Polycystic Ovary Syndrome Clinical Trial
Official title:
A Comparative Study of Homoeopathic Treatment Versus Integrated Approach of Homoeopathy and Yoga in the Treatment of Menstrual Disorders in Females With Polycystic Ovarian Syndrome.
This study is undertaken to compare effectiveness of homoeopathic treatment versus integrated approach of homoeopathy and yoga in the treatment of menstrual disorders in females with Polycystic ovarian syndrome.
Polycystic ovarian syndrome (PCOS) is a complex metabolic, endocrine and reproductive
disorder affecting approximately 5-10% of the female population in developed countries. The
developing countries like China and India, undergoing rapid nutritional transitions due to
westernised diets and lifestyle also indicate similar prevalence (9.13%). Its prevalence
among infertile women is 15%-20%. The aetiology of Polycystic ovarian syndrome remains
unclear; however, several studies have suggested that Polycystic ovarian syndrome is X-linked
dominant condition.Women with Polycystic ovarian syndrome have abnormalities in the
metabolism of androgens and oestrogen and in the control of androgen production. High serum
concentrations of androgenic hormones, such as testosterone, androstenedione, and
dehydroepiandrosterone sulfate (DHEAS), may be encountered in these patients. However,
individual variation is considerable, and a particular patient might have normal androgen
levels.
Polycystic ovarian syndrome is also associated with peripheral insulin resistance and
hyperinsulinemia, and obesity amplifies the degree of both abnormalities. Insulin resistance
in Polycystic ovarian syndrome can be secondary to a post binding defect in insulin receptor
signalling pathways, and elevated insulin levels may have gonadotropin-augmenting effects on
ovarian function. In addition, insulin resistance in Polycystic ovarian syndrome has been
associated with adiponectin, a hormone secreted by adipocytes that regulates lipid metabolism
and glucose levels. Both lean and obese women with Polycystic ovarian syndrome have lower
adiponectin levels than women without Polycystic ovarian syndrome .
An anovulation and elevated androgen level suggests that under the increased stimulatory
effect of luteinizing hormone (LH) secreted by the anterior pituitary, stimulation of the
ovarian theca cells is increased. In turn, these cells increase the production of androgens
(eg, testosterone, androstenedione). Because of a decreased level of follicle-stimulating
hormone (FSH) relative to LH, the ovarian granulosa cells cannot aromatize the androgens to
estrogens, which lead to decreased estrogen levels and consequent anovulation. Growth hormone
and insulin-like growth factor 1 may also augment the effect on ovarian functioning.
The clinical manifestation of Polycystic ovarian syndrome varies from a mild menstrual
disorder to severe disturbance of reproductive and metabolic functions. Women with Polycystic
ovarian syndrome are predisposed to type 2 diabetes or develop cardiovascular disease .
Factors implicated in the low fertility in these patients include anovulation, increased risk
of early miscarriage, and late obstetric complications.
The diagnostic criteria of the syndrome were revised by the Rotterdam European Society for
Human Reproduction/American Society of Reproductive Medicine (ASRM), where the following
criteria were established: oligo/amenorrhea, clinical and biochemical signs of
hyperandrogenism, and sonographically confirmed Polycystic ovarian syndrome. . Diagnostic
criteria for Rotterdam diagnosis of polycystic ovary syndrome
Two of the following three criteria are required:
- Oligo/Anovulation
- Hyperandrogenism
- Clinical (hirsutism or less commonly male pattern alopecia) or
- Biochemical (raised FAI or free testosterone)
- Polycystic ovaries on ultrasound Other aetiologies must be excluded such as congenital
adrenal hyperplasia, androgen secreting tumours, Cushing syndrome, thyroid dysfunction
and hyperprolactinaemia Sonographic features of Polycystic ovarian syndrome include the
presence of 12 or more follicles in each ovary measuring 2-9 mm in diameter and/or
increased ovarian volume (>10 mL). This is regardless of follicle distribution or
ovarian stromal echogenicity. One ovary fulfilling this definition is sufficient to
define Polycystic ovarian syndrome.
Hirsutism is often classified in terms of the distribution and degree of hair growth, such as
through pictorial scales. The most widely recognized scoring method is the Ferriman-Gallwey
scale.
The Ferriman-Gallwey scale for hirsutism. A score of 1 to 4 is given for nine areas of the
body. A total score less than 8 is considered normal, a score of 8 to 15 indicates mild
hirsutism, and a score greater than 15 indicates moderate or severe hirsutism. A score of 0
indicates absence of terminal hair.
In a Cochrane Database Systematic Review article, Treatment options for polycystic ovary
syndrome, It's mentioned about Alternative medicine and Polycystic ovarian syndrome.
Alternative medicine has been emerging as one of the commonly practiced medicines for
different health problems. Alternative medicines include many modalities, such as
kinesiology, herbalism, homeopathy, reflexology, acupressure, acupuncture, and massage
therapy.
Homoeopathy can be defined as a system of drug therapeutics based on the law of
similars.Polycystic ovarian syndrome has a specific set of problems which need an
individualistic approach.The concept of individualization takes into consideration the total
response of the individual to unfavourable environment. This total response is seen through
signs and symptoms on three planes: emotional, intellectual and physical where the life force
manifests itself.The teachings of Dr Samuel Hahnemann(founder of homoeopathy)-that the human
being is a unit -mind, body and spirit and that these are so correlated as to act freely and
without any impediment when the vital principle, the spirit like force or dynamis is in
equilibrium; yet if this equilibrium of health be thrown out of balance by the dysfunction of
one member the whole is affected to a greater or less degree.Homoeopathy is the dominant
option to treat Polycystic Ovarian Syndrome. Homoeopathic approach towards management of
Polycystic ovarian syndrome is constitutional taking into account the patient's physical
symptoms along with their mental and genetic makeup that individualizes the person. Early
intervention with Homoeopathy can assist in preventing further progress and hence
deterioration caused by Polycystic ovarian syndrome .
Homoeopathic constitutional treatment will help balance hyperactivity of the glands, regulate
hormonal balance, dissolve the cysts in the ovaries and force them to resume normal
functioning. Homoeopathic medicines will not upset the balance of endocrine secretions ,for
the similimum(indicated remedy) will fill the demands of the system in all its parts without
stimulating too much those organs which have maintained a relatively secure balance, in other
words our remedies affect directly the vital energy which in itself establishes equilibrium.
All the homoeopathic polycrest remedies (deep acting with a wide sphere of action) will yield
richly to our search for effective remedies in endocrine disorders.Hence, Homoeopathic
medicines can restore hormonal balance, normal ovulation, menstrual cycles, and also
eliminate the need for hormone therapies and surgery. This can significantly increase the
chances of conception. The different expressions of this disease can be managed effectively,
safely and gently with Homoeopathic remedies.
Homoeopathy works towards nature. All homeopathy medicines are proved in human beings. It is
very refined. It comforts modern living. The medicines have no negative side-effects. They
are safe, effective and easy to attain cure. By taking homoeopathy medicines, ovulation and
regular menses can be attained in a natural way.
Yogic life style, a form of holistic mind-body medicine, is known to reduce stress and
sympathetic tone. Recent randomized controlled trial found holistic yoga program for 12 weeks
to be significantly better than physical exercise in reducing Anti-Mullerian Hormone,
Luteinizing Hormone and Testosterone, Modified Ferriman and Gallway (mFG) score for hirsutism
and improving menstrual frequencies in Polycystic ovarian syndrome patients. Yoga not only
addresses the problems of Polycystic ovarian syndrome but is likely to prevent the long term
complications such as Cardio-vascular diseases, diabetes.
Following yogic practices are found to be useful in Polycystic ovarian syndrome :
1. Physical postures (Asanas - 1 min each):
1. Surya Namaskara (Sun Salutation) for 10 min [5 rounds];
2. Prone asanas:
- Cobra Pose (Bhujangasana),
- Locust Pose (Salabhasana),
- Bow Pose (Dhanurasana)
3. Standing asanas:
- Triangle Pose (Trikonasana),
- Twisted Angle Pose (Parsva -konasana),
- Spread Leg Intense Stretch (Prasarita padottanasana),
4. Supine asanas -
- Inverted Pose (Viparita Karni),
- Shoulder Stand (Sarvangasana),
- Plough Pose (Halasana);
5. Sitting asanas
- Sitting forward Stretch (Paschimottanasana),
- Fixed angle Pose (Baddha- konasana),
- Garland Pose (Malasana)
2. Breathing Techniques (Pranayama - 2 min each):
- Sectional Breathing (Vibhagiya- Pranayama),
- Forceful Exhalation (Kapalabhati),
- Right Nostril Breathing (Suryanuloma Viloma) 2 min,
- Alternate nostril breathing (Nadishuddhi)
3. Guided relaxation (Savasana) for 10 min
4. OM Meditation (OM Dhyana) for 10 min
5. Group Lecture: Lectures, in the form of cognitive restructuring based on the spiritual
philosophy underlying yogic concepts, spiritual coping strategies.
Homoeopathic medicines and yoga therapy being holistic approaches might effectively treat the
complexity of the symptomatology in Polycystic ovarian syndrome.
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