USE OF HERBAL PRODUCTS, PRESCRIBED MEDICINES AND NON-PRESCRIBED MEDICINES BY COMMUNITY-DWELLING OLDER WOMEN
SAUN-JOO LEE YOON
A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
DOCTOR OF PHILOSOPHY UNIVERSITY OF FLORIDA 1999
Copyright 1999 By
Saun-Joo Lee Yoon
To my husband, Sung-Hwa,
and daughters, Alyssa and Hyunji for
their love, patience, and encouragement
I wish to thank the members of my supervisory committee for their encouragement and support from the inception of this research study to its completion. I am especially grateful to Dr. Claydell Homne, chairperson of my committee, for her counseling, support and patience throughout my doctoral program.
I extend my sincere appreciation to Dr. Kathleen Long
for her support and encouragement to conduct this research. I am grateful to Dr. Hossein Yarandi for his expertise with the data analyses, and to Dr. Robin West for her encouragement and support throughout the doctoral program. I am especially appreciative of Mr. Jeffery Delafuente for his insight and guidance throughout this endeavor.
I wish to thank my parents and parents-in-law for their support and love from Korea. My infinite thanks go to my husband, Sung-Hwa, and daughters, Alyssa and Hyunji, for their love, patience, support, and confidence. Finally, I am very appreciative of the grant from Alpha Theta Chapter, Sigma Theta Tau International Honor Society and of support from the College of Nursing for providing transportation during data collection.
TABLE OF CONTENTS
ACKNOWLEDGEMENTS . . . . . . . .. iv
LIST OF TABLES . . . . . . . .. vii
ABSTRACT . . . . . . . . . . viii
CHAPTER I: INTRODUCTION . . . . . . 1
Introduction . . . . . . . 1
Problem Statement . . . . . 6
Research Aims . . . . . . 9
Research Hypotheses . . . . . 10 Research Questions . . . . . 10
Operational Definition of Terms . . 11 Assumptions . . . . . . .. 12
Limitation . . . . . . . 13
Summary . . . . . . . . 13
CHAPTER II: REVIEW OF LITERATURE . . . . . 16
Differences between Alternative
Medicine and Conventional Medicine ...... 16
History of Herbal Products and
Their Use . . . . . . . .. 21
Prevalence of Alternative Medicine
and Herbal Products . . . . . 26
Choice Between Alternative and Conventional
Medicines . . . . . . . . 29
Older Women and Health Problems . . 32
Patterns of Drug Use Among Older
Adults . . . . . . . . .. 37
Polypharmacy . . . . . . .. 40
Toxicities of Herbal Products and
Possible Interactions with Drugs of
Conventional Medicine . . . . . 45
CHAPTER III: METHODOLOGY . . . . . . . 50
Research Design . . . . . . 50
Setting . . . . . . . .. 50
Sample . . . . . . . . 51
Inclusion and Exclusion Criteria . . 52 Instrument . . . . . . . 53
Operationalization of Variables . .. 54 Procedure . . . . . . . .. 60
Data Collection . . . . . .. 62
Data Analysis . . . . . . .. 67
CHAPTER IV: RESULTS . . . . . . . .. 68
Research Design . . . . . .. 68
Sample . . . . . . . . 68
Demographic Characteristics of the
Sample . . . . . . . . 71
Research Hypotheses . . . . .. 75
Description of the Research
Questions . . . . . . . .. 88
Other Findings . . . . . . 93
CHAPTER V: DISCUSSION AND RECOMMENDATIONS . . .. 95
Discussion and Conclusions . . . 95
Implication for Nursing and
Recommendations . . . . . . 106
REFERENCES . . . . . . . . . . 109
APPENDIX A: QUESTIONNAIRE . . . . . . .. 118
APPENDIX B: CONSENT FORM . . . . . . 128
APPENDIX C: THE 20 MOST POPULAR ASIAN PATENT MEDICINES
THAT CONTAIN TOXIC INGREDIENTS . . 133
BIOGRAPHICAL SKETCH . . . . . . . .. 137
LIST OF TABLES
4.1 Frequency Distribution of Total Sample . . 70
4.2 Age of Herbal Users, Non-Users, and Total
Sample . . . . . . . . . . 71
4.3 Demographic Characteristics of the Total Sample,
Herbal Product Users, and Non-Users . . . 74
4.4 Perceived Overall Health by Herbal Users,
Non-Users, and Total Sample . . . . . 78
4.5 Perceived Physical Health by Herbal Users
Non-Users, and Total Sample . . . . . 79
4.6 Perceived Emotional Health by Herbal Users
Non-Users, and Total Sample . . . . . 80
4.7 Types of Health-Related Problems . . . .. 82
4.8 Frequently Used Non-Prescribed Medicines
Taken Regularly . . . . . . . . 86
4.9 Use of Prescribed, Non-Prescribed
Medicines by Sample . . . . . . . 87
4.10 Types of Herbal Products Used by Subjects . . 89
4.11 Purposes of Using Herbal Products by Subjects
and by Number of Herbal Products . . . .. 90
5.1 Frequencies and Percentages of Females
and Males Aged 65 and Over in a North
Central Florida County . . . . . . .. 96
5.2 Summary of Races among Females Aged 65
and Over . . . . . . . . . .. 97
Abstract of Dissertation Presented to the Graduate School Of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy
USE OF HERBAL PRODUCTS, PRESCRIBED MEDICINES AND
NON-PRESCRIBED MEDICINES BY COMMUNITY-DWELLING OLDER WOMEN
Saun-Joo Lee Yoon
Chairperson: Claydell Horne, PhD Major Department: Nursing
As alternative health care is becoming more prevalent among persons in the United States, the use of herbal products is on the increase. Although herbal products are considered to be natural, these products have not been subjected to scientific clinical studies and, therefore, have not been FDA approved. The number of women aged 65 years and older in the US using herbal products is unknown. The purpose of this research is to explore the use of herbal products for medicinal purposes and to compare differences in demographic characteristics and health status between the herbal product users and non-users among community-dwelling older women. Sampling criteria were viii
women 65 years and over and living independently in a North Central Florida county. A random sample was selected from a list of 8,344 women 65 years and over obtained from the State Department of Highway Safety and Motor Vehicles. Structured interviews were completed on 86 subjects.
The interview questionnaire was comprised of three parts including health status and use of conventional medicines, use of herbal products, and demographic data. Data indicated that herbal products were used by 45.3% of the sample in the past 12 months. The total sample reported using a mean of 3.2 prescribed medicines and 3.8 non-prescribed medicines per person. The mean number of herbal products used by the sample was 2.5. The sample reported using a total of 98 herbal products. Subjects reported only 28% of the total number of herbal products used to their health care providers. No differences in demographic characteristics and health status were found between users and non-users of herbal products except in the area of memory problems. More herbal product users claimed memory problems than non-herbal users. It is important for health care providers to be knowledgeable of the use of herbal products in order to provide comprehensive health care to older women and to prevent unintended herbal-drug interactions.
Persons who are 65 and older comprise the fastest
growing age group in the United States. Among 249 million people in the United States, 34 million are aged 65 and older (U.S. Bureau of Census, 1990). In the 65 years and older population, women outnumber men and this gap widens with increasing age (Cobbs & Ralapati, 1998). Older women in this age group have a higher disability rate and are more likely than men to live longer with chronic conditions (Kart, 1994).
Although persons 65 and older represent about 14% of the American population, they consume three times more prescription drugs than their younger counterparts (Gormley, Griffiths, McCracken, & Harrison, 1993). Four out of five people aged 65 and older have at least one chronic disease (Delafuente, 1991), and persons in this age group have almost twice the risk of iatrogenic disease and visit the clinics more often than do younger people (Lamy, 1986). Researchers show that community-dwelling elderly use an average of 4.4 drugs including prescription and
non-prescription drugs, and about 85% of these persons take two or more drugs (Pollow, Stoller, Foster, & Duniho, 1994).
Many elderly people are dependent on conventional drug therapy to treat their chronic conditions and to maintain their health. The goals of drug therapy in the elderly are to (a) alleviate pain, (b) improve functional capacity, (c) promote quality of life, and (d) prolong life (Sloan, 1992) Multiple drug use in the elderly, even when each drug has a therapeutic purpose, can increase the risk of significant drug-related problems such as adverse drug reactions or drug-drug interactions (Noyes, Lucas, & Stratton, 1996; Sloan, 1992). While the use of multiple prescription and non-prescribed drugs among the elderly has been studied extensively (Chrischilles et al., 1992; Fillenbaum, Horner, Hanlon, Landerman, Dawson, & Cohen, 1996; Helling, Lemke, Selma, Wallace, Lipson, & CornoriHuntley, 1987; Stewart, Moore, May, Marks, & Hale, 1991), little is known about the use of herbal products by this age group and how herbals react when taken with prescribed and/or non-prescribed medicines.
Recently, herbal products have increasingly received attention in the United States as complementary and
alternative medicine. Many researchers have used different terms to explain complementary and alternative medicine (CAM) such as unconventional, alternative or complementary, unproven, and unorthodox therapies. Eisenberg, Kessler, Forster, Norlock, Calkins, and Delbanco (1993) defined CAM as medical interventions not taught widely at U.S. medical schools or those not generally available at U.S. hospitals (i.e. acupuncture, chiropractic, and herbal medicine). The definition of CAM was further refined in the CAM Research Methodology Conference in 1995 as a broad domain of healing resources that comprises all health systems, modalities, and practice other than a dominant health system of a particular society in a given historical period (Panel on Definition and Description, CAM Research Methodology Conference, April 1995, 1997).
Recently, attention to CAM has been given by governmental health agencies. Examples include the establishment of the Office of Alternative Medicine (OAM) in National Institutes of Health (NIH) in 1992, and the passage of new regulation of herbal products as dietary supplements in the Dietary Supplement Health and Education Act (DSHEA) in 1994 (Taylor, 1996). Even before the passage of new regulations on herbal products in 1994, sales of
herbal products in the United States in 1991 were estimated at over one billion dollars (McCaleb, 1993). Although it may not necessarily reflect the actual use of CAM including herbal medicines, changes in the regulation of herbal products and more research focused on CAM certainly bring higher public interest than ever before.
In the United States, one in three study participants reported using at least one unconventional therapy in the past year (Eisenberg et al., 1993). In the same study, three percent of Americans surveyed used herbal medicines during the past twelve months while approximately 80% of the worldwide population were estimated to depend on traditional herbal medicines (World Health Organization, 1993). According to Eisenberg and colleagues (1993), the majority of people used unconventional therapies for chronic medical conditions, hut not for life-threatening situations. Eisenberg and colleagues (1993) inferred that a substantial number of unconventional therapies were used for nonserious medical conditions, health promotion, or disease prevention.
Because of the variability of complementary and
alternative medicines, natural health food stores selling herbal products are expanding businesses in the United
States. The botanical industry has grown from almost nothing to a $1.5 billion industry in 20 years and is expanding at a rate of 15% a year (Marwick, 1995). Herbal products are becoming more familiar to the public because these products are considered to be natural and safe to use without adverse effects and are easy to obtain in the natural health food stores.
Today, people have access to a wide availability of herbal products and many of these products have been imported from foreign countries without strict safety regulations. Herbal products can be toxic and can sometimes be mixed with toxic ingredients with or without knowledge of the user. People can suffer adverse effects because of misinformation about products, possible interactions with conventional drugs, and substance overdose. Because the elderly are a group of people using herbal products for their health care, they are most at risk of suffering adverse effects by using these herbal products alone or combined with conventional drugs.
Because of the increased attention and consumption of herbal products, there must be more i research to study the patterns of herbal use alone or with prescribed and/or nonprescribed medicine. More needs to be known about the
prevalence and the reasons for taking herbal products among the elderly as well as possible interactions between drugs of conventional medicine and herbal products.
It is known that there are altered pharmacological
mechanisms and decreased functional capacity of the major organ systems with aging (Montamat, Cusack, & Vestal, 1989). However, people who are aged 65 and older consume three times more prescription drugs than those under 65 (Gormley, Griffiths, McCracken, & Harrison, 1993). In addition to prescribed medications, the older adults are, also, frequent users of nonprescription drugs (Pollow, Stoller, Foster, & Duniho, 1994). The overall incidence of adverse drug reactions or interactions in the elderly is two to three times higher than the occurrence in their younger counterparts (Nolan, & O'Malley, 1988). These figures, however, do not include reaction or interaction with the use of herbal products.
Most older persons have at least one chronic condition and many have multiple conditions. According to the Administration on Aging, the most frequently occurring conditions per 100 elderly in 1994 included arthritis (50), hypertension (36), heart disease (32), hearing impairments
(29), cataracts (17), orthopedic impairments (16), sinusitis (15), and diabetes (10). Women who are aged 65 and older have the highest rate of chronic conditions such as arthritis (U.S. Department of Health and Human Services, 1997).
Eisenberg and colleagues (1993) pointed out that the use of unconventional therapies was not limited to the person's principal medical condition as adjuncts to conventional therapy, but extended to nonserious medical conditions, health promotion, or disease prevention. A full one-third of their study respondents who used unconventional therapies did not use these therapies for any of their principal medical problems (Eisenberg et al., 1993).
According to the earlier study by Eisenberg and
colleagues (1993), prevalence rate of persons 18 years and older who use herbal products in the United States is three percent. However, since the Dietary Supplement Health and Education Act in 1994, the use of herbal products has increased; and since that time, researchers have found an increasing prevalence of herbal product use among persons in the United States. The World Health Organization estimated that traditional herbal medicines were the most
frequently used types of therapies for the majority of people in the world.
There were controversial results relating to the
prevalence of reported use of herbal medicines among age groups in studies conducted in the United States (Eisenberg et al., 1993; Frate, Croom, Frate, Juergens, & Meydrech, 1996) Frate and colleagues (1996) stated that over 70 percent of the adults in their sample used at least one plant-derived medicine during the past year, while three percent of the study population used herbal therapies in the study by Eisenberg and colleagues (1993) Differences in study results may occur because of research methodology, definitions of herbal medicine and plant-derived therapies, and settings of data collection.
The use of herbal products has been studied in certain types of illnesses. Researchers showed the use of herbal products among AIDS patients (Greenblatt, Hollander, McMaster, & Henke, 1991; Kassler, Blanc, & Greenblatt, 1991), Alzheimer's patients (Coleman, Fowler, & Williams, 1995), rheumatoid arthritis patients (Boisset & Fitzcharles, 1994), and cancer patients (Cassileth & Chapman, 1996).
While researchers reported the use of herbal products among disease specific groups of people, very little is
known about the prevalence of use of herbal products among the elderly residing the community. Also, little information is available related to the potential adverse effects of herbal products and possible interactions between conventional drugs and herbal products in the elderly.
The purpose of this research is to study the use of herbs and/or herbal products for medicinal use as well as the possible interactions between herbals with prescribed and/or non-prescribed medicines among community-dwelling older women.
1. To identify the prevalence of use of herbal products
and/or herbs among community-dwelling women 65 years
2. To identify the purpose for which women 65 and older
take herbal products and/or herbs and to determine
for which physical symptoms or health conditions
women most likely take herbal products.
3. To describe the frequency of use of herbal products
and/or herbs and whether herbal products and/or
herbs are used alone or in combination with prescribed and/or non-prescribed medicines.
4. To identify the sources of information related to
herbal products and/or herbs used by women 65 years
i. There are differences in demographic characteristics
between herbal users and non-herbal users among
women aged 65 and older.
2. There are differences in health status between
herbal users and non-herbal users among women aged
65 and older.
1. What is the prevalence of women aged 65 years and over who use herbal products and/or herbs?
2. What is the purpose for taking herbal products
and/or herbs by women aged 65 years and over? Do
older women take herbal products more for
prevention or for treatment of symptoms?
3. What is the frequency of use of herbal products by older women? Do women who use herbal products use
them continuously over time or on an as needed
basis? Do women who use herbal products use them
alone or in combination with prescribed and/or nonprescribed medicines?
4. What sources do women 65 and over use to obtain
information about the use of herbal products?
Operational Definition of Terms
For the purpose of this research, terms are operationalized as follows: l.Complementary and Alternative Medicine (CAM) is defined
as a broad domain of healing resources that comprises all
health systems, modalities, and practice other than a
dominant health system in the United States. CAM is used
interchangeably with alternative medicine,
unconventional, complementary, or unorthodox therapies.
2. Older woman is defined as a woman 65 years and older. 3. Drugs of conventional medicine include the prescribed
and non-prescribed medicines. Non-prescribed medicines
include vitamins and minerals. Drugs of conventional
medicine can be used interchangeably with conventional
5. Herb is defined as a plant or plant part valued for its
6. Herbal product is defined as a product that (a) is
excluded from definition of 'drug' by FDA; and (b) is not labeled as a vitamin, a mineral, or food additive;
and (c) contains active ingredients aerial or
underground parts of plants, other plant material in a
crude state or plant preparation, or combinations
preparations; or (d) contains natural organic or
inorganic active ingredients, which are not of plant
origin by tradition, a concentrate metabolite,
constituent, or extract. Herbal products include
7. Conventional medicine is defined as a dominant health
system in the United States which is widely taught
at U.S. medical schools or which is generally available
at the U.S. hospitals.
8. Polypharmacy is defined as the use of four or more
drugs, including both prescribed and non-prescribed
drugs, by a single person.
1. Participants have some knowledge of their health status,
including herbal products and drugs used for health
promotion and care.
2. Participants can identify reasons to choose or not to
choose herbal products.
3. Participants have access to various sources of
information about herbal products.
4. Participants may feel that it is not necessary to
communicate the use of herbal products to their
physicians or other regular health care providers,
because herbal products are from natural sources and
considered as dietary supplements.
5.Although herbal products are considered to be safe and
beneficial for maintaining or promoting health conditions
in general, certain herbal products may have potential
toxicity or may interact with certain conventional drugs.
The generalizabiiity of results of this study is limited to older women who live independently in north Florida. However, the population is believed to be similar to the populations of older white community-dwelling women in other parts of the United States.
Persons aged 65 and older are a rapidly growing group in the United States. In an aging population, there is an increase in the number of persons with chronic illnesses who need health care services. As persons age, there is a greater population of women than of men; and women have a higher disability rate than their male counterparts.
The known facts about herbal products are as follows. First, complementary and alternative medicines are receiving increased attention by society. Second, consumption of herbal products has increased and continues
to increase among people. Third, few toxicities and benefits of herbal products have been studied and recognized. Finally, primary physicians and other health care providers are not always aware that patients are taking herbal products. That is not only because patients lack knowledge about the contradistinctions of herbal products and conventional drugs but also because primary physicians or health care providers do not ask the patients about the use of herbal products.
However, there are facts that are not known clearly. Since herbal products are more likely to be used for chronic conditions and for maintaining and promoting health status, no known research data exist related to the use of herbal products by older women. Although data are available reflecting the need for better communication between health care professionals and patients to prevent the polypharmacy causing the drug-drug interactions of conventional drugs, little is known about the information related to the prevalence of use of herbal products or potential side effects of herbal products among the older women.
It is important to enhance understanding related to
prevalence of use of herbal products, specific purposes of using herbal products alone or in combination with drugs of
conventional medicine as well as differences between herbal product users and non-users among older women. The results of this research give a better understanding about the use of herbal products among older women and encourage extensive communication between health care providers and clients for comprehensive care, which results in improving the quality of life of older women.
REVIEW OF LITERATURE
The review of literature pertaining to herbal products research includes summation of the following topics: (a) differences between alternative medicine and conventional medicine; (b) history of herbal products and their use; (c) prevalence of the use of alternative medicine; (d) choice between conventional and alternative medicines; (e) older women and health problems; (f) patterns of drug use among older adults; (g) polypharmacy among the elderly; and (h) toxicities of herbal products and possible interactions of herbal medicines with conventional medicines. Differences between Alternative Medicine and Conventional Medicine
Alternative medicine is often defined as: (a) medical interventions not taught widely at U.S. medical schools or those not generally available at U.S. hospitals; (b) treatments which lack sufficient documentation in the U.S. for safety and effectiveness against specific diseases and conditions; and (c) practices that are not generally reimbursable by health insurance providers (Stalker, 16
1995). Seven categories of alternative medical practice are listed by the Office of Complementary and Alternative Medicines, the National Institute of Health (Workshop on Alternative Medicine, 1994). These include (a) mind-body interventions, (b) bioelectromagnetic therapies, (c) alternative systems of medical practice, (d) manual healing methods, (e) pharmacologic and biologic treatments, (f) herbal medicine, and (g) diet and nutrition. Mind-body interventions include psychotherapy, hypnosis, imagery, meditation, biofeedback, support groups, dance therapy, yoga, music therapy, art therapy, prayer, and mental healing. Mind-body intervention helps patients experience and express their illnesses in new ways by using placebo response and spirituality, as well as religion. Bioelectromagnetics (BEM) is the science that studies how living organisms interact with electromagnetic (EM) fields and purports that changes in the body's natural fields may produce physical and behavioral changes. BEM includes blue light treatment, artificial lighting, electroacupuncture, electromagnetic fields, electrostimulation and neuromagnetic stimulation devices, and magnetoresonance spectroscopy.
Worldwide, 70% to 90% of human health care is
delivered by alternative systems of medical practices,
varying from self-care according to folk principles to care by organized health care system based on an alternative tradition or practice. There are a variety of practices including acupuncture, traditional oriental medicine, ayurveda, environmental medicine, homeopathic medicine, Native American practices, naturopathic medicine, anthroposophically extended medicine, and Latin American rural practices.
Manual healing methods are based on the understanding that dysfunction of a part of the body affects secondary function of other body parts. These methods include osteopathy, acupressure, Alexander technique, chiropractic medicine, massage therapy, biofield therapeutics, and therapeutic touch (Workshop on Alternative Medicine, 1994).
Pharmacological and biological treatments are an assortment of drugs and vaccines not yet accepted by mainstream medicine, and include but are not limited to, anti-oxidizing agents, cell treatment, metabolic therapy, and oxidizing agents (Ozone, Hydrogen Peroxide) Diet and nutrition devised for the prevention and treatment of chronic disease include changes in dietary lifestyle, diet, Gerson therapy, macrobiotics, megavitamins, and nutritional supplements.
Herbal products are mostly a part of plants or plant products that have a long history of traditions in all cultures. Although many drugs commonly used today are of herbal origin, herbal products can be marketed only as food supplements in the United States. Despite the skepticism by Food and Drug Administration (FDA), a growing number of Americans are exhibiting interest in herbal preparations. The increased use of plant medicines has a potential benefit for improving public health, but issues related to safety, efficacy, and appropriateness of medicinal herbs need to be solved (Workshop on Alternative Medicine, 1994).
In contrast to alternative medicine, conventional
medicine is the medical practice that is widely available at American medical schools or in U. S. hospitals, and is considered to be the world's standard health care system among most people in the United States. There are many differences between alternative medicine and conventional medicine. Conventional medicine is based on the empiricism that relies on a mechanistic model; wherein, body and mind are viewed as separate entities with illness being explained in terms of measurable physical phenomena. Therefore, the primary goal of conventional medicine is to bring about measurable objective improvement in disease states. In contrast, one of the primary goals of
alternative medicine is to alter the subjective state of the person, which can eventually promote objective improvements in disease states (Burg, 1996).
Conventional medicine and alternative medicine can also be distinguished by their approaches to the role of the patient in treatment (Burg, 1996), by administration of therapies, and by the interaction between the patient and health care provider (Workshop on Alternative Medicine, 1994). In biomedicine, patients receive the standardized treatment and medical advice on the basis of diagnosis or symptomatic categories. In this system, the patientpractitioner interaction is "physician centered." The physician, thus, is the authoritative expert and the patient is a receptive participant (Brunton, 1984). In contrast, alternative medical practitioners tend to individualize treatment and to create elaborate procedures for identifying individual suitability and sensitivity to the interventions. They often apply multiple treatment modalities and judge effectiveness by using subjective and patient derived outcomes (Jonas, 1993). Alternative systems of medicine emphasize a client-centered relationship and patient responsibility in the healing process, which can maximize the collaboration between the medical
practitioners and patients, thus enhancing the benefits of a therapy.
Although all complementary medicine practitioners do not share a common epistemology, several principles are common to most of their practices. These include emphasis on the: (a) Patients' feeling rather than their diagnosis;
(b) Holistic view rather than conventional medical view: All aspects of the person (i.e. physical, emotional, mental, and psychosocial health, lifestyle, etc.) are interrelated and must be considered through the process of care; (c) Promotion of the use of a variety of therapeutic options for the purposes of prevention and treatment, and viewing treatment as a process; (d) Maintaining basic ethics of patient care such as do no harm; (e) Balance in a patient's body system, and relationship to other individuals, society, or environment; (f) Production of fewer side effects by using whole foods and herbs rather than using conventional drugs; and (g) Expectation that the patient is not a passive recipient but an active participant through the treatment process (Burg, 1996; Murray, 1994; Workshop on Alternative Medicine, 1994).
History of Herbal Products and Their Use
An herb is defined as a seed-producing annual,
biennial, or perennial that does not develop persistent
woody tissue but dies down after flowering. The second definition is a plant or plant part valued for its medicinal, savory, or aromatic qualities (Merriam-Webster's Collegiate Dictionary, 1993). The herbs referred to in this paper are included under the second definition. An herbal medicine is a plant-derived material or preparation with therapeutic or other human health benefits, which contains either raw or processed ingredients from one or more plants (World Health Organization, 1993).
Herbal prescriptions are available for the entire range of medical ailments, including pain, hormonal disturbances, breathing disorders, infections, and chronic debilitating illnesses. These are classified according to their energetic qualities and are prescribed for their action on corresponding organ dysfunction, energy disorders, disturbed internal energy, blockage of the meridians, or seasonal physical demands (Workshop on Alternative Medicine, 1994).
Early humans treated illness by using plants, animal
parts, and minerals that were not part of their usual diet. Herbal medicines using plants and plant products have been utilized in medical practice for thousands of years, and have made a great contribution to maintaining human health.
For example, the Ebers Papyrus, the preserved Egyptian manuscripts, were written around 1500 B.C. and contain 876 prescriptions made up of more than 500 different substances including many herbs. De Matefia Medica written in the 1st century A.D. offers about 950 curative substances including 600 plant products and other 350 of animal or mineral origin in Greece and Rome (Ackernecht, 1973) This text explains a description of the plant, an account of its medicinal qualities, methods of preparation, and warnings about undesirable effects. The Arabs preserved a body of knowledge in the Muslim matera medica, which lists more than 2,000 substances, including many plant products (Ackernecht, 1973).
Herbs played an important role in Ayruvedic medicine in India, and were described in Ayruvedic books more than 2000 years ago. The history of Chinese herbal medicine can be traced to the end of the third century B.C. The Encyclopedia of Traditional Chinese Medicine Substances,
the most definitive compilation of China's herbal tradition to date, has evolved from the Classic of the Matera Medica which was written almost 2,000 years ago. Traditional Chinese medicine influenced Korea and Japan and markedly simplified Japanese traditional medicine, called Kampo (Workshop on Alternative Medicine, 1994).
In contrast, the United States has a relatively short history of the use of herbal products compared to that of other countries. Early explorers of North America exchanged knowledge with the Native Americans to learn which herbs to use in the New World. Until the early 20th century, plants remained as a mainstay of country medicine, and were used not only by physicians to treat common ills, but also as important home remedies by many families (Buchman, 1980). A textbook of pharmacognosy contained hundreds of medically useful comments on herbs until the 1940s. As medicine evolved with advanced technology in the 20th century, remedies from natural resources were gradually forgotten in modern society. Today, however, many commonly used drugs are of herbal origin. About one-quarter of the prescription drugs dispensed by community pharmacies in the United States contain at least one active ingredient derived from plant material (Workshop on Alternative Medicine, 1994).
Recently, Americans have shown an increased interest
in the use of herbs and herbal medicines due in part to the changing health care system's focus on preventive care as well as interest in natural therapies (Youngkin, & Israel, 1996). There are other factors contributing to an increased interest in herbal products in America. one factor is the wide availability of such products from European countries,
China, Japan, South America, and Mexico, in most U.S. health food stores. Secondly, people are willing to try herbs and herbal preparations for chronic illnesses or as an adjunct to other treatment. And, finally, herbs and/or herbal products are generally considered to be less toxic than drugs from conventional medicines (Workshop on Alternative Medicine, 1994).
It is now easier to gain access to herbal products
since they are considered dietary supplements rather than a part of conventional drugs as a consequence of the Dietary Supplement Health and Education Act of 1994. In the United States, $1.5 billion of herbs were sold in 1995, and their sales rate has been growing from 12% to 18% per year averaging about 15% a year (Gray, 1996). There were about 8,000 natural health food stores in the United States in 1995 (Marwick, 1995).
With an increased use of herbal products, safety and toxicity are becoming issues. Although it is generally perceived that natural products are safe, there are risks when these are used because not all herbal remedies are harmless. Herbs or herbal products can be incorrectly identified by manufacturers as nontoxic herbs. Since many herbal products are mixtures, some of them may be toxic, particularly if they are misused. Some ayurvedic botanical
products contain high levels of heavy metals that can cause toxic effects. Another threat posed by herbal remedies is a lack of proper knowledge in using them, which results in an overdose causing irreversible organ damage (Marwick, 1995). It is important for herbal product users to collect information about the herbal products prior to their use. Health care providers need be more attentive to thorough history assessments of their clients related to the use of herbal products as well as the use of conventional drugs.
Prevalence of Alternative Medicine and Herbal Products
Alternative medicine has gained in popularity and
respectability in recent years, becoming widely used to promote or to maintain health, to treat diseases, to alleviate symptoms, and to prevent recurrence of illnesses. A 1990 national telephone survey revealed that 34% of Americans reported using at least one alternative medicine in the previous year including 10% who visited alternative practitioners, and spent $13.7 billion on these visits. Americans made more visits to alternative practitioners (425 million) than to primary care physicians (388 million) (Eisenberg et al., 1993).
The results of the study by Paramore (1997) are
consistent with that of Eisenberg and colleagues(1993). Paramore (1997) found that nearly 10% of the U.S.
population, almost 25 million persons, saw a professional in 1994 for at least one of the following four therapies: chiropractic, relaxation techniques, therapeutic massage, or acupuncture. The use of alternative medicines was correlated with poor health rather than maintaining or promoting health. The use of alternative medicines was frequently used among middle-aged whites who had more education and higher incomes (Eisenberg et al., 1993; Paramore, 1997). These researchers reported no significant gender differences in the use of four alternative medicines.
Alternative medicines were more frequently used to treat medical conditions such as back problems, insomnia, headache, anxiety, and depression (Eisenberg et al., 1993), and were also used for minor ailments, for health promotion, and as prophylaxis for recurrent problems (Murray & Shepherd, 1993). These therapies were generally used as adjuncts to conventional medicine rather than replacements for conventional medicine, (Eisenberg et al., 1993; Murray & Shepherd, 1993).
Overall, persons with chronic, nonspecific, and hardto-treat illnesses are likely to be frequent users of complementary medicines. Researchers studying polypharmacy among patients attending an AIDS clinic found that 29% of
patients with AIDS used alternative medicines during the three month period prior to the interview, and the use of alternative medicines was associated with their stage of illness (Greenblatt, Hollander, McMaster, & Henke, 1991). The use of medicinal herbs was more frequent in HIVinfected patients than in the general population, which showed that 22% of 114 randomly selected HIV-infected patients reported using one or more herbal products in the past three months (Kassler, Blanc, & Greenblatt, 1991).
According to Coleman, Fowler, and Williams (1995), 55% of caregivers of patients with Alzheimer's disease reported that they had tried at least one alternative therapy to improve the patient's memory, including 11% who used herbal medicines. Although the proportion of cancer patients using alternative therapies is a smaller percentage compared with the percentage of all patients who do so, the prevalence of alternative cancer therapy in the United States ranged from a low of 6.4% to a high of 14.7% (Lerner & Kennedy, 1992).
A study in Canada showed that 66% of 235 Canadian
patients with rheumatologic diseases had used alternative therapies in the preceding 12 months. The most frequently used alternative treatment modality was non-prescribed over the counter products including herbs, minerals, and topical remedies (Boisset, & Fitzcharles, 1994).
According to Eisenberg and colleagues (1993), the most common types of therapies used were relaxation techniques, chiropractic, and massage. Over a 12 month period, herbal medicines were used by only 3% of Americans surveyed (Eisenberg et al., 1993), while the World Health Organization estimated that 80% of the world population used herbal medicine for some aspect of primary health care (Farnsworth, Akerele, Bingel, Soejarta, & Eno, 1985).
Data from the rural, central Mississippi area (Frate, Croom, Frate, Juergens, & Meydrech, 1996) was close to the prevalence rate from World Health Organization, and showed that over 70% of the adults from the sample of 223 households used at least one plant-derived medicine during the past year. Herbal remedies were frequently used by people who were married, from larger households, of higher socioeconomic status, or who had consulted alternative healers (Brown, & Marcy, 1991) However, there is little factual evidence concerning the use of herbal medicines among the elderly and characteristics of users compared to those of nonusers.
Choice Between Alternative and Conventional Medicines
Despite the advances of conventional medicines,
alternative therapies have received increased attention in the United States and other developed countries, and have
been chosen for use in treating various health problems by an increasing number of people (Eisenberg et al., 1993; MacLennan, Wilson & Taylor, 1996; Paramore, 1997). Compared to conventional medicine, alternative medicines rely heavily on the following factors: participation by patients in their own care; the relationship between the expectations of patients, cultural context, and lifestyle activities; and effects on therapeutic outcome of patients' choices of treatment (Workshop on Alternative Medicine, 1994).
In an earlier year, Kronenfeld and Wasner (1982)
focused on the marginalized groups in society to study the relationship between alternative medicine and traditional folk medicine which has developed from ethnographic tradition. In recent studies, researchers have recognized that unconventional therapies are accepted and practiced by a significant number of people, and are believed to be a part of contemporary culture (Eisenberg et al., 1993; MacLennan, Wilson, & Taylor, 1996; Paramore, 1997).
Since significant numbers of persons have recognized the use of alternative medicine, many researchers have investigated factors associated with the choices of alternative therapies. Vincent and Furnham (1996) reported the principal reasons by patients for choosing alternative
medicine over conventional medicine. These reasons included
(a) belief in the positive value of alternative medicine,
(b) previous experience of ineffective treatment of conventional medicine, and (c) concern about the adverse effects of medical care.
Other factors influencing the choice of alternative medicine were the poor communication between patients and health care practitioners in conventional medicine, the willingness of alternative practitioners to discuss emotional factors, and the chance to take an active role in their treatment (Vincent and Furnham, 1996) Choices of alternative therapies were influenced by the prognosis for specific diseases such as AIDS, cancer, arthritis, or Alzheimer's disease (Boisset & Fitzcharles, 1994; Cassileth & Chapman, 1996; Coleman, Fowler, & Williams, 1995; Greenblatt, Hollander, McMaster, & Henke, 1991) ; dissatisfaction with the effectiveness of conventional medicine (Cassileth & Chapman, 1996; Sutherland & Verhoef, 1994) ; negative relationship to perceived health status and to health care providers (Sutherland & Verhoef, 1994) ; and a lack of confidence in conventional medicine (McGregor & Peay, 1996).
In summary, a single factor cannot be used to explain the choice of alternative therapies for one's care.
According to Kelner and Wellman (1997), many factors influence people in their choice of alternative therapies. Predisposing factors include level of education and age, enabling factors (i.e. income, knowledge, and accessibility of services), and the need for care. Kelner and Wellman (1997) point out individuals in their study who choose to try alternative therapies assume responsibility for their health and well-being. Kelner and Wellman (1997) also indicate that people do not make dichotomous choices between conventional medicine and alternative medicine. Rather, people choose specific kinds of treatments for specific problems, and many use multiple therapies concurrently. In addition, a wide range of possibilities of health care as well as public and private testimonials about successful alternative treatments result in more people deciding to use alternative therapies to cope with their problems and concerns (Kelner & Wellman, 1997).
Older Women and Health Problems
The majority of older Americans are women, and the number of older women will increase continuously. The number of women surpasses the number of men in the age range of 65 years and over, and this gap widens with increasing age (Cobbs & Ralapati, 1998). In 1994, there were 20 million older women and 14 million older men. Among
those 85 years and older, there are 44 men for every 100 women; women outnumber men by 100 to 26 over the age of 95; and four out of five centenarians are women. There is a rapid increase in the number of centenarians in the United States (U.S. Bureau of the Census, 1996).
Although a majority of older adults live independently in the community and consider their health to be good or excellent, chronic disease becomes more prevalent with age (Cobbs & Ralapati, 1998). Four out of five people aged 65 and older have at least one chronic disease (Delafuente, 1991) The use of multiple conventional drugs among older adults is a serious issue in the United States (Lamy, 1986; Noyes, Lucas, & Stratton, 1996). Even with functional disability increasing with age, most older women report that they are emotionally vital; but health status, level of disability, and sociodemographic status influence their emotional vitality (Penninx et al., 1998).
Many researchers, who studied the use of conventional drugs among community-dwelling older adults, reported gender differences in the use of conventional drugs (Chrischilles et al., 1992; Fillenbaum et al., 1996; Simons et al., 1992) Based on the data from the Established Populations for Epidemiologic Studies of the Elderly (EPESE), Chrischilles and colleagues (1992) reported that
prescription drugs were used by 60-68% of men and 68-78% of women, while non-prescription drug use was 52-68% and 6476% respectively (Chrischilles et al., 1992). While studying community-dwelling older adults, Simons and colleagues (1992) found that 76% of women and 56% of men who used multiple prescription drugs also used multiple non-prescription drugs.
Fillenbaum and colleagues (1996) and Simons and
colleagues (1992) reported that female gender is one of the best predicting factors for the use of non-prescription drugs. Women reported taking more medications than men in each of these studies. Although Lassila and colleagues (1996) did not consider gender as a significant factor associated with the use of number of conventional drugs, most researchers who examined the use of non-prescription drugs accounted for 'female' as an important factor.
Gender difference was recognized in the types of
health problems and health actions as well as in the use of conventional drugs. Musil (1998) reported that there are significant gender differences in psychological and physical health as well as the health actions among older adults residing in the community. The significant gender differences in psychological health were found in anxiety, depression, and body awareness; however, no gender
differences were found in self-assessed health and total number of health problems (Musil, 1998).
The gender differences in physical health are that women aged 65 years and over experience more arthritis, cataracts, hypertension, and asthma while their male counterparts have more problems with hearing, ulcers, abdominal hernias, and heart disease (Musil, 1998). By 80 years of age, 70% of women have two or more chronic conditions, most likely arthritis and hypertension, and other common chronic conditions such as heart disease and visual or hearing problems (Cobbs & Ralapati, 1998).
According to a study of health problems and related health actions among older adults (Musil, Ahn, Haug, Warner, Morris, & Duffy, 199B), frequent health actions in response to health problems are the use of non-prescription medicines (83%), self-care activities (72%), use of prescription medicines (539), and professional consultation (43%). The gender differences in health actions suggest that women are more likely to use self-care while men incline towards seeking professional consultation (Musil, 1998) because, historically, women have played a major role in the healing process serving as caregivers of their own families (Burg, 1996). Self-care actions that are frequently used by community-dwelling older women include
taking non-prescription medicines, using home remedies, or making lifestyle changes (Musil, 1998).
The results of studies by Musil (1998) and Musil and colleagues (1998) are not surprising when considering frequent self-care actions by women including using home remedies. Burg (1996) states that most female patients may use some form of complementary medicine some time in their lives for their chronic health conditions; and women may use complementary medicines in combination with conventional medicines, which makes health assessment important to evaluate the potential interactive effects.
Although there are no known data specifically looking at women's use of complementary medicine in the United States, Burg (1996) suggested that certain groups of women may utilize complementary medicines based on genderspecific illness patterns and general knowledge about using complementary medicines. These groups of women who may use complementary medicines frequently are people with chronic, non-specific, or difficult for treating illnesses such as arthritis, depression, anxiety, HIV/AIDS, and cancer (Burg, 1996). In summary, it is important to examine health care practices among older women related to the use of herbal products as a part of complementary medicine since women live longer than men in their later stages of life with
increasing number of chronic health problems as they age. It is vital to understand the patterns of the use of herbal products in combination with conventional drugs in order to understand and prevent potential interactions between herbal products and conventional drugs. This knowledge and understanding assist health care providers to improve comprehensive health care for older women and subsequently, promote the quality of life of older women.
Patterns of Drug Use Among Older Adults
The population of the United States is 249 million including 34 million people aged 65 years and older (U.S. Bureau of the Census, 1990). The elderly are the fastest growing age group, and continue to grow faster than any other age group in the United States. Although most people are able to carry on their normal activities and functions up to the age of 75 or older, approximately four out of five people aged 65 and older have at least one chronic disease with an average of four diseases per person (Delafuente, 1991). There are many factors influencing drug use in the older adults including disease states, psychosocial factors, physicians who prescribe medications, and advertisement by the pharmaceutical industry (Stewart, 1995). Stewart (1995) states that other factors will influence patterns of drug use in the future such as the
development of new drug treatments with expanded coverage of prescription services by government and the influence of private insurers. Other factors associated with drug use in older adults are reported. These include prior drug use, number of health care visits, poorer health or selfperceived poor health, white race, female gender, impaired physical function, depression, hospitalization, insurance coverage, and smoking or drinking alcohol in previous year (Chrischilles et al., 1992; Fillenbaum et al., 1996; Lassila et al., 1996).
While there are great advantages of conventional drug therapy, there are problems associated with and resulting from conventional drug use by older adults. The use of conventional drugs for therapeutic purposes by older adults can contribute to significant drug-related problems because older adults are in an increased risk group due to impaired organ reserve capacity, multiorgan system dysfunction associated with multiple disease states, polypharmacy with drug interactions, and altered pharmacokinetics and pharmacodynamics (Sloan, 1992) other problems associated with conventional drug use include polypharmacy, issues of compliance, drug-drug interactions in combination use of conventional drugs (Chenitz, Salisbury, & Stone, 1990; Lamy, 1986; LeSage, 1990; Noyes, Lucas & Stratton, 1996;
Stewart, 1995; Stewart & Cooper, 1994; Swonger & Burbank, 1995).
Several national and community-based studies have provided information on conventional drug use patterns among older adults. Patterns of prescribing practice of conventional drugs by health care providers for older adults have varied over time depending on the data collecting time and geographical differences (Stewart, Moore, May, Marks, & Hale, 1991). Data from the Florida retirement community of Dunedin, a relatively healthy and ambulatory group, were collected during 1978-1979 (May, Stewart, Hale, & Marks, 1982), and 1987-1988 (Stewart et al., 1991). The average number of drugs, including both prescription and non-prescription, taken by the older adults in Dunedin, Florida was 3.2 during the 1978-1979 period (May et al., 1982) and 3.7 in the ten-year overview of the Dunedin study (Stewart et al., 1991).
Researchers in the Iowa Rural Health Study gathered data during 1981-1982 from the community-based, generally elderly population and reported a mean of 2.9 prescribed medicines (Helling, Lemke, Semla, Wallace, Lipson, & Cornoni-Huntley, 1987). Other studies of drug use patterns in the older adults were conducted in North Carolina and Pennsylvania. These studies included urban as well as rural
areas as well as a significant proportion of AfricanAmericans. Older adults in the Piedmont area of North Carolina were studied in 1986-1987 (Fillenbaum, Hanlon, Corder, Ziquba-Page, Wall, & Brock, 1993) and in 1989-1990 (Fillenbaum et al., 1996), and researchers reported a mean of 3.4 and 3.7 prescribed drugs per person in the two studies. In the MoVIES Project by Lassila and colleagues (1996), data were collected during 1987-1989 in the rural mid-Monongahela Valley community of Pennsylvania, a largely white (97%), blue-collar population. The result of the MoVIES Project showed subjects used a mean of 2.0 prescription drugs (Lassila et al., 1996).
Despite the differences in the time and the location of the study sites, findings are similar among these studies. When compared cross-sectionally and longitudinally, the proportion of the older adults who took conventional drugs increased with age, as did the number of medications taken (Chrischilles et al., 1992; Fillenbaum et al., 1993; Fillenbaum et al., 1996; Helling et al., 1987; Lassila et al., 1996; May et al., 1982; Stewart et al., 1991).
Polypharmacy has been recognized as a problem in the geriatric population (Gormley, Griffiths, McCracken, &
Harrison, 1993; Lamy, 1986; Noyes, Lucas, & Stratton, 1996; Shimp, Wells, Brink, Diokno, & Gillis, 1988). The elderly aged 65 and older, who represent only 14% of all American population, consume three times more prescription drugs than people under aged 65 years (Gormley, Griffiths, McCracken, & Harrison, 1993). The use of prescribed drugs has been projected to be 40% of the total drug expenditures in developed countries by year 2030 (Cusack, 1989). The older adults frequently use nonprescription drugs in addition to prescribed medications (Pollow, Stoller, Foster, & Duniho, 1994).
Polypharmacy has been defined in many different ways (LeSage, 1990; Michocki, Lamy, Hooper, & Richardson, 1993; Montamat & Cusack, 1992; Noyes, Lucas, & Stratton, 1996). In Healthy People 2000 (1990), polypharmacy was defined as the use of multiple prescription and nonprescription drugs, especially by elderly with chronic disease, while Noyes, Lucas, and Stratton (1996) considered multiple drug use synonomous with polypharmacy. LeSage (1990) defined polypharmacy as the concurrent use of several different drugs; whereas, Montamat and Cusack (1992) defined polypharmacy as the prescription, administration, or use of more medications than are clinically indicated in a given patient.
Other researchers (Michocki, Lamy, Hooper, &
Richardson, 1993) considered polypharmacy only as the use of multiple drugs. Definition of polypharmacy by Michocki and colleagues (1993) was that particular patients received too many drugs, for too long a time, or in exceedingly high doses. Although there is neither a specific number of medications to define polypharmacy, nor a unanimously accepted definition of polypharmacy, polypharmacy consistently represents the use of multiple medications by a single patient (Stewart & Cooper, 1994).
Possible causes of geriatric polypharmacy are multiple health problems; multiple prescribers; noncurrent medication storage; prescription patterns of physicians; and self-medication behavior (LeSage, 1990). Since it has been known that older adults often take a large number of drugs for various reasons, possible adverse consequences of the use of multiple medications exist. These consequences are adverse drug reactions, drug interactions, medication errors, noncompliance, quality of life and functional decline, and high financial cost (LeSage, 1990; Stewart & Cooper, 1994).
Swonger and Burbank (1995) pointed out the problems of polypharmacy and drug misuse associated with both physician and client. Multiple drug regimens are often too
Complicated or lack adequate rationale for each individual drug. Multiple chronic conditions of the elderly often require the use of more than one physician, which can lead to poorly coordinated care and adverse drug reactions.
Physician-centered problems are negative attitudes toward older people, difficulty in accurately diagnosing and dosing due to heterogeneity of the elderly, lack of client education about drugs and inadequate follow-up. Client-centered problems are unintentional resulting from a lack of knowledge or special instructions, forgetfulness in taking medicine, confusion, intentional omission, dosage adjustment, sharing drugs with other people, and stretching dosage requirements to save money (Swonger & Burbank, 1995).
Issues related to multiple drug use have been
recognized in other studies (Col, Fanale, & Kronholm, 1990; Michocki, Lamy, Hooper, & Richardson, 1993; Ranelli & Aversa, 1994; Stewart & Caranasos, 1989) Ranelli and Aversa (1994) studied medication-related stress among family caregivers, and reported that 32% of the caregivers had medication-related problems and 19% had difficulty in managing medications. More than half of the caregivers experienced problems in the past year, including scheduling difficulties, compliance problems, difficulty organizing
medications for the patient, and lack of professional advice. Although only 7.7% of the total time was spent providing drug-related care by caregivers, medications did contribute to the stress of the caregiving experience (Ranelli & Aversa, 1994).
Compliance is another issue related to polypharmacy.
Many factors were associated with compliance (Noyes, Lucas, & Stratton, 1996; Stewart & Caranasos, 1989) Among the factors related to compliance documented in literature, it was consistently mentioned that the number of medications taken and the complexity of the medication regimens were critical factors for patient's compliance.
One study of compliance rates related to dosage pattern, e.g. number of times per day, showed that compliance rate decreased when the number of times a medication was taken per day increased (Cramer, Mattson, Prevey, Scheyer, & Ouellette, 1989) Cramer and colleagues (1989) found only 39% of compliance rate with four times a day dosage schedule, while reporting 87% of compliance rate when medication was scheduled once a day for the elderly. Prescription of multiple drugs may increase noncompliance and cause adverse drug reactions or clinically significant drug interactions (Col, Fanale, & Kronholm, 1990) Adverse drug reactions are defined broadly by the United States
Food and Drug Administration (FDA) as any adverse event associated with the use of a drug in humans (Sills! Tanner, & Milstien, 1986).
According to Col and colleagues (1990), patients admitted to hospitals with medication noncompliance increased, when the number of different medications or the number of physician visits increased. Approximately 28% of hospital admissions among older adults were drug-related, and more specifically, were due to noncompliance (11.4%) and adverse drug reactions (16.8%). Although there are variations in reported hospitalization rates caused by adverse drug reactions, from 6.3% to 16.8% (Col, Fanale, & Kronholm, 1990; Colt, & Shapiro, 1989; Grymonpre, Mitenko, Sitar, Aoki, & Montgomery, 1988; Ives, Bentz, & Gwyther, 1987; Lindley, Tulley, Paramsothy, & Tallis, 1992) it is apparent that adverse drug reactions are serious and costly.
Toxicities of Herbal Products and Possible Interactions
with Drugs of Conventional Medicine
In recent years, the use of herbal products has
increased in developed countries, even though herbals have been a dominant form of health care in developing countries for many years. Although Eisenberg and colleagues reported that three percent of Americans were using herbal products
in the early 1990s, this number is assumed to be growing rapidly (Eisenberg et al., 1993).
The risk of potential toxicity of herbal medicines is accelerated by many factors. First of all, herbal medicines are not subject to standard Food and Drug Administration (FDA) tests for safety, effectiveness, and quality control because herbals are not considered conventional drugs but rather dietary supplements. Secondly, many herbal products are imported from foreign countries not mandating safety or manufacturing regulations. Finally, these medicines do not have the active or inactive ingredients listed on the package label (Anderson, 1996). Other factors contributing to the potential problems of using herbal products include
(a) misidentification of a plant, or the unknown or ignored toxicity of a correctly identified plant; (b) persistent use of herbs known to be toxic; (c) difficulty in identification of chopped or mixed herbs; (d) variability in chemical constituents of herbs; (e) problems with nomenclature; (f) difficulty in establishing the cumulative effects of a plant; (g) contamination with heavy metals; and (h) possible adulteration with prescription drugs or with other substances (Drew & Myers, 1997; Huxtable, 1990).
Certain groups of people using herbal products are at higher risk of intoxication than other groups. Huxtable
(1990) points out that high risk groups are people using herbs or herbal products for a long time, consumers of large amounts or a wide variety of herbs, babies, the elderly, those with concomitant diseases and concurrent medications, and the malnourished or undernourished. Also, toxicities can be selective depending on gender and cultural groups (De Smet, 1995; Huxtable, 1990). Nevertheless, it is widely perceived that natural products are safe, and people will continue to use herbal medicines in ever-growing numbers (Marwick, 1995).
Although the risk of using herbal medicine is much less than that of using conventional medicine, many researchers suggest that using herbal products is not without risk and, consequently, safety of using these products needs to be considered.
Only nine herbal products are approved by the Food and Drug Administration (FDA) for selected applications (Youngkin & Israel, 1996). Recently, Youngkin and Israel (1996) reviewed the safety of herbal therapies compared to the safety and efficacy data derived from the German Commission E and other biomedical literature for selected commonly used herbs. Among the 56 herbal products reviewed, only seven were approved by the FDA; 36 were considered to be effective for one or more specified complaints by the
German Commission E; and only four were approved by both FDA and German Commission E (Youngkin & Israel, 1996).
Drew and Mayers (1997) proposed classification of
adverse effects associated with herbal medicine into two categories, intrinsic and extrinsic effects. Intrinsic effects are those of the herb itself, and are characterized as type A and type B reactions for pharmaceutical purposes. Type A reactions are predictable and dose-dependent including effects with deliberate over-dose or accidental poisoning and interactions with pharmaceuticals. Type B are unpredictable and idiosyncratic reactions.
Extrinsic effects are not related to the herbal medicine itself, but to a problem in manufacture or compounding. Extrinsic effects may result from failing to adhere to a code of Good Manufacturing Practice and include contamination, misidentification, lack of standardization, substitution, adulteration, incorrect preparation and/or dosage, and inappropriate labeling and/or advertising. Extrinsic effects make it difficult for health care practitioners or users of herbal medicines to identify the correct herbal remedies or to assess the adverse effects (Drew & Mayers, 1997).
Information regarding toxicities and safety of herbal medicines is currently limited. The workshop on Alternative
Medicine (1994) listed the 20 most popular Asian patent medicines that contain toxic ingredients (see Appendix C). Other authors (Gray, 1996; Youngkin & Israel, 1996) summarized the scientific information and potential adverse effects of selected common herbal remedies. Currently, there is little information available related to interactions of herbal products in combination with the use of conventional drugs, although, it is assumed that there are possibilities of interactions between herbal products and conventional drugs (Drew & Mayers, 1997; Huxtable, 1990; Noyes, Lucas, & Stratton, 1996). More studies are needed to investigate the interactions between herbal products and conventional drugs.
Although the prevalence of the use of herbal products among older women is unknown, it is assumed that women aged 65 years and over consume more herbal products than their younger counterparts. older women report more chronic health problems than younger women. Also, older women attempt to prevent deterioration of health in the later stages of their life. It is clear that older adults are susceptible to medication related problems because of their overall increased use of medication.
The purpose of this research was to study the use of herbs and/or herbal products for medicinal use and to compare the differences in demographic characteristics and health status between herbal product users and non-herbal users among community-dwelling older women. This chapter contains the research methodology and is comprised of five sections: research design, setting, sample, instruments, data collection procedure, and data analysis.
This research utilized a cross-sectional and
descriptive design to examine the prevalence of herbal product use, the types of the herbs used, and to identify the reasons for use of herbal products among women aged 65 and over. Subjects were categorized into two groups: Group 1, women 65 years and older who used herbal products and Group 2, women 65 years and older who did not use herbal products.
The setting for this study was a county located in North Central Florida.
It was statistically determined that a sample size of 84 subjects (42 subjects in each group) would provide the desired sensitivity to test the study hypotheses. This determination was based on a formulation of 95% power, a medium critical effect size of 0.40 for each of the dependent variables, and a significance level of 0.05 for a two-tailed test of means.
Sampling criteria were women who were 65 years and over and lived in the designated North Central Florida county. The principal investigator requested names and addresses of all women 65 years and older who resided in the selected county from the Division of Drivers' License, State Department of Highway Safety and Motor Vehicles. This list yielded 8,344 names and addresses of women aged 65 and older.
According to Waltz, Strickland, and Lenz (1991), 30% response rate was not unusual in mailed questionnaire surveys. Therefore, it was necessary to select at least three times the number of subjects needed for the total sample of 84 subjects to test the hypotheses. The investigator randomly selected 252 subjects from the total list utilizing the table of random digit (Rand Cooperation, http://www.rand.org/software-and-data/random/digits.txt).
After a random selection of names, 252 letters were
mailed to the potential subjects, introducing the study and requesting participation in the study. A return self-addressed, stamped postcard was enclosed with each introductory letter. Of the 252 letters mailed, 53 subjects were included in the sample. Thirty-one more subjects were needed to attain a desired sample size of 84; therefore, 150 additional letters were mailed. From the second group of letters mailed, 33 subjects were included in the sample. Therefore, a total of 86 subjects completed the interview, resulting in 39 subjects in Group 1 (herbal product users) and 47 subjects in Group 2 (non-herbai users).
Inclusion and Exclusion Criteria
The inclusion criteria were as follows: (a) women who were 65 years and older living independently in the community; (b) currently living in the selected county; (c) ability to speak and understand English; and (d) able to verbally communicate with intact memory. Subjects who could respond to the requests for participation were considered to have adequate communication skills and memory ability. Exclusion criteria were as follows: (a) women who had severe health conditions, (b) resided in nursing home or other type of assisted living facility, (c) resided out of
the selected county, or (d) unable to contact after multiple attempts.
The questionnaire was developed by the investigator because there were no known established questionnaires to perform this study. This questionnaire was used to obtain knowledge related to the prevalence and purpose of use of herbal products and how the herbal products were used with prescribed and non-prescribed medicines among women aged 65 and over. The questionnaire was comprised of three parts:
(a) health status and use of conventional drugs including prescribed and non-prescribed medicines, (b) use of herbal products, and (c) demographic data.
The interview lasted approximately 15-30 minutes for the participants who did not use the herbal products, and were classified as group 2. The participants in this group were asked to answer part A and part C of questionnaire. The interview took approximately 30-45 minutes for the participants who responded 'yes' to the use of herbal products. These participants were classified as group 1. The participants in this group were asked to answer the entire questionnaire Part A (Health Information), Part B (Herbal Product Use Information), and Part C (Demographic Information).
Operationalization of Variables Demographic Variables
Demographic characteristics of subjects were examined by six indicators: race, education, income, religious preference, insurance status, and marital status.
Race. Race was a categorical variable coded as white, black, Hispanic-nonwhite, and other.
Education. Education was categorized into four
groups according to the number of years of formal education which the participants completed: less than a high school diploma, high school graduate, less than a college graduate, college graduate, and graduate school and higher.
Income. Income was the total annual household
income of the participant. This measure was coded into four categories reflecting an income range from $0.00 to over $50,000: less than $20,000, $20,000 $34,999, $35,000 $49,999, and $50,000 and above.
Religion. Religious preference of participant was
divided into five categories: None, Protestant, Catholic, Jewish, and other.
Insurance status. Status of insurance was
categorized into five groups: None, Medicare, Medicaid, private insurance, and other.
Marital status. Marital status was coded into one of four categories reflecting the status of married, widowed, divorced/separated, or never married. Herbal products variables
Eleven indicators were examined for the variables related to the use of herbal products. These were (a) number and type of herbal products used, (b) general purpose of using herbal products, (c) route, (d) preparation, (e) reasons used, (f) duration of use, (g) effectiveness of herbal products, (h) experience of adverse reactions by using herbs or herbal products, (i) sources of information for use of herbal products, (j) source of payment for herbal product, and (k) physician's awareness about using herbal product.
Number and type of herbal products used. The
participant was asked to list the names of all the herbal products used in the last 12 months. The total number of herbal products used by each participant was counted. The mean number of herbal products used was calculated to measure the average number of herbal products used by the participants. Examination of frequencies identified the most common herbal products used.
General purpose of using herbs or herbal products.
The participant was asked the general purpose of taking
herbal products in the last 12 months. Purposes were categorized into one of three indicators: to treat illness, to maintain or prevent any possible health problems, and both treat and prevent illness.
Route. The route of using herbal products was a categorical variable identified as internal use and external use.
Preparation. Preparation was a categorical variable identified as self-prepared or purchased from a health food store or a regular retail store. Self-prepared herbal product defined the remedy that could not be used directly as it was obtained and thus required preparation time at home such as herbal tea. Purchased included the product that could be used directly without any preparation time after obtaining it such as an herbal tablet or a capsule.
Reasons used. Reasons to use herbal products were
listed based on the types of health problems and were coded from 6 through 29. The codes starting from 6 through 28 were matched with specific illnesses on the Health Information Form in the questionnaire Part A (see Appendix A). Item number 29 was related to the use of herbal products for maintaining current health status or for preventing possible health problems.
Duration of use. Duration of using an herbal product was categorized into two groups: used continuously or used only when symptoms occurred. If the herbal product was used continuously, the participant was asked how long the product had been used. If the herbal product was used when symptoms occur, the participant was asked how many times in the last 12 months the product was used.
Effectiveness of herbal product. Effectiveness of herbal product had four indicators that included not at all, somewhat effective, very effective, and don't know.
Experience of adverse reaction. Experience of an adverse reaction from using an herbal product was a dichotomous variable coded zero/no when participant did not experience any adverse reaction and one/yes when the participant experienced any type of adverse reaction. If the answer was yes, the participant was asked what kind of adverse reaction she had experienced.
Sources of information. The participant was asked
where she had obtained the knowledge about herbal products. The sources of information to use herbal products were categorized into nine groups: (a) family members; (b) friends and neighbors; (c) books or magazines; (d) TV, radio, and newspapers; (e) computer Internet; (f) health
food stores; (g) health care providers; (h) alternative care practitioners; and (i) others. Health status variables
Eight indicators were utilized to identify the health status and the use of prescribed and non-prescribed medicines related to the health problems. These included
(a) overall health, (b) physical health, (c) emotional health, (d) visit to doctor's or other health care provider's clinic, (e) existence of health problems, (f) seriousness of health problems, (g) number of medications used and medication identification, and (h) use of any herbal products.
Overall health, Physical health, and Emotional ealth.
A visual scale numbered one through five measured
these three variables. One indicated a poor health status and five indicated an excellent health status.
Visit to a health care provider office or clinic.
The participant was asked two sets of questions. One question asked whether she had visited a health care provider office or clinic in the past 12 months. This dichotomous variable was coded no or yes. If the response was yes, a follow-up question asked was what health care provider she had visited. Seven categories included (a) family practitioner, (b) internal medicine, (c) surgeon,
(d) gynecologist, (e) nurse practitioner, (f) osteopathic doctor (D. 0.), and (g) others.
Health problems. The participant was asked to
identify her health problems from 23 different illnesses. The answer was coded zero when the problem did not exist and one if the problem existed.
Interference with normal activities. The participant was asked how seriously an illness interfered with her normal activities. Interference with normal activities was measured by a visual scale rating from one to five. One on the visual scale indicated that the health problem did not interfere with normal activities and five indicated that the health problem interfered greatly with normal activities.
Use of medications. The use of medications was a
dichotomous variable coded zero or one for each identified illness. If the answer was yes, the participant was asked to name ail prescribed and non-prescribed medications for each illness.
Use of herbal products. The use of herbal products
was a dichotomous variable coded zero when herbal products had not been used and one when herbal products had been used for each identified illness.
The investigator obtained the list of names and
addresses of women aged 65 and over who resided in a North Central Florida County from the Department of Motor Vehicle and Safety in Tallahassee, Florida. The number of possible accessible population was identified as 8,344 women in the selected county. From the accessible population, at least 84 participants (42 subjects in each group) were required to meet the effect size.
The investigator used a table of random digits (Rand Cooperation: http://www.rand.org/software-and-data/ random/digits.txt) to select a sample. The Investigator picked a starting point from the table of random digit by closing eyes and pointing pencil on one number. From the starting point of the table of random digits, 252 numbers between 0001 and 8,344 were selected. The numbers selected from the table were matched with the names from the list of accessible population.
Letters were mailed to all 252 potential participants to introduce the purpose of the study and request participation in the study. A return self-addressed, stamped postcard was enclosed with each letter. On the back of the postcard, the investigator requested the return response 'yes, I will participate in the study' and
requested a phone number to contact for interview, and 'no, I will not participate in the study.' From the first 252 letters mailed, 53 subjects met the inclusion criteria and completed the interview successfully. It was necessary to recruit at least 31 more subjects for this research study. The investigator repeated the same procedure of random sampling technique for the first mailing list except the first 252 names selected at the first round of sampling were excluded. For the second round of sampling, 150 subjects were calculated to meet the minimum necessary 31 subjects.
The investigator made a telephone call to each participant who returned the postcard indicating a willingness to participate in the study. The investigator had a brief telephone conversation with each subject to arrange the time and the meeting place for the interview. Prior to conducting a structured interview, an informed consent was obtained and a copy of the informed consent and business card of the chairperson were provided to each participant. Each participant was advised of her right as a research participant and the right to decline without penalty.
After an informed consent was obtained, the subject
was asked to answer the questions related to health status,
the use of prescribed and non-prescribed medicines, the use of herbal products, and demographic information. The entire interview required approximately 15-45 minutes per subject. The participants were categorized into group 2, if they answered 'no' to question number A76 of Questionnaire Part A (Health Information). The participants in group 2 were not asked to answer Part B (Herbal Product Use Information) and continued to Part C (Demographic Information). The participants were categorized into group 1, if they answered 'yes' to the question number A76 of Questionnaire Part A (Health Information). The participants in group 1 were asked to answer both Part B and Part C. Data collection was completed when the total subjects numbered 86 (39 subjects in group 1 and 47 subjects in group 2). After completion of the interview, the data were entered into a data spreadsheet for analysis.
Data were collected to test the two research
hypotheses and to answer the four research questions. Research Hypotheses
Hypothesis One: There are differences in demographic characteristics of women aged 65 years and older between the herbal users and non-herbal users.
Demographic characteristics included education levels, incomes, insurance status, race or religion. To test hypothesis one, all participants were asked to answer the 'Health Information' questionnaire which included whether the participant used herbal products. If the participant used an herbal product, she was asked to answer the 'Herbal Product Information' questionnaire and the 'Demographic Information' questionnaire. If the participant did not use an herbal product, she was asked to answer the 'Demographic Information' questionnaire without 'Herbal Product Information'. Subjects were divided into two groups, one group of herbal product users and another group of non-users, to compare differences in demographic characteristics including education level, income, insurance status, race or religion.
Hypothesis Two: There is a difference in health status between herbal users and non-herbal users. Differences in health status between the two groups was tested by comparing illnesses, number of prescribed and nonprescribed medicines the participant used, perception of the participant's health status, and seriousness of interference of normal activities.
Question 1: what was the prevalence of use of herbal products among women 65 years and older?
Three types of information were collected to answer question 1: First, the participant was asked to name the all of the herbal products she had used in the last 12 months. The total number of herbal products used was counted to calculate the average number of herbal products used by all subjects. The most commonly used herbal products were identified within the total group of subjects. Secondly, to identify the period of time herbal products were used, each participant was asked how long herbal products had been used. She was also asked if she ingested the herbal by mouth (internally) or applied the herbal externally. The participant was asked whether she used the herbal on a continual basis or intermittently. Lastly, the participant was asked whether she purchased the herbal product from a store in a ready-to-take form or if she needed to prepare the herbal product prior to its use.
Question 2: What was the purpose for taking herbal
products by women aged 65 years and older? Did older women take herbal products more for prevention or for treatment of symptoms?
The following information was collected to identify the purpose for which women 65 and older took herbal products and to determine for which physical symptoms or health conditions women most likely took herbal products. The participant was asked about her overall health, physical health, and emotional health status. The health status was measured by a visual scale with a range of one through five with one representing poor health and five representing excellent health status. The participant was asked the general purpose of taking herbal products to identify whether she took herbals to treat illness, to prevent possible health problems or to maintain her current health status, or for both treatment and preventive purposes.
To identify the specific reasons for using herbal products, the investigator identified common health problems of the subject. The subject was asked the specific reasons for taking the herbal products based on identified common health problems among older women. The perceived benefit of taking the herbal product was identified by the participant and then whether she felt that the herbal product was effective or ineffective. Data of perceived adverse reactions were collected including the types of adverse reaction experienced by the participant.
Question 3: What was the frequency of use of herbal
products by older women? Did women who use herbal products use them continuously over time or on an as needed basis? Did women who use herbal products use them alone or in combination with prescribed and/or non-prescribed medicines?
Three types of information were collected to answer
question three. First, the participant was asked the names of prescribed and/or non-prescribed medicines she took for her health problems. This information was later compared with the findings of question two to describe whether the herbal products were used alone or used in combination with the conventional drugs. Secondly, the findings of question three were compared with the findings of question two to describe the use of herbal products alone or in combined use with prescribed and/or non-prescribed medicines. Thirdly, the investigator identified the frequency and dosages of herbal products taken by each subject. Frequency included either continual use or on an as needed basis.
Question 4: What sources did women 65 and over use to obtain information about the use of herbal products?
To identify the source of information related to herbal products used by women 65 years and over, the participant was asked where she obtained information about
the herbal products that she was taking. Data related to health insurance status and primary health care provider were collected to identify a possible relationship between types of providers or insurance status and the use of herbal products. Data were collected to determine if the primary physician or other health care provider was aware of her use of herbal products.
Descriptive statistics were performed to identify the demographic characteristics of the participants, number of medications used, number of herbal medications used, sources of information and reasons for taking herbal medications. Analysis of frequency was used to address each research question. The student t-test and Chi-Square test were used to determine if differences existed between older women who used herbal products and those who did not use herbal products.
This chapter includes a description of the research design, sample, demographic characteristics, and health related characteristics of the sample. Also included in this chapter are the results of the statistical analyses of the data corresponding to the research hypotheses and research questions.
This research utilized a cross-sectionai and
descriptive design to examine the prevalence of herbal product use, types of herbal products used by the subjects, and to identify the reasons herbal products were used among women aged 65 and over. The investigator used a random selection process to facilitate the selection of two groups of subjects those who used herbal products and those who did not use herbal products.
A random sample of women who were 65 years of age and over residing in a North Central Florida county was selected for this study. A total of 8,344 women who were
registered at the Florida Division of Drivers License, were identified as eligible sample by the State Department of Highway Safety and Motor Vehicles. To obtain a sample size of 84 subjects, three times this number or 252 possible subjects were randomly selected from the 8,344 women (see Table 4.1). Letters were mailed to the 252 possible subjects describing the research purpose and requesting the return of an enclosed postcard to schedule an interview. From this mailing, 16 letters were undeliverable and 101 (40.1%) persons responded. of the 101 respondents who returned the postcards, 53 subjects completed interviews; 29 respondents declined participation; and 19 did not meet inclusion criteria. Thirty-one additional subjects were needed to attain the desired sample size.
An additional group of 150 people was selected for the second mailing to add the needed 31 subjects. Random sampling was repeated from a list of 8,344 persons, excluding the 252 names of the first selection. From the second mailing, 12 letters were undeliverable and 64 (42.7%) persons responded. Of the 64 respondents, 33 subjects completed interviews; 22 respondents declined participation; and nine did not meet inclusion criteria.
In summary, 402 letters were mailed; 28 of the 402
letters were undeliverable, leaving 374 potential subjects.
Of 374 potential subjects, 165 (44.1%) responded. Of the total 165 respondents, 86 subjects were completed interview (52%), 51 declined an interview (31%), and 28 did not meet inclusion criteria (17%). Reasons for exclusion were (a) five subjects had severe health problems, making an interview impossible; (b) three subjects resided in nursing homes or other types of assisted living facilities; (c) 12 subjects resided out of the county at the time of the interview; (d) six subjects were deceased; and (e) two subjects were unable to be contacted for the interview. Of the 86 subjects who completed the interview, 39 used herbal products and were assigned to group one and 47 did not use herbal products and were assigned to group two. Table 4.1
Frequency Distribution of Total Sample
Number 1't mailing 2 d mailing Total
letters mailed 252 iso 402
Undeliverable 16 12 28
Excluded respondents 19 9 28
Non-Respondents 135 74 209
Declined Interview 29 22 51
Interview completed 53 33 86
Demographic Characteristics of the Sample
The mean age of the sample was 74.9 years with a
standard deviation of 5.55 (range 65 90) (see Table 4.2). The mean age of the 39 subjects of group one who used herbal products was 75.4 years with a standard deviation of
5.80 (range 65 90). The mean age of the 47 subjects of group two who did not use herbal products was 74.4 years with a standard deviation of 5.37 (range 65 87). Table 4.2
Age of Herbal Users, Non-Users, and Total Sample Age Herbal Users Non-Users Total Sample
(n=39) (n=47) (N=86)
Mean years (SD) 75.4 (5.80) 74.4 (5.37) 74.9 (5.55) Group (years) N (%) N M N (%)
65 74 17 (43.6) 24 (51.1) 41 (47.7)
75 84 18 (46.2) 20 (42.6) 38 (44.2)
85 and over 4 (10.2) 3 (6.3) 7 (8.1)
Total Number 39 (100.0) 47 (100.0) 86 (100.0)
Of the total group of subjects, 41 (47.7%) were
married, 37 (43.0%) were widowed, and eight (9.3%) were divorced (see Table 4.3). From the 39 herbal users in the group one, 14 (35.9%) were married; 21 (53.8%) were widowed; and four (10.3%) were divorced. Among the 47 nonusers in the group two, 27 (57.5%) were married; 16 (34.0%) were widowed; and four (8.5%) were divorced.
The sample consisted of 85 (98.8%) White Americans and one (1.2%) Black American. No other race was reported. The one Black American was an herbal product user and was placed in group one.
Among the total sample, 27 (31.4%) had some college education; 22 (25.6%) reported graduate level education after completion of college; 21 (24.4%) were high school graduates; 13 (15.1%) had college degrees; and three subjects had less than high school education. Of the 39 herbal product users in group one, three (7.7%) subjects had less than high school education; nine (23.1%) subjects finished high school; 12 (30.8%) had some college education; five (12.8%) subjects were college graduates; and 10 (25.6%) subjects had graduate level education after completion of college. Among the 47 subjects in group two, no one had less than a high school education; 12 (25.5%) completed high school; 15 (31.9%) had some college education; eight (17.0%) were college graduates; and 12 (25.5%) had graduate level education after completion of college.
Annual household income was categorized into four groups: less than $ 20,000, $20,000 $34,999, $35,000 $49,999, $50,000 or more. Seventy-nine (91.9%) subjects responded while seven (8.1%) declined to answer the
question related to income. Eighteen (22.8%) subjects reported their income to be less than $20,000; 23 (29.1%) reported incomes of $20,000 $34,999; 18 (22.8%) reported incomes of $35,000 $ 49,999; and 20 (25.3%) reported their income level to be $50,000 or more per year. Of the 39 herbal product users in group one, household income of eight (23.5%) subjects was less than $20,000; 12 (35.3%) reported their income to be between $20,000 and $34,999; seven (20.6%) reported their income to be between $35,000 and $49,999; and seven (20.6%) reported incomes of $50,000 or more per year. Among 47 non-users in group two, annual household income of 10 (22.2%) subjects was less than $20,000; 11 (24.4%) subjects were between $20,000 and $34,999; 11 (24.4%) reported their income to be between $35,000 and $49,999; and 13 (28.9%) reported an income of $50,000 or greater.
With regards to religious preference, Protestant was the most common religion (58, 67.4%) followed by Catholic (11, 12.8%). Three (3.5%) subjects practiced the Jewish religion; six (7.0%) reported other types of religion; and eight (9.3%) claimed no religious preference. Protestant was main religious preference in both herbal product users (26, 66.7%) and non-users (32, 68.1%).
Seventy-nine (92.9%) subjects had Medicare and
supplemental insurance; three (3.5%) reported Medicare as their only insurance; two (2.3%) claimed Medicare and Medicaid; one (1.2%) had only Medicaid; and one (1.2%) had only private insurance. of 39 the herbal product users, 35 (89.7%) had Medicare and supplemental insurance; one (2.6%) had Medicare only; two (5.1%) reported Medicare and Medicaid; one (2.6%) had private insurance. Among 47 nonusers of group two, 44 (93.6%) subjects claimed Medicare and supplemental insurance; two (4.3%) had Medicare only; and one (2.1%) had Medicaid only. The summary of demographic characteristics including marital status, ethnicity, education, annual household income, religion, and insurance status for the total sample, for the group of herbal users, and for the group of non-herbal users is illustrated in Table 4.3.
Demographic Characteristics of the Total Sample, Herbal Product Users, and Non-users
Herbal Users Non-Users Total Sample Characteristics (n=39) (n=47) (N 86)
Marital Status N (%) N (%) N (%) NS
Married 14 (35.9) 27 (57.5) 41 (47.7)
Widowed 21 (53.8) 16 (34.0) 37 (43.0)
Divorced 4 (10.3) 4 (8.5) 8 (9.3)
Never Married 0 (0.0) 0 (0.0) 0 (0.0)
Table 4.3. (continued)
Herbal Users Non-Users Total Sample Characteristics (n=39) (n=47) (N=86)
White American 38 (97.4) 47 (100) 85 (98.8)
African American 1 (2.6) 0 (0.0) 1 (1.2)
Hispanic-nonwhite 0 (0.0) 0 (0.0) 0 (0.0)
Other 0 (0.0) 0 (0.0) 0 (0.0)
< High School 3 (7.7) 0 (0.0) 3 (3.5)
=High School 9 (23.1) 12 (25.5) 21 (24.4)
< $20,000 8 (23.5) 10 (22.2) 18 (22.8)
$20,000- $34,999 12 (35.3) 11 (24.4) 23 (29.1) $35,000 $49,999 7 (20.6) 11 (24.4) 18 (22.8) 50, 000 7 (20.6) 13 (28.9) 20 (25.3)
Missing Data 5 (12.8) 2 (4.3) 7 (8.1)
Protestant 26 (66.7) 32 (68.1) 58 (67.4)
Catholic 4 (10.3) 7 (14.9) 11 (12.8)
Jewish 1 (2.6) 2 (4.3) 3 (3.5)
Other 4 (10.3) 2 (4.3) 6 (7.0)
None 4 (10.3) 4 (8.5) 8 (9.3)
Supplement 35 (89.7) 44 (93.6) 79 (92.9)
Medicare only 1 (2.6) 2 (4.3) 3 (3.5)
Medicaid 2 (5.1) 0 (0.0) 2 (2.3)
Medicaid only 0 (0.0) 1 (2.1) 1 (1.2)
Private Ins. Only 1 (2.6) 0 (0.0) 1 (1.2)
NS = Statistically no significant difference between the group of herbal-product users and the group of non-users (P = 0.05)
Research Hypothesis One
The first hypothesis stated that there was a
difference in demographic characteristics of women 65 years
or over between the group of herbal product users and the group of non-users. To test the hypothesis, demographic characteristics including age, education levels, marital status, annual household income, and religious preference, were compared between the two groups. Ethnicity was not compared because all subjects except one Black American were identified as White Americans. Insurance status was not compared between the two groups since the total sample had some type of insurance and the large majority had Medicare (98%).
The research hypothesis one was not supported. The ttest was performed to test differences in age between the two groups and no significant difference in mean age was found between the two groups (t 0.76, p=0.45). The two groups were homogeneous with regard to marital status (X2
4.089, p=0.129). There was no significant difference in education between the group of herbal users and the group
of non-users (X2=3.926, p=0.416) There were no significant differences in annual household income (X2 =3.265, p=0.514) and in religious preference (X2=1 .709, p=0.789) between the two groups. In summary, the two groups were not significantly different in demographic characteristics
including age, marital status, education, annual household income, and religious preference. Research Hypothesis Two
The second hypothesis stated that there was a
difference in heaith-related characteristics between the group of herbal product users and that of non-herbal users. The health-related characteristics included perception of own health status, number of health care providers who were visited, types of health-related problems and perception of its seriousness, number of health problems, and number of prescribed and non-prescribed medicines.
Perception of health status and health care providers.
Perceptions of health including overall health,
physical health, and emotional health were measured by a visual scale that ranged from one to five. Five on the visual scale represented excellent health; and one on the visual scale represented poor health (see Appendix A). Overall health was rated five on the visual scale by 25 (29.1%) of the total sample; four on the visual scale by 39 (4S.4%); three on the visual scale by 20 (23.3%); and two on the visual scale by two (2.3%). No subject gave a rating of one on the visual scale (see Table 4.4). Among 39 herbal product users in group one, no subject gave a rating of either one or two suggesting poor overall health; nine
(23.1%) subjects rated three on the visual scale; 16 (41.0%) subjects rated four; and 14 (35.9%) subjects rated five suggesting excellent overall health. Among 47 nonherbal product users in group two, no subject gave a rating of one; two (4.3%) subjects rated two on the visual scale; 11 (23.4%) subjects rated three; 23 (48.9%) subjects rated four; and 11 (23.4%) subjects rated five. There was no significant difference in perception of overall health between the two groups (X2 = 3.100, p = 0.378) Table 4.4
Perceived Overall Health by Herbal-Users, Non-Users, and Total Sample
Visual Scale Herbal Users Non-Users Total Sample (1-5) (n=39) (n=47) (N=86)
1 (Poor) 0 (0.0%) 0 (0.0%) 0 (0.0%)
2 0 (0.0%) 2 (4.3%) 2 (2.3%)
3 9 (23.1%) 11 (23.4%) 20 (23.3%)
4 16 (41.0%) 23 (48.9%) 39 (45.4%)
5 (Excellent) 14 (35.9%) 11 (23.4%) 25 (29.1%) Total 39 (100.0%) 47 (100.0%) 86 (100.0%)_Physical health was rated two on the visual scale by three (3.5%) subjects; three on the visual scale by 21 (24.4%) subjects; four on the visual scale by 41 (47.7%) subjects; and five on the visual scale by 21 (24.4%) subjects (see Table 4.5).
Table 4. 5
Perceived Physical Health by Herbal-Users, Non-Users, and Total Sample
Visual Scale Herbal Users Non-Users Total Sample (1-5) (n=39) (n=47) (N=86)
1 (Poor) 0 (0.0%) 0 (0.0%) 0 (0.0%)
2 1 (2.6%) 2 (4.3%) 3 (3.5%)
3 10 (25.6%) 11 (23.4%) 21 (24.4%)
4 18 (46.2%) 23 (48.9%) 41 (47.7%)
5 (Excellent) 10 (25.6%) 11 (23.4%) 21 (24.4%) Total 39 (100.0 % 47 (100.0%) 86 (100.0%)
Among subjects in group one, no subject gave a rating of one suggesting poor physical health; one (2.6%) subject rated two; 10 (25.6%) subjects rated three; 18 (46.2%) subjects rated four; and 10 (25.6%) subjects rated five suggesting excellent physical health. Among 47 non-herbal product -users in group two, no subject gave a rating of one; two (4.3%) subjects rated two; 11 (23.4%) subjects rated three; 23 (48.9%) subjects rated four; and 11 (23.4%) subjects rated five. There were no significant differences in perception of physical health between the two groups (X2
0.297, p 0.961) .
Emotional health was rated two on the visual scale by one (1.2%) subject; rated three on the visual scale by six (7.0%); rated four by 27 (31.4%); and five or excellent on the visual scale by 52 (60.4%) subjects (see Table 4.6).
Table 4. 6
Perceived Emotional Health by Herbal-Users, Non-Users, and Total Sample
Visual Scale Herbal Users Non-Users Total Sample
(1-S) (n=39) (N=86)
1 (Poor) 0 (0.0%) 0 (0.0%) 0 (0.0%)
2 1 (2.6%) 0 (0.0%) 1 (1.2%)
3 2 (5.1%) 4 (8.5%) 6 (7.0%)
4 10 (25.6%) 17 (36.2%) 27 (31.4%)
5 (Excellent) 26 (66.7%) 26 (S5.3%) 52 (60.4%) Total 39 (100.0%) 47 (100.0%) 86 (100.0%)
Among subjects in group one, no subject gave a rating of one suggesting poor emotional health status; one (2.6%) subject rated two; two (5.1%) subjects rated three; 10 (25.6%) subjects rated four; and 26 (66.7%) subjects rated five suggesting excellent emotional health. Among subjects in group two, no subject gave a rating of either one or two on the emotional health status; four (8.5%) subjects rated three; 17 (36.2%) subjects rated four; and 26 (55.3%) subjects rated five, which represents excellent emotional health. There was no significant difference in perceived emotional health between the group of herbal product users and that of non-users (X2 =2.761, p = 0.430).
A large number of the total sample visited at least one health care provider in the past 12 months. Eightythree subjects (96.5%) visited at least one health care provider in the past 12 months. Only three subjects (3.5%)
had not visited any type of health care provider within the past 12 months. Two of three subjects who did not visit any health care provider were herbal product users.
The mean number of health care providers reported by the sample was 2.56 (SD = 1.38, range 0 7). The average number of health care providers the herbal product users reported was 2.31 (SD = 1.42, range 0 7) in comparison to
2.77 health care providers (SD = 1.32, range 0 6) reported by non-users. There was no significant difference in number of health care providers that the sample had between the group of herbal product users and the group of non-users (t =1.549, p = 0.063). Internal medicine was the most frequently visited specialty reported by 55 (64%) subjects, and the second most frequently visited was family practice reported by 35 (40.7%) subjects.
Types and seriousness of health-related problems.
Among 86 subjects of the total sample, 85 (98.8%) reported at least one or more problems from the 23 categories of health-related problems (see Table 4.7). Of the heaith-related problems reported, arthritis (55.8%), allergies (48.8%), and fatigue (45.3%) were identified as major health-related problems by about half of the total sample followed by back problems (39.5%), digestive problems (34.9%), and urinary problems (32.6%). Other
health problems commonly reported by subjects were skin problems (29.1%), heart problems (27.9%), high blood pressure (26.7%), and memory problems (22.1%). The average number of health-related problems reported by each subject was 5.8 problems. The group of herbal users (39 subjects) identified an average of 6.1 health-related problems while an average of 5.5 health-related problems was reported by the group of non-users (47 subjects).
Each health-related problem in 23 different areas was compared between the group of herbal users and that of nonusers. There was significant difference in memory problem between the two groups (X2 = 5.238, p = 0.022). Thirteen subjects in the group of herbal product users reported memory problems while six subjects of the counter part reported memory problems. Differences were not found in other areas of health-related problems between the two groups (see Table 4.7).
Types of Health-Related Problems (N=86)
Number and Types of Herbal Non- Total
Problems Product Users Users P
No. of Health Problems
X 6.08 5.53 5.78
SD 3.13 3.15 3.13
Range (1-14) (0-12) (0 14)
Arthritis 23 25 48 (55.8) NS
Table 4.7 (continued)
Number and Types of Herbal Non- Total
Problems Product Users Users p
users N (%)
Allergies 20 22 42 (48.8) NS
Fatigue (low energy) 17 22 39 (45.3) NS
Back problems 20 14 34 (39.5) NS
Digestive Problems 14 16 30 (34.9) NS
Urinary problems 13 15 28 (32.6) NS
Skin problems 13 12 25 (29.1) NS
Heart problems 9 15 24 (27-9) NS
High Blood Pressure 8 is 23 (26.7) NS
Dizziness 10 9 19 (22.1) NS
Memory problems 13 6 19 (22.1) P=0.02
Anxiety 6 9 15 (17.7) NS
Blood & Circulatory 7 7 14 (16.3) NS
Chronic Pain 9 5 14 (16.3) NS
Cold & Flu 6 8 14 (16.3) NS
Obesity 8 4 12 (14.0) NS
Headache 4 7 11 (12.8) NS
Cancer 2 7 9 (10.5) NS
Diabetes 1 7 8 (9.3) NS
Depression 4 3 7 (8.1) NS
Lung problems 3 4 7 (8.1) NS
Gynecological problems 1 0 1 (1.2) NS
Others 26 28 54 (63.8) NS
Notes: NS = no significant difference between the group ooff
herbal product users and the group of non-users
Each subject was asked about the seriousness of
identified health-related problems in her daily living by
using a visual scale which ranged from one to five. One represented no interruption in daily living from the health problem, while five represented an extremely serious interruption in daily living from the identified healthrelated problem. Seriousness of each health-related problem was compared between the two groups in all 23 areas. The two groups were homogeneous with respect to seriousness of health-related problems in all areas except obesity. The group of herbal product users and the group of non-users were not homogeneous in regards to seriousness of obesity (Fisher's Exact 2-Tail Test, p = 0.0222) although the two groups were homogeneous with regards to obesity as a
health-related problem (X2=2.557, p=0.129) .
Of all subjects who reported health-related problems, the majority indicated that the seriousness of health problems in their daily living was three, two or one on the visual scale. The seriousness of memory problems in interfering with everyday life was not significantly different between the group of herbal product users and the group of non-users (X2 =2.219, p=0.708) although the two groups were different in the frequency of memory as a health-related problem.
Use of prescribed and non-prescribed medicines.
The use of prescribed medicines was reported by 75 (87.2%) of the total sample. The average number of prescribed medicines used by the total sample was 3.20 medicines (SD 2.40; range 0 10); herbal product users reported a mean of 3.00 medicines (SD = 2.21; range 0 8); and non-users reported mean of 3.36 medicines (SD = 2.56; range 0 10). There was no significant difference in the use of prescribed medicines between the group of herbal product users and that of non-users (t=1.75, p=0.08).
All but one of the total sample (98.8%) reported the use of non-prescribed medicines. The mean number of nonprescribed medicines used by the total sample was 3.79 medicines (SD = 1.90; range 0 9); herbal product users reported a mean of 4.18 medicines (SD = 1.94; range 1 9); and non-users reported a mean of 3.47 medicines (SD = 1.82; range 0 to 8).
Of the non-prescribed medicines used by sample, many of them were taken on a regular basis. The most frequently used non-prescribed medicines taken regularly were multivitamin, calcium, vitamin E, vitamin C, and aspirin (see Table 4.8). More than one-third of the total sample was using at least one of these five non-prescribed medicines. of the forty-eight subjects (55.8%) in the total
sample who used multivitamins, 22 (56.4%) were herbal product users and 26 (55.3%) were non-herbal product users. Calcium was the second most frequently used non-prescription medicine among the sample. Forty-seven (54.7%) subjects in the total sample were taking calcium including 20 (51.3%) were herbal-product users and 27 (57.4%) were non-users. Forty-one subjects (47.1%) in the total sample were taking Vitamin E; 22 (56.4%) subjects from the herbal-product users and 19 (40.4%) from the nonusers. Among 29 subjects (33.3%) from the total sample who used vitamin C, 18 (46.2%) were herbal-product users; and 11 (23.4%) were non-users. Aspirin was regularly used by 27 subjects (31.4%) in the total sample. Eleven subjects (28.2%) were herbal-product users and 16 (34.0%) were nonusers.
Frequently Used Non-prescribed Medicines Taken Regularl
Non-prescribed Herbal-Product Non-Users Total
medicines Users (n=39) (n=47) (N 86)
No. (%) No. (%) No. (%)
Multivitamin 22 (56.4) 26 (55.3) 48 (55.8)
Calcium 20 (51.3) 27 (57.4) 47 (54.7)
Vitamin E 22 (56.4) 19 (40.4) 41 (47.1)
Vitamin C 18 (46.2) 11 (23.4) 29 (33.3)
Aspirin 11 (28.2) 16 (34.0) 27 (31.4)
There was no significant difference in the number of non-prescribed medicines used between the group of herbal product users and non-users (t=0.69, p=0.49). In summary, the average number of medicines including both prescribed and non-prescribed medicines for each subject of the total sample was 6.99 medicines (SD = 2.85; range 1 17). The average number of total medicines used by herbal product users was 7.18 medicines (SD = 2.80; range 1 17), while the non-herbal product user group used 6.83 medicines (SD 2.9; range 2 15). There was no significant difference in the use of total number of medicines between the two groups (t=0.56, p=0.57). The summary of the use of prescribed, non-prescribed, and total number of medicines used by sample is illustrated in Table 4.9. Table 4.9
Use of Prescribed, Non-prescribed Medicines by Sample (N=86)
Herbal Users Non-Users Total Sample Medicines (n) (n=39) (n 47) (N=86)
x SD x SD x SD
(Min-Max) (Min-Max) (Min-Max)
Total 7.18 2.80 6.83 2.91 6.99 2.85 NS
Medicines (1 17) (2 15) (1 17)
Prescribed 3.00 2.21 3.36 2.56 3.20 2.40
Medicines (0 8) (0 10) (0 10)
Non-prescribed 4.18 1.94 3.47 1.82 3.79 1.90 NS Medicines (1 9) (0 8) (0 9)
NS = Statistically not significant between the group of herbal product users and non-users (p = 0.05)
Description of the Research Questions Research Question One
The first research question was stated as, what is the prevalence of use of herbal products among women 65 years and older. Of the total sample of 86 subjects, 39 (45.3%) reported using herbal products in the past 12 months. A total of 98 herbal products were used by the 39 subjects, which averaged 2.51 herbal products per subject (SD = 2.16; range 1 11) The three most commonly used herbal products were Ginkgo Biloba or Ginkgo Biloba with other combinations (12 subjects), garlic tablets and cloves (11 subjects), and Glucosamine with Chondroitin (8 subjects) Ninety-two herbal products (93.9%) were taken orally, while six (6.1%) herbal products were used externally. About three-quarters (76%) of the total number of herbal products were in a ready-to-take form such as tablets, capsules, or liquid preparations; and 24% of the herbal products required some preparation by the subjects. The types of herbal products used by the subjects are illustrated in Table 4.10.
Types of Herbal Products Used by Subjects
Name (n) Name (n)
Ginkgo or Ginkgo combinations Paprika Powder (1)
Garlic (11) Hot Spicy Pepper (1)
Glucosamine w/ chondroitin (8) Shark Cartilage (2) Aloe (5) Barley Green (1)
Herbal Tea (Parsley, Basil, Grapefruit Seeds Extract (1) Peppermint tea) (4)
Echinacea (4) Anica (1)
Ginger (4) MSM (1)
St. Johns Wort (3) Bakuchi Oil (1)
Vinegar w/Honey (3) Triphala Tea (1)
Primrose (3) Grape Seeds Extract (1)
G.H.3 (2) Spiru-Tein (1)
Ginseng (2) Co Q-10 (1)
Green Tea (2) Acidophilus (1)
Selenium (2) Cod Liver Oil w/ Whole Milk
Flax Oil Complex or Flax Tea Soy Bean Oil Beta Carotene
Pure Cranberry Juice (1) Lecithin Capsules (1)
Pantothenic Acid (1) Provex (1)
Melatonin (1) Seven Forests (1)
Papaya Capsules (1) Eight Prunes (1)
Manchurian Mushroom Tea (1) Chromium Picolinate (1) Sesame Oil w/ five whole Liver Flush (Mix of Olive
cloves (1) Oil, Lime Juice, Apple Cider
Vinegar, & Red Pepper) (1) Stevia Liquid Extract (1) Calms Forte (1)
Cayenne Pepper Capsules (1) Ghee w/ boiled Butter (1) Nature's Tea (Colon Cleanser) Brewer's Yeast w/ Orange
(1) Juice, or Milk and Honey (1)
Research Question Two
The second question was stated as what is the purpose for taking herbal products and/or herbs by women 65 years and over. Do older women take herbal products more for prevention or for treatment of symptoms?
Of the persons taking herbals, 16 (41%) reported using herbal products to maintain health or to prevent possible health problems. Nine subjects (23%) used herbal products for treatment of health problems. Fourteen subjects (36%) used herbal products both to prevent and to treat health problems (see Table 4.11). Of the 98 herbal products used by the subjects, 55 (56.1%) products were used to prevent health problems or to maintain health, while 43 (43.9%) of the herbal products were used to treat health problems. The three major purposes for using herbal products other than prevention were to improve memory, to treat arthritis, and to remedy digestive problems. Table 4.11Purposes of Using Herbal Products by Subjects and by Number of Herbal Products
Reasons to take herbal Subjects No. of Herbal
products (n=39) Products (n=98)
To treat health problems 9 (23%) 43 (43.9%)
To maintain health or
prevent health problems 16 (41%) 55 (56.1%)
For both treatment and
prevention purposes 14 (36%) N/A
Total 39 (100%) 98 (100%)
The perceived benefit of taking the herbal products
was also identified. About one-half of the herbal products (47.9%) were perceived by subjects to be somewhat effective or very effective while the effectiveness of 40.6% of herbal products was unknown. only one subject reported any side effect from taking the herbal products. This subject reported diarrhea as a side effect after taking qingerroot tablets for a period of three months. Research Question Three
The research question was stated as what is the
frequency of use of herbal products by women aged 65 and over. Do women who use herbal products use them continuously over time or on an as needed basis? Do women who use herbal products use them alone or in combination with prescribed and /or non-prescribed medicines?
Thirty-nine subjects in group one used a total of 98 herbal products with a mean of 2.51 herbal products per subject (SD = 2.16, range 1 11). Subjects reported that 85.4% of the herbal products used were taken on a continual basis. These products had been used for a mean of 34.8 months with a standard deviation of 92.3 months (range onehalf month 600 months). Fourteen herbal products (14.6%) were used when symptoms occurred. Of the 98 total herbal