PATIENT REPORTING OF HERBAL REMEDY USE: A COMMUNICATION PROBLEM IN PRIMARY CARE By Carol Christine Flanders, RN, BSN Submitted in Partial Fulfillment of the Requirements for the Master of Science in Nursing Degree Edinboro University of Pennsylvania Approved by: /I Judith Schilling, CRNP, PhD Committee Chairperson 'Date^ "7'^9 -to Jan ^3ejgel, PhD, RN Committee Member Date Abstract Patient Reporting of Herbal Remedy Use: A Communication Problem in Primary Care There has been a large increase over the last 10 years in the use of herbal remedies by the general population of the United States (Greenwald, 1998). The FDA does not regulate herbal remedies as drugs but as nutritional supplements (Glisson, Crawford, & Street, 1999). Up to 75% of patients are self-medicating with herbal remedies without consulting primary care physicians and practitioners (Glisson et al., 1999). There is a potential for drug-drug interactions, side effects from inappropriate dosing, and delay in the treatment of serious medical conditions with self-medication with herbal remedies (Barnes, Mills, Abbott, Willoughby, & Ernst, 1998) Understanding the reason for the nondisclosure of herbal remedy use is critical to the improvement of physician-patient communication and patient care and safety (Glisson et al.)). A self-administered survey was conducted in a large rural primary care facility to further define demographics of herbal remedy users, to assess why they choose to utilize herbal remedies, and to assess the patient-provider communication barriers concerning herbal remedy use. The survey had an 86.5% return rate and showed that in this population sample of 865 subjects, 49% had used herbal remedies at some time. The herbal remedy users were more likely to be 36 to 45 years of age (%2=7.2, p=0.01), have about the same household income as nonusers, 2 be married, have some college or vocational education (% =13.4, p=0.001) or bachelor degree (X2=9.8, p=0.01), and, like nonusers, rate their overall health as "good" on the day of the survey. In summary, the percent of herbal remedy users in primary care practices is much higher than the previous studies have shown. Fifty-seven percent of all subjects had not offered or asked information about herbal remedies from their providers and staff. Ninety-five percent of i Abstract Patient Reporting of Herbal Remedy Use: A Communication Problem in Primary Care There has been a large increase over the last 10 years in the use of herbal remedies by the general population of the United States (Greenwald, 1998). The FDA does not regulate herbal remedies as drugs but as nutritional supplements (Glisson, Crawford, & Street, 1999). Up to 75% of patients are self-medicating with herbal remedies without consulting primary care physicians and practitioners (Glisson et al., 1999). There is a potential for drug-drug interactions, side effects from inappropriate dosing, and delay in the treatment of serious medical conditions with self-medication with herbal remedies (Barnes, Mills, Abbott, Willoughby, & Ernst, 1998) Understanding the reason for the nondisclosure of herbal remedy use is critical to the improvement of physician-patient communication and patient care and safety (Glisson et al.)). A self-administered survey was conducted in a large rural primary care facility to further define demographics of herbal remedy users, to assess why they choose to utilize herbal remedies, and to assess the patient-provider communication barriers concerning herbal remedy use. The survey had an 86.5% return rate and showed that in this population sample of 865 subjects, 49% had used herbal remedies at some time. The herbal remedy users were more likely to be 36 to 45 years of age (%2=7.2, p=0.01), have about the same household income as nonusers, 2 be married, have some college or vocational education (% =13.4, p=0.001) or bachelor degree 0,2=9.85 p=0.01), and, like nonusers, rate their overall health as "good" on the day of the survey. In summary, the percent of herbal remedy users in primary care practices is much higher than the previous studies have shown. Fifty-seven percent of all subjects had not offered or asked information about herbal remedies from their providers and staff. Ninety-five percent of ii respondents had not been asked about them by the staff. Communication barriers may be causing a situation where herbal remedy users might have drug/herbal remedy interactions that would affect their medical care. Suggestions are offered for better provider/patient communication as well as future research. iii Acknowledgments I would like to express my sincere appreciation to all those people who helped me complete this research project. To Dr. Judith Schilling, thank you for being the chairperson of this committee and for interrupting my tunnel vision to allow me to see the whole picture. To Dr. Alice Conway, thank you for your objective views of the research and your knowledge of herbal remedies. To Dr. Janet Geisel, thank your for your day-to-day input, encouragement, and understanding of the research process. To Dr. Buckwaiter, thank you for your statistical expertise and interest in the subject of herbal remedies. Thank you to the Westfield Family Physicians organization for their cooperation and support of this research. Dr. Don Brautigam's enthusiasm and the tireless efforts of the staff helped this project to be meaningful not just for their offices but for providers and patients in other rural areas. This study received partial support from Nu Theta Chapter, Sigma Theta Tau on April 1, 2000. iv Table of Contents Content Page Abstract i Acknowledgements List of Tables List of Figures Chapter 1: Introduction Background of the Problem ni viii ix 1 1 Communication 2 Natural is Better 3 Statement of the Problem 4 Theoretical Framework .4 Statement of the Purpose 7 Assumptions 7 Limitations 8 Definition of Terms 8 Summary 9 Chapter 2: Review of the Literature. History. 11 11 Ayurveda 11 Traditional Chinese Medicine 12 Naturopathy. 12 Homeopathy 13 V Content Complementary and Alternative Medicine Page 13 Regulation of Herbal Remedies 15 Nutritional Supplements 15 Manufacturing 16 Research 18 Prescriptive Authority 18 Self-Care and Self-Medication 19 The Risk of Herbal Remedy Use 20 Demographics of Herbal Remedy Users 21 Provider-Patient Communication, 24 Summary 26 Chapter 3: Methodology 28 Research Questions 28 Research Design, 28 Sample, Setting, and Procedure 29 Instrumentation 29 Protection of Human Rights 30 Pilot Study, 30 Data Analysis 31 Summary 32 Chapter 4: Findings Sample, 33 33 vi Content Page Results 33 Herbal Remedy Users 34 Demographics 34 Overall Health 39 Herbal Remedy Use 40 Risk/Benefit Knowledge 42 Adverse Reactions .48 Herbal Remedy Knowledge 50 Communication 51 Summary 55 Chapter 5: Discussion Herbal Remedy Users 57 58 Demographics 58 Herbal Remedy Use 60 Risk/Benefit Knowledge 61 Knowledge 63 Communication 62 Conclusions 64 Limitations of the Study 64 Recommendations for Further Study 65 Summary 65 vii Content Page References 67 Appendix A: Side Effect Profiles of Common Herbal Remedies 73 Potentially Toxic Herbs Appendix B: Patient/Provider Communication Strategies Communication Strategies for the Patient 75 78 80 Appendix C: Herbal Remedy Survey 81 Appendix D: Raw Data Tables 86 viii List of Tables Table Page 1: Gender: Percentage of Total Sample (N=865), User and Nonuser Status 34 2: Age Comparison of Herbal Remedy Users and Nonusers 35 3: Income Comparison of Herbal Remedy Users and Nonusers 36 4: Marital Status Comparison of Herbal Remedy Users and Nonusers 37 5: Highest Education Level Comparison of Herbal Remedy Users and Nonusers 38 6: Herbal Remedy Use Comparison Of Users and Nonusers 42 7: Who Recommended Herbal Remedies Comparison of Users and Nonusers .44 8: Who Could Recommend Herbal Remedies, Comparison of Users and Nonusers 46 9: Are Herbal Remedies More Natural, Comparison of Users and Nonusers .47 10: Comparison of Herbal Remedy Users and Nonusers Interpretation of the word “Natural” 48 11: Comparison of herbal Remedy Users and Nonusers, Reasons for Using Herbal Remedies 50 12: Communication: Updating Medications List Comparison of Herbal Remedy Users and Nonusers 52 13: Communication: Staff Asking About Herbal Remedies Comparison of Users and Nonusers.... 5 3 14: Communication: Volunteering of Herbal Remedy Use Comparison of Users and Nonusers 54 15: Communication: Ask Information from MD/NP Comparison of Users and Nonusers 56 ix List of Figures Figure 1. Revised Health Promotion Model 2. Spearman Rank Order Correlation Scattergram: Overall Health Page 5 40 1 Chapter 1 Introduction This chapter provides a brief overview of the use of herbal remedies by the general population of the United States. This study utilized a survey to determine the demographics of herbal remedy users in a primary care setting, their perceived risk and benefits of herbal remedies, and what barriers they perceived to communication with their clinicians about their use of the herbal remedies. The Health Promotion Model by Nola J. Pender, PhD, RN, FAAN (1996) was the theoretical framework for this study. Assumptions, limitations, and definition of the terms utilized in the survey are also included. Background of the Problem It has been estimated that up to one in three patients have used some form of unconventional therapy within the past year, including megavitamins and herbal remedies (Hadley & Petry, 1999; Glisson, Crawford, & Street, 1999; O’Koon, 1999; Greenwald, 1998). This commercial boom comes years after the common use of herbal remedies in the rest of the world (Greenwald, 1998; Berg, Amelia, Gagan, & McArthur, 1998). The Federal Drug Administration does not regulate herbal remedies as medications. They are nutritional supplements that do not have to go through the rigorous testing and proof of efficacy that prescription drugs are required to pass (Glisson et al., 1999). Patients are not asking their primary care providers’ advice about the herbal remedies. Many patients may not tell their provider that they take herbs and other nutritional supplements. One estimate is that up to 75% of patients did not notify their primary caregiver about their use of alternative medicine (Glisson et al.), while an 2 estimated 15 million adults in 1997 took prescription medications concurrently with herbal remedies and/or high-dose vitamins (Eisenberg et al., 1998). Another interesting finding is from a recent British study of patients experiencing a serious adverse drug reaction to an herbal or other over-the-counter remedy (Barnes, Mills, Abbot, Willoughby, & Ernst, 1998). Over 42% would not consult their physician about the adverse reaction. Of the 26% who would call their physician with a severe adverse reaction, none said they would if it was an herbal remedy rather than an over-the-counter medicine had caused the problem (Barnes, et al., 1998). More than 60 million people in the United States use alternative medicines (Fetrow & Avila, 1999). Herbal remedies are being used with increasing frequency by patients who seek treatment with largely unresearched therapies. This has become a daily problem in primary care practices everywhere (Fetrow & Avila., 1999). The focus of further research could be best guided by a general fact finding survey in these busy primary care practices. Communication. Fetrow & Avila (1999) wrote about the rights of patients to information from their health care providers about herbal remedies just as they have the right to information about prescription medications. Patients need to know drug-drug interactions, side effect profiles, dosing, and duration of treatment. This all needs to be done in a nonjudgmental manner to promote communication (Wisneski, 1999a). Traditional (allopathic) medicine has often taken a paternalistic role in health care, while the alternative or integrative approaches have tended to work in partnership with patients (Berg, Amelia, Gagan, & McArthur, 1998). 3 Most allopathic approaches tend to be aggressive or invasive, while integrative therapies generally take a gentler or slower approach. Moreover, most integrative therapies focus on optimizing and fortifying health while ameliorating symptomatology. In a review of integrative therapies, Chung described the ’softness’ of integrative therapies that use soothing words, such as “to restore balance,’ ‘to tonify,’ and ‘to enhance,’ while allopathic approaches use harsher words like ‘painkillers’ ‘antibiotic’, and ‘anti-inflammatory.’ (Berg et al., 1998, p. 542) Natural is Better. Patients who self-medicate with herbs for preventive and therapeutic purposes may assume that these products are safe because they are "natural,” but some products cause adverse effects or have the potential to interact with prescription medications (Berg, Amelia, Gagan, & McArthur, 1998; Greenwald, 1998). Physicians and practitioners need to educate themselves and their patients about the efficacy and adverse interactions of herbal agents and especially the limitations of our present knowledge about them (Zink & Chaffin, 1998). Lay literature, whether written, on radio and TV, or on the Internet, freely endorses the use of herbal medicines (Greenwald, 1998). Anecdotal accounts of so-called cures promote the use of the plants. Fetrow & Avila (1999) documented that occasionally these stories of success with herbs have taken on almost mythical or supernatural proportions. To avoid drug-herb interactions or exacerbation of an existing medical condition, nurse practitioners and all providers need to be available to their patients to help in the decision making process concerning self- medication with herbal remedies. 4 Statement of the Problem Natural herbal remedies are a large part of the national movement to the use of complementary and alternative medicine (Fetrow & Avila, 1999). More than 60 million people in the United States report using alternative medicines (Fetrow & Avila, 1999). Of these, three out of four patients did not notify their primary care provider about their use of alternative medicine (Glisson, Crawford, & Street, 1999). Understanding the reason for nondisclosure is critical to the improvement of provider-patient communication and patient care (Glisson et al., 1999). Primary care practices, whether rural or urban, need to become more educated in phytomedicine and other alternative therapies (Fetrow & Avilla, 1999). Barriers to communication between providers and patients need to be addressed to reverse the 75% who do not reveal their alternative therapies during acute or routine primary care visits (Glisson, Crawford, & Street, 1999). Talking with patients about their use of alternative therapies is not significantly different "from exploring patients' use of alcohol or drugs, exposure to abuse, or preferences for cardiopulmonary resuscitation. Each is critically important to maintaining health and, respecting patient values, each takes time.” (Hadley & Petry, 1999, p. 122) Theoretical Framework Barriers that prevent patients’ communication of self-medication to primary care providers need to be assessed (Glisson, Crawford, & Street, 1999). Herbal remedies highly advertised by the media, and on display in grocery stores and pharmacies, are being self prescribed by patients (Hadly & Petry, 1999; Glisson et al., 1999). Serious drug-drug interactions with prescription medications, and side effects from mega-dosing 5 of herbal remedies, are becoming an every day problem in primary care practices (Barnes, Mills, Abbot, Willoughby, & Ernst, 1998). The Revised Health Promotion Model (HPM) by Nola Pender, PhD, RN, FAAN (Figure I) assesses the cues to action and the barriers to action for health promoting behaviors (Pender, 1996). This is a wellness-oriented model rather than a disease oriented model such as Becker’s Health Belief Model (1974). BEHAVIOR SPECIFIC COGNITIONS INDIVIDUAL CHARACTERISTICS AND EXPERIENCES BEHAVIORAL OUTCOME PERCEIVED BENEFITS OF ACTION PRIOR PERCEIVED BARRIERS RELATED BEHAVIOR IMMEDIATE COMPETING TO ACTION DEMANDSAND PREFERENCES PERCEIVED SELF-SUFFICIENCY PERSONAL FACTORS BIOLOGICAL ► ACTIVITY-RELATED AFFECT PSYCHOLOGICAL SOCIOCULTURAL INTERPERSONAL INFLUENCES; FAMILY, PEERS, PROVIDERS u V COMMITMENT TO A PLAN HEALTH OF ACTION PROMOTING BEHAVIOR > SITUATIONAL INFLUENCES 4 I Figure 1. Revised Health Promotion Model: Balance of perceived benefits and barriers to health promotion resulting in behavioral outcomes of health promoting behavior (Pender, 1996, p. 160-161). One of the incentives to action might be to prevent illness or injury by taking an herbal remedy. Pender proposes another incentive to action, the desire for enhanced well 6 being. Herbal products to boost the immune system, for example, could be used to attain this goal (Fetrow & Avila, 1999). The HPM is based on social cognitive theory in which cognition, affect, actions, and environmental events all interact in determining health promoting behaviors (Polit & Hungler, 1999). There are two phases in Pender’s HPM, a decision making phase and an action phase. Pender cites seven factors in the decision making phase that directly affect participation in health promoting behaviors: (a) the importance of health, (b) perceived self-sufficiency, (c) definition of health, (d) perceived health status, (e) perceived benefits of health promoting behavior, and (f) perceived barriers. There are also five modifying factors that indirectly influence patterns of health behavior: (a) demographic characteristics, (b) biologic characteristics, (c) interpersonal influences, (d) situational factors, and (e) behavioral factors (Pender, 1996). Patients move back and forth between the decision and action phases. Patients who decide to take an herbal over-the-counter remedy have consciously or unconsciously gone through the processes described in the HPM (Pender, 1996). Patients seem to have a barrier to discussing self-medication with their primary care physician (Glisson, Crawford, & Street, 1999). Patients taking herbal remedies may not sense any harm or adverse consequences in taking these products (Greenwald, 1998), and so do not seek the advice or approval of these products (Barnes, Mills, Abbot, Willoughby, & Ernst, 1999). They may fear disapproval by the physician for the use of an unknown treatment or because the physician’s health care directives were not exclusively followed (Belson, 1999). 7 The HPM by Pender (1996) provided a framework to help define the problem of patient self-medication versus the traditional allopathic medications. The model helped to focus research on the barriers to communication and the knowledge gaps that are producing the patients’ self-medication without disclosure or the knowledge of risks (Glisson, Crawford, & Street, 1999). Statement of the Purpose The purpose of this research was to understand who is taking herbal remedies and why. The users' perceived risk and benefits of herbal remedy use needs to be understood. Barriers to patient communication and consultation about herbal remedy use and efficacy with primary care providers need to be uncovered. Assumptions For the purpose of this study, the following assumptions were made: 1. Patients are motivated to learn. 2. Patients would ask for help in deciding whether to add herbal remedies to their medications if they perceived no barrier to communication with their provider. 3. The current model of medicine is changing to one of partnering in health care rather than a paternalistic directing of health care. 4. Nurse practitioners’ educational focus on health promotion and communication make them ideal providers to lead the integration of complementary therapies such as herbal remedies that have been proven safe and effective. 5. The research subjects could read English and comprehend the survey. 8 Limitations The limitations of the study were identified as follows: 1. The research subjects were comprised of a convenience sample in a large primary care practice in western New York, which has three locations and approximately 4,500 patient visits per month. Survey results, therefore, may not apply to other primary care populations. 2. The survey instrument was researcher-developed. Definition of Terms 1. Complementary or alternative medicines (CAM) are self-initiated treatments, as well as approaches and techniques, that were not traditionally taught in medical or nursing schools, and that were not prescribed by clinicians trained in the Western Medical Tradition (Berg, Amelia, Gagan, and McArthur, 1998). These include traditional Chinese medicine, acupuncture, homeopathy, massage therapy, therapeutic touch, guided imagery, and herbal remedies to name a few. 2. Herbal remedies are plant-based remedies that are outside of the traditional biomedical paradigm and that are designated nutritional supplements by the FDA (Fetrow & Avilla, 1999). 3. Phytomedicine is the practice of using plants or plant parts to achieve a therapeutic improvement (Fetrow & Avila, 1999). 4. Allopathic medicine is traditional Western-based medicine as we know it in the United States (Integrative Medicine Primer [IMP], 1999). 5. Self-medication is the practice of patients who decide without the advice or counsel of their health care provider to take an over-the-counter (OTC) medication. This 9 can be for an acute or chronic physical complaint. It can also be to prevent an illness or disease. Patients can use one that is a FDA approved OTC medication or a nutritional supplement such as an herbal remedy (IMP, 1999). 6. Adverse event refers to any unintended physical problem caused by a medication that requires medical attention. An example would be an anaphylactic reaction to penicillin or to an herbal remedy such as feverfew (IMP). 7. Side effect refers to a physical problem caused by the use of a medication that is not serious enough to stop the medication or to seek professional help. An example would be diarrhea with the administration of erythromycin or a photosensitivity reaction to St. John’s Wort (IMP). 8. Drug-drug interaction refers to either the enhancement of a drug’s action in the body or the decreased efficacy of a drug when taken with another prescription or OTC medication. An example is the enhanced anticoagulation effect of coumadin when taken with the herbal remedy gingko biloba (IMP). Summary The problem of the increased use of herbal remedies without the knowledge or advice of primary care providers was discussed (Glisson, Crawford, & Street, 1999). The use of herbal remedies by the public without fear of adverse effects or a proof of benefit is a concern that needs to be assessed (Greenwald, 1998). The need for communication and trust between health providers and patients in the context of the use of herbal supplements also needs to be assessed (Fetrow & Avilla, 1999). The Revised Health Promotion Model, designed by Pender (1996), is the theoretical framework for the study 10 and was utilized in the design of the survey as well as to interpret the results. The assumptions, terminology, and limitations of the study were presented. 11 Chapter 2 Review of the Literature This chapter provides a brief history of herbal remedies as a part of alternative and complementary therapies. A review of the literature on herbal remedy usage in the United States, the regulations governing herbal remedies, and risk of adverse reactions are presented. Current demographic studies on herbal remedy users are discussed. Patient­ physician communication literature is reviewed for barriers to communication as they might relate to self-prescribed over-the-counter herbal remedies. History The interplay of plants and human health has been documented for thousands of years. Herbs are integral to Ayurvedic medicine which dates back over 5000 years, and to Traditional Chinese Medicine (TCM) which dates back 4000 years or more (Hadley & Petry, 1999). According to the World Health Organization, approximately 75% of the global population currently depend on botanical medicines for their basic health care (Barrett, Kiefer, & Rabago, 1999). Ayurveda. Traditional Indian medicine or Ayurveda emphasizes the relationship between the inner life of an individual and the external world (Integrative Medicine Primer [IMP], 1999; Berg, Amelia, Gagan, & McArthur, 1998). Herbal remedies are prescribed according to their effects on vayus (organ centers) and are often mixed with warm milk, clarified butter (ghee), or used as a nasal rinse (nasyes) (IMP, 1999). The most common remedies are triphala to help with elimination and trikata to increase digestive force and aid in nutritive absorption (IMP). Ayurvedic medicine and its practitioners are not licensed in the U.S. (IMP). 12 Traditional Chinese Medicine (TCM). TCM is a broad range of therapies, that includes acupuncture as well as herbal remedies (Berg, Amelia, Gagan, & McArthur, 1998; IMP, 1999). The effect of the herbs is the result of the herb's specific qualities or energetics (IMP, 1999). Herbs are categorized by flavors: sour, pungent, sweet, bitter, and salty. The flavor determines the value of the herb for a specific diagnosis (IMP; Fetrow & Avila, 1999). As a modem pharmacotherapy, the TCM herbal remedy has a very specific formula which considers the targeted disorder, how each ingredient interacts with others, as well as how the addition of certain substances can reduce or cause side effects (IMP). Unlike traditional pharmacotherapy, TCM remedies are compounded for each individual (Fetrow & Avila, 1999). The U.S. government recognizes and regulates only acupuncture as a therapy, and practitioners of TCM are not licensed (IMP). Their TCM herbal remedies are considered nutritional supplements. Naturopathy. Based on vis medicatrix naturae or the healing power of nature, naturopathy originated in Germany (IMP, 1999). Benedict Lust started the first school of naturopathy in the U.S. in 1902. Naturopathy uses the standard medical physical assessment and testing but also uses elimination diets and nutritional botanical supplements to help in diagnosis (IMP). Naturopathy is now practiced in Europe and parts of India and Asia, as well as in 11 states in the U.S. (IMP). The national College of Naturopathic Medicine was recently the recipient of a National Institute for Health (NIH) grant for a long-term study of natural therapies for the treatment of AIDS (National Center for Complementary and Alternative Medicine, 1999). It also operates the first American Alternative Medicine Clinic in Washington DC for the National Center of 13 Complementary and Alternative Medicine (NCCAM), first funded in 1996 as part of the NIH (IMP; NCCAM). Homeopathy. Samuel Hahneman, a German physician in the late 18th century, developed the 'like cures like’ theory which became the basis for Homeopathy (IMP, 1999). He proposed that the symptoms of an illness are a sign that the body's defense system is trying to ward off infection or adapt to stress. The remedies act as a catalyst that aids the body's inherent healing mechanism (IMP). Hahneman wrote extensively about the mental and emotional component of any physical disease. Homeopathic remedies are infinitesimal doses of an herb, mineral, or animal product where the more extreme the dilution, the higher the potency (Fetrow & Avila, 1999; IMP). Each individual has a set of chronic tendencies which form a constellation referred to as their constitutional type. Homeopathy refers to the practice of looking for a single remedy that can alleviate or lessen these global tendencies (IMP). Two states license physicians to practice homeopathy and homeopathic physician assistants are licensed in most states (IMP). Homeopathy is currently the most well researched blend of both allopathic and complementary medicine (IMP). Complementary and Alternative Medicine (CAM) In contrast to traditional Western allopathic medicine, CAM remedies do not suppress symptoms, eradicate harmful organisms, or eliminate disease (IMP, 1999). CAM herbal remedies try to correct deficiencies in the body's homeostatic balance (IMP). "Symptoms are viewed as an integral pail of the body's attempt to heal itself by boosting its own defenses to combat illness" (IMP, p. 8). 14 Herbal remedies are increasing in popularity because: (a) they are a continuation of the 'green is natural' movement of the 1960s which was partly a reaction against the products and pollution of an aggressively industrialized society, (b) Western medicine is viewed as too expensive and often ineffective, (c) prescription and over-the-counter (OTC) medicines are believed to have many side effects compared with natural products which are perceived as having low or no side effects (Lee, Tyler, & Weart, 1999). Greenwald (1998) added that the main reason for the rise in CAM use is "the fears of 80 million aging baby boomers who are eager to seize control of their medical destinies" (p. 61). There is a perceived coldness and remoteness of conventional medicine. The tangled red tape of managed care makes readily available herbs and other supplements particularly appealing (Greenwald). The public does not consider herbal remedies to be drugs, a misconception that is perpetrated by nutritional manufacturers and marketers (Glisson, Crawford, & Street, 1999). An herbal remedy timeline, more directly connected to current Western pharmacotherapy, first identified the age of herbal medicines, then the age of antibiotics, leaving us now in the post antibiotic era (Alschuler, Benjamin, & Duke, 1997). There is now a proliferation of resistant microbes and attenuated antimicrobial efficacy that are causing drug researchers and herbalists, along with many patients, to look back to the older medications (Alschuler et al., 1997). Botanicals are the source for many of our contemporary synthetic medications such as digitalis. Many authorities in drug development see the botanical world, and the rain forests in particular, as the best remaining source of new drugs once those currently available are exhausted (Alschuler et al.). 15 The use of botanicals or herbal remedies is in the process of changing from an eclectic, intuitive science to the practice of rational phytotherapy through research (Hadley & Petry, 1999; IMP, 1999). Herbal remedies are designated as dietary or nutritional supplements by the United States federal government (Fetrow & Avila, 1999). Regulation of Herbal Remedies. Herbal remedies are not regulated under drug laws by the Federal Drug Administration (FDA); safety and effectiveness do not have to be demonstrated before these products are marketed (Zink & Chaffin, 1998). Herbal remedies fall through governmental cracks, permitting herbal supplement marketers to promote various health benefits for their products (Rose, 1999). John Renner, MD, head of the National Council for Reliable Health Information, wrote that it is not the herbs that are necessarily dangerous but the hype of the marketing (Rose). Renner felt that people use these products before sufficient research, and do not realize that they are the guinea pigs. If a product states that it promotes a healthy heart, it is not subject to federal regulation (Rose; Zink & Chaffin, 1998). If it stated that it helps to reduce the risk of heart disease, the herbal remedy would need to be backed up by scientific studies and be subject to FDA review (Rose; Zink & Chaffin; Alschuler, Benjamin & Duke, 1997). Zink & Chaffin added that, in addition to no FDA regulations of effectiveness, there are no legal standards applied to herbal harvesting, processing, or packaging. The possibility of poor quality, adulteration, contamination, and varying strengths must be kept in mind when evaluating herbal remedies (Zink & Chaffin). Nutritional Supplements. The FDA has designated all herbal remedies including homeopathic remedies as nutritional supplements via the Dietary Supplements Health & 16 Education Act of 1994 (Fetrow & Avila, 1999; IMP, 1999). Manufacturers can make claims concerning the structure-function and possible effects of their products but no claims of cure, or use of medical terminology or disease name (Fetrow & Avila, 1999; IMP). In Europe the regulating of herbal remedies is done through Germany's Commission E who, in 1978, issued 200 monographs about the most often used herbal remedies (Alschula, Benjamin, & Duke, 1997; D'Epiro & Benjamin, 1999; NIEHS NewsrEnvironmental Health Prospectives, 1998; Fetrow & Avila.; Zink et al., 1998). While very comprehensive, these monographs are less rigorous than FDA approval of medications (Fetrow et al.). The Commission E Monographs require "reasonable certainty" of efficacy compared with the FDA's regulation of "absolute certainty" of efficacy (Alschula et al., 1997). Manufacturers of herbal remedies in the U.S. have difficulty justifying the approximately $350 million generally required to bring a new drug onto the market when it can not then be patented because it is of plant origin (Alschula et al.). Glisson, Crawford, and Street (1999) discussed the labeling of herbal remedies, which must state that the product is not evaluated by the FDA and "is not intended to treat, diagnose, prevent or cure a disease" (p. 46). Unfortunately, literature with claims of efficacy is often legally displayed right next to the product (Glisson et al., 1999). Manufacturing. Manufacturers are also not required to report injury or illness claims to the FDA (Glisson, Crawford, & Street, 1999). Adverse effect claims, however, can be voluntarily reported to the FDA department MEDWATCH (1-800-332-1088). This may lead to proof that a given product is unsafe and its removal from the market (Glisson et al., 1999). A joint FDA and nutritional supplement manufacturer effort is 17 being developed to track adverse effects in post marketing surveillance because physicians and researchers are in search of a rational, evidence-based way to safely integrate CAM with primary care (Klinger, 1998). Benjamin Klinger, MD called for an even greater role of the FDA, National Institute of Health, and the herbal supplement industry in collecting data on outcomes of herbal medicine use, both adverse and beneficial. Some manufacturers make products with little or no active ingredients or use parts of the plant that do not contain the active ingredient (Glisson et al.). Products may also contain a plant that is only similar to the one on the label, or be contaminated with heavy metals, prescription medicine drugs such as digitalis, or toxic chemicals (Glisson et al.). Concern about the purity, dilution, and manufacturing of herbal remedies has been voluntarily addressed by the Council for Responsible Nutrition (Glisson et al.; O'Koon, 1999). This trade association for dietary supplement manufacturers monitors and accredits manufacturers of herbal remedies by applying the "good manufacturing practices" utilized by the FDA (Borins, 1998; O'Koon; Zink & Chaffin, 1998). Voluntary accreditation involves the monitoring of: (a) variations in the source (plant) and the part of the plant used, (b) the listing of additives and, (c) cleanliness of manufacturing (O'Koon). The word “standardized” used on an herbal remedy label means that one manufacturer's batch of a product will be the same as the next (O'Koon). New labels for nutritional supplements, including herbal remedies, have been mandated by the federal government and must be user friendly and formatted like food labels, including: (a) serving size, (b) list of ingredients, (c) percentage of the recommended daily intake (RDI), (d) parts of the plant used, (e) labeled as high potency 18 or antioxidant if criteria are met, and (f) printed in a type size mandated for ease of reading by the general public ( MedWatch News, 1997; O’Koon, 1999). Research. Because there is a gap in the research of U.S. herbal remedies and other CAMs, the NIH National Center for Complementary and Alternative Medicine (NCCAM) has chosen 10 different research centers to provide comprehensive research on CAM (Lee, Tyler, & Weart, 1999). Health and Human Services secretary Donna Shalala announced a new council on August 30°’, 1999 that provides advice to the NCCAM in order to focus the research of the 10 sites on usable alternative therapies (Lee et al., 1999). The council is made up of 50% practitioners of CAM, 25% physicians, and 25% consumer representatives (Lee, et al.). As an example, the FDA originally banned all nonprescription medications for benign prostatic hypertrophy (BPH) in 1990 (Alschuler, Benjamin, & Duke, 1997). FDA action was based on a lack of evidence of efficacy and concern that patients would fail to seek medical attention for the serious life threatening complications of BPH (Alschuler et al., 1997). Now, including research on Saw Palmetto, there are more than 12 independent research studies of CAM herbal remedies under review by the FDA (Alschuler; D'Epiro & Benjamin, 1999). Less that a decade after being banned, Saw Palmetto is expected to be the first herbal product to be licensed as an herb with a specific indication (D'Epiro et al., 1999). Prescriptive Authority. Another aspect of the regulation of herbal remedies concerns whom may prescribe or recommend the remedies. The practitioners of CAM who may be licensed in some, not all, states are acupuncturists, chiropractors, and naturopaths (IMP, 1999). Their licenses are limited and cannot be considered the practice of medicine: "the diagnosis, treatment, prevention, cure and mitigation of disease" 19 (IMP, 1999, p. 25). Their scope of practice is limited by the same guidelines as are used to label herbal remedies: no diagnosis or treatment of a medical disease (IMP, 1999). It is common for lay practitioners recommending herbal remedies to state that they are not practicing medicine, and that the remedies are not prescription drugs, and that the remedies are available in any health food store (IMP). Self-Care and Self-Medication Awareness of self-care has increased in recent years from the use of daily-living help books to books on medical self-care (Sorofman, 1992). The notion of self-health care is the oldest form of medicine. Information is obtained through a wide variety of promotional activities about symptoms and treatment options. Lay self-care information sources include: (a) traditional health industry advertising, (b) lay-initiated self-care/selfhelp information, and (c) manufacturer's direct-to-the-consumer-activities such as 'medical breakthrough' news releases (Sorofman). Talk shows, news shows, and newspapers often do medical breakthrough releases on Wednesdays, quoting from The Journal of the American Medical Association and The New England Journal of Medicine (Sorofman). The 35 to 54 year age group is leading the boom in self-medication with "neutraceuticals," vitamins, minerals, and designer prescription drugs (Krantz & Bjerkler, 1994). Once the average American turns 65, the proportion of medications used becomes predominantly by prescription and less OTC (Feinberg, 1997). The National Drug Manufacturing Association (NDMA) found by survey that 70% of all OTC drug consumers never consulted a health care professional before choosing a product (Feinberg). The people who self-medicate because of the high cost and side-effect profile of prescription drugs, and who mistrust the HMOs, are self-medicating to help prevent 20 illness, rather than to treat acute symptoms (Krantz & Bjerklie, 1997). The trend toward self-medication has the benefit of increasing the empowerment of patients while being counterbalanced by the risk of uninformed choices as to the type and amount of the remedy (Blenkinsopp & Bradley, 1999). The Risk of Herbal Remedy Use Patients who self-medicate with herbs for preventive and therapeutic purposes may assume that these products are safe because they are natural. Some products, however, cause adverse effects or have the potential to interact with prescription medications (Zink & Chaffin, 1998) (Appendix A). Historically, herbs and drugs have been two very different treatment modalities which have rarely, if ever, been used together (Chen, 1999). Now, patients may be taking multiple drugs from multiple providers concurrently with herbs and vitamins (Chen). There are very few studies published in English to document the safety and effectiveness of combining herbs with prescription drugs (Chen). Drug-drug interactions rest on the possibility that one substance may alter the bioavailability or the clinical effectiveness of another substance when they are given together (Chen, 1999). Herb-herb interactions are noted in Traditional Chinese Medicine in the 18 Incompatibilities or in the 19 Counteractions (Chen). Herb-drug interactions have the highest risk of clinically significant interactions with preparations that have sympathomimetic, cardiovascular, diuretic, or antidiabetic effects (Chen). Appendix A documents side-effect profiles and toxicity of common herbal remedies. Herbal use during pregnancy is not recommended because of possible teratogenic effects; herbal remedies have not been subjected to clinical research concerning efficacy 21 or safety during pregnancy (Chen, 1999). Along with the NCCAM division of the NIH, the Society for Women’s Health Research supports initiatives for increased research of herbal products and clinical trials that evaluate the safety and efficacy of herbal remedies (Greenberger, 1998; HHS News, 1999; NCCAM, 1999). Demographics of Herbal Remedy Users An informal observational study by Grevier (1998) of her own patient population correlated the number of prescription and OTC drugs taken with the patient’s state of health. Sicker patients tended to take fewer total medications, with the number of unconventional remedies decreasing as the number of medical conditions increased (Grevier). In 1999, Astin identified who utilized CAM, with a random mail survey. A 69% return, equaling 1035 surveys, showed CAM users to be: (a) more educated; (b) in poorer health status; (c) to have a holistic orientation to health; (d) to be feminists; (e) to be interested in spirituality and personal growth; (f) and to be those whose common health problems were anxiety, back problems, chronic pain, or urinary tract problems. All but 4.4% relied on both CAM plus conventional primary care. Dissatisfaction with conventional medicine was not a predictor of CAM use (Astin). Zeil (1999) characterized a CAM user as a white, educated woman aged 25 years and up with a family income of $50,000 or more. Trends in alternative medicine in the U.S. were tracked with a before and after comparison telephone survey in 1990 and 1997 (Eisenberg et al., 1998). Of 1500 subjects in 1990, 33.8% used CAM and of 2000+ subjects in 1997, 42.1% used CAM. Therapies increasing the most were herbal remedies, message therapy, and mega-vitamin use. CAM 22 therapy was used most frequently by those with chronic conditions, back problems, anxiety, depression, and headache (Eisenberg et al.). Of those surveyed, the lack of disclosure of herbal use to their physicians was 39.8% in 1990 and only down to 38.5% in 1997. The number of patients using both prescription and herbal products remained steady at 18.4% (Eisenberg). Critics of Eisenberg’s research charge that he inflated the consumption numbers by including relaxation techniques, meditation, commercial weight loss programs, and self-help groups in his definition of CAM (Weber, 1998). Sibbald's Canadian study (1999) showed that among the users of natural products, 30% got information about herbal remedies from family and friends; 18% from health care books; and 7% from other health professionals, printed articles, and product information. Herbal users were more likely to use conventional OTC and also prescription medications when compared with the general population (Sibbald, 1999). Users who cited physicians as their source of information about herbal remedies rose from 3% in 1996 to 11% in 1998. Herbal remedy users are well educated and embrace alternative modalities that are more congruent with their beliefs and philosophical orientations toward health and life (Weber, 1998). In Weber’s survey, only one-half of the 18% of patients who had gone to alternative practitioners come away satisfied, although 82% acknowledged some improvement in their condition (Weber). A study by the Medical Expenditure Panel Survey (MEPS) of 16,000 U.S. adults reported a lower use of unconventional therapies, including herbal remedies, than the study by Eisenberg (Druss & Rosenhek, 1999). Of the 65% of the group surveyed by MEPS in 1996 who made visits to both conventional and CAM providers, 1.8% used 23 only unconventional services, 59.5% used conventional care only, and 32.2% used neither. This study, along with others, showed that unconventional care is not being used as a substitute for conventional medical care (Druss & Rosenhek, 1999). While this study answered the question of concomitant use of traditional and CAM therapies, critics felt that the definition of CAM therapies used deflated the number of CAM users (Weber, 1998). A positive critique is that, unlike the study of Eisenberg et al., this one was not telephone based, and not dependent on fluency in English, so included a broader economic base of subjects (Wisneski, 1999b). A large survey by Consumer Reports (May, 2000) of 46,806 readers yielded results that show a 35% use of alternative therapies. Alternative therapies were classified as megavitamins, nutritional supplements, deep tissue message, chiropractic, accupressure, and mind-body therapies (Mainstreaming, 2000). Their sample was 70% male, with a higher educational level and income than the national norm. This selective sample is interesting in its size, but may not reflect herbal remedy or CAM usage in the general population. Fifty percent tried new remedies on their own, with 25% trying them at the recommendation of either a nurse or a physician. Of the new remedies, 50% were herbal remedies. Fifty-eight percent reported conditions such as respiratory infections, prostate enlargement, insomnia, head aches, depression, and back pain that were treated conventionally. Twenty-five percent of these problems were treated with both CAM and traditional therapies, and 9% were alternative therapies only. Those who turned to alternative therapies did so for conditions that had not yielded to traditional treatment. Four percent of users of CAM reported side-effects, but not sufficient to worsen their condition (Mainstreaming). 24 Provider-Patient Communication The study by Eisenberg et al. (1998) showed a 380% increase in the use of herbal remedies between 1990 and 1997, yet the majority of patients did not tell their physicians about using herbs. "We are now obliged as the standard of care to ask about herbs, vitamins, and other OTC products.. ..and open ourselves up to potential medical liability if we have no record of having asked" (D'Epiro & Benjamin, 1999, p. 30). The three biggest obstacles to a good provider-patient relationship are: (a) fear that a symptom means the worst disease, (b) embarrassment concerning use of nontraditional therapies or that undisclosed drug or alcohol problems will be treated as a moral rather than a medical problem, and (c) forgetfulness under stress leading to failure to mention key facts to the doctor (Belson, 1999). In the Consumer Report survey, 60% of the CAM users reported their use of alternative therapies to the provider. This is higher than reported in all other studies. Fifty-five percent of the providers showed approval, 40% showed neutrality, and 5% disapproved of the CAM therapy (Mainstreaming, 2000). A 1996 patient satisfaction survey by the Kaiser Family Foundation and the Prevention Survey Research Association found that, for 84% of adults, the main issue in choice of a physician was how well the physician communicated with patients and showed a caring attitude (Weber, 1999). The patients assumed that their physician would have technical competence (Weber). Provider-patient relations may be viewed on a continuum between the extremes of the paternalistic model where the provider decides and the patient complies, and the informative model where the provider provides information and the patient decides (Benbassat & Pipel, 1998). Published evidence shows 25 that patients who ask questions, elicit treatment options, and express their preferences have better health outcomes than those who do not (Benbassat et al., 1998). Health care providers should ask patients if they are considering or are already using other therapies, avoiding the use of the word ‘alternative’ because it is not an alternative treatment to the patient (Kent, 1999). In An Integrative Medical Primer (1999), it was suggested that an integrative approach is best between provider and patient but that a patient’s wishes should not override a physician's professional judgment. Physicians and patients should dare to disagree, especially about therapies for which scientific support is anecdotal, equivocal, or preliminary. "Often the most sensitive barometer of a relationship is the ability to resolve disagreements" (IMP, 1999, p. 5). Seligson (1996) wrote of an altruistic reason for patients to "come out of the closet.” Even conservative providers can learn from patients’ accounts of herbal drug use. While awaiting specific research results on herbal remedies, patient information gives a picture of what herbal remedies can and cannot do (Seligson). To illustrate the barriers to communication, a study by Adler & Fosket (1999) of women with breast cancer found that discussion of CAM therapies including herbal remedies was less well integrated into the traditional medical encounter (54%) than is biomedical treatment with an alternative practitioner (94%). Clinicians should be concerned about nondisclosure of herbal remedy use and about global patient-physician communication because of a recent decrease in the continuity of doctor-patient relationships, and an increase in the use of acute episodic health care (Korsch, 1994). More malpractice litigation results from communication breakdown than from technical errors alone. Patient satisfaction reflects interpersonal, 26 lather than the instrumental (technical), aspect of the communication process (Korsch). (For a list of patient-physician communication strategies see Appendix B.) Lowe & Kerridge (1997) wrote that physicians have an ethical obligation to provide health care that does not differ depending on the form of treatment being offered, whether traditional or CAM. For the patient, this includes receiving information for decision making, and being informed about the risks and benefits of any proposed treatment (Lowe & Kerridge). Doctors are often seen as keeping their thoughts about alternative therapies separate from their understanding of the body, and neglecting opportunities for insight into disease or for refuting suspected ideologies (Lowe & Kerridge). Continuing the patient-physician relationship while monitoring the patient’s progress with an herbal product provides a mutual learning opportunity (Zink & Chaffin, 1998). Allopathic providers today, despite their vast armory of medications, devices, and surgical techniques have lost some of the art of the oldtime MD.. .and must regain charisma and humility, the sincere hand­ shake, the ability to listen and the willingness to share the inner thoughts and concerns of their patients. (Zeil, 1997, p. 88) Summary This literature review has presented a history of herbal remedy use as a part of complementary and alternative medicine therapies. Herbal remedy usage in the U.S. is profiled as well as the regulations governing the manufacture and marketing of herbal remedies, and the licensing of providers. The tracking of potentially serious drug-herbal remedy reactions was discussed. Review of the demographic studies relating to herbal 27 remedy users was presented along with critiques of the studies. Physician-patient communication literature was reviewed to obtain a picture of the barriers to reporting patient herbal remedy use in the primary care setting. 28 Chapter 3 Methodology This chapter concerns the methodology utilized in this study to describe the population of herbal remedy users seen in a primary care setting. After obtaining demographic information, a self-administered survey addressed patients' perceptions of the risks and benefits of herbal remedies. The survey also described the barriers to communication and mutual learning between provider and patient relating to herbal remedies. Protection of human rights for those completing the survey is addressed. Pilot study modifications to the researcher-designed survey are outlined. A summary of the goals of the study is provided. Research Questions The research questions were as follows: 1) Who is using herbal remedies and why? 2) What are the patients' perceived risks and benefits of herbal remedies? 3) Are there patient/provider communication difficulties concerning the use of herbal remedies? Research Design This quantitative study utilized a descriptive survey research design. Findings of this study may help to pinpoint those patients at most risk for herbal remedy and prescription drug interactions. This research augments information from other recent descriptive studies. 29 Sample, Setting, and Procedure The targeted sample included all English speaking patients over the age of 18 who were seen in the three rural locations of a primary care facility in Chautauqua County, NY, duiing the month of January, 2000. The survey was administered in this family practice setting of approximately 4500 patient visits per month. The study population included those patients who were seen for well-visits, acute same-day visits, allergy and vaccination visits, obstetrical-gynecologic visits, and post-hospitalization visits. It also included the parents of children brought in for their visits. Subjects were given the survey as they registered at the main desk, and returned it when they were called into the examination room by the nurse. The receptionists gathered the completed anonymous surveys and locked them into a safe until collected by the researcher. Instrumentation A researcher-designed survey was utilized as the research tool. It was a self-administered questionnaire (Appendix C). The survey consisted of a cover letter explaining the purpose of the study, and instructions for the completion of the survey. Following a reference list of the most commonly used over-the-counter herbal products, there were 22 dichotomous and multiple-choice questions. The first five consisted of demographic questions. Age, gender, household income, marital status and educational level were included along with a multiple choice question on perceived overall health status at the time of the current visit. Later there was a visual analogue scale on overall health status for comparison with the multiple-choice question asked at the start of the survey. The next five multiple-choice questions dealt with the use of herbal remedies: if 30 "ever used,” currently using daily,” or "as needed,” whether the subjects have ever bought an herbal remedy; if one has ever been recommended and, if so, by whom. The next three multiple-choice questions concerned discussion, during the subject's last primary care visit, of any herbal remedy use. If discussed, subjects were asked to indicate whether the interaction was staff-initiated or patient-initiated. Adverse reactions to herbal remedy products and whether they were reported to the primary care office were covered in the next two multiple-choice questions. Respondents who were not herbal remedy users were asked whom they would be willing to trust for advice, with an open fill-in option. The last four questions dealt with the relative risks perceived in herbal remedy use: (a) by comparing them with prescription medications, (b) by asking what subjects perceived the word natural to mean on a label, (c) by asking what they hoped to achieve with the remedy, and (d) asking if they ever had actively sought herbal remedy information from a primary care provider. Protection of Human Rights An introduction on the face sheet of the survey explained the purpose of the study. Potential participants were informed that their care would in no way be affected by their participation or nonparticipation in the study. The completion and return of the survey to the researcher constituted informed consent. All data remained anonymous. No names or numbers were required on the surveys. Only over-all grouped data were reported. The surveys remained in a locked file. Pilot Study The survey was pilot tested in a primary care employee in-service meeting in Chautauqua County, NY. The population included physicians, nurse practitioners, 31 registered nurses, office management, and staff. There were 35 surveys given and 35 completed and returned. The survey took an average of 8 to 10 minutes to complete. As a lesult of the analysis, three questions were reworded to elicit more definitive answers. Question 7 was changed to include a response for those who take herbal remedies on an intermittent basis along with those who take them daily to expanded the definition of an herbal remedy user. This eliminated the necessity of skipping questions if herbal remedies were not currently being taken. All questions were worded to include the response "not taking any herbal remedies" as an option. Question 11 was split into two separate questions to determine more clearly who initiated the communication about herbal remedies, the staff or the patient. Question 15 was moved to the end of the survey for better flow of information, and a question was added to ask directly if subjects had ever initiated conversation with their primary care provider about herbal remedies. Data Analysis The survey data were analyzed using descriptive statistics. The responses on the dichotomous and multiple-choice questions were reduced and summarized as frequency distributions. The inferential Chi-square Rank Order Correlation statistic was used to determine if the subgroups of users and nonusers were statistically different from the total sample. As noted the survey included two questions to assess the perceived overall health status of the respondent, one a Likert multiple-choice and the other a visual analogue scale. This analogue scale was divided for analysis into five sections reflecting the five Likert responses. The reliability and internal consistency of this repeated measure attribute was assessed using the Spearman Rank Order Correlation Coefficient. The 32 Likert question was placed before all of the herbal remedy questions, but the visual analogue was positioned after most of the questions about the patient’s self-initiated health care to assess internal reliability of the survey.. There were five questions that offered the option of an open-ended response. A content analysis of these responses was reported separately from the other survey responses. All statistics were calculated using StatView software by Abacus. Summary A goal of this study was to determine if self-medication with herbal remedies is common in those patients utilizing primary care facilities. The study also sought to gain some insight into the perceived risks and benefits that patients consider when using herbal remedies. The final goal was to determine if banders to communication between providers and patients existed in relation to self-medication with herbal remedies. The research design and pilot study modifications of the survey have been described. Human rights provisions and projected data analysis strategies have also been discussed. In a population that is most likely to be taking herbal remedies and prescription medications concomitantly, tactics could be developed and utilized by nurse practitioners in primary care practices to open the lines of education and communication. 33 Chapter 4 Findings This chapter presents the results from a researcher-developed survey (Appendix C) concerning herbal remedy use by patients in a rural primary care practice located in western New York State. The results were analyzed using descriptive statistics. Statistical significance was calculated using the Chi-square test of differences between groups and the Spearman Rank Order Correlation Coefficient. Results were reported in aggre£ate and according to the total group of subjects, male and female subsets of the subjects, female and male users of herbal remedies, and users and nonusers of herbal remedies. Additional data is displayed in full in Appendix D. Sample The surveys were given to all patients 18 years or older registering for a visit at the primary care practice in three New York locations during January 2000. The surveys were filled out prior to the patients being taken into an examination room, and took between 5 and 10 minutes to complete. Of the 1000 surveys that were dispensed, 865 surveys were returned to the researcher, for a return rate of 86.5%. All of the returned surveys were complete and used in the analysis. Results The results are presented in number and percentage of the total subject population and for the above-mentioned subgroups. Percentages were calculated to two decimal points and rounded to the nearest whole percentage. Questions with no response by the subject are included in the tables. The Chi-square statistic was calculated with a 95% confidence level and one degree of freedom. 34 Herbal Remedy Users To answer the first research question, who is using herbal remedies, the survey results weie analyzed for demographic characteristics. The subjects’ perception of their overall health and the reason they used herbal remedies was analyzed. Demographics. In the total sample (N=865), females comprised 68% (Table 1). Fifty percent (n-296) of the female subgroup were users of herbal remedies at some time, but 175 were not currently using the remedies. Of the 274 male research subjects, 60 were current users, but 126 of the male subgroup (46%) had been users of herbal remedies at some time. Table 1 Gender: Percentage of Total Sample (N=865), User and Nonuser Status Groups n % Females 591 68 Males 274 32 Female Users 296 34 Male Users 126 14 Notes. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. Age comparison of users and nonusers of herbal remedies showed that 60% of those 36 to 45 years were herbal remedy users (XM.2, p=0.01). Fifty-eight percent of 35 those 25 to 35 years of age were nonusers. Nonusers had more subjects in the >65 age bracket, 62% versus users with 48% (%2=5.2, p=0.05). Table 2 Age Comparison of Herbal Remedy Users and Nonusers Age Groups Total Users Nonusers n (%) n (%) n (%) <25 134 (15) 60 (45) 74 (55) 25-35 188 (22) 78 (42) 109 (58)* 36-45 178 (21) 107 (60) 71 (40)* 46-55 156 (18) 85 (54) 39 (46) >65 124 (14) 46 (48) 78 (62)* Total 865 422 442 Notes. Percentages of the total sample are within the group. User and nonusers percentages calculated within age categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. *Chi-square comparisons of user and nonuser calculated at oc 0.05 level of significance with df=l. Income levels showed more similarities than differences across the subgroups (Table 3). Males had a higher percentage in the $50,000+ income (30%) when 36 compared with 21% of the total sample and with only 17% of females (n=100). There weie moie (61 /o) nonusers in the $10,000-14,999 income category than users (%2=4.8, p 0.05). One percent (n—8) of the total subjects did not choose to answer this question. Table 3 Income Comparison of Herbal Remedy Users and Nonusers Income Total Users Nonusers n (%) n (%) n (%) 104 (12) 42 (40) 62 (60) 10-14,999 86 (10) 34 (49) 52 (61)* 15-24,999 179 (21) 83 (47) 96 (53) 25-49,999 302 (35) 155 (51) 146 (49) >50,000 185 (21) 103 (56) 82 (44) No Ans. 8 (1) 4 (50) 4 (50) $ 5-9,999 Total 865 422 442 Notes. Percentages of the total sample are within the group. User and nonuser percentages calculated within income categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. -Chi-square comparisons of user and nonuser calculated at oc= 0.05 level of significance with df~l. 37 Comparison of marital status between herbal users and nonusers showed more similaiities than differences (Table 4). Sixty-six percent of the total sample indicated that they were currently married. Females who were married comprised 62% of this subgroup conti asted with 75% of males. Users and nonusers of herbal remedies showed equality in the married category (50%). By number, slightly more nonusers were separated or living with someone than those who used herbal remedies. Table 4 Marital Status Comparison of Herbal Remedy Users and Nonusers Users Total Status Nonusers n (%) n (%) n (%) Single 143 (17) 71 (50) 72 (50) Mamed 572 (66) 284 (50) 287 (50) Separated 22 (3) 8 (33) 14 (67) Divorced 54 (6) 28 (52) 26 (48) Widowed 38 (4) 14 (37) 24 (63) Living with 37 (4) 17 (46) 20 (54) Total 865 422 442 Notes. Percentages of the total sample are within group. User and nonuser percentages calculated within marital status categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. There were no significant Chi-square comparisons of user and nonuser calculated at oc 0.05 level of significance with df=l. 38 At first glance, educational levels across the subgroups appeared to be comparable, but if information was combined within subgroups, a trend for higher education levels in herbal remedy users appeared (Table 5). Sixty percent of users of herbal remedies had some college or vocational training or higher, contrasted with 40% of nonusers (%2=13.4, p=0.001). Table 5 Highest Education Level Comparison of Herbal Remedy Users and Nonusers Education User Total Nonusers n (%) n (%) n (%) 359 (42) 126 (35) 233 (65) College/V. 34 (39) 199 (60) 132 (40)* Bachelors 111 (13) 72 (65) 39 (35)* > Masters 53 (6) 25 (47) 39 (53) < H.S. Total 865 422 442 Notes. H.S. indicates High School. Percentages of the total sample are within group. User and nonuser percentages calculated within highest education group. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. •Chi-square comparison of user and nonuser calculated at oc = 0.05 level of significance with df-1. 39 Comparison at the bachelor degree level showed that users comprised 65% of the total subjects with bachelor degrees (%2=9.8, p=0.01). The difference between users and nonusers was not significant at the master degree level of education. Overall Health. The subjects' overall health on the day they took the survey was measured with a Likert multiple-choice question and with a visual analog scale. Within the herbal remedy user subgroups, female users chose ’’fair” to "poor” on the multiple­ choice question 19% of the time while male users chose the same categories 14% of the time. Male users chose "good” to "excellent” 86% of the time contrasted with female users with 81%. Nonusers of herbal remedies (n=78) comprised 54% of the total subjects (n=144) who ranked their health as "fair" on the day they filled out the survey. The nonusers comprised 65% of all subjects who considered their health "poor." The visual analog health scale was interpreted as a measurement in inches as well as expressed in a percentage of the 6 inch line. The mean measurement in inches for all groups was rounded to two decimal places. Percentages of the total weie rounded to the nearest whole integer (Appendix D, Table 7). The visual health analog (key: 0 equals death and 100 represents perfect health) measured overall health a second time. The mean percentage of the 6 inch analog line for all subjects was 72.5% (4.36 inches). Comparison of the two overall health questions was tested for correlation using Spearman Rank Order Correlation Coefficient. A moderate correlation was shown (^=0.73), with all subjects ranking their overall health one category higher (" very good") on choice question ("good") (Figure 2). the visual analog scale than on the Likert multiple 40 7 61 51 w ID >s; • Multiple Choice Visual Analog 3- 21 11 0 Observations Figure 2. Spearman Rank Order Correlation Scattergram showing the comparison of overall health multiple choice ranking (black) and visual analog overall health ranking (red) of the total sample (n=865). Key: 4=”good” and 5= "very good" on Likert scale. Herbal Remedy Use. Of the total subjects, 27% were currently using herbal remedies (Table 6). Of more significance, because herbal remedies are not all used on a daily basis, 49% of the total subjects indicated that they had at some time used herbal remedies. Female users (n=172) comprised 73% of those subjects who currently use herbal remedies with male users comprising 25%. This is mirrored in the female group who had ever used herbal remedies, which made up 70% of the total users. 41 Subjects who had ever bought herbal remedies were fewer than subjects who had evei used the remedies. Female users of herbal remedies represented 70% and males represented 27% of those who had ever bought herbal remedies. Eighty-seven percent of the subjects who had had herbal remedies recommended to them were herbal remedy users. Only 10% of nonusers reported herbal remedies recommended. Question 11 offered a choice of answers concerning who recommended herbal remedies to the subjects. Among herbal remedy users 94% took advice from family members (n=179), contrasted with 6% of the nonusers (x2=127, p=0.001). Eighty-nine percent of users had herbal remedies recommended by a nutritionist or herbalist (%2=32.4, p=0.001). Fifty-five percent of herbal remedy users indicated that they took recommendation from magazines, pamphlets, books and TV shows contrasted with 45% (n=6) for nonusers (%2=97.4, p=0.001). Eighty-four percent of users utilized doctor/nurse practitioner as a source for recommending herbal remedies (% 25.8, p 0.001). Pharmacists were generally ranked lowest among users compared with nonusers (%2=10.8, p=0.01). The alternatives for Question 11 included the following: friend (n=62), coworker (n=7), chiropractor (n=6), teacher/educator (n=3), and midwife (n=3). Another 16 answers ranged from naturopath to counselor to yoga instructor, each with one entry, 42 Table 6 Herbal_Remedy Use Comparison of Users and Nonusers Groups Currently Use Ever Used Ever Bought Recommended n (%) n (%) n (%) n (%) Total 235 (27) 422 (49) 377 (44) 354 (41) Users 231 (55) 422 (100) 365 (87) 308 (73) 0 (0) 11 (3) 45 (10) Nonusers 0 (0) Notes. Percentages are calculated within groups. Percentages will not total 100% due to multiple questions within each group. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. Risk/Benefit Knowledge How patients perceived their personal risks and benefits of using herbal remedies was related to their knowledge of those remedies. Adverse reactions were reviewed as well as knowledge of why herbal remedies were taken and what the word natural really means. Adverse Reactions. Questions 16 and 17 addressed whether the subjects had ever had a reaction to over-the-counter herbal remedies, and, if so, whom they had consulted, Of the total subjects, only 3% (n 27) stated that they had had an adverse reaction to an , was defined in Question 16 as either the condition herbal remedy. An adverse reaction was detinea v 43 getting much worse or having a rash, nausea, or trouble breathing. Female users (n=296) reported 21 adverse reactions contrasted with 6 for male users of herbal remedies (Appendix D). Question 17 addressed whether or not the subjects with an adverse reaction to an herbal remedy had called their doctor or nurse practitioner. Of the total subjects, 10 out of the 27 had had adverse reactions and called their provider (37%). Only one subject went to the emergency room. Eighty-five percent of herbal remedy users indicated that they had had no adverse reaction to herbal remedies. Nineteen percent (n=164) did not answer Question 17 (Appendix D). Herbal Remedy Knowledge. Questions 18, 19, 20, and 21 dealt with the subjects' knowledge and beliefs about herbal remedies. Of those who chose the pharmacist as a reference they would use for herbal remedy use, 60% were users (%2-6.6, p-0.05) (Table 8). Sixty-one percent of nonusers indicated that they would accept information about herbal remedy use from a doctor or nurse practitioner in this rural primary care patient population &M3.4, p=0.001). This contrasts with Table 7, "who recommended herbal remedies to you,” where nonusers had a doctor or nurse practitioner recommend herbal remedies only 16% of the time. Seventy--one percent of those who utilized magazines and pamphlets were herbal remedy users (%2=9.4. p=0.01). Users were also 67% of those who would take advice from an herbalist (%2-11.2, p-0.001). 44 Table 7 WhoRecommended_He±alRemedies Comparison of Herbal Remedy Users and Nonusers Categories Total Users Nonusers n (%) n 199 (23) 179 (90) 20 (10)* 46 (5) 41 (89) 5 (U)* 120 (14) 114 (95) 6 (5)* Pharmacist 21 (2) 18 (86) 3 (14)* MD/NP 57 (47) 47 (84) 9 (16)* Other 111 (13) 88 (79) 23 (21) None recommended 248 (29) 52 (23) 183 (77) Family Member Nutritionist/Herbalist Magazine/Pamphlet/Book (%) n (%) Notes. Percentages of the total sample are within group. Percentages will not equal 100% due to multiple choices per subject. User and nonuser percentages calculated within the categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. *Chi-square comparisons of user and nonuser calculated at a 0.05 level of significance with df=l. 45 Question 18 (Table 8) also included an open-ended option. Responses included: friend (n=9), family (n=6), would never take (n=3), and with own research (n=3). Eighteen othei responses of who could recommend herbal remedies ranged from chiropractor to boyfriend to witch, all with one response each. Of the total subjects, 65% believed that herbal remedies were more natural than prescribed medications (Table 9). Only 4% of the total were unsure of the answer. Fifty­ eight percent of those who felt herbal remedies were more natural were users (%2=7.5, p-0.01). Sixty-eight percent of the subjects who thought they were not more natural than prescription medications were nonusers (%2=34.7, p=0.001). Of the total subject population, 54% indicated that natural means "no chemicals" when applied to over-the-counter herbal remedies (Table 10). Fifty-five percent of both users and nonusers indicated that a "natural" product means that it contains no chemicals. Users were 57% of those who chose "made from plants only" as natural (%2= 5.4, p=0.05). Fifty-two percent of nonusers thought herbal remedies were safe (%-- 4.6, p=0.05) Forty subjects wrote in that "natural" meant the following: derived from nature (n=6), not man-made (n=5), non-synthetic (n=3), and not controlled (n=2). Nineteen other entries by one subject each included: unprocessed, not standardized, not under FDA regulation, and less expensive. Two subjects addressed deceptive advertising: make you think it is "better for you, "and it's "a marketing ploy." 46 Table 8 Who Could Recommend Herbal Remedies Comparison of Herbal Remedy Users and Nonusers Answers Total Users Nonusers n (%) n (%) n Magazine/pamphlet 52 (6) 37 (71) 15 TV/Advertisement 19 (2) 10 (53) 9 Herbalist 92 (11) 62 (67) 30 (33)* Pharmacist 165 (19) 99 (60) 30 (33)* MD/NP 572 (66) 99 (60) 66 (40)* 51 (6) 29 (57) 22 (43) I already take 136 (16) 132 (98) 3 (2) No answer 142 (16) 73 (51) 69 (49) Other (%) (29)* (47) Notes. Percentages of the total sample are within group. User and nonuser percentages calculated within categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. *Chi-square comparisons of user and nonuser calculated at a 0.05 level of significance with df-1. 47 Table 9 Are Herbal Remedies More Natural Comparison of Herbal Remedy Users and Nonusers Answers Total Users Nonusers n (%) n (%) n Yes 565 (65) 328 (58) 236 (42)* No 271 (31) 87 (32) 184 (68)* 29 (4) 7 (23) 23 Unsure Total 865 422 (%) (77) 442 Notes. Percentages of the total sample are within group. User and nonuser percentages calculated within answer categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies.*Chi-square comparisons of user and nonuser calculated at Ot = 0.05 level of significance with df-1 48 Table 10 Comparison of Herbal Remedy Users and Nonusers Interpretation of the Word “Natural.” Choices Total Users Nonusers n (%) n (%) n (%) Pure 223 (26) 98 (44) 124 (56) Better for you 251 (29) 132 (53) 118 (47) Safe 181 (21) 87 (48) 94 (52)* Plants only 312 (36) 176 (57) 135 (43)* No chemicals 469 (54) 31 (51) 29 (49) None 62 (7) 24 (39) 38 (61) Other 40 (5) 23 (58) 17 (42) Notes. Percentages of the total sample are within group. Percentages will not total 100% due to multiple choices per subject. User and nonuser percentages calculated within answer categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. *Chi-square comparisons of user and nonuser calculated at a = 0.05 level of significance with dM. 49 Of the total subjects, 36 /o indicated the choice "to feel better" and 28% indicated "to enhance the immune system" for what they hoped to accomplish with herbal remedies (Table 11). Only 5 /o of the total indicated that they hoped to have herbal remedies "cure a sudden illness. Eighty-seven percent of herbal remedy users indicated "to feel better" for their reason to use herbal remedies (x,2-40.2, p=0.001). Eighty-nine percent of users indicated "to enhance the immune system" (x2=l44.2, p=0.001). Eighty-four percent of those who chose "to cure a sudden illness" (n=44) were users (x2=20.4, p=0.001). Ninety- two percent of those who hoped "to prevent an illness" with herbal remedies were users (X2= 166.1, p=0.001). An open-ended option was included in question 21, and responses written in concerning what the subjects hoped herbal remedies would do for them were as follows, to increase energy (n=12), for weight control (n=9), for arthritis (n—6), for memory improvement (n=5), to relieve cold symptoms/relieve sinus problems (n=3), to help with PMS symptoms (n=2), and to clean/help the system (n=2). Thirteen other responses of one entry each included benign prostatic hypertrophy, allergies, thyroid, and acne. 50 Table 11 Comparison of Herbal Remedy Users and Nonusers, Reasons for Using Herbal Remedies Choices Total Users Nonusers n (%) n (%) n (%) 44 (5) 37 (84) 7 (16)* To feel better 313 (36) 272 (87) 40 (13)* Immune system 240 (28) 213 (89) 27 (11)* Prevent illness 164 (19) 151 (92) 13 (8)* 53 (6) 49 (93) 4 (2) 351 (41) 17 (5) 39 (95) Cure sudden illness Other Never taken HR iple are within group. Percentages will not Notes. Percentages of the total sam] total 100% due to multiple choices per subject. User and nonuser percentages calculated within answer categones. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used prisons of user and nonuser calculated at herbal remedies. *Chi-square comparisons a = 0.05 level of significance with df“l • 51 Communication The following questions, 12, 13,14, and 22, related to the issue of communication between patients and providers in a primary care setting. The options were always given on the communication questions for the subject to differentiate between not taking herbal remedies” (currently) and "never having taken" them. Of the subjects who had ever used herbal remedies, 55% had not updated their medication lists to include herbal remedies at their last primary care visit (%2=5.8, p=0.05) (Table 12). Ninety-four percent of those who did update their medications list with over the counter medication were herbal users, which upholds the internal validity of the survey (%2=41.6, p=0.001). Ninety-five percent of the total and 100% of nonusers were not asked by any staff members at their last primary care visit if they took over-the-counter herbal remedies (Table 13). There were no significant differences between users and nonusers. Providers and staff were no more likely to ask women remedy use. than men about over-the-counter herbal 52 Table 12 Communication: UpdatinaMedication List Comparison of Herbal Remedy Users and Nonusers Answer Total Users Nonusers n (%) n (%) n (%) Yes 53 (6) 50 (94) 3 (6)* No 486 (57) 269 (55) 216 (45)* Not Taking 194 (22) 77 (45) 93 (55) (15) 1 (1) 130 (99) Never Taken 132 Notes. Percentages of the total sample are within group. User and nonuser percentages calculated within answer categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. There were no significant Chi-square comparisons of user and nonuser calculated at Ct - 0.05 level of significance with d 53 Table 13 Communication: Staff Asking About Herbal Remedies Comparison of Users and Nonusers Answers Total n (%) Yes 46 (5) No 819 (95) Total 865 Users n Nonusers (%) n (%) 36 (100) 0 (0) (47) 442 (53) 386 422 442 Notes. Percentages of the total sample are within group. User and nonuser percentages calculated within answer categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remedies. There were no significant Chi-square comparisons of user and nonuser calculated at a 0.05 level of significance with df-l. Question 14 mirrored question 12, but was more specific for herbal remedies only, excluding other over-the-counter medications (Table 14). Fifty-nine percent of herbal remedy users did not volunteer this information to the primary care staff (X2=14.4, p=0.001). Female users were les. likely (61%) than male users (70%) .0 keep herbal remedy use from their provider and/or staff members. 54 Table 14 Communication: Volunteering of Herbal Remedy Use Comparison of Users and Nonusers Answer Total Users Nonusers n (%) n (%) 57 (100) 0 (0) n (%) Yes 58 (7) No 453 (52) 267 (59) 186 Not Taking 184 (21) 95 (51) 92 (49) 70 (20) 35 (18) 164 (82) Never Taken Total 865 422 (41)* 442 Notes. Percentages of the total sample are within group. User and nonuser percentages calculated within answer categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have not used herbal remedies. *Chi-square comparisons of user and nonuser calculated at a = 0.05 level of significance with df=l. Question 22 sought to detenttine whether th. subjects had ever asked their providers for inflation about herbat .en.ed.es and the., use (Tab,. 15). Eighty percent of the total subjects answered that they had not asked their prov.de,. Seven.y-f.ve percent of the nonusers said no, as did 75 /o of the u 55 Only 5 /o (n 40) of the total thought that the provider was not interested, and 2% (n=15) were unsure how to ask the provider about herbal remedies. Nonusers comprised 56 /o of those who did not ask information from the providers contrasted with 44% of the herbal remedy users (%M 1.4, p=0.001). Herbal remedy users were 90% of those who asked information from their MD/NP (x2=57.6, p=0.001). The open-ended other” option (Table 15) provided additional reasons why subjects had not asked their doctor or nurse practitioner about herbal remedies. Responses included: he doesn't take them (herbal remedies) seriously (n=l), my former MD wouldn't talk about it (n=l), I did, but wouldn't do it again! (n=l), and they don't know about herbal remedies (n=l). Three additional subjects circled "other" but did not write in any reason for not asking for advice about herbal remedies. Summary The results from a researcher developed questionnaire (Appendix C) concerning herbal remedy use by patients in a rural primary care practice located in western New York State were presented in text, graph, and table form. Results were presented as the total sample (N=865), users (n: 422), and nonusers of herbal remedies (n=422). Results were grouped according ro the research questions. All significant differences between users and nonusers were valtdated wrth Chi-Square stalrstics at the alpha = 0.05 level of significance and with one degree of fieedom. The Speacan Rank Order Correlation Coefficient was used to validate the two tneasures of overal! health. Addition.! data is presented in full in Appendix D. 56 Table 15 Communication: Ask Information from MD/NP Comparison of Users and Nonusers Answers Total Users Nonusers n (%) n (%) n (%) Yes 91 (11) 81 (90) 9 (10)* No 695 (80) 303 (44) 392 (56)* Not Interested 40 (17) 23 (58) 17 (42) Not sure how 15 (2) 6 (40) 9 (60) Other 6 (1) 2 (33) 4 (67) No Answer 7 (1) 3 (43) 4 (57) Total 865 422 442 Notes. Percentages of the total sample are within group. User and nonuser percentages calculated within answer categories. User indicates a subject who has ever used herbal remedies. Nonusers are subjects who have never used herbal remed.es. •Chi-square comparisons of user and nonuser calculated a. a = 0.05 level of significance with df"l. 57 Chapter 5 Discussion This chapter provides a summary of the study to define demographics of herbal remedy users who are currently followed in primary care. The research question determining who is using herbal remedies and if herbal remedy use is frequent in primary caie patients is discussed. Also reviewed are the users' beliefs about the risks or benefits of herbal remedy use. Provider/patient communication difficulties concerning herbal remedy use in the users and nonusers is reviewed. Limitations of the study, and conclusions are presented. Recommendations for further research based on this study are included in this chapter. The literature review of herbal remedy use showed that information about herbal remedy users was predominantly obtained from the general public, rather than an actual patient population. The potential for herbal remedy/prescription drug interactions and worsening of existing diseases through inappropriate dosing of herbal remedies made it important to do a fact-finding study within the population of primary care practice patients. This study was conducted in a large rural primary care practice in New York State. A researcher-developed survey was adnruuatered to dibit: (a) the demographies of herbal remedy users along with their perception of overaU hcaith status and their amount of herbal remedy use. (b) uncover the subjects' herb.! remedy beltefs and pledge and incidence of adverse reactions to herbal reme barriers between provider and patient. and (c) to find any communication 58 Herbal Remedy Users To answer the first research question about whom is using herbal remedies the demographic information obtained from the surveys is discussed. Demographics, overall health, who uses, has bought, or has had herbal remedies recommended to them is compared with the literature search surveys. Demographics. Of the total subjects, all patients in a large rural New York primary care practice, 68% of the respondents were female and 32% male (Table 1). Fifty percent of females and 46% of males had used herbal remedies at some time (Table 8). However, the literature search showed that herbal remedy users comprised onethird of those surveyed (Arnold, 1999; Groman, 1998; Hadley & Petry, 1999; Glisson Crawford & Street, 1999; O’Koon, 1999). Sixty percent of 36 to 45 year olds were users of herbal remedies (%2=7.2, p=0.01), with 58% of those from 25 to 35 years of age nonusers (%2=5.2, p=0.05) (Table 2). Forty-five percent of all users of herbal remedies were between 36 to 55 years of age compared with non-users at 32%. Krantz & Bjerkler (1994) wrote that the 35 to 54 age group is leading the boom in self-medication with "neutraceuticals", vitamins, minerals, and designer prescription drugs. This study, 6 years later, concurs with his statement. Zeil (1999) characterized herbal remedy users as female, age25 and up, with a family income of $50,000 or mom. Demons from this survey showed that 60% of $25,000 to >50,000 compared to 51% of nonusers herbal remedy users' income was / mho «10 000 to 14,999 category (x2=4.8, p=0.05). This (Table 3). Nonusers were 61 /o of the $1 , 59 agrees with the literature review of herba! remedy users earning more income, hut not at the >$50,000 level. Astin (1999) characterized herbal remedy users as more highly educated, in poorer health, feminist, and to have a holistic outlook on health. All subjects (66%) and all subgroups tended to married, including 67% of users and 65% of nonusers (Table 4). Educational levels (Table 5) showed herbal remedy users to be more educated, with 60% of users having completed some college/vocational education or higher compared with 40% of non-users (x2=13.4, p=0.001). Users comprised 65% of those with bachelor degrees (%2=9.8, p=0.01). Nonusers were 53% of those with master or higher degrees but 65% of those with high school or less. Overall health on the day of the survey was measured using both a multiplechoice Likert question as well as on a visual analog health scale. Forty-two percent of the total subjects chose the "good" category of overall health (Table 6). The visual analog health scale showed the same total population scoring 72% (Table 7), analogous to "very- good" (60-80%) or the next to highest of the five choices in the multiple-choice question. Users were the same as nonusers in the "good.” "very good,” and "excefient" choices on the multiple-choice question, but nonusers were 65% of subjects who ranked their heahh as "'poor.” This study contrasts with previous surveys with the overall health of users and nonusers generally the same (good to very good). Comparison of ,Ms survey with others cited in the review, shows near), 50% of the subjects users of herbal remedies. This research is consistent with earlier 60 showing that herbal remedy users are often fema|e (73%) educated, and with a somewhat higher income level than uonusers. HsMReme^, Herbal remedy use, thls study, was defined as -cumnt|y using" or "have ever used" herbs! remedies. Research focused in the Iherature often combined herbal remedy use with the use of other complementary and alternative medicine (CAM) (Astin, 1999; Eisenberg et al., 1998). Druss and Rosenhek (1999) showed that 65% of those they surveyed were using both CAM and conventional primary care services, indicating that conventional care is not being replaced by alternative therapies, but is being used concurrently. This researcher survey in a primary care practice showed that 50% of females and 46% of males used herbal remedies concurrently with their other traditional primary care therapies. This is contrasted with the Consumer Reports' survey obtained around the same time as this research. Twenty- five percent of their sample used CAM concurrently with traditional care (Mainstreaming, 2000). The concurrent use of herbal remedies and conventional medicine increases the chances for herb/prescription drug interactions (Appendix A). Of the 422 users of herbal remedies in this study. 87% bought the herbs themselves, and 73% had had the remedy recommended to them by someone (Tab!e 8). Sibbald's Canadian study (1999) found that 30% of subjects got tnformalton about herba! remedies from friends/fmnily. In Uns cement study, 23% of the total sarmple got their recommendations from family G* 9). Twenty-^ percent of those surveyed by ■ „ 7000) had their CAM therapy recommended to them Consumer Reports (Mainstreaming, ) 61 taken the recommendation from a MD/NP Thio u-rr lhis difference points out the communication gap between patiems/providers. Sibbald (1999) a|s0 got their herbal remedy information ftom the aggregate articles, and product information. Sibbald (1999) also wrote that users who cited physicians as their source of information rose from 3% in 1996 to 11% in 1998. Eleven percent of herbal remedy users in this current study also cited MD/NP as the source of their recommendation for herbal remedy use and were 84% of those who chose that category ((Table 9). Risk/Benefit Knowledge The perceived risks and benefits of herbal remedies are discussed for users, nonusers, and the total subjects of the survey. Comparisons are made with the literature reviewed. Knowledge. Herbal remedy knowledge is increasing through controlled randomized studies. Knowledge is also enhanced by a newly released PDR (Physician Desk Reference) of herbal remedies, and by seminars or other source materials for providers. The National Institute of Health National Center for Complementary & Alternative Medicine continues to sponsor research. Th. Revised Health Pmmonon Medel (Pender, 1996) addled patient knowledge mrd behefs. The nse of herb.) temed.es depended on the herbal remedy users' , „f ,be U S popnlation and, in particular, those in pnm^y growing among all segments oi the u.o. f f i mdv as a whole, felt that herbal remedies were care practices. The subjects in this rura s Rations (65%) (T*H). and that ^ey —no more natural than prescription 62 chemicals (54%) (Table 12). Users toot ,Krbs p them immune system (51%) (Table 13). Only 5% that herbal remedies wouid cure a sudden ihness. The herbs! remedy users reported 27 adverse reactions to herbal remedies, but only 8 reported to their provider. Eighty-five percent of users reported no adverse reactions to herbal remedies. The subjects did not perceive taking herbal remedies as a significant risk to their health, and so did not seek qualified advice. They did not feel that herbal remedies were a medication and did not report their use to providers and staff at the primary care office. Communication. Communication between patients and providers was assessed by asking questions about whether they (a) updated their medication list at their last primary care visit, (b) were asked by the staff if they took OTC herbal remedies, and (c) directly ask their provider about herbal remedies. Sixty-four percent of herbal remedy users did not volunteer information about their herbal remedy use. Eisenberg et al. (1998) also found that the majority of patients did not tell their physicians about using herbs. Of additional significance in this study is that 95% of all subjects indicated that they were not asked by medical office staff about herbal remedy use (Table 15). This question had not been addressed in earlier studies. To illustrate communication barriers, combine the finding that 96% of patients were not ashed about herb use with the fact that 65% of these ash information on herba! remedies fiom their P-iders. These figures vaiidate concerns that: (a) herbal remedy users are relying on family n not their providers, for information and recotnmendations about herba! remedy use and cense,uenfiy nay no. more than anecdotal information,, - (fi)tha. staffmembers are not base their choices on 63 consistently asking patients if they take OTC herbal remedies. This barrier to communication is the most powerfu! and possibly the eaaieu, to remedy by teaming staff members to always ask tn a nonjddgmentat f*, about all 0TC including herbal remedies (Appendix B). All subjects were reluctant to ask their MD/NP about herbal remedies. Forty respondents thought their provider was not interested. Herbal remedy users are subjects who are the most vulnerable for herbal remedy/prescription drug interactions. Korsch (1994) wrote that more malpractice litigation results from communication breakdown than from technical errors alone. Communication lines need to be opened in order for providers and patients to share information about herbal remedy use, its benefits and risks, and side-effect profiles. For patients, the newer randomized herbal remedy studies could form the basis for education and information dissemination from the provider. For providers, discussion with patients gives an anecdotal picture of what herbal remedies can and cannot do (Seligson, 1996). These patient experiences might help the provider give better informed care until more definitive evidence-based information is available in the literature. Continuing and promoting the patient/provider relationship through open communication while monitoring the patients' progress whh » herba! product provides a mutual learning opportuntly (Zink & Chaffin, 1998). Comments horn this study's primtuy at almost every encounter since the survey was conducted. herbal remedy use Communication barriers have been changed in this pra 64 Conclusions Overall, the survey results from this study met the goal of describing herbal remedy users in a rural setting of New York State who also utilize primary care. The study also met its goal of confirming the demographics of herbal remedy users in the year 2000 for comparison with previous studies. This study addressed herbal remedy users rather than combining herbal remedy use with other CAM (complementary and alternative medicines) therapies. This gave a clearer picture of herbal remedy users' (a) usage, (b) adverse reaction profile and the subjects' knowledge and perceived risk/benefit view of herbal remedies, and (c) communication with providers concerning herbal remedies. Herbal remedy use is more prevalent than previously reported. Although the knowledge base of providers may be growing, patients are not consulting providers for information and guidance in the use of herbal remedies. Herbal remedy information is often obtained from friends, family, and herbal manufacturers' advertising. The nonreporting of herb use is making it inoreasingiy difficult for providers io practice good preventive health care. Limitations of the Study While this sample size was large, the results can be applied only to primary care archer-developed survey demonstrated patients in a rural eastern location. The rese< in different words, for the same internal validity with several questions asking, id reliability. • r ■ n rther testing for both validity an information, but requires further te 65 Recommendations for Further Study Communication is the key to demystiiying herba, providers. Without communion, no decision can be made either about herbal remed, concurrent use with prescription medications or their substitution for conventional evidence-based treatments. Without this knowledge, providers will not have the information needed to safely choose the best course for their patients' health care. This survey needs to be tested on other populations and in different locations to further evaluate its validity and refine its effectiveness as a tool to elicit patient/provider communication barriers and the herbal remedy knowledge of the subjects. In future studies, the refinement of information would be furthered by surveying in urban primary care practices, specialty practices, and primary care practices in other geographic locations. Future surveys should include questions asking how many prescriptions the subjects are taking at the time of the survey. Questions should be added to delineate the disease processes of the subjects. These questions would help to estimate the risk of concurrent herbal remedy use with prescription medications and chrome disease processes such as diabetes, hypertension, renal 01 hepatic dise Summary Increased herba! remedy use by patients conventional prescription immunication problem for providers of primary medication and therapies presents a co acknowledges the needs of patients who care. The most effective communication style • nn making (Belzer, 1999) (Appendix B). want to participate in their care and in ecisi 66 For the patient, telling providers about herbal remedy use and alternative therapies, and making sure they become a part of the medical record could safeguard their health (Seligson, 1996). Maybe the two worlds of medicine, conventional with complementary/altemative medicine, will become closer together and benefit the health of the patients they both serve. 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Skeptic, 7(1), 86-90. Zink, T., & Chaffin, J. (1998). Herbal ‘health’ products: What family physicians need to know. American Family Physician, 58(5), 1133-1140. 73 Appendix A Side Effect Profiles of Common Herbal Remedies (Borins, 1998) Common Name Potential Side Effects Aconite Dangerous arrhythmias, cardiovascular collapse. Aloe GI catharsis, diarrhea when ingested, nephritis, abdominal pain, dermatitis when used topically. Buckthorn bark Catharsis, diarrhea. Calamus Beta asarone found in some calamus species may be carcinogenic. Chamomile Allergies, anaphylaxis (especially in persons sensitive to Compositae family), contact dermatitis. Chaparral Hepatitis. Comfrey Liver damage. Devil’s claw Abortion Dong quai Abortion, affects estrogen levels. Garlic Dermatitis, vomiting, diarrhea, anorexia, flatulence, antiplatelet. 74 Common Name Potential Side Effects Germander Hepatitis Ginsing Hypertension, diarrhea, nervousness, depression, amenorrhea, insomnia, skin rashes. Jimsonweed Dry mouth, blurred vision, sedation, tachycardia. Licorice Hypokalemia, hypertension, sodium and water retention. Mistletoe Gastroenteritis, cardiac effects. Ragwort Hepatitis. Sassafras potential carcinogenic effects, nosebleeds. Seim a Diarrhea, abdominal pain. Wormwood Hallucinations. 75 Potentially Toxic Herbs (Lee, Tyler, & Weart, 1999) Common Name Potential Toxicity Blue Cohosh This herb may induce labor. Borage Traditionally used for coughs and illnesses of the throat, it has liver toxicity and may contain ingredients that are hepatocarcingenic. Calamus Used as a tea to treat dyspepsia, gastritis, and ulcers, it should not be used chronically as long-time use has been associated with malignant tumors in rats. Chaparral Once popular as an underground anticancer dmg, it has never been proven effective. It has liver toxicity. Colt's foot Used to reduce throat irritations and coughing, it may have carcinogenic potential and liver toxicity. 76 Common Name Potential Toxicity Comfrey Used for many years for external wound healing. It was used starting in the 1970s internally in the US. It contains very toxic pyrrolizidine alkaloids, which have caused liver cancer in small animals and veno-occlusive disease in humans. The herb remains on the US market. Ephedra This CNS and sympathomimetic stimulant has been used as a general stimulant, treatment for asthma, and for weight loss. If used for more than one week, it requires medical supervision. In extremely high dosages, it can lead to asphyxiation and heart failure Germander Although this herb has been used to help digestion and treat gall bladder disease, it has strong liver toxicity. Licorice Used for gastric and duodenal ulcers, this herb has liver toxicity, if used in large doses over extended periods of use. 77 Common Name Potential Toxicity Poke root This herb has been used as an emetic and as a treatment for rheumatic disorders, but it is poisonous, containting toxic lectins and mucous-membrane irritating eaponins. Sassafras This herb has been used to treat urinary tract disorders, but the FDA has banned the food or drug use of both the herb itself and safrole, a constituent in the oil in sassafras, because they have caused cancer of the liver in small animals. Because the ban has not been enforced, sassafras tea remains on the market. Wormwood This is the key ingredient in the alcoholic beverage absinthe, which is ilegal in the US because it contains a toxic combination of thijone and isothijone. 78 Appendix B Patient-Provider Communication Strategies Provider Speedbar (Belzer, 1999) 1. Physicians have less time today to build rapport with patients and must refine their communication skills to maximize their time. 2. Patients who have a strong relationship with their provider are more likely to be compliant with their health care. 3. Busy providers should remember the pleasantries such as calling patients by their name and shaking hands; doing so builds good relationships. 4. Communicating with a dual purpose helps you obtain crucial information about a patient's health even during informal conversation. 5. To obtain more information from patients in less time, don't interrupt them. 6. Using a structured patient interview, such as the BATHE technique, will help you maximize your time with the patient. 7. Try to build patient trust. Patients who trust their physicians cut to the heart of what's bothering them more quickly. 8. The most effective communication style acknowledges the needs of patients who want to participate in their care and in decision making. 9. Patient satisfaction depends on the provider's ability to manage patient expectations about what can be accomplished in one visit. aterial into the office visit helps you provide more 10. Integrating patient education m; information without investing more time. 79 11. Time-saving tips include delegating patient education to staff members and maintaining a patient education library. 12. A workplace designed for convenience and efficiency will enable you to spend more time with patients. 13. A welcome letter for new patients lets you ease their transition to a new practice and share your philosophy of health care. 14. The letter might invite patients to take responsibility for their health and explain the type of provider-patient relationship you hope to build. 15. To meet patient expectations for more information, use e-mail to keep in touch and answer patients' questions; it can be a time saver. 16. You can use your computer as a patient information tool and tell patients about helpful web sites. 17. A good patient-staff relationship can build patient satisfaction. Staff should attend training sessions on patient communication. 18. Call patients with lab results as soon as they are in, and create a system to remind the staff to call for results that are overdue. 19. Patients today evaluate physicians based on how they interact with patients, not solely on their clinical skills. 20. To increase patient retention, evaluate your interaction style and understand how it affects patient satisfaction. 80 Strategies for the Patient (Seligson, 1996) 1. Listen first, don t assume your provider can’t help. Your health care provider can rule out underlying problems, A diagnosis does not necessarily wed you to mainstream therapy. 2. Tell your story: try to reach a mutual goal about your health problem. Bring up alternative treatments and if derided, ask why. If no specific contraindications, ask that your alternative treatment be added to your chart, as a good provider always wants to know what his patient is doing. Mention your herbal remedies when asked about medications currently being taken. 3. Strategize together: agree on a time to reassess. Ask your provider for symptoms that should be reported to him for medical attention. 4. Get it in writing: ask your provider to note your alternative therapies in your chart. If a problem arises, every possible clue should be documented. 5. Set a revisit: to reassess the therapies in 4-8 weeks with your provider. 6. Make introductions: if your provider is open-minded, have your alternative therapist contact him. They are actually practicing in parallel. They will then both be better equipped to meet your health needs. 7. Even if all you do is tell your provider about your nontraditional therapies, get them written into your chart, and let your provider know how they are working, you'll have safeguarded your health and perhaps brought the two worlds of medicine a little closer together. 81 EDINBORO UNIVERSITY o~f pen nITVTVaYTTT Department of Nursing Edinboro, PA 16444 (814) 732-2900 Appendix C I would like to introduce myself. My name is Chris Flanders, RN, FNPs. This survey is part of a research project that I am doing for an advanced nursing degree at Edinboro University of Pennsylvania. It will provide information about herbal remedies and who is using them and what questions they may have about these remedies and their current medications . This survey should take about 5-10 minutes for you to complete. Please do not place your name on the survey. Your answers will be strictly anonymous. All information will be reported as group information. Your care here will in no way be affected whether or not you wish to participate in the survey. ********************************** For your information, the results of this survey will be posted at the reception desk in March of 2000. If you have any questions, S0™”8’CRM>’PhD Thank you very much for your participation. 82 Echinacea St. John’s Wort Fish Oils/Cartilage Melatonin Yohimbine Kava Kava Ginkgo Biloba Garlic Glucosamine Valerian Ephedra Milk Thistle Probiotics DHEA Ginseng Feverfew Ginger Aloe Vera Black Cohosh Dong Quai Sassafras Saw Palmetto Chamomile Goldenseal Root Please answer all the questions to the best of your ability and return the survey to the receptionist or the nurse. 1. What is your gender? (Please circle one answer) 1. Male 2. Female 2. What is your present age? (Please circle one answer) 1. Under 25 years 2. 26-35 years 3. 36-45 years 4. 46-55 years 5. 56-65 years 6. Over 65 years 3. Which of the following categories best describes your yearly total household income? (Please circle one answer) 1. $5000-9,999 2. $10,000-14,999 3. $15,000-24,999 4. $25,000-49,999 5. $50,000 or more 4. What is your marital status? (Please circle one answer) 1. Single 2. Married 3. Separated 4. Divorced 5. Widowed 6. Living with someone 83 5. What is the highest level of education that you have completed? (Please circle one answer) v 1. High School or less 2. Some College/Business School or Vocational Training 3. Bachelor’s Degree 4. Masters or above 6. How would you describe your overall health today? (Please circle one answer) 1. Excellent ""~ 2. Very Good 3. Good 4. Fair 5. Poor 7. Do you currently take any form of herbal remedy either daily or as needed? (Please circle one answer) (For help see the partial listing of herbal remedies at the top of this survey) 1. Yes 2. No 8. Have you ever taken an herbal remedy, even for a short time? (Please circle one answer) 1. Yes 2. No 9. Have you ever bought an herbal remedy for yourself? (Please circle one answer) 1. Yes 2. No 10. Has an herbal remedy ever been recommended to you? (Please circle one answer) 1. Yes 2. No 11. If so, who recommended it to you? (Circle all answers that apply) 1. Family Member 2 Nutritionist or Herbalist 3. A Magazine, Pamphlet, Book or TV Program 4. Pharmacist 5 Your Doctor or Nurse Practitioner 6. Other —------------------6. None recommended. 84 . your as visit, did you update your medication list by adding any herbal remedies that you are currently taking? (Please circle one answer) 1. Yes 2. No 3. Not taking any herbal remedies. 4. Have never have taken herbal remedies 13. ,At your last visit, did the staff ask you if you took any herbal remedies? (Please circle one answer) 1. Yes 2. No 14. At your last visit did you volunteer information about your herbal remedies to the staff? (Please circle one answer) 1. Yes 2. No 3. Not taking any herbal remedies. 4. Never taken herbal remedies. 15. On the line below, please place a single pen mark to show where you think your overall health score is today on a scale of 0 = death on the left to 100 = perfect health on the right. (If you feel as if your health is great today, place the mark closer to 100, or if your over-all health is horrible today, place your mark closer to the 0) { 0 death 50 __________ } 100 perfect health 16. Have you ever had an adverse reaction to an herbal remedy? (Either your condition got much worse or you had a rash, nausea, or trouble breathing) (Circle one answer) 1. Yes 2. No 3. Do not take herbal remedies. 4. Have never taken herbal remedies. 17. If you had an adverse reaction to an herbal remedy, did you call your doctor’s office? (Please circle one answer) 1. Yes 2. No 3. Went to the emergency room. 4 Do not take herbal remedies, so no adverse reaction. 85 18.1If you have never taken any herbal remedies, would you be willing to try one with the advice --- of: cf: (Circle all that apply) 1. A magazine or a pamphlet at the health food store 2. A TV program or advertisement 3. Advice of an herbalist 4. Advice of a pharmacist 5. Advice of your doctor 6. Other 7. I already take herbal remedies. 19. Do you think that herbal remedies are more natural than medications prescribed for you by your doctor? (Please circle one answer) 1. Yes 2. No 20. What does the word natural on an over-the-counter herbal remedy mean to you? (Please circle all answers that apply) 1. Pure 2. Better for your body 3. Safe 4. Made from plants only 5. No chemicals 6. Effective 7. None of the above 8. Other 21. If you have ever used herbal remedies, what were you hoping to do? (Circle all answers that apply) 1. To cure a sudden illness 2. To make you feel better 3. 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