Safety, efficacy and use of herbal

in clinical settings

Jarir At Thobari, MD, MSc, DPharm, PhD

Department of Pharmacology & Therapy
Faculty of Medicine, Universitas Gadjah Mada (UGM)
Yogyakarta, Indonesia
Conservation International (CI) considers Indonesia to be one of 17 “mega-
diversity” countries -- with two of the world’s 25 “hotspots. Although
Indonesia covers only 1.3 percent of the earth’s land surface, it includes:

10 % of world’s 25 % of world’s fish

flowering plant species species

12 % of world’s
mammals species 17 % of world’s
bird species
16 % of world’s reptile and
amphibian species
2
 INDONESIA BIODIVERSITY

Indonesia is a mega center of biodiversity in the world’s with

largest tropical plants and marine biota

40,000 Tropical plants Research and developement

7500 potential efficacious for medicine for health and economic
90 % Asia drug plant are available in improvement
Indonesia Maintaining sustainalibity

http://www.parekraf.go.id/ (Ministry of Tourism, Republic Indonesia)

3
TRADITIONAL MEDICINE IN INDONESIA
 The use of traditional medicines in
Indonesia is part of national
cultivation and has begun from
centuries ago
 Relief Karmawibhangga
Drink Jamu Borobudur Temple
 Jamu (Jampi): Javanese Language,
can be found on ancient
manuscripts, Ghatotkacasraya
(Mpu Panuluh)
 Other ancient manuscript: Serat
Centhini (1814), Serat Kawruh
Chapter Jampi-Jampi Jawi (1831)
www.who.searo.int/ (Traditional Medicine in Republic Indonesia)
4
 TRADITIONAL MEDICINE IN INDONESIA
 Script of Indonesia herbs (colonial time)
 Historia Naturalist et Medica Indiae (Yacobus Bontius, 1627)
 Herbarium Amboinense (Gregorius Rhumpius)
 Het Javaansche Receptenboek (Javanese Treatment Receipt Book)
(Van Hien, 1872)
 Indische Planten en Haar Geneeskracht (Native plants and its healing
power) (Kloppenburg-Versteegh, 1907)
 De Nuttige Planten van Indonesie (K. Keyne, 1913)
 Heilkunde und Volkstum auf Bali (W. Weck, 1937)

www.who.searo.int/ (Traditional Medicine in Republic Indonesia)

5
HERBAL MEDICINE IN INDONESIA

6
 COSMETICS & SPA
FROM TRADITIONAL HERBAL INDONESIA

Communication on Progress PT. Martina Berto 2010 7

 THE USE OF SPICES & HERBS
IN INDONESIA

1. Spice Seasoning 3. Fruit

• Lempuyang (Zingiber Oronaticum)
• Temu Lawak/ Wild Ginger (Curcuma
Cautkeridza)
• Kunyit/ Tumeric (Curcuma Domestica)
• Kencur/ Greater Galingale (Kaemferi Galanga)
• Lengkuas/ Ginger Plant (Elpina Galanga)
• Bengle (Zingiber Bevifalium)
• Jahe (Zingiber Officinale)
• Ceplukan (Physalic Angulata Him)
• Nyamplung (Calophylum Inaphyllu)
• Jeruk Nipis/ Calamondin (Citrae
Aurantifalia Sivingle)
4. Bark
• Kayu Manis/ Cinamon (Gijeyzahyza
Glabra)

2. Foliage (leaves) 5. Flower

• Secang (Caesalpinia Sappan Hinn) • Melati/ Yasmin (Jataninum Sunbac
• Sambang Dara (Rexco Ecaria Bicolar Hassk) Ait)
• Brotowali (Tiospora Rumpii Boerl) • Rumput Alang-alang (Gramineae)
• Adas (Foeniculum Vulgare Mill)

Tradtional Medicines in Indonesia – National Agency for Food and Drug Control (NAFDC)
8
 THE USE OF SPICES & HERBS IN INDONESIA
50 45.17
40.71
40 % age group (15 years old
or above
30
20
9.76
10 4.36
0 60 55.16
Everyday Sometime Rare Never
50 43.99
40
30
20.43
20
11.58
10
Type of
preparation 0

Capsule/tablet Powder Decoction Liquid

Basic Health Research; 2010 (Ministry of Health, Republic Indonesia) 9

 CLASSIFICATION OF INDONESIAN
TRADIITONAL HERBAL MEDICINES

Indonesian Indigenous Standardized of Standardized of

Herbal Medicines Indonesian Herbal Indonesian Herbal
(empirical based herbal Medicines (scientific Medicines (clinical
medicine) based herbal medicine) based herbal medicine)

Tradtional Medicines in Indonesia – National Agency for Food and Drug Control (NAFDC)
10
 Types of Indonesian Traditional Medicine

Jamu Standardized Herbal

Jamu Gendong Phytopharmaca
Medicine

Based on Based on Based on Based on

empirical used empirical used preclinical study clinical study

> 10.000 prep. ± 10.000 prep. 16 prep. 8 prep.

Not regristed Regristed by National Agency for Drug and Food Control
 INTEGRATION OF TRADITIONAL MEDICINES
INTO THE HEALTH CARE

HEALTH CARE PROVIDERS TRADITIONAL MEDICINES

Evidence on Quality, Safety

PERCEPTION & WILLINGNESS & Benefit (efficacy)

12
STRATEGIC ISSUES

QualitySafety

Efficacy
STRATEGIC ALLIANCES
INTER UNIVERSITIES

13
Conventional pharmaceutical Suggested models for Traditional
development Herbal Research
Screening of chemical substances Biological mechanism

Component efficacy
Biological mechanisms
Comparative effectiveness
Phase I CT
Safety status
Phase II CT
Context, paradigms, philosophical
Phase III CT understanding, and utilization

Clinical Practice/Community
Clinical Practice

14
 Translation Research

Scientific Routine Public

Discovery
Human Clinical
T1 T2 T3 Use in T4 Health
Use Use
(T0) Practice Benefit

Backward Translation
Does something need to be clarified? The continuum could also start from any part of the process.
(e.g. A rare yet fatal adverse event occurred.)

(Woolf, 2008; Laan and Boenink, 2015; Westfall, Mold, and Fagnan, 2007; Khoury, et al., 2007, Hoehn and Abbot, 2015, Vanniasinkam and Tsui,
2012)
USE OF TRADITIONAL HERBAL & RESEARCH AREA

NADFC

Jamu as medicine
Ministry of
Trading
Phyto Pharmaca
MoH
JAMU as drink
Standardized herbal or snack
Minsitry of JAMU as NADFC
medicine
Tourism Complimentary &
Alternative Jamu as JAMU as
Jamu as SPA Jamu MedicineAM Suplemen cosmetics

SIMPLISIA (NADFC)
HERBAL RAW MATERIAL (MINISTRY OF AGRICULTURE)

WHO ARE DOING RESEARCH?

UNIVERSITIES & HOSPITALS, INDONESIA ACADEMIC OF SCIENCE, PRIVATE RESEARCH
INSTITUTES, MOH, MINISTRY OF AGRICULTURE, ETC

16
 TRACK OF HERBAL R&D
Medicinal plant

(1) Active
drug Health Services
ingredient

Complementary medicine

(2) Jamu Jamu Scientification

(MD) Evidence based jamu

Ethomedicine study

(3)
Jamu Traditional health services
(non-MD)
17
Elfahmia, Herman J. Woerdenbagb, Oliver Kayserc. Jamu: Indonesian traditional herbal medicine towards rational phytopharmacological use. Journal of Herbal Medicine, 2014: 4; 51-73
18
STANDARD HERBAL QUALITY IN INDONESIA
 Indonesia Herbal Pharmacopeia
 70 monograph (37 simplisia & 33 extract)
 Pharmacopeia Herbal Indonesia Suplement I
 55 monograph (26 simplisia & 29 extract)
 Material Medica Indonesia I s/d VI,
 244 monograph for medicinal plants
 Standard of Exctract
 35 monograph
 GMP
 all aspects of production such as raw material, production process, quality control,
factory building, workers, management, instrumentation, and sanitation

19
 Research on Traditional Medicine in
Indonesia Universities
 Research on traditional medicines of some tribes, which
includes original formulation, usage, preparation,
activities:
 Research on standardization of plant materials,
determination of chemical constituents, bioactivity tests,
toxicity tests, pre-clinical and clinical tests
 Collaboration between research institutions and
industrial sectors for product development

20
5 MAIN TYPES OF CAM
 Alternative medical systems
 Homeopathy, Naturopathy
 Mind-body interventions
 hypnosis, imagery, support groups
 Biologically-based treatments
 Herbal, dietary treatment,
 Manipulative and body-based methods
 chiropractic, acupressure, osteopathy
 Energy therapies
 magnets, therapeutic touch
Global Use of Alternative or
Traditional Medicines

33%
25-50% 15% 40%
25% >90% >80%
50-75%
75% 60-70%
60%
>80%
40% ~60%
40-70% 60-80%
55%
>80% ~50%
70%

WWW.WHO.org
Herbal/traditional growth

% y-o-y growth
• >10%
• 6% to 10% Key Point: Contrasts in growth
• 2% to 5% Growth in developed economies remains weak or flat as
• 0% to 1% regulation increases.
• < 0% In contrast, in populous countries in developing regions
growth derives from increasing recognition and presence
of packaged options.
THE USE OF HERBS
 14% percent of the population takes at
least 1 herbal/supplement each week*
 16% of prescription drug users also use
1+herbal/supplement
 $17.8 BILLION on dietary supplements
 $4.2 Billion for Herbal products**

*JAMA Jan 16, 2002 **NEJM Dec 19, 2002

YET - only 38% told their doctor

THE USE OF HERBS
 14% percent of the population takes at
least 1 herbal/supplement each week*
 16% of prescription drug users also use
1+herbal/supplement
 $17.8 BILLION on dietary supplements
 $4.2 Billion for Herbal products**

*JAMA Jan 16, 2002 **NEJM Dec 19, 2002

YET - only 38% told their doctor

 The medicinal properties of popular herbs and plants

Digestive Health Cardiovascular Health Immune System Men’s Health Women’s Health

Ginger Garlic Ginseng Saw Palmetto Horse Chestnut

Fibre Red Yeast Rice Morinda (Noni) Dong Quai Calendula

Milk Thistle Centella Asiatica Rose Hip Yohimbe Cranberry

Senna Witch Hazel Astragalus Horny Goat Weed Red Clover

Mental Health Skin Health Analgesic Calming and Soothing Respiratory Health

Ginkgo Biloba Tea Tree Oil Devil’s Claw Valerian Peppermint

St John’s Wort Aloe Vera Feverfew Passionflower Echinacea

Evening Primrose
Ashwagandha Capsaicin Lavender Eucalyptus
Oil

Schizandra Neem Opiates Kava Lemon

WHY DO PEOPLE TAKE HERBS?

• 60% of US physicians recommended

CAM at least once

• 47% of physicians reported using

alternative therapies themselves
PROBLEMS OF HERBAL

Many ‘drugs’ came from plants. So, why

shouldn’t there be potential for
efficacy of herbs?

Herbs have pharmacological properties

including side effects & interactions

Suggestive evidence exists on efficacy

PROBLEMS OF HERBAL

 WHO 65%-80% of the world's population use

traditional medicine as their primary form of
health care.
 dominant in developing countries, increasing
in developed countries
 safety and efficacy are an important issue for
the health professions.
 Potential adverse drug reactions (ADRs).
PROBLEMS: REGULATORY ISSUE
 1906 Food and Drug Act - Accurate labeling, purity
required
 1962 Kefauver-Harris Amendment - ‘Safe &
Effective’ required
 1994 Dietary Supplement Health and Education
Act
 FDA lost authority over Herbs, Vitamins unless proven to
be unsafe
 Became ‘Nutritionals’
PROBLEMS: REGULATORY ISSUE

 Unmonitored, uncontrolled, non-uniform

products
 No standards of bioequivalence between
brands, or between lots
 Ingredients not required to be completely listed
 Producers do not need to prove safety or
efficacy
 Adulteration has commonly been described
PROBLEMS WITH HERBAL MEDICINE
Many touted for prevention -
hard to evaluate

Placebo effect is strong

Quality of science varies

Much of the research is

not in English
CLASSIFICATION ADE
 Intrinsic effects
 Intrinsic effects are those of the herb itself and are
characterized, as for pharmaceuticals
 type A (predictable, dose dependent)
 type B (unpredictable, idiosyncratic) reactions
 overdose or accidental poisoning and interactions
with pharmaceuticals.
CLASSIFICATION ADE
• Extrinsic effects
• Manufacture or extemporaneous compounding.
• Good Manufacturing Practice

Misidentification Lack of standardization

Contamination Substitution

Incorret dosage/preparation Adulteration

Inappropriate labelling/adv
SUBSTITUTION

 A report of nine cases of rapidly progressive

interstitial nephritis in young women taking a
Belgian slimming treatment
 Aristolochia fangchi, containing the nephrotoxic
component aristolochic acid
 Eighty cases have now been identified and more
than half of these patients developed terminal renal
failure
SUBSTITUTION

 Early 90s: renal damage in more than seventy Belgian

users of a slimming drug  35 renal transplant
patients
 Chinese herbs Stephania tetrandra en Magnolia officinalis
were declared on packaging
 An analysis of the suspected agent showed that the
root of Stephania tetrandra (Chinese name Fangji)
was substitute with the root of Aristolochia fangchi
(Chinese name Guang fangji)
 ADULTERATION

 Product contains/mix with chemical drugs

 Unethical herbal compund
 Mefenamic acid and diazepam
 acute interstitial nephritis, reversible renal failure, loss of
blood pressure control and peptic ulceration
 a Chinese herbalist was prosecuted for adding a steroid
cream to a herbal preparation, which produced severe
facial erythema in a patient
PREPARATION AND LABELLING

 The processing of crude plant material carried

out by a manufacturer, practitioner or the patient
is a major determinant of the pharmacological
activity of the finished product.
 The alkaloid composition and plant's toxicity
 Products claim a certain unproven effect
Factor affecting integration herbal medicine
into modern medical practices

 Quality issue
 Good manufacturing practice (GMP)
 Chemical constituents, bioavailability,
mechanism action
 Interaction (herb-drug or herb-herb)
 Efficacy measurement
 Safety issue
Governmental Regulation of Herbal Supplements and Pharmaceuticals

http://www.nature.com/nrd/journal/v2/n1/images/nrd990-f1.gif
International Regulation of Herbal Supplements
 The European Union (EU) requires that dietary
supplements be DEMONSTRATED to be safe in
quantity and quality. And, ONLY those supplements
that are proven to be safe may be sold without a
prescription. This makes obtaining dietary supplements
much more difficult and controversy from consumers
has arisen. Several petitions have been signed to change
this law process.

 In Russia, Dietary Supplements are defined as

“Biologically Active Dietary Supplements” (BADS).
BADSs are “foodstuffs with clinically proven
effectiveness. [They are] recommended prophylactically
and included into a complex therapy for the prevention
of pharmaceutical therapy’s side effects and for the
achievement of complete remission.” The focus in
Russia is based more on preventive medicine for
chronic disease rather than as a daily part of a person’s
regimen.

 In China, PRIOR TO MARKET ENTRY, manufactures

must register dietary supplements with the SFDA-
China’s equivalent to our FDA. These registrations are
valid for 5 years and then must be renewed. This
process involves a “strict testing protocol, including
ANIMAL AND HUMAN STUDIES” in comparison to
the U.S. process for pharmaceutical approval. 19
 GINGER ROOT
 Traditional use: stimulant, diuretic, antiemetic,
dyspepsia, prevention of motion sickness
 Evidence: RCTs
 > placebo in postop nausea, similar to metoclopramide
 > placebo in seasickness

 Safety:
 low toxicity; no side effects;
 platelet changes;
 not recommended during pregnancy
 HORSE CHESTNUT SEED EXCTRACT
 Traditional use: arthritis/rheumatism; congestion (leaves)
 Evidence: Numerous RCTs, systematic review
 superior to placebo, reduced edema, leg circumference;
 better compliance than compression hose;
 improved pain, fatigue, itching, leg tension (observational)
 Safety:
 No Contraindications; mild and
 rare adverse effect
 (occais. pruritis, nausea, GI c/o);
 no restrictions in pregnancy;
 whole seed is toxic.
 VALERIAN ROOT

 Traditional use: sedatives, insomnia,

Restlessness, sleeping disorders based
on nervous conditions
 Evidence: RCTs
 Improvement in sleep latency, quality
 REM maintained
 Releases GABA in brain; weak affinity for
benzodiaz. receptors
 Safety:
 No known side effects, interactions,
contraindications, non addictive
 BLACK COHOSH

 May relieve menopausal symptoms

(mood, flushes, sleep)
 No evidence of other protection
benefits of estrogen
 Safe –
 no drug-herb interactions
 Possible interaction with tamoxifen
Black Cohosh (Cimicifuga racemosa)

 It was used by Native American Women in the Cherokee

tribe to stimulate breast milk after childbirth and for other
menstruation problems

 Uses:
 Diarrhea, Fluid retention, Inflammation, and
Menopause symptoms13-14

 Interactions:
 Anti-hypertensive drugs

 Common Dosage:
 8-2400 mg daily

 Side Effects:
 Nausea or vomiting, symptoms of low blood pressure
(dizziness), nerve irritability and headache. If taken in
high doses may cause miscarriage13-14
 FEVERFEW
 Prevention of migraines
 Cochrane review, 2003:
 3 of 4 trial suggest beneficial effect;
 1 showed no difference vs.. placebo
 Conclusion: Suggestive, but efficacy not established beyond a doubt
 Avoid:
 In pregnancy,
 W/antiplatelet agents
 ECHINACEA
 Wide variability in products,
adulteration
 Positive and negative results have
been reported:
 Poor evidence for prevention of URI’s,
flu (no proven evidence)
 Possible mild decrease in
length/severity
 Appears generally safe
 Avoid in HIV, immuno-
compromised pts, longer then 8-10
weeks
Echinacea & Preventing URIs:
The Evidence
 Cochrane review, updated 2007
 3 RCTs—none found any benefit over placebo
 2008 RCT, double blinded
 90 healthy adults treated bid x 8 wk
 No difference in # sick days/person
 No difference in adverse effects

C
GARLIC
 Evidences:
 Insufficient data on clinical CV outcomes (claudication and MI)
 Possible small, positive, short-term effects on lipids
 Inconsistent reductions in blood pressure
 Promising but inconclusive on antithrombotic activity.
 Use < 3 to 5 years not associated with decreased risks of breast,
lung, gastric, colon, or rectal cancer.
 Cautions:
 Problems with standardization
 Watch in combination with anti-platelet agents
 Garlic & URI prevention
 Cochrane review, updated  Safety
2009  Safe, well tolerated
 Only 1 dbl blind RCT  Avoid before surgery given
 146 adults took garlic daily vs. potential bleeding risk
placebo x 3 months  Not proven to affect glucose
 Fewer total URIs, no
difference in duration of
illness if sick

C
Garlic (Allium sativum)
 Uses:
 Asthma, athlete’s foot, bacterial infections,
constipation, diabetes, fungal infections, heavy-metal
poisoning, hypertension, hyperlipidemia (high
cholesterol), wounds

 Interactions:
 Antiplatelet drugs (Persantine) and blood thinners
(warfarin) 13-14

 Common Dosage:
 600-900mg daily or up to 4 grams of fresh garlic
daily13-14

 Side Effects:
 Dizziness, nausea, skin rash, sweating, vomitting13

 “highly-publicized” studies found garlic ineffective at

lowering cholesterol12

 Is found to be safe by the FDA13

Ginko (Ginkgo biloba)
 May be the most popular herbal in the world as it comes
specifically as a standardized extract world-wide

 Uses:
 Asthma, blood vessel disease, dementia, inner-ear
disorders, improving brain function, impotence
treatment, poor memory, premenstrual syndrome,
macular degeneration, Alzheimer's (via increased
mental alertness)

 Interactions:
 Blood thinners like Coumadin and Aspirin

 Common Dosage:
 120-240mg daily

 Side Effects:
 Digestive upset (diarrhea, gas, nausea), headache,
seizures, skin irriation, unusual bleeding or bruising
 GINSENG
 Use: For fortification; fatigue; improve capacity
for work, concentration; colds and flu; diabetes;
immune support; herpes; general well being;
stress; male sexual function; sports performance
 COCHRANE (2003): “efficacy is not established
for any outcomes”
 Concerns:
 Adulteration is common
 Expensive
 Anti-platelet properties
 Insomnia, diarrhea, vaginal bleeding, SJ syndr
St. John’s Wort (Hypericum perforatum)

 Most scientifically studied herbal supplement

on the market over the last 20 years
 Uses:
 Anxiety, Bed-wetting, Bronchial inflammation, Burns,
Cancer, Depression, Hemorrhoids, Insect bites,
Insomnia, Kidney disease, Scabies, Digestive issues,
Wound healing
 Interactions:
 Allergy medications, alcohol, amphetamines,
antidepressants called MAOIs and tricyclics,Desyrel®,
and oral contraceptives/pregnancy
 Sunlight alters efficacy
 Common Dosage:
“Milton had an interesting side effect from
Taking St. John’s Wort”  100-500mg by mouth three times daily
 Side Effects:
 Allergic reactions, constipation, dizziness, dry mouth
, restlessness, sensitivity to sunlight, stomach upset,
sleep disturbances13,14
 TURMERIC
Anti-inflammatory Evidence grade B1
Dyspepsia Evidence grade B1
Billiary dyskinesia Evidence grade B2
Gallstone prevention Evidence grade B2
Osteoarthritis Evidence grade B2
HIV Evidence grade B2
Peptic ulcers Evidence grade C
Rheumatid arthritis Evidence grade C
Uveitis Evidence grade C
Cancer prevention Evidence grade D
Hyperlipidemia Evidence grade D
SJW & Depression:
The Evidence
 Cochrane review, updated 2008
B
 18 RCTs SJW vs. placebo in pts with major depression
 Heterogeneity of results, beneficial effect
 Large studies RR for response: 1.28
 Smaller studies RR 1.87
 (also 17 RCTs vs. other anti-depressants finding
equivalency in efficacy but more side
effects/withdrawals in Rx group)
 2010 RCT adults w/ depression & atypical
features
 Benefit in validated depression scores vs. placebo

Dose: 300mg tid

Omega-3 & Depression:
The Evidence
 No Cochrane reviews
 Pubmed search 2010 meta-analysis
 Included 35 RCTs
 Pooled data showed benefit for those w/ depression
 (No benefit if non-depressed pts)
 Concerns: heterogeneous, probable publication bias

 3 RCTs
 varying pop: childhood bipolar, women w/ psych distress, preventing peri-
partum depression
 Mixed results

C +
 Omega-3s & Safety
 Generally safe in doses up to 3g/day
 No significant harms id’d in literature
 Theoretical harm of very high dosing increasing
bleeding risk
 Greater concern of contaminants if consumed in fish
products (mercury poisoning etc)
 Tolerability
 Fish burps! Can be managed by freezing capsules
 Cranberries and UTI prevention:
The Evidence
 Cochrane review, updated 2008
 10 RCTs, 1049 patients
 Significant reduction in UTIs, RR 0.65
 Specifically effective in women w/ recurrent UTIs
 3 further placebo controlled RCTs for prevention
 Children, spinal cord injury, older women
 All showed benefit

Dose: 3-16 oz cranberry juice

cocktail bid
B-
 Cranberries and UTI treatment:
The Evidence
 Cochrane review, updated 2008
 NO RCTs exist addressing cranberry products
as treatment for UTI

C
Bitter Orange & Weight loss
 Citrus aurantium
 synephrine
 Chemical composition similar
to ephedra/phenylephrine
 Extracts now used in place of
ephedra in weight loss
supplements since ephedra off
the market
Bitter Orange & Weight Loss:
The Evidence
 No Cochrane Reviews
 A 2004 meta-analysis
 1 study of 20 people x 6 wks, no benefit
 did not address safety
 Additional RCT of 8 people
 No benefit

C
Creatine & Muscle building
 Supplement, not actually
an herbal
 Touted as building muscles,
increasing strength
 Anecdotally, used by many
male college students, esp
those who lift weights
Creatine & Muscle Building:
The evidence
 No cochrane reviews or meta-analyses
 Multiple RCTs
 Heterogeneous populations, dosing, duration, outcome
measurements
 Gestalt: the majority--but not consistently-- show some
favorable outcomes

A A-
Creatine & Safety
 Concern: harm to kidney
 Those w/ renal disease advised to not use this supplement
 Actual harm not born out in literature
 Encourage good hydration if using
 Large quantities over long-term use formaldehyde
LEVEL OF EVIDENCE
NO EVIDENCE YET
 Cochrane Review :
 No firm evidence of efficacy for any medicinal
herbs for Hepatitis C infection
 Some herbs may work in Chronic Hep B, but
evidence is too weak to recommend any
HERBS-DRUGS INTERACTION

• Garlic
• Ginger
• Ginko  Aspirin
 Warfarin
• Ginseng
• Feverfew
• Clove oil
Phyllanthus sp. (Stimuno) for Hepatitis B – none
of meta analysis proved its efficacy

 Cochrane Review - Phyllanthus species for

chronic hepatitis B virus infection
 Cochrane Review - Chinese medicinal herbs for
asymptomatic carriers of hepatitis B virus
infection
 Cochrane Review - Chinese medicinal herbs for
chronic hepatitis B
PRACTICE POINTS

 Ask every patient about herbs and

supplements
 Address
 “natural doe not mean safe”
 “If it sounds too good to be true, it probably is…”
 Avoid preparations with >1 herb
 Avoid switching brands frequently
 Buy packaged products with
 name/address of manufacturer, batch/lot number
common and scientific name, standardization when
possible dosing guidelines, side effects
 Herbal/traditional products SWOT analysis
Strengthne Weakne
ss ss
• Industry • Consumers • Industry • Consumers
• Questionable products • Consumers are paying • Only a few products can • Contaminated and
still exist in the more attention to novel rightfully claim health tainted herbal/traditional
marketplace. The “safe and natural” benefits backed by products lead to mistrust
industry is working to options as they become scientific evidence. that can affect future
denounce illegal or more proactive in their • Reliable information purchases.
unethical producers and health. about the interactions of • Consumer watchdog
remove deceiving • The fear of “toxic” herbal/ traditional groups and members of
products from reaching conventional drugs products and the medical community
consumers. pushes some people to conventional drugs is are applying pressure to
• Many companies are try herbal/traditional very limited or non- inform the public on the
introducing a wider array products. existent. dangers of “quack” or
of products for different “fake” remedies tied to
consumer segments. herbal/traditional
remedies.
Opportunities Threat
Industry Consumers • Industry • Consumers
• International • Consumers may be • Stricter regulation on • Competitive pressure
programmes are willing to adopt healthy good manufacturing and heavy advertising
recognising and lifestyles and increase practice (GMP). can lure consumers
supporting the use of their expenditure on • Increasing pressure to back to conventional
herbal/traditional herbal/ traditional provide scientific drugs.
products. products as the evidence that supports • The risk of negative
• Traditional and economy improves. quality, safety and interactions with
Complementary • Digital media can create efficacy. prescription drugs in
Alternative Medicine positive awareness ageing populations may
(CAM) are becoming about alternative slow growth in sales.
more common as treatments.
treatments.
 Resource Evaluation
 Introduction
 Who runs this site?
 Who pays for the site?
 What is the purpose of the site?
 Where does the information come from?
 What is the basis of the information?
 How is the information selected?
 How current is the information?
 How does the site choose links to other sites?
 What information about you does the site collect, and why?
 How does the site manage interactions with visitors?
A Guide for Providers Using CAM
Government sites

 National Center for CAM:

http://nccam.nih.gov/
 Office of Dietary Supplements:
http://ods.od.nih.gov/Research/CARDS_Database.aspx
 MedWatch:
http://www.fda.gov/medwatch
 CAM on PubMed:
http://www.nih.gov/news/pr/feb2001/nccam-05a.html
NCCAM Website
 Acupuncture  Introduction to Naturopathy
Arthritis  New Herbs at a Glance: Grape Seed
Black Cohosh Extract
Cancer
Chelation  AARP/NCCAM Report on Older
Chiropractic Americans
Chondroitin  Past Highlights
Depression
Dietary Supplements

 Echinacea
Ephedra  News from NCCAM:
Ginkgo  Subscribe to quarterly newsletter
Ginseng
Glucosamine  Monthly e-bulletin
Herbs at a Glance
Homeopathy
Menopause
St. John's Wort
 A Guide for Providers Using CAM
Academic sites
 Boston-Longwood Herbal Task Force:
 http://www.longwoodherbal.org/
University of Pittsburgh:
http://www.pitt.edu/~cbw/database.html
 Beth Israel Medical Center NYC:
http://www.healthandhealingny.org/
 Columbia University:
http://www.rosenthal.hs.columbia.edu/Botanicals.html
 University of California, Berkeley Newsletter:
http://www.wellnessletter.com/html/ds/dsSupplements.php
 Courses and Websites
 Herbs and Dietary Supplements-Wake Forest University
http://northwestahec.wfubmc.edu/learn/herbs/index.asp#CurrDesc
 Botanicals and Health series-University of Arizona
http://integrativemedicine.arizona.edu/online_courses/#botanicals
 Botanical Medicine in Modern Clinical Practice (NYC)
http://cait.cpmc.columbia.edu:88/dept/rosenthal/Botanicals_CME.html
 Consumer Labs
http://www.consumerlab.com
 Natural Medicines Comprehensive Database
http://www.therapeuticresearch.net/(ctt54155qny2vs55ryiv2d32)/home.aspx?li=
0&st=0&cs=&s=ND
 Quackwatch http://www.quackwatch.com.
 Natural Medicine Database
 Search - enter natural product name, disease or condition, or drug
name: objective product information, Effectiveness Ratings, or
potential interactions with drugs
 Natural Product Effectiveness Checker - tells you the level of
effectiveness for natural products used for various medical conditions.
 Natural Product / Drug Interaction Checker - tells you potential
interactions between any natural product and any drug.
 Disease / Medical Conditions Search - shows you medical conditions,
and allows you to see which natural products might be effective.
 Search Colleagues Interact - shows you questions, answers, and
comments posted by other health professionals.
CONCLUSION
 Fundamental questions for EBM CAM
1. Does it work?
2. How does it work?
3. Is it safe?

 Additional questions
1. How does one determine ‘Does it work?’ and ‘How does it work?’
2. Should a form of medicine be permitted until 1. 2. and 3. have been
determined?
 Looking at these considerations closely, a large
number of problematic issues arise for CAM
modalities.
RESOURCES
 American Botanical Council: http://www.herbalgram.org
 NIH National Center for Complementary and Alternative Medicine:
http://nccam.nih.gov/
 Sloan Kettering Cancer Cntr “Information About Herbs” www.mskcc.org/aboutherbs
 MEDLINEplus http://medlineplus.gov/ then search “Herbs”
 Office of Dietary Supplements (NIH) http://ods.od.nih.gov/
 iHerb www.iherb.com/health.html , then use “The Natural Pharmacy” and
“Commission E Monographs”
 ClinicalTrials.gov http://clinicaltrials.gov/ then type in “Herbs”
 FDA Safety and Adverse Reporting Program http://www.fda.gov/medwatch For
warnings on dietary supplement see also http://www.cfsan.fda.gov/%7Edms/ds-
warn.html
Herbs & Natural Supplements

An Evidence-based Guide

Second Edition