Complementary and Alternative Health Care: The Other Mainstream?

Complementary and Alternative Health Care: The Other Mainstream?

Research shows that, over the past several years, more and more Canadians have been turning to complementary and alternative health care (CAHC) and natural health products (NHPs) to treat illness and promote health. Now, legislators and policy makers are facing some difficult questions about how to assure the safety and effectiveness of such products and practices, while not unnecessarily restricting consumer access. This in turn raises questions about what constitutes an acceptable level of evidence for safety and effectiveness.

This issue of the Health Policy Research Bulletin explores these and other questions by:

• defining CAHC and NHPs and exploring how they are positioned among the array of health services and products available to Canadians
• presenting key utilization data on CAHC and NHPs and examining how and why consumers are using them
• discussing the evidentiary challenges that governments face in balancing safety and effectiveness needs with concerns about consumer access and informed choice
• chronicling how Health Canada addressed these concerns in developing the new regulatory framework for NHPs, which comes into effect in January 2004

Finally, the authors question whether, by addressing these challenges, CAHC and NHPs will become more integrated with conventional health care or whether they will remain the "other mainstream."

Our mission is to help the people of Canada maintain and improve their health.

Health Canada

About the Health Policy Research Bulletin

Health Canada's Health Policy Research Bulletin is published three times a year. The Bulletin is part of a larger policy research dissemination program designed to enhance Health Canada's policy-relevant evidence base.

A departmental steering committee guides the development of the Bulletin. The committee is chaired by Cliff Halliwell, Director General of the Applied Research and Analysis Directorate (ARAD) of the Information, Analysis and Connectivity Branch. The Research Management and Dissemination Division (RMDD) within ARAD coordinates the Bulletin's development and production. RMDD would like to thank the steering committee members for their contributions, as well as Nancy Hamilton, Managing Editor, Jaylyn Wong, Assistant Editor, and Tiffany Thornton, Coordinator. Special thanks go to the Guest Editor of this issue, Philip Waddington, Director General of the Natural Health Products Directorate, Health Products and Food Branch.

We welcome your feedback and suggestions. Please forward your comments and any address changes to bulletininfo@hc-sc.gc.ca.

An electronic version of the bulletin is available.

Note: The information contained in this issue is accurate as of October 2003.

Health Policy Research Bulletin

The opinions expressed in these articles, including interpretation of the data, are those of the authors and are not to be taken as official statements of Health Canada.

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Some Commonly Used Terms

Complementary and alternative health care (CAHC);
complementary and alternative medicine (CAM): diagnosis, treatment and/or prevention that complements mainstream medicine by contributing to a common whole, by satisfying a demand not met by conventional approaches, or by diversifying the conceptual framework of medicine.¹ Some common CAHC practices include: chiropractic services, massage therapy and traditional Chinese medicine. While CAM is the term most often used internationally, CAHC recognizes the diversity of practice areas, including medicine, and is the term most commonly used by Health Canada in a policy context.

Health: a state of complete physical, social and mental well-being, and not merely the absence of disease or infirmity.²

Health care: refers to all services, products and activities used by individuals for the purpose of promoting, maintaining, monitoring or restoring health.³

Health promotion: the process of enabling people to increase control over and to improve their health.⁴

Holistic health: physical, mental, emotional and spiritual components of health, and their interrelationship.

Informed choice: the ability of individuals and groups to make choices about their health based on their understanding of the evidence, facts, benefits and risks related to the issue, product or behaviour.⁵

Natural health products (NHPs): NHPs include herbs, vitamins, minerals, essential fatty acids and homeopathics, etc.These products are used to prevent, diagnose or treat disease, restore or correct function, or maintain or promote health. NHPs may be derived from plants, animals or micro-organisms.⁶

Self care: the decisions and actions that individuals take in the interest of their own health.⁷

For More Information . . .

For more information on natural health products, the new Natural Health Product Regulations, or complementary and alternative health care, please go to the Natural Health Products Directorate (NHPD) website at: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/index_e.html or e-mail the NHPD at: NHPD_DPSN@hc-sc.gc.ca or call toll free 1-888-774-5555.

Alternative Practices and Products: A Survival Guide

Michael J. Smith and Joan E. Simpson, Natural Health Products Directorate, Health Products and Food Branch, Health Canada

Although many people are familiar with the terms "complementary and alternative health care" (CAHC) and "natural health products" (NHPs), they often mean different things to different people. The authors provide definitions for both terms and discuss how consumers' understanding and use of these products and practices have been key factors in the quest for "integrated health care."

Canadians are faced with a sometimes overwhelming choice of health care options. In addition to the many choices offered as part of conventional health care, they can also choose from among a range of CAHC therapies and NHPs. However, the choice is not always as simple as picking between option A - the conventional, or option B - the alternative. Increasingly, consumers are regarding CAHC and NHPs as useful tools in a comprehensive health care "toolbox" and are looking at ways to combine conventional and alternative therapies and products to achieve the best results.

What Is CAHC?

CAHC is an umbrella term used to describe numerous individual therapies and health care approaches (see page 2). As many as 4,000 different practice or discipline areas have been catalogued, including chiropractic, therapeutic massage, homeopathy and herbalism.¹ Until recently, CAHC was frequently defined as alternative to conventional health care. However, the definition of CAHC is evolving to better reflect Canadians' increasing use of these therapies, especially as complements - rather than alternatives - to conventional health care.²

CAHC therapies range in complexity from entire systems of medicine, such as Aboriginal healing and traditional Chinese medicine, to specific physical/spiritual/pharmacological interventions, such as reflexology, relaxation therapy and herbalism.³,⁴The majority of CAHC therapies do not follow the biomedical model of conventional health care; instead, they are often based on paradigms of health and healing that are considered "outside the norm" in developed countries.

Although CAHC encompasses a diverse range of therapies (see box on page 3), they share some common characteristics. For example, they:

• work in conjunction with the body's own self-healing mechanisms
• are "holistic"- i.e., treat the whole person
• involve the patient as an active participant
• focus on disease prevention and well-being

These characteristics are not exclusively the domain of CAHC.³ In fact, many CAHC therapies have more in common with conventional care than with other forms of CAHC. For example, massage therapy is more similar to physiotherapy than it is to homeopathy.

A Sampling of CAHC Therapies

Alexander technique
Aromatherapy
Ayurvedic medicine
Bach flower therapy
Craniosacral therapy
Iridology
Kanpo medicine
Reiki
Rolfing
Tibetan medicine

Natural Health Products

Natural health products (NHPs) is a general term (see page 2) used to describe a variety of products, such as herbal medicines, homeopathic remedies and nutritional supplements. NHPs should not be considered a subset of CAHC therapies, as there are some important distinctions between the two. For example, NHPs are generally self-selected by the consumer, while practitioners typically play a key role in the use of CAHC therapies. Moreover, NHPs - like other health care products - are regulated by the federal government, while primary responsibility for CAHC - as for other health care services - rests with the provinces and territories.

Continuum of Product and Practice

It is useful to consider CAHC and NHPs on a continuum that positions specific products and practices in relation to each other, as well as to those in conventional care. For example, a product continuum could go from drugs to NHPs to food. In constructing such a continuum or situating a specific product or practice along it, a number of factors should be considered, including:

• the potency of the pharmacological/therapeutic action
• the nature of the evidence base
• the degree of regulation
• the extent of cultural acceptance

Taking these factors into account, drugs are often placed at one end of the product continuum: their use is typically supported by rigorous scientific evidence; the products are of high quality; and access is generally restricted to mitigate any potential risk. Food products would fall at the opposite end of the continuum because they pose low health risks and there is little need for supporting evidence of their effectiveness. Food quality is assured through regulation and consumer guidance (provided through informative labelling), and products are widely available. Generally, NHPs fall between food and drugs on the product continuum. The continuum approach ensures that specific categories of products are not classified as superior to one another, but are measured against appropriate parameters and standards of evidence (see article on page 23).

Where a product or practice is placed on the continuum would vary from country to country. For example, reflexology is a relatively minor therapy in North America, but is a major practice in Scandinavian countries.⁵ Similarly, while the evidence base for homeopathy is the same the world over, the therapy enjoys a much higher profile in Britain than in North America because of its widespread acceptance by British medical practitioners.⁶ In some countries, certain types of CAHC or NHPs are considered a dominant healing practice, for example, traditional Chinese medicine in China and Ayurvedic medicine on the Indian subcontinent.⁷

While the concept of a continuum is informative, it is also useful to keep in mind basic definitions, which are often influenced by regulations. For example, if new evidence supports a specific health benefit of a particular food, it is not automatically classified as an NHP. This particular food might be closer to the middle of the continuum than some NHPs, but it would still be a food. In the same way, CAHC therapies that are supported by scientific evidence - for example, acupuncture to treat nausea⁸ or chiropractic services for uncomplicated acute low back pain⁹ - are not necessarily regarded as conventional care.

Integrative Health Care

Since many of the same people who are using CAHC therapies and NHPs are also using "mainstream" medicine, links need to be established between the two types of health care options. Consumers have identified this need and are the driving force behind the current move toward "integrative health care." Integrative care is more than using CAHC/NHPs and conventional care together. It is rooted in the belief that consumers should have the ability to make informed choices about all their health care options. This concept of integrative health care was explored at a recent workshop sponsored by Health Canada's Health Policy Research Program (see page 35).¹⁰

Fundamental to integrative care is the notion that there must be effective communication among all involved parties, including the patient, the conventional health care provider, the complementary health care provider and government. Enhancing communication is particularly important as consumers appear to be reluctant to discuss CAHC and NHPs with members of their conventional health care team. Until recently, it has fallen to consumers themselves to bridge the divide between alternative and conventional health care practitioners. However, as more and more people turn to alternative interventions to complement their conventional health care, practitioners from both sides are starting to communicate with each other, individually and through their organizations. Health Canada is facilitating such linkages by working with community groups, non-governmental organizations and educational bodies on initiatives aimed at better preparing family physicians to counsel patients on the use of CAHC and NHPs, and increasing research literacy among CAHC practitioners.¹¹

A Final Word

Many of the health care products and practices that consumers once considered to be alternative therapies are now viewed as complementary to conventional approaches. Moreover, consumers are recognizing the need for CAHC and NHPs to be "integrated" with mainstream health care options and are calling for action on this front. It has yet to be seen whether this vision of integrated use will be realized, or if CAHC and NHPs will remain distinct as the "other mainstream."

A Policy Challenge: Innovative Solutions

An interview with Philip Waddington, Director General of the Natural Health Products Directorate, Health Products and Food Branch, Health Canada, conducted by Nancy Hamilton, Managing Editor of the Health Policy Research Bulletin.

An increasing number of people appear to be turning to complementary and alternative health care (CAHC) and natural health products (NHPs) as a way of treating illness and promoting health. Does the evidence support this observation?

Yes, as pointed out in the article on utilization trends (see page 9), the research shows that the use of CAHC therapies and NHPs has been on the rise over the past several years. However, the evidence also shows that while sales of NHPs increased substantially four or five years ago, sales have now levelled off and, in some cases, even declined.

To what do you attribute this recent decline?

While some of the decline is probably due to general economic downturn, the feedback we've received indicates that the decline may also be due to growing consumer dissatisfaction with the outcomes of products that have been available in a relatively unregulated marketplace. In other words, it could be a result of what we call "under-regulation." For example, if consumers tried a product based on a specific health claim and then found it did not deliver the expected effects, they may have turned away from NHPs entirely. I must add, however, that many manufacturers are making NHPs that work well and meet consumer expectations.

Your last point suggests a relationship between what you call "under-regulation" and consumer confidence.

To optimize consumer confidence, I believe governments need to find a balance between "under-regulation" and "over-regulation." With under-regulation, there are fewer barriers restricting consumer access, so consumers have access to a wider array of products and services. However, some of these are likely falling short in delivering expected outcomes to consumers. In the case of over-regulation, the market is more restricted. There are fewer products available, but these are supported by a very strong evidence base. Our consultations have shown that what people really want is a balance between these two extremes. They want assurances that products are safe and effective, but they also want access to as many options as possible.

How are CAHC practices and NHPs regulated in Canada?

CAHC practices are regulated at the provincial level, so I'll only make a few comments about them. Perhaps the most important point is that the provinces and territories are all moving forward at different speeds. Also, the regulatory environment varies from one practice to another. For instance, while some practitioners, like chiropractors, are regulated consistently across the country, others, like naturopaths, are regulated differently in each province. Although the federal government is not responsible for practitioner regulation, we are consulting with practitioners and provincial governments as they address issues related to scope of practice, training and accreditation.

Currently, NHPs must fit into either the "food" or the "drug" category under the federal Food and Drugs Act (FDA). According to the FDA, NHPs sold for their nutritional value are regulated as food while those making other health claims are regulated as drugs. However, there is widespread concern that the Food and Drug Regulations (FDR) are inappropriate for NHPs (see article on page 19) and that their application might lead to the removal of many NHPs from the marketplace.

What approach did Health Canada take to resolve what appears to be a regulatory dilemma?

The House of Commons Standing Committee on Health recognized that application of the FDR to NHPs served neither the consumer nor the industry. In its 1998 report, the Committee recommended that a new regulatory approach be developed. The Office of Natural Health Products - which later became the Natural Health Products Directorate - was established within Health Canada to oversee the development of a new framework that would be more appropriate to the range of products in this sector.

A pivotal factor in this regulatory initiative has been the extensive consultations held with all major stakeholders, including consumers, manufacturers, practitioners and importers. I believe the time invested in the consultative process has paid off well. As a measure of its value, the new regulatory framework was approved with few amendments and will come into force in January 2004. It is important to clarify that this framework will apply only to NHPs sold over the counter. Products that require practitioner intervention or have a narrow safety margin will continue to be regulated as before under the FDR.

What are the main pillars of this new regulatory framework and what makes it unique?

The two main pillars of the framework are, first, the good manufacturing practices (GMPs) and site licensing arrangements and, second, the standards of evidence (SOE) (see articles on pages 19 and 23). What makes the framework unique is that the GMPs and SOE have been developed with the specific characteristics of the industry in mind. Our goal was to ensure that the GMPs would maximize the benefits and minimize the negative impacts of the new Regulations. Unlike the pharmaceutical industry, which tends to be dominated by large-scale manufacturers, our Business Impact Test shows a relatively large number of small- to medium-sized NHP manufacturers. We also know that much of the innovation in this industry occurs in smaller companies because they are able to adapt more rapidly as new methods of processing or new products are developed. Imposing unnecessarily strict GMPs could have shut down many of the smaller operations, thereby limiting innovation.

How have the SOE been tailored to this sector?

Two points are key. First, the SOE for NHPs call for an examination of the "totality of evidence." For example, two Canadian randomized control trials are typically conducted before a new drug can be brought into Canada. But, under the new SOE, an NHP may not be considered new in Canada if it had been in use somewhere else. In that case, data from the other country could be used to substantiate safety and health claims for the product.

The second point relates to the different levels of evidence that are allowed under the SOE. The Committee recommended that the SOE be appropriate for a range of health claims. For instance, if a product makes treatment claims for a scratch or cut, then one level of evidence is required. However, if the claims apply to a more serious condition, a higher level of evidence is necessary.

What are some examples of the different levels of evidence provided for under the new SOE?

As I mentioned, we consider the totality of evidence, including how the product is made and sold, the safety profile of the ingredients and how it is marketed in other countries, as well as evidence from those jurisdictions. We take into account both the traditional and scientific literature. If there are clinical trials, we look at those. We also consider non-randomized trials, as well as expert opinion reports (see article on page 23).

Another level of evidence focuses on whether there has been a history of traditional use. By this, we mean a practice of using that product which has been passed down within a community from one generation to the next. Under the new SOE, a minimum of 50 years is required to make a claim for traditional use. At the other end of the spectrum are products that are "globally" new - they have never been used anywhere. In the case of a new product where the company provides insufficient evidence that the product can be used safely for the indicated conditions, additional testing or clinical trials are required.

What will happen after the new NHP Regulations come into effect in January 2004?

It will take six years to fully implement the new Regulations. During the first two years, we'll focus on product safety by making sure that all manufacturers have site licences and are using the approved GMPs. Approximately 10,000 NHPs (of the estimated 50,000 to 60,000 on the market) currently have Drug Identification Numbers (DINs) issued under the FDR. These products will have six years to transition to the new framework. The NHPD will be targeting compliance and enforcement actions on a risk-based approach to gradually bring the remaining products into full compliance throughout the first four years that the Regulations are implemented. There is some uncertainty and a lot of work associated with implementing such a novel regulatory approach, but we're committed to being vigilant in our follow-up activities so that consumers can realize the maximum benefits.

In closing, how would you respond to potential critics who might say that support for CAHC and the new regulatory approach for NHPs is not sufficiently science based?

I believe we are science based. In my view, science is the practice of observation, recording, making observation-based changes and then moving forward. This is the approach that has been taken by researchers, regulators and others working in the field to ensure that consumers have access to products and practices that are safe and effective. Our bottom line is about enabling consumers to make informed choices about their health care options.

Utilization Patterns and Trends

Joan E. Simpson, Natural Health Products Directorate (NHPD), Health Products and Food Branch, Health Canada

Special thanks for the input provided by Sari Tudiver, Women's Health Bureau, Health Policy and Communications Branch; David Hoe, HIV/AIDS Policy, Coordination and Programs Division, Population and Public Health Branch; Nancy Lloyd, Centre for Chronic Disease Prevention and Control, Population and Public Health Branch; and Isabelle Caron, NHPD.

The popularity of complementary and alternative health care (CAHC) and natural health products (NHPs) is well documented. Drawing largely from recent studies prepared for Health Canada,¹-³ this article highlights current utilization patterns and trends, and examines how and why consumers are using these therapies and products. It also explores the challenges of gathering comprehensive information on consumer utilization.

The Big Picture

There is strong supporting evidence that CAHC and NHPs are a large and generally increasing part of the Canadian health care reality.⁴ For example, the Berger Population Health Monitor recently reported that the proportion of Canadians using one or more NHPs in the previous six months rose from 70 percent in 1999 to 75 percent in 2001.⁵ Millar's 2001 analysis of National Population Health Survey data estimated that 19 percent of Canadians made use of CAHC practitioners in 1998 to 1999 (an increase of four percentage points from 1994 to 1995) for services ranging from chiropractic, yoga and massage to acupuncture, homeopathy and meditation.⁶,⁷ A 1998 survey by the Fraser Institute estimated that Canadians spent $3.8 billion on CAHC and NHPs between 1996 and 1997.

Although utilization of NHPs increased significantly in the mid- to late 1990s, according to some measures there has been a slight decrease in the past few years. For instance, Figure 1 indicates that while the use of herbal remedies more than doubled during the period 1996 to 1999, there has been a subsequent levelling off since then. This drop may be due to lessened product demand (see interview on page 6), overall market reductions, or some combination thereof.

Figure 1: Use of herbal Remedies, 1996-2002

Note: These data do not include vitamin and mineral usage.
Source: Nonprescription Drug Manufacturers Association of Canada, updated to 2002 from Hay Health Care Consulting Group's Berger population Health Monitor, Survey #23 (R.Marles).

Figure 2 presents trends in Canadians' use of different types of CAHC practitioners from 1994 to 2001. Overall, Canadians are making significant use of health care approaches that, until recently, were considered outside the scope of mainstream health care in North America.⁸

Figure 2: Use of CAHC practitioners, 1994-1995 to 2000-2001

Note: These data do not include visits to chiropractors, the most extensively used CAHC practitioners in Canada.
Source: National Population Health Survey, 1994-2000.

About Consumer Utilization Data

Information on consumer utilization offers insights into CAHC product and practice issues, and can help determine the agenda for future policy research. In his reports to Health Canada, De Bruyn¹,² describes relevant data sources and groups consumer utilization studies into three categories: research studies,⁹-¹² studies based on data from Canadian health surveys⁶,¹³-¹⁵ and public opinion polls.¹⁶

Gathering comprehensive information on the use of CAHC and NHPs presents many challenges, some relating to survey methodologies and others to the definitions of CAHC and NHPs employed in the studies. For instance, reports of CAHC use are affected by respondents' understanding of the terms, as well as their reasons for using a particular product or therapy. For this reason, researchers usually decide to ask about specific CAHC products, practice areas and practitioners in their surveys and define these clearly for respondents. Utilization responses can also be affected by consumers' views about whether a particular product or practice (e.g., prayer, meditation, use of herbal teas) is a component of health care or just part of daily living. Another significant challenge is the need to appropriately represent Canada's ethnocultural diversity in survey databases - clearly an area requiring further attention.¹,¹⁷

Similar to enhanced utilization studies, gathering information about the health outcomes of using NHPs and CAHC therapies has not been a major focus of health policy research to date.

Why the Widespread Use?

A number of factors may account for the increase in popularity of CAHC and NHPs, such as the rising prevalence of chronic diseases, greater public access to global health information, reduced deference for the decision-making role of conventional health care providers, and an increased sense of entitlement to quality of life.³

The reasons people give for using CAHC and NHPs range widely, from maintaining health and improving quality of life and well-being, to preventing disease, reducing stress, treating a condition or disease, and easing symptoms.³ Eisenberg et al.¹⁰ reported that 58 percent of CAHC treatments were used, at least in part, to prevent future illness or to maintain health and vitality, while 42 percent were used to treat existing illness.

Normally, consumers themselves select an approach, with perceived effectiveness as the major reason for choosing between therapies. CAHC and NHPs tend to be used more often for chronic conditions, such as back pain and allergies, than for acute or life- threatening conditions.¹⁷,¹⁸ Moreover, most people cite positive reasons for choosing CAHC and NHPs, such as a desire to take control over their health, or compatibility with their belief systems, rather than negative reasons such as a fear of or disillusionment with conventional care.¹⁸ While CAHC and NHPs are sometimes used as an alternative to conventional medicine, they are generally employed as an adjunct to other therapies. According to current estimates, only 6 percent of Canadians use CAHC and NHPs to the exclusion of conventional medicine.¹⁷

Who Uses CAHC and NHPs?

Many consumer populations are using CAHC and NHPs, including:³

• the concerned well (who aim to enhance their health for the long term)
• people with specific health problems, ranging from minor to major (e.g., mental health concerns, infectious disease, acute illness or injury, mental illness, long-term disability, chronic disease)
• people with a life-threatening illness
• the terminally ill

Utilization can also vary by specific population groups or among people with different health problems.

Women

As Table 2 shows, women make greater use of CAHC and NHPs than men. In part, this is likely due to women's unique physiology and reproductive roles, which may lead them to seek alternative or complementary treatment, for example, to relieve nausea during pregnancy, induce or decrease lactation and relieve menopausal symptoms. As the "gatekeepers" of family health, women also tend to play a key role in decisions about the type of practitioner to be consulted and under what circumstances. Findings such as these indicate that women and men may have differing CAHC and self-care information needs.

People Living with Chronic Illnesses

The use of alternative therapies by chronically ill populations has been the focus of several recent surveys. For example, surveys of people suffering from arthritis and rheumatism report prevalence rates ranging from 82 percent to 94 percent.²⁰-²² A British Columbia self-care study on the use of alternative therapies among adults aged 50 and older with arthritis, heart disease or hypertension concluded that "the illness context is critically important in affecting the propensity of individuals to use alternative therapies."²³

People Living with HIV/AIDS

As discussed in the article on page 16, the use of CAHC and NHPs is particularly high for people living with HIV/AIDS.²⁴ Multiple reasons for this use are cited by consumers, most particularly to gain control over their health, boost immune function, delay and treat symptoms of the disease, help with side effects, relieve stress and improve general well-being.

People Living with Cancer

The 1998 National Population Health Survey indicates that 10 percent of Canadians with cancer report some use of alternative health care, while the related medical literature suggests that upwards of 60 percent of cancer patients use some form of CAHC.²⁵ The most commonly reported reasons are to boost the immune system, improve quality of life and prevent recurrences. Among those living with cancer, people with breast cancer, gastrointestinal cancer and lung cancer are the most frequent users of CAHC and NHPs (see "Who's Doing What?" on page 28). As well, CAHC is commonly used for children with cancer; in one study, almost 60 percent of child patients were reported to have used one type of complementary or alternative medicine (CAM) during their cancer treatment.⁶

Table 1: Use of NHPs*

Use of NHPs is highest in British Columbia and lowest in the Atlantic provinces: Forty-one percent of respondents in British Columbia reported using three or more NHPs in the previous six months, compared with 15 percent of respondents in the Atlantic provinces.

Pharmacies and health food stores are the main source of NHPs: Fifty-eight percent of respondents purchased their last NHP at a stand-alone pharmacy, 22 percent at a health food store and 7 percent at a supermarket or discount store pharmacy. Few NHP purchases were made on the Internet.

More people are consulting their physician or pharmacist about NHPs: Between 1998 and 2000, there was a substantial increase in the number of people discussing the use of NHPs with their physician (from 31 percent to 38 percent) or pharmacist (from 22 percent to 38 percent). Women were more likely than men to discuss NHPs with a conventional health care professional.

*Based on Hay Health Care Consulting Group's Berger Population Health Monitor, 2001.

Assessing Products and Practitioners

Canadians using CAHC and NHPs may be doing so with or without the involvement of mainstream health care providers or any other practitioner.⁸ For this reason, it is critical that tools be provided to help consumers make informed decisions about how to access and use the various health care options (as discussed in the following article). Tables 1 and 2 highlight specific patterns and trends concerning access to and utilization of NHPs and CAHC practitioners, based on analyses of Canadian national population survey results.² Although not presented here, more in-depth analysis of user characteristics, for example, use of NHPs and CAHC by various ethnic groups, would be a valuable area for further study.

Moving Forward

Studies are needed to determine with greater detail the extent to which Canadians are opting for CAHC and NHPs. Enhanced studies on the utilization and health outcomes of these products and practices would assist in evaluating the potential for substantial health gains across population groups.

The demand for NHPs and CAHC has implications for health care delivery in Canada. As discussed throughout this issue, Health Canada's attention has been directed at several key policy areas: developing an appropriate regulatory framework for NHPs; assessing CAHC health system impacts; and exploring the needs of specific consumer populations for access to and utilization of holistic health care approaches.

Table 2: Use of Alternative Practitioners (APs)*

More Canadians are using APs than ever before: The use of APs among Canadians aged 18 or older increased from 15 percent in 1994-1995 to 19 percent in 1998-1999. Since use of chiropractors remained stable during that period, the overall increase may be attributed to the growing popularity of other types of APs (e.g., massage therapists, acupuncturists, homeopaths or naturopaths).⁷

Use of APs increases with education and income: People with some post- secondary education are more likely to consult an AP than people with less than a high school diploma. People with a household income of $50,000 or above consult an AP more often than those with a household income under $20,000.⁷

Women are more likely than men to consult APs: Nineteen percent of women reported consulting an AP in the previous year, compared with 14 percent of men. However, men and women are equally likely to consult a chiropractor.⁷

Residents of Western Canada are more likely to use APs: The use of APs increases from east to west, with the highest rate of use in Alberta. Between 3 percent and 9 percent of people in the Atlantic provinces report consulting an AP, compared with 15 percent in Québec and Ontario, and 21 percent to 25 percent in the western provinces. The higher use in Western Canada may be a reflection of provincial health care plans, which offer some coverage for chiropractic services.⁷

Use of APs is greater among people with chronic conditions or chronic pain: 2001 survey data indicate that 59 percent of Canadians suffer from one or more chronic conditions.19 In 1998 to 1999, 25 percent of people with three or more chronic conditions consulted an AP, compared with 11 percent of those reporting no chronic conditions. Twenty-six percent of people who reported chronic pain consulted an AP, compared with 15 percent of those with no chronic pain. Use of APs was highest among people suffering from back problems.

*Based on the 1998-1999 National Population Health Survey.

Did You Know?

Did You Know? is a regular column of the Health Policy Research Bulletin examining aspects of health information, data and research that may be subject to misconceptions. In this issue, we investigate the perception that all natural health products and complementary and alternative health care therapies are safe.

It's Natural, So It Can't Hurt Me - Right?

Michael J. Smith and Robin J. Marles, Natural Health Products Directorate, Health Products and Food Branch, Health Canada

Many consumers and even some practitioners believe that natural health products (NHPs) and complementary and alternative health care (CAHC) therapies are always safe, no matter what the dosage is or how they are used (see Figure 1). Is this perception accurate? If not, how can we help people make informed, healthy choices, bearing in mind that the typical consumer of NHPs and CAHC is proactive about health care, inquisitive and well educated?

Natural Does Not Necessarily Mean Safe

Like most other things in life - including drugs, food and even motorcycle riding - the safety of NHPs and CAHC therapies depends on the amount or dosage, the characteristics of the user and the context in which they are used. More specifically, many of the risks associated with NHPs and CAHC fall into the following three categories:¹

Figure 1: Perception of the Potential Risks Associated with the Misuse of NHPs, 1998

Source: Canada Health Monitor, 1998 Price Waterhouse Coopers National Survey Centre.

Errors of Omission

Put simply, this means that by not doing the right thing, you are doing the wrong thing. For example, taking a herbal medicine that is inappropriate may cause consumers to ignore more proven or appropriate care (either complementary or conventional). As a result, their condition may deteriorate.

Intrinsic Procedural Risks

These are problems that arise directly from using a product or practice. Because the body's organ systems and metabolic processes are complex and interactive, any health product is likely to have side effects. There is also the risk that NHPs may be adulterated with other substances (e.g., drugs), contain the wrong herb, or be contaminated as a result of poor manufacturing practices. NHPs may also interact with other substances, including conventional drugs, other NHPs or even foods.

Situational Amplifications

In this case, the condition worsens - usually temporarily - as a result of taking the "correct" NHP or CAHC. An example is the temporary and minor muscle aches some people experience after chiropractic manipulation.

Different Strokes (and Doses) for Different Folks

Not everyone responds the same way to conventional medications or NHPs. For example, children experience different growth and development characteristics as neonates (< 1 month), infants (1-12 months), toddlers (12-42 months), preschoolers (3.5-6 years), children (6-12 years), and adolescents (12-18 years). These stages of development affect how children absorb, distribute, metabolize and excrete drugs, as well as the product's actions. Children are also more susceptible than adults to the effects and toxicity of some products, but are better able to tolerate others.²-⁴

For many NHPs, documents describing traditional use provide little or no specific information on dosage for children, leaving parents and practitioners to either guess at or calculate the appropriate amount. (The situation is not much better for conventional drugs, since their use in children is commonly "off-label" as well due to the lack of clinically-derived information on children's dosage and pharmacology.) A number of dosing formulae for children have been proposed for use by health care practitioners, none of which is regarded as completely reliable.⁵,⁶

Similarly, seniors often have special safety issues because of low body weight, coexisting health conditions and the use of multiple medications, including both conventional drugs (over-the-counter and prescription) and NHPs. As NHP use is not generally recorded in a patient's history, it is difficult to watch for NHP-drug interactions in seniors, or in other groups with infectious or chronic diseases.⁷ Physicians are encouraged to start medications at a low dose and to monitor for side effects while increasing the dose to the lowest effective level, which may also help to minimize interactions.⁸,⁹

Ginkgo Leaf Extract - An Example

Ginkgo leaf extract is an excellent example of how NHP use and dosage varies by population. Ginkgo extract contains a blood-thinning agent and has been clinically shown to reduce cognitive impairment in geriatric patients by improving blood flow throughout the brain.¹⁰ However, ginkgo may interact with other blood thinners to increase the risk of hemorrhage, emphasizing the importance of good patient-physician communication about the use of NHPs.

Advertisers have falsely extrapolated the benefits of ginkgo products by promoting them to young people as a way of improving their memory and cognitive functioning. Although these products are unlikely to help young people (as most have normal blood flow in the brain), ginkgo extract does have a potential use in children. Clinical evidence supports its use as an adjunct in the treatment of bacterial blood infections.¹¹ However, as children are not generally included in clinical trials, practitioners can only guess at an appropriate dose.

A Question of Communication

Effective communication between consumers, conventional and complementary health care providers, and government is critical in ensuring consumer safety. Results from several surveys¹² suggest that two thirds of people who use NHPs and CAHC do not tell their physicians they are doing so. Health Canada is collaborating with partners such as the Association of Canadian Medical Colleges to improve physicians' knowledge of CAHC and NHPs so they can better counsel their patients.

When something does go wrong, consumers are less likely to report the problem with an NHP than a drug, and are more likely to tell a neighbour or family member than their doctor or pharmacist.¹³ Effective reporting of adverse events is a major research priority and Health Canada is working with domestic and international partners to ensure proper reporting procedures, provide for effective risk communications with CAHC providers, and determine when an adverse event results from an adulterating substance or other factor rather than the NHP itself.

Communication between CAHC providers and conventional health care providers is a two-way process in which the responsibility lies equally with both groups to establish a good working relationship. For instance, conventional providers may not always be familiar with a specific NHP or CAHC therapy and, thus, they need to know when to refer a patient to a CAHC practitioner. Similarly, CAHC providers may not always have the necessary training to make the best decision for a patient and must know when to make a referral to a conventional practitioner. Increasing consumer and practitioner understanding of the potential risks (and benefits) associated with CAHC and NHPs is vital in helping Canadians use them safely, effectively and respectfully.