(9):935-9. Erratum: Circulation 1998;98(17):1828.

18. Amatruda JM. Very low energy diets for the treatment of simple and complicated obesity.
Curr Opin Endocrinol Diabetes Obesity 1991;1(3):171-9.
19. Food and Drugs Act: Natural Health Products Regulations. SOR/2003-196, 2003. Ottawa
(ON): Health Canada; 2004 [cited 2014 Feb 7]. Available from: http://lawslois.justice.gc.ca/eng/regulations/SOR-2003-196/
20. Bronstein AC, Spyker DA, Cantilena LR Jr, Green JL, Rumack BH, Dart RC. 2010 annual
report of the American Association of Poison Control Centers National Poison Data System
(NPDS): 28th annual report. Clin Toxicol 2011;49(10):910-41.
21. ANH exclusive! Natural health products ultra-safe and drugs as dangerous as war. Dorking,
Surrey (UK): Alliance for Natural Health International; 2012 [cited 2013 Jan 30]. Available
from: www.anhinternational.org/news/anh-exclusive-natural-health-products-ultra-safe-anddrugs-dangerous-war

Safety considerations in herbal therapy

What is herbal therapy?
Herbal therapy is a method of medical treatment that relies primarily on the application or
ingestion of plants and plant extracts. Plants have been used for medicinal purposes since long
before recorded history. However, in the early 19th century scientists began making their own
versions of various plant compounds, thereby establishing medical science and relegating
herbal medicine to the status of an alternative modality. Herbal medicines are now sold in the
form of teas, syrups, oils, liquid extracts, tinctures and dry extracts (pills or capsules).
What role does regulation play in the safety of herbal therapy?
Although herbs have been known as remedies for medical problems for thousands of years, the
modern focus within the health care system is on purity and potency, properties that are now
enforced through regulations.
The Canadian Natural Health Products Regulations have been in effect since January 1, 2004.
These regulations apply to all natural health products, including herbal products. Strict
enforcement of the regulations by Health Canada ensures that Canadians have access to
products that are safe and of high quality. Under these regulations, any product claims must be
substantiated by traditional and/or scientific evidence and must be approved by the Natural
Health Products Directorate before a licence for manufacture and distribution is granted.
The evidence stipulated by the regulations may be difficult, though not impossible, to obtain. For
example, herbs typically contain more than one active ingredient, and the effects may vary with
the preparation (e.g., dry leaves or decoctions). As such, complex analyses may be required to
link specific herbal preparations with specific effects.
Most of the preclinical studies conducted to date have been in vitro studies, meaning that the
substances are investigated in the laboratory setting with a variety of analytical techniques. For
example, cultured cells from organisms such as mice or humans may be exposed in test tubes to
extracts of herbal compounds (also known as phytochemicals). In this type of study, the extract is
typically highly concentrated, and the cells are exposed directly. However, such studies do not
necessarily replicate what occurs when patients ingest herbal compounds therapeutically. In the
therapeutic setting, only some of the phytochemicals are absorbed; the rest may be too large to
squeeze through the intestinal barrier, so they are eliminated with the feces or are broken down
by stomach acid or intestinal flora before absorption.1 Yet others require specific conditions if they
are to be absorbed; for example, the compound curcumin is active only if it has been heated in oil
before ingestion.
What are the risks of herbal therapy?
According to the US National Poison Data System, not a single death was caused by any herbal
product (e.g., Gingko biloba, ginseng, St. Johns wort), amino acid, dietary mineral supplement
(e.g., calcium, magnesium, iron) or vitamin in 2008.2 With regard to supplements, including herbs,
the Alliance for Natural Health International3 has published data showing that people are almost
900 times more likely to die from food poisoning than from supplements. In addition, the Alliance
has reported that death due to adverse reactions to pharmaceutical drugs is 62,000 times more
likely than death due to food supplements and 7,750 times more likely than death due to herbal
remedies. A person resident in the United Kingdom is an incredible 36,625 times more likely to
die from preventable medical injuries than from taking a herbal medicine!
Overall, then, the risks of herbal therapy are actually much lower than the risks of other forms of
medical care. Nonetheless, the use of herbs does entail a few minimal concerns and precautions.
x For most herbs, cautions and contraindications apply in pregnancy and lactation.
x Gingko (Gingko biloba) and cats claw (Uncaria tomentosa) may decrease blood viscosity
and therefore should not be given to patients who are already receiving anticoagulants,

x
x
x
x

such as warfarin, acetylsalicylic acid (ASA), ticlopidine (Ticlid), clopidogrel (Plavix) or

dipyridamole (Persantine).4
St. Johns wort (Hypericum perforatum) may induce photosensitivity or phototoxicity,
manifesting as elevated, itching, erythematous lesions.5 This herb should be prescribed
with caution when used in conjunction with antidepressants or medications that are
metabolized by the cytochrome P450 3/4 system. For example, therapy should be
initiated at the lowest dose (e.g., 300 mg) and then increased slowly over 1 to 2 weeks,
with monitoring for symptoms of serotonin syndrome (diagnosed on a clinical basis). For
patients who are taking other medications that may cause hepatic effects, it would be
wise to check liver function weekly.6
Echinacea (genus Echinacea) should be used at low doses and for short periods of time
for people with autoimmune conditions. Such patients should be monitored for worsening
of their autoimmune condition, and the echinacea discontinued if such worsening occurs.
Turmeric (Curcuma longa) is reputed to increase the flow of bile and should therefore be
avoided in individuals with blockage of the common bile duct or gallstones.7
Ginseng (genus Panax) increases the level of warfarin and therefore should not be given
in conjunction with that drug. It also induces insomnia, so should not be ingested in the
evening.8
Allergic reactions to herbal medicines, which sometimes occur without warning, have
been reported. A patient with a known serious allergy to one plant species should avoid
using products that contain other plant species from the same family. For example,
individuals with allergies to the sunflower family (Asteraceae or Compositae) may
experience an allergic reaction, including (rarely) anaphylaxis, when ingesting echinacea,
which is from the same family.9

Conclusion
Herbal medicine can be a useful addition to any medical practice because it is safe, effective and
within the financial means of most patients. Patients are now seeking authoritative information
and expect their health care professionals to be knowledgeable about herbs, as well as more
traditional treatments. A useful general reference is Boon and Smiths book The Complete
Natural Medicine Guide to the 50 Most Common Medicinal Herbs.8

Barbara Powell, MD, CCFP, FCFP

PO Box 72099
Kanata North Postal Station
Kanata ON K2K 1W8
Telephone: 613-591-3942
Email: dr.barbara.powell@gmail.com
Website: www.celiacbrain.blogspot.com

10

References
1. Wright JV. Are anti-herb studies all theyre cracked up to be? Wading through the anti-herb
coverage. In: Dr. Jonathan V. Wrights nutrition and healing [website]. Baltimore (MD):
Nutrition
&
Healing;
[cited
2012
Aug
20].
Available
from:
http://wrightnewsletter.com/2010/12/20/anti-herb-coverage/
2. Bronstein AC, Spyker DA, Cantilena LR Jr, Green JL, Rumack BH, Giffin SL. 2008 annual
report of the American Association of Poison Control Centers National Poison Data System
(NPDS): 26th annual report. Clin Toxicol 2009;47(10): 911-1084.
3. ANH exclusive! Natural health products ultra-safe and drugs as dangerous as war. Dorking,
Surrey (UK): Alliance for Natural Health International; 2012 [cited 2013 Jan 30]. Available
from: www.anhinternational.org/news/anh-exclusive-natural-health-products-ultra-safe-anddrugs-dangerous-war
4. Cupp MJ. Herbal remedies: adverse effects and drug interactions. Am Fam
Physician 1999;59(5):1239-44.
5. Golsch S, Vocks E, Rakoski J, Brockow K, Ring J. [Reversible increase in photosensitivity to
UV-B caused by St. Johns wort extract.] Hautarzt 1997;48(4):249-52. In German.
6. Whitten DL, Myers SP, Hawrelak JA, Wohlmuth H. The effect of St Johns wort extracts on
CYP3A: a systematic review of prospective clinical trials. Br J Clin Pharmacol
2006;62(5):512-26.
7. Chen C, Johnston TD, Wu G, Ranjan D. Curcumin has potent liver preservation properties in
an
isolated
perfusion
model.
Transplantation
http://www.ncbi.nlm.nih.gov/pubmed/170389092006;82(7):931-7.
8. Boon H, Smith M. The complete natural medicine guide to the 50 most common medicinal
herbs. 2nd ed. Toronto (ON): Robert Rose Inc.; 2004.
9. Myers SP, Wohlmuth H. Echinacea-associated anaphylaxis. Med J Aust 1998;168(11):5834.

11

Safety considerations in the practice of acupuncture

What is acupuncture?
Acupuncture is a system of medicine that involves the insertion of fine, solid stainless steel
needles into specific sites on the body to reduce pain, achieve homeostasis, promote healing,
treat disease and normalize physiology. Its origin and development occurred in China, beginning
perhaps 2500 years ago.1
The ancient theories of acupuncture are based on an energetic paradigm that includes the
concept of energy or qi (pronounced chee), which has two aspects, yin and yang, that must be
in balance. The qi is believed to flow through the body along energy channels commonly referred
to as meridians. If energy is deficient, blocked or unbalanced, symptoms such as pain will appear.
Inserting needles into specific points can increase, unblock or balance the qi, improving the
persons symptoms. Acupuncture can be practised as a system of medicine wherein the
practitioner makes a traditional Chinese diagnosis using classically derived methodologies and
chooses the sites for insertion of needles (known as acupuncture points or acupoints) according
to that diagnosis.
Alternatively, the choice of acupoints can be based on Western medicine integrated with
knowledge of the location of acupuncture points and meridians. Since the mid-1970s, approaches
that utilize an understanding of functional anatomy and basic physiology have been introduced.
Within the medical profession in Canada, anatomical acupuncture, originated by Dr. Joseph
Wong through the Acupuncture Foundation of Canada Institute program, is used in conjunction
with traditional acupuncture approaches.
According to anatomical acupuncture, the choice of effective acupuncture points for
supraspinatus tendinitis (wherein swelling of the tendon of the supraspinatus muscle leads to
painful pinching of the tendon between the humerus and the acromion of the scapula at about 90
abduction of the arm) can be based on the fact that needling of acupoint LI 16 stimulates the
tendon of the supraspinatus muscle and that needling of acupoint SI 12 stimulates the
suprascapular nerve to the muscle. Electrical stimulation of both points reduces the inflammation
of the tendon and shrinks it enough that relief is usually obtained immediately after the first
treatment, and improvement is cumulative with subsequent treatments.
How do acupuncture needles differ from hypodermic needles?
Hypodermic needles are bevelled. Each consists of a hollow tube that is cut across on an angle,
which creates a cutting edge that can readily slice through tissue. Acupuncture needles, which
are atraumatic, are solid and rounded at the tip, which allows them to slide through tissue without
inflicting damage. Acupuncture needles are also far thinner than hypodermic needles. The
needles commonly used range from 0.16 to 0.25 mm in diameter.
What are the risks of acupuncture?
The risks of acupuncture can be classified as minor and major.
Large prospective studies from the United Kingdom,2,3 Germany4 and Japan5 have led to a
consensus that the incidence of minor adverse events (e.g., bruising, bleeding, pain associated
with needle insertion, fatigue, orthostatic events, temporary aggravation of symptoms) is very low.
For example, in one of these studies,4 which encompassed approximately 763,900 treatments in
97,733 patients, the incidence of such effects ranged from 0.46% (orthostatic problems) to 3.28%
(needling pain).
Although the risk of major adverse events is also very low (cumulative worldwide incidence
estimated at 0.05 per 10,000 treatments and 0.55 per 10,000 individual patients3), they can be
avoided if practitioners are knowledgeable about anatomy, are careful to avoid areas of the body
that are vulnerable to needling and use single-use, sterile needles.

12

The major risks can be divided into two broad categories: trauma and infection.
Trauma
In 1996, the incidence of the most common traumatic event, pneumothorax, was estimated to be
three per million treatments, based on three studies that included 184,036 treatments.6-8 Since
then, there have been seven cases of pneumothorax reported in 13 prospective studies totalling
over 4 million treatments.2 Ten of these studies reported no cases of pneumothorax in 203,382
treatments.
Although epidemiology experts have concluded that the incidence of major adverse events
caused by acupuncture is low and the risk has been described as negligible,2 many cases of
pneumothorax probably go unreported. Anecdotally, there seems to be an impression among
emergency room physicians in some locales that many spontaneous cases of pneumothorax
have been caused by acupuncture that the patient will not admit to having undergone.9
Published reports on the consequences of various other forms of trauma inflicted by acupuncture
needles range from temporary pain and tetraplegia10 to death from cardiac tamponade due to
penetration of the heart by a needle.11 The latter complication can be avoided by always inserting
needles over the sternum at a very shallow angle. In 5%8% of individuals there is a sternal
foramen, usually at the level of the fourth intercostal space, the result of incomplete fusion of the
sternal plates during embryonic development.12 The location of this foramen is also the site of a
commonly used acupuncture point, CV 17, so insertion of a needle perpendicular to the skin
could lead to puncture of the heart in patients with a previously unidentified foramen.
Infection
The introduction of bacteria or viruses into the body via acupuncture needles may result in local
or systemic infection. Such infections can sometimes be treated successfully with antibiotics.
However, needle-related infection may also lead to development of an abscess, which could
affect vital structures such as the spinal cord (in the case of an epidural abscess).13
Immunocompromised individuals are particularly vulnerable to infection, including acupuncturerelated infection, which can lead to serious consequences, such as necrotizing fasciitis.14,15
What are the contraindications for acupuncture?
There are no absolute contraindications for acupuncture with needles alone (i.e., without
electrical stimulation).
Pregnancy is arguably the most important of the relative contraindications. Although all of the
classic acupuncture texts and ancient writings warn of the risk of inducing a miscarriage with
acupuncture, and certain acupoints are identified as being likely to initiate labour, there is no
convincing evidence to support this belief. Some of the prohibitions make anatomical or
physiological sense, such as points that stimulate the sacral nerves; others are known to have a
strong effect on the autonomic nervous system and should therefore be avoided. In spite of these
warnings, no cases have been reported (to the authors knowledge). Nonetheless, it is wise from
a medico-legal perspective to avoid acupuncture treatment during the first trimester. If treatment
is provided later in pregnancy, the patient must provide informed consent specifically absolving
the practitioner of responsibility in case of a coincidental spontaneous abortion, although it would
be impossible to guarantee that a spontaneous abortion, if it did occur, was unrelated to the
treatment.
Anticoagulant therapy is usually considered a relative contraindication, but over the authors 21
years of clinical experience treating many patients who were taking warfarin or heparin,
anticoagulation has not been a problem.

13

What precautions must be taken when performing acupuncture?

For certain areas of the body, the practitioner must exercise extra caution and must have
excellent knowledge of anatomy to prevent puncture of organs, mainly the lung. Most cases of
traumatic pneumothorax involve puncturing the apex of the lung while inserting a needle into the
upper trapezius midway between the spinous process of the seventh cervical vertebra and the tip
of the acromion (acupoint GB 21).
In addition, acupuncture is forbidden for specific parts of the body: the fontanelle, genitalia,
nipples and eyeballs.
The loci of some acupuncture points are intra-articular. For insertions in these areas, the skin
should be swabbed with a mixture of chlorhexidine and alcohol or with povidoneiodine (e.g.,
Betadine). Needles should never be inserted into artificial joints.
Individuals whose immune systems are compromised by illness or medications should be treated
with extra caution. Needles should not be inserted into soiled or inflamed skin.
Electrical stimulation should be avoided in patients with cardiac pacemakers, although there is no
evidence of cases of electroacupuncture causing arrhythmias. This form of therapy should also
not be used near the carotid sinus, over the heart or, for individuals with epilepsy, on the scalp.
Six cases of bacterial endocarditis associated with acupuncture treatment of 109,152 individuals
who received a total of approximately one million treatments included one person with Marfans
syndrome who required emergency redo of the aortic root and valve replacement with a
homograft.16 However, no cases of endocarditis occurred after acupuncture treatment in 36
patients with valvular disease who underwent a total of 479 treatments in a prospective 10-year
study; as such, antibiotic prophylaxis was deemed unnecessary.17
What are the risks for practitioners?
The risk that the practitioner will contract infection from a needle-stick injury when treating a
patient with a blood-borne viral illness has been of concern, but the large UK survey published in
2004 found no evidence of any such cases.3
Conclusion
Acupuncture is a safe form of treatment, with essentially no risks of serious adverse events when
treatment is provided by properly trained practitioners with a good knowledge of anatomy.

Linda Rapson, MD, CAFCI

Assistant Professor, Department of Family and Community Medicine
University of Toronto
Adjunct Scientist, UHN/Toronto Rehabilitation Institute
Rapson Pain and Acupuncture Clinic
207-600 Sherbourne Street
Toronto ON M4X 1W4
E-mail: drrapson@sympatico.ca
Website: www.rapsonclinic.com

14

References
1. Gwei-Djen L, Needham J. Historical growth. In: Celestial lancets: a history and rationale of
acupuncture and moxa. Cambridge (UK): Cambridge University Press; 1980. p. 69-153.
2. White A. The safety of acupunctureevidence from the UK. Acupunct Med 2006;24
Suppl:53-7.
3. White A. A cumulative review of the range and incidence of significant adverse events
associated with acupuncture. Acupunct Med 2004;22(3):122-33.
4. Melchart D, Weidenhammer W, Streng A, Reitmayr S, Hoppe A, Ernst E, et al. Prospective
investigation of adverse effects of acupuncture in 97 733 patients. Arch Intern Med
2004;164(1):104-5.
5. Yamashita H, Tsukayama H, Tanno Y, Nishijo K. Adverse events in acupuncture and
moxibustion treatment: a six-year survey at a national clinic in Japan. J Altern Complement
Med 1999;5(3):229-36.
6. Umlauf R. Analysis of the main results of the activity of the acupuncture department of
faculty hospital. Acupunct Med 1988;5(2):16-8.
7. Chen FP, Hwang SJ, Lee HP, Yang HY, Chung C. Clinical study of syncope during
acupuncture treatment. Acupunct Electrother Res 1990;15(2):107-19.
8. Melchart D, Liao J, Hager S. Projektbericht 1994 uber die Erste Deutsche Klinik fur
Traditionelle Chinesischen Medizin Kotzting. Munich (Germany): TCM Klinik Kotzting; 1995.
9. Kelsey JH. Pneumothorax following acupuncture is a generally recognized complication
seen by many emergency physicians. J Emerg Med 1998;16(2):224-5.
10. Lee JH, Lee H, Jo DJ. An acute cervical epidural hematoma as a complication of dry
needling. Spine (Phila Pa 1976) 2011;36(13):E891-3.
11. Halvorsen TB, Anda SS, Naess AB, Levang OW. Fatal cardiac tamponade after acupuncture
through congenital sternal foramen. Lancet 1995;345(8958):1175.
12. Cooper PD, Stewart JH, McCormick WF. Development and morphology of the sternal
foramen. Am J Forensic Med Pathol 1988;9(4):342-7.
13. Yazawa S, Ohi T, Sugimoto S, Satoh S, Matsukura S. Cervical spinal epidural abscess
following acupuncture: successful treatment with antibiotics. Intern Med 1998;37(2):161-5.
14. Hsieh RL, Huang CH, Uen WC. Necrotizing fasciitis after acupuncture in a patient with
aplastic anemia. J Altern Complement Med 2011;17(9):871-4.
15. Saw A, Kwan MK, Sengupta S. Necrotising fasciitis: a life-threatening complication of
acupuncture in a patient with diabetes mellitus. Singapore Med J 2004;45(4):180-2.
16. Nambiar P, Ratnatunga C. Prosthetic valve endocarditis in a patient with Marfans syndrome
following acupuncture. J Heart Valve Dis 2001;10(5):689-90.
17. Stellon A. Acupuncture in patients with valvular heart disease and prosthetic valves.
Acupunct Med 2003;21(3):87-91.

15

Safety considerations in the practice of homeopathy

What is homeopathy?
The word homeopathy derives from two Greek words, homios, meaning similar, and pathos,
meaning suffering. Founded in 1810 by the German doctor, chemist and scholar Samuel
Hahnemann, homeopathic medicine is based on the principle of like cures like. Although
Hahnemann was the first to define the practice of homeopathy using a methodical and systematic
approach, the principle of like cures like has been found in the ancient writings of Hippocrates
and Paracelsus. In its simplest terms, this principle states that a substance capable of causing
disease can also be used to treat disease. To learn the symptoms that any given substance can
produce, it must be taken in repeated doses. When experienced during an episode of disease,
these symptoms can then be cured by taking the same substance in its homeopathic form (as a
remedy). Homeopathy was widely practised by the mid-19th century, but its popularity waned in
the early 20th century. With the recent resurgence of complementary and alternative therapies,
patients are seeking safe, noninvasive alternative therapies, and the profession of homeopathy is
being revived.
Provings
The earliest research in homeopathy began with tests of substances on healthy subjects, called
provings. A group of healthy volunteers took predetermined doses of a chosen substance and
carefully recorded the symptoms that developed; the symptoms were then verified by the
homeopath who was conducting the proving. This information, in addition to toxicological reports
on known toxic elements, such as arsenic and phosphorus, were compiled in the Materia Medica,
the fundamental text for homeopaths.1 Today, many software programs are available to help
homeopaths find the correct remedy for a patient according to symptoms observed and
discovered during an intake appointment. This initial consultation requires a thorough discussion
of the patients subjective and objective symptoms, which allows the homeopath to select one
remedy out of thousands, making the treatment highly individualized.
Dilutions
Homeopathic remedies are made by dilution and succussion, the main approaches set out in the
homeopathic pharmacopeia. The manufacturing process begins with a crude substance, such as
calcium derived from oysters. This substance is diluted in water at a ratio of 1:100 to make a CH
(centesimal Hahnemanian) dilution or at a ratio of 1:10 to make a D (decimal) dilution. The
substance is typically diluted beyond the Avogadro constant (number of atoms or molecules in
one mole of the substance), making it devoid of any detectable substances. Although basic
chemistry laws would indicate that such a dilute solution is inactive as a medical agent, recent
materials science research conducted by Dr. Rustum Roy and colleagues of Pennsylvania State
University has shown that remedies can be differentiated in terms of substance and potency
when tested using raman and ultravioletvisible (UV-VIS) spectroscopy.2
How has homeopathy been studied?
The National Center for Complementary and Alternative Medicine, part of the US National
Institutes of Health, has stated that there is little evidence to support homeopathy as an effective
treatment for any specific condition.3 However, according to the UK Faculty of Homeopathy, by
the end of 2011, a total of 163 randomized controlled trials (RCTs) of homeopathy, spanning over
75 medical conditions, had been published in peer-reviewed journals, 67 (41%) with positive
outcomes, 11 (7%) with negative outcomes and 85 (52%) with inconclusive results.4
What are the risks of homeopathy?
There has been no recorded evidence of deaths caused by the use of homeopathic medicine. In
the year 2000, Dantas and Rampes published a systematic review of papers on the adverse
effects of homeopathy with publication dates between 1970 and 1995.5 They found that the
adverse effects recorded were temporary aggravations of symptoms or other mild and transient
effects (mostly headaches, tiredness, skin eruptions, dizziness or diarrhoea).6 In fact, these are

16

common phenomena known as similar aggravation. Upon taking the first dose, patients often
report such aggravations, which are transient and pass within 2448 hours. The review also
noted that only a very few isolated reports of proper adverse effects were attributable to
homeopathic medicines. The authors concluded that Homeopathic medicines in high dilutions,
prescribed by trained professionals, are probably safe and unlikely to provoke serious adverse
reactions.5
Traditionally, homeopathic remedies were prescribed under the guidance and care of a
homeopath. The homeopathic interview allowed for careful assessment of the patients
symptoms, lifestyle, illness and personality and provision of individualized care for the patient.
Now, many homeopathic remedies are available over the counter and can be purchased without
a consultation. This over-the-counter availability creates the potential for unwanted side effects,
even if temporary (such as the similar aggravations mentioned above).
Although many homeopathic remedies are of plant or mineral origin, some come from animal
sources, including humans. A few others, known as nosodes, are derived from diseased tissues
or secretions. The practice of isopathy, a field derived from and related to homeopathy, uses
various other starting materials, such as pollen, animal dander and mould. Remedies with dilution
beyond the Avogadro constant have a lower risk of transmission of pathogens, but risks may be
associated with the low-dilution remedies. Fortunately, over-the-counter availability of nosodes
has become restricted, and these agents should be available only through qualified homeopaths.
As a result of concerns regarding the safety of production processes for homeopathic medicines,
the World Health Organization published a document outlining safe manufacturing practices, to
help regulate the quality and purity of homeopathic medicines.7 This document aims to create
consistency in manufacturing processes across the globe and should be adopted by all countries
with major homeopathic manufacturers. Another step in minimizing risk would be to enforce good
manufacturing practices,8 which would ensure the quality, potency and purity of both raw
materials and final products. In Canada, the majority of homeopathic remedies are imported from
Belgium through Boiron Canada (Saint-Bruno-de-Montarville, Quebec) or Seroyal Inc. (Richmond
Hill, Ontario). Most Canadian suppliers and manufacturers adhere to good manufacturing
practices, and their products are approved by Health Canada.
Homeopathy in Ontario
The Regulated Health Professions Act came into effect in December 1993. This act provides a
common legislative framework under which all regulated health professions in Ontario must
function.9 Five of the 28 health professions covered by this act, including homeopathy, have
transitional status, with regulation currently in progress. The Homeopathy Act, which came into
effect in 2007, defines the practice of homeopathy as the assessment of body system disorders
and treatment using homeopathic techniques to promote, maintain or restore health. Once the
regulatory process is complete, in 2014, only those homeopaths registered with the College of
Homeopaths of Ontario and meeting the requirements set out by the College will be allowed to
use the title homeopath. With so much evidence on homeopathys safety and efficacy, and with
over 200 years of use all over the globe, homeopathy has a strong place under the umbrella of
complementary and alternative medicine.
Parul Sanduja, BSc, DCHM
Registered Homeopath (RHom)
16 McMurray Street
Dundas ON L8S 3Y6
Telephone: 289-808-1438
Fax: 905-524-5479
E-mail: parulsanduja@gmail.com
Website: www.samuelhomeopathy.com

Jozef Krop, MD (ret.), HD

EcoHealth and Wellness Inc.
6517A Mississauga Road
Mississauga ON L5N 1A6
Telephone: 905-816-9657
Fax: 905-816-9661
E-mail: ecohealth3000@gmail.com

17

References
1. Hahnemann S. Materia medica pura. 2 volumes. New Delhi (India): B Jain Publishers Ltd.
First English translation by C. Hempel; published by William Radde (1846).
2. Rao ML, Roy R, Bell IR, Hoover R. The defining role of structure (including epitaxy) in the
plausibility of homeopathy. Homeopathy 2007;96(3):175-82. Erratum: Homeopathy
2007;96(4):292.
3. Homeopathy: an introduction [fact sheet]. Rockville (MD): National Institutes of Health,
National Center for Complementary and Alternative Medicine; modified 2012 Jul 19 [cited
2013 Jan 22]. Available from: http://nccam.nih.gov/health/homeopathy
4. The research evidence base. Luton (UK): British Homeopathic Association, Faculty of
Homeopathy; [cited 2014 Feb 7]. Available from: www.britishhomeopathic.org/wpcontent/uploads/2013/05/evidencesummary.pdf
5. Dantas F, Rampes H. Do homeopathic medicines provoke adverse effects? A systematic
review. Br Homeopath J 2000;89 Suppl 1:S35-8.
6. Safety and cost benefit. Luton (UK): British Homeopathic Association; updated 2011 Oct 21
[cited 2013 Jan 22]. Available from: www.britishhomeopathic.org/research/safety_cost_benefit.html
7. Safety issues in the preparation of homeopathic medicines. Geneva (Switzerland): World
Health
Organization;
2009
[cited
2013
Feb
1].
Available
from:
www.who.int/medicines/areas/traditional/prephomeopathic/en/index.html
8. Good manufacturing practices. Ottawa (ON): Health Canada; updated 2012 Dec 21 [cited
2013 Apr 12]. Available from: www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/indexeng.php
9. Regulation of homeopathy. Toronto (ON): Transitional Council of the College of Homeopaths
of Ontario; [cited 2013 Jan 22]. Available from: www.collegeofhomeopaths.on.ca/reg.html

Additional resources
Whole Health Now
Website: www.wholehealthnow.com
British Homeopathic Association
Hahnemann House
29 Park Street West
Luton UK LU1 3BE
Telephone: 01582-408675
Fax: 01582-723032
E-mail: Info@britishhomeopathic.org
Website: www.britishhomeopathic.org/
Faculty of Homeopathy
Educational branch of British Homeopathic Association
Website: www.facultyofhomeopathy.org
National Center for Complementary and Alternative Medicine
National Institutes of Health (US)
9000 Rockville Pike
Bethesda MD 20892
Website: www.nccam.nih.gov/health/homeopathy

18

Safety considerations in the practice of manual medicine

What is manual medicine?
Manual or musculoskeletal medicine is the medical discipline that deals with the most common
causes of pain and disability, namely reversible dysfunctions of the locomotor system, including
the spine. Manual medicine is as old as recorded history, with evidence in Thai statuary of
manual techniques dating back 4000 years. Hippocrates is known to have used manual
techniques, especially on the spine.1 Manipulation, the mainstay of modern manual medicine, is
used to restore altered structurefunction relationships.
In the context of manual medicine, the term manipulation is almost universally understood to refer
to the specific technique of high-velocity, low-amplitude (HVLA) thrust. However, this definition is
problematic, in that it defines the modality in terms of one specific technique, rather than the
therapeutic end point, which is the accepted tradition in the rest of medicine. For example,
cholecystectomy is, by definition, removal of the gallbladder, irrespective of technique. As such,
manipulation should more properly be regarded as restoration of altered structurefunction
relationships within the musculoskeletal system, irrespective of technique. American osteopathy
teaches six separate techniques that can be used manually, and these should all be considered
manipulative techniques.1 Furthermore, it is certainly possible to practise manual or
musculoskeletal medicine without ever using HVLA thrust techniques on the spine (personal
experience of the author).
Safety issues
Spinal manipulation is currently undergoing close scrutiny, as it is the most risk-inherent aspect of
manual medicine. A collaborative project involving the University of Alberta, the University of
Calgary and the University of Toronto is exploring a number of issues concerning the safety of
spinal manipulation.2 At the same time, the International Federation for Manual/Musculoskeletal
Medicine (FIMM) is developing a policy statement on the safety aspects of clinical practice
(Guidelines on basic training and safety, draft 1.7, dated July 22, 2012; p. 36-52).
Safety concerns related to spinal manipulation are also receiving increasing attention in the
literature because of some potentially serious adverse effects, particularly in the cervical spine. In
contrast, manipulation of the sacroiliac joints, thoracic spine and ribs involving HVLA thrust can
be regarded as very safe. In its recent review of the literature, related to the development of the
draft policy statement mentioned above, the FIMM found no reports of significant safety concerns
related to these areas of the axial skeleton. The FIMM also noted that, in the most recent review
of lumbar spine manipulation by HVLA thrust, published in 2004, Oliphant reported a very low
incidence of adverse effects, on the order of 1 in 3.7 million manipulations.3
Over the past 20 years, various types of studies on the adverse effects of cervical spine
manipulation (specifically by HVLA thrust) have revealed a wide range of incidence rates.4-10
Virtually all of these studies have been retrospective, and the reporting of adverse events is likely
incomplete, making it difficult to ascertain the true incidence and prevalence.
In its 2011 Policy Compendium, the American Osteopathic Association published a synopsis of
known adverse effects of cervical spine manipulation dating back to 1925.11 The policy states, A
conservative estimate of the number of cervical spine manipulations per year is approximately 33
million and may be as high as 193 million in the US and Canada. The estimated risk of adverse
outcome following cervical spine manipulation ranges from 1 in 400,000 to 1 in 3.85 million
manipulations. The estimated risk of major impairment following cervical spine manipulation is
6.39 per 10 million manipulations. The American Osteopathic Association acknowledged that
most of the untoward effects relate to HLVA techniques, and the most serious complications have
been vertebrobasilar accidents, but added that the risk of a vertebrobasilar accident occurring
spontaneously, is nearly twice the risk of a [vertebrobasilar accident] resulting from cervical spine
manipulation. This includes cases of ischemic stroke and vertebral artery dissection. The

19

Association concluded that Osteopathic manipulative treatment of the cervical spine, including
but not limited to [HVLA] treatment, is effective for neck pain and is safe, especially in comparison
to other common treatments. Such common treatments would include pharmacotherapy,
specifically the nonsteroidal anti-inflammatory drugs and cyclo-oxygenase-2 inhibitors, agents
that are well known for their adverse effects.
It is true that more definitive information is needed on the risk of significant neurovascular
adverse effects of manipulation generally and of HVLA thrust techniques specifically. However,
current evidence suggests that these effects are uncommon, if not rare, and that the safety of
manual medicine and manipulative techniques compares favourably with that of standard medical
approaches. Nonetheless, more research is needed to develop accurate, noninvasive screening
tests to identify patients at higher risk of adverse effects. Individual risk factors should also be
elucidated, as conventional thinking in this regardthat factors thought to predispose patients to
atherosclerosis are the major determinants of risk with manual medicinehave not proven
reliable.

Craig Appleyard, MD, FCFP

552 Raglan Street S
Renfrew ON K7V 1R8
Telephone: 613-432-3240
Fax: 613-432-9567
E-mail: drappleyard@bellnet.ca

References
1. DeStefano L. Greenmans principles of manual medicine. 4th ed. Philadelphia (PA):
Lippincott Williams & Wilkins; 2010.
2. CARE: Program for Integrative Health and Healing [website]. Edmonton (AB): University of
Alberta. Available from: www.care.ualberta.ca/
3. Oliphant D. Safety of spinal manipulation in the treatment of lumbar disk herniations: a
systematic review and risk assessment. J Manip Physiol Ther 2004;27(3):197-210.
4. Patijn J. Complications in manual medicine: a review of the literature. Man Med 1991;6:8992.
5. Carey PF. A report on the occurrence of cerebral vascular accidents in chiropractic practice.
J Can Chiropr Assoc 1993;37(2):104-6.
6. Dvorak J, Baumgartner H, Brun L, Dalgaard JB, et al. Consensus and recommendations as
to the side-effects and complications of manual therapy of the cervical spine. Man Med
1991;6(3):117-8.
7. Lecocq J, Vautravers P. Complications des manipulations vertebral. Frquence, aspects
cliniques, pathogniques et thrapeutiques. Prvention. Ann Radapt Md Phys
1995;38(2):87-94.
8. Lecoq J, Vautravers P, Boohs PM. Frquence des accidents des manipulations vertebral
(MV) [abstract]. Ann Radapt Md Phys 1996;39(6):398.
9. Dupeyron A, Vautravers P, Lecocq J, Isner-Horobeti ME. Evaluation de la frquence des
accidents lis aux manipulations vertbrales partir dune enqute rtrospective ralise
dans quatre dpartements franais. Ann Radapt Md Phys. 2003;46(1):33-40.
10. Assendelft WJJ, Bouter LM, Knipschild PG. Complications of spinal manipulation. A
comprehensive review of the literature. J Fam Pract 1996;42(5):475-80.
11. H315-A/04: Osteopathic manipulative treatment (OMT) of the cervical spine. In: Policy
compendium. Chicago (IL): American Osteopathic Association; 2012 [cited 2012 Nov 14].
Available from: www.osteopathic.org/inside-aoa/about/leadership/Documents/policy-compendium.pdf

20

Safety considerations in the practice of neural therapy

What is neural therapy?
Neural therapy is an approach to illness and disease based on identifying foci of
electrophysiological instability that are causing local areas of autonomic nervous system
dysfunction. These foci, which may occur anywhere in the body, may be stabilized by caine
anesthetics, in the same way that ventricular arrhythmias can be treated by lidocaine. The
treatment usually involves injections of dilute procaine directly into the foci (which are called
interference fields), as well as into a convenient vein on the ipsilateral side of the body.
Neural therapy was developed in Germany in the 1930s and 40s. It is widely practised in
Germany and in the Spanish-speaking countries of Europe and Latin America. Its theoretical
basis is standard western anatomy and neurophysiology. In classical neural therapy, dilute
procaine (sometimes with a small amount of caffeine) is the only drug used, although some
practitioners have been using energetic devices such as the TensCam in place of procaine
injections in recent years.
What are the risks of neural therapy?
Procaine has been in use for over 100 years and is established as a very safe drug. However,
adverse reactions occasionally do occur. The risks of classical neural therapy (i.e., therapy
involving procaine injection) may be divided into two categories:
x those related to the procaine itself, specifically overdose and allergy
x those related to injections in particular locations
Overdose
The maximum tolerable dose of procaine administered depends on a number of factors: where
and how the procaine is administered (e.g., local infiltration or intravascular administration), the
concentration of the solution, and the patients rate of metabolism and sensitivity to the
compound.
The systemic concentration will peak earlier, and the peak concentration will be higher, when the
injection is given intravenously or into highly vascularized tissues such as the head, the neck or
the perineum. Conversely, the body will tolerate a larger dosage better if it is administered into
less well vascularized tissues (e.g., the extremities) or if multiple injections are given over a
period of time. Since the toxicity of a local anesthetic increases as the square of its concentration,
lower-concentration doses (e.g., 0.5% or 1%) are safer. Some physicians add 0.25% caffeine to
higher concentrations of procaine (2%) with the aim of reducing the toxicity of procaine.
Patients sensitivity to injected procaine varies considerably. Transient hypotension lasting no
more than a few minutes is the most common adverse effect; however, certain patients
metabolize caine anesthetics very slowly, and in these patients, the mild hypotensive symptoms
may be prolonged. The recommended maximal dose of procaine for a 70-kg adult is 1 g (or 100
ml of a 1% solution), far higher than that administered in everyday neural therapy practice. More
detailed information about appropriate dosages is provided in the Manual of Neural Therapy
According to Huneke.1
Allergy
Allergy to pure (preservative-free, vasoconstrictor-free) procaine is extremely rare. Nonetheless,
significant adverse effects have been reported, mostly with injections of large amounts of the drug
into a vein or artery. Serious allergic reactions can be identified and avoided by starting all neural
therapy treatments with small superficial injections. A skin reaction is the warning sign of allergy.
If in doubt, a subcutaneous test injection or instillation of procaine onto the conjunctiva can be
used to test for allergy. Additional information about allergies is provided in the Manual of Neural
Therapy According to Huneke.2

21

Injections into particular locations

In most neural therapy treatments, the procaine is injected into a scar, the skin, a superficial
nerve or the mucosa adjacent to the teeth, and the risk of adverse effects is very low. However,
some advanced techniques carry more risk and should be considered only to address more
difficult problems.
Injections into the autonomic ganglia, the tissues near the spine or lungs, the neck or even the
suboccipital cistern constitute part of the therapeutic armamentarium. Some of these approaches
are straightforward and may be safely performed in the physicians office. Others should be
reserved for the hospital setting or facilities with resuscitation equipment and trained personnel
available.
Needle puncture of the lungs may result in pneumothorax. Injection of procaine into the spinal or
cerebrospinal fluid carries the risk of spinal headache or respiratory arrest. Inadvertent injection of
excessive amounts of procaine into the carotid or vertebral arteries may result in seizures. Most
of these techniques require special training and should be approached with caution. These
techniques and the associated risks are described in detail in the Manual of Neural Therapy
According to Huneke.3
Clotting disorders or the presence of anticoagulants are not absolute contraindications to neural
therapy injections. However, care should be taken to identify and treat inadvertent bleeding at
puncture sites.
Infected tissues (e.g., in cases of periodontal infection or cutaneous ulcers) should be injected
with caution. Indirect techniques should be used and/or the patient should be warned of the
possibility of systemic spread of the infection. The needle should be discarded immediately after
infected tissue is injected, and a new needle will be required for each injection. Patients with
valvular heart disease or artificial valves should be given prophylactic antibiotics, as would be
done if they were undergoing dental procedures.
Neural therapy of veins should be avoided in patients with deep vein thrombosis, to avoid
dislodging emboli.
Neural therapy without injections
In recent years, new energetic devices have been developed that seem to be just as effective as
procaine injections, with no discernible risk. Devices such as the Electrobloc (no longer
manufactured), various lasers and the TensCam device (described by Crosby4 and Kidd5) deliver
electrical, light or scalar impulses to the interference fields, abolishing them within minutes. No
adverse effects have been reported with any of these instruments.

Robert F. Kidd, MD,CM

175 Argyle Street S
Renfrew ON K7V 1T6
Telephone: 613-432-6596
Fax: 613-432-6599
E-mail: rfkidd@on.aibn.com
Website: http://rfkidd.com/

22

References
1. Dosch P, Dosch M. Manual of neural therapy according to Huneke. 2nd English ed.
(translation of 14th German ed.). Gutberlet R, translator. Stuttgart (Germany) and New York
(NY): Thieme; 1995. Part III-4, The question of dosage. p. 275-6.
2. Dosch P, Dosch M. Manual of neural therapy according to Huneke. 2nd English ed.
(translation of 14th German ed.). Gutberlet R, translator. Stuttgart (Germany) and New York
(NY): Thieme; 1995. Part III-5, Procaine hypersensitivity and accidents. p. 277-9.
3. Dosch P, Dosch M. Manual of neural therapy according to Huneke. 2nd English ed.
(translation of 14th German ed.). Gutberlet R, translator. Stuttgart (Germany) and New York
(NY): Thieme; 1995. Part III-8, Alphabetical list of injection techniques. p. 289-382.
4. Crosby CJ. Beyond pills, knives & needles: relieve pain and inflammation with 21st century
quantum-based technology. Orlando (FL): Self-published; 2010. Ordering information:
www.tenscam.com/dr-crosbys-book
5. Kidd RF. Neural therapy: applied neurophysiology and other topics. Renfrew (ON): Selfpublished; 2005. Ordering information: www.neuraltherapybook.com/

23

Safety considerations in the practice of prolotherapy

What is prolotherapy?
The concept of prolotherapy originated in the nonsurgical treatment of hernias, varicose veins
and hemorrhoids, all of which are due to weakness of the connective tissue. Prolotherapy, as it is
practised today, is also known as nonsurgical reconstruction of the ligament or tendon or as
regenerative injection therapy. It is a permanent treatment for chronic pain due to laxity or
nonhealing of ligament and tendon injuries. The prefix prolo, short for proliferation, indicates that
this treatment causes the proliferation (formation and growth) of new tissue in areas where the
existing tissue has become weak.
What is prolotherapy used for?
Prolotherapy is used to treat chronic pain due to injury of the ligaments or tendons.
Ligaments and tendons are connective structures at the joints of the musculoskeletal system. A
ligament connects two bones, helping to create stability of the joint. A tendon connects a muscle
to a bone and is involved in movement of the joint. The greatest stresses to the ligaments and
tendons occur where these structures attach to the bone, the fibro-osseous junction. The most
sensitive structures producing pain in the joints are the periosteum (the covering of the bone) and
the ligaments themselves. Because ligaments and tendons have a poor blood supply, healing
after injury is often incomplete. Left to nature, healing of connective tissue such as an injured
ligament or tendon is usually complete by 6 to 8 weeks and certainly by 3 months. If the ligament
or tendon heals back to its normal length and strength, the joint regains its stability, and there is
no pain. However, if the ligament or tendon remains stretched or elongated, the joint may become
chronically unstable. Thus, incomplete healing leads these normally taut, strong bands of fibrous
or connective tissue to become relaxed, weak and inefficient. The inefficient connective tissue
(ligament or tendon) then becomes a source of chronic pain and weakness.
Prolotherapy is an excellent treatment for many types of musculoskeletal pain, including back and
neck pain, pain due to whiplash or sports injuries (including knee injuries and elbow tendinitis,
also known as tennis elbow), temporomandibular joint pain and headaches. If a trained medical
practitioner administers the prolotherapy, and patient selection criteria are correctly applied, there
is a 75% chance that patients with chronic pain will become pain-free and that most will have
significantly less pain.1
How is prolotherapy performed?
Prolotherapy involves injection of a substance into the affected ligament or tendon at the point of
palpable tenderness. The substance is a mild chemical or natural irritant that stimulates the
immune system, leading to local inflammation. The localized inflammation triggers a woundhealing cascade, which results in the deposition of new collagen, the material that forms
ligaments and tendons. New collagen shrinks as it matures, which causes the treated tissue to
become tighter and hence stronger. Other direct stimulators of tissue growth, such as platelet-rich
plasma or stem cells, can also be used for prolotherapy. Regardless of the solution that is
injected, the process motivates the body to heal itself through a variety of natural responses, with
the same end result: the creation of new tissue; the stabilization of joints, ligaments and tendons;
and the repair of joint surfaces.
When and how often is prolotherapy performed?
Whether an injury is just a week old or occurred years ago, prolotherapy seems to have the same
benefit. Of course, other factors, such as nutrition, sleep and hormone balance, must be
corrected before prolotherapy can achieve its maximum benefit. Prolotherapy is performed every
3 to 4 weeks, with most patients needing four to six treatments. Most patients notice a few days
of discomfort after the injection, with a gradual improvement in their condition over time.
Appropriate physical therapy or similar care enhances the results.

24

Who performs prolotherapy?

The physicians who perform prolotherapy have typically had additional specialized training. In a
2002 position statement based on an extensive literature review,2 the Florida Academy of Pain
Medicine stated, RIT [regenerative injection therapy, another term for prolotherapy] is a safe and
effective treatment modality that is very useful in a significant number of pain syndromes arising
from ligament and tendon diathesis, as well as other clearly delineated pain problems. Physicians
who use RIT must be knowledgeable in clinical anatomy and function and should be properly
trained in this technique via a combination of seminar/workshops, apprenticeships or visiting
fellowships in order to safely and effectively utilize this treatment.
What are the risks of prolotherapy?
In the nearly five decades since prolotherapy was first introduced, with millions of treatments
having been given, no serious adverse effects of the procedure itself have been reported in the
medical literature. In one case, reported in the Journal of the American Medical Association in
1959, a patient died following a neurosurgical operation that was performed 4 months after a
prolotherapy treatment, but the prolotherapy was not related to the death.3 Three cases of minor
adverse effects were reported in the Journal of Neurosurgery in 1961,4 but all three cases were
related to injection of an inappropriate solution as a result of improper or no training.
Despite the relative safety of the procedure, as evidenced by the paucity of literature on adverse
events, patients must be carefully selected on the basis of their medical history and patterns of
referred pain, as well as the results of physical examination and laboratory evaluation.
Furthermore, every practitioner of prolotherapy must be a student of anatomy and must
appreciate it in three dimensions. Careful palpation and attention to the patients input during
injection are critical to avoiding injury to a vital structure.
Although injection of an inflammatory substance into a ligament or tendon carries minimal risk,
both practitioner and patient should be aware of certain risks resulting from needle-related trauma
and inadvertent needle placement. Common adverse effects related to needle placement that
may occur at the treatment site include pain, stiffness, bleeding, bruising and swelling. Less
common adverse events related to needle trauma include injury to a nerve, ligament or tendon;
spinal headache; pneumothorax; injury to the spinal cord or a vertebral disk; and infection. As for
all spinal injections, needle trauma from prolotherapy injections into the spine carries serious
risks, including risk of injury to the spinal cord and even death, although these are extremely rare.
Allergic and anaphylactic reactions to the agents injected may also occur.
The most recent review of adverse events related to prolotherapy for neck and back pain was a
survey of practitioners published in 2006.5 Consistent with earlier reviews of this treatment, the
authors of this survey study concluded that adverse events are similar in nature to those
occurring with needle trauma from other widely used spinal injection procedures. More
specifically, of 350,000 patient treatments accounted for by the survey respondents, a total of 452
(< 1%) were associated with adverse effects: spinal headache (n = 164), pneumothorax (n =
123), temporary systemic reactions (n = 73), nerve damage (n = 54), hemorrhage (n = 27),
nonsevere spinal cord insult (n = 9) and disk injury (n = 2).

Robert Banner, MD, CCFP, FCFP, FRCP, IFMCP, Dip AAPM,

Dip CAPM, ABIHM, COT, CPT
620 Richmond Street, Unit I
London ON N6A 5J9
Telephone: 519-850-6575
Fax: 519-850-6583
E-mail: drbanner@bellnet.ca
Website: www.drrobertbanner.com

25

References
1. Rabago D, Slattengren A, Zgierska A. Prolotherapy in primary care practice. Prim Care
2010;37(1):65-80.
2. Florida Academy of Pain Medicine. Regenerative injection therapy (RIT): effectiveness and
appropriate usage. Pain Clin Mag 2002;4(3):38-45. Available from: http://fapmmed.net/Position.htm
3. Schneider RC, Williams JJ, Liss L. Fatality after injection of sclerosing agent to precipitate
fibro-osseous proliferation. JAMA 1959;170(15):1768-72.
4. Hunt WE, Baird WC. Complications following injection of sclerosing agent to precipitate fibroosseous proliferation. J Neurosurg 1961;18:461-5.
5. Dagenais S, Ogunseitan O, Haldeman S, Wooley JR, Newcomb RL. Side effects and
adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for
back and neck pain: a survey of practitioners. Arch Phys Med Rehabil 2006;87(7):909-13.
Additional resources
Alderman D. Free yourself from chronic pain and sports injuries. Glendale (CA): Family Doctor
Press; 2008. Ordering information: www.familydoctorpress.com
Hauser RA, Maddela HS, Alderman D, et al. Journal of Prolotherapy International Medical
Editorial Board consensus statement on the use of prolotherapy for musculoskeletal pain. J
Prolother 2011;3(4):744-64.
Ravin TH, Cantieri MS, Pasquarello GJ. Principles of prolotherapy. Denver (CO): Self-published;
2008. Ordering information: www.principlesofprolotherapy.com

International organizations and other resources for prolotherapy

American Academy of Musculo-Skeletal Medicine (AAMSM)
45 S Dahlia Street
Denver CO 80246
Telephone: 303-270-9191
Website: www.aamsm.com
American Academy of Osteopathy (AAO)
3500 DePauw Boulevard, Suite 1080
Indianapolis IN 46268
Telephone: 317-879-1881
Fax: 317-879-0563
Website: www.academyofosteopathy.org
American Association of Orthopaedic Medicine (AAOM)
600 Pembrook Drive
Woodland Park CO 80863
Telephone: 888-687-1920
Fax: 719-687-5184
Website: www.aaomed.org
American Osteopathic Association of Prolotherapy Integrative Pain Management
(AOAPIPM) (formerly College of Sclerotherapeutic Pain Management)
303 S Ingram Court
Middletown DE 19709
Telephone: 302-376-8080
Toll-free: 800-471-6114
Fax: 302-376-8081
Website: www.acopms.com

26

Canadian Association of Orthopaedic Medicine (CAOM)

E-mail: caom@rogers.com
Website: http://caom.ca/
Florida Academy of Pain Management
PO Box 13489
St. Petersburg FL 33733
Telephone: 727-581-4319
Fax: 727-581-8537
Website: www.fapmmed.net
GetProlo.com (list of US doctors practising prolotherapy)
Beulah Land Corporation
715 Lake Street, Suite 600
Oak Park IL 60301
Telephone: 708-848-5011
Fax: 708-848-8053
Website: www.getprolo.com
Hackett Hemwall Foundation
2532 Balden Street
Madison WI 53713
Website: www.HackettHemwall.org

27

Safety considerations in the practice of environmental medicine

What is environmental medicine?
Environmental medicine addresses the effects of environmental factors on individuals, within the
context of clinical practice. As such, it contrasts with the realm of public health, which focuses on
the well-being of populations. Public health practitioners use statistical analyses to assess risks
and then develop environmental and other policies to prevent or treat disease. Indeed,
governments have regulated water, air and food quality for much longer than they have been
involved in modern health care.
However, even with modern policies, some individuals become sick as a result of their
environment. They may fall outside the norms used to establish standards (e.g., if indoor air
quality should be acceptable to 80% of those entering a room, it may be unacceptable for the
remaining 20%) or for toxicant risk assessments, they may experience exposures that exceed
acceptable risks (e.g., in cases of spills or accidents, in the workplace or in military situations),
or they may live in unhealthy circumstances not subject to regulations.
Some people are particularly vulnerable to these factors as a result of genetics, nutrition,
infections, toxic exposures, life history or other circumstances, and may spiral into poor health.
Environmental medicine addresses these root causes of chronic disease, recognizing that some
individuals have a lower capacity to deal with environmental stresses.
Physicians practising environmental medicine invest a great deal of time and effort familiarizing
themselves with the intricacies of both the diagnosis and the treatment of environmental illnesses.
Very little training for this type of work is provided in standard medical education, so this
knowledge must be acquired directly from the research literature, professional organizations and
continuing education concentrating on environmental medicine.
Why is environmental medicine important?
The effects of the environment on human health may be subtle, recognized by neither the patient
nor the patients physician. Nevertheless, many diseases of industrial countries are increasing in
prevalence at rates greatly outpacing genetic changes, and research implicates complex
causation from environmental intolerances and toxicant exposures. The following are just a few
examples:
x The prevalence of autism has grown exponentially. In the mid-1980s, the frequency was 1 in
2500; by the mid-1990s, it had risen to 1 in 300 and by 2006, to 1 in 110.1 In 2008, the
frequency in the United States was 1 in every 54 boys and 1 in every 252 girls.2
x Drugs prescribed for depression increased three-fold between 1995 and 2007.3
x The incidence of rheumatoid arthritis in women rose 2.5% between 1997 and 2005, whereas
in men it declined slightly, by 0.5%.4
x Fibromyalgia and chronic fatigue syndrome now affect 5% of the Canadian population. This
rate approaches the prevalence of diabetes, which affects 6.8%.5
How is environmental medicine practised?
Diagnosis is a primary challenge in environmental medicine. Not only must occult environmental
stresses (known as incitants) be uncovered, but also the individuals ability to tolerate, metabolize
and excrete toxicants must be evaluated. Central to environmental medicine is the need to
minimize the total load of incitants.
Environmental illness is usually multifactorial, so many physiological, biochemical and
immunological processes must be assessed. This assessment requires time-consuming and
meticulous history-taking, careful physical examination, and extensive laboratory and other
testing. As a result, it is not unusual to spend 90 minutes to 2 hours on a patients first encounter.

28

Safety considerations in diagnosis

A criticism often levelled at contemporary practitioners of complementary medicine is that patients
risk having serious conditions misdiagnosed by nonstandard examinations. Misdiagnosis may
involve missing a condition or the cause of a symptom; alternatively, it may involve attributing
symptoms to, and acting on the basis of, an incorrect causal factor.
A missed diagnosis is of course possible in any field of medicine, but in environmental medicine,
this risk is very low. In fact, patients frequently seek care from an environmental physician
following various unfruitful investigations by other physicians. Regardless, in environmental
medicine, the search to understand a patients problems always includes standard investigations
for more common diagnoses, in a process called diagnosis of initial exclusion. At the same time,
basic scientific methods are applied, such as testing levels of particular nutrients (e.g., zinc,
magnesium and selenium). Repletion of essential nutrients is an essential first step so that
patients basic metabolic pathways function properly, to help them to recover.
The environmental physician usually carries diagnostic investigations further and may use testing
methods additional to the minimum standard of care in conventional medicine. For example,
individual sensitivities, to food and to substances in the environment, are commonly encountered.
Standard scratch testing for allergies involves testing multiple items at one time, an approach that
can leave the patient very ill and that has no inherent therapeutic value. A physician practising
environmental medicine may perform what is known as provocation/neutralization or PN skin
testing in the office. PN testing involves investigating one substance at a time, using individual
antigens. When a reaction occurs, the response can be neutralized with sequential application of
dilutions of the same substance, before the next antigen is tested.
Testing for food allergies may be done by simple elimination and reintroduction, possibly guided
by blood testing for immunoglobulins E and G (IgE and IgG). Another method for discovering food
intolerances is the use of immunoglobulin A (IgA) stool testing.
Safety considerations in treatment
Very few risks are associated with treating environmental illnesses, because the first principle of
treatment is removal of the environmental incitant from the patient or removal of the patient from
the unhealthy environment. For example, if toxic mould is found in the home or workplace,
elimination or avoidance of the toxin takes precedence in the treatment plan.
Nutritional support
Nutritional support is often required as part of the treatment for environmental illnesses. When
nutrient supplementation is given orally, the risks are extremely low; however, in some patients,
intestinal absorption of nutrients is so poor that intravenous (IV) supplementation is required. IV
nutrient therapy results in much higher intra- and extra-cellular concentrations of nutrients than
any dose of oral supplementation. As well, IV nutrients bypass the gastrointestinal tract and the
first pass of the liver, making IV administration more effective than oral supplementation to meet
the patients nutritional needs.
The physician must be alert to certain contraindications to IV nutrient supplementation, including
allergies to nutrients such as yeast-derived B vitamins and organic selenium. For patients who
are environmentally hypersensitive, nutrient therapy is best started slowly, with low doses of
vitamins, and gradually increased. If appropriate, allergy testing can be performed and the patient
desensitized if any allergies are found.
A variety of vitamins and minerals can be given intravenously. IV nutrient solutions are made safe
by balancing the pH and making them isotonic. In addition to being isotonic, IV solutions must be
preservative-free and are therefore usually prepared by compounding pharmacies. No case of
anaphylaxis has been reported in association with IV nutrient supplementation. Nonetheless,
such a reaction is theoretically possible, and physicians administering this form of therapy must
be equipped with proper resuscitation equipment.

29

Other reactions are possible with IV nutrients, so administration is tailored to minimize risks.
Patients with allergy to nickel may have a local reaction to the butterfly needle (which contains
this metal). Some patients will react to the chemicals in PVC (polyvinylchloride) tubing, so it is
important to use PVC-free supplies, if available, and to minimize the amount of plastic used.
Sauna therapy
For a patient who is affected by toxins such as mould, metals or other chemicals, excretion of the
toxins may be increased with infrared sauna therapy. To ensure safety for a weakened patient,
the therapy is started slowly with regular monitoring by a physician, and the duration and
frequency of sessions, as well as the temperature, are increased at the patients own pace. The
patient receives nutrients and organic (alkaline) salts before and after each sauna session, and
drinks plenty of fluids during the sessions.
Chelation therapy
When removal of the environmental source, dietary supplementation and sauna are not sufficient
to ease symptoms of toxic metals in the body, oral or IV chelation is another option. This therapy
is paced such that the metal is excreted efficiently, rather than being redistributed elsewhere in
the body. See the article on intravenous chelation therapy for further information.
Treatment of infection
A patient with an underlying infection will not respond as expected to good environmental
practices, such as ensuring availability of clean air, clean water and healthy food and enhancing
the excretion of toxins. A broad array of symptoms may be associated with chronic infections,
including joint inflammation, skin rashes, chronic fatigue, chronic pain, neurological symptoms
and signs, mood disorders and cognitive dysfunction.
Bacteria commonly encountered by environmental doctors include C. pneumoniae, Mycoplasma
spp., Bartonella spp. and Borrelia spp. These organisms generally grow slowly, causing occult
infections, and over time may invade less accessible tissues such as joints and the central
nervous system. Many protocols have been created to treat chronic occult infections. These
protocols typically involve two antibiotics, administered orally, and so far no antibiotic resistance
has been documented. This may be because patients who are recovering while on antibiotics are
developing a stronger immune system that controls potentially transmissible infections.
Antibiotic therapy may trigger yeast over-growth, so some patients may initially require an
adjunctive antifungal agent. Typically the antifungal can be discontinued after a short time, as the
immune system becomes stronger with eradication of the chronic infection.
One potential side effect of long-term antibiotic therapy (several months to a year) is the
development of antibiotic resistance in communicable microorganisms. To prevent this problem,
the antibiotic regimen is modified from time to time. As well, it is sometimes necessary to treat
two or more infections, which can further complicate the treatment regimen.
During treatment of infections, it is important for the patient to minimize his/her total load, as is
standard in environmental medicine. Supporting the patient in this way helps to minimize the
duration of antibiotic treatment, to maximize the efficacy of treatment and ultimately to optimize
safety.
The theory of environmental medicine is to do no harm and to use as few medicines as possible.
Practising these principles means the patient has the opportunity, through lifestyle changes and
detoxification, the use of nutrients and the avoidance of allergenic and toxic materials, to live a
happier, stronger and perhaps even longer and healthier life. Often what occurs is that as patients
are recovering, they get better as they get older. Governments are now looking at these
principles as a way to ensure the health of aging populations.

30

Jennifer Armstrong, BSc, MD, DIBEM, FAAEM

Ottawa Environmental Health Clinic
3364 Carling Avenue
Ottawa ON K2H 5A8
E-mail: dr@oehc.ca
Website: www.oehc.ca
Acknowledgement: The author thanks Meg Sears, MEng, PhD, for valuable assistance in
preparing this material.
References
1. Yeargin-Allsopp M, Rice C, Karapurkar T, Doernberg N, Boyle C, Murphy C. Prevalence of
autism in a US metropolitan area. JAMA 2003;289(1):49-55.
2. Community report from the Autism and Developmental Disabilities Monitoring (ADDM)
Network. Prevalence of autism spectrum disorders (ASDs) among multiple areas of the
United States in 2008. Atlanta (GA): Centers for Disease Control and Prevention; 2012 [cited
3.
4.
5.

2013 Aug 22]. Available from: www.cdc.gov/ncbddd/autism/documents/addm-2012-communityreport.pdf.

Lockhart P, Guthrie B. Trends in primary care antidepressant prescribing 19952007: a

longitudinal population database analysis. Br J Gen Pract 2011;13:e565-e572.
Arthritis: rheumatoid arthritis. Atlanta (GA): Centers for Disease Control and Prevention;
2012 [cited 2014 Jan 15]. Available from: www.cdc.gov/arthritis/basics/rheumatoid.htm
Park J, Knudson S. Medically unexplained physical symptoms. Health Rep 2007;18(1):43-7.
Also available from: http://statcan.gc.ca/pub/82-003-x/2006001/article/sympt/82-003-x2006002eng.pdf

Additional resources
American Academy of Environmental Medicine. A US-based organization with international
membership that offers CME-accredited courses (online and face-to-face learning). Website:
www.aaemonline.org
Barron SR, Russell P. Survey of the medical impact on environmentally hypersensitive people of
a change in habitat. Ottawa (ON): Canada Mortgage and Housing Corporation; 1990.
Available from: http://publications.gc.ca/collections/collection_2011/schl-cmhc/nh18-1/NH181-194-1990-eng.pdf
Environmental Health Clinic, Toronto, Ontario. A multidisciplinary clinic established in 1996 as a
provincial resource in promoting environmental health and to improve health care for people
with environment-linked conditions. Part of a joint clinical and research program of Womens
College
Hospital
and
the
University
of
Toronto.
Website:
www.womenscollegehospital.ca/programs-and-services/environmental-health-clinic469/
Integrated Chronic Care Services (formerly the Nova Scotia Environmental Health Centre),
Halifax, Nova Scotia. Treatment facility within Capital Health for environmental sensitivities
and complex chronic conditions. Website: www.cdha.nshealth.ca/integrated-chronic-careservice-iccs
Kimata H. Effect of exposure to volatile organic compounds on plasma levels of neuropeptides,
nerve growth factor and histamine in patients with self-reported multiple chemical sensitivity.
Int J Hyg Environ Health 2004;207(2):159-63.
McKeown-Eyssen G, Baines C, Cole DE, Riley N, Tyndale RF, Marshall L, et al. Case-control
study of genotypes in multiple chemical sensitivity: CYP2D6, NAT1, NAT2, PON1, PON2
and MTHFR. Int J Epidemiol 2004;33(5):971-8.
Research house for the environmentally hypersensitive: description and technical details. Ottawa
(ON): Canada Mortgage and Housing Corporation; 1994. Available from: www.cmhcschl.gc.ca/en/inpr/bude/heho/upload/Research-House-for-the-EnvironmentallyHypersensitive.pdf
Sears M. The medical perspective on environmental sensitivities. Ottawa (ON): Canadian Human
Rights Commission; 2007. Available from:www.chrccdp.ca/sites/default/files/envsensitivity_en.pdf

31

Safety considerations in the practice of intravenous chelation therapy

What is chelation therapy?
The word chelation is derived from chele, the Greek word for claw. This term describes the way in
which chelation agents bind to metal cations, thereby allowing their elimination from the body.
The medical use of chelation therapy was pioneered in Germany in the 1930s, when EDTA
(ethylenediaminetetra-acetic acid) was administered intravenously to shipyard workers with lead
poisoning. In addition to EDTA, two other chelators are in modern use. DMPS (2,3dimercaptopropane-1-sulfonic acid) can be given by the oral, transdermal, intravenous and
intramuscular routes, and DMSA (2,3-dimercaptosuccinic acid) is given orally. Older chelators,
including penicillamine and British anti-lewisite (2,3-dimercaptopropanol), are rarely used for
medical purposes.
In the 1950s, US physicians reported that patients with angina had significant improvement in
their cardiovascular symptoms following intravenous EDTA treatment.1 This observation led to
widespread use of EDTA chelation therapy in patients with cardiovascular problems, until the
advent of cardiovascular surgery in the 1970s. Thereafter, a smaller number of physicians
continued to administer this agent intravenously to patients with cardiovascular risk factors and
overt cardiovascular disease.
Chelation therapy is also used to treat heavy metal toxicity, which is usually identified on the
basis of elevated levels of the metal in urine after a single challenge dose of a chelating agent.
Chelators differ in their affinity for specific metals, so use of such agents can be tailored to the
individual patients metal burden.
There is good evidence that EDTA chelation therapy can slow the progression of chronic renal
insufficiency.2 Although clinical practice guidelines do not yet recommend its use for this
indication, its long-term safety and efficacy have been demonstrated in randomized controlled
trials.2 Preventing the need for dialysis may have an enormous impact on the health care system,
and large-scale clinical trials should be considered.
Chelation therapy is also used as an adjunct in the treatment of a wide range of other conditions,
on the basis of growing evidence that heavy metals promote the progression of many diseases.
For example, the total body burden of cadmium is associated with osteoporosis, renal failure,
several cancers and all-cause mortality.3 Low-level lead toxicity is associated with hypertension,4
cataracts,5 decreased IQ in children,6 and cardiovascular and all-cause mortality.7 Mercury is
associated with infertility,8 lichen planus,9 cardiovascular disease and all-cause mortality,10 as
well as a wide range of neuropsychiatric symptoms in children11 and adults.12
Chelation therapy is sometimes used to treat metal allergy, a common and underdiagnosed
potential cause of chronic health symptoms.13 The health risks of aluminum, arsenic, nickel and
other metals have not been well established, but physicians and patients may opt to remove
them, with the patients informed consent, according to the precautionary principle.
What are the risks of chelation therapy?
Modern protocols for the safe and effective use of chelation therapy have been developed by the
American College for Advancement in Medicine, which conducts accredited continuing medical
education courses and an examination leading to certification in chelation therapy. Physicians are
advised to obtain this certification before performing chelation therapy and to follow the
standardized protocols whenever possible. When properly administered, risks and adverse
effects, as summarized below, are minor and uncommon.

32

Renal failure
The early use of EDTA chelation therapy involved large doses infused at rapid rates, and acute
renal failure was a common complication. Modern protocols do not lead to renal failure, as
revealed by the Trial to Assess Chelation Therapy (TACT), in which over 70,000 infusions were
administered with no cases of renal failure.14
Serum creatinine should be monitored regularly, at the physicians discretion, according to the
patients baseline renal function. A significant (i.e., > 10%) increase from baseline should lead to
discontinuation of treatment for at least two weeks or until serum creatinine levels return to
normal, at which point treatment can be resumed.
Pre-existing moderate to severe renal failure is a relative contraindication to chelation therapy.
The treatment may be beneficial in cases where metal toxicity is suspected to have contributed to
renal failure, but the dose and infusion rates should be adjusted and serum creatinine should be
monitored more closely.
Hypocalcemia
Magnesium EDTA induces a transient drop in serum calcium levels, which is one of its proposed
mechanisms of action. Therefore, if the agent is infused too rapidly, symptomatic hypocalcemia
may result. To avoid this risk, physicians should adhere to the standardized infusion protocols
(with maximum infusion rate 20 mg/min). In addition, calcium gluconate should be readily
available for intravenous administration as needed.
Allergy
Hypersensitivity reactions to DMPS have been reported. These have usually been limited to skin
reactions, but serious allergic reactions have also been reported, if only rarely.15 A test dose of
any chelating agent should be administered before initial use, and the patient should be observed
for 15 minutes before the full dose is administered.
Fluid overload
Chelation agents are usually administered in or with infusions of saline or another crystalloid
solution. For patients with severe congestive heart failure, large volumes or rapid infusions may
lead to exacerbation or pulmonary edema. These effects are strictly due to the fluid volume
administered and are unrelated to the chelation agents themselves. Nonetheless, physicians
should exercise caution when treating patients who are at risk.
Infection
Thrombophlebitis or cellulitis may occur at the venipuncture site. The risk is minimal when routine
precautions for venipuncture are taken.
Pain
Discomfort may occur during the infusion and can be treated symptomatically by adjusting the
position of the catheter, applying warm or cold packs, or applying a topical local anesthetic to the
affected area. Persistent pain is uncommon, but if it does occur it can be treated by injection of
local anesthetic, acupuncture, neural therapy or other modalities with which the physician is
familiar.
Richard Nahas, MD, CCFP, ABIHM
Assistant Professor, Department of Family Medicine, University of Ottawa
Undergraduate curriculum content expert, Faculty of Medicine, University of Ottawa
Chief of Staff, Seekers Centre for Integrative Medicine
942 Merivale Road
Ottawa ON K1Z 5Z9
Telephone: 613-727-7246
E-mail: richard@seekerscentre.com

33

References
1. Clarke CN, Clarke NE, Mosher RE. Treatment of angina pectoris with disodium ethylene
diamine tetraacetic acid. Am J Med Sci 1956;232(6):654-66.
2. Lin JL, Lin-Tan DT, Hus KH, Yu CC. Environmental lead exposure and progression of
chronic renal diseases in patients without diabetes. N Engl J Med 2003;348(4):277-86.
3. Nawrot TS, Staessen JA, Roels HA, Munters E, Cuypers A, Richart T, et al. Cadmium
exposure in the population: from health risks to strategies of prevention. Biometals
2010;23(5):769-82.
4. Nash D, Magder L, Lustberg M, Sherwin RW, Rubin RJ, Kaufmann RB, et al. Blood lead,
blood pressure, and hypertension in perimenopausal and postmenopausal women. JAMA
2003;289(12):1523-32.
5. Schaumberg DA, Medes F, Balaram M, Dana MR, Sparrow D, Hu H. Accumulated lead
exposure and risk of age-related cataract in men. JAMA 2004;292(22):2750-4.
6. Canfield RL, Henderson CR Jr, Cory-Slechta DA, Cox C, Jusko TA, Lamphear BP.
Intellectual impairment in children with blood lead concentrations below 10 microg per
deciliter. N Engl J Med 2003;348(16):1517-26.
7. Menke A, Muntner P, Batuman V, Silbergeld EK, Guallar E. Blood lead below 0.48
micromol/L (10 microg/dL) and mortality among US adults. Circulation 2006;114(13):138894.
8. Gerhard I, Waibel S, Daniel V, Runnebaum B. Impact of heavy metals on hormonal and
immunological factors in women with repeated miscarriages. Hum Reprod Update
1998;4(3):301-9.
9. Laeijendecker R, Dekker SK, Burger PM, Mulder PG, Van Joost T, Neumann MH. Oral
lichen planus and allergy to dental amalgam restorations. Arch Dermatol 2004;140(12):14348.
10. Virtanen JK, Voutilainen S, Rissanen TH, Mursu J, Tuomainen TP, Korhonen MJ, et al.
Mercury, fish oils, and risk of acute coronary events and cardiovascular disease, coronary
heart disease, and all-cause mortality in men in eastern Finland. Arterioscler Thromb Vasc
Biol 2005;25(1):228-33.
11. Davidson PW, Myers GJ, Weiss B. Mercury exposure and child development outcomes.
Pediatrics 2004;113(4 Suppl):1023-9.
12. Ritchie KA, Gilmour WH, Macdonald EB, Burke FJ, McGowan DA, Dale IM, et al. Health and
neuropsychological functioning of dentists exposed to mercury. Occup Environ Med
2002;59(5):287-93.
13. Kanerva L, Rantanen T, Aalto-Korte K, Estlander T, Hannuksela M, Harvima RJ, et al. A
multicenter study of patch test reactions with dental screening series. Am J Contact
Dermatol 2001;12(2):83-7.
14. Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, et al.; TACT Investigators.
Effect of disodium EDTA chelation regimen on cardiovascular events in patients with
previous myocardial infarction: the TACT randomized trial. JAMA 2013;309(12):1241-50.
15. Storim J, Stoevesandt J, Anders D, Kneitz H, Brcker EB, Trautmann A. [Dithiols as
chelators. A cause of bullous skin reactions]. Hautarzt 2011;62(3):215-8. In German.

34

Safety considerations in bio-identical hormone replacement therapy

What is hormone replacement therapy?
Supplementation of the bodys existing hormones is a vast and controversial topic. This article
touches on only some of the safety issues related to this form of therapy. For more information,
readers are encouraged to consult the resources listed at the end of the article.
Hormones are important for many biochemical activities in the human body. However, the
synthesis and release of these compounds declines with age, resulting in the development of
various symptoms and illnesses. The most widely recognized hormone deficiencies in both
sexes are those due to imbalances of cortisol (a condition known as adrenopause or adrenal
fatigue), thyroid hormones, estrogen and progesterone (menopause in women), and testosterone
(andropause in men). The term bio-identical hormones refers to hormones that are molecularly
the same as those produced in the human body, but synthesized from plants (specifically, yams).
As such, although bio-identical hormones are natural compounds, they are not native to the
human body.
Good nutrition and adequate exercise are vital for the production and maintenance of all
hormones. For example, the following nutrients are essential for hormone production and activity:
vitamins A, C, D, E, B1, B5, B6, B12 and folate; all the antioxidants; the minerals selenium, zinc and
iodine; and various amino acids, such as tyrosine. Conversely, some factors negatively affect
hormone production, including stress, trauma, low calorie intake, inflammation, infection, radiation,
certain medications, liver and/or kidney dysfunction, exposure to toxins (pesticides, mercury,
cadmium, arsenic and lead) and autoimmune diseases, such as celiac disease. In cases of
suspected hormonal imbalance, all of these factors must be considered and addressed before
consideration of hormone replacement therapy. Hormone therapy should be used only as a last
resort and only when appropriate for relief of symptoms, improvement of quality of life and
improvement in overall health.
What are the steps involved in bio-identical hormone replacement therapy?
Bio-identical hormone replacement therapy (BHRT) is commonly assumed to consist solely of
replacement of estrogen and progesterone in postmenopausal women. In fact, BHRT entails a
systematic approach to identifying and addressing glandular dysfunction, beginning with an
assessment of adrenal function. The adrenal glands are often thought of as the source of cortisol
and dehydroepiandrosterone (DHEA), nothing more. In reality, the adrenal glands secrete 53
different hormones and, in women, they assume the production of sex hormones as the ovaries
begin to fail with age. Therefore, when addressing cases of apparent hormonal imbalance, the
adrenal glands must be assessed and treated first; then, normal thyroid function must be
established. In fact, the adrenals and the thyroid work in tandem, as normal cortisol levels are
required for conversion of T4 (thyroxine) to T3 (tri-iodothyronine), the most active thyroid
hormone. Yet dysfunction of these glands is widespread. By the same token, many systemic
symptoms will improve with correction of adrenal and thyroid function. Once these two hormonesecreting glands have been optimized, production and function of the sex hormones can be
addressed, if necessary.
Estriol, the predominant component for estrogen supplementation in BHRT therapy, acts to block
the potent effects of estradiol on breast tissue growth and possible cancer promotion. BHRT
uses this weak estrogen as part of the overall strategy to reduce breast cancer risk.1(p. 122) In the
1970s, Lemon, a US gynecology professor, became well known for his extensive clinical and
basic research on the protective actions of estriol in breast cancer.2 He was an active proponent
of estriol for BHRT and breast cancer protection. More recently, Paoletti has summarized
numerous studies showing a reduced risk of breast cancer with estriol use.3 As a result of this
work, estriol is preferred over tamoxifen in Europe for the treatment of breast cancer survivors.

35

An important aspect of BHRT is the customization of therapy for each individual patient,
according to the persons specific needs, as determined with the aid of appropriate monitoring by
laboratory testing. Without such monitoring, treatment may be continued even if the patient is not
experiencing any benefit. In addition, there is the potential for harm caused by overstimulation of
hormone receptors, as well as systemic adverse effects caused by hormonal overload. In this
regard, the primary concern is stimulation of hormonally dependent cancers.
What are the risks of bio-identical hormone replacement therapy?
Few researchers have compared and contrasted the use of synthetic hormones with the use of
bio-identical compounds, and many studies of hormone replacement therapy do not state
whether the products used were synthetic or bio-identical. This is an important distinction, given
that, in those studies that have properly identified the compounds used, the synthetic forms have
always been associated with adverse effects. For example, in one long-term study that followed
more than 80,000 postmenopausal women in France for 8 years, the risk of breast cancer
increased by 70% among women using the synthetic hormone, whereas the risk did not increase
among those using bio-identical progesterone.4 Similar numbers were found in another study of
54,000 postmenopausal women in France.5
A smaller study (involving 150 women between 30 and 70 years of age)6 compared the risk of
heart disease between BHRT and conventional synthetic hormone replacement therapy
(combined with additional drugs) to control symptoms such as pain, depression and high blood
sugar. After 12 months, the women receiving BHRT had a lower risk of heart disease, with
healthy blood pressure, blood glucose and triglycerides and greater relief of depression, anxiety
and pain. Unlike synthetic hormone replacement therapy, BHRT did not increase blood clots or
inflammation.
How can the risks of using compounded bio-identical hormones be minimized?
The compounding of customized bio-identical hormones is a potential source of risk if unsafe
processes or ingredients are used. However, reputable compounders employ appropriately
qualified, well-trained pharmacists and use high-quality ingredients. The Professional
Compounding Centers of America (PCCA) is an international organization that supports the
provision of high-quality compounding services by individual pharmacies. Established in 1981 and
currently headquartered in Houston, Texas (with the Canadian arm based in London, Ontario;
www.pccarx.ca), the PCCA represents more than 3,500 pharmacists in Canada, the United
States, Australia, Europe and New Zealand. These pharmacists must adhere to particular
standards set by the PCCA in the delivery of compounded prescription products to their patients.
The PCCAs quality control department is devoted to assuring the quality of all chemicals
received, repackaged and sold to participating pharmacists, who then use these chemicals to
prepare prescriptions for patients. Quality control steps include obtaining a certificate of analysis
for all chemicals received, verifying the identity of every bulk chemical received both before and
after repackaging, conducting regular tests of all chemicals in inventory and verifying all unique
identifier numbers before shipping. The PCCA also supports its members through education,
offering hands-on primary and aseptic compounding courses, as well as continuing education
programs, seminars and symposiums for both pharmacists and physicians.
Recently, the US Centers for Disease Control and Prevention has been reporting on an outbreak
of fungal infections among patients who used a preservative-free steroid preparation for injection
that was compounded by a single pharmacy in New England.7 In Ontario in 2013, underdosing of
chemotherapy preparations was identified in four hospitals, all of which had obtained the products
from a single compounding vendor.8 Such events are worrisome and may affect the decision to
use BHRT. Reassurance comes from the widespread application of current PCCA standards, as
well as regulatory bodies. For example, the Ontario College of Pharmacists accredits and
inspects all community pharmacies in Ontario, including those that offer compounding services.
The Ontario government has worked with the Ontario College of Pharmacists to introduce a new
regulation expanding the colleges mandate to oversee pharmacists and pharmacy technicians.
The provincial government also wrote to drug preparation facilities, requiring them to declare their

36

regulatory framework, their accreditation and their quality assurance practices. Because the
safety of compounding is a national issue, Health Canada has put in place a new policy requiring
drug facilities to be regulated under the federal Food and Drugs Act and to operate under the
supervision of a provincially licensed pharmacist, either in the community or in a hospital.
Beyond these regulatory steps, practitioners recognize that it is never good enough to rely on
symptoms alone to determine if the course of therapy is working as it should. Therefore, BHRT
involves the use of appropriate testing before and during treatment to ensure that the route of
administration is providing safe and effective normalization of hormone levels: neither too low nor
too high, with no inappropriate metabolism of the bio-identical hormones.
Conclusion
BHRT, using molecularly identical products to those produced by the body, titrated to individual
requirements, is a safe approach to balancing cortisol, thyroid hormones, estrogen, progesterone
and testosterone. The goal is to restore optimal physiology and, at the same time, lessen
symptoms in a safe and natural way.
After analyzing the research literature comparing bio-identical and synthetic hormone therapy,
Holtorf concluded that, Based on both physiological results and clinical outcomes, current
evidence demonstrates that bioidentical hormones are associated with lower risks than their nonbioidentical counterparts. Until there is evidence to the contrary, current evidence dictates that
bioidentical hormones are the preferred method of [hormone replacement therapy].9
Robert Banner, MD, CCFP, FCFP, FRCP, IFMCP, Dip AAPM,
Dip CAPM, ABIHM, COT, CPT
620 Richmond Street, Unit I
London ON N6A 5J9
Telephone: 519-850-6575
Fax: 519-850-6583
E-mail: drbanner@bellnet.ca
Website: www.drrobertbanner.com
References
1. Brown R. Discovering your true balance with bioidentical hormones. Self-published; 2011.
2. Lemon HM. Estriol prevention of mammary carcinoma induced by 7,12dimethylbenzanthracene and procarbazine. Cancer Res 1975;35(5):1341-53.
3. Paoletti JE. The physiologic role and use of estriol. Int J Pharm Compounding
2009;13(4):270-5.
4. Rossouw JE. Implications of recent clinical trials of postmenopausal hormone therapy for
management of cardiovascular disease. Ann N Y Acad Sci 2006;1089:444-53.
5
Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al.;
Writing Group for the Womens Health Initiative Investigators. Risks and benefits of estrogen
plus progestin in healthy postmenopausal women: principal results from the Womens Health
Initiative randomized controlled trial. JAMA 2002;288(3):321-33.
6. Stephenson K, Kurdowska A, Neuenschwander P, Loewenstein I, Olusola
P, Pinson B,
et al. Transdermal estradiol and progesterone improve mood indicators, quality of life, and
biomarkers of cardiovascular disease in perimenopausal and postmenopausal women
[abstract P260]. Circulation 2007;115(8):e277.
7. Multistate fungal meningitis outbreak investigation: current situation. Atlanta (GA): US
Centers for Disease Control and Prevention; [updated 2013 Mar 5; cited 2014 Jan 2].
Available from: www.cdc.gov/hai/outbreaks/currentsituation/
8. Cancer drug supply. Toronto (ON):Ontario Ministry of Health and Long-Term Care; [updated 2014
9.

Oct 10; cited 2014 Jan 2]. Available from: www.health.gov.on.ca/en/public/programs/cancer/drugsupply/

Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and
progesterone) safer or more efficacious than commonly used synthetic versions in hormone
replacement therapy? Postgrad Med 2009;121(1):73-85.

37

Additional resources
Arem R. The thyroid solution: a revolutionary mind-body program for regaining your emotional
and physical health. New York (NY): Random House International; 2001.
Barnes BO, Barnes CW. Solved: the riddle of heart attacks. Fort Collins (CO): Fries
Communications; 1976.
Brownstein D. Overcoming thyroid disorders: a holistic approach to treating thyroid disorders
including hypothyroidism, Graves disease and Hashimotos disease. West Bloomfield (MI):
Medical Alternatives Press; 2002.
Diaminti-Kandarakis E, Bourguignon JP, Giudice LC, Hauser R, Prins GS, Soto AM, et al.
Endocrine-disrupting chemicals: an Endocrine Society scientific statement. Endocr Rev
2009;30(4):293-342.
Gray J, Evans N, Taylor B, Rizzo J, Walker M. State of the evidence: the connection between
breast cancer and the environment. Int J Occup Environ Health 2009;15(1):43-78.
Jefferies WM. Safe uses of cortisol. 3rd ed. Springfield (IL): Charles C Thomas; 2004.
Lee JR, Zava D, Hopkins V. What your doctor may not tell you about breast cancer: how
hormone balance can help save your life. Warner Books; 2002.
Manson JE, Hsia J, Johnson KC, Rossouw JE, Assaf AR, Lasser NL, et al.; Womens Health
Initiative Investigators. Estrogen plus progestin and the risk of coronary heart disease. N
Engl J Med 2003;349(6):523-34.
Morgentaler A. Testosterone for life: recharge your vitality, sex drive, muscle mass and overall
health. New York (NY): McGraw-Hill; 2009.
Rudel RA, Perovich LJ. Endocrine disrupting chemicals in indoor and outdoor air. Atmos Environ
2009;43(1):170-81.
Schwartz ET, Holtorf K. Hormones in wellness and disease prevention: common practices,
current state of the evidence, and questions for the future. Prim Care 2008;35(4):669-705.
Starr M. Hypothyroidism type 2: the epidemic. Irvine (CA): New Voice Publications; 2013.
Warshowsky A, Oumano E. Healing fibroids: a doctors guide to a natural cure. New York (NY):
Touchstone; 2002.
Wassertheil-Smoller S, Hendrix SL, Limacher M, Heiss G, Kooperberg C, Baird A, et al.; WHI
Investigators. Effect of estrogen plus progestin on stroke in postmenopausal women: the
Womens Health Initiative: a randomized trial. JAMA 2003;289(20):2673-84.
Wilson JL. Adrenal fatigue: the 21st century stress syndrome. Petaluma (CA): Smart Publications;
2001.
Wright JV, Lenard L. Stay young and sexy with bio-identical hormone replacement: the science
explained. 2nd ed. Petaluma (CA): Smart Publications; 2010.

38