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Biomedical subjects

Heather Boon

Publications and source records attributed to Heather Boon.

At least 19 recordsLinked to original sources
PubMed2006

U.S. and Canadian pharmacists' attitudes, knowledge, and professional practice behaviors toward dietary supplements: a systematic review.

BACKGROUND: Although dietary supplements (DS) are widely sold in pharmacies, the legal, ethical, and practice responsibilities of pharmacists with respect to these products have not been well defined. This systematic review of pharmacists' attitudes, knowledge, and professional practice behaviours toward DS is intended to inform pharmacy regulators' and educators' decision making around this topic. METHODS: Eligible studies were identified through a systematic database search for all available years through to March 2006. Articles were analyzed for this review if they included survey data on U.S. or Canadian pharmacists' attitudes, knowledge, or professional practice behaviors toward DS published in 1990 or later. RESULTS: Due to the heterogeneity of the data, it was not possible to draw a conclusion with respect to pharmacists' general attitudes toward DS. Approximately equal numbers of pharmacists report positive as well as negative attitudes about the safety and efficacy of DS. There is strong agreement among pharmacists for the need to have additional training on DS, increased regulation of DS, and quality information on DS. In addition, survey data indicate that pharmacists do not perceive their knowledge of DS to be adequate and that pharmacists do not routinely document, monitor, or inquire about patients' use of DS. Despite this, a large proportion of pharmacists reported receiving questions about DS from patients and other health care practitioners. CONCLUSION: Further research is needed to explore the factors that influence pharmacists' beliefs and attitudes about DS, to accurately evaluate pharmacists' knowledge of DS, and to uncover the reasons why pharmacists do not routinely document, monitor, or inquire about patients' use of DS.

Canada↗
PubMed2006

How far can complementary and alternative medicine go? The case of chiropractic and homeopathy.

This paper examines the efforts of two complementary and alternative occupations, chiropractors and homeopaths, to move from the margins to the mainstream in health care in the province of Ontario. We use a variety of theoretical perspectives to understand how health occupations professionalize: the trait functionalist framework, social closure, the system of professions, and the concept of countervailing powers. The research traces the strategies that the leaders of the two groups are employing, as well as the resources they are able to marshal. These are analyzed within the context of the larger institutional and cultural environment. The data are derived from in-person interviews with 16 leaders (10 chiropractic and 6 homeopathic) identified through professional associations, teaching institutions and informants from the groups. The responses were analyzed with qualitative content analysis. We also used archival materials to document what the leaders were telling us. The data revealed four main strategies: (1) improving the quality of educational programs, (2) elevating standards of practice, (3) developing more peer reviewed research, and (4) increasing group cohesion. Although both groups identified similar strategies, the chiropractors were bolstered by more resources as well as state sanctioned regulation. The efforts of the homeopaths were constrained by scarce resources and the absence of self-regulation. In both cases the lack of strong structural support from government and the established health professions played an important role in limiting what was possible. In the future, it may be to the state's advantage to modify the overall shape of health care to include alternative paradigms of healing along with conventional medical care. Such a shift would put complementary and alternative medicine occupations in a better position to advance professionally and become formal elements of the established health care system.

Chiropractic↗
PubMed2006

The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors.

BACKGROUND: The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance. METHODS: Twenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes. RESULTS: The major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size. CONCLUSION: The Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.

Canada↗
PubMed2006

New Canadian natural health product regulations: a qualitative study of how CAM practitioners perceive they will be impacted.

BACKGROUND: New Canadian policy to regulate natural health products (NHPs), such as herbs and vitamins were implemented on January 1st, 2004. We explored complementary and alternative medicine (CAM) practitioners' perceptions of how the new regulations may affect their practices and relationships with patients/consumers. METHODS: This was an applied ethnographic study. Data were collected in fall 2004 via qualitative interviews with 37 Canadian leaders of four CAM groups that use natural products as a core part of their practises: naturopathic medicine, traditional Chinese medicine (TCM), homeopathic medicine and Western herbalism. All interviews were transcribed verbatim and coded independently by a minimum of two investigators using content analysis. RESULTS: Three key findings emerged from the data: 1) all CAM leaders were concerned with issues of their own access to NHPs; 2) all the CAM leaders, except for the homeopathic leaders, specifically indicated a desire to have a restricted schedule of NHPs; and 3) only naturopathic leaders were concerned the NHP regulations could potentially endanger patients if they self-medicate incorrectly. CONCLUSION: Naturopaths, TCM practitioners, homeopaths, and Western herbalists were all concerned about how the new NHP regulations will affect their access to the products they need to practice effectively. Additional research will need to focus on what impacts actually occur as the regulations are implemented more fully.

Biological Products↗
PubMed2006

Redefining the randomized controlled trial in the context of acupuncture research.

BACKGROUND: The randomized controlled trial (RCT) is considered the 'gold standard' methodology for evaluating efficacy of an intervention. It has been argued that RCTs cannot be used to examine the effectiveness of acupuncture. PURPOSE: The purpose of this paper is to examine the applicability of an RCT study design for acupuncture research. FINDINGS: RCTs would be more effective in studying acupuncture if study participants were randomized to groups based on the acupuncture diagnosis and not solely on the Western diagnostic criteria. Treatments must also be standardized somewhat to ensure replicability of the study and the information it provides. Blinding is not absolutely necessary for a good-quality RCT; however, if used, control groups need to be standardized and sham techniques evaluated to ensure accurate interpretation of results. CONCLUSIONS: With these factors combined, it is possible to greatly increase internal and external validity in acupuncture RCTs.

Acupuncture Therapy↗
PubMed2006

Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement.

Herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized, controlled trials (RCTs). The authors' objective was to develop recommendations for reporting RCTs of herbal medicine interventions, based on the need to elaborate on the 22-item CONSORT (Consolidated Standards of Reporting Trials) checklist. Telephone calls were made and a consensus meeting was held with 16 participants in Toronto, Canada, to develop these recommendations. The group agreed on context-specific elaborations of 9 CONSORT checklist items for RCTs of herbal medicines. Item 4, concerning the herbal medicine intervention, required the most extensive elaboration. These recommendations have been developed to improve the reporting of RCTs using herbal medicine interventions.

Herbal Medicine↗
PubMed2006

Quality of reporting of randomized controlled trials of herbal medicine interventions.

BACKGROUND: Public interest in herbal medicines has generated an increasing number of trials evaluating their efficacy. Trials with poor methodologic quality have exaggerated estimates of treatment effect, and incomplete reporting of trials causes difficulties in assessing trial methodologic quality. The objective of this project was to examine the quality of reporting of randomized controlled intervention trials of herbal medicine. METHODS: MEDLINE (1966 to September 2003) was searched for randomized controlled trials of 10 herbal medicines. Two individuals (J. G. and J. D.) independently assessed trials using the Consolidated Standard of Reporting Trials checklist. Disagreements were resolved by consensus. The mean number of checklist items reported across all and for individual herbal medicines was calculated. The influence of decade of publication and species of herbal medicine tested was explored using an analysis of variance. RESULTS: A total of 206 randomized controlled trials of herbal medicine were included. Interrater reliability on reporting quality assessment was high. A total of 45% of items were reported across all trials. The quality of reporting improved across decades from the 1970s to the 2000s. Individual herbal species differed in the total number of items reported, with echinacea, ginkgo, St. John's wort, and kava trials reporting the most items. CONCLUSIONS: Important methodologic components of randomized controlled trials of herbal medicines are incompletely reported including allocation concealment, method used to generate the allocation sequence, and whether an intention-to-treat analysis was used. Also, key information unique to these trials may be missing, such as percentage of active constituents and type or form of the herbal medicine preparation. We suggest trialists consult a recent extension of the Consolidated Standard of Reporting Trials statement specific to herbal medicine trials when designing and reporting randomized controlled intervention trials of herbal medicines.

Biomedical Research↗
PubMed2006

Improving the quality of reporting of randomized controlled trials evaluating herbal interventions: implementing the CONSORT statement [corrected].

BACKGROUND: Given that herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized controlled trials (RCTs), such RCTs must clearly report the specifics of the intervention. OBJECTIVE: Our objective was to develop recommendations for reporting RCTs of herbal medicine interventions. METHODS: We identified and invited potential participants with expertise in clinical trial methodology, clinical trial reporting, pharmacognosy, herbal medicinal products, medical statistics, and/or herbal product manufacturing to participate in phone calls and a consensus meeting. Three phases were conducted: (1) Premeeting item generation via telephone calls, (2) Consensus meeting, and (3) Postmeeting feedback. Sixteen experts participated in premeeting phone calls for item generation, and 14 participants attended a consensus meeting in Toronto, Ontario, Canada, in June of 2004. During the consensus meeting, a modified Delphi technique was used to aid discussion and debate of information required for reporting RCTs of herbal medicines. RESULTS: After extensive discussion, the group decided that context-specific elaborations of nine Consolidated Standards of Reporting Trials (CONSORT) items to RCTs of herbal medicines were necessary: Item 1 (Title and Abstract), 2 (Background), 3 (Participants), 4 (Interventions), 6 (Outcomes), 15 (Baseline data), 20 (Interpretation), 21 (Generalizability), and 22 (Overall evidence). DISCUSSION: The elaboration of item 4 of the CONSORT statement outlines specific information required for complete reporting of the herbal medicine intervention. The reporting suggestions presented will support clinical trialists, editors, and reviewers in reporting and reviewing RCTs of herbal medicines and readers in interpreting the results.

Consensus↗
PubMed2006

Recommendations for reporting randomized controlled trials of herbal interventions: Explanation and elaboration.

Controlled trials that use randomized allocation are the best tool to control for bias and confounding in trials testing clinical interventions. Investigators must be sure to include information that is required by the reader to judge the validity and implications of the findings in the reports of these trials. In part, complete reporting of trials will allow clinicians to modify their clinical practice to reflect current evidence toward the improvement of clinical outcomes. The consolidated standards of reporting trials (CONSORT) statement was developed to assist investigators, authors, reviewers, and editors on the necessary information to be included in reports of controlled clinical trials. The CONSORT statement is applicable to any intervention, including herbal medicinal products. Controlled trials of herbal interventions do not adequately report the information suggested in CONSORT. Recently, reporting recommendations were developed in which several CONSORT items were elaborated to become relevant and complete for randomized controlled trials of herbal medicines. We expect that these recommendations will lead to more complete and accurate reporting of herbal trials. We wrote this explanatory document to outline the rationale for each recommendation and to assist authors in using them by providing the CONSORT items and the associated elaboration, together with examples of good reporting and empirical evidence, where available, for each. These recommendations for the reporting of herbal medicinal products presented here are open to revision as more evidence accumulates and critical comments are collected.

Complementary Therapies↗
PubMed2006

Trial of Essiac to ascertain its effect in women with breast cancer (TEA-BC).

BACKGROUND: Breast cancer is a major cause of morbidity, mortality, and medical expenditures among women in Canada. Essiac (Resperin Canada Limited, Waterloo, Ontario, Canada), a blend of at least four herbs (burdock root [Arctium lappa], Indian rhubarb [Rheum palmatum], sheep sorrel [Rumex acetosella], and the inner bark of slippery elm [Ulmus fulva or U. rubra]), has become one of the more popular herbal remedies for breast-cancer treatment, secondary prevention, improving quality of life, and controlling negative side-effects of conventional breast-cancer treatment. OBJECTIVES: Our primary objective was to determine the difference in health-related quality of life (HR-QOL), as assessed by the Functional Assessment of Cancer Therapy Breast Cancer Version, between women who are new Essiac users (since breast cancer diagnosis) and those who have never used Essiac. Secondary endpoints included differences in depression, anxiety, fatigue, rate of adverse events, and prevalence of complications or benefits associated with Essiac during standard breast-cancer treatment. Additionally, we described the pattern of use of Essiac in this cohort of women. METHODS: We performed a retrospective cohort study in 510 women, randomly chosen from the Ontario Cancer Tumour Registry, with a diagnosis of primary breast cancer in 2003. RESULTS: With the exception changes in a Physical well-being subscale and a relationship with doctor subscale, Essiac did not have a significant effect on HR-QOL or mood states. Even for Physical well-being and relationship with doctor, Essiac seemed to have a negative effect, with Essiac users doing worse than the non-Essiac users. This might be attributed to the fact that the group of users comprised younger women with more advanced stages of breast cancer, and both of these subgroups of patients have been shown to be at a significantly increased risk for negative mood states and/or a decreased sense of well-being. The women were taking low doses (total daily dose 43.6 +/- 30.8 mL) of Essiac that corresponded to the label directions found on most Essiac products. Friends were the most common source of information, and most women were taking Essiac to boost their immune systems or increase their chances of survival. Only 2 women reported minor adverse events, whereas numerous women reported beneficial effects of Essiac. CONCLUSIONS: Essiac does not appear to improve HR-QOL or mood states. Future studies are needed to determine whether other clinical outcomes, such as cancer reoccurrence, are affected by Essiac.

Adult↗
PubMed2005

Integrating complementary and alternative medicine into academic medical centers: experience and perceptions of nine leading centers in North America.

BACKGROUND: Patients across North America are using complementary and alternative medicine (CAM) with increasing frequency as part of their management of many different health conditions. The objective of this study was to develop a guide for academic health sciences centers that may wish to consider starting an integrative medicine program. METHODS: We queried North American leaders in the field of integrative medicine to identify initial sites. Key stakeholders at each of the initial sites visited were then asked to identify additional potential study sites (snowball sampling), until no new sites were identified. We conducted structured interviews to identify critical factors associated with success and failure in each of four domains: research, education, clinical care, and administration. During the interviews, field notes were recorded independently by at least two investigators. Team meetings were held after each visit to reach consensus on the information recorded and to ensure that it was as complete as possible. Content analysis techniques were used to identify key themes that emerged from the field notes. RESULTS: We identified ten leading North American integrative medical centers, and visited nine during 2002-2003. The centers visited suggested that the initiation of an integrative medicine program requires a significant initial outlay of funding and a motivated "champion". The centers had important information to share regarding credentialing, medico-legal issues and billing for clinical programs; identifying researchers and research projects for a successful research program; and strategies for implementing flexible educational initiatives and establishing a functional administrative structure. CONCLUSION: Important lessons can be learned from academic integrative programs already in existence. Such initiatives are timely and feasible in a variety of different ways and in a variety of settings.

Academic Medical Centers↗
PubMed2005

Guggul for hyperlipidemia: a review by the Natural Standard Research Collaboration.

OBJECTIVE: To evaluate the scientific evidence on guggul for hyperlipidemia including expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing. METHODS: Electronic searches were conducted in nine databases, 20 additional journals (not indexed in common databases), and bibliographies from 50 selected secondary references. No restrictions were placed on language or quality of publications. All literature collected pertained to efficacy in humans, dosing, precautions, adverse effects, use in pregnancy/lactation, interactions, alteration of laboratory assays, and mechanism of action. Standardized inclusion/exclusion criteria were utilized for selection. RESULTS: Before 2003, most scientific evidence suggested that guggulipid elicits significant reductions in serum total cholesterol, low-density lipoprotein (LDL), and triglycerides, as well as elevations in high-density lipoprotein (HDL) [Kotiyal JP, Bisht DB, Singh DS. Double blind cross-over trial of gum guggulu (Commiphora mukul) Fraction A in hypercholesterolemia. J Res Indian Med Yoga Hom 1979;14(2):11-6; Kotiyal JP, Singh DS, Bisht DB. Gum guggulu (Commiphora mukul) fraction 'A' in obesity-a double-blind clinical trial. J Res Ayur Siddha 1985;6(1, 3, 4):20-35; Gaur SP, Garg RK, Kar AM, et al. Gugulipid, a new hypolipidaemic agent, in patients of acute ischaemic stroke: effect on clinical outcome, platelet function and serum lipids. Asia Pacif J Pharm 1997;12:65-9; Urizar NL, Liverman AB, Dodds DT, et al. A natural product that lowers cholesterol as an antagonist ligand for the FXR. Science 3 May 2002 [Science Express Reports]; Nityanand S, Srivastava JS, Asthana OP. Clinical trials with gugulipid. A new hypolipidaemic agent. J Assoc Physicians India 1989;37(5):323-8; Kuppurajan K, Rajagopalan SS, Rao TK, et al. Effect of guggulu (Commiphora mukul-Engl.) on serum lipids in obese, hypercholesterolemic and hyperlipemic cases. J Assoc Physicians India 1978;26(5):367-73; Gopal K, Saran RK, Nityanand S, et al. Clinical trial of ethyl acetate extract of gum gugulu (gugulipid) in primary hyperlipidemia. J Assoc Physicians India 1986;34(4):249-51; Agarwal RC, Singh SP, Saran RK, et al. Clinical trial of gugulipid-a new hypolipidemic agent of plant origin in primary hyperlipidemia. Indian J Med Res 1986;84:626-34; Verma SK, Bordia A. Effect of Commiphora mukul (gum guggulu) in patients of hyperlipidemia with special reference to HDL-cholesterol. Indian J Med Res 1988;87:356-60; Singh RB, Niaz MA, Ghosh S. Hypolipidemic and antioxidant effects of Commiphora mukul as an adjunct to dietary therapy in patients with hypercholesterolemia. Cardiovasc Drugs Ther 1994;8(4):659-64; Ghorai M, Mandal SC, Pal M, et al. A comparative study on hypocholesterolaemic effect of allicin, whole germinated seeds of bengal gram and guggulipid of gum gugglu. Phytother Res 2000;14(3):200-02]. However, most published studies were small and methodologically flawed. In August 2003, a well-designed trial reported small significant increases in serum LDL levels associated with the use of guggul compared to placebo [Szapary PO, Wolfe ML, Bloedon LT, et al. Guggulipid for the treatment of hypercholesterolemia: a randomized controlled trial. JAMA 2003;290(6):765-72]. No significant changes in total cholesterol, high-density lipoprotein (HDL), or triglycerides were measured. These results are consistent with two prior published case reports [Das Gupta R. Gugulipid: pro-lipaemic effect. J Assoc Physicians India 1990;38(12):346]. CONCLUSION: The effects of guggulipid in patients with high cholesterol are not clear, with some studies finding cholesterol-lowering effects, and other research suggesting no benefits. At this time, there is not enough scientific evidence to support the use of guggul for any medical condition. Guggul may cause stomach discomfort or allergic rash as well as other serious side effects and interactions. It should be avoided in pregnant or breast-feeding women and in children. Safety of use beyond 4 months has not been well studied.

Clinical Trials as Topic↗
PubMed2005

CAM in Canada: places, practices, research.

This paper reflects on the practice and research of complementary and alternative medicine (CAM) in Canada. Although certain trends in use, as well as the regulation and integration of CAM, are mirrored in many other developed countries, some are highlighted as uniquely Canadian with distinct political and economic geographies. Similarly, although like in other countries the research of CAM is growing rapidly, Canadian scholars have been particularly productive in terms of providing unique disciplinary perspectives and the ways in which they have organized their research training and collaborations. CAM is clearly not a fully integrated and researched option in Canadian health care, yet Canada exhibits the foundations for an integrated CAM practice, supported by a growing, wide-ranging and well-articulated research evidence-base.

Canada↗
PubMed2005

Complementary and alternative medicine whole systems research: beyond identification of inadequacies of the RCT.

Complementary and alternative medicine (CAM) often consists of whole systems of care (such as naturopathic medicine or traditional Chinese medicine (TCM)) that combine a wide range of modalities to provide individualised treatment. The complexity of these interventions and their potential synergistic effect requires innovative evaluative approaches. Model validity, which encompasses the need for research to adequately address the unique healing theory and therapeutic context of the intervention, is central to whole systems research (WSR). Classical randomised controlled trials (RCTs) are limited in their ability to address this need. Therefore, we propose a mixed methods approach that includes a range of relevant and holistic outcome measures. As the individual components of most whole systems are inseparable, complementary and synergistic, WSR must not focus only on the "active" ingredients of a system. An emerging WSR framework must be non-hierarchical, cyclical, flexible and adaptive, as knowledge creation is continuous, evolutionary and necessitates a continuous interplay between research methods and "phases" of knowledge. Finally, WSR must hold qualitative and quantitative research methods in equal esteem to realize their unique research contribution. Whole systems are complex and therefore no one method can adequately capture the meaning, process and outcomes of these interventions.

Complementary Therapies↗
PubMed2005

Integrative health care: how can we determine whether patients benefit?

OBJECTIVE: Evaluation of integrative health care (IHC) models is becoming increasingly important. One of the areas that requires further attention is the development of an appropriate set of outcome measures. The purpose of this study was: (1) to identify how cancer patients phrase and frame the beneficial outcomes they experienced from IHC, and (2) to develop recommendations for an appropriate outcome measures package for evaluation of IHC. DESIGN: This study involved two different parts: (1) a secondary analysis of qualitative data consisting of transcripts from 42 personal interviews and three focus groups from previous studies related to IHC use by cancer patients; and (2) a content analysis of goal-setting data collected from patients attending an IHC clinic to categorize the type and range of their treatment goals. RESULTS: Six types of benefits were identified: physical well-being, change in physiological indicators, improved emotional well-being, personal transformation, feeling connected, global state of well-being, and cure. Types of goals identified by patients confirmed these benefits and include: to improve state of being, to be cancer free, to have more energy, more effective pain management, and improved quality of life. CONCLUSIONS: A patient's perspective is crucial in understanding the process and outcomes of intentional selfhealing. Assessing self-identified goals suggests the need for patient empowerment through participation in outcome evaluation. We present recommendations for an appropriate outcomes package that is relevant, practical, and based on patient experiences.

Complementary Therapies↗