Background

20

III. Hormonal Therapy

1. Steroid Hormonal contraceptives:

Combined oral contraceptive pills (COC): Although COC are commonly used

their efficacy in primary dysmenorrhoea is limited. Their mode of action is supposed to

be inhibition of ovulation and decreasing endometrial production of prostaglandins and

leukotrienes by inducing endometrial atrophy and thereby reducing the amount of

endometrial tissue available for the production of these mediators.44,

2. Other Hormonal methods

Progestin only contraceptive, (e.g. desogestrel 75 mcg.), effectively inhibits

ovulation and thus probably relieves symptoms of dysmenorrhoea. Although primarily

designed for parous women, the Levo-Norgesterol Intrauterine System (LNG-IUS) may

be an effective treatment of dysmenorrhoea.45

Other alternatives include injectable

progesterone- depomedroxyprogesterone acetate, progestin releasing implanted rods

(Norplant) have been shown to be effective; However their main side effect is they

render most of the women amenorrhoeic.

3. Gonadotropin-Releasing Hormone (GNRH) Agonists and androgens:

These agents through their oestrogen lowering effect lead to endometrial atrophy

and diminish prostaglandin production. Although they have been shown to be effective

in treating dysmenorrhoea, their substantial side effects (e.g. hirsuitism, masculinizing

effect) preclude their routine and long term use.

Background

21

Complementary and Alternative Medicine:

It is interesting to note that South African TMP have used plants with significant

COX-inhibitory activity to treat menstrual pain.46

A double-blind, randomized

controlled study indicated that extract of Psidium guajava L. (guava) leaf reduced

menstrual pain significantly compared to conventional treatment and placebo.47

Several

non-drug therapies have also been studied, including behavioral, use of exercise, topical

heat, acupuncture, acupressure, chiropractic care and the use of Transcutaneous

Electronic Nerve Stimulation (TENS).48

Other Methods:

Beta-adrenergic agonists and calcium channel blockers are known to reduce

uterine contractility and thus potentially effective; but clinical trials have not been

conducted49

. Transdermal glyceryl trinitrate has also been evaluated 50

and so also an

orally active vasopressin receptor antagonist which has been shown to be effective. 51

In a study comparing montelukast, a leukotriene-receptor antagonist, to placebo in

patients with dysmenorrhea, montelukast was effective in reducing pain.52

Clinicians

may consider this as an alternative to hormonal therapy or in lieu of NSAIDs.

Surgery:

Cases of dysmenorrhoea refractory to conservative management are unusual; for these

women, Laproscopic Uterine Nerve Ablation (LUNA) and presacral neurectomy 53

may

Background

22

be indicated. There is limited evidence to support the use of surgery. However, for long

–term pain relief is significantly greater with presacral neurectomy as compared to

LUNA.53

2.2.2: Menorrhagia:

Menorrhagia is the main presenting complaint of a women presenting to general

practitioners and referred to gynaecologists. It may account for most of the

hysterectomies and nearly all endometrial ablation.

Menorrhagia may be defined in two ways:

Subjectively, as defined by The Royal College of Obstetricians and

Gynaecologists (RCOG): ‘heavy cyclical bleeding over several consecutive cycles’ 54

or

‘Excessive or prolonged loss of blood on a regular cyclical basis’.

Objectively, ‘menses lasting longer than 7 days or menstrual blood loss

exceeding ≥80ml for the whole period. 55

The generally accepted objective definition is based upon population studies

which demonstrated that approximately 10% of women experienced this level of

bleeding and that it carries an association with iron deficiency. 55

Quantification of menstrual blood loss:

It is very difficult to assess the amount of blood loss. In clinical practice, only

40% of women complaining of menorrhagia have menstrual loss ≤ 80ml.56

Many

methods have been described for quantifying the blood loss, such as collection of

Background

23

menstrual blood in a menses cup or the alkaline haematin method, estimation of

Haemoglobin and haematocrit values, Pictorial blood loss assessment chart.

1. The alkaline haematin method: This method is considered to be the ‘gold standard’

for measuring the blood loss.55

Here sanitary napkins are soaked in 5% sodium

hydroxide to convert haemoglobin to haematin. Optic density of haematin is

measured by spectrophotometrically.

2. Estimation of haemoglobin and haematocrit values:

3. Haemoglobin concentration of ≤12 gm% increases the chance of identifying women

with menorrhagia. However, normal value does not exclude menorrhagia.

4. The pictorial bleeding assessment chart (PBLAC): Warner and his colleagues

found positive correlation between objective menorrhagia with passing clots more than

1.1 inches in diameter and changing pads more frequently than every 3 hours. Attempt

to standardize this type of evaluation have lead to development of the Pictorial Blood

Loss Chart (PBLAC) (Annexure No. XV). Scores are assigned as follows:

Table No. 2.2.2.1: Pictorial Blood Loss Chart (PBLAC) Score

Lightly stained Moderately stained Heavily stained

Tampoon 1 5 10

Sanitary pads 1 5 20

Blood clots (small) 1

Blood clots (large) 5

Total score ≥ 100 points per menstrual cycle have been shown to indicate

≥80ml. objective blood loss.56-59

Background

24

Causes of Menorrhagia: Following are the different causes of menorrhagia.

I. Uterine:

1. Infections: Endometritis, Pelvic inflammatory diseases.

2. Neoplasms: Fibroid, ovarian neoplasm

3. Adenomyosis, Endometriosis

4. Malignancies: endometrial carcinoma, Ca cervix

II. Systemic:

1. Coagulation disorders

2. Endocrinal disorders: hypothyroidism

3. Ideopatic thrombocytopenic purpura

4. Diseases like early stages of tuberculosis, severe anaemia

III. Functional:

Dysfunctional uterine bleeding

IV. Iatrogenic:

1. Inadvertent use of sex steroids hormones

2. Progestogen only contraceptives

3. Intrauterine contraceptive devices.

4. Anticoagulants

Dysfunctional Uterine Bleeding:

The term ‘Dysfunctional Uterine Bleeding’ (DUB) is used in cases where

organic causes are excluded. It can be defined as ‘excessive uterine bleeding which is

not due to demonstrable pelvic disease, complication of pregnancy or systemic disease.’

Background

25

Up to 50% of women with menorrhagia have dysfunctional uterine bleeding.60

The

majority of cases of DUB are secondary to hormonal dysfunction and includes both

ovulatory and anovulatory. In 80-90% of these cases, bleeding results from dysfunction

of the hypothalamic-pituatary-ovarian axis, which leads to anovulation. In another 10-

20% of women with DUB, ovulation occurs cyclically, and menorrhagia is thought to

be due to defective control of mechanism of menstruation.

Pathophysiology:

Since in majority of cases cycles are anovulatory and therefore progesterone

production is absent. Hence there is constant, noncyclic, high level of oestrogen which

has unopposed action on endometrial growth. This leads to proliferative changes

(without periodic shedding) in endometrium which will outgrow its blood supply

leading to ischaemic tissue break down. At the tissue level, persistent proliferative

endometrium associated with stromal breakdown, decreased spiral arteriole density, and

increased dilated unstable venous capillaries61

. At the cellular level, the availability of

arachidonic acid is reduced, and prostaglandin production is impaired. Hence

anovulatory DUB is as a result of changes in endometrial vascular structure and in

prostaglandin production, and from increased endometrial response to vasodilating

effect of prostaglandins.62, 63

Background

26

Presentation:

Patients with menorrhagia commonly complain of increased menstrual loss

requiring more sanitary protection or the passage of clots and flooding. Patient having

underlying pathology may complain of dysmenorrhoea, dyspareunia, irregular bleeding

etc. Symptoms related to anemia e.g. fatigue, light-headedness or symptoms suggestive

of coagulopathy or endocrinological disorder may be present.

Diagnosis:

The diagnostic goal with abnormal uterine bleeding (particularly in

perimenopausal age group) is to exclude malignancy and to identify underlying

pathology to allow optimal treatment.

The American College of Obstetrician and Gynaecologists (ACOG) (2000)

recommends any woman older than 35 years with abnormal bleeding and in those

younger than 35 years who are suspected to have an ovulatory bleeding and refractory

to medical line of management should be thoroughly investigated to rule out

endometrial carcinoma 64

.

Clinical Evaluation:

History: The history should focus on the likely causes of abnormal menstrual bleeding

as well as to establish the amount and frequency of bleeding. Always pregnancy should

be excluded. The presence of pelvic pain, dyspareunia, pressure symptoms indicate the

presence of uterine pathology.

Background

27

History of risk factors identified for endometrial cancer should be specifically

elicited. A relevant family history should be established.

Examination: General physical examination should include assessment for anaemia,

thyroid disease and clotting disorders.

Abdominal palpation, speculum examination and bimanual pelvic examination

is necessary to rule out any organic cause of menorrhagia.

Cervical smear, vaginal smear, Pap smear should be taken for microbiology as

well as for ruling out malignancy of genital tract.

Investigations:

Haematologic testing:

A complete haemogram including platelet count (diagnosis of

thrombocytopenia) should be obtained to evaluate anaemia due to chronic blood loss as

well as the degree of blood loss. A Serum ferritin level may be useful if there is any

doubt about iron deficiency. Investigation to diagnose systemic diseases, bleeding

disorders and endocrinal disorders (e.g. hypothyroidism) should be carried out only if

history and physical examination are suggestive of these disorders.

Ultrasonography:

Transabdominal or transvaginal ultrasonography can be used to assess size,

number and location of fibroids, endometrial thickness, ovarian pathology and other

Background

28

pelvic pathology. Transvaginal sonography (TVS) can be used to measure endometrial

thickness (≤ 5mm on TVS, is said to exclude endometrial carcinoma in postmenopausal

women). The RCOG’ guideline development group concluded that 10-12mm

represented reasonable cut-off to decide about the further evaluation of endometium.54

Saline-Infusion Sonography (SIS):

This simple, minimally invasive and effective sonographic procedure can be

used in accurate evaluation of myometrium, endometrium and endometrial cavity.

Sterile saline is infused through small catheter introduced transcervically and TVS is

performed.

Transvaginal colour Doppler:

To identify and differentiate endometrial pathology in cases of abnormal uterine

bleeding this technique is evaluated. It is reported that to differentiate between

endometrial polyp and myomas this technique is useful.

Hysteroscopy:

Modern hysteroscopy combine miniaturization with excellent image resolution

and visualization and it is an outpatient procedure without any general anaesthesia. In

addition to visualization of uterine cavity for pathologies like endometrial polyp or

submucous fibroid it allows their excision as well as endometrial biopsy. In fact, many

Background

29

studies considered hysteroscopy as the gold standard for evaluation of intrauterine

pathology.

Endometrial sampling:

An endometrial sampling is mandatory in all women with abnormal

ultrasonographic results or persistent menorrhagia, especially women above 40years

and those with increased risks of endometrial malignancy, even if a hysteroscopy is

normal.

Dilatation and Curettage:

Dilatation and curettage is now of historical interest.

Magnetic resonance imaging (MRI):

Evidence shows that magnetic resonance imaging does not have advantage over

ultrasound, but it may be reserved for problem solving where ultrasound provides

indeterminate results.

Management:

The aim of therapy is to reduce blood loss, reduce the risk of anaemia and to

improve quality of life. While planning the management of the case, the factors taken

into consideration are age, severity of bleeding and patient’s interest to retain fertility.

Following are the different line of managements (Table No. 2.2.2.1):

Background

30

Table No. 2.2.2.1: Management of Dysfunctional uterine Bleeding

Medical Management

1. Non-Hormonal:

A. Non-steroidal anti-inflammatory drugs (NSAIDs) e. g. mefenamic

acid, naproxane, ibuprofen, diclofenac, celecoxib, valedocoxib.

B Anti-fibrinolytic drugs e.g. Tranexamic acid, epsilon-amino caproic

acid –Ethamsylate

2. Hormonal

A. Progestogens-

-Oral progestogens: e.g. norethisterone, medroxyprogesterone

acetate, Dydrogesterone

-Intrauterine progestogens: e.g. levonogesterel IUS (Mirena),

progesterone IUS (progestasert)

B. Combined oestrogen/ progestogens: e.g. oral contraceptive pills

(OCP),

C. Oestrogen

D Other

- Androgen

- Gonadotropin-releasing hormone

Surgical Management

A. Minimal invasive surgeries

Endometrial ablation

B. Hysterectomy

Medical Management:

Medical therapy is indicated when there is no obvious pelvic pathology and the

women wishes to retain her fertility and in young patients. The different types of

medical therapies used for the treatment of DUB are shown in Table No.2.2.2.1

Background

31

Table No. 2.2.2.2: Medical Therapies of DUB: Non-Hormonal therapy

Therapy Drugs and

dosage

Mode of action Efficacy Side effects

1. NSAID Cox 1 and 2

inhibitors

1. Mefanamic

Acid

2. Ibuprofen

3. Naproxane

Inhibits Cox 1

and 2 pathway

thereby prevent

PG production

22-45%67 Inhibit platelet

aggregation by

inhibiting Cox 1.65

Nausea, vomiting and

gastritis

Cox 2 inhibitors

1. Celecoxib

2. Valedocoxib

Selectively

inhibit Cox 2

enzyme (hence

more effective

Increases chances of

MI, stroke, heart

failure66, 67

2. Antifibrinolytic Tranaxemic acid

2-4.5 gms/day X

4 days

Inhibition of

plasma

activator

34-59% 68 GI tract related ,

thromboembolism

Background

32

Table No. 2.2.2.3: Medical Therapies of DUB: Hormonal therapy

Therapy Drugs and dosage Mode of action Efficacy Side effects

1. Progestogen Oral

Medroxy-acetate 10

mg OD X 21 days

Norethisterone 0.5

mg TDS or BD 6 to

26th day.68,69

Progestin brings

about changes

and cause

atrophic changes

in endometrium

Mood changes,

weight gain,

bloating, increase

in lipid profile70

LNG IUS

Mirena 20 μg/24 hrs

Progestasert 65

μg/24 hrs

74.97%

(after 3

months

use),61,71

also effective

contraceptive

Break through

bleeeding,

irregular bleeding,

spotting

amenorrhoea

2. Combined

oral

contraceptive

pills (COC or

OCT)

Acute episode – 4

Tab 6th Hrly Until

bleeding stops + 24

hrs followed by,

3 Tabs/day X 3 days

further, 2 Tab/day X

2 days

1 OD X 21 Days

Endometrial

atrophy,

decreases PG

synthesis,

fibrinolysis

40 to 70% 72 Nausea

breakthrough

bleeding

3. Estrogen Acute episode – 10

mg/Day Oral or IV

2.5 mg every 4th

hour X 3 days

Promotes rapid

growth of

endometrium to

denuded surfaces

Nausea, vomiting,

break through

bleeding, water

retention

4. Androgens Danazole

Derivative of 17α-

ethinyl-testosterone

200 mg BD for 30

days

Centrally acts on

HPO axis,

peripheral causes

endometrial

atrophy

80%-79%73 Weight gain, oily

skin, acne,

hirsuitism,

amenorrhoea

Gastrinone

19-nortestosterone

derivative

2.5 mg daily

Anti-

Progestogenic,

anti histogenic

androgenic

activity

Same as Danazole

5. Gonatropin

releasing

hormone

(GNRH)

agonist

Leuprolide acetate

3.75 mg depot IM

monthly

Goserelin

3.6 mg depot SC

monthly

Down regulating

action on

expression on

GNRH receptors

thereby blocking

gonadotropic

secretions and

ovarian

suppression

Typical like

menopause, bone

loss, not cost

effective

Background

33

Surgery:

For many women, surgical treatment may ultimately be necessary in spite of the

effectiveness of medical therapy.

Surgery may be necessary in following cases:

1. Medical therapies may not be effective or contraindicated

2. Sometimes medical therapies may be associated with significant side effects

3. Cause of the menorrhagia may be organic e.g. fibroid, polyp, chronic pelvic

inflammatory masses etc.

Surgical Management of the menorrhagia:

1. Dilatation and curettage (D& C)

2. Minimal invasive surgeries ( procedures involving destruction or resection of

endometrium): e.g. Endometrial ablation, thermal balloon therapy

3. Hysterectomy: Total abdominal Hysterectomy(TAH), vaginal hysterectomy (VH),

Laproscopically Assisted Vaginal Hysterectomy(LAVH)

1. Dilatation and Curettage:

This is mainly used as temporary line of management mainly for stabilization of

patients in acute episode of bleeding where medical therapies fail to control

bleeding.

Background

34

2. Minimal invasive Surgeries:

Endometrial ablation was introduced in 1980s as an alternative to hysterectomy.

These less invasive procedures have been devised to either destroy or resect the

endometrium and lead to amenorrhoea. Endometrial ablation should only be offered to

women who are not interested in further childbearing since it leaves behind the

damaged endometrial cavity.

Endometrial ablation techniques are described as first- or second generation

techniques according to their temporal instruction into use and their need for

hysteroscopic guidance (Table No.2.2.2.4. The advantages of these endometrial ablation

methods are, they are daycare procedures and also recovery is fast. All these procedures

require dilatation of cervix prior to the procedure. Overall success rate of 70-80% has

been reported.74

several reports on long term (upto 4years) follow ups emerged with

recurrence of symptoms in 34% of women.74

ACOG (2007) recommends endometrial sampling prior to surgery since women

with endometrial hyperplasia and cancer should not undergo ablation.75

Background

35

Table No. 2.2.2.4: Difference between First and Second Generation Technologies

No. First Generation Second Generation

1. Methods 1. Transcervical Resections

of the endometrium

(TCRE)

2. Endometrial Laser

Resection (ELR-

neodymium:yttrium-

aluminum-garnet or Nd-

YAG laser)

3. Roller Ball Endometrial

Ablation (REA)

1. Thermal Balloons

(Thermachoice, Cavatherm)

2. Microwave Endometrial

Ablation (MEA)

3. Circulatng Hot Saline (Hydro

therm Ablator)

4. Crayotherapy

5. Impendance Controlled

Ablation

2. Hysteroscopy Required (also personnel with

hysteroscopic skill required)

Not required

3. Anaesthesia General anaesthesia IV sedation/ paracervical block

4. Distending

media

Required Not required

5. Complications Rare(1%)

Uterine perforation

Haemorrhage

Fluid overload &

pulmonary oedema

Rare (1%)

Infection

Long term surveillance of women following ablation shows an approximate

20% ultimate hysterectomy rate.76

Hysterectomy:

Removal of uterus is obviously the most effective treatment for bleeding and

overall satisfaction rates approximate 85%. Depending upon route and technique of

surgery there are three choices abdominal (TAH), vaginal (VH) or laparoscopically

Background

36

assisted with the first being the most common. The choice between first two procedures

depends upon the size of the uterus, the degree of uterine descent, the wish to remove

the ovaries, and the skill and preferences of the surgeon. As with any surgical treatment

procedure, cost and morbidity are of concern. The majority of complications of

hysterectomy are due to febrile morbidity and haemorrhage. Other complications

include bowel injuries, urinary tract injuries, infection, postoperative thromboembolism.

Overall complication rate for abdominal hysterectomy has been reported to be 9.1%,

for vaginal hysterectomy 7.8% and for laparoscopic hysterectomy 8.8%.67,77

The modern/ conventional therapies used in management of these three gynaecological

conditions have substantial evidences about their safety and efficacy, whereas TM , a

widely practiced and preferred therapy by women, does not have such support in this

era of evidence based medicine. Therefore, it is high time that these TM practices need

exploration. The rural population has deep rooted faith in TM and it is believed to be

without any adverse effect. Hence, validation of TM is essential.

2.3: Role of Traditional Medicine in Reproductive Health:

The modern/ conventional therapies for the management of the three more

common gynaecological conditions have substantial evidence. However, TM is more

widely practiced in developing country like India and also it is preferred by women.

Hence, in this era of evidence based medicine, it is necessary to explore the role of TM

and evidence for the efficacy of these age old practices in which people have deep

enrooted faith.

Background

37

According to WHO estimate, over world 80% of population especially from

developing countries relies upon traditional system of medicine for primary health care

where plants form the dominant component. 9

In China, traditional herbal preparations

accounts for 30-50% of the total medicinal consumption. In developed countries like

Germany 90%, Canada 70%, and in Europe 40 - 50% of population have used

Complimentary & Alternative Medicine (CAM) at some point in their life. 9, 78

Since time immemorial, bio-diversity of natural resources has served not only

for the primary human needs but also for health care. The Indian subcontinent, with a

history of one of the oldest civilization, harbors many traditional health care systems.

Well recognized codified system like Ayurveda, Unani, Siddha, Homeopathy; and other

non-codified traditional and folklore systems of health care were developed in the

different time periods, where more than 7500 plant species have been used for various

medicinal properties. History of Ayurveda goes back to 5000 B.C. and is one of the

ancient health care systems. Ayurveda reports more than 2000 plant species for their

therapeutic potentials79

. The medicines in the codified systems are generally of plant,

mineral and animal origins or mixture of two or three of these. There are well laid

procedures to make these preparations as result of which it is claimed that

bioavailability is enhanced. The medicines of non-codified system/folklore medicine,

on the other hand, are herbal household remedies. These traditional systems of medicine

are promoted verbally through generations and thus lack documentation. At times, the

knowledge gets distorted during the process of transfer of the knowledge. The younger

generations of these TMPs are reluctant to acquire this treasure of knowledge due to its

low remunerations. Some of the youngsters have moved to urban areas for bread

Background

38

earning. Hence this knowledge of TM is slowly getting vanished. The folklore

medicines are still patronized by large population and they enjoy popularity particularly

in rural areas and tribal belts. The urban population also is interested in revitalization of

TM due to the awareness of the advantages of these natural therapies. The reasons for

popularity in urban and rural area are different, in-former it is due to increased

awareness whereas in later it is essential for the health care.

The Reasons for acceptance of traditional medicine are:

In Developing Countries:

Easy accessibility availability and affordability of the local traditional system of

medicine.

Ignorance, poverty, and unavailability of modern medical facilities due to lack

of means of communication

Qualified doctor to patient ratio is 0.1% as compared to traditional healers to

patients and qualified doctors are concentrated only in urban areas.

In Developed Countries:

Awareness about adverse effects of drugs used in modern medicine or synthetic

medicinal preparations

Awareness and questioning approaches and assumptions of modern medicine

Greater public access to health information.

Emergence of newer diseases for which no treatment is available.

Background

39

Life style diseases like hypertension, heart disease, cancer etc. and also due to

increased life expectancy.

In India, due to improvement in the economic condition there is increased

incidence of these life-style diseases.

2.3.1: What is traditional medicine?

‘Traditional medicine’ is a comprehensive term used to refer both to codified

(greater) traditional systems such as traditional Chinese medicine, Indian Ayurveda and

Arabic Unani medicine and non- codified (lesser traditional medicine) various forms of

indigenous medicine. It is transmitted through specific cultural and traditional

information exchange mechanisms, for example, maintained and transmitted orally

through elders or specialists (breeders, healers etc.) and often to only a select few

people within community.80

According to WHO traditional medicine can be defined as.9, 78

‘Traditional medicine refers to health care practices, approaches, knowledge,

and beliefs incorporating plant, animal and mineral based medicines, spiritual therapies,

manual techniques, applied singularly or in combination to treat, diagnose and prevent

illnesses or maintain well-being.’ In countries where the dominant healthcare system is

based on allopathic medicine, or where TM has not been incorporated into the national

healthcare system, TM is often termed as ‘complementary’, ‘alternative’ or non-

conventional’ medicine.78

Various herbs have been used in the traditional system of medicine since ancient

times for the treatment of large range of diseases and they have played key role in world

Background

40

health. In spite of the great advances observed in modern medicine in recent decades,

plants still make an important contribution to health care. Medicinal plants are

distributed worldwide, however, they are most abundant in tropical countries and

Western Ghats of India is one of the 25 hotspots of the world for the Ethnomedicine.

2.3.2: Ethnobotany: 80, 81

The study that aims to explore the interaction between plant and people is called

‘ethnobotany.’ Some interdisciplinary topics or subdisciplines of ethnobotany are:

ethnoagriculture, ethnoarchaeobotany, ethnoecology, ethnogastrology,

ethnohorticulture, ethnomedicobotany, ethnomusicology, ethnopharmacology,

ethnopharmacognosy, ethnophytotaxonomy, ethnopteridology, ethnobryology,

ethnoalgology, ethnolichenology and ethnoveternary.81

2.2.3: Ethnomedicine: 80, 81

A traditional healthcare practice of indigenous people pertaining to human

health is termed as ‘ethnomedicine’. It is concerned with the cultural interpretations of

health, disease and illness and also addresses the healthcare-seeking process and healing

practices. In other words it is an area of research that deals with medicines derived from

plants, animals, minerals etc. and used in the treatment of various diseases and ailments,

based on indigenous pharmacopoeia, folklore, and herbal charms.82

This is the mother

of all systems of medicine such as Ayurveda, Siddha, Unani, Nature cure, even modern

medicine. From ethnographical beginnings, now ethnomedicine has turned its attention

to laboratory research, also involving biomedicine and pharmacology.

Background

41

2.3.4: Herbal Medicine Scenario in India:

India is sitting on a gold mine of well-recorded and traditionally well-practiced

knowledge of herbal medicine. It is estimated that, in India, out of the total plant species

available, 89% of the plant still need to be explored for their potential therapeutic value.

Only 1% are commonly used in Indian system of medicine, 3% are reported in

traditional literature but used sparingly and 7% of the plants are reported to have

medicinal activity but not being used frequently (Figure 4).83

commonly used inIndian system of medicine

reported in traditional medicine

medical activity reported but not mentioned frequently

unexplored plants

India, officially, recognizes over 3000 plants for their medicinal value. It is

generally estimated that over 6000 plants in India are in use in traditional, folk and

herbal medicine. There are about 9000 firms manufacturing traditional Ayurvedic

medicines in India.83

Indian system of medicine is gaining popularity worldwide for alternative and

complementary therapies in view of their economic value, patient compliance and less

Figure No. 4: Medicinal Plants scenario in India

Background

42

toxicity. With the advance in modern technology, the validation of such traditional

preparations as potential / effective and safe formulations for global acceptance is the

need of the hour.

2.3.5: Role of physicians in Ethnomedicinal research: 84, 85

Research is the hallmark of progress and rationality. Since the use of plant,

whether validated or not, is going to be utilized by the people, especially by the

womenfolk, it is the responsibility of medical personnel to provide them safe medicine.

Thus physician can apply his/her expertise not only for evaluation of the practices but

also to document and preserve this treasure of knowledge. Renewed interest of

developing as well as developed countries in the natural resources has opened new

horizon for the exploration of natural sources with the perspectives of safety and

efficacy. This will help not only to preserve this traditional heritage but also to

rationalize them in modern therapeutics globally. Over the past decade, interest in drugs

derived from higher plants has increased tremendously. It is estimated that about 25%

of all modern medicines are directly or indirectly derived from higher plants. In some

particular cases, such as anti-tumor and anti-microbial drugs, about 60% of the

medicines currently available on the market and most of those in the late stages of

clinical trials are derived from natural products, mainly from higher plant. The plant

species mentioned in the ancient texts of these Ayurveda and other Indian systems of

medicines may be explored with the modern scientific approaches for better leads in the

health care.

Presently in India, operational research studies are going on in the area of

healthy aging, using Aurvedic drugs for specific problems like benign prostate

hypertrophy, reduction in menopausal symptoms, preventive cardiology, arthritis and

Background

43

use of ‘Rasayana’ for rejuvenation. Likewise operational research studies have been

designed to cover nine specific areas affecting women and children’s health which

includes menstrual disorders, reproduction tract infections, antenatal care, postnatal

care, complications of pregnancy (vomiting, oedema) galactogogues, health promotion

of neonates and infants, and the management of common colds, etc. ICMR has adopted

a disease oriented strategy for validating the claims of efficacy of traditional remedies

and have initiated clinical trials of such drugs in various areas.

It is necessary to have sufficient information on safety and efficacy of CAM to

make informed decision concerning use of them. Compelling data will facilitate

meaningful interaction between conventional and complimentary practitioners and

ultimately lead to the development of interdisciplinary partnership that incorporate

validated complimentary practices into patient care.86

The present study was planned with the adoption of disease oriented strategy for

validating the claim. The three common gynaecological conditions were identified from

the community. The information regarding herbal formulations used by TMPs was

collected and efforts were made to validate these claims scientifically. The present

study is conducted in four phases:

Phase I: Collection of ethnomedicinal information, documentation, authentication of

plants, selection of formulations and standardization of formulation

Phase II: Acute oral toxicity studies in animals

Phase III: Validation of formulations (conducting limited clinical evaluation of

formulations)

Phase IV: Analysis of data and publishing the results.

Need for Study

44

NEED FOR STUDY

In developing countries, priority setting in the health sector, traditionally focuses

on the principal causes of mortality. More recently, the Global Burden of Disease

approach incorporates assessment of morbidity and quality of life in identifying

priorities. Yet, little attention is paid to understanding and ameliorating women’s

gynaecological complaints. As quoted earlier, the incidence of gynaecological disorders

is quite high. Available data from developing countries on the frequency of menstrual

disorders and their impact on women’s health status, quality of life and social

integration suggests that evaluation and treatment of menstrual disorders should be

given a highest priority in primary health care programme. RTI are major and

commonest problems which disturb the physical as well as mental wellbeing of women.

In India, especially in rural area, the discussion of the gynaecological conditions

is taboo and majority of women try to avoid medical help. Hence either the burden of

diseases will be carried silently or available primitive local health care facilities will be

utilized by these women. In this situation, rural population should be guided properly to

avail therapies which are safe and effective which can be achieved by validation of the

traditional knowledge through research.

Although patient has access to the modern therapies, these are not without

adverse effects and at times, these invasive and expensive therapies require

hospitalization. Majority of women from rural area due to their poor socio-economical

status neither can afford these expensive treatment modalities nor hospitalization. Since

Need for Study

45

most of these women have to support their family and sometimes they are sole bread-

earners, they cannot afford hospitalization.

In developed countries and urban population of developing countries patients

have greater access to information. Their needs and values change. They become more

involved in their overall healthcare and are taking more natural and holistic approach to

achieve this. The TM, unlike modern medicine, affords overall well-being through its

holistic approach. Hence there is an imperative to make TM/CAM research a high

priority. Valid and reliable empirical data must document the clinical efficacy and

safety of TM/CAM practices.

Another issue with traditional medicine is lack of documentation. Since TM is

disseminated through verbal route; there is always fear that some of the safe, effective

and also cost effective therapies will become obsolete. Hence this study is undertaken to

document the traditional therapies, and to validate some of these therapies by

subjecting them for clinical evaluation.