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.
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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
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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
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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.
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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
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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):
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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
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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
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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
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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.
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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
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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.
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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
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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.
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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
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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.