Herbal Med 2008-09-05 (Narrow, No Anima)

Balan, Lim, J., Lim, V., Macasaet, Madulara, Maulion, Medina, Nallas, Ong, Ongoco, Palma

HERBAL MEDICINE

University of Santo TomasFaculty of Medicine and Surgery

Department of Pharmacology

Seminar on

HERBAL MEDICINE

Lim, Maria Joane Faye C. Class No. 22

HERBAL MEDICINE Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions

Definition of Terms

Traditional and Alternative Health Care

The sum total of knowledge, skills and practices on health care, other than those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical or mental disorder


HERBAL MEDICINE

Definition of Terms

Traditional Medicine

The sum total of knowledge, skills and practice on health care, not necessarily explicable in the context of modern, scientific philosophical framework, but recognized by the people to help maintain and improve their health.

Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions


HERBAL MEDICINE

Definition of Terms

BIOMEDICINE

A discipline of medical care advocating therapy with remedies that produce effects differing from those of the diseases treated.



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Definition of Terms

BIOMEDICINE

Practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses



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Definition of Terms

BIOMEDICINE

Also called allopathy, western medicine, regular medicine, conventional medicine, mainstream medicine, orthodox medicine, or cosmopolitan medicine.



HERBAL MEDICINE

Definition of Terms

Alternative Health Care Modalities

Other forms of non-allopathic, occasionally non-indigenous or imported healing methods, though not necessarily practiced for centuries nor handed down from one generation to another.

Some of the modalities are reflexology, acupuncture, chiropractic care, acupressure, massage, applied kinesiology, homeopathy, diet, and herbal medicine.



HERBAL MEDICINE

Definition of Terms

HERBAL MEDICINE

Finished, labeled medicinal products that contain as active ingredient/s aerial or underground part/s of plant or other materials or combination thereof, whether in the crude state or as plant preparations.

However, it may contain excepients in addition to the active ingredient(s).

Medicines containing plant material(s) combined with chemically-defined active substances, including chemically-defined, isolated constituents of plants, are NOT considered to be herbal medicines.



HERBAL MEDICINE

Definition of Terms

Natural Product

Foods that grow spontaneously in nature whether or not they are tended by man.

Foods that have been prepared from grains, vegetables, fruits, nuts, meats, fish, eggs, honey, raw milk, and the like, without the use or addition of additives, preservatives, artificial colors and flavors, or manufactured chemicals of any sort after harvest or slaughter



HERBAL MEDICINE

Definition of Terms

Manufacture

Any and all operations involved in the production:

including preparation, propagation, processing, formulating, filling, packing, repacking, altering, ornamenting, finishing, or otherwise changing the container, wrapper, or labeling of a consumer product in the furtherance of the distribution of the same from the original place of manufacture to the person who makes the final delivery or sale to the ultimate consumer.



HERBAL MEDICINE

Definition of Terms

Traditional Healers

Relatively old, “highly” respected people with a profound knowledge of traditional remedies

They have strong ethical principles that they extend to all life.

They believe it is their duty to foster life in all its forms and to alleviate suffering.

They also believe that Nature's laws must be obeyed in order to avoid decline and ultimate disaster.



HERBAL MEDICINE

Definition of Terms

Intellectual Property Rights

Legal basis by which the indigenous communities exercise their rights 'to have access to protect, control over their cultural knowledge and product, including but not limited to, traditional medicines, and includes the right to receive compensation for it.


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National Integrated Research Program on Medicinal Plants (NIRPROMP)

is a multi disciplinary, multi-agency effort iniated by National Science and Development Authority (NSDA), now the Department of Science and Technology (DOST) in 1974 which aims to:

provide the scientific ground work for the further development of Herbal medicine in the Philippines

systematize the study of medicinal plants in the Philippines with an end goal of providing safe, effective, and affordable pharmaceutical products derived from commonly available plants

Ongoco, Renncee A. Class No. 113


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Two IMMEDIATE DRUG NEEDS identified by NIRPROMP

1. Need to distribute medicines within the reach of most Filipinos (safe, effective but affordable to Filipinos)

2. Need to discover new or better drugs for common diseases in the Philippines.




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Done researches in developing herbal plants in dosage forms with consistent potency. 2 preliminary steps:

They plan and develop the fastest way to get the raw materials needed ( in terms of cultivation, growing, maintenance and harvest of plants)

Harvested leaves are then brought to U.P. College of Pharmacy to be processed, but first tested –

Harvested plant shouldn’t contain: MUTAGENIC and TERATOGENIC COMPOUNDSPESTICIDE RESIDUESAFLATOXINHEAVY METALS(shouldn’t exceed WHO approved levels)Microbial counts not exceeding 100,000 colony forming units

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To date, NIRPROMP has transferred the technology to pharmaceutical manufacturers for the production of 7 herbs in commercial form:

LAGUNDI SAMBONG TSAANG GUBAT

HIERBA BUENA ATIS ACAPULCO

AMPALAYA

HERBAL MEDICINE




Latest Achievements of NIRPROMP

Recent reclassification of ampalaya back to its previous status as a scientifically validated herbal medicinal plant by using a phase 3 clinical trials.

Compared the efficacy and safety of Momordica Charantia, L (ampalaya Makiling variety) leaf tablet and glibenclamide among patients with Type 2 DM

Pascual Laboratories Inc. has secured the license to manufacture, distribute and market a new Ampalaya (bitter gourd) tablet as an anti-diabetic medicine developed by NIRPROMP.

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NIRPROMP Today:


Screens more plants for possible inclusion in pharmacologic studies.

More plants are being screened for possibly effectiveness in treating malaria, dengue fever, and tuberculosis


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What is the PITAHC?

A government owned and controlled corporation (GOCC) in association with the DOH

Answers the present needs of the people on health care provision and delivery of traditional and alternative health care (TAHC) products, services and technologies that have been proven safe, effective and affordable

Philippine Institute of Traditional and Alternative Health Care (PITAHC)

Lim, Vanessa Class No. 25


HERBAL MEDICINE

Philippine Institute of Traditional and Alternative Health Care (PITAHC)

VISION-MISSION of PITAHC


VISION: "Traditional and alternative health care

in the hands of the people"

MISSION: "PITAHC upholds the right of every Filipino

for better health through the provision of safe, effective and affordable traditional and alternative health care products, services and technologies."



President GMA's 2007 SONA

quest for cheaper medicines through parallel importations without complementary support for developing our own drugs, including alternative

or herbal medicines

Palma, Sharlene Mae S. Class No. 132

HERBAL MEDICINE

DR. JAIME GALVEZ-TAN- former director of the National Institutes of Health (NIH)- president of Health Futures Foundation Inc.

Health research and development over the past 30 years has focused on only 10 medicinal plants.

about P20 million to complete necessary chemical and clinical tests on one plant

at least P200 million for the research and development of a new batch of herbal medicines


10 Medicinal Plants (Feria. 2007)


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Philippine Council for Health Research and Development (Jaime Montoya, executive director)• coordinates and helps fund studies in alternative medicine

Eight new ongoing research projects• four involve plants on the old-10 list but for new uses

SambongUlasimang batoTsaang gubatBayabas


10 Medicinal Plants (Feria. 2007)


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This is the list of the 10 medicinal plants that the DOH endorsed through its "Traditional Health Program"

All 10 herbs have been thoroughly tested and clinically proven to have medicinal value in the

relief and treatment of various ailments.



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THE LIST

1. Akapulko (Cassia alata) 2. Ampalaya (Momordica charantia) 3. Bawang (Allium sativum) 4. Bayabas (Psidium guajava)5. Lagundi (Vitex negundo)6. Niyog-niyogan (Quisqualis indica L.)7. Sambong (Blumea balsamifera)8. Tsaang Gubat (Ehretia microphylla Lam.)9. Ulasimang Bato /Pansit-pansitan (Peperomia pellucida)10. Yerba Buena (Clinopodium douglasii)



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AKAPULKO (Cassia alata)

abundant throughout the Philippines

“Bayabas-bayabasan" and “Ringworm bush“

The plant is six feet in height belonging to the legume family.



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Active substance: Chrysophanic acidtoxic to cattles

Saponin content of leaf extractlaxative useful in expelling intestinal parasitestoxic in rats

Toxic effectschronic diarrhea, loss of appetite, weight loss (in rats)



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In-vitro studies : high anti-fungal activity on dermatophytic fungi

low activity on non-dermatophytic fungi

plant water extract was also reported to have anti-fungal activity against Candida albicans, and even anti-bacterial activity against E. coli



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Bioactivity studies on Cassia alata Linn. leaf extracts (Villaseñor, et. al. 2002)

5 mg/20 g mouse the hexane extract was analgesic

5 mg/20 g mouse hexane and EtOAc (Ethyl Acetate)extracts exhibited anti-inflammatory activity with a 65.5% and 68.2% decrease in carrageenan-induced inflammation, respectively



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2 mg/20 g mouse extract was antimutagenic with a 65.8% inhibition in the mutagenicity of tetracycline

50 mg/mL hexane most active against Trichophyton mentagrophytes, at a concentration of but it had no activity against Candida albicans.

EtOAc extract more active against C. albicans. hypoglycemic at a dosage of 5 mg/20 g mouse,decreased the blood sugar level by 58.3%



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AMPALAYA (Momordica charantia)

“Bitter gourd” or “Bitter melon”

Treatment ofDiabetes Mellitus(non insulin dependent)

Fruit is used

Contraindications: Individuals with liver disease, pregnant women



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Active constituents: - sterols (charantin)- triterpenes (momorcharaside A and

momorcharaside B)- proteins (momorcharin A and B, MAP-30)



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Contains flavanoids and alkaloids make the Pancreas produce more insulin

Good source of vitamins A, B and C, iron, folic acid, phosphorus and calcium

Hypoglycemic effect: insulin secretagogue effect; insulin like activity found in seeds



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Reduces hepatic cholesterol and triglyceride in a dose dependent manner

MAP30 (anti-HIV plant protein) – acts on some stages in viral cycles in acute and chronic infections



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Anti-diabetic potentials of Momordica charantia and Andrographis paniculata and their effects on estrous cyclicity of alloxan-induced diabetic rats (Reyes, et. al. 2005)

The blood glucose levels in the groups used in the study were significantly reduced



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An Inquiry to the Hypoglycemic Action of Momordica charantia Among Type 2 Diabetes Patients (Rosales and Fernando. 2001)

Ampalaya fruit prepared as a tea can be a useful dietary adjunct in the treatment of diabetes. It is well tolerated and safe with minor gastrointestinal side effects particularly increased bowel movement



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The effect of Momordica charantia capsule preparation on glycemic control in Type 2 Diabetes Mellitus needs further studies (Dans, et. al 2006)

More RCT’s with a bigger sample size should be made because results are inconclusive



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BAWANG (Allium sativum)

Hypertension - reduces cholesterol in the blood and hence, helps control blood pressure

Fresh bulbs are the main part utilized for its therapeutic effect

primary active compound in garlic is Allicin (derived from cysteine)



HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions


Therapeutic effects:Antihypertensive,

Anticholesterolemic, Antilipidemic, Reduces platelet aggregation, Vasodilator, Expectorant, Antihistaminic, Antimicrobial




Medicinal plants for toothache relief (Marasigan, et. al 2000)

The efficacy of crude ethanolic and aqueous extracts of guava, yerba-buena, avocado, bawang and calachuchi in inhibiting the growth of Lactobacillus acidophilus

Antibacterial activity was determined by paper disc-agar plate method of assay



BAYABAS (Psidium guajava)

Used as an antiseptic, to disinfect wounds

mouth wash: tooth decay and gum infection

Rich in tannins, phenols, triterpenes, flavonoids, essential oils, saponins, carotenoids, lectins, vitamins, fiber and fatty acids


HERBAL MEDICINE


Other flavonoids and triterpenes in guava leaves show antispasmodic activity

Polyphenols (leaves) – antioxidant; Bark and leaf extracts - antibacterial propertiesantifungal, anti-yeast (candida), anti-amebic, and anti-malarial actions



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A Comparative Study on the Drying Effects of Guava Decoction, 70% Isopropyl Alcohol and Water on Umbilical Cords of Newborns, An In Vitro Experimental study (Dacumos. 2008) Guava decoction double strength has better drying properties (percentage decrease in weight cord) compared to distilled water and 70% Green Cross Isopropyl Alcohol



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LAGUNDI (Vitex negundo)


relief of coughs and asthma

endorsed by the DOH as effective in the treatment of colds, flu, and pharyngitisprevent the body's production of leukotrienes


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Chrysoplenol D: smooth muscle relaxant with anti-histamine properties

Isoorientin

Casticin

Luteolin-7-0-glucoside – anti-histamine effect

Inhibit leukotriene release

National Integrated Research Program on Medicinal Plants, DOST



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Main constituents are volatile oil, resin, alkaloid, lichen acids and glucoside

May be used as a leaf decoction for

fever, headache, toothacheanalgesic and antitussive (prepared as a pleasant tasting cough syrup)



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Replacement for Dextromethorphan in public health systems

Reduces coughing and relaxes bronchial smooth muscles

Lagundi is one of the few herbs recently registered with the Bureau of Foods and Drugs (BFAD) as medicines



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NIYOG-NIYOGAN (Quisqualis indica L.)

“Chinese honey suckle”

seeds are utilized for its therapeutic effect; dried seeds are preferred

Chemical components of seeds include quisqualic acid (active ingredient), fatty oils, gum and resin


Balan, Ralph Class No. 03

HERBAL MEDICINE

NIYOG-NIYOGAN (Quisqualis indica L.)

Uses

Antihelminthics (ascariasis) alleviation of nephritis remedy for boils and ulcers relief from ache caused by fever treatment of rheumatism

Adverse Effects

diarrhea, abdominal pain, distention and hiccups, especially if the seeds are eaten fresh or continuously for consecutive days



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SAMBONG (Blumea balsamifera)



also known as “Camphor”

high in essential oils, and contains significant amounts of camphor oil

commonly used in capsule form or as teas

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Diuretic that helps in the excretion of urinary stones

Anti-urolithiasis

Hypertension Mild to moderate congestive heart failure



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THE PHILIPPINE CLINICAL PRACTICE GUIDELINES ON THE DETECTION AND MANAGEMENT OF HYPERTENSION

Report of the Multisectoral Task Force on the Detection and Management of Hypertension Convened by the Philippine Society

of Hypertension (Phil. J. Internal Medicine, 35:67-85, March-April, 1997)

No indigenous herbal preparations have been adequately tested for its antihypertensive effect



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Among the many herbal preparations being speculated as having anti-hypertensive properties, only “sambong” is undergoing a rigorous evaluation.

At present, a randomized, double-blind crossover study is ongoing to test the efficacy of this herbal medicine among mild hypertensiveness [reference unpublished].



HERBAL MEDICINE

TSAANG GUBAT (Ehretia microphylla Lam.)

“Wild Tea”, “Forest Tea”, “Alibungog” (Visayas Region), “Putputai” (Bicol Region) and Maragued (Ilocos Region)

available commercially in capsules, tablets and tea bags

BFAD registered as an herbal medicine



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antispasmodic for abdominal (stomach) pains

high fluoride content – mouthwash; effective in treating intestinal motility

Active compounds are triterpenes



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UsesGastroenteritisDysenteryDiarrhea or Loose Bowel Movement (LBM)Body cleanser/wash



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Dr. Gerard Penecilla- pharmaceutical scientist of the National Council of the Philippines (DOST)

Yeast Bioassay- to determine pharmacologic activities (anticancer) of medicinal plants

Tsaang Gubat-high potential in fighting growth and multiplication activities of cancer cells

Philippine Star , 18 July 2008



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Ulasimang Bato /Pansit-pansitan (Peperomia pellucida)



“Olasiman-ihalas” & “Tangon-tangon” in the Philippines

English name: Peperomia

Small herb that grows from 1 to 1 1/2 feet, leaves and stalk are edible

HERBAL MEDICINE


main components are Dillapiole (39.7%) and Trans-caryophyllene (10.7%)

Apiole, a phenolic ester, may stimulate uterine contractions and also hepatotoxic

as a salad, helps relieve rheumatic pains and gout



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Uses

skin disorders (abscesses, pimples and boils)leaves and/or stalks boiled and pounded then applied directly to the afflicted area

Infusion or Decoction:

boil 1 cup of leaves/stem in 2 cups of water and taken twice a day



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YERBA BUENA (Clinopodium douglasii)

Herb of the mint family & commonly known as Peppermint

Primary active component is menthol responsible for antispasmodic, antiseptic, carminative, anesthetic, and choleretic properties

Main parts used are flowers and leaves



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YERBA BUENA (Clinopodium douglasii)

Main components

volatile peppermint oil, composed of 50-78% menthol and 5-20% menthol esterfied with various organic acids, such as acetic and bovaleric

Other important components include

flavonoids (luteolin, menthoside), phenolic acids, and triterpenes



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HERBAL PLANT CLINICAL USEAkapulko Antifungal

Ampalaya NIDDM

Bawang Antihyperlipidemic

Bayabas Antiseptic

Lagundi Asthma/Cough

Niyog-niyogan Antihelminthic

Sambong Diuretic

Tsaang gubat Antispasmodic

Ulasimang-Bato Rheumatism/Gout

Yerba Buena Antiseptic/Antispasmodic



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Other Commonly Used Herbal Medicines in the Philippines

Not approved by regulatory agencies such as the Philippine BFAD or the US FDA

In general, due to lack of pharmacologic and toxicologic data, avoid use in pregnancy

Evidence of effects sometimes anecdotal



HERBAL MEDICINE

Other Commonly Used Herbal Medicines in the Philippines


Plant Uses

Banaba Non-insulin dependent diabetes

Luya/Ginger (Zingiber officinale)

cold, cough, fever, sore throat, lowering cholesterol levels, nausea and vomiting; anti-fungal, anti-viral, and anti-inflammatory properties

Sabila (Aloe barbardensis)

moisturizing and hydrating the skin; supposed anti-oxidant effect when ingested (anti-hypertensive effects as well as for arthritis and diabetes)

Ginseng (Panax ginseng) improved physical and cognitive performance, mood, and metabolism, Additive anti-coagulant effect if used with warfarin



Usual Formulations Available for Herbal Preparations

For External Applications

• Oils

• Lotion

• Expressed from leaves, flowers of plants/herbs and peels of fruits, mostly citrus fruits

• Diluted before applied topically

• For massage, aromatherapy, mild astringent, carminative, stimulant, anti-septic

• Liniments

• Ointments• Semi-solid preparation with

one or more herbal medicaments dissolved or dispersed in suitable base

• Applied on skin and mucous• Base + Essential/Herbal

Oils

• Liquid or semi-liquid preparation

• Applied on skin without friction

• Mixtures of Oils, Creams and Glycerin

• Liquid or Semi-liquid preparation

• Applied on intact skin with friction

• Mixtures of Oils

• Pastes

• Semi-solid mixture of paraffin or mucilages as the base and finely powdered herbal medicaments

• External use only• More of powdered herbs than

base

Maulion, Marienelle R. Class No. 66


Usual Formulations Available for Herbal Preparations

For Oral Intake

Maulion, Marienelle R. Class No. 66

• Elixirs

• Infusions

• Capsules

• Juices

• Syrups

• Aromatic liquid preparation with high proportion of alcohol, glycerin and propylene glycol

• For potent or nauseous herbal medicaments

• Ground-powdered fresh or dried herbs contained in hard or soft gel capsules

• Easily swallowed, tasteless

• Very popular to consumers

• Expression from fruits, flowering tops, leaves

• Taken immediately after extraction

• Can be stored and refrigerated in tightly sealed bottle

• Dilute solutions of water-soluble herbal extracts

• Maceration for varying short periods of time (5 mins to 2 hours)

• Herbs enclosed in cloth and suspended like a tea bag

• Concentrated solutions of sucrose

• Sweet vehicle for nauseous herbal medicines

• Higher sucrose concentration for preservation of herbal extracts

HERBAL MEDICINE

Herbal Therapies +

Prescription and Non-prescription

Medications

HERB-DRUG INTERACTIONS Herbal therapies and drugs can interact in the body, causing changes in the way the herbs and/or drugs work. Interactions can be beneficial or harmful.

= possible dangerous side effects and/or reduced benefits from the medications

Medina, Kristianne Rachel P. Class No. 69


HERBAL MEDICINE

Research on herbal therapies is not nearly as advanced as research on drugs

Herbal studies are not studied or monitored for safety and potential interactions

Herbal products have not been regulated for purity and potency

Very little is known about herb-drug interactions

– anecdotal information– clinical experience– case reports

Sources of information

– in vitro studies– observational studies– pharmacokinetic studies



HERBAL MEDICINE

DIETARY SUPPLEMENT-a product (other than tobacco) that is intended to

supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients

- not subject to premarket safety evaluations - must meet the requirements of other safety provisions

Dietary Supplement Health and Education Act of 1994 (DSHEA)



HERBAL MEDICINE

Claims to prevent, treat, or cure a specific disease are expressly prohibited.

Statements describing the supplement's effects on the "structure and function" or general "well-being" of the body are allowed, as long as they are truthful and should bear the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.“

The product label must identify the product as a dietary supplement.- Dietary Supplement Health and

Education Act of 1994

Labeling of Dietary Supplements




HERBAL MEDICINE

Populations most susceptible to interactionsPatients with Cardiac or CVD disease

Take drugs with narrow therapeutics windowsAnticoagulants, cardiac glycosides

ElderlyChronic drugs

DiabeticsEffects on glucose controlSecondary problems warranting drug therapy

Who is at risk of herb-drug interactions?



Significant risk for patientsImmunosuppressives

cyclosporine

AnticoagulantsWarfarin

Protease inhibitors (AIDS)

Who is at risk of herb-drug interactions?



Absorption a herb/drug that alters the stomach pH (anti-acids) or intestinal motility (laxatives)

Metabolism duration of an herb or drug in the body depends on whether the liver’s metabolism is induced or inhibited

Elimination affected by the individual’s kidneys function or by drugs’ toxic side effects

Health condition, age, body weight, metabolic rate and dosage

Pharmacokinetic Interactions



Substances may interact by direct chemical action with each other, either before ingestion, or while mixed together in the stomach and intestines.

Herb and drugs may work together (synergistically) or in opposition (antagonistically).

Difficult to predict or prevent

Pharmacodynamic Interactions



Herb-Drug and Herb-Herb Interactions


Decreased bioavailability of drug

↓ Absorption fibersmucilage herbs↑ p-glycoprotein

↑ Metabolism ↑ CYP 450

↑ Eliminationlaxative herbsdiuretic herbs

Increased bioavailability of drug

↑ AbsorptionGingerCayenneBlack Pepper

↓ Metabolsim ↓ CYP 450 Grapefruit Juice

↓ EliminationLicorice- anti-

diuretic


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Potentiation of drug via similar activityDrug diuretic and herb diuretic

Potentiation of drug via complementary activity↓ P-glycoprotein system (Eluthero and antibiotics)Bitter melon, gymnema, fenugreek and insulin or oral

hypoglycemicsDecreased effectiveness of drug via antagonistic activity

CNS stimulant with CNS depressantReduced side effects of drug

Milk Thistle and hepatotoxic drugsLicorice and corticosteroidsAstragalus and chemotherapeutics


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May ↑ bleeding with anticoagulants

May ↑ effects of antibiotics

↑ efficacy of vincristine and 5-fluoroiuracil

Bromelain


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↑ metabolism of drugs by enhancing absorption (↑ bioavailability)

↓ gastric mucosal damage when taken 30 minutes before ASA

Aggravates ACE inhibitor cough and reduces drug action

Cayenne


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Additive effect on neurotransmitter levels with MAO inhibitors

↓ drug performance of beta blockers, may cause arrythmias or BP elevation

↑ steroid drug clearance thus, reducing therapy effectiveness

Ephedra


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May ↑ bleeding times with anticoagulants risk of spontaneous and post-op bleeding

↓ blood levels of protease inhibitors

↑ indomethacin, insulin, statins

Preparations containing allicin may increase the activity of 3A4

Garlic


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May ↑ absorption of drugs

↑ bioavailability

Synergistic with anticoagulants, possible ↑ coagulation

May ↑ cholesterol lowering effects of statins

Reduces after-effects of general anesthesia (↓ N & V)

Case reports of ↓ effect of antacids (heartburn)

Ginger


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May ↑ spontaneous and post-op bleeding with anticoagulants, ASA and general anesthetics

May ↑ activity and side effects of MAO inhibitors

May ↑ efficacy (potency) of haloperidol in schizophrenia (study)

↑ nifedipine plasma levels

Gingko

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Potentiation when taken with anticoagulants

↑ alcohol metabolism leading to ↑ clearance

Synergistic with insulin, improves diabetic symptoms

Synergistic with influenza vaccine, reduces flu symptoms, frequency and severity

Ginseng



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Inhibits absorption of codeine or theophylline

May ↓ effect of coronary vasodilator drugsSynergistic with sulindac and/or tomaxifen, ↓ adverse effects

Contains vitamin K, thus, can render warfarin ineffective

Should not be mixed with aspirin because they both prevent platelets from clotting

Green Tea


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Take the herbs and the drugs at different times of day, or at least separated by many hours.

Just because it’s natural does not mean it is harmless.

Knowledge is the best defense againstdrug-herb and herb-herb interactions.

Remember that no drug or herb has “no known side effects”.

HERBAL MEDICINE Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb InteractionsLaws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices

Proclamation No. 698

IntrinsicGenetic factors

Growth Characteristics

On August 19, 2004, Pres. Gloria Macapagal-Arroyo declared the month of November as

“TRADITIONAL & ALTERNATIVE HEALTH MONTH”

to promote and be able to provide an array of adorable, accessible and effective traditional and complementary / alternative health care

options for our people to choose from

to accelerate the development of traditional and alternative medicine for the good of our people

HERBAL MEDICINELaws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices

BA 2008-002

BFAD Health Advisory on January 16, 2008Immediate Recall of Penrex Herbal Supplement For Men

It was found to contain Sildenafil Citrate, a component dangerous to persons with heart ailments

Classified as herbal supplement, so it should not contain any active ingredient for drug products


HERBAL MEDICINE

BA 2001-001

BFAD Health Advisory on March 26, 2001Warning on the use of Glo-herbal drink/products

It is NOT REGISTERED with the Bureau NOR ALLOWED TO BE ADVERTISED OR PROMOTED

FOR ANY THERAPEUTIC INDICATION.

manufacturer of said products have not submitted scientifically valid proofs to show and substantiate the therapeutic effects that are being claimed for the products

Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices



BA 2000-006

BFAD Health Advisory on September 1, 2000

Warning on the use of “CURE-ALL” products

Adverse events being associated with the use of some “cure all” products such as the "PDA Water" from Tarlac City, Mahogany seeds and other herbal preparations have been reported.

Products that are being promoted as "cure-all" do not have any scientific basis of safety and efficacy



Important Guidelines in Taking Herbal Medicine

Factors Affecting Safety and Quality Control of Raw Materials

IntrinsicGenetic factors

Growth Characteristics

ExtrinsicEnvironment

Collection methods

Cultivation

Harvest

Post-harvest

Processing

Transport

Storage practices

Macasaet, Aelleen P. Class No. 44

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WHO Guidelines on Good Agricultural Collection Practices

Reasons for Formulation of the Guidelines:


Increase in use of herbal medicines worldwide

Increase in reports of adverse effects

Insufficient attention paid to the quality assurance and control of herbal medicines


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WHO Guidelines on Good Agricultural Collection Practices

STRUCTURE


Section 1: General Introduction

Section 2: Good agricultural practices for medicinal plants

Section 3: Good collection practices for medicinal plants

Section 4: Common technical aspects of good agricultural

practices for medicinal plants and good collection practices for

medicinal plants

Section 5: Other relevant issues



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Section 2


• Selection of Medicinal PlantsConsult national pharmacopoeia or authoritative national documents of the end-user's country or that of other countries

Identification/authentication of cultivated medicinal plants


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Section 2


• Selection of Medicinal Plants– Consult national pharmacopoeia or authoritative

national documents of the end-user's country or that of other countries

– Newly introduced plants• Species/botanical variety used in traditional medicine

of the original country



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Section 2


• Botanical Identity– Scientific name• Genus, Species, subspecies/variety, Author,

Family– Local and English common names if available– Others (e.g. Cultivar) as appropriate


HERBAL MEDICINE

Section 2


• Specified• Provide information– Identity, Quality, Performance, Breeding

history• Of best quality

Seeds and other propagation materials



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Section 2


• Intensive care and management• Different plant materials vary in conditions and

duration• Should have a basis– Scientifically published– Traditional methods– Research

• Apply Conservation Agriculture (CA) techniques– Prevent build-up of organic matter– Conserve soil humidity

Cultivation


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Section 2


• Optimal season or time period• Depends on the plant part to be used• Should have a basis

N.B. Best time of harvest based on the quality and quantity of biologically active constituents not on the total vegetative yield.

Harvest


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Section 2


• Adequate knowledge• Maintain appropriate personal hygiene• Apply agrochemicals: wear appropriate

protective clothing• Receive instruction on proper agricultural

stewardship

Personnel

HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing

Permission to Collect

Nallas, Anna Pauline R. Class No. 91

Need to procure permission prior to collectCollection permits and related documents (government and landowners)National “red” listsExport from country of origin – permits also

WHO General Strategies and Methods for Collection of Fresh Medicinal Plants




Technical Planning


“Geographical distribution and population density” of any medicinal plant

Location of the collection area from the home base and the quality of the plant after being transported

Research and the Team: Personnel and Transportation

Social and Ecological Impact

Sustainability and Management



Selection of Medicinal Plants for Collection


“National Pharmacopoeia” or those recommended by other “authoritative national documents” for the target country

Sufficient identification, documentation and description of the plant (traditional medicine)

Prepare and submit botanical specimens to the “regional or national herbaria” for authentication

“Recorded and maintained” for identification



Collection


“Long-terms survival of wild populations and their associated habitats” Demographic structures Government and environmental authorities ensure the continuous cultivation Best possible quality, Best time of collectionEcologically non-destructive systemsLocation cautionProper collected and packed, Preliminary processing



Personnel


ExpertsFull documentationBotanical trainingInstructions protection, sustainability, maintenanceKnowledgeable linksWelfare and safetyProtect personnel clothing and health


Post Harvesting

Ong, Maynard Ivan F. Class No. 110

Inspection and sortingvisual inspection for cross-contamination visual inspection for foreign matter

EvaluationAppearancefree from contamination and decomposition

Storage and Transportationensure their integrity

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Processing


Dryingmoisture content kept as low as possible reduce damage from mould and other microbial infestationtemperature and humidity should be controlled

MethodsIn the open air (shaded from direct sunlight)Direct sunlight, if appropriate

WHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing

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Processing


Indirect fireDrying ovens/rooms and solar dryersBakingLyophilizationMicrowave or infrared devices


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Specific Processing


To improve the purityEnhance efficacyReduce time of processingReduce damage due to environment exposureMethods

pre-selection peeling the skins of roots and rhizomes


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Specific Processing


boiling in water steaming soaking pickling distillationfumigationroasting natural fermentationtreatment with lime and chopping


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Processing Facilities


Location– Accessibility– Drainage– Odors ,smoke, dust

Building– Design and layout of station areas– Construction materials– Environment control



Handling Areas


Construction considerations Preventing accumulation of dirt, moulds, and general cleanliness

Objective Preventing contamination Preserving their therapeutic integrity Provide minimal alterations to their physical

or chemical properties


Other Considerations


Water SupplyEffluent and Waste DisposalChanging facilities and ToiletsHand-washing and disinfection facilitiesLightingVentilationBulk packaging and Labeling

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Storage and TransportationMaterialsIdentificationQuality AssuranceDocumentationPersonnel


HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing Evaluation of Safety and Efficacy

Classification of Herbal Medicines

Madulara, Glaiza M. Class No. 47

World Health Organization (WHO)• Guidelines for the regulation of herbal medicines in the South-East Asia Region • based on origin, evolution and the forms of current usage

assessment of the ways in which quality, safety and efficacy of these medicinal plants can be determined and further improved

HERBAL MEDICINE Evaluation of Safety and Efficacy

Classification of Herbal Medicines


Category 1 --- Indigenous herbal medicines• historically used medicinal plants in a local community or region

Category 2 --- Herbal medicines in systems• used for a long time and officially documented with their special theories and concepts

Category 3 --- Modified herbal medicines• modified medicinal plants• shape, form, dose, dosage form, mode of administration, herbal medicinal ingredients, methods of preparation and medical indications

Category 4 --- Imported products with a herbal medicine base• all imported herbal medicines


Requirements for Assessment of Safety of Herbal Medicines


SAFEcauses no known or potential harm to user

Categories of Safety WHO

To determine the nature of the safety requirements that would have to be ensured

Three categories


Requirements for Assessment of Safety of Herbal Medicines


Three Categories of Safety:

Safety Category 1 • safety is well-established due to use over long time

Safety Category 2 • safe under specific conditions of use

Safety Category 3 • uncertain safety • the safety data required for this class of drugs will be identical to that of any new substance



Guidelines for Toxicity Investigation of Herbal Medicines General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine by the WHO

Specify the standard methods of toxicological studies assessing the safety and efficacy of herbal medicines

Two Main Toxicity Tests used in the study of herbal medicine Acute toxicity studies

necessary for any pharmaceutical intended for human use

Long term toxicity test observe symptoms, herbal actions and toxicity after prolonged treatment

Data Gathering



Data Gathering

Acute-Toxicity Testing

Animal species At least two species: rodents AND non-rodents

Sex In at least one of the species, males and females should be used.

Number of animals Rodents

at least five animals per genderNon-rodents

at least two animals per gender.

Route of administration oral route - normal route of clinical administrationparenteral route of administration

Long-term Toxicity Testing

Animal species At least two species: rodents AND non-rodents

Sex Same number of male and female animals should be used

Number of animals Rodents

at least 10 males and 10 femalesNon-rodents

at least 3 males and 3 females

Route of administration oral route parenteral route of administration



Data Gathering

Acute-Toxicity Testing

Dose levels Rodents

Verify the approximate lethal dosenon-rodents

Observation of overt toxic signs.

Frequency of administration Test substance should be administered in one/more doses during a 24-hr period.

Observation Observed and recorded in relation to dose & time

Toxic signs Severity, onset, progression and Reversibility of the signs

Observed for at least 7 - 14 days

Dead and surviving animalsshould be autopsied, histopathological examination



Data Gathering

Long-term Toxicity TestingExpected Period of

Clinical UseAdministration period for the Toxicity Study

Single Administration or Repeated

Administration for < 1 week

2 weeks – 1 month

Repeated Administration,

between 1 – 4 weeks

4 weeks – 3 months

Repeated Administration,

between 1 – 6 months

3 – 6 months

Long-term repeated administration for > 6

months

9 – 12 months

Administration period • test substance should be administered 7 days a week.

• the commonly used ranges of administration periods



Establishment of Safety and Efficacy

Guiding principle in the assessment of safety when the product has been traditionally used without demonstrated harm

Lack of any reported or documented side-effects not an absolute assurance of safety for herbal medicines

Additional toxicity studies must be performed only whendoubts about its safetyno documentation of long historical use in-vitro studies -- preferredin-vivo study -- conducted humanely

Safety



Establishment of Safety and Efficacy

Requirements for proof of efficacy -- supporting documentation Well-established, randomized controlled clinical trials

provide the highest level of evidence for efficacy designed to determine the efficacy and safety of the product under normal conditions of use

Efficacy


Traditional/Herbal Medication Quality Assurance and Promotion in the Philippine Setting


Quality assurance and control measuresNational quality specification and standards for herbal materials, good manufacturing practices (GMP) for herbal medicines, labeling, and licensing schemes for manufacturing, imports and marketingvital for ensuring the safety and efficacy of herbal medicines

Weak regulation and quality control may result in a high incidence of adverse reactions attributable to poor quality of herbal medicines

Regulation and control of herbal products Under the authority of the Bureau of Food and Drugs (BFAD) of the DOH

Quality Assurance BFADOnce achieved High promotion of the BFAD seal of good quality to

physicians and pharmacists

Balan, Lim, J., Lim, V., Macasaet, Madulara, Maulion, Medina, Nallas, Ong, Ongoco, Palma

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THANK YOU.

University of Santo TomasFaculty of Medicine and Surgery

Department of Pharmacology

Seminar on

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Documents

Herbal Med 2008-09-05 (Narrow, No Anima)