Developing a Research Agenda in Natural Health Products, Complementary and Alternative Health Care and HIV/AIDS: A Discussion Paper

Si vous avez besoin d'aide pour accéder aux formats de rechange, tels que Portable Document Format (PDF), Microsoft Word et PowerPoint (PPT), visitez la section d'aide sur les formats de rechange.

Return to the Health Promotion - Population Groups and Issue Areas page

Table of Contents

• Executive Summary
• Introduction
• Definitions and Context
  • Complementary and alternative health care
  • Natural health products
  • Context
• The Sponsors of the Roundtable
  • Natural Health Products Directorate
  • Health Human Resource Strategies Division
  • HIV/AIDS Policy, Coordination, and Programs Division
• Key Aspects of the Use of CAHC/NHP by People with HIV/AIDS
  • A shift in approach to health care
  • Use of complementary/alternative products, practices, and practitioners
  • Perceived benefits and risks
  • Access to information
  • Relationships with practitioners
• Research Priorities in CAHC, NHP and HIV/AIDS
  • Develop research infrastructure
  • Build capacity to conduct research
  • Research areas
  • Dissemination and uptake of research findings
• Building Research Capacity and Advancing Research Priorities in CAHC/NHP: Outcomes of Health Canada Consultations
  • Building research capacity
    • Canadian Institutes of Health Research
    • Natural Health Products Directorate
    • Workshop on Research Capacity and Literacy
    • Roundtable on Information and Informed Choice
    • Roundtable on Health Law and Ethics
  • Advancing research priorities
    • Research Priority-Setting Conference
    • Research Priorities in NHP-Drug Interactions
• Next Steps
  • Building research capacity
  • Methodological development
  • Natural health products research
  • Health practices/services research
  • Research dissemination and uptake
  • Building or strengthening liaisons
• References

Executive Summary

This discussion paper provides a broad overview of issues concerning the development of a research agenda in the area of natural health products (NHPs), complementary and alternative health care (CAHC) and HIV/AIDS. The purpose of this report is to facilitate discussion and the identification of priority needs at the Invitational Roundtable on the Role of Natural Health Products and Complementary and Alternative Health Care: Developing a Research Agenda. The roundtable is being convened in March 2002 by the Natural Health Products Directorate (NHPD), in collaboration with the Health Human Resource Strategies Division and the HIV/AIDS Policy, Coordination and Programs Division of Health Canada.

The objectives of the roundtable are:

• to assist in the further development of a research agenda in the area of NHPs, CAHC and HIV/AIDS, building on the priorities first established in the document "Toward Integrative Care: National Strategic Planning Meeting on Complementary Therapies and HIV/AIDS." This report, along with others referred to in this discussion paper, have set out the main lines of a research agenda. The purpose of this roundtable is to develop this agenda further by suggesting specific steps.
• to build capacity to conduct research in Canada in NHPs and CAHC, with HIV/AIDS serving as an area with readiness to explore ways to accomplish this. There is widespread recognition of the need to build research capacity - to increase the ability and readiness of individuals and organizations to identify, develop and conduct research - in NHPs and CAHC in Canada. What is needed now are specific steps to do this in areas where there is sufficient readiness. HIV/AIDS is one such area.
• to contribute to the NHPD's process of identifying and advancing research priorities in NHPs and CAHC within the national arena. The NHPD is seeking to identify and advance research priorities both through its own funds (intended primarily for developmental purposes) and in collaboration with other funders (such as the Canadian Institutes of Health Research, the Hospital for Sick Children Foundation and other funders).

The groundwork for the roundtable began in previous consultations within the HIV/AIDS field and the CAHC/NHP field. Drawing from these consultations, this discussion paper:

• summarizes key aspects of the use of CAHC/NHPs by people with HIV/AIDS
  
• summarizes research priorities that have been identified in the area of NHPs, CAHC and HIV/AIDS
  
• summarizes the outcomes of Health Canada's consultations on building research capacity and advancing research priorities in CAHC/NHPs
  
• outlines a process for considering next steps

Next Steps

There is growing momentum in Canada to build research capacity and to advance the research agenda with regard to CAHC and NHPs. Researchers, practitioners, consumers, information providers, industry, government, and research funders are actively looking at specific and concrete ways to move forward.

In this context, there is a potential for synergy between the HIV/AIDS field and the broader CAHC/NHP field. With their considerable experience in the use of CAHC/NHPs, research, community organization, industry relations, and consultation and lobbying, people and organizations in the HIV/AIDS field have much to contribute to CAHC/NHP research.

At the same time, the momentum in the broader CAHC/NHP field may help to strengthen the capacity of the HIV/AIDS field to identify, participate in, and advance research on CAHC and NHPs, particularly research that is of special relevance to people with HIV/AIDS.

The roundtable on March 10-11, 2002 is intended to explore the potential for mutual strengthening and collaboration in the following areas:

• building research capacity
  
• methodological development
  
• NHP research
  
• health services research
  
• knowledge dissemination and uptake
  
• building and strengthening liaisons

In HIV/AIDS consultations and/or in CAHC/NHP consultations, these areas have been identified as areas for action. The overall objective of the roundtable is to identify and select top priorities and opportunities for each of these areas and to identify strategies to move forward in advancing these priorities.

Introduction

The purpose of this discussion paper is to provide background information and stimulate strategic planning to advance a research agenda in natural health products (NHPs), complementary and alternative health care (CAHC) and HIV/AIDS. It is intended to be a resource for participants in the March 10-11, 2002 Invitational Roundtable on the Role of Natural Health Products and Complementary and Alternative Health Care in HIV/AIDS - Developing a Research Agenda. The roundtable is being convened by the Natural Health Products Directorate (NHPD), in collaboration with the Health Human Resource Strategies Division and the HIV/AIDS Policy, Coordination and Programs Division in Health Canada.

The objectives of the roundtable are:

• To assist in the further development of a research agenda in the area of NHPs, CAHC and HIV/AIDS first established in the document "Toward Integrative Care: National Strategic Planning Meeting on Complementary Therapies and HIV/AIDS." This report, along with others referred to in this discussion paper, have set out the main lines of a research agenda. The purpose of this roundtable is to develop this agenda further by suggesting specific steps.
• To build capacity to conduct research in Canada in NHPs and CAHC with HIV/AIDS serving as an area with readiness to explore ways to accomplish this. There is widespread recognition of the need to build research capacity - to increase the ability and readiness of individuals and organizations to identify, develop and conduct research - in NHPs and CAHC in Canada. What is needed now are specific steps to do this in areas where there is sufficient readiness. HIV/AIDS is one such area.
• To contribute to the NHPD's process of identifying and advancing research priorities in NHPs and CAHC within the national arena. The NHPD is seeking to identify and advance research priorities both through its own funds (intended primarily for developmental purposes) and in collaboration with other funders (such as the Canadian Institutes of Health Research, the Hospital for Sick Children Foundation and other funders).

The groundwork for the roundtable has been laid in previous consultations, both within the HIV/AIDS field and within the CAHC/NHP field (see References, below). This discussion paper draws on these consultations to:

• summarize key aspects of the use of CAHC/NHPs by people with HIV/AIDS
  
• summarize research priorities that have been identified in the area of NHPs, CAHC and HIV/AIDS
  
• summarize the outcomes of Health Canada's consultations on building research capacity and advancing research priorities in CAHC/NHPs
  
• outline a process for considering next steps

Definitions and Context

Complementary and alternative health care

The United States National Center for Complementary and Alternative Medicine describes CAHC (also referred to as complementary and alternative medicine or CAM) as follows (http://nccam.nih.gov/health):

• Complementary and alternative medicine (CAM) covers a broad range of healing philosophies, approaches, and therapies. Generally, it is defined as those treatments and health care practices not taught widely in medical schools, not generally used in hospitals, and not usually reimbursed by medical insurance companies.
• Many therapies are termed "holistic," which generally means that the health care practitioner considers the whole person, including physical, mental, emotional, and spiritual aspects. Many therapies are also known as "preventive," which means that the practitioner educates and treats the person to prevent health problems from arising, rather than treating symptoms after problems have occurred.
• People use these treatments and therapies in a variety of ways. Therapies are used alone (often referred to as alternative), in combination with other alternative therapies, or in addition to conventional therapies (sometimes referred to as complementary).
• Some approaches are consistent with physiological principles of Western medicine, while others constitute healing systems with a different origin. While some therapies are far outside the realm of accepted Western medical theory and practice, others are becoming established in mainstream medicine.

Natural health products

CAHC may involve the use of NHPs. According to the proposed Natural Health Products Regulations (Canada Gazette, Part I, December 22, 2001, p. 4939), "natural health product" refers to a substance or combination of substances, a homeopathic preparation, or a traditional medicine that is manufactured, sold, or represented for use in:

• the diagnosis, treatment, mitigation, or prevention of a disease, disorder, or abnormal physical state or its symptoms in humans;
  
• restoring or correcting organic functions in humans; or
  
• maintaining or promoting health or otherwise modifying organic functions in humans.

For the purposes of the regulations, certain substances are included (Schedule 1) and others are not included (Schedule 2) within the scope of the regulations.

Context

This roundtable, and other initiatives like it, are taking place in a context in which the use of CAHC and NHPs is growing among Canadians. Many people practice or use CAHC as a form of self-care, and may combine several products and/or practices at once. Although more people are disclosing the fact that they use CAHC or NHPs to their physicians and pharmacists, many still do not do so. More people are, in fact, taking NHPs instead of filling a prescription or seeing a physician. There is a widespread desire for reliable information about CAHC and NHPs - What is it? Will it work? Where can I get it? How much will it cost? Who will pay for it? - also a corresponding lack of ready access to information. Because of the uncertain and often negative status of CAHC and NHPs within the prevailing conventional (or Western) medical health care system, relationships are not fostered in which people who use CAHC and NHPs discuss this with their health care providers, disclose adverse reactions, and obtain helpful information from their health care providers. But there are initiatives under way - some of which are described below - to gather better information about CAHC and NHPs, to improve professional education and training in CAHC and NHPs, to provide reliable and accessible information to people who use CAHC and NHPs and to establish the value of CAHC and NHPs within the health system.

Within this context, this roundtable is focusing on how to advance research on CAHC and NHPs in Canada - specifically, how to advance research on CAHC and NHPs in relation to HIV/AIDS.

The Sponsors of the Roundtable

The sponsors of the roundtable have distinct roles in relation to the focus of the roundtable: namely, how to advance research on CAHC and NHPs in relation to HIV/AIDS. These are described below.

Natural Health Products Directorate

The NHPD (originally know as the Office of Natural Health Products), Health Products and Food Branch, Health Canada, was created in 1999 with the mandate to "ensure that all Canadians have ready access to natural health products that are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity." In keeping with its primary role as a product regulator, the NHPD published a proposed regulatory framework for NHPs in December 2001.

Although the directorate's primary role is as a product regulator, provisions were made for it to support NHP-based research. The research budget for the directorate currently stands at $1 million per year. To date, the directorate has been consulting on how best to use its research funds. These consultations have been both general - developing an overall research agenda for the directorate - as well as focused - exploring a number of specific areas through a series of priority-setting conferences. These specific topics include drug interactions with NHPs, the role of NHPs in child-and-youth health, and NHP standards and quality control. The directorate has explored these subjects alone or in partnership with both community-based organisations and government partners. The intention is that the directorate will be in a position to actively support research projects and initiatives within the very near future both directly and in partnership with other funding agencies. While CAHC has a contextual impact on some NHPs, the research agenda of the directorate is focused more on products than on practice.

While the directorate has no specific mandate in HIV/AIDS, NHPs have long been a health care option chosen by people living with HIV/AIDS. As part of its mandate to build partnerships within the community, the directorate is keen to facilitate ways in which research can be conducted investigating the use of NHPs in the prevention and treatment of HIV/AIDS.

Health Human Resource Strategies Division

The Health Human Resource Strategies Division, Health Policy and Communications Branch, Health Canada, has developed a policy file on CAHC, looking at broad health system impacts of this emerging health issue and at future health system implications. In 2001/2002, the areas receiving attention include:

• health human resources: investigating labour market and human resource issues for CAHC practitioners
  
• information and informed choice: investigating information quality, appropriateness, and balance; understanding prerequisites of informed health choices at multiple levels
  
• health law and ethics: investigating practitioner-, practice- and product-related issues, including consideration of regulatory policies and impact of value systems on service delivery
  
• education: investigating curriculum approaches related to CAHC integration; promoting balanced program activity across health sciences and CAHC education
  
• health care system: exploring the role of CAHC in health care delivery
  
• encouraging the development of an information framework that includes CAHC practices and practitioners

The CAHC policy file will be transferred to the NHPD as of April 1, 2002, providing an enhanced opportunity for the consideration of inter-related practice, practitioner and product issues. Within its ongoing mandate in relation to health human resource and health system issues, the Health Human Resource Strategies Division will continue to provide an opportunity for attention to CAHC in relation to allied health and interdisciplinary approaches, and to support the current initiative focused on CAHC in health sciences curriculum.

HIV/AIDS Policy, Coordination and Programs Division

The HIV/AIDS Policy, Coordination and Programs Division of the Centre for Infectious Disease, Prevention and Control, Health Canada, is responsible for coordinating the Canadian Strategy on HIV/AIDS (CSHA). The CSHA was launched in 1998, based on extensive national consultations. As a sequel to the previous two national AIDS strategies, the CSHA is not time limited, thus permitting long-term planning.

As part of the national consultations, recommendations were made regarding CAHC. Projects, which Health Canada funds to this end, include:

• the Canadian AIDS Treatment Information Exchange, which disseminates information on treatment issues in this field
  
• the Canadian HIV/AIDS Legal Network's project on CAHC, which has resulted in a report by Crouch et al., Complementary/Alternative Health Care and HIV/AIDS: Legal Ethical and Policy Issues in Regulation

Many people living with HIV/AIDS use CAHC and NHPs as part of health maintenance and/or as the significant modality in health promotion and maintenance. The CSHA will continue to evolve in this field, guided by the recommendation to remove barriers to access to complementary and alternative treatments and treatment information.

Of the $42.2 million allocated annually for the CSHA, $13.5 million is allocated to research. Of this allocation, the Canadian Institutes of Health Research administers $11.7 million. Of this amount, $3.5 million supports the Canadian HIV Trials Network. The HIV/AIDS Policy, Coordination and Programs Division administers the remaining $1.8 million of the allocation, which is dedicated to community-based research. Of this amount, $800,000 must be spent on Aboriginal community-based research.

Key Aspects of the Use of CAHC/NHP by People with HIV/AIDS

A shift in approach to health care

There has been a shift in the approach of people with HIV/AIDS to their care, treatment and support (MacDonald et al, v; MacAmmond, 13; Cain et al, v):

• They are making choices on the basis of a global assessment of their health and wellness, rather than on the basis of more narrowly defined medical interventions. Health encompasses not only the physical, but also the mental, emotional, spiritual and sexual aspects of life.
• They are taking an active role in decisions about their health care. They are seeking to make informed choices through collaborative, empowering consultations with health care providers.

This shift has been associated with the advent of multidrug antiretroviral therapy (Kendall, 1; Cain et al, 9). Positively, the success of these drugs in suppressing viral load and preventing disease progression has encouraged people with HIV/AIDS to think about long-term health promotion and disease prevention. Negatively, the side effects of the drugs have required that people with HIV/AIDS look for ways to manage the toxicities of these drugs and to make decisions about treatment in light of their overall health.

Use of complementary/alternative products, practices and practitioners

CAHC and NHPs are an integral component of the health and wellness strategies of people with HIV/AIDS. The range of therapies used is wide. Frequently mentioned therapies include vitamins and minerals, nutrition and special diets, mind-body techniques, physical therapies and massage, and herbal and medicinal agents (including marijuana). There are important differences between women and men in the use of CAHC/NHPs. For a summary of Canadian studies, see Crouch et al, 122-124 (cf. Achilles et al, 269; MacAmmond, 11; Kendall, 5).

The number of people with HIV/AIDS who report using a complementary/alternative therapy is greater than the number who report consulting a complementary/alternative practitioner (Cain et al, 20). For some, this is because they cannot afford to consult a practitioner (Kendall, 12). It may also be because many complementary/alternative therapies do not require a practitioner (Cain et al, 21). Self-medication with NHPs is one strategy used by people with HIV/AIDS when their funds for CAHC are limited. Another strategy is to rotate the use of CAHC/NHPs, using one product one month, another the next. Some people with HIV/AIDS limit their food intake to pay for NHPs (Kendal, 12-13).

Perceived benefits and risks

The most common reasons given by people with HIV/AIDS for using complementary/alternative therapies include (Crouch et al, 16; Kendall, iv, 5-10; MacAmmond, 12):

• to take active control over one's health care
  
• to improve general well-being
  
• to boost immune function
  
• to lower viral load and prevent, delay, or treat symptoms of HIV disease progression or opportunistic infections
  
• to help with side effects of conventional therapies (especially antiretroviral therapies), which facilitates adherence to a prescribed regime
  
• to manage hepatitis co-infection
  
• to help relieve stress, depression and fatigue
  
• to cope with addiction

Risks associated with the use of CAHC and NHPs by people with HIV/AIDS include (Kendall, iv, 12-13):

• limiting food intake and self-medicating because of the cost of CAHC and NHPs
  
• lack of communication about use of CAHC and NHPs with conventional practitioners
  
• the potential for adverse interactions between NHPs and drug

Access to information

It is challenging for both people with HIV/AIDS and for health care practitioners (both conventional and complementary/alternative) to get reliable and useful information about CAHC and NHPs, particularly on the safety and efficacy of therapies and on potential interactions between NHPs and drugs (MacDonald, 14, 27, 29, 33). In addition, many people with HIV/AIDS have difficulty understanding information because it is not in an easily understood format at an appropriate level of literacy (MacDonald, 17).

For people with HIV/AIDS, primary sources of information include knowledgeable individuals, national AIDS organizations, local/regional AIDS organizations, conferences and meetings, and the popular media (MacDonald, 23; Kendall, 15). Lay networks of people with HIV/AIDS - which combine knowledge of HIV/AIDS with knowledge of CAHC and NHPs - are an important source of information (Kendall, 17). Many people with HIV/AIDS prefer to receive treatment information in person from someone with whom they have developed a relationship of trust, such as their health care provider, a staff member or volunteer with an AIDS service organization, or another person with HIV/AIDS (MacDonald, 16).

Some people with HIV/AIDS work intensely with the Internet, but there are populations who do not access the Internet (MacDonald, 12, 17). It is, however, difficult and time-consuming to assess the quality of any given website (MacDonald, 41). Critical skills in assessing and applying information are required.

Relationships with practitioners

While people with HIV/AIDS look to health care providers for information in making decisions about their health, both conventional practitioners and complementary/alternative practitioners are often of limited help. Conventional practitioners may not be knowledgeable about, interested in, or supportive of CAHC and NHPs. Complementary practitioners are often not knowledgeable about HIV/AIDS (Kendall, 18). However, when conventional practitioners are prepared to engage in a dialogue with their patients about CAHC and NHPs, they have the confidence of their patients, help to reduce the possibility of interactions between NHPs and drugs, and help to reduce the cost and pill burden associated with CAHC (Kendall, 24).

Both conventional practitioners and complementary/alternative practitioners underscore the need for more evidence-based information on complementary and alternative therapies (MacDonald, 31, 33). In addition, complementary/alternative practitioners desire information as to when various therapies might or might not be appropriate in relation to a particular stage of HIV disease or a particular opportunistic infection (MacDonald, 32).

Research Priorities in CAHC, NHP, and HIV/AIDS

The consultations on CAHC, NHPs and HIV/AIDS have identified numerous ways in which research in this area should be advanced ("Toward Integrative Care," 9-11; Crouch et al, 107-116; MacAmmond, 35-42; Kendall, viii). These are summarized here under the following headings:

Develop research infrastructure

• increase funding and expand the funding base for CAHC/NHP research
  
• increase priority for CAHC/NHP research within Canadian Institutes of Health Research
  
• increase priority for CAHC/NHP research within the Canadian Association for HIV/Research
  
• provide funding for community-based research on CAHC/NHPs
  
• include NHPs in post-approval product surveillance systems
  
• develop a research agenda in CAHC/NHPs and HIV/AIDS
  
• develop mechanisms to set research priorities in CAHC/NHPs and HIV/AIDS
  
• develop mechanisms for multi-stakeholder ethics review
  
• develop protocols to govern conduct of health research with and within Aboriginal communities in accordance with principles determined by Aboriginal communities
  
• develop a 'virtual' institute or Centre of Excellence for research in CAHC/NHPs

Build capacity to conduct research

• training and personnel awards and research grants in CAHC/NHP research
  
• community-based skills development in research methodologies and critical skills in assessing information
  
• conferences on research questions and methodologies
  
• networks to facilitate networking and collaboration among researchers
  
• develop, test and promote acceptance of a wider range of research methods required to investigate complementary/alternative therapeutic approaches
  
• increase conventional practitioners' knowledge of research methods other than the randomized control trial

Research areas

• use of CAHC/NHPs by people with HIV/AIDS (see Crouch et al, 107-108 for details)
  
• health care interventions aimed at enhanced well-being and quality of life
  
• measures of efficacy that recognize a broad range of desirable outcomes
  
• barriers to integrative care (at the systemic or structural level, at the clinical level, and with respect to specific populations or remote areas)
  
• models and best practices of integrative care (pilot projects and applied research on different models of collaborative clinical practice)
  
• delivery of integrative care to specific populations (e.g., women, Aboriginal peoples, drug users, remote areas)
  
• models of informed consent, shared decision-making, and shared liability in effective therapeutic relationships
  
• safety, efficacy, risks, dosage, indications and counter-indications of NHPs
  
• NHP-drug interactions
  
• role of CAHC/NHPs in preventing or moderating side-effects from drugs and in managing antiretroviral therapy
  
• role of CAHC/NHPs in managing hepatitis co-infection
  
• cost-effectiveness of integrative care including specific products and practices
  
• cost-benefit and cost-effectiveness analysis of extending public and private insurance coverage to CAHC/NHPs (for health promotion; for disease prevention; as an alternative to more expensive conventional therapies)
  
• regulatory, legal and ethical questions associated with CAHC/NHPs (see Crouch et al, 115 for details)
  
• consumer information and knowledge (see Crouch et al, 108 for details)
  Top of Page

Dissemination and uptake of research findings

• promote resources such as EMBASE, the Cochrane Collaboration and the Canadian Health Network
  
• develop and expand CAHC/NHP information provided by CATIE, the British Columbia Persons with AIDS Society, AIDS service organizations and other stakeholders
  
• consolidate and synthesize existing knowledge and evidence
  
• establish linkages between information providers and the CAHC/NHP research field
  
• develop capacity for critical analysis, interpretation and synthesis of evidence
  
• needs assessments with consumers regarding their information needs
  
• needs assessments with practitioners regarding their information needs

Building Research Capacity and Advancing Priorities in CAHC/NHP: Outcomes of Health Canada Consultations

The Natural Health Products Directorate (NHPD) and the Health Human Resource Strategies Division, Health Canada, have held consultations on many aspects of CAHC/NHPs: research priorities, research capacity and literacy, NHP-drug interactions, information and informed choice, and health law and ethics. These consultations provide a picture of the broader context of CAHC/NHP research, as well as information about suggested strategies to move forward.

Building research capacity

Canadian Institutes of Health Research

Canadian Institutes of Health Research (CIHR), as the main funder of health research in Canada, has a central role in building research capacity in CAHC/NHPs. The objective of CIHR is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products, and a strengthened Canadian health care system.

CIHR funds research in the following broad range of areas:

• biomedical research
  
• clinical research
  
• research with respect to health systems and services
  
• research with respect to the social, cultural, and other factors that affect the health of populations

Regular funding opportunities within CIHR include:

• operating grants
  
• personnel support
  
• trainee support
  
• clinical trials
  
• group grants (infrastructure support for three or more investigators with CIHR grants involved in an integrated program of research that would benefit from shared resources)

Strategic funding opportunities within CIHR include:

• future training program competitions
  
• Institute developmental meetings/workshops
  
• Institute strategic requests for applications
  
• cross-Institute strategic requests for applications (multiple Institutes partner in a priority area of common interest)
  
• pan-CIHR crosscutting initiatives (engaging a majority of Institutes)

While CIHR did not agree to establish an institute for CAHC/NHP research, as was initially hoped for, it is taking an interest in the field. Several Institutes are collaborating with the NHPD in identifying strategic research priorities in CAHC/NHPs. Important considerations regarding CIHR's involvement in the field include:

• review procedures and panels for training, personnel and grant applications: will there be sufficient expertise in CAHC/NHPs?
  
• methodological innovation: how will it be developed and evaluated?
  
• strategic initiatives: where should the research begin?

Natural Health Products Directorate

Since its creation in 1999, the NHPD has allocated $1 million per year of its budget to supporting NHP research. As the primary role of the NHPD is as a product regulator and not as a funder of research, it has acted to date as a facilitator and partner in research. When acting alone, the NHPD has a mandate to support research activities related to NHPs alone. To address broader CAHC research issues, the NHPD is collaborating with other partners.

The NHPD has been bringing together stakeholders to identify NHP research needs and has been building partnerships with CIHR and other research foundations. It is also in a position to undertake specific projects to 'jump-start' NHP research. These include CIHR/NHPD personnel training awards, curriculum development, seed grants for research projects, etc.

Through its consultations, the NHPD has identified four strategic initiatives (Smith, 4-5):

• building research capacity in an interdisciplinary way (complementary/alternative and conventional, researchers and practitioners) through such initiatives as graduate training programs, network support, training centre grants and curriculum development
  
• supporting research that is clinically relevant to Canadians, addressing such topics as NHP product standards and quality control, NHP-drug interactions, new research methodologies and the role of NHPs in children
  
• fostering collaboration and partnership building with other units in Health Canada such as the Canadian Strategy on HIV/AIDS, CIHR and other health research foundations
  
• supporting information retrieval and knowledge transfer (database development, patient/practitioner communication) to ensure that Canadians have access to quality information and that research-based information is translated into language that is appropriate for consumers

The NHPD recently sought the advice of stakeholder on its future activities in the area of NHP research. The consultation suggested that, in the short term, the NHPD (O'Hara, i-ii):

• continue to ensure community and practitioner input at all levels (without repeating work that has already been done)
  
• form a central advisory committee with members who have a wide variety of NHP expertise or experience, and have sub-committees feed into this committee
  
• continue to focus on the wellness model of health care
  
• facilitate a process to develop research projects that might be funded in part by the NHPD
  
• continue to forge partnerships and collaboration that leverage funding from other agencies and encourage them to be more receptive to NHP research
  
• fund workshops that lead to the sharing of perspectives between conventional and complementary/alternative researchers/practitioners on research methodology
  
• fund workshops on research methodology in NHP
  
• establish a network for information exchange and knowledge transfer, especially to facilitate training of NHP researchers
  
• continue to maintain a priority on product-related matters such as quality control and standardization of NHPs

The NHPD's activities with regard to NHP research are intended to support the proposed new regulatory framework for NHPs in Canada, which includes such activities as generating new information about NHPs, building research capacity, etc. Proposed Natural Health Product Regulations were published in Canada Gazette, Part I, December 22, 2001, pp. 4912-4971 (available at http://canadagazette.gc.ca/partI/2001/20011222/pdf/g1-13551.pdf) (PDF Version) . The regulations would apply to products falling within the definition of an NHP (see above). NHPs would be considered a subset of drugs under the Food and Drugs Act. The main components of the proposed regulations are:

• definitions
  
• product licensing
  
• adverse reaction reporting
  
• site licensing
  
• good manufacturing practices
  
• clinical trials
  
• labelling and packaging

Under the new regulations, the NHPD will be the agency responsible for approving clinical trials involving NHPs.

Workshop on Research Literacy and Capacity

A barrier to research in CAHC/NHPs is lack of awareness, knowledge, experience and skill in research and research methods among complementary/alternative practitioners and educators. A recent workshop identified four key needs (Boon, 2, 10-13):

• a need for more awareness and understanding of the value of research in CAHC/NHP educational institutions, among practitioners and with undergraduates
  
• a need for mentors, role models and champions for CAHC/NHP research in CAHC/NHP educational institutions
  
• a need for more training of CAHC/NHP practitioners, educators and students in conducting research and using research findings
  
• a need for more funding for CAHC/NHP research, training and infrastructure
  Top of Page

The workshop made many specific suggestions as to how to meet these needs and identified four strategies as high priority (Boon, 2):

• completion of a CAHC/NHP research needs assessment (under way)
  
• support for a network of CAHC/NHP researchers and clinician investigators
  
• development of CAHC/NHP research learning modules
  
• development of CAHC/NHP research training support programs for faculty

Roundtable on Information and Informed Choice

The dissemination and use of reliable information about CAHC/NHP, as well as the enabling of people to make informed choices about CAHC/NHP, is an ongoing theme in consultations about CAHC/NHP, including consultations among people with HIV/AIDS. A recent Health Canada roundtable on Information and Informed Choice dealt with four broad areas of concern (de Bruyn 2001a):

• sources and systems of expert information
  
• collecting, evaluating, selecting and presenting accessible information for practitioners and consumers
  
• public and professional education in receiving and using information
  
• improving connections, consistency and integration in providing information

Participants made a number of suggestions about how to generate information and knowledge that would address the needs of consumers and practitioners:

• funding for an infrastructure that would support the links between information gathering, clinical practice and community care (the infrastructure could support such activities as the gathering of case reports, pilot studies in preparation of research grant applications, development of methodologies, mentoring of CAHC/NHP researchers, training and personnel awards for CAHC/NHP practitioners/researchers)
  
• training, funding and support for complementary/alternative practitioners to write up case reports
  
• systematic reviews of literature relating to products and practices that have been in use in other countries
  
• controlled pilot studies in institutional settings to foster dialogue and collaboration between complementary/alternative and conventional practitioners
  
• use of dual-trained practitioners (conventional and complementary/alternative training) to build bridges, design research and interpret evidence

Roundtable on Health Law and Ethics

The use of health care and health products - whether conventional or complementary/alternative - involves considerations relating to the ethical and legal conduct of health providers, health care facilities and health product manufacturers. These were the subject of a recent Health Canada roundtable on health law and ethics. Among other topics, the areas of discussion included (de Bruyn 2001b):

• the relationship between the practitioner and the person seeking care
  
• legal and ethical issues raised by the use of CAHC/NHP in diverse settings
  
• access to CAHC/NHPs
  
• research ethics boards for research projects involving CAHC/NHPs

The discussion about the relationship between practitioners and people who use CAHC/NHPs is of particular relevance to research on best practices in health care service delivery. Participants noted the need for practitioners who are practiced in (de Bruyn 2001b, 8):

• ongoing learning and modification of clinical practice
  
• understanding and respecting people's approaches to their health and well-being
  
• supporting people in making informed choices
  
• communicating the boundaries of the practitioner's responsibilities
  
• conveying disagreement or contra-indication

Also relevant to CAHC/NHP research are the participants' concerns about ethics review for research involving CAHC/NHPs (de Bruyn 2001b, 16). Participants noted that the knowledge and judgement required to assess clinical trial protocols for NHPs are significantly different from those in trials of allopathic products. Some participants feared that members of research ethics boards may not be sufficiently knowledgeable about NHPs and may be too conservative when assessing innovative research methodologies. Participants suggested that it would be challenging for research ethics boards to recruit people with the appropriate expertise in NHPs.

Advancing research priorities

Research Priority-Setting Conference

The 1999 Research Priority-Setting Conference laid out an initial direction for research on NHPs for Health Canada (Priority-Setting Conference, 1). It recommended that research supported by Health Canada:

• be of a seed nature
  
• give priority to cross-cutting research across disciplines
  
• be delivered within a framework of an NHP research network
  
• support research relevant to industry and health care practitioners

The conference also identified five research priorities (Priority Setting Conference, 12):

• a credible and complete database which will allow assessment of knowledge to date
  
• research on the safety (toxicities, NHP-drug interactions), efficacy and mechanism of action of NHPs (basic, pre-clinical animal studies, clinical studies and long-term follow-up research)
  
• research to aid in the development of quality control methodologies and the development of standards
  
• research on consumer usage and health economics
  
• development of methodologies that can demonstrate the efficacy of NHPs in the contexts in which they are used, which do not lend themselves to the randomized controlled clinical trial (individualized treatment in relation to multiple aspects of health and lifestyle, unique preparations, incremental dosing)

Research Priorities in NHP-Drug Interactions

The issue of NHP-drug interactions has come up repeatedly in consultations about CAHC/NHP research. The NHPD recently held a conference to identify research priorities in this area (de Bruyn 2002).
In general, participants suggested that priority should be given to research dealing with:

• NHPs that are in high use
  
• populations that are at risk of NHP-drug interactions (e.g., populations defined by age, gender, diseases or conditions, genetic factors, etc.)
  
• interactions with drugs that have critical dose requirements
  
• interactions with potential or known severe outcomes

In the area of biomedical, clinical, and epidemiological research, the four top priorities were:

• to develop methodologies and conduct research to characterize NHPs in use (in their natural form and in prepared formulations), develop standards for NHPs used in research and practice and publish monographs providing a complete characterization of NHPs used in research and practice
  
• to identify the mechanisms of action of NHPs
  
• to determine the clinical relevance of potential or theoretical NHP-drug interactions
  
• to determine the use of NHPs in the population in order to determine the priority to be given to research on a particular NHP, assess the relative significance of demonstrated NHP-drug interactions and determine the priority to be given to research on potential NHP-drug interactions

In the area of research related to reporting, dissemination and use of information about interactions, the four top priorities were:

• research into early warning systems for NHP-drug interactions (systems and strategies that can be used or developed to provide early indications of potential NHP-drug interactions, including population-based and product-based monitoring)
  
• assessment of the needs of stakeholders (consumers, practitioners, regulators, distributors, delivery systems) regarding information on NHPs and NHP-drug interactions
  
• using a focused, population-based approach to determine areas of greatest risk for NHP-drug interactions and mechanisms for collecting information about NHP-drug interactions
  
• identifying ways to make it easier for stakeholders to report information about adverse drug reactions/drug interactions, to make stakeholders more willing to report information, and to make stakeholders more capable in providing information
  Top of Page

Next Steps

As the above summary of recent activities indicates, there is growing momentum in Canada to build research capacity and to advance the research agenda with regard to CAHC and NHPs. Researchers, practitioners, consumers, information providers, industry, government and research funders are actively looking at specific and concrete ways to move forward.

In this context, there is a potential for synergy between the HIV/AIDS field and the broader CAHC/NHP field. With their long experience in the use of CAHC/NHPs, in research (biomedical, clinical, epidemiological, sociocultural, community-based), in community organization, industry relations, and in consultation and lobbying, people and organizations in the HIV/AIDS field have much to contribute to CAHC/NHP research. At the same time, the momentum in the broader CAHC/NHP field may help to strengthen the capacity of the HIV/AIDS field to identify, to participate in and to advance research on CAHC and NHPs, particularly research of special relevance to people with HIV/AIDS.

The roundtable on March 10-11, 2002 is intended to explore the potential for synergy - mutual strengthening and collaboration - in several specific areas. These have been selected because they have been identified as areas for action in HIV/AIDS consultations and/or in CAHC/NHP consultations:

• building research capacity
  
• methodological development
  
• NHP research
  
• health services research
  
• knowledge dissemination and uptake
  
• building and strengthening liaisons

Brief summaries of these areas follow. These summaries are not meant to be definitive, but are rather meant to identify some recurring themes with regard to the area. The overall objective of the roundtable is, in each of these areas:

• to identify priorities/opportunities
  
• to select three top priorities/opportunities
  
• to identify strategies to advance these top priorities/opportunities

Building research capacity

Building research capacity refers to efforts to increase the ability and readiness of individuals and organizations to identify, develop and conduct research on CAHC/NHPs. Some of the needs identified in recent consultations include:

• funding for CAHC/NHP training awards, research projects and research infrastructure
  
• mentors, role models and champions for CAHC/NHP research
  
• training in conducting research and using research findings for CAHC practitioners, educators and students
  
• training and funding for CAHC practitioners to write up case reports
  
• networks of researchers and practitioners to develop and implement research agendas
  
• research funding panels with appropriate expertise to review CAHC/NHP research projects
  
• research ethics boards with appropriate expertise to review CAHC/NHP research projects

Methodological development

CAHC/NHP researchers have emphasized the need to use or develop research methodologies that are appropriate to the therapy under investigation. This can be challenging. For example, what research methods are appropriate when studying practices based on the mind-body dynamic? Or, what research methods are appropriate when dealing with non-standardized therapies (e.g., individualized treatment regimens, incremental dosing of products, use of non-standard products or unique product preparations, etc.)? While randomized controlled clinical trials may be used or modified in some circumstances, in other circumstances other research methods such as individual case reports, case series, case-control studies, etc. may be needed. Researchers are asking for meetings and mechanisms by which they can address methodological issues and build bridges between different methodological schools (e.g., with conventional medical researchers). Among the issues to be addressed are types of evidence (What counts as evidence? What evidence is appropriate?) and measures of outcomes (What is being measured? Is the measure appropriate?).

Natural health products research

There have been recurring priorities in consultations about research on NHPs. These have included:

• review and evaluation of existing research
  
• product standards and quality control methodologies
  
• methods to characterize NHPs
  
• safety, efficacy, risks, dosage, indications and counter-indications of NHPs
  
• mechanisms of action for NHPs
  
• NHP-drug interactions (biomedical and clinical research)
  
• utilization of NHPs (widely-used NHPs, specific populations)
  
• the role of NHPs in managing HIV/AIDS and/or HIV antiretroviral therapy
  
• the role of NHPs in managing hepatitis C

Health practices/services research

Health practices research includes research to understand complementary/alternative modalities of practices and care, research to document their health outcomes, research to determine their efficacy and research to establish their cost-effectiveness, etc. Health services research includes research into the ways in which CAHC is provided, research into different types of combinations of CAHC and conventional health care, and research into the costs of CAHC, etc. Suggested areas of activity have included:

• research on the utilization of complementary/alternative practices and practitioners
  
• the review and evaluation of existing research
  
• case reports and case series
  
• controlled pilot studies to build bridges between complementary/alternative and conventional practitioners
  
• research on models of 'integrated' (complementary/alternative and conventional) health care
  
• research on therapeutic relationships that promote disclosure, informed consent and shared decision-making (particularly with conventional practitioners about CAHC/NHPs)
  
• research on the efficacy and cost-effectiveness of complementary/alternative practices or care
  
• the role of complementary/alternative practices or care in managing HIV/AIDS and/or HIV antiretroviral therapy
  
• the role of complementary/alternative practices or care in managing hepatitis C

Research dissemination and uptake

Consumers of CAHC/NHPs are looking for reliable, accessible and easy-to-understand information about CAHC/NHPs. Consequently, health intermediaries and information providers are working to evaluate and select information, to present information in ways that will be accessible to consumers, and to increase the skills of practitioners and consumers in working with information about CAHC/NHPs. Suggested ways to facilitate the dissemination and uptake of research have included:

• systematic reviews of research
  
• development of standardized concepts and terminology across CAHC modalities
  
• directories and networks that facilitate access to experts
  
• training for health intermediaries in understanding and evaluating research findings (critical appraisal skills, knowledge of research methods, knowledge of statistics and knowledge of the therapy under consideration)
  
• education of conventional practitioners about CAHC/NHP
  
• education of CAHC practitioners about conventional health care and health research

Building or strengthening liaisons

The effort to promote research on CAHC/NHPs is gathering momentum in Canada. People with HIV/AIDS, their national and community organizations and their practitioners have contributed to this momentum. However, other parties and stakeholders - other health communities and organizations, CAHC practitioners, industry and Health Canada - have also contributed. What are some specific ways to build or strengthen liaisons between the HIV/AIDS field and the broader CAHC/NHPs field?

References

Achilles R, Adelson N, Antze P, Biggs CL, Chabot P, Gilmour J, Jensen P, Muldoon J. York "Complementary and Alternative Health Practices and Therapies: A Canadian Overview." Toronto: York University Centre for Health Studies, 1999.

[Advisory Group = ] Advisory Group on Complementary and Alternative Health Care. "Towards an Integrative Health System." Pp. IV.45-52 in Perspectives on Complementary and Alternative Health Care: A Collection of Papers Prepared for Health Canada. Ottawa: Minister of Public Works and Government Services, 2001.

Boon H. "Assessing Research Literacy in Complementary and Alternative Health Care Products and Practices: An Invitational Roundtable." Toronto, August 13-14, 2001.

Cain R, Pawluch D, Gillett J. "Practitioner Perspectives on Complementary Therapy Use Among People Living with HIV." March 1999.

Crouch R, Elliott R, Lemmens T, Charland L. Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation. Montreal: Canadian HIV/AIDS Legal Network, 2001.

de Bruyn T (2001a). "Information and Informed Choice in the Use of Complementary and Alternative Health Care and Natural Health Products: An Invitational Roundtable." Vancouver, October 21-22, 2001.

de Bruyn T (2001b). "Health Law and Ethics in Relation to the Use of Complementary and Alternative Health Care and Natural Health Products: An Invitational Roundtable." Toronto, December 1-2, 2001.

de Bruyn T (2002). "Drug Interactions with Natural Health Products: A Research Priority-Setting Conference." Draft. Ottawa, January 10-11, 2002.

[Toward Integrative Care = ] "Toward Integrative Care: Report from a National Strategic Planning Meeting on Complementary Therapies and HIV/AIDS." Montreal, January 12-13, 2001.

Kendall T. "Optimal Environments for Integrated Care: Complementary and Alternative Medicine in HIV Management in British Columbia." March 2001.

MacDonald CA, Blair S, MacDonald D, Ryan B, Bowmer I, Bognar C, Mills B. "National HIV/AIDS Treatment Information Environmental Scan." December 2000.

McAmmond D. "Facilitating the Integration of Complementary Therapies into HIV Care and Treatment: Current Status and Ideas for Action." Draft. October 2000.

O'Hara DP. "Reviewing and Assessing the Role of the Natural Health Products Directorate in Research: An Invitational Roundtable." Ottawa, October 4-5, 2001.

[Priority Setting Conference = ] "Natural Health Products Research Priority-Setting Conference." Health Canada, Health Protection Branch, November 6-8, 1999.

Smith MJ. "Proposed Research Agenda for Natural Health Products Directorate 2001/2002." Draft. September 24, 2001.