Chapter II

Theoretical Framework

This chapter presents the relevant theories, review of related literature, studies,

conceptual framework, hypothesis and definition of various relevant terms used in the

study.

Relevant Theories

Gerard Bodeker, a leading international expert on medicinal plants from Green

College, Oxford, thinks that the issues on the production of herbal products are

conservative (Edwards, 2014). Most of the processes involved in supplying the growing

market for herbal remedies are result of unsustainable and often destructive practices

driven by poverty. He said that people do not replace what they take. For instance, the

market for African cherry (Prunus africana), the bark of which is popular in Europe as a

treatment for prostate enlargement, has collapsed because too many trees have been

destroyed. In the past the trees, which grow in Africa's mountain regions, survived because

traditionally less than half of their bark was harvested. But according to a study by Kristine

Stewart, from consultants Keith and Schnars in Florida, growing commercial pressures

have led to whole forests being stripped or felled. Exports of dried bark halved between

1997 and 2000. Bodeker also says that there is a complete lack of awareness and lack of

education amongst consumers. And those that use herbal medicines might be expected to

be more environmentally aware than most.

 According to Vickers, Jolly & Greenfield (2014) in their study entitled herbal

medicine: women’s view, knowledge and interaction with doctors, they have concluded

that women in Chesire, UK aged 18 years and above that belong to a higher socio-economic

grouping had little knowledge about herb-drug interactions and rarely disclosed use of

herbal medicines to their doctor. They have found out that motivations for herbal medicine

use were varied but all included at least one of three subcategories: perceived advantages

of herbal medicines, beliefs about the disadvantages of conventional health care and

medicines. They have also cited in their background that people may use complementary

and alternative medicines because prescribed medication is not working or has side effects.

In addition, they’ve cited that previous studies have indicated primary predictors of herbal

medicine use is female gender, white, ethnic origin, high educational status and high

income. Studies have found different age ranges for the highest prevalence of herbal

medicine use ranging from young to late middle age.

According to McCaleb, Leigh & Morien (2014) there is a major trend today toward

greater personal responsibility and choice of health care. People are taking the initiative to

learn more about their health and different treatment options for health conditions. People

are becoming more involved in the decision-making process on issues affecting their own

treatment. They are less willing to simply follow doctor’s orders without better

understanding what alternatives may exist such as herbal medicine. Herbal medicines are

also preventive medicine. Amongst the best-researched European phytomedicne are agents

that can reduce the risk of heart disease, cancer, respiratory distress, and liver disease. And

one of the herbal remedies that are best-researched for reducing cholesterol and prevention

against stomach cancer includes garlic. In addition to preventive actions, herbal medicine
can save as safe and effective direct replacements for over-the counter drugs. One of the

strongest benefits of herbs is that they work within the body that brings superior results and

less risk than strong synthetic drugs.

Related Literature

What are the profile of parents in terms of:

1.1 Age

1.2 Socioeconomic Status

1.3 Occupation

1.4 Civil Status

1.5 Employment Status

1.6 Educational Attainment

2.1 Environment Air pollution remains a leading cause of many respiratory diseases

including chronic cough. Although episodes of incidental, dramatic air pollution are

relatively rare, current levels of exposure of pollutants in industrialized and developing

countries such as total articles, diesel exhaust particles and common cigarette smoke may

be responsible for the development of chronic cough both in children and adults. The

present study analyses the effects of common environmental factors as potential causes of

chronic cough. Different PubMed-based researches were performed that related the term

cough to various environmental factors. There is some evidence that chronic inhalation of

diesel can lead to the development of cough. For long-term exposure to nitrogen dioxide

(NO2), children were found to exhibit increased incidences of chronic cough and decreased

lung function parameters. Although a number of studies did not show that outdoor pollution

directly causes the development of asthma, they have demonstrated that high levels

pollutants and their interaction with sunlight produce ozone (O3) and that repeated

exposure to it can lead to chronic cough. In summary, next to the well-known air pollutants

which also include particulate matter and sulfur dioxide, a number of other indoor and

outdoor pollutants have been demonstrated to cause chronic cough and therefore,

environmental factors have to be taken into account as potential initiators of both adult and

pediatric chronic cough.

Coughing and mucus secretion are coordinated neuronal reflexes that protect the

respiratory tract from noxious exogenous substances under physiological conditions.

However, within chronic exposure to noxious substances such as tobacco smoke, urban

dust, or occupational factors, the originally protective mechanisms may lead to a states of
chronic distress with hypersecretion and chronic coughing. The neurophysiology of the

cough reflex and its relation to bronchoconstriction and different forms of adult and

pediatric asthma is very complex. However, there is little doubt that chronic cough can be

related to the exposure to different environmental air pollutants. Amongst them, pollutants

such as diesel exhaust, ozone, nitrogen and sulfur dioxide have all been suggested to

participate as main causes or co-factors in the development of chronic cough. These

suggestions do not only base on epidemiological and clinical observations, but also on the

neurophysiological and -anatomical understanding of the cough reflex. In this respect it is

generally accepted, that airway pollutant-caused airway irritation leading to chronic cough

displays a complex phenomenon involving a variety of reflex mechanisms.

Neurophysiologically, a subgroup of rapidly adapting receptors (RARs) among the

three major types of vagal sensory receptors is suggested to act as "cough receptors". Next

to these RARs, a further effect by bronchopulmonary C-fibers on the cough reflex has been

suggested, and there are data indicating that i.e. ozone, one of the main environmental air

pollutants, exerts an influence on vagal-sensory innervation. Also, transient receptor

potential vanilloid-1 seems to play a role in the mediation of the cough reflex and airway

nerves and their mediators in general are likely to play an important role in the general

pathology of cough and airway inflammation.

In the light of the clinical, epidemiological and experimental data which point to a

major role of environmental pollutants as co-factors for the development and progression

of chronic cough, the present study analyzed the data available on the association between

environmental pollutants and chronic cough on the basis of a large amount of existing
recent literature reviews and original articles. It illustrates the deposition of some

environmental pollutants related to cough in the respiratory tract.

2.2 Personal Hygiene Mental hygiene, industrial hygiene, oral hygiene, vocal

hygiene, respiratory hygiene. There are many “hygienes,” but what does the word actually

mean? Its definition the science of preventive medicine and the preservation of health is

broad enough to incorporate concepts such as exercise and diet. But the original and still

generally understood usage is in the context of preventing the transmission of infection.

Public concerns about SARS (severe acute respiratory syndrome) and current efforts to

identify community practices to respond to avian influenza outbreaks or pandemic

influenza have returned hygiene concepts to the public sphere. Home hygiene and

community hygiene are now recurrent themes in public health messages.

Hand hygiene, household cleaning and food safety constitute the main focus for

hygiene interventions in the home and community. Consistent recommendations are to

clean hands often by washing with soap and warm water, or to use alcohol-based gel

sanitizers if running water is not accessible. Hands should be washed before eating, before

preparing food, after using the toilet, changing diapers or other similar exposure, and after

playing with or feeding pets. Hand hygiene after contact with potentially infected fomites

or infected people is also appropriate. Consistent environmental cleaning with detergent,

especially of frequently touched objects, is also recommended. Respiratory hygiene, or

respiratory etiquette, is another current message directed to potentially infected people. It

includes turning away and covering the mouth or nose when coughing or sneezing, together

with appropriate disposal of tissues, hand hygiene, and staying home when ill with a cough

and fever.
3. Herbal Plants

Among patients who see mainstream health care providers, 33% to 42% use herbal

remedies (Fetrow & Avila 2014). Many of these patients fail to disclose this fact to their

primary health care providers. Market sales of herbs in the United States were an estimated

$14 billion in 2000, and rate of growth has increased dramatically in recent years. Studies

indicate that many patients who use alternative medicines and also seek conventional

treatment exercise more; are more careful about avoiding fatty foods, tobacco, and alcohol;

are more compliant with their regular medication regimen; and make lifestyle

modifications more readily than patients who seek conventional health care alone. The

National Institute of Health (NIH) estimates that in the United States about one in three

persons pursues some form of complementary or alternative medical therapy, such as

herbal medicine, acupuncture, aromatherapy, Ayurvedic medicine, or Bach flower

remedies. The use of such therapies is probably greatest in certain subgroups of the

population, such as the terminally or chronically ill. Many drugs commonly used today are

of herbal origin. Indeed, about 25 percent of the prescription drugs dispensed in the United

States contain at least one active ingredient derived from plant material. Some are made

from plant extracts while others are synthesized to mimic a natural plant compound.

According to the World Health Organization (2014) estimate, four billion people

or 80 percent of the world’s population presently use herbal medicine for some aspect of

primary health care. Herbal medicine is a major component in all indigenous peoples’

traditional medicine and a common element in Ayurvedic, homeopathic, naturopathic,

traditional oriental and Native American Indian medicine. The World Health Organization

(WHO) notes that of 119 plant-derived pharmaceutical medicines, about 74 percent are
used in modern medicine in ways that correlated directly with their traditional uses as plant

medicines by native cultures. Major pharmaceutical companies are currently conducting

extensive research on plant materials gathered from the rain forests and other places for

their potential medicinal value.

As part of primary health care and because of the increasing costs of drugs, the

Department of Health of the Philippines had been promoting products of medicinal plants

as alternative medicines (Reyala, 2013). Many local plants and herbs in the Philippine

backyard and field have been found to be effective in the treatment of common ailments as

attested to by the National Science Development Board, other government and private

agencies engaged in research.

The Department of Health (DOH) said its campaign to promote alternative health

care and herbal medicines in the country has been successful (Philippine Nurses

Association (2015). The Department of Health’s health education and promotion officer

said Filipinos have been using alternative health care to avoid hospital expenses. Herbal

medicines are also becoming widely popular with the high price of imported medicines.

This was shown by results of a National Demographic and Health Survey (NDHS) done

by the National Statistics Office (NSO). DOH health education and promotion officer said

this is proof that DOH's promotion is successful. The survey showed that in Central Visayas

alone, about 67.6 percent of households are familiar with acupressure or therapeutic

massage and iridology. Other modes relatively known are acupuncture and aromatherapy.

As to herbal medicines, the NSO survey showed that guava is the most commonly used in

Central Visayas, with 59.8 percent of households having at least one member using the

herbal medicine. Other popular herbal medicines are sambong, ampalaya and bawang
(garlic). The NDHS also said most Filipinos are aware of the serious diseases in the country

today, such as the acquired immune deficiency syndrome (AIDS), dengue, malaria,

diabetes, leprosy and cancer. This shows the DOH has been successful in its information

campaign. The NDHS data was made for decision makers to improve health services in the

country.

Extensive research by Filipino scientists is done because the cheap yet effective

herbal medicine helps many Filipino families (Lacanilao, 2014). The Department of

Science and Technology has scientifically validated 102 plants for safety and efficacy. Ten

of these plants are under different stages of development, and that studies have been

completed on sambong, lagundi, and akapulko. From sambong and lagundi alone, a local

maker of herbal drugs is earning millions of pesos. But recent reviews of the scientific

literature on herbal medicinal products have a warning: they are not risk free. One such

review was conducted by scientist from the Department of Complementary Medicine,

Universities of Exeter and Plymouth, United Kingdom. It was published in the journal

Pharmacoepidemiology and Drug Safety in 2014. The study focused on the toxicity,

interactions, and quality of herbal products. Toxicity data indicate that some herbal drugs

have the potential to cause serious adverse events and fatalities. They affect

pharmacokinetic and pharmacodynamic factors and thus cause herb-drug interactions.

Contamination, adulteration, or substitution of botanical material has repeatedly put

patients in danger, and that most often implicated are herbal drugs from Asia. The review

concludes that the widespread notion of herbal drugs being inherently safe is naive at best

and dangerous at worst, and that more research and more information are required to ensure

consumer’s safety.
Cough

Breathing is synonymous with life. The experience of difficulty of breathing is

perceived by the person as a threat to life itself (Quiambao O-udan, 2009 p. 111) . All

human beings experienced cough due to different reasons. Coughing greatly affects the

life or activity of daily living of each and everyone of us. Coughing can either alter level

of concentration of a person thus making him/her unable to perform usual task.

Cough are often common symptoms caused by many factors. It can result from

a bacterial or viral spread, or can be due to an underlying condition. The seriousness of a

cough depends on the amount and color of sputum, the frequency and the duration of the

coughing episodes. Cough syrups are abundantly available in the market today. But the

controversy of their effectiveness troubles a lot of consumers. Understandably, most cough

syrups do have sedative side effects that can affect your daily activities. Although the drug

provides coughing relief, the use of these over-the-counter drugs should be observed

carefully especially when given to children.

Cough medications come in different classes: antitussiives, expectorants,

mucolytics, and suppressants. Antitussives are specially formulated to prevent the

coughing action. Expectorants contribute to the expulsion of phlegm from the airway

passages. Mucolytics are intended to unclog the respiratory passages by “melting” the

mucus and phlegm. Suppressants act on coughs by suppressing the coughing reflex. A

natural way to treat common coughs is to take herbal meds. Although some people frown

on its use, studies and testimonials from other users have found herbal medicine effective

for the treatment and relief of coughing episodes. Still, precaution should be practiced, and
you should get advice from medical experts to check if you bear allergies to these herbs.

Here are the commonly used herbs for coughs:

(Premna odorata) The alagaw is a herbal plant from the Philippines that is used to

loosen phlegm and relieve coughs. Fresh alagaw leaves with sugar for taste are boiled in

water. Drinking this concoction will relieve coughing.(Echinacea angustifolia/E. pallida/E.

purpurea) This is a highly recommendable herb for colds, cough and flu especially for those

who reside in North America and Europe. This herb alleviates cough in tincture form.

(Eucalyptus globules) The essential oil found in eucalyptus acts to loosen the phlegm

within the air passages. Inhaling eucalyptus vapors can help treat coughs. It is

recommended to use fresh leaves in teas or gargles to soothe irritated throats brought by

coughs. Also, ointments containing this herb can be applied to chest area to relieve

congestion.(Vitex negundo L) Lagundi is recognized as an effective expectorant. It is a

common herbal plant found in the Philippines. The dried or fresh lagundi leaves are

boiled. Drinking this concoction will yield cough and asthma relief.

The literature on phytotherapeutic treatments for cough was searched in March

2013, via the Cochrane Library, MEDLINE (PubMed), Scopus, and Embase databases.

Initially, ‘cough' was searched as a generic symptom, not related to specific medical

conditions or etiologies, treated with different complementary and alternative medicine

(CAM) approaches. The treatments were chosen according to the definitions provided by

the National Institutes of Health's National Center for Complementary and Alternative

Medicine. Other search terms focused on ‘cough' as a symptom of varied respiratory

conditions including: ‘bronchitis', ‘common cold', ‘respiratory tract infection', ‘upper

respiratory tract infection', ‘lower respiratory tract infection', ‘pneumonia', ‘chronic

pulmonary diseases', ‘chronic obstructive pulmonary disease', ‘pulmonary disease',

‘respiratory dysfunction', ‘flu', and ‘influenza'. These terms were then combined with

different phytotherapeutic agents.

Clinical Effects of Herbal Medicine

The World Health Organization is fully aware of the importance of herbal

medicines to the health of many people throughout the world, as stated in a number of

resolutions adopted by the World Health Assembly and the Regional Committee for the

Western Pacific. Thus herbal medicines have been recognized as a valuable and readily

available resource for primary health care, and WHO has endorsed their safe and effective

use. A comprehensive program for the identification, cultivation, preparation, evaluation,

utilization and conservation of herbal medicines has been developed. Meanwhile, it has

been realized that medicinal plants are a valuable resource for new pharmaceutical products

and thus a potential source of new drugs as well as for economic development.

WHO supports the appropriate use of herbal medicines and encourages the use of

remedies that have been proven to be safe and effective. A few herbal medicines have

withstood scientific testing, but others are used simply for traditional reasons to protect,

restore or improve health. Most herbal medicines still need to be studied scientifically,

although the experience obtained from their traditional use over the years should not be

ignored. Member States have been seeking the cooperation of WHO in identifying safe and

effective herbal medicines for use in their national health care systems. As there is not

enough evidence produced by common scientific approaches to answer questions of safety

and efficacy about most of the herbal medicines now in use, the rational use and further

development of herbal medicines will be supported by further appropriate scientific studies

of these products, and thus the development of criteria for such studies. (World Health

Organization 2018)

The extent to which the traditional use of an herb ensures that a

corresponding herbal drug is safe, however, is a debachart matter. A new draft regulation

published by the Brazilian National Health Surveillance Agency (Anvisa) brought this

controversial topic to the center stage. The proposed regulation, which has recently

undergone a public consultation for reviews and comments, defines two categories of

herbal drugs for registration: “phytotherapeutic medicines” and “traditional

phytotherapeutic products” (TPTP) (Anvisa, 2013). A product fits into the latter category

if a long-standing (traditional) use is identified that has not been proven unsafe and is

recognized in the literature or demonstrated by ethno- pharmacological and/or ethno-

botanical studies. Once the traditional use is recognized, safety and efficacy data from pre-

clinical and/or clinical studies are no longer essential requirements to obtain approval

for commercialization.

The proposed new rules for herbal medicine registration in Brazil are, to some

extent, similar to the regulation released by the European Parliament in 2014. According

to EC Directive 2004/24, herbal medicines with traditional use that are acceptably safe,

albeit not having a recognized level of efficacy, can be classified as “traditional herbal

medicines products” (THMP), as detailed by Calapai (2013), Quintus and Schweim

(2014) and Silano et al. (2014).

The extent to which the traditional use of an herb ensures that a

corresponding herbal drug is safe, however, is a debachart matter. A new draft regulation

published by the Brazilian National Health Surveillance Agency (Anvisa) brought this
controversial topic to the center stage. The proposed regulation, which has recently

undergone a public consultation for reviews and comments, defines two categories of

herbal drugs for registration: “phytotherapeutic medicines” and “traditional

phytotherapeutic products” (TPTP) (Anvisa, 2013). A product fits into the latter category

if a long-standing (traditional) use is identified that has not been proven unsafe and is

recognized in the literature or demonstrated by ethno- pharmacological and/or ethno-

botanical studies. Once the traditional use is recognized, safety and efficacy data from pre-

clinical and/or clinical studies are no longer essential requirements to obtain approval

for commercialization.

The proposed new rules for herbal medicine registration in Brazil are, to some

extent, similar to the regulation released by the European Parliament in 2014. According

to EC Directive 2004/24, herbal medicines with traditional use that are acceptably safe,

albeit not having a recognized level of efficacy, can be classified as “traditional herbal

medicines products” (THMP), as detailed by Calapai (2013), Quintus and Schweim

(2013) and Silano et al. (2014). In order for a medicinal product,or its corresponding

products (i.e., products having the same active ingredients, the same or similar intended

purpose, equivalent strength and posology and the same or similar route of administration),

to be classified as THMP, it must have been in medicinal use for a period of at least 30

years, of which more than 15 years must relate to the European Union. Herbal drugs in the

THMP category undergo a simplified registration procedure. Aspiring herbal products are

required to demonstrate the traditional use of the herb, but this requirement is lifted if the

product complies with the European positive list established by the Committee on Herbal

Medicinal Products (HPMC) (Knöss and Chinou, 2013). Herbal monographs prepared by
HPMC are not binding, and member state agencies may not agree with every single aspect

of the monograph. For instance, applicants that refer to a HPMC monograph may be

required to provide additional points on safety.

Related Literature
The use of herbal medicine has been practiced to cure diseases, ease pain and heal

bodily discomforts and ills. For example, ancient Chinese and Egyptian papyrus writings

describe medicinal plant uses. No one knows exactly when people first began using plants

for medicine, but evidence of at least six medicinal plants was found in a Neanderthal burial

site estimated to be 60,000 years old. In addition, indigenous cultures like African and

Native American used herbs in their healing rituals, while others developed traditional

medical systems like Ayurveda and Traditional Chinese Medicine. Scientists have found

that people in different parts of the globe tend to use the same or similar parts for the same

purposes (McCaleb, Leigh, & Morien, 2013).

Herbal medicines today are now being improved due to the found effectiveness on

the more complex-developing diseases. This is not surprising because many of the current

synthetic drugs have been derived from plants at some point. Herbal medicine are approved

and sold around the world with medicinal claims throughout Europe and most of Asia

(McCaleb, Leigh & Morien 2013). The use of herbal medicine has been gaining popularity

these past few years here in the Philippines as clinical proof emerges that validates many

of the age-old alternative medicines used by Filipino. And the use of herbal medicine in

the Philippines has been passed on from generation to generation (Philippine Herbal

Medicine Site, 2013). It is also readily available and abundant here in the country. Garlic,

for an instance is known to lower cholesterol levels and used to prevent heart diseases.
Bitter gourd is another vegetable grown here in the Philippines which is known for

improving the health status of those who have diabetes, liver problems and human

immunodeficiency virus (HIV) (Wikipedia, 2014).

Traditional or folk medicine comprises practices, approaches, knowledge and

beliefs not based on scientific evidence that are applied to treat, diagnose and prevent

illness within a society. It is defined by a culture's knowledge and values and thus is

context-specific, as are social constructions and negotiations of risk. According to Crellin

(2013) he stated that when modern societies adopt such long-standing health practices

outside of their traditional context, these practices become "complementary, non-

conventional or alternative medicine".

The extent to which the traditional use of an herb ensures that a corresponding

herbal drug is safe, however, is a debachart matter. A new draft regulation published by

the Brazilian National Health Surveillance Agency (Anvisa) brought this controversial

topic to the center stage. The proposed regulation, which has recently undergone a public

consultation for reviews and comments, defines two categories of herbal drugs for

registration: "phytotherapeutic medicines" and "traditional phytotherapeutic products"

(TPTP) (Anvisa, 2013). A product fits into the latter category if a long-standing

(traditional) use is identified that has not been proven unsafe and is recognized in the

literature or demonstrated by ethno-pharmacological and/or ethno-botanical studies. Once

the traditional use is recognized, safety and efficacy data from pre-clinical and/or clinical

studies are no longer essential requirements to obtain approval for commercialization.

The proposed new rules for herbal medicine registration in Brazil are, to some

extent, similar to the regulation released by the European Parliament in 2004. According
to EC Directive 2004/24, herbal medicines with traditional use that are acceptably safe,

albeit not having a recognized level of efficacy, can be classified as "traditional herbal

medicines products" (THMP), as detailed by Calapai (2013), Quintus and Schweim

(2012) and Silano et al. (2014). In order for a medicinal product,or its corresponding

products (i.e., products having the same active ingredients, the same or similar intended

purpose, equivalent strength and posology and the same or similar route of

administration), to be classified as THMP, it must have been in medicinal use for a period

of at least 30 years, of which more than 15 years must relate to the European Union.

Herbal drugs in the THMP category undergo a simplified registration procedure. Aspiring

herbal products are required to demonstrate the traditional use of the herb, but this

requirement is lifted if the product complies with the European positive list established

by the Committee on Herbal Medicinal Products (HPMC) (2013). Herbal monographs

prepared by HPMC are not binding, and member state agencies may not agree with every

single aspect of the monograph. For instance, applicants that refer to a HPMC monograph

may be required to provide additional points on safety (e.g., on genotoxicity).

In summary, both the European Medicines Agency (EMA) and the Brazilian National

Health Surveillance Agency (ANVISA) recognize a special class of

phytopharmaceuticals and take tradition into account for pre-marketing demonstrations of

safety and efficacy, thereby opening a wider door for the registration of manufactured

herbal products as medicines.

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World Health Organization (WHO). General Guidelines for Methodologies on Research

and Evaluation of Traditional Medicines. 2014.

World Health Organization (WHO). National Policy on Traditional Medicine and

Regulation of Herbal Medicines. Geneva: 2015. Report of WHO global survey.

World Health Organization (WHO). “Traditional Medicine.” http://www.who.int/topics

/traditional_medicine/en/ (accessed January 15, 2019)

Edwards, R. (2015). Herbal medicine boom threatens plants. Retrieved September 5, 2007
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Fetrow, C. W. & Avila, R. (2014). Herbal Medicine Handbook. USA: Lippincott Williams
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Herbal Use… (2015). Retrieved January 16, 2019 from http://www.gov.ph/news.
Herbal Medicine. (2017). Retrieved January 18, 2019 from http.//www.wikipedia.com.
Lacanilao, F. (2016). Medicinal Plants. Retrieved August 29,2017 from
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