the case for health supplements

Report
Greens for green:
the case for health supplements
Isidro C Sia, Susie O Sio, Andrea C Quitain
University of the Philippines Manila and
Philippine Institute of Traditional and Alternative
Health Care, Department of Health
International Academic Colloquium, 2014 September 09
Bicol University, Legaspi City
Tendencies and trends
People take more active participation in their
health care/ wellness
 Nutrition: diets, organic food, natural
products, health supplements
 Exercise: gym, sports
 Stress management: spa, massage
Middle class/ upper class phenomenon
Terms








Dietary supplement FDA, FDA Ph
Food supplement
Nutritional supplement
Herbal supplement
Dietary herbal supplement
Functional food China, FNRI
Nutraceutical Industry
Health supplement ASEAN Harmonization in 2015
Definitions
Term
Definition
Nutrient
Any substance normally consumed as constituent of
food that provides energy or that is needed for growth
and development and maintenance of healthy life, a
deficit of which will cause a characteristic biochemical
or physiological change.
Dietary supplement; or
food supplement; or
nutritional supplement
Intended to supplement the diet; may contain vitamin,
mineral, herb or other botanical excluding tobacco, an
amino acid, a concentrate, metabolite, extract,
constituent or combination of any of the above US
DSHEA 1994)
Functional food
Whole, fortified, enriched or enhanced food that
provide health benefits beyond the provision of
essential nutrients (Hasler 2002)
Health supplement
ASEAN definition
 Any product that is used to supplement a diet and
to maintain, enhance and improve the healthy
function of human body and
 contains one or more, or a combination of the ff:
(a) Vitamins, minerals, amino acids, fatty acids, enzymes,
probiotics and other bioactive substances.
(b) Substances derived from natural sources, including animal,
mineral and botanical materials in the forms of extracts,
isolates, concentrates, metabolites.
(c) Synthetic sources of ingredients mentioned in (a) and (b).
 It is presented in dosage forms (to be administered) in
small unit doses such as capsules, tablets, powder,
liquids and it shall not include any sterile preparations
(i.e. injectable, eyedrops).
Health supplements
 contains one or more, or a combination of
the ff:
(a) Vitamins, minerals, amino acids, fatty acids,
enzymes, probiotics and other bioactive
substances.
(b) Substances derived from natural sources,
including animal, mineral and botanical
materials in the forms of extracts, isolates,
concentrates, metabolites.
Health supplements
 In practice, many of so-called dietary
supplements, or the like, contain or
consist of botanical materials derived
from traditional medicine
Philippine scenario: No
approved therapeutic claims









Memori Plus
Sleapasil
Optein
Liveraide
Lungcare
Kidneycare
Kolestrim
Diabetrol
Robust, Fitrum
Philippine scenario: No
approved therapeutic claims











CNS: ginkgo, St Johns wort, melatonin
Eye: lutein
CVS: 4Gs, policosanol, garlic, omega3, resveratrol
Skin: glutathione
Liver: silymarin
Kidney: balbas pusa
RH: tongkat ali, saw palmetto, lycopene
Women’s health: black cohosh
Diabetes: ampalaya, banaba, turmeric, chromium
Joint: glucosamine, chondroitin
Tonic/immune: ginseng, echinacea
Philippine scenario:
Panacea – come and go
IMPORTED
 Comfrey
 Kargasok tea
 Apple cider
 Aloe
 Noni
 Barley
 Wheat grass
 Ashitaba
Philippine scenario:
Panacea – come and go
HOMEGROWN
 Narra
 Mahogany
 Pitupito
 Virgin coconut oil
 Malunggay
 Guyabano
 Mangosteen
Not each natural product
is safe





Kavakava
Aristolochia
Mahuang
Comfrey
Ginkgo
HERBS THAT HARM:
Kava Piper methysticum
 Some evidence: maybe
beneficial for anxiety
 Risk of liver damage
 Traditional use: ceremonial
drink Pacific islands
 Use withdrawn by FDA
HERBS THAT HARM:
Comfrey
 Panacea
 Hepatotoxic
 Pyrrolizidine
 Not recommended for
systemic use
HERBS THAT HARM:
Aristolochia
 For weight reduction
 Nephropathy [interstitial
fibrosis]
 Aristolochic acid
 Use withdrawn in the
Philippines
HERBS THAT HARM:
Mahuang
 Ephedra
 For weight reduction: high
doses
 Stroke
ASSESSING HERBS
BASED ON STRENGTH OF EVIDENCE
Randomized controlled trial [RCT]
Non-randomized RCT
Cohort study
Case-control study
Epidemiological study
Case report
Expert opinion
Anecdotal report
Milk thistle
Silybum marinum
 Silymarin [Liveraide]
 Clinical studies done for various liver diseases
[alcohol-related, toxin-induced, viral]
 Some promising results reported: amanita
poisoning
 NO conclusive evidence to prove claims:
* Small study population
* Poor study design
* Poor quality of reporting
Evidence Report No 21. Agency for Healthcare Research and Quality
Enjalbert F, et al. Treatment of amatoxin poisoning: 20-year retrospective
analysis. J Toxicol Clin Toxicol 2002; 40: 715–57.
Milk thistle
Silybum marinum
Ongoing studies by the NIH National
Center for Complementary and
Alternative Medicine [NCCAM] for:
* Chronic hepatitis C
* Non-alcoholic steatohepatitis
* Cancer prevention
* Complications in HIV patients
Ginkgo
Ginkgo biloba
 Promising results for dementia,
intermittent claudication, tinnitus
 Needed to be confirmed by large, welldesigned studies Agency for Healthcare Research
and Quality
 National Institute of Aging study on
200 adults: no improvement in memory
JAMA 2002
 No convincing evidence Birks J. Ginkgo biloba
for cognitive impairment and dementia. Cochrane library
 Known interaction with coumadin:
increased risk of bleeding
Ginkgo
Ginkgo biloba
Ongoing studies by the NIH National Center for
Complementary and Alternative Medicine
[NCCAM] for:
• Alzheimer’s
• Asthma
• Symptoms of multiple sclerosis
• Intermittent claudication
• Sexual dysfunction due to antidepressants
• Interactions with prescription drugs
Ginseng





•
•
•
Panax ginseng
Asian ginseng
Many claims: well-being, immune, etc
Some claims based on animal studies
Some human studies: may lower blood
glucose, or possible immune
enhancement
NOT conclusive to prove claims
Most studies small
Flaws in study design
Flaws in reporting
Agency for Healthcare Research and Quality
Ginseng
Panax ginseng
Ongoing studies by the NIH National
Center for Complementary and
Alternative Medicine [NCCAM] for:
• Drug interactions
• Chronic lung infection
• Impaired glucose tolerance
• Alzheimer’s
Garlic
Allium sativum
 Some evidence that garlic can lower
blood cholesterol for short-term use [13 months]
 Preliminary results: may slow
development of atherosclerosis
 Mixed results on hypertension
 No effect on glucose or insulin
sensitivity
 Decreased effect of saquinavir
Agency for Healthcare Research and Quality
Garlic
Allium sativum
NCCAM studies
• For lowering blood cholesterol
• As anticoagulant
• Interactions with other drugs
Ginger
Zingiber officinale
 Studies suggest short-term use can
safely relieve pregnancy-related nausea
and vomiting
 Mixed results for nausea caused by
motion, chemotherapy, or surgery
 Unclear if effective for rheumatoid
arthritis, osteoarthritis, muscle and joint
pains
Agency for Healthcare Research and Quality
Ginger
Zingiber officinale
NCCAM studies
• For nausea in chemotherapy
• Drug interactions with
immunosuppressants
• General safety
• Active components and effects on
inflammation
Green tea
Camellia sinensis
 Laboratory studies: may help protect
from or slow growth of certain
cancers
 Human studies: mixed results
 Some evidence to improve mental
alertness [caffeine]
 Not enough reliable data for weight
loss, decreasing cholesterol
Agency for Healthcare Research and Quality
Green tea
Camellia sinensis
NCCAM studies
• Cancer
• Diabetes
• Heart disease
St John’s wort
Hypericum perforatum
 23 European studies: maybe useful for
mild to moderate depression BMJ 1996
 Pfizer study: not effective for major
depression JAMA 2001
 NCCAM study: not effective for major
depression JAMA 2002
 Decreased effects of indinavir, cyclosporin,
irinotecan
St John’s wort
Hypericum perforatum
NCCAM studies
• Minor depression
• Social phobia
• Obsessive-compulsive disorder
• Interactions with narcotic
analgesics, oral contraceptives
Saw palmetto
Serenoa repens
 Earlier small studies: maybe effective
for BPH symptoms
 Large study [225 men]: no improvement
in moderate to severe BPH NEJM
2006;354:557-66
 NOT enough evidence to support use
for reducing size of BPH
 Side effects: tender breast, decline in
sexual desire
Cranberry
Vaccinium macrocarpon
 Inconclusive results for UTI
NCCAM studies for
• Prevention of UTI
• Prevention of formation of
dental plaque
Echinacea
Echinacea purpurea,
E pallida, E angustifolia
 2 NCCAM studies have not
proven that echinacea
shortens the course of colds
or flu JAMA 2003;290:2824-30, Annals Intern
Med 2002;137:939-46
 Other studies show
beneficial effects Seminars in
Integrative Medicine 2003;1:106-11
 Results not consistent Linde K.
Echinacea for preventing and treating the common
cold. Cochrane Library
The case for antioxidants




Vitamin A
Vitamin C
Vitamin E
Selenium
Useful supplements
FOR DEFICIENCIES
 Vitamin A
 Iron
 Iodine
 [Protein]
 Folic acid + iron
 Calcium + Vitamin D
 Zinc
Supplements/TM into
medicines
WITH EVIDENCE OF EFFICACY
 Omega-3
 Ginger
 Capsaicin
 Honey
 Mentholated rub
 Garlic +/ Glucosamine +/-
Strength of evidence on
foods/supplements that
give health benefit WHO 2003
Condition
Grade of evidence
Factor/s
OBESITY
Convincing
Regular physical activity; high
dietary fiber intake
Possible
Low GI foods
Convincing
Weight loss; regular physical
activity
Probable
High fiber intake; low
saturated fat
Possible
n-3 fatty acids; low GI foods
Insufficient
Vitamin E; chromium;
magnesium
DIABETES TYPE 2
Strength of evidence on
foods/supplements that
give health benefit WHO 2003
Condition
Grade of evidence
Factor/s
CARDIOVAS
CULAR
DISEASE
Convincing
Regular physical activity; linoleic acid;
EPA/DHA; fruits and vegetables;
potassium; low sodium intake; TFA
Probable
Alpha-linolenic acid; oleic acid; dietary
fiber; whole grains; unsalted nuts; plant
sterols/stanols; folate
Possible
Flavonoids; soy products
Insufficient
Calcium, magnesium; Vit C, Vit E
Probable
Fruits and vegetables
Possible/Insufficient
Fiber; soya, n-3 fatty acids; carotenoids;
Vitamins B2, B6, folate, C, D, E; calcium;
zinc; selenium; allium compounds;
flavonoids; isoflavones; lignans
CANCER
Strength of evidence on
foods/supplements that
give health benefit WHO 2003
Condition
Grade of evidence
Factor/s
DENTAL HEALTH
Convincing
Good oral hygiene;
flouride; vitamin D (for
enamel defects)
Probable
Hard cheese; sugarfree chewing gum
Possible
Milk; dietary fiber;
xylitol
Convincing
Regular physical
exercise; vitamin D
and calcium
BONE HEALTH
Recommendations for
regulation: REGISTER PRODUCT
BASED ON INTRINSIC ACTIVITY
ACTIVITY/EFFECT
CLASSIFICATION
Provide energy and nourishment; maintain
physiologic functions
Food
Supplement lack in the usual diet
Health
supplement
Diagnose disease, cure disease, alleviate symptom,
alter structure or physiologic function
Medicine/ drug
As above in the context of cultural belief and
practice
Traditional
medicine
Cleanse
Personal care
product
‘Beautify’
Cosmetic
Recommendations for
research: IN BICOL
THE CASE FOR PILI
 Canarium ovatum: pulp and peel are
rich in phytochemicals such as fiber
and phenolic compounds which are
antioxidants
 Canarium luzonicum : Manila elemi
 Local names for Canarium spp: pili-pili,
piling okai, malapili, pisa, basiad,
hagushus, anagi, liputi, pilaui, pili-pilauai
Take home messages
Use supplements only where needed:
 For deficiency: Vitamin A, iron, iodine,
 Where indicated: folic acid + iron
calcium + Vitamin D, pyridoxine, zinc
Take home messages







Eat right.
Exercise.
Get enough sleep.
Practice hygiene.
Manage stress.
Do not smoke.
Feed your soul.
Take home messages
Use supplements only where needed:
 For deficiency: Vitamin A, iron, iodine,
 Where indicated: folic acid + iron
calcium + Vitamin D, pyridoxine, zinc
Thank you !
HERBS AS SOURCE OF
MAINSTREAM MEDICINES
 Active ingredients identified
 Evidence of safety and
efficacy
 More than 40% of modern
medicine armamentarium
HERBS AS SOURCE OF
MAINSTREAM MEDICINES
Medicine
Plant source
Folkloric use
Modern use
Atropine
Atropa belladonna
To dilate eyes
Anticholinergic
Hyoscyamine
Hyoscyamus niger
Sedative
Anticholinergic
Tubocurarine
Chondrodendron tomentosum
Arrow poison
Skeletal muscle
relaxant
Physostigmine
Physostigma venenosum
Ordeal poison
Anticholinesterase
Pilocarpine
Pilocarpus jaborandi
Poison
Parasympathomim
tic
Morphine
Papaver somniferum
Sedative,
analgesic
Analgesic
Codeine
Papaver somniferum
Sedative,
analgesic
Antitussive,
analgesic
HERBS AS SOURCE OF
MAINSTREAM MEDICINES
Medicine
Plant source
Folkloric use
Modern use
Ouabain
Strophantus gratus
Arrow poison
Cardiotonic
Digitoxin
Digitalis purpurea
Cardiotonic
Cardiotonic
Reserpine
Rauwolfia
serpentina
Tranquilizer
Tranquilizer,
antihypertensive
Ephedrine
Ephedra sinica
Chronic
bronchitis
Decongestant
Pseudoephedrine
Ephedra sinica
Chronic
bronchitis
Decongestant
Theophylline
Camellia sinensis
Stimulant,
diuretic
Bronchodilator
Sennosides
Senna alexandrina
Laxative
Laxative
HERBS AS SOURCE OF
MAINSTREAM MEDICINES
Medicine
Plant source
Folkloric use
Modern use
Vincristine
Catharanthus
roseus
Antidiabetic
Anticancer
Vinblastine
Catharanthus
roseus
Antidiabetic
Anticancer
Etoposide
Podophyllum
peltatum
Anticancer
Anticancer
Podophyllotoxin
Podophyllum
peltatum
Anticancer
Escharotic
Quinine
Cinchona
ledgeriana
Antipyretic,
antimalarial
Antimalarial
Artemether
Artemisia annua
Antipyretic
Antimalarial
Aspirin
Salix alba
Antipyretic
Antipyretic,
Terms/ paradigms
 Mainstream medicine
 Complementary medicine
 Alternative medicine
 Traditional medicine
 Indigenous medicine
 Integrative medicine
Mainstream medicine
 Medicine as practiced by holders
of degree of medicine, nursing,
PT, etc
 Synonyms: conventional,
standard, regular, orthodox,
western, allopathic
 Practice based on evidence
Complementary and
alternative medicine [CAM]
 Group of diverse medical and
health care systems, practices
and products which are not part
of mainstream medicine
 Vs traditional medicine
 Vs indigenous medicine
 Vs Oriental medicine
CAM
 Complementary medicine
is used along with
mainstream medicine
 Alternative medicine is
used in place of
mainstream medicine
Integrative medicine
 A total approach to care that
involves the patient’s body,
mind, and spirit
 Combines mainstream medicine
with CAM practices that have
shown the most promise or is
beneficial or effective
POPULARITY OF HERBS AND
NON-MAINSTREAM MEDICAL
MODALITIES WORLDWIDE
 FROM NATURE: PERCEIVED
TO BE SAFE
 INADEQUACY OF
MAINSTREAM MEDICINE
 HEAVY PROMOTIONS AND
WORD OF MOUTH
HERBS AS ‘PANACEAS’
Philippine panacea galore: imported fads
• Comfrey
• Kargasok tea
• Taheebo
• Herbalife
• Noni
UNDELIVERED PROMISES… FORGOTTEN
HERBS AS ‘PANACEAS’
Philippine panacea galore: homegrown fads
• Mahogany
• Narra
• Ampalaya-banaba-luyang dilaw
• Pitupito
UNDELIVERED PROMISES… FORGOTTEN
DO HERBS WORK?
.
ASSESSING HERBS
DEPENDENT ON WHOSE
VIEWPOINT
 CRITERIA USED
ASSESSING HERBS BY
REGULATORY AUTHORITIES
VARYING CRITERIA FOLLOWED
ONE PRODUCT, EXAMPLE GINKGO, VARIOUSLY
REFERRED TO AS:
•
•
•
•
•
•
•
•
•
Natural product [Canada]
Food supplement [EU]
Dietary supplement [US]
Food with specific health use [Japan]
Health function food [Korea]
Function food [China]
Complementary medicine [Australia]
Traditional medicine [Malaysia]
Dietary supplement or drug [Philippines]
ASSESSING HERBS
DEPENDENT ON STRICTNESS OF CRITERIA:
Available scientific literature, advice from
authorities, national viewpoints
 GERMAN COMMISSION E
 EUROPEAN SCIENTIFIC COOPERATIVE ON
PHYTOTHERAPY ESCOP www.escop.com
 EUROPEAN MEDICINES AGENCY EMEA
 WORLD HEALTH ORGANIZATION WHO
www.who.int
WHO monographs
CRITERIA
 Widespread use, particularly in countries that
rely heavily on medicinal plants to meet
primary health care needs
 Traditionally used to treat such common
complaints as diarrhea, constipation,
headache, appetite loss, sleep disorders,
fatigue, and mild respiratory, gastrointestinal,
and skin disorders.
 Additional medical applications assessed
range from the lipid-lowering potential of garlic,
through the possible antiplasmodial activity of
brucea fruit, to the role of curcumin in
promoting peptic ulcer healing.
WHO monographs
PURPOSE
 To encourage standardized scientific
approaches to ensuring the safety, quality and
efficacy of medicinal plants and their products
 To promote international harmonization in the
quality control and use of herbal medicines
 To serve as models for the development of
national formularies.
Draft monographs were finalized following review
by over 100 experts in 40 countries with some
1400 references for Volume 1.
WHO monographs
STANDARD FORMAT
 Pharmacopoeial summaries for quality
assurance, botanical features,
distribution, identity tests, purity
requirements, chemical assays, and
active or major chemical constituents.
 Latin binomial pharmacopoeial name
WHO monographs
STANDARD FORMAT
 Dosage forms
 Medicinal uses as supported by clinical data
 Uses described in pharmacopoeias and in
traditional systems of medicine but not yet
supported by experimental or clinical data.
 Extensive review of available data on
experimental and clinical pharmacology
 Contraindications, warnings, precautions,
particularly in such special groups as pregnant
and breast-feeding women, adverse reactions
 Dosage
 References
WHO monographs
VOLUME 1
www.who.int
Bulbus Allii Cepae
Bulbus Allii
Sativi Aloe
Aloe Vera Gel
Radix Astragali
Fructus Bruceae
Radix Bupleuri
Herba Centellae
Flos Chamomillae
Cortex Cinnamomi
Rhizoma Coptidis
Rhizoma Curcumae
Longae
Radix Echinaceae
Herba Echinaceae
Purpureae
Herba Ephedrae
Folium Ginkgo
Radix Ginseng
Radix Glycyrrhizae
Radix Paeoniae
Semen Plantaginis
Radix Platycodi
Radix Rauwolfiae
Rhizoma Rhei
Folium Sennae
Fructus Sennae
Herba Thymi
Radix Valerianae
Rhizoma Zingiberis
WHO monographs
VOLUME 2
 30 monographs approved by 120 experts
in more than 50 countries
 Together with volume 1, they are a
comprehensive scientific reference for
drug regulatory authorities, physicians,
traditional practitioners, pharmacists,
manufacturers, and research scientists.
WHO monographs
VOLUME 2
www.who.int
Radix Althaeae
Herba Andrographidis
Radix Angelicae
Sinensis
Flos Calendulae
Flos Caryophylli
Rhizoma Cimicifugae
Folium cum Flore
Crataegi
Radix Eleutherococci
Aetheroleum
Eucalypti
Folium Eucalypti
Cortex Frangulae
Folium et Cortex
Hamamelidis
Semen Hippocastani
Herba Hyperici
Aetheroleum
Melaleucae
Folium Melissae
Aetheroleum
Menthae Piperitae
Folium Menthae
Piperitae
Folium Ocimi sancti
Oleum Oenotherae
Biennis
Rhizoma Piperis
Methystici
Cortex Pruni
Africaniae
Cortex Rhamni
Purshianiae
Flos Sambuci
Radix Senegae
Fructus Serenoae
Repentis
Fructus Silybi Mariae
Herba Tanaceti
Parthenii
Radix Urticae
Folium Uvae Ursi
ASSESSING HERBS
DEPENDENT ON STRICTNESS OF
CRITERIA: Randomized controlled
clinical trials & meta-analysis review
 COCHRANE NETWORK
 US NATIONAL INSTITUTES OF
HEALTH (National Center for Complementary and
Alternative Medicine & National Cancer Institute)
 US AGENCY FOR HEALTHCARE
RESEARCH AND QUALITY
ASIAN HERBS GALORE:
Facts and myths
 China: Qinghaosu, mahuang,
fangchi
 India: Turmeric
 Japan: Kanpu
 Indonesia: Jamu
 Malaysia: Tonkat ali, ganoderma
 Thailand: Ginger, turmeric, etc
SIZING UP PHILIPPINE
HERBS
Vigorous research in the 30s to
50s
• Darak as source of tikitiki
SIZING UP PHILIPPINE
HERBS
1970s:Community-based health programs
• SLK: sampalok, luya, kalamansi syrup for
cough
• BLS: bawang, luya, sili liniment for
rheumatism
• ABK: abukado, bayabas, kaymito
decoction for diarrhea
• Makabuhay ointment for scabies
• Akapulko ointment for fungal infect
SIZING UP PHILIPPINE
HERBS
NIRPROMP: National
Integrated Research
Program on Medicinal
Plants
• Akapulko for skin fungal
infection
• Bayabas as antiseptic
• Niyogniyogan for
ascariasis
SIZING UP PHILIPPINE
HERBS
NIRPROMP: National Integrated
Research Program on
Medicinal Plants
• Lagundi for cough
• Sambong for urinary stones
• Yerba buena as analgesic
• Tsaang gubat as
antispasmodic
PCHRD Technology Transfer Documents
SIZING UP PHILIPPINE
HERBS
NIRPROMP: National Integrated
Research Program on
Medicinal Plants
• Bawang to lower cholesterol
• Ulasimang bato to lower uric
acid
• Ampalaya to lower blood
sugar
PCHRD Technology Transfer Documents
SIZING UP PHILIPPINE
HERBS
Other initiatives
• University of Santo Tomas: Tunkin
ointment for wounds
• Manila Central University:
Makabuhay ointment for scabies
• PGH: Malunggay capsule to
increase milk production
SIZING UP PHILIPPINE
HERBS
Five minutes of fame
• Burburtak for goiter
• Tsaang gubat for dental
caries
• Homegrown panaceas:
pitupito, mahogany
Use of herbs in the context
of integrative medicine
 As a total approach to care that
involves the patient’s body, mind,
and spirit
 Combines mainstream medicine
with CAM practices that have
shown the most promise or is
beneficial or effective
Use of herbs in the context
of integrative medicine
HOUSEHOLD LEVEL
Herbs and other
remedies that are
 SAFE TO USE
 BENEFICIALFOR
TRIVIAL AILMENTS
 ACCESSIBLE
 ACCEPTED
YERBA BUENA
SULASI
OREGANO
MANSANILYA
SABILA
LUYA
ONION
PARACETAMOL
ORAL REHY SOL
Headache
Dizziness
Cough
Colic
Minor burns
Rheumatism
Colds
Fever
Diarrhea
Use of herbs in the context
of integrative medicine
CLINIC LEVEL
 PARADIGM: MAINSTREAM vs
INTEGRATIVE
 PHYSICIAN-PATIENT RELATION
 PLACEBO ROLE
Summary
 Rational use of herbal medicines
considers the criteria of high
quality, effectiveness, safety,
affordability, and suitability to the
patient.
Summary
Some herbs are proven harmful and
should not be used
 Kava
 Aristolochia
 Mahuang
 Mahogany
 Comfrey
 Others
Summary
RCTs as gold standard for efficacy: By
this standard, considered effective
are:
• Garlic for short-term use in
dyslipidemia (1 to 3 months use)
• Ginger for nausea and vomiting of
pregnancy
Summary
RCTs as gold standard for efficacy: By this
standard, more studies are needed for:
• Silymarin for liver disease
• Ginkgo for dementia
• Ginseng as immune enhancer
• Garlic for hypertension
• Green tea for weight loss
• St John’s wort for depression
• Saw palmetto for benign prostatic hypertrophy
• Echinacea to shorten duration of cold
• Cranberry for urinary tract infection
Summary
Use of 10 medicinal plants is
endorsed by the DOH based on
NIRPROMP studies
• Akapulko for skin fungal infection
• Bayabas as antiseptic
• Niyogniyogan for ascariasis
• Sambong for kidney stones
• Lagundi for cough
Summary
Use of 10 medicinal plants is
endorsed by the DOH based on
NIRPROMP studies
• Yerba buena for pain
• Tsaang gubat for colic
• Bawang to lower cholesterol
• Ulasimang bato to lower uric acid
• Ampalaya to lower blood sugar
Summary
 Use herbs with proven efficacy and
safety.
 Discourage use of herbs which have
been proven to be harmful.
 Rationally use those which lack solid
evidence of efficacy but have shown
beneficial outcomes.
EMAIL [email protected]
Thank you !
Wholistic approach to
health
 Feed your body right
 Exercise
 Do not smoke
 Drink moderately, if you must
 Manage stress
 Feed your soul
Biologically-based
practices
 Herbs
 Vitamins and minerals
 Enzymes, amino acids, fatty acids, probiotics
and other bioactive substances
 Foods
 Special diets
 Aromatherapy, homeopathy
SUBSTANCES DERIVED FROM NATURAL SOURCE, INCLUDING ANIMAL,
MINERAL, AND BOTANICAL MATERIALS IN THE FORM OF EXTRACT,
ISOLATE, CONCENTRATE, OR METABOLITE
The case for sambong
PARTS USED AND CONSTITUENTS
 Parts used: Mature leaves
 Constituents:
• Terpenes - cineol, limonene, camphor,
borneol, sesquiterpenes, monoterpenes,
triterpenes
• Alkaloids
• Flavonoids
• Saponins, tannins
COULD BE COMMERCIAL SOURCE OF CAMPHOR
The case for sambong
SAFETY STUDIES
Toxicity:
 Acute toxicity: LD 50 = 143.6
g/kg
 Subchronic toxicity
The case for sambong
SAFETY STUDIES
Mutagenicity:
 REC assay
 Ames test
 Micronucleus test
 Host-mediated assay
ALL NEGATIVE FINDINGS
EVEN EXHIBITED ANTI-MUTAGENIC POTENTIAL VS MITOMYCIN D,
DIMETHYLNITROSOAMINE AND TETRACYCLINE
The case for sambong
INITIAL CLINICAL STUDIES
 For cough
 Side effect: diuresis
The case for sambong
SUBSEQUENT CLINICAL
STUDIES
 As diuretic
 Serendipitous finding:
passage of kidney stones
The case for sambong
SUBSEQUENT CLINICAL
STUDIES
 For kidney stone
Clinical trials of sambong
for kidney stones
 Subjects:13 sambong group, 12 placebo group
 Intervention: 40 mg/kg in 3 divided doses for 4
weeks
 Results: 9 sambong patients passed stone
(69%) vs 1 patient for placebo (8.3%)
 Composition of stones not determined
 Mechanism as to how stones are passed:
Diuretic action ? Smooth muscle relaxant
effect?
Sigua H, Molina C. Blumea balsamifera L (sambong) for the treatment of urinary tract
stone: a randomized double-blind placebo-controlled study. DOST-PCHRD 1990
Clinical trials of sambong
for kidney stones
 Subjects:11 sambong group, 2
placebo group
 Intervention: 40 mg/kg in 3 divided
doses for 4 weeks
 Results: 3 sambong patients passed
stone
Purificacion J, Maramba NPC. Phase 3 clinical trial of Blumea
balsamifera L (sambong) tablet in the treatment of urinary tract
stone: a randomized double-blind placebo-controlled study.
DOST-PCHRD 1994
Chemolytic effect of sambong:
in vitro (Rico study)
OBJECTIVE
 TO DETERMINE THE EFFECT OF
SAMBONG ON CALCIUM STONE IN
VITRO
Rico F. Sambong (Blumea balsamifera): its effect on
calcium stone. Philippine Journal of Urology 1992; 2: 913
Chemolytic effect of sambong:
in vitro (Rico study)
APPARATUS
 Modified flowby dissolution apparatus
 IV fluid bottle as urine infusion reservoir >
tubing > 30 cc syringe with 1cm calcium stone
> tubing > drainage bottle
Rico F. Sambong (Blumea balsamifera): its effect on calcium stone.
Philippine Journal of Urology 1992; 2: 9-13
Chemolytic effect of sambong:
in vitro (Rico study)
APPARATUS
Rico F. Sambong (Blumea balsamifera): its effect on calcium stone.
Philippine Journal of Urology 1992; 2: 9-13
Chemolytic effect of sambong:
in vitro (Rico study)
CALCIUM STONES
 Retrieved by open operation from a patient with
multiple stones
 Analysis by Merckognost kit: Calcium 60%, oxalates
20, phosphates 10, uric acid 5, ammonium 0.5,
(carbonates, magnesium, cystine 0)
 Stone size for the study 1cm: fragments rounded at 1
cm diameter, air-dried until a constant weight was
obtained.
 Stones for each comparative trial were of approximate
size and weight and taken from adjacent location
Rico F. Sambong (Blumea balsamifera): its effect on calcium stone. Philippine Journal
of Urology 1992; 2: 9-13
Chemolytic effect of sambong:
in vitro (Rico study)
CLYSING MEDIA
 Urine from 15 normal subjects
 45 clysing trials done
Rico F. Sambong (Blumea balsamifera): its effect on
calcium stone. Philippine Journal of Urology 1992; 2: 913
Chemolytic effect of sambong:
in vitro (Rico study)
STONE DISSOLUTION
 Was greatest for sambong given at 40
mg/kg
Rico F. Sambong (Blumea balsamifera): its effect on
calcium stone. Philippine Journal of Urology 1992; 2: 913
Ranking of studies in the
assessment of evidence
FDA 2005









Randomized, controlled clinical trials
Cohort studies [longitudinal]
Case-control studies
Cross-sectional studies
Uncontrolled case series or cohort studies
Time-series studies
Ecological studies [cross-population
Descriptive epidemiology
Case reports

similar documents