Herbal Supplements E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 867

Veröffentlichungsjahr: 2011

Beschreibung

HERBAL SUPPLEMENTS

An evenhanded study of pharmacological interactions between Western drugs and herbal supplements

Today, a significant percentage of Americans turn to complementary and alternative medicine practices. Despite their popularity and wide use, these products do not undergo the same pre-market testing for safety and efficacy that is required of pharmaceuticals. In Herbal Supplements: Efficacy, Toxicity, Interactions with Western Drugs, and Effects on Clinical Laboratory Tests, editors Amitava Dasgupta and Catherine Hammett-Stabler present a comprehensive introduction to both safe and unsafe herbal supplements. The book emphasizes the pharmacological interactions identified between Western drugs and herbal supplements, and the effects of herbal supplements on clinical laboratory tests.

Herbal Supplements provides a guide to the interpretation of abnormal test results in otherwise healthy subjects due to use of herbal remedies. Focusing on interactions between herbals and pharmaceuticals, sources of contamination in herbal supplements, and analytical techniques used in the investigation of herbal remedies, the book details:

• Pharmacological interactions between Western drugs and herbal supplements
• Effects of herbal supplements on clinical laboratory tests
• Key interactions between herbal supplements and various pharmaceutical drugs
• Medicinal plants and toxic effects
• Contamination of herbal supplements from metals, pharmaceuticals, and plant poisoning
• Analytical techniques, including immunoassays, used in the investigation of herbal remedies

Unbiased and literature-based, this text offers toxicologists, clinical chemists, analysts, and pharmacologists a no-nonsense take on the efficacy, toxicity, and drug interactions of herbal supplements and medicines.

Leseprobe

Table of Contents

Cover

Table of Contents

Title page

Copyright page

DEDICATION

PREFACE

CONTRIBUTORS

Part I: INTRODUCTION AND OVERVIEW

1 INTRODUCTION TO COMPLEMENTARY AND ALTERNATIVE MEDICINE

1.1 INTRODUCTION TO COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM)

1.2 WHAT IS COMPLEMENTARY AND ALTERNATIVE MEDICINE?

1.3 DEMOGRAPHICS OF CAM

1.4 THE REASONS FOR USING CAM

1.5 GROWTH OF CAM AND HERBAL USE

1.6 REGULATION OF HERBAL SUPPLEMENTS IN THE UNITED STATES

1.7 REGULATIONS OUTSIDE THE UNITED STATES

1.8 RESOURCES

1.9 CONCLUSIONS

2 RELATIVELY SAFE HERBAL REMEDIES

2.1 INTRODUCTION

2.2 CRANBERRY

2.3 ECHINACEA

2.4 FENUGREEK

2.5 FEVERFEW

2.6 GARLIC

2.7 GINGER

2.8 GINKGO BILOBA

2.9 GINSENG

2.10 HAWTHORN

2.11 MILK THISTLE

2.12 SAW PALMETTO

2.13 SOY

2.14 ST. JOHN’S WORT

2.15 TURMERIC

2.16 VALERIAN

2.17 CONCLUSIONS

3 RISK OF TOXICITY ASSOCIATED WITH UNREGULATED HERBAL PRODUCTS

3.1 INTRODUCTION

3.2 EPHEDRA ALKALOIDS MA HUANG (EPHEDRA SINICA) AND BALA (SIDA CORDIFOLIA)

3.3 ST. JOHN’S WORT (SJW) (HYPERICUM)

3.4 YOHIMBINE FROM PAUSINYSTALIA YOHIMBE (BARK EXTRACT)

3.5 KAVALACTONES AND KAVA PYRONES FROM PIPER METHYSTICUM (KAVA)

3.6 PYRROLIZIDINE ALKALOIDS (PAs) FROM SYMPHYTUM OFFICINALE (COMFREY)

3.7 ARISTOLOCHIC ACID (AA) FROM ARISTOLOCHIA FANGCHI

3.8 CONCLUSIONS

Part II: EFFECTS OF HERBAL REMEDIES ON SPECIFIC ORGAN SYSTEMS

4 HERBAL MEDICINES WITH IMMUNOMODULATORY EFFECTS

4.1 INTRODUCTION

4.2 ALBIZZIA

4.3 ANGELICA

4.4 ASTRAGALUS

4.5 ATRACTYLODES

4.6 BUPLEURUM

4.7 CHASTEBERRY (VITEX)

4.8 CHRYSANTHEMUM

4.9 CINNAMOMUM

4.10 CISSAMPELOS

4.11 CNIDIUM

4.12 CODONOPSIS

4.13 CORDYCEPS

4.14 CORNUS

4.15 CORYDALIS

4.16 CUSCUTA

4.17 DANSHEN

4.18 DIOSCOREA

4.19 EPHEDRA

4.20 GANODERMA

4.21 GARLIC

4.22 GINGER

4.23 GINKGO BILOBA

4.24 GINSENG

4.25 INDIGO

4.26 JIAOGULAN

4.27 LEONURUS

4.28 LICORICE

4.29 LIGUSTRUM

4.30 LOBELIA

4.31 MORINDA (NONI)

4.32 MUSHROOM

4.33 OROXYLUM

4.34 PEONY

4.35 PLATYCODON GRANDIFLORUM

4.36 POLYGALA

4.37 POLYGONUM

4.38 PORIA

4.39 PRUNELLA

4.40 REHMANNIA

4.41 SCHIZANDRA

4.42 SILYBUM

4.43 SMILAX

4.44 RELATED HERBS POPULAR IN THE UNITED STATES

4.45 CONCLUSIONS

5 KELP AND THYROID FUNCTION

5.1 INTRODUCTION

5.2 IODINE AND THYROID

5.3 KELP

5.4 CONCLUSIONS

6 HERBAL REMEDIES AND THE PATIENT WITH CHRONIC KIDNEY DISEASE

6.1 INTRODUCTION

6.2 POTENTIAL DANGERS OF HERB AND SUPPLEMENT USE IN PATIENTS WITH KIDNEY DISEASE

6.3 POTENTIATION OF GLUCOSE/ELECTROLYTE ABNORMALITIES

6.4 PHARMACOKINETIC INTERACTIONS

6.5 POTENTIAL BENEFITS OF HERBS IN PATIENTS WITH KIDNEY DISEASE

6.6 MISCELLANEOUS USES

6.7 CONCLUSIONS

7 ABNORMAL LIVER FUNCTION TESTS DUE TO HEPATOTOXIC HERBS

7.1 INTRODUCTION

7.2 LIVER FUNCTION TESTS (LFTs)

7.3 ABNORMAL LFTS DUE TO USE OF HERBAL SUPPLEMENTS

7.4 CONCLUSIONS

8 HOMEOPATHIC MEDICINE: PRINCIPLE, EFFICACY, AND TOXICITY

8.1 INTRODUCTION

8.2 HISTORICAL BACKGROUND

8.3 BASIC PRINCIPLES OF HOMEOPATHY

8.4 CURRENT USE OF HOMEOPATHY

8.5 COMMONLY USED HOMEOPATHIC REMEDIES

8.6 ARE HOMEOPATHIC REMEDIES EFFECTIVE?

8.7 HOMEOPATHY AND ADVERSE EFFECTS

8.8 CONCLUSIONS

9 INDIAN AYURVEDIC MEDICINES: AN INTRODUCTION

9.1 INTRODUCTION

9.2 AYURVEDIC MEDICINE: BASIC PRINCIPLES

9.3 BENEFITS OF MEDITATION AND YOGA

9.4 HERBALS AND REMEDIES FROM OTHER SOURCES

9.5 EFFICACY OF AYURVEDIC MEDICINE

9.6 DANGERS OF AYURVEDIC MEDICINES: HEAVY METAL TOXICITY

9.7 CONCLUSIONS

10 TRADITION AND PERSPECTIVES OF GRECO-ARAB AND ISLAMIC HERBAL MEDICINE

10.1 INTRODUCTION

10.2 A BRIEF HISTORY OF ARAB MEDICINE

10.3 INNOVATIONS INTRODUCED BY ARAB PHYSICIANS

10.4 PHARMACOLOGY

10.5 POISONS AND ANTIDOTES

10.6 SAFETY OF MEDICINAL PLANTS

10.7 CURRENT STATUS

10.8 HERBAL MEDICINES FROM TRADITION TO EVIDENCE BASE

10.9 COMMONLY USED HERBAL MEDICINES IN THE MEDITERRANEAN

10.10 CONCLUDING REMARKS

ACKNOWLEDGMENTS

11 LICORICE AND LABORATORY TESTS

11.1 INTRODUCTION

11.2 THE LICORICE PLANT

11.3 MEDICINAL PREPARATION OF LICORICE

11.4 PHYSIOLOGICAL EFFECTS OF LICORICE

11.5 SAFETY PRECAUTIONS AND LICORICE–DISEASE AND LICORICE–DRUG INTERACTIONS

11.6 CONCLUSIONS

Part III: DRUG INTERACTIONS

12 DRUG INTERACTIONS WITH ST. JOHN’S WORT

12.1 INTRODUCTION

12.2 HISTORICAL BACKGROUND

12.3 USE OF ST. JOHN’S WORT IN TREATING DEPRESSION

12.4 PHARMACOKINETIC EFFECTS OF ST. JOHN’S WORT

12.5 MOLECULAR MECHANISM OF ENZYME AND TRANSPORTER INDUCTION

12.6 CONCLUSIONS

13 DRUG–HERB INTERACTIONS IN PATIENTS WITH HIV/AIDS

13.1 INTRODUCTION

13.2 USE OF HERBAL PREPARATIONS IN PEOPLE WITH HIV

13.3 CONSIDERATIONS FOR DRUG–HERB INTERACTIONS FOR ARV AGENTS

13.4 DRUG–HERB INTERACTIONS WITH ARV DRUGS IN HEALTHY VOLUNTEERS AND IN HIV-INFECTED PATIENTS

13.5 CONCLUSION

14 INTERACTIONS BETWEEN FRUIT JUICES AND DRUGS

14.1 INTRODUCTION

14.2 INTERACTIONS BETWEEN VARIOUS DRUGS AND GRAPEFRUIT JUICE

14.3 INTERACTION BETWEEN ORANGE JUICE AND DRUGS

14.4 DRUG INTERACTIONS WITH POMEGRANATE AND POMELO JUICE

14.5 DRUG INTERACTIONS WITH CRANBERRY JUICE

14.6 CONCLUSIONS

15 DRUG INTERACTIONS WITH GINKGO BILOBA AND GINSENG

15.1 INTRODUCTION

15.2 DRUG INTERACTIONS WITH GINKGO BILOBA

15.3 DRUG INTERACTIONS WITH GINSENG

15.4 CONCLUSIONS

16 DRUG INTERACTIONS WITH GARLIC AND GINGER SUPPLEMENTS

16.1 INTRODUCTION

16.2 REGULATORY ASPECT

16.3 HERB–DRUG INTERACTION

16.4 GARLIC (ALLIUM SATIVUM)

16.5 GINGER (ZINGIBER OFFICINALE)

16.6 CONCLUSION

Part IV: CONTAMINATION

17 HEAVY METAL TOXICITY AND HERBAL REMEDIES

17.1 INTRODUCTION

17.2 COMMON HEAVY METALS FOUND IN HERBAL SUPPLEMENTS

17.3 HOW CAN HERBAL SUPPLEMENTS BECOME CONTAMINATED?

17.4 ANALYSIS OF HEAVY METALS

17.5 HEAVY METAL TOXICITY AND HERBAL REMEDIES

17.6 REGULATORY GUIDELINES AND QUALITY ASSURANCE

17.7 REMAINING QUESTIONS AND CONCLUSIONS

18 ADULTERATION OF HERBAL REMEDIES WITH CONVENTIONAL DRUGS: ROLE OF THE CLINICAL LABORATORY

18.1 INTRODUCTION

18.2 CONTAMINATION WITH ANALGESICS AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs)

18.3 CONTAMINATION WITH HYPOGLYCEMIC AGENTS

18.4 CONTAMINATION WITH ERECTILE DYSFUNCTION DRUGS

18.5 CONTAMINATION WITH PSYCHOTROPIC DRUGS

18.6 CONTAMINATION WITH STEROIDS

18.7 CONTAMINATION WITH WEIGHT LOSS PRODUCTS

18.8 CONTAMINATION WITH OTHER DRUGS

18.9 ROLE OF THE CLINICAL LABORATORY IN IDENTIFYING SUCH ADULTERANTS

18.10 CONCLUSIONS

19 BEYOND HERBALS: AN INTRODUCTION TO POISONOUS PLANTS

19.1 INTRODUCTION

19.2 SURVIVAL OF THE FITTEST

19.3 EPIDEMIOLOGY OF PLANT EXPOSURE

19.4 TOXIC COMPOUNDS IN PLANTS

19.5 INVESTIGATIONS AND ANALYSIS

Part V: ANALYTICAL IMPLICATIONS

20 INTERFERENCES OF HERBAL REMEDIES WITH IMMUNOASSAYS FOR THERAPEUTIC DRUGS: FOCUS ON DIGOXIN

20.1 INTRODUCTION

20.2 HERBAL SUPPLEMENTS AND IMMUNOASSAYS FOR DRUGS

20.3 HERBAL SUPPLEMENTS AND DIGOXIN IMMUNOASSAYS

20.4 CONCLUSIONS

21 ROLE OF THE CLINICAL LABORATORY IN DETECTING PLANT POISONING

21.1 INTRODUCTION

21.2 VARIOUS PLANT TOXINS

21.3 LABORATORY APPROACH TO THE DIAGNOSIS OF PLANT POISONING

21.4 COMMON PLANT POISONINGS: CLINICAL PRESENTATION AND LABORATORY ASSESSMENT

21.5 CONCLUSIONS

Index

Copyright © 2011 by John Wiley & Sons, Inc. All rights reserved

Published by John Wiley & Sons, Inc., Hoboken, New Jersey

Published simultaneously in Canada

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Library of Congress Cataloging-in-Publication Data:

Herbal supplements : efficacy, toxicity, interactions with western drugs and effects on clinical laboratory tests / edited by Amitava Dasgupta and Catherine A. Hammett-Stabler.

p. ; cm.

Includes bibliographical references and index.

ISBN 978-0-470-43350-8 (cloth)

ISBN 978-0-470-92275-0 (ebk)

 1. Herbs–Toxicology. 2. Herbs–Therapeutic use. 3. Drug-herb interactions. I. Dasgupta, Amitava, 1958– II. Hammett-Stabler, Catherine A., 1952–

[DNLM: 1. Plants, Medicinal–chemistry. 2. Plants, Medicinal–toxicity. 3. Dietary Supplements–toxicity. 4. Herb-Drug Interactions. 5. Pathology, Clinical–methods. 6. Phytotherapy– adverse effects. QV 766 H5349 2011]

RA1250.H47 2011

615′.321—dc22

2010019504

We dedicate this book to Alice and Tom.

PREFACE

Today, a significant percentage of Americans turn to complementary and alternative medicine (CAM) practices. These range from biological-based products, which include herbal remedies, supplements, and traditional medicines, to noninvasive modalities such as massage, acupuncture, meditation, and yoga. Although many alternative modalities such as massage, yoga, and meditation are safe and may also have efficacy, there are significant safety issues regarding the use of herbal supplements and many traditional medicines (e.g., Ayurvedic medicines). A number of herbal supplements have been found to cause organ-specific toxicity, while other herbal supplements are capable of interacting both pharmacodynamically and pharmacokinetically with many Western drugs. Contamination of some Asian herbal supplements and Indian Ayurvedic medicines with heavy metals and possibly with undisclosed Western drugs is a serious public health hazard. Numerous herbals have been used for many years as traditional medicines and many appear to be safe when used appropriately. Research has yet to show many to be as effective as pharmaceuticals, and this is an area in which considerable work is needed.

We decided a book such as this was needed because of the cases of toxicity we have seen and the questions we each receive as clinical laboratory professionals. While we present both safe and unsafe herbal supplements, we emphasize the pharmacological interactions identified between Western drugs and herbal supplements and the effects of herbal supplements on clinical laboratory tests. Other books and reviews discuss some of these issues, but there are few that discuss the effects of herbal supplements on clinical laboratory tests despite the fact that these tests are often the first indicators of a problem, that is, toxicity or an unwanted drug–herb interaction.

This book is divided into five parts. The first part provides a general introduction to CAMs as well as an introduction to herbals considered safe versus those with a darker reputation. The second part provides more detailed information in an organ- or disease-based focus and delves into some of the traditional practices of which most allopathic professionals have limited knowledge. These are by no means intended to provide all that is known about these practices but to give a sound overview that one could use to engage patients and others in discussions about their use of such practices. Part III is dedicated to the key interactions between herbal supplements and various pharmaceutical drugs. Despite much play by the media several years ago, patients continue to mix herbals and pharmaceuticals without telling their allopathic providers. This often becomes the explanation of many unexpected drug reactions. Importantly, contamination of herbal supplements, especially those manufactured in various Asian countries, and Indian Ayurvedic medicines with heavy metals is a serious public safety issue. The metals found include, but are not limited to, lead, mercury, arsenic, and cadmium, and there are numerous case reports in the literature describing heavy metal toxicity following consuming such supplements. In addition, more than a few products have been found to contain significant amounts of pharmaceuticals. Part IV (Contamination) addresses these important points. Part V discusses various analytical techniques used in the investigation of herbal remedies.

This book is dedicated to healthcare professionals who we hope will find it valuable in their practice of medicine. We thank our authors for taking time to conduct thorough literature reviews and we respect the opinions their work derived. We have tried to provide an unbiased, literature-based opinion on each herbal supplement. Most importantly, we thank our spouses for putting up with us during the time we worked on this project.

Amitava Dasgupta

Catherine A. Hammett-Stabler

CONTRIBUTORS

Charbel Abou-Diwan, PhD, Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA; Email: [email protected]

Jeffrey K. Actor, PhD, Professor of Pathology and Laboratory Medicine, University of Texas Medical School at Houston, Houston, TX; Email: [email protected]

John L. Blau, MD, Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA

Steven W. Cotten, PhD, Division of Medicinal Chemistry and Natural Products, Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill; Email: [email protected]

Amitava Dasgupta, PhD, Professor of Pathology and Laboratory Medicine, University of Texas Medical School at Houston, Houston, TX; Email: [email protected]

Angela M. Ferguson, PhD, Assistant Professor of Pathology and Laboratory Medicine, Children’s Mercy Hospitals and Clinics, University of Missouri-Kansas City School of Medicine; Email: [email protected]

Uttam Garg, PhD, Professor of Pathology and Laboratory Medicine, Children’s Mercy Hospitals and Clinics, University of Missouri-Kansas City School of Medicine; Email: [email protected]

Catherine A. Hammett-Stabler, PhD, Professor of Pathology and Laboratory Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC; Email: [email protected]

Matthew D. Krasowski, MD, PhD, Assistant Professor of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA; Email: [email protected]

Loralie J. Langman, PhD, Associate Professor of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN; Email: [email protected]

Mariana S. Markell, MD, Associate Professor of Medicine, SUNY Downstate Medical Center, Brooklyn, NY; Email: [email protected]

Ronald W. McLawhon, MD, PhD, Professor of Pathology and Laboratory Medicine, University of California, San Diego, School of Medicine, La Jolla, CA; Email: [email protected]

Natella Y. Rakhmanina, MD, Associate Professor of Pediatrics, Division of Infectious Diseases and Pediatric Clinical Pharmacology, Children’s Medical Center, The George Washington University School of Medicine, Washington, DC; Email: [email protected]

Semyon A. Risin, MD, PhD, Professor of Pathology and Laboratory Medicine, University of Texas Health Science Center at Houston, Houston, TX; Email: [email protected]

James Ritchie, PhD, Professor of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA; Email: [email protected]

Bruce Rosenzweig, PhD, Rosenzweig Consulting, Louisville, KY; Email: [email protected]

Bashar Saad, PhD, Professor of Cell Biology, The Galilee Society R&D Center, Shefa Amr, Israel, and Qasemi Research Center, Al-Qasemi Academic College, Baga Algharbiya, Israel; and Arab American University, Jenin, Palestine; Email: [email protected]

Omar Said, PhD, Professor of Pharmacology, The Galilee Society R&D Center, Shefa Amr, Israel, Al-Maissam Center, Kafr Kanna, Israel; Email: [email protected]

Salvador F. Sena, PhD, Department of Pathology and Laboratory Medicine, Danbury Hospital, Danbury, CT; Email: [email protected]

Christine L. H. Snozek, PhD, Assistant Professor of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN

Ashok Tholpady, MD, Department of Pathology and Laboratory Medicine, University of Texas Health Science Center at Houston, Houston, TX; Email: [email protected]

John N. van den Anker, MD, PhD, Professor of Pediatrics, Pharmacology & Physiology, Pediatric Clinical Pharmacology, Children’s Medical Center, The George Washington University School of Medicine, Washington, DC

Part I: INTRODUCTION AND OVERVIEW

1

INTRODUCTION TO COMPLEMENTARY AND ALTERNATIVE MEDICINE

Catherine A. Hammett-Stabler

The University of North Carolina at Chapel Hill, Chapel Hill, NC

1.1 INTRODUCTION TO COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM)

The past 109 years have witnessed amazing advances in medicine, and, without a doubt, the world’s population has benefited from the scientific discoveries elucidating the mechanisms of diseases, as well as the therapeutic interventions that followed. We live longer, healthier lives compared with our ancestors, with much of that due to medical advances. A child born at the beginning of the twentieth century had a life expectancy of ∼50 years, while a child born today can expect to reach 75–80 years, or beyond [1, 2]. True, we have yet to conquer heart disease, cancer, and many other diseases, but we are making advances in every corner. In the United States, where cancer is the second leading cause of death, the mortality rate attributed to cancer has declined steadily since 1950 for both men and women across all age groups [3, 4]. But shouldn’t we expect such benefits in a country with one of the best healthcare systems in the world? A recent World Health Organization (WHO) report suggests the benefits extend well beyond the United States as adult and childhood mortality rates around the world have declined steadily since the 1990s [5]. The reasons for this decline are many, but the WHO attributes a significant portion specifically to medical advancements. For children, oral rehydration treatment during severe diarrhea, the use of artemisinin-based combination therapies for the prevention and treatment of malaria, and the use of immunizations (for the prevention of measles, diphtheria, pertussis, tetanus, hepatitis B, and hemophilus influenzae B) made the difference. For adults, the decline in mortality rates was related to improved therapies for infectious diseases such as tuberculosis, HIV, and malaria [5].

From these and other studies, it is clear that scientific and medical advancements now permit many diseases and conditions to be diagnosed earlier and to be treated more effectively, with the end result of a longer, higher-quality life for many individuals. For this reason, it is intriguing that so many individuals have turned to and embraced the CAM treatments and systems that will be discussed in the following chapters.

1.2 WHAT IS COMPLEMENTARY AND ALTERNATIVE MEDICINE?

CAM encompasses a variety of practices and products ranging from recently introduced New Age modalities to complete medical systems that have evolved over thousands of years. Many of the practices are readily recognized as outside of allopathic (conventional or mainstream) medicine, but others are less obvious. Furthermore, some practices that were once considered CAM have moved into the mainstream. The definition applied by Eisenberg et al. 17 years ago—”medical interventions not taught widely at US medical schools or generally available in US hospitals”—has certainly changed as medical schools have initiated courses in CAM and hospitals have developed departments of integrative medicine [6–8].

Today, the National Center for Complementary and Alternative Medicine (NCCAM) has broadened the definition to “a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine” [9]. NCCAM further distinguishes between CAM and complementary medicine consisting of those practices used in conjunction with allopathic (conventional) medicine, whereas alternative medicine encompasses those practices used instead or in place of allopathic medicine [9]. The Center also uses the term “integrative medicine” to describe the combination of allopathic medicine with those CAM treatments that appear “to be safe and have merit based upon scientific study” [9] (though it is not clear how safety and efficacy were demonstrated for this definition).

Using the NCCAM classification scheme, practices can be divided into five categories (Table 1.1):

Biological-based therapies employ naturally occurring substances derived from plants, animals, and minerals, such as herbal preparations (the most widely used of all CAMs), botanicals, and dietary supplements.Energy therapies include both those involving energy fields believed (by practitioners) to surround and penetrate the body, as well as the application of an energy field (magnetic, electric, or electromagnetic) to the body. Examples include Reiki, bioelectromagnetic therapy, and therapeutic touch.Manipulative and body-based practices apply physical stimulation, movement, manipulations, and massage or rubbing of muscles and other soft tissues to stimulate blood flow and oxygenation for preventative or healing purposes. Chiropractic, osteopathic manipulation, and therapeutic massage are among the most popular.Mind–body therapies use a number of techniques to enhance the mind’s ability to control bodily functions. Examples of practices within this classification include meditation, yoga, prayer, tai chi, biofeedback, and relaxation.Whole medical systems are quite complex and often include combinations of practices from the aforementioned groups. A number of these have evolved over thousands of years, notably, traditional Chinese medicine, Indian Ayurvedic medicine, and Arabic Unani medicine.

TABLE 1.1 NCCAM Classifications of Complementary and Alternative Practices

Whole medical systems Mind–body medicine Biological-based practices Manipulative and body-based practices Energy medicine

Agreeably, the practices listed in Table 1.2 are quite varied, and often overlap between the broad categories given. Many individuals would also argue that some, however, are not CAMs but are recreation or even conventional forms of therapy. For example, is the massage enjoyed at a spa a practice of CAM? Is the practice of taking a daily vitamin? If tai chi and yoga are CAM, is running? How should prayer for health and spirituality be classified (some surveys have considered prayer for health a form of CAM practice) [10]. Are these truly complementary and alternative medical practices or perhaps an overclassification? Added to the controversy is the question as to when does a practice make the transition from CAM to conventional—and how? Does the transition occur simply out of acceptance, or must there be sound evidence supporting its use?

TABLE 1.2 Listing of Practices Defined as CAM

Acupuncture/acupressure Alexander technique Aromatherapy Ayurvedic medicine Autogenic training Autologous blood therapy Bach flower remedies Balneotherapy Bioelectromagnetic therapy Biofeedback and bioresonance Bone setting Chelation therapy Chinese herbal medicine, traditional Chinese medicine Chiropractice therapy Colonic irrigation Counterirritation Craniosacral therapy Crystal therapyCupping diets Dietary supplements Electromagnetic therapy Enzyme therapy Herbal medicine Homeopathy Hydrotherapy Hypnotherapy Iridology Kampo Kinesiology Kirlian photography Laser therapy Massage Meditation Mental healing Naturopathy Osteopathic manipulation Pulse diagnosisPhytomedicine Prayer Qi gong Reiki Reflexology Relaxation therapy Spa therapy Spiritual healing Tai chi Thalassotherapy Therapeutic touch Tongue diagnosis Traditional medicine Trager psychophysical integration Transcranial magnetic stimulation Vega testing Water injection Yoga

1.3 DEMOGRAPHICS OF CAM

Interestingly, the demographics of CAM use in the United States have changed little over the past 17 years. The majority of studies characterizing the use of CAMs in this country are based upon the data generated through the National Center for Health Statistics of the Centers for Disease Control and Prevention (CDC) [10, 11]. There are additional, though smaller, surveys focusing on specific subpopulations. When reviewing any of these, it is important to realize that the data acquired are directly dependent upon both the survey tool and the surveyor. As mentioned previously, there is disagreement as to what is a CAM, and surveys differ with regard to what is or is not included. For example, the 2007 National Health Interview Survey (NHIS) survey included nine additional CAM therapies and 10 additional biological-based products not captured in the 2002 survey. The 2002 survey included prayer as a CAM practice, though the 2007 survey did not. Neither survey included the use of some types of home remedies. The point here is that these surveys, while extremely valuable, have limitations when trying to discern specific details regarding CAM use and may, in fact, underestimate utilization (a problem reemphasized in subsequent sections). Several investigators have tried to probe more deeply into the differences in CAM use and in practices between the various populations that make up this country’s citizenship. The results of these studies reflect the diversity of ethnicity and demonstrate the need for much more work in this area.

About 40% of adults report using at least one form of CAM within the previous year, most often in pursuit of general good health or to prevent illness [10, 11]. Biological-based therapies are, by far, the CAM of choice with ∼20% of respondents reporting use of these types of products (Table 1.3). Deep breathing exercises, meditation, and manipulation therapies round out the more popular practices. Consistently, surveyors find the person who chooses to use a CAM is most likely to be a middle-aged Caucasian female with a higher education level and of higher economic status. It is extremely important to recognize, however, that CAMs are used by all ages and all populations.

TABLE 1.3 Ten Most Popular Biological-Based Products, 2002 versus 2007

2002 (Past Year)2007 (Past 30 Days)Echinacea (40.3%)Fish oil/omega-3 (37.4%)Ginseng (24.1%)Glucosamine (19.9%)Ginkgo biloba (21.1%)Echinacea (19.8%)Garlic (10.9%)Flaxseed oil (15.9%)Glucosamine (14.9%)Ginseng (14.1%)St. John’s wort (12.0%)Combination herb pills (13.0%)Peppermint (11.8%)Ginkgo biloba (11.3%)Fish oils/omega fatty acids (11.7%)Chondroitin (11.2%)Ginger (10.5%)Garlic supplements (11.0%)Soy supplements (9.8%)Coenzyme Q10 (8.7%)

In fact, the 2007 survey found ∼12% of U.S. children use a CAM [11]. Not surprisingly, the parents of these children are more likely to turn to these therapies and, accordingly, the children tend to use practices similar to those used by the parent(s): herbal products followed by manipulation therapies and deep breathing exercises [11]. This may have been the case for sometime, as between 26% and 80% of young, college-age adults (∼18–21 years) (Table 1.4) have reported using a CAM within the past year since the late 1990s [12–15]. Consistent with other surveys, herbals and supplements are the CAM of choice for this group and are used in pursuit of health and as preventatives.

TABLE 1.4 Use of CAMs by College Students

N%Products100026.3Ginseng, echinacea, protein power/amino acids27248.5Echinacea, ginseng, St. John’s wort, ginkgo biloba, ephedra, chamomile175451.0Echinacea, ginseng, St. John’s wort, chamomile, ginkgo biloba50679.0 58.0Green tea, ginseng, chamomile, ginger, echinacea

CAM use peaks between ages 50 and 59 (44.1%) but is relatively consistent from ages 18 to 84 (36.3% and 32.1%, respectively). Many are surprised to discover that older individuals use CAMs at rates similar to younger individuals. Biological-based products, notably, supplements, were most frequently reported in the NHIS survey. Others have found many of this population turn to a range of home remedies involving materials readily available to them such as vinegar, baking soda, and homegrown or local herbs [16]. Even those living under supervised, or semisupervised, conditions such as in assisted living facilities are found to use CAMs. A limited survey conducted by Moquin et al. found that 5–9% of residents in assisted living facilities used some kind of herbal remedy [17]. More concerning was the fact that the use of such was not known to the facility staff in many cases. Since the older population is more likely to be receiving prescriptive medications, their use of herbals is important as some of these are known to increase the risk of adverse drug reactions (ADRs) when combined with prescriptive medications. If herbal use is not documented or suspected in such an individual, the ensuing ADR could be misdiagnosed and could lead to inappropriate care.

Adequate documentation of CAM use, both on the part of the patient/individual and the healthcare provider, remains a significant problem. This problem is not unique to the United States but is reported worldwide with less than half of patients who use CAM reporting such activities to their healthcare providers [18–22]. Although most physicians, nurses, and other providers are now trained to seek the information, many patients still report not being asked about use, and some providers report being uncomfortable with the inquiry [23, 24]. Shelley et al. determined that whether or not these discussions take place is largely determined by three factors: the patient’s perception of the provider’s acceptance of CAM and how nonjudgmental the provider appears to be, whether or not the provider initiates the conversation, and concerns the provider has about the safety and efficacy of the specific CAM [24]. They found that patients who use CAMs expect the conversation to be initiated by the provider and that patients were more likely to admit to use if they felt the response was or would be nonjudgmental. Patients specifically reported that they were unlikely to admit use if the response was negative—that they did not want to disappoint or, more importantly, anger the provider. Furthermore, most patients did not expect their allopathic provider to necessarily be a CAM expert. This study was particularly revealing because it also found providers correlate low communication on the part of the patient to be indicative of low CAM use, which may be anything but the case!

1.3.1 Variations in U.S. CAM Utilization Based upon Ethnicity

As noted previously, the 2007 NHIS found that ∼40% of the U.S. population used at least one of the more than 40 CAMs queried [11]. Highest use was reported by Native American and Alaska Natives, while lowest use was reported among Hispanics and African Americans. Use among Asians and Pacific Islanders was similar to that reported by Caucasians. How race and ethnicity impact CAM use has been the focus of numerous studies of previous NHIS data and independent surveys, and their findings are quite interesting.

For example, Native Americans and Alaska Natives report the highest use of alternative medical systems primarily in the form of traditional medicine, a complex and often challenging system to study since Native American traditional medicine does not represent a single, unified medical system [11, 25–28]. Practices and beliefs vary between the more than 600 distinct tribes (including both those officially recognized by federal or state governments and those that remain unrecognized). However, a common theme is the interconnection of everything (living or not) on Earth and the relationship of the mind, body, and spirit. Health and well-being are related to the harmony and balance within and between an individual and the external world [25–28]. Since illness may result when this harmony and balance is disturbed, an important and fundamental part of the healing process is to restore this balance. Traditional healers take a very personalized approach in assessing the situation and in guiding the individual through steps necessary for healing. These may include the use of rituals and practices such as dances, smudging, sweats, and quests, to name but a few. Minerals, animals, and plants are often used as well, and it should be noted that many of the popular herbals discussed in later chapters have a historical use by Native Americans. Ginseng, garlic, echinacea, and St. John’s wort are all documented to have been used as traditional medicines though often for very different purposes than currently [29].

Several studies evaluating prevalence of use among African Americans have found this population to engage in the use of home remedies, manipulation (chiropractic) therapies (15–20%), and mind–body practices (∼13%) such as mediation and religiosity (prayer). Home remedies not only include the use of herbals but also many other items found within the home. For example, a small amount of vinegar may be taken to help prevent hypertension related to salt intake [16, 30–32]. These types of practices often go unreported or recognized in many surveys.

The use of CAMs among Asian Americans is quite diverse and is dependent upon the region of origin, that is, China, Japan, Vietnam, Korea, Pacific Islands, or India. This group may significantly underreport use in the NHIS as many other surveys have reported higher incidence of use. Ahn et al., for example, found use to range between 55% and 72% among Chinese and Vietnamese populations in several large cities around the United States [33]. A consistent finding is that, in general, Asian Americans are among the most likely to use herbal therapies [10, 11, 34–37]. One should use this statement with caution, remembering the diversity of the population, and indeed there is considerable variability in the pattern of CAM and herbal use within Asian Americans that is further complicated by their geographic distribution within the United States. In practice, Chinese Americans are more likely to use herbals and acupuncture, while Vietnamese Americans typically turn to coining, massage, and cupping, and Asian Indians are more likely to engage in mind–body therapies [33–35]. Across all Asian populations, CAMs are more likely to be used for health maintenance or for prevention rather than for the treatment of a specific condition [34, 35].

Another diverse, heterogeneous group, the Hispanic population in the United States, represents individuals primarily from Central America, South America, and the Caribbean. The health-related traditions brought from each country are as distinct as the dialects and foods. This is another population that underreports CAM use as evidenced by the NHIS finding of only 23.7% of this group reporting CAM use, yet other reports find use as high as 75% [11, 38, 39]. As a whole, this group participates in a wide range of CAM practices that includes biological-based practices, mind–body, manipulative, and traditional practices. As with the Caucasian population, women are more likely to use CAM products compared with men, and ∼36% of Hispanic women report using a CAM [32]. Quite a few studies have found medicinal herbs, teas, and traditional medicine practices to be widely used, often for digestive complaints, pain, and osteoporosis [32, 40, 41].

The traditional medicine form most practiced within the Hispanic population is curanderismo, a practice that has evolved from the melding of Central and South American indigenous beliefs, in which the natural forces of the sea, the earth, and the moon are central, and from humoralism, brought by the Spanish conquistadors. This blending has given rise to a hot and cold theory in which disease occurs as a result of an imbalance between these two humors, and specific diseases or conditions are classified accordingly, that is, as hot (caliente) or cold (frio) (Table 1.5). Treatments are similarly classified and usually have the opposite property of the disorder for which they are used in order to negate or neutralize the problem—a hot disease is thus treated with a cool or cold remedy. For example, hypertension, a hot disease, is treated using cold remedies such as lemon juice, linden tea, passion flower tea, and sapodilla tea [40].

TABLE 1.5 Examples of Hot/Cold Theory Disease Classification

HotColdConstipationArthritisDiarrheaChildbirthDiabetesCommon coldFeverIndigestion and stomachacheHypertensionMenstrual painPregnancyMuscle spasmUlcer 

1.4 THE REASONS FOR USING CAM

A number of surveys have found correlations between health and CAM use, and in fact the U.S. surveys consistently reveal prevalence of use among those who have been hospitalized in the past year. While those who use CAMs for medical purposes are usually satisfied with the allopathic medical care they receive, they often have a chronic condition or illness that is difficult to treat or manage and report seeking greater control over their health care [42–44]. Hypertension, upper respiratory infections, arthropathies and related disorders, malignancies, diabetes, depression, and lipid disorders are among the most frequently listed reported conditions leading to visits to primary care providers so it should not be surprising that these are often associated with CAM use [45–51].

In the United States, peri- and postmenopausal women (age 40–65 years) may be one of the largest groups who use CAMs for symptomatic relief. With the baby boomers well into this age range, this group now includes ∼18 million women. The Study of Women’s Health Across the Nation (SWAN) has shown that more than half of women in this period turn to a CAM to control or alleviate their symptoms [52]. Most often, nutritional remedies were used, followed by herbal remedies and folk medicine [53]. Typically, the women in this group reported a greater range of symptoms than those who did not use CAM. Importantly, the few who were surveyed had consulted their primary care provider for information, obtaining their information solely from alternative practitioners. Perhaps even more important was the finding that <50% reported having been asked about the use of herbals by their primary care providers. Black cohosh, St. John’s wort, and dong quai were the most commonly used products, and the users rated symptom relief at about 50%. This is one group that does deviate from the finding of many other studies that those who turn to CAM are relatively satisfied with allopathic care for this group tends to turn to herbals out of fear or distrust of hormone replacement therapy (HRT) [52, 53].

1.5 GROWTH OF CAM AND HERBAL USE

To understand the growth of CAM utilization by the U.S. population, consider that ∼$10 billion was estimated to have been spent on these practices in 1990, an impressive figure that increased to ∼$30 billion by 1997 [54]. Given this was during a time of public concern and focus on rising healthcare costs, it is remarkable that the U.S. population was willing to spend this amount of money out of pocket! Expenditures have continued to increase slightly as reported in the 2007 NHIS survey, which found ∼$34 billion spent toward CAM [55]. This represented 354 million visits to CAM practitioners at a cost of $11.9 billion and ∼835 million purchases of which ∼$14.8 billion went toward nonvitamin, nonmineral natural products (typically herbals) and $7.2 billion for other products. In economic terms, the dollars spent represent ∼11% of total out-of-pocket healthcare expenditures. To be fair, it is important to recognize that while these figures are staggering, they represent only a small portion of the $2.2 trillion in estimated total costs for healthcare services.

A few studies have begun to attempt to answer the question of cost-effectiveness of these practices. In one, Eisenberg et al. compared the effectiveness and cost of standard care for acute low back pain versus standard care plus the choice of acupuncture, chiropractic, or massage therapy. Patients presenting with low back pain at four study sites were randomized to two groups: those to receive “standard” care and those who had the additional choice of the aforementioned therapies. After 5 weeks of treatment, there was no difference between the two groups in terms of clinical outcome—neither group had a significant benefit in terms of reduction in symptoms and functional status. However, the group allowed to choose additional alternative therapy reported greater satisfaction with care. Although an important part of medical care, this increase in satisfaction came at an increased cost of ∼$244 per patient, with most of the added costs as out-of-pocket expenditures [56].

1.6 REGULATION OF HERBAL SUPPLEMENTS IN THE UNITED STATES

Pharmaceuticals are regulated by the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA). In contrast, the majority of herbals and supplements sold in the United States are overseen by the Center for Food Safety and Applied Nutrition of the FDA and are regulated under the 1994 Dietary Supplement Health and Education Act (DSHEA). As a result, there are a number of differences in the way supplements are regulated compared to pharmaceutical preparations.

To start, the manufacturer assumes responsibility for assuring premarket safety. The manufacturers must register with the FDA and adhere to the 2007 Current Good Manufacturing Guideline, but the actual products are neither registered with the FDA, nor do they go through any regulatory approval process as do pharmaceutical products. The FDA becomes involved when there are concerns about the product’s safety after marketing or concerns are raised about the product’s labeling, package inserts, or claims.

Under DSHEA, there are strict limitations to the claims a manufacturer of a product may make regarding its actions. In fact, the statements must be of a broad, general nature. A manufacturer may, for example, claim that taking the product helps to “maintain cardiovascular function and a healthy circulatory system,” but it cannot claim to “reduce the risk of heart disease.” While the FDA has authority for ensuring that a manufacturer’s claims fall within the laws, the Federal Trade Commission is also involved as it has oversight of advertising for all food products (including supplements). Herbals and supplements must be labeled with all ingredients, other food ingredients and additives such as preservatives or processing aids, and the net contents of the product. The labels must also provide information about the manufacturer or distributor.

Consumers and healthcare providers can report suspected adverse effects to the FDA through the MedWatch program. Many of these may also reported through the Toxic Exposure Surveillance System of the American Association of Poison Control Centers. If there is sufficient evidence, the FDA will issue an alert and/or a product recall. Since 2001, alerts have been issued regarding aristolochic acid, products containing colloidal silver, kava, and others (Table 1.6). When an adverse event is suspected, there is often the question of how can one determine the contents or have it tested. Such testing is beyond the scope of most clinical laboratories. While there is the possibility that the laboratory could test for specific compounds (undeclared drugs such as digoxin or phenytoin) or heavy metals for which the laboratory has a validated analytical method, a better solution is to contact an analytical laboratory that specializes in such testing.

TABLE 1.6 Examples of FDA Alerts and Recalls

DateAlert or Recall2001Alert regarding nephrotoxicity associated with aristolochic acid used and recall of products containing the compound2001Alert regarding hepatotoxicity associated with comfrey and removal of products from the market2001Warning regarding dietary supplement “Lipokinetix”2002Alert regarding PC SPES and SPES2001–2002Reports of hepatotoxicity associated with kava use2004Warning regarding use of Better than Formula Ultra Infant Immune Booster 1172005Alert regarding Liqiang 42007Alert regarding red yeast rice products (possible contamination with lovastatin)Recall of erectile dysfunction supplements (contain undeclared drugs: tadalafil, aminotadalafil, acetidenafil, piperadino vardenafil)2008Recall of erectile dysfunction supplements due to contamination with hydroxyhomosildenafil2008Recall of dietary supplements containing bumetanide (diuretic)2008Recall of dietary supplements containing sibutramine (appetite suppressant)2009Recall of steroid-containing bodybuilding supplements2009Advisory to consumers and healthcare professionals that products containing colloid silver may cause discoloration of skin and mucous membranes

1.7 REGULATIONS OUTSIDE THE UNITED STATES

Some have criticized the regulatory system and suggested the United States turn to a more rigid process similar to those of other countries. Most of the member countries of the European Union consider herbals to be medicinal products and regulate them accordingly under the 2004 Traditional Herbal Medicine Directive. Any plant, a part of a plant, or a plant-based preparation for which there is a therapeutic claim is considered a medicinal product and must go through an approval process before being marketed. Exceptions are made for products compounded by an herbalist for an individual. The classification of some herbs is a bit complex and they may fall under different criteria depending on the specific use or claim—for example, senna can be classified as either a food or a medicinal.

Manufacturers must show traditional use for at least 30 years with 15 years of traditional use within the EU. Evidence of traditional use includes bibliographic or expert evidence of use including authoritative manuscripts, expert testimony, and records of products in use. The products can be administered only by mouth, require no physician supervision, and the marketed use must be consistent with tradition or supporting data. The packaging must include a warning to seek medical attention should the symptoms persist or if unexpected symptoms develop. Imported products are usually treated as new “chemical entities.” The manufacturer or distributor must present proof of quality, safety, and efficacy as part of the review process.

In Australia, where more than 50% of the population reports using herbals or complementary medicines, herbals are regulated by the Australian Therapeutic Goods Administration (TGA) as medicines under the Therapeutic Goods Act 1989. Complementary medicines include herbals, vitamins and minerals, nutritional supplements, homeopathic medicines, and traditional medicines (Australian indigenous medicines, Ayurvedic medicine, Chinese medicines, etc.). The TGA uses a risk-based premarket assessment that includes evaluation of the toxicity of the ingredients, dosage form, indications for use, and potential adverse side effects, and from this assessment, products are classified as listed (low risk) or as registered (higher risk). Listed medicines are restricted to indications for health enhancement or for nonserious, self-limiting conditions and claims relating to health maintenance. They cannot indicate they are to be used for treatment or prevention. Registered medicines must undergo evaluation for quality, safety, and efficacy. All products are produced under the same code of good manufacturing practice adhered to by pharmaceutical manufacturers, and postmarket surveillance is similar to any other drug.

1.8 RESOURCES

Obtaining reliable information about herbals and other forms of CAM is challenging. The tendency is to simply conduct Internet searches using one’s favorite search engine. This approach will bring a plethora of sites of mixed reliability. Table 1.7 provides a listing of several sites that may be useful. The information found on these databases is regularly updated and assessed using systematic, evidenced-based approaches. The sites also provide excellent resources for reported drug interactions, toxicities, and interferences with laboratory tests. The reader may also find the translations of the German Commission E monographs to be quite useful.

TABLE 1.7 Useful Resources

National Center for Complementary and Alternative Medicinehttp://www.nccam.nih.gov/Food and Drug Administrationhttp://www.fda.gov/http://www.fda.gov/Food/DietarySupplements/default.htmCenters for Disease Controlhttp://www.cdc.gov/Natural Medicines Comprehensive Databasehttp://www.naturaldatabase.com/Cochrane Collaborationhttp://www.cochrane.org/National Health Statistics Reportshttp://www.cdc.gov/nchs/index.htmAmerican Botanical Council (translations of German Commission E monographs available)http://abc.herbalgram.org/

1.9 CONCLUSIONS

CAMs are widely used within the United States with between 23% and 75% of the American population reporting use of such a practice within the previous year. Most individuals report using CAM as a means of improving health or preventing illness. CAMs are used by all populations and ethnicities and across all ages, though the type of CAM favored varies.

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2

RELATIVELY SAFE HERBAL REMEDIES

Angela M. Ferguson and Uttam Garg

Children’s Mercy Hospitals and Clinics, University of Missouri-Kansas City School of Medicine, Kansas City, MO

2.1 INTRODUCTION

An herb can be defined as any part of a plant or a plant product, including leaves, stems, flowers, roots, and seeds [1]. Herbs and herbal extracts have been used for thousands of years in all parts of the world to treat various ailments, and the use of complementary and alternative medicine (CAM), which includes the use of herbal remedies, has been on the rise in the United States in recent years. The U.S. Department of Health and Human Services reported that in 2007, almost 4 out of every 10 adults had used one type of CAM or another, with nonvitamin, nonmineral, natural products being the most common therapy used (17.7%) [2]. The report also stated that if patients were worried about the cost of a conventional treatment, they were more likely to use CAM. This is because herbal remedies are usually much less expensive than traditional pharmaceuticals and can be purchased over the counter without a prescription.

Herbal products are considered dietary supplements and are regulated by the Dietary Supplement Health and Education Act of 1994 [3]. As such, manufacturers of herbal products do not have to submit safety data to the Food and Drug Administration (FDA), and in order to pull a product off the market, the FDA is required to prove that it is unsafe [1]. This is quite different from the process in Europe, where most countries require approval of herbal products before they are made available to the public. With the use of herbal remedies on the rise, there is a surprising lack of evidence of clinical efficacy and safety of these supplements in treating various health conditions. The majority of the literature on the physiological effects of different herbs and their active constituents is focused on basic research using in vitro and animal models of disease. Confusing the issue of efficacy further is the fact that the clinical trials that have been conducted often have inconsistent results. There are many reasons for this, including the lack of standardization in the different brands and preparations of the herbal remedies, the amounts of the herb used in each study, the size of the population in the study, and the outcomes measured in each study. Basic differences make it difficult to compare studies and to conduct powerful meta-analyses. Some of the trials assessing efficacy also examine the safety of the herbal remedy, but often the treatment period is short and does not provide information on adverse events after long-term usage. This is important because most of the public assumes that herbal remedies are safer than traditional pharmaceuticals because they are natural [4].

As the popularity of herbal remedies increases, there is an increased need for more well-controlled clinical studies examining both the efficacy and safety of these preparations. This chapter discusses several popular herbal remedies that are generally assumed to be safe and effective. Table 2.1 lists all of the herbal remedies included in the chapter along with the disorders they are used to treat.

TABLE 2.1 Herbal Treatments Classified by Symptom or Disease

Symptom/DiseaseHerbReferencesAtherosclerosis/hypercholesterolemiaGarlic Fenugreek Soy[22a, 23] [16] [74]Benign prostatic hypertrophySaw palmetto[63–67, 69, 90]CancerGinseng Turmeric Soy[48, 49] [86, 91] [73]Cognitive functionGinkgo[38–40]Cold prevention and treatmentEchinacea[8–11]DepressionSt. John’s wort[75–80]Diabetes/hyperglycemiaGinseng Fenugreek[50] [14–16]Erectile dysfunctionGinseng[51]Heart failureHawthorn[54–57]HypertensionHawthorn Garlic[53, 58] [24, 25]InflammationTurmeric[81–85]InsomniaValerian[87–89]LactationFenugreek[12]Liver diseaseMilk thistle[59–62]Menopause symptomsSoy[70–72]Migraine headacheFeverfew[17–20]Nausea/vomitingGinger[31–36]Platelet functionGinseng Garlic Ginkgo Saw palmetto St. John’s wort[26] [26, 92] [26] [26] [26]TinnitusGinkgo[41, 42]Urinary tract infectionCranberry[5–7]VascularGinkgo[43, 44]

2.2 CRANBERRY

Cranberry (Vaccinium macrocarpon) is the red berry fruit from a small evergreen shrub in the Ericaceae family [5]. Cranberries contain a high percentage of water (88%) along with vitamin C, organic acids, flavonoids, anthocyanidins, catechins, and triterpinoids, with anthocyanidins thought to be the active constituent. For therapeutic use, cranberry can be ingested as whole berries, gelatinized products, juices, or capsules [5]. Cranberry has long been recommended for the prevention of urinary tract infections (UTIs), and many studies have found clinical evidence to support this. The hypothesized mechanism for the prevention of UTIs is that cranberries prevent bacteria from adhering to cells and from infecting them [6]. Most of the published studies focus on the use of cranberry in the prevention rather than the treatment of UTIs. One advantage that a natural treatment, such as cranberry, has over the extended use of antibiotics is the absence of antibiotic resistance or superinfection with another organism due to the reduction in the body’s natural flora.

A systematic review looked at the efficacy of cranberry compared to placebo and other treatments in the prevention of UTIs in susceptible populations [6]. Ten studies containing 1049 patients were included, and subjects were given cranberry juice or another type of cranberry product or placebo for at least 1 month. A meta-analysis of four of these studies showed that cranberry products significantly reduced the incidence of UTIs at 12 months when compared to placebo. Out of the five studies not included in the meta-analysis, only one showed a significant result between cranberry and placebo in the reduction of UTIs. The conclusion of the reviewers is that there is some evidence that cranberry is effective in preventing UTIs in some groups, with most significant results coming from studies of women with recurrent infections.

Another review suggests that cranberry should not be recommended for prophylaxis of recurrent UTIs due to the modest effect of cranberry products (35% reduction in recurrence rates of infection over 1 year) and the heterogeneity of the studies that have been conducted [5]. These studies also had quite a high dropout rate, with the reasons for discontinuing cranberry products including gastrointestinal issues, weight gain, and some cranberry–drug inter­actions, which could prove problematic for long-term prophylactic use [5, 6].