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
Nutrient
Definition
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
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Pacific islands


HERBS THAT HARM:
Comfrey
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HERBS THAT HARM:
Aristolochia
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HERBS THAT HARM:
Mahuang
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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 [1-
3 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
•
•
•

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
OBESITY
Grade of evidence Factor/s
Convincing
Possible
Regular physical activity; high dietary fiber intake
Low GI foods
DIABETES TYPE 2 Convincing
Probable
Possible
Insufficient
Weight loss; regular physical activity
High fiber intake; low saturated fat n-3 fatty acids; low GI foods
Vitamin E; chromium; magnesium

Strength of evidence on foods/supplements that give health benefit
WHO 2003
Condition Grade of evidence
CARDIOVAS
CULAR
DISEASE
Convincing
Probable
CANCER
Possible
Insufficient
Probable
Possible/Insufficient
Factor/s
Regular physical activity; linoleic acid;
EPA/DHA; fruits and vegetables; potassium; low sodium intake; TFA
Alpha-linolenic acid; oleic acid; dietary fiber; whole grains; unsalted nuts; plant sterols/stanols; folate
Flavonoids; soy products
Calcium, magnesium; Vit C, Vit E
Fruits and vegetables
Fiber; soya, n-3 fatty acids; carotenoids;
Vitamins B2, B6, folate, C, D, E; calcium; zinc; selenium; allium compounds; flavonoids; isoflavones; lignans

Strength of evidence on foods/supplements that give health benefit
WHO 2003
Condition
DENTAL HEALTH
Grade of evidence
Convincing
BONE HEALTH
Probable
Possible
Convincing
Factor/s
Good oral hygiene; flouride; vitamin D (for enamel defects)
Hard cheese; sugarfree chewing gum
Milk; dietary fiber; xylitol
Regular physical exercise; vitamin D and calcium

Recommendations for regulation:
REGISTER PRODUCT
BASED ON INTRINSIC ACTIVITY
ACTIVITY/EFFECT
Provide energy and nourishment; maintain physiologic functions
Supplement lack in the usual diet
CLASSIFICATION
Food
Diagnose disease, cure disease, alleviate symptom, alter structure or physiologic function
As above in the context of cultural belief and practice
Cleanse
‘Beautify’
Health supplement
Medicine/ drug
Traditional medicine
Personal care product
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

HERBS AS SOURCE OF
MAINSTREAM MEDICINES
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HERBS AS SOURCE OF
MAINSTREAM MEDICINES
Medicine Plant source
Atropa belladonna Atropine
Hyoscyamine Hyoscyamus niger
Folkloric use
To dilate eyes
Modern use
Anticholinergic
Sedative Anticholinergic
Tubocurarine Chondrodendron tomentosum Arrow poison Skeletal muscle relaxant
Physostigmine Physostigma venenosum Ordeal poison Anticholinesterase
Pilocarpine Pilocarpus jaborandi Poison
Morphine Papaver somniferum
Parasympathomime tic
Analgesic
Codeine Papaver somniferum
Sedative, analgesic
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
Reserpine Rauwolfia serpentina
Tranquilizer
Ephedrine
Pseudoephedrine
Theophylline
Sennosides
Ephedra sinica
Ephedra sinica
Camellia sinensis
Senna alexandrina
Chronic bronchitis
Chronic bronchitis
Stimulant, diuretic
Laxative
Cardiotonic
Tranquilizer, antihypertensive
Decongestant
Decongestant
Bronchodilator
Laxative

HERBS AS SOURCE OF
MAINSTREAM MEDICINES
Medicine Plant source Folkloric use Modern use
Vincristine Catharanthus roseus
Vinblastine
Etoposide
Catharanthus roseus
Podophyllum peltatum
Podophyllotoxin Podophyllum peltatum
Antidiabetic
Antidiabetic
Anticancer
Anticancer
Anticancer
Anticancer
Anticancer
Escharotic
Quinine
Artemether
Aspirin
Cinchona ledgeriana
Artemisia annua
Salix alba
Antipyretic, antimalarial
Antipyretic
Antipyretic
Antimalarial
Antimalarial
Antipyretic, analgesic, etc

 Mainstream medicine
 Complementary medicine
 Alternative medicine
 Traditional medicine
 Indigenous medicine
 Integrative 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

 Complementary medicine is used along with mainstream medicine
 Alternative medicine is used in place of mainstream 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
•

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
•
•
•

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 ndic@druginfo.ph

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
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The case for sambong
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The case for sambong
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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: 9-
13

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: 9-
13

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: 9-
13

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