Index
A
Academic Health Centers for Integrative Medicine, 22, 149–150
Accountability, 171–173
Acupuncture, 16, 38–39, 133, 202
analgesia effects, 147
attitudes of conventional physicians, 203, 206
cost-effectiveness, 49–50
ethical practice, 180
NIH consensus statement, 141–142
practice characteristics, 63
regulation, 20–21
strategies for improving research quality, 144–145
Acupuncture and Oriental Medicine Commission, 180
Adherence, 10, 11, 60–61, 65, 66, 161
Advertising, 263
Advocate model of integrative medicine, 219
Age, consumer
CAM use patterns and, 44–45, 48
dietary supplement use and, 256
Agency for Healthcare Research and Quality, 29, 267
evidence reports, 141
AIDS/HIV, 45, 244–245, 248–249
Alternative medical systems, 18, 42
American Association of Naturopathy, 180
American Chiropractic Association, 180
American Herbal Pharmacopoeia, 268
American Herbal Products Association, 268
Anderson Cancer Center, 202
Antioxidants, 261
Anxiety, 64
Aromatherapy, 133
Assessment, 180–181
Attention and hyperactivity disorders, 45
Attribute-treatment interaction analyses, 3, 118
B
cost-effectiveness of CAM, 49
Basic science excellence model of research, 122
Behavioral medicine, 203
Behavioral Risk Factor Surveillance Survey, 154
Belmont Report of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, 174–175
Biofeedback
attitudes of conventional physicians, 203, 206
education and training in, 227
patterns of use, 48
Biologically based therapies, 18, 42
Black cohosh, 262
Bundled therapies, 3, 108, 115
C
Canada, 263–264
NIH CAM research, 26–27
sources of information about CAM therapies, 59
Cardiovascular disease, 46, 133
Case-control studies, 3, 82, 114
Children, use of CAM by, 44, 63
Chiropractic treatment, 16
attitudes of conventional physicians, 206
defining features, 18–19
ethical practice, 180
licensure, 237
patterns of use, 38–39, 44, 202
practice characteristics, 63–64
reimbursement, 23
treatment goals, 64
Classification of CAM modalities, 18–19
Cochrane Library, 132–140
Cohort studies, 3, 81–82, 113–114, 152–154
Co-morbid conditions, 92–93
Compliance. See Adherence
Concierge model of integrative medicine, 219
Confidence intervals, 90–91
CONSORT guidelines, 144
Consortium of Academic Health Centers for Integrative Medicine, 22, 231
Consultant model of integrative medicine, 217
Consumer characteristics, 41–45
economic status, 41–42
educational attainment, 10, 41, 42, 254–256
ethnic and cultural subgroups, 43–44, 64–65, 152, 162, 278
health beliefs, 55
Conventional medicine
CAM interactions, 45, 61, 66, 115
consumer perceptions, 56
effectiveness research, 17–18, 145, 230
ethical issues regarding reimbursement, 172–173
gaps in outcomes research, 146–147, 161
patient disclosure regarding CAM use, 34, 35–38, 44, 63, 65
patterns of CAM use and, 34, 39–40, 54–55, 62, 203–206
quality improvement goals, 14
See also Integration of CAM and conventional medicine
Cost-effectiveness of CAM, 5
analytic method, 88–90
current understanding of, 49–50
research model, 123
research needs, 148
Cost of care
chronic illnesses, 46
conventional medicine spending, 35
dietary supplement spending, 35, 253
distribution by medical condition, 46
ethical issues regarding CAM healing, 172–173
health-seeking behavior and, 40
integrative medicine, 218, 219–220
out-of-pocket spending, 13, 34, 35, 41–42
systematic reviews of research, 142–143
See also Cost-effectiveness of CAM
Cross-disciplinary research, 148, 149
in CAM Research Centers, 159
Cross-sectional studies, 83
Cultural contexts, 43–44
concept of causality in research, 99
research needs, 66
D
Dana-Farber Cancer Institute, 7, 202
Data collection and management
Cochrane Library data, 132–140
cultural considerations, 43–44
on dietary supplements, 28, 272–274
gaps in CAM research, 146–151, 161
MEDLINE data, 130–132
for outcomes research, 76
recommendations for, 6, 10–11, 145–146
sentinel surveillance system, 154–155, 159–160
sources of CAM information, 1, 58–60, 66, 103, 130, 161
Declaration of Helsinki, 174–175
Definition of CAM, ix, 16–20, 40, 44–45, 64
value judgments in, 174
Definition of health, 210–211
Department of Health and Human Services, 7–8, 29, 222
Department of Veterans Affairs, 7–8, 23, 222
Depression, 64
Diabetes, 46
Diagnostic classification, 126
Dietary Supplement Health and Education Act (1994), 4–5, 20, 59, 190, 257–260, 271, 274–275, 280
Dietary supplements, 18
adherence issues, 61
advertising claims, 58–59, 258, 260–261, 263
consumer beliefs, 256–257
consumer characteristics, 254–256
definition, 257–258
drug interaction risk, 13, 23, 35, 270
good manufacturing processes, 266
label claims, 260–262
NIH research activities, 28
off-label use, 261
patterns of use, 13, 35, 44, 253–257
quality control, 4, 5, 265–270, 274, 280
recommendations for regulation and research, 4–5, 274–275
regulation, 4, 5, 190–191, 256–260, 263–265, 270–271
research, 272–274
See also Herbal medicine
Dietetic practices, 43–44
Dose-response relationship, 100
Double-blind trials, 126–127
Drug interactions, 13, 23, 35, 270
E
Ecological model of health, 210–211
Economic status of consumers, 41–42
Education and training of health professionals
for AIDS/HIV research, 244–245
in CAM modalities, 237–238
CAM training in medical schools, 17, 22, 226–227, 230–237, 248, 279–280
career development grants, 151
core competencies, 228
in geriatric medicine, 242–244
model programs in research training, 150–151
NCCAM funding, 24
in practice-based research networks, 158
rationale for CAM instruction, 228–230
recommendations for, 8–10, 248, 249–250
for research, 9, 239–245, 248–249
standards of evidence for research and, 100–101
trends, 226
Educational attainment of consumers, 10, 41, 42
dietary supplement use and, 254–256
Effect size, 98
Effectiveness of treatment(s)
acceptance of new therapies and, 196–198
AHRQ evidence reports, 141
attribute-treatment interaction analyses, 3, 118
challenges in CAM research, 103–105, 108–111, 115–116, 123
Cochrane Library data, 134–140
conventional therapies, 17–18, 145, 230
criteria for establishing cause-and-effect relationships, 99–100
determinants of, 79
efficacy studies, 91–92, 98, 103–104, 120
ethical issues in prescribing, 184
expectation effects in, 117–118
framework for medical decision making, 213–215
goals of CAM healing, 171–172
information needs for clinicians, 101–102
instruction in CAM based on, 230
insurance providers’ concerns, 102
levels of evidence for, 94–98, 103, 124–127
measurement error, 92
NIH consensus statements, 141–143
observational studies, 113
patient perceptions, 38, 51, 197–198, 199–200
placebo effects in, 110, 117–118
predictive modeling, 86–87
prescription drug regulation, 76–77
qualitative research, 119
quality of research, 143–146
recommendations for research, 5–6, 124–127, 279
research challenges, 2–3
research designs, 79–83, 111–120
sources of consumer information, 103
standards of evidence for, ix–x, 2, 99–103, 124–125, 184, 230
systematic reviews of research, 129–130
technical and conceptual development of research on, 74–76
therapeutic relationship factors, 109–110, 126
training of practitioners in, 100–101
See also Cost-effectiveness of CAM;
Outcomes research
Efficacy studies, 91–92, 98, 103–104, 120
outcomes measurement, 110
patterns of use, 48
access to research participation, 179
commitment to public welfare, 169
conceptual basis, 168–171
definition and scope of CAM, 174
duty of nonabandonment, 184–185
evidence of therapeutic efficacy required for prescribing, 184–185
informed consent issues, 177–178
in integration of CAM and conventional medicine, 179–183
issues of concern, 168
legal issues and, 183–192
nonmaleficence in, 169
in prescribing CAM therapies, 181–182
professional codes and guidelines, 179–180, 187
public accountability and, 171–173
recognition of medical pluralism, 169–171, 184–185
in research, 174–179
respect for patient autonomy, 169
sociocultural context, 192
Ethylenediaminetetraacetic acid, 262
Evidence-based practice, 2, 11, 77–79, 85–86
commitment to medical pluralism and, 184–185
conceptual development, 77–78, 85–86
in development of CAM practice guidelines, 246–247
goals, 78
status of CAM research, 145
Evidence-Based Practice Centers, 29, 267
Expectation effects, 84
CAM research challenges, 110
informed consent for research and, 177–178
research design for, 3, 117–118
F
Fatigue disorders, 133
Federal Food, Drug, and Cosmetic Act, 77, 269, 270
Federation of Practice Based Networks, 156
Federation of State Medical Boards of the United States, 7, 22, 187, 203
Fitness center model of integrative medicine, 217
Folic acid, 261
Food and Drug Administration, 20, 77
dietary supplement regulation, 4, 256, 257, 258, 260–261, 263, 266, 270–271
Framington Heart Study, 154
France, 265
G
Garlic, 262
Gastroenterological disease, 45
Geriatric medicine, 242–244, 248–249
Germany, 264–265
Ginkgo biloba, 21
H
Headache treatment, 38
cost-effectiveness of CAM, 49–50
Health food stores, 59–60
Cochrane Library data, 133
patterns of use, 35, 44, 48, 254
pharmacist education in, 227
sources of information about, 58–59
See also Dietary supplements
Holistic care, 211
Homeless people, 42
attitudes of conventional physicians, 203
insurance coverage, 47
licensure for, 238
N-of-1 research studies, 112
Hypericum. See St. John’s wort
I
Indinavir, 23
Informed consent, 177–178, 181, 183
patient preference for CAM therapy in absence of proof of effect, 184–188
Institute of Medicine, 29–31, 270–271
Insurance. See Reimbursement
Integration of CAM and conventional medicine, x
CAM-centric services model, 218
CAM training in medical schools, 17, 226–227, 230–237, 248
cancer treatment, 202
complementary services model, 218
conceptualization of health in, 210–211
concierge model, 219
consultant model, 217
consumer demand and, 208–209
continuity of care concerns, 219
ethical and legal considerations, 8, 179–192
financial considerations, 218, 219–220
fitness center model, 217
implementation models, 217–220
in institutions, 201–202, 208, 215–217
integrative medical doctor/DO-centric service model, 218
motivation of health care practitioners for, 208–209, 218
NCCAM efforts, 25
patient oriented delivery system, 219
patient–physician relationship in, 209, 210
patient preference for CAM therapy in absence of proof of effect, 184–188, 214–215
physician characteristics and, 209
primary-care model, 217
recognition of medical pluralism in, 169–171
recommendations for research, 7–8, 221–222
reimbursement patterns, 206–208
spectrum model, 210
trends, 6–7, 196, 201–206, 278
virtual model, 217
See also Translating research findings into practice
International Ethical Guidelines for Biomedical Research Involving Human Subjects , 174–175
Isoflavone formononetin, 147
J
Journal of the American Medical Association, 21
K
Knowledge-based medicine, 15
L
Labeling of dietary supplements, 260–262
assumption of risk, 188–189
food and drug law, 190–191
health care fraud, 191
informed consent, 183–184
malpractice liability, 188–190
patient preference for CAM therapy in absence of proof of effect, 185–188, 214–215
referral obligation, 189–190
sociocultural context, 191–192
Licensing and certification, 61
characteristics of CAM practitioners, 63–64
institutional credentialing for integrative medicine, 216–217
recommendations for, 9–10, 249–250
state authority for, 188
Licorice root, 147
Longitudinal studies, 83, 152–154
M
Malpractice liability, 188–190
Manipulative and body-based therapies, 18–19, 42
cost-effectiveness, 50
See also Massage therapy
Manualized therapies, 115–116
attitudes of conventional physicians, 203, 206
cost-effectiveness, 49
education and training in, 227
licensure for, 238
patterns of use, 48
practice characteristics, 63–64
treatment goals, 64
Medicaid, 42
Medical decision making, 14, 278
cost of care as factor in, 40
decision models, 76
efficacy–safety framework for, 213–215
ethical practice, 8
goals of integrative medicine, 211–213, 220
knowledge-based, 15
models of integrative medicine, 217–220
patient-centered, 15
patient participation in, 55
sources of CAM information, 58–60, 66, 103
types of illnesses treated with CAM, 34, 45–46, 63, 64
See also Use of CAM therapies
Meditation, 18
attitudes of conventional physicians, 206
education and training in, 227
immune function and, 149
patterns of use, 44
MEDLINE, 130–132
Memorial Sloan-Kettering Cancer Center, 6–7, 202
Menopause, 45
Mental healing, 18
Mind-body medicine, 18, 147, 148–149
holistic approach, 211
Modalities of CAM
classification, 18–19
concurrent use of multiple modalities, 108, 115
consumer socio-demographic characteristics and use of, 42
medical school curricula, 226–227
patterns of use, 38–39
practitioner training in, 237–238
Motivation to investigate or use CAM
health care provider, 208–209, 218
patient, 40, 46, 48–49, 50–58, 65–66, 161
Musculoskeletal disorders, 133
N
National Center for Complementary and Alternative Medicine (NCCAM), 1, 9, 17, 21, 23, 121
classification of CAM modalities, 18–19
dietary supplement policies, 267, 272, 273
education projects, 233–234
integration activities, 25
legislative mandate, 23
outreach efforts, 24
research activities, 23–25
research funding, 24
National Center for Health Statistics, 152
National Health and Nutrition Examination Survey, 154
National Institutes of Health, 9, 20, 21
basic research spending, 121
consensus statements, 141–143
dietary supplement research, 272–273
recommendations for, 6, 7, 10–11, 66, 162
research activities, 25–28.
See also National Center for Complementary and Alternative Medicine
in translating research findings into practice, 199
National Library of Medicine, 11, 23, 67
Natural Medicines Comprehensive Database, 268–269
Natural Standard, 269
ethical practice, 180
licensure for, 237
patterns of use, 48
NCCAM. See National Center for Complementary and Alternative Medicine
Neck pain, 50
New England Journal of Medicine, 21
N-of-1 trials, 112
Nuremberg Code, 174–175
Nurses’ Health Study, 154
Nurses/nursing, 204–206
CAM education for, 227, 229, 232, 235
O
Observational studies, 3, 80–81, 113–114
Office of Alternative Medicine, 20, 21
Office of Cancer Complementary and Alternative Medicine, 26–27
Office of Dietary Supplements, 28, 272–273
Office of Unconventional Therapies, 20
Omega-3 fatty acids, 261
Outcomes research
in case-control studies, 82
clustering of outcomes, 94
in cohort studies, 82
cointervention effects, 92–93
co-morbidity effects, 92–93
confidence intervals, 90–91
gaps in CAM research, 146–147, 161
goals, 76
intermediate and distal outcomes, 87–88
measurement error, 91
measurement of health state preferences, 90
multicenter studies, 92–93
national surveys of CAM use, 152–154
origins and development, 74–76, 77–79
research needs for integrative medicine, 7, 221–222
standardized measures, 88
subjective outcomes, 83–84, 105, 110–111, 126, 171–172
See also Effectiveness of treatment(s)
P
Pain
acupuncture analgesia, 147
outcome measurement, 84, 110–111
placebo effects, 147
framework for medical decision making, 213
informed consent and, 177–178
preference for CAM therapy in absence of proof of effect, 184–188, 214–215
principle of ethical practice, 169, 178–179
Patient-centered treatment, 15, 20, 220
in CAM, 238
as core competency of health care, 228
research needs, 238
Patient–healer relationship, 109–110, 126
ethical practice, 181–182
in integrative medicine, 209–210
as patient motivation for CAM therapy, 182
Pharmacotherapy
CAM instruction for pharmacists, 227
concurrent dietary supplement use, 254
drug interactions, 13, 23, 35, 270
regulation, 76–77
Physician’s Desk Reference, 269
Placebo effects
analgesia, 147
CAM research challenges, 110
research design for, 3, 117–118
Practice-based research, 5–6
Practice-based research networks
definition, 156
in model of CAM research, 155–158, 160
organizational structure, 156–157
origins and development, 156
practitioner training in, 158
research activities, 157–158, 160
Practice guidelines, 7, 8, 9–10, 22, 203–204
acceptance of new therapies, 200
development of, 246–248, 249–250
for ethical practice, 179–180, 187
goals for, 246
rationale, 246
recommendations for, 249–250
Preventive care
levels of evidence for research on, 94–98
NCCAM research, 24
research challenges, 105–106
use of CAM for, 48–49, 51–54, 64, 65
Public awareness and understanding, 10, 11
dietary supplement use and, 254, 256–257, 265
NCCAM outreach efforts, 24–25
perceptions of health care providers, 56
sensitivity to scientific evidence, 254, 256
sources of CAM information, 1, 58–60, 66, 103, 161
PubMed, 23
Pure Food and Drug Act, 76
Q
Qi gong, 19
Qualitative research, 119
Quality-adjusted life years, 89–90
Quality of evidence model of research, 122
QUOROM guidelines, 144
R
Race/ethnicity of consumers, 43–44, 64–65
survey of health practices among minority populations, 152, 162
Randomized controlled trials, 3, 79–80, 96, 98, 120, 184
alternative research designs, 3, 111–119
basic features, 129
challenges in CAM research, 103–105, 108
Cochrane Library data, 132–140
MEDLINE data, 130–132
preference studies, 112–113, 123
preventive and wellness treatments, 105–106
quality of studies, 143–144
strategies for improving quality, 144–146
Recursive partitioning, 115
Red clover, 262
legal obligations, 189–190
models of integrative medicine, 217
Regulation
dietary supplements, 4, 5, 190–191, 256–260, 263–265, 270–271
evolution of CAM, 20–22
international comparison, 263–265
prescription drugs, 76–77
public opinion, 256–257
See also Legal issues;
Licensing and certification
Reiki therapy, 19
Reimbursement, 102
acceptance of new therapies, 200
ethical issues regarding CAM healing, 172–173
evidence of treatment effectiveness and, 102
for integrative practice, 219
potential problems of CAM coverage, 207
utilization and, 35, 47, 64, 207
Relaxation techniques, 16
Cochrane Library data, 133
Religious-spiritual practices, 44
ethical and legal considerations, 191
measurement of CAM effectiveness and, 171–172
Research centers
in model of CAM research, 6, 158–160, 162
Research methodology
case series studies, 82–83
challenges in CAM research, 2–3, 103–105, 108–111, 123
cohort studies, 81–82, 113–114
conceptual models, 122–123
conceptualization and measurement of health, 210–211
control of confounding variables, 80–81
cost constraints, 120
criteria for establishing causality, 99–100
cross-disciplinary efforts, 148, 149
cross-sectional studies, 83
education of health professionals in, 9, 239–244, 248–249
evidence-based medicine, 77–79, 85–86
hierarchies of evidence, 94–98, 103, 124–127
independent review, 178
individualization of treatments and, 109, 111, 115–116
informed consent issues, 177–178
innovative designs for CAM research, 3, 111–120, 123–124
longitudinal studies, 83
N-of-1 trials, 112
observational studies, 80–81, 113–114
in practice-based research networks, 157
preference randomized controlled trials, 112–113, 123
for preventive and wellness treatments, 105–106
qualitative methods, 119
quality of studies, 143–144
quantification of CAM treatment elements, 109–110, 111, 115–116, 125–126
randomized studies, 79–80
recommendations for standardization, 2, 124–125
research goals and, 120
for research on widely used treatments, 104
respect for research subjects in, 178–179
risk-benefit considerations, 177
simulation of CAM use patterns in clinical trials, 62
special needs for CAM research, 99
standards of evidence, 99–103
strategies for improving quality, 144–146
subject selection, 176–177
superiority/noninferiority trials, 92
technical and conceptual development of effectiveness research, 74–76
validity in, 176
See also Outcomes research
Research personnel
education and training of, 9, 239–245, 248–249, 279
interdisciplinary teams, 5
sources of, 239
strategies for expanding CAM research, 148–151
Research settings
funding, 25
National Institutes of Health CAM programs, 23–28
practice-based, 5–6
recommendations for, 6
See also Research centers;
specific organization
Research topics
in CAM Research Centers, 158–159
CAM use and outcomes, 10–11, 151–154
dietary supplements, 5, 272–274
disincentives to CAM testing, 173
gaps in CAM research, 146–151, 161
health-seeking behaviors
integration of CAM and conventional medicine, 7–8, 221–222
in NCCAM Research centers, 158
in practice-based research networks, 157–158, 160
recent evolution of CAM research, 20–23
recommendations for, 5–6, 66–67, 124, 279
selection criteria, 3–4, 199, 279
social or scientific value in, 175
See also Data collection and management;
Research methodology
Retrospective research, 80, 114
Rheumatology problems, 45
Rhinosinusitis, 45
S
Safety
of dietary supplements, 265–272, 274
framework for medical decision making, 213–215
standards of evidence for, ix–x, 2
Society for Integrative Oncology, 202
Society of Teachers of Family Medicine Group on Alternative Medicine, 231
Soy isoflavones, 147
St. John’s wort, 21, 23, 60, 133, 254, 262
drug interactions, 270
STRICTA guidelines, 144–145
Subjective outcomes, 83–84, 105, 110, 126
Surveillance
in CAM research model, 155, 159–160
passive/active, 155
purposes, 154–155
Surveys, health care, 6
in CAM research model, 152
components, 152
frequency, 152
minority populations in, 152
recommendations for, 162
Systematic reviews of research, 129–130, 142–143
Cochrane Library data, 132–140
MEDLINE data, 130–132
quality of studies, 143
strategies for improving quality, 144–146
Systematic reviews of reviews, 141
T
Therapeutic misconception, 177–178
Therapeutic relationship. See Patient–healer relationship
Traditional healers, 43
Cochrane Library data, 133–134
ethical issues regarding reimbursement, 172–173
Translating research findings into practice
acceptance of new therapies, 199–200
in CAM research model, 159–160
challenges to, 158
ethical issues, 168
hypothesis generation and testing, 197, 198–199
insurance coverage, 200
patient demand as factor in, 197–198, 199–200
role of practice-based research networks, 158
selection of interventions for testing, 199
See also Integration of CAM and conventional medicine
Transpersonal psychology, 173
U
U.S. Pharmacopeia-National Formulary, 269–270
U.S. Preventive Services Task Force, 94–98
Use of CAM therapies, 1, 13, 34–41, 64–65
clinical supervision for, 61–62, 65
concurrent use of multiple modalities, 108, 115
cost as decision factor in, 40
data sources, 31–32, 34, 39, 40, 44–45
dietary supplements, 13, 35, 44, 253–257
ethical practice in prescribing, 181–182
for health promotion or disease prevention, 48–49, 51–54, 64, 65
high-frequency users, 46–47, 64
insurance coverage and, 47, 64, 207
long-term trends, 47–49
medical conditions, 34, 45–46, 64, 65
in nursing practice, 204–206
patient disclosure to medical doctor
regarding, 34, 35–38, 44, 63, 65, 278
patient motivation, 46, 50–58, 65–66, 161
recommendations for research, 10–11, 162
referral patterns, 63
use of conventional therapies and, 34, 39–40, 45, 54–55, 61, 62, 203–206
See also Consumer characteristics
Utility, health state, 89–90
V
consumer characteristics, 42
patterns of, 44
W
White House Commission on Complementary and Alternative Medicine, 21–22
Women’s use of CAM, 10, 41, 63, 64
World Health Organization, 269