Brenden Skudder: Ayurvedic Medicine Diploma student, Wellpark College of Natural Therapies, Auckland New Zealand.
Introduction: The purpose of this study is to establish if Asparagus racemosus also known by its Sanskrit name Shatavari, a herb from the Ayurvedic medical tradition of India has an effect on the symptoms of menopause.
What is Menopause?
Menopause is a natural occurring event of women’s life’s as they transit from the reproductive stage of life to the non-reproductive stage. The age at which menopause occurs is genetically predetermined, and varies from 48 to 55 years of age with the average/mean age being 51.4 years old in the United States of America.1 Female life expectancy is approaching 80 years of age, meaning that on average 30 years of a women’s life is spent in the postmenopausal stage of life. 2 Some women may experience menopause with out any complication or serious discomfort, however other women find the experience debilitating.
Towards the end of the reproductive stage of life the ovaries become unresponsive to hormonal stimulation resulting in changes to ovarian and menstrual cycles. As the ovary continues to become less responsive the greater the effect on the female reproductive cycle eventually leading to the failure of the follicle inside the ovary to respond and produce estrogen.3 Women having undergone a hysterectomy also experience menopausal symptoms due to the functional organs of the reproductive system being removed.
The symptoms often experienced by women encountering menopause include hot flushes, night sweats, palpitations, insomnia, anxiety, headaches, irritability and depression. As the changes to the reproductive system progress physical changes to the female reproductive organs and genitalia take place due to hormonal changes. Women experience vaginal dryness and vaginal atrophy, atrophy and thinning of the vulva, atrophy of the cervix and decrease in size of the uterus.4
Clinical confirmation that a woman is experiencing menopausal is achieved through the results of hormone assays. Postmenopausal women have elevated levels of serum follicle stimulating hormone (FSH) and serum luteinizing hormone (LH). FSH and LH are important hormones in the female reproductive system helping to regulate and stimulate ovarian cycles through feedback mechanisms to the ovaries and the hypothalamus. Perimenopausal women (women who have begun to move from the reproductive stage to the non-reproductive and are experience menstrual irregularity and vasomotor symptoms (hot flushes, sweating) have increased FSH levels with initially normal range LH levels. As menopause continues to progress in the perimenopausal individual FSH levels continue to rise with LH also beginning to rise until both hormone levels are well elevated past their normal values. 5 6
Serious health conditions affect postmenopausal women who show a rapid loss of bone density (osteoporosis) in the ten years following menopause and no longer have the pre-menopausal protection from ischaemic heart disease due to hormonal changes. 5 6
Treatment of Menopausal Symptoms
A common practice to relieve women from the symptoms of menopause is to administer Hormone Replacement Therapy (HRT). Research conducted in recent years has proven that medications used presently (steroidal and non-steroidal) for the treatment of post-menopausal syndrome are not free from adverse effects.7-10 Women concerned about the adverse effects of HRT are turning to natural medicine in an attempt to find a safe alternative to treat menopausal symptoms and protect their quality of life.
The goal of any treatment for menopause should be not only directed at bringing relief from the symptoms of menopause and to protect women from postmenopausal health conditions but also to consider the adverse effects of the medicine on the individuals health.
For this reason health practitioners and scientists have become interested in phytoestrogens (chemical constituents from plants that mimic hormones) to see how these chemical structures work and what health effects they have on the body. Asparagus racemosus a herb from the traditional medical system of India called Ayurveda is a known Phytoestrogen11 and as such further research into its phytoestrogen effect needs to be researched.
What is Ayurveda?
Ayurveda is an ancient medical system that originated from the Vedic culture that survived thousands of years ago on the banks of the legendary Sarasvati River in the Indus Valley located in Pakistan and Kashmir. The Sanskrit name “Ayurveda” means “the science of life” and it deals with physical, mental and spiritual health of the individual. The ancient texts of the Vedic culture are the foundation for Hindu religion which is widely practiced in India giving India its cultural and social identity. Many of the Vedic sciences are still practiced in India such as Yoga, Vedic astrology, Vastu - the art of placement, and Ayurveda. There has been world wide interest generated in these topics with Yoga becoming very popular as an exercise and a stress reducing tool in the corporate world today.
The fundamentals of Ayurveda are based upon a philosophical view of the creation of the universe, the composition of matter and the relationship of qualities. Ayurveda believes that all that exits is composed of five elements, ether-space, air, fire, water and earth. The varying degrees of the quantity of elements in matter give each object its individual quality (e.g. Rock is made from the elements earth which is cold, heavy, solid/dense, and non-moving, combined with a little space which is cold, dry and inanimate. This gives a rock the qualities of heavy, dry, solid/dense, stable, cool and inanimate).
To treat disease from an Ayurveda perspective, one must use mediums such as herbal medicine, food or specific treatments that either have the opposite quality than that of the disease or that generate an opposite effect. This is demonstrated in obesity where the condition presents as heavy, slow, cold and stagnant. An Ayurvedic practitioner would introduce medicines or treatments that are warming, moving and lightening in their effect to counter the qualities of obesity thus bringing balance to the individual’s expression and establishing “normality.”
Ayurveda has an extensive pharmacopoeia that is only now being appreciated due to modern research establishing factual material to support the traditional application of the herbs. Asparagus racemosus is one of the many herbs from Ayurveda that is being studied to establish its action from a scientific perspective and comparing these findings with its traditional application.
Background of Asparagus racemosus
Asparagus racemosus is traditionally used as a female tonic and its Sanskrit name Shatavari means “she who possesses a hundred children” indicating that this herb is highly regarded as an agent that supports the female reproductive system. In Ayurveda the action of a herb is established by its energetic qualities in relation to the elemental combination of the five elements, its taste and its digestive and post digestive action. The herbs effect on different aliments is noted and the combined information would give an individual herb its unique profile.
Asparagus racemosus is believed to the have the energetic qualities of heavy and oily, to have a sweet and bitter taste as well as having a cooling digestive action and a building post digestive action.12-14 Asparagus racemosus is used to treat diseases that portrays the opposite qualities. Traditionally it is also used to treat disorders that arise from excessive heat such as hyperacidity,15 and disorders that present wasting and drying.13 In the ancient text Caraka Samhita, Asparagus racemosus is also revered as an agent that increases the sperm count as well as strengthening the sperm and as an anti-aging herb.16 It is also highly regarded as a Rasayana,16 17 ie an agent that imparts longevity, memory, intelligence, wellbeing, youth, good complexion, improves sensory perception, and increases bodily strength.
Modern research into the clinical effects of Asparagus racemosus have shown it to have anti-tumor,18-20 immunomodulator,21 and galactagogue properties;22 23 it additionally produced results in treating male infertility,24 duodenal ulcers,25-30 and nausea and vomiting.31
The traditional application of Asparagus racemosus to treat various disorders is in part being supported by the finding of clinical research. Based on these conclusions, the effect that Asparagus racemosus has on adverse menopausal symptoms is an area that warrants investigation due to its traditional application as a women’s health tonic.
Historical view of menopause in Ayurveda
Menopause may not have been a disorder that affected women in ancient times as Ayurvedic textbooks do not mention any female reproductive disorders whose symptoms correspond with menopause.16 32 Caraka Samhita written by Caraka, and Astanga Hrdayam written by Vagbhata, both revered as two of the main text on Ayurvedic medicine mention many gynecological disorders known to modern medicine. Both text list Asparagus racemosus as part of formulas to treat disorders affecting women’s health.16 32 Modern Ayurvedic practitioners utilize Asparagus racemosus in formulas to treat menopausal symptoms33 and to specifically counter vaginal dryness34 a symptom experienced amongst perimenopausal and postmenopausal women.
The cause behind menopausal symptoms according to Ayurveda
Ayurveda believes that the functions in the body are governed by three mediums Vata, Pitta, and Kapha. Each of these mediums known collectively as doshas, have distinct roles in maintaining the stages of the cycles involved in the female reproductive system. Each dosha has a distinct expression due to it elemental composition. Vata consisting of space and air is drying, rough, light, clear, changeable and cold. It is the most volatile of the doshas due to its light changeable qualities. Pitta consisting of fire and water is hot, oily, mobile, light, liquid and fleshy smell. Kapha is heavy, slow cold, oily, slimy, dense, soft and static having been composed from earth and water.
Vata is responsible for movement in the body and in regards to women’s health is the energy behind the movement of follicle in the ovary as it matures. Vata is the energy behind the release of the follicle from the ovary and the movement of the ovum to the uterus. It is also the energy responsible for the elimination of the menstrual fluid and is the catabolic action responsible for aging. Pitta is the functional energy of transformation and as such it is associated with the endocrine system as the actions of the hormones instigate change. Body temperature is also maintained by pitta whose elemental combination includes fire. Kapha is the nutritive energy that protects and nourishes the tissues of the reproductive system during the cycles. Its heavy cold qualities counter the drying and catabolic qualities of vata and the hot qualities of pitta.
Health issues occur when one or more of the doshas increase in quanity affecting the functional ability of the lesser quanity dosha(s) causing functional imbalance. When vata is increased in quantity it causes irregular ovarian and menstrual cycles, amenorrhea, and vaginal dryness. Excessive vata also affects the memory and can cause insomnia which is often experienced as a menopausal symptom. Other menopausal symptoms such as hot flushes, sweating and irritability are aspects of the element fire that creates the functional medium of Pitta, being affected by the fluctuating movement of vata.
Ayurvedic approach to treatment with herbal medicine
Traditionally the use of single herbs to treat either disease or injury was not commonly practiced in Ayurvedic herbal medicine. Traditional application of herbs for treatment was usually in the form of a formula that contained numerous ingredients so as the action of the medicine was not linked to one herb in particular but to a combined affect of many. However Asparagus racemosus is listed as a herb that can be used by itself as a medicine. 35
Ayurveda’s approach to treatment is to observe the qualities of the symptoms presented by the disorder, ascertain the elements believed to be responsible, then treat the functional medium that the elemental combination creates with the opposite qualities ie hot – cold, light - heavy. Any herbal treatment directed at treating menopause would by its energetic qualities decrease both vata and pitta. Asparagus racemosus does this as well as promoting the nutritive aspects of Kapha, the functional medium behind protection and formation of the tissues.14
Modern Ayurvedic practitioners working with Asparagus racemosus basing their approach to the treatment of menopausal symptoms via the energetic principles of herbal medicine have recorded results with their clients menopausal conditions that suggest that Asparagus racemosus can be effective in reducing adverse menopausal symptoms.34 These results from the practice based use of Asparagus racemosus supports the need for further clinical research into the effect of Asparagus racemosus on adverse menopausal symptoms.
In this research paper Asparagus racemosus will be administered as a single herb in a measured dose of 6 grams a day over a six month period to twenty women. Ten women experiencing initial menopausal symptoms (perimenopausal) and ten postmenopausal women so as to ascertain if Asparagus racemosus has any effect on the symptoms associated with menopause, and if so which of the two groups has greater benefit from its administration.
Scope: This research will study perimenopausal women and post menopausal women. The sample groups will be small having ten participants for each group, which will not give a true indication of the effects on the greater menopausal population but will allow for interest to be generated should there be a trend that supports the research hypothesis that Asparagus racemosus alleviates the adverse symptoms of menopause whilst protecting the health of the individual consuming it. Hormone assays will be undertaken to establish if there are changes in FSH and LH during the period of research and if these changes can be linked to any change in severity and frequency of menopausal symptom. This will present credible proof that Asparagus racemosus requires further study on its effect on the female reproductive.
Whilst the effect of phytoestrogen on osteoporosis is of interest it is beyond the scope of this research to ascertain the effect that Asparagus racemosus has on osteoporosis and bone re-absorption. This topic would warrant a separate research proposal and could be addressed at a later date should the results from the current proposal support the need for further research.
Aim: The aim of this research contains four points; firstly the aim is to establish if Asparagus racemosus reduces the severity of adverse menopausal symptoms in perimenopausal and postmenopausal women. Secondly this research aims to establish that the use of Asparagus racemosus in treating menopausal symptoms increases the quality of life for the individual suffering from menopausal symptoms. Thirdly the aim of this research is to substantiate if Asparagus racemosus affects the level of FSH and LH in menopausal women and if there is a change to the level of hormones, can these changes be observed through the physical manifestation of reduction in severity and frequency of menopausal symptoms. And lastly the aim is to establish if Asparagus racemosus is a safe natural alternative to HRT for women.
Objectives: The objective of this research is to find in Asparagus racemosus, a safe and effective agent for the treatment of adverse menopausal symptoms and a supplement that will help postmenopausal women maintain a quality of life that they enjoyed premenopause. These objectives will be measured against the data received from regular interview papers completed by the sample participants and by information gained from regular medical testing of sample groups.
Justification: Asparagus racemosus is highly regarded as a women’s tonic in Ayurvedic medicine, it has been used for hundreds of years for this purpose and as such further research into its effect on gynecological disorders are of importance in order to understand its action and utilize it to best effect.
Literature review:
Asparagus racemosus and the actions of its constituents.
Asparagus racemosus contains steroidal saponins and isoflavones as chemical constituents.36 Steroidal saponins and isoflavones have been found to mimic hormones in the body due to the chemical structure of the constituents resembling hormones and attaching to hormone receptors.37 These chemical structures from plants that mimic hormones are called phytoestrogens. Phytoestrogens are weaker than natural estrogen in action38 however they compete with estrogen for estrogen receptors. In the presence of excess estrogen in the body, phytoestrogens having taken up some of the receptors buffer the effect of excess estrogen.37 When there is a depletion of estrogen the phytoestrogens engaging vacant receptors stimulates an estrogen reaction.37 The symptoms of menopause are due to the body experiencing a withdrawal to estrogen. Due to low levels of estrogen being produced in the body the numerous estrogen receptors are not engaged due to the low estrogen concentration. As these estrogen receptors are not engaged the reaction from the presence of estrogen on the receptors are not triggered resulting in the breakdown of feedback mechanisms that the endocrine system is reliant on to function efficiently. Asparagus racemosus having known phytoestrogen properties11 would act to engage vacant estrogen receptors completing the stimulus required in order for the estrogen required reaction to take place.
Health effects of HRT
The common approach of the past by doctors of allopathic medicine was to prescribe their patients Hormone Replacement Therapy (HRT) to counter the symptoms associated with menopause. Of late the trend to prescribe HRT has been reduced due to clinical research on the health effects of HRT on women.
In 2002 the Women’s Health Initiative (WHI) Study released a report stating that HRT in comparison to a placebo group increased the risk of cardiovascular disease, breast cancer, stroke and thromboembolic disease.39 Continued research from WHI has shown that HRT does not elevate the quality of life40 nor does it have any beneficial affect on the incidence of dementia or mild cognitive impairment in postmenopausal women.41 Findings from another study on the cardioprotective effects of HRT have caused doubt on its intended protective action on the cardiovascular system which is one of the alleged benefits for its administration.42 The mounting evidence against the use of HRT is sufficient motivation for the medical world to seek a safe alternative.
Asparagus racemosus having phytoestrogen actions and showing no adverse side effects is a herb that deserves further research not only into its effect on adverse menopausal symptoms but also the long term effect that it has on health in general.
Health effects of Phytoestrogens
Phytoestrogens have not been associated with the side affects that have been seen with HRT and research into the actions of phytoestrogens is promising. Phytoestrogens (isoflavones) are thought to increase levels of sex hormone-binding globin (SHBG), which is regarded as favourable for protection against breast cancer and coronary heart disease in women.43 Studies on cultures that recorded low incidence of breast cancer found that these populations had higher urine and plasma levels of isoflavones.44 Soy is a plant that contains isoflavones and it is reported that the incidence of hot flushes are lower amongst menopausal women in Asian countries where soy intake is high.45 Since phytoestrogens have been reported to exert antioxidant properties46, they may reduce the rate of bone loss in postmenopausal women partly by antioxidant effects.47
The effect of phytoestrogens not only in regards to menopause but to women’s health in general show promising results that supports the need for further investigation of plants that exhibit phytoestrogen properties. A large majority of the research in phytoestrogen actions comes from the study of Soy, however individual study on herbs and food sources of phytoestrogens needs to be undertaken in order to establish which sources of phytoestrogens are beneficial for medical use. Research on the phytoestrogen properties of Asparagus racemosus will establish if it is a medicinal plant that can used to treat menopausal symptoms.
Clinical research on a formula that contained Asparagus racemosus
Whilst no research can be found on the use of Asparagus racemosus as a single herb to treat menopausal symptoms there have been clinical studies conducted on an Ayurvedic preparation called Menosan marketed to treat menopausal symptoms by the Himalaya Drug Company of Bangalore India.
The extract of Asparagus racemosus is one of eight ingredients contained in Menosan.48 The administration of Menosan in clinical research concluded that it relieved hot flushes, night sweats, insomnia, mood swings and depression.11 49-52 Menosan was not only found to effective in relieving the symptoms of menopause but it was also found to be safe and have no side effects.51-53
In clinical studies carried out on Menosan, hormonal assays taken before and after the studies produced evidence that participants exhibited a decrease in FSH after ingesting Menosan over the period of study .11 50 No significant change to LH was noted. 50
Of the six research papers reporting the effects of Menosan only one paper50 showed no connection either financial or administrative with the Himalaya Drug Company that produces Menosan.
Asparagus racemosus cannot be held solely responsible for the effect that Menosan has on menopausal symptoms as the product contains seven other ingredients, some that are known phytoestrogens. However the fact that Asparagus racemosus has been included in this preparation suggests that it is a herb that is believed to have some effect on menopausal symptoms and warrants further research.
Methodology: Research will be conducted as a quasi-experimental design with a qualitative aspect. The research project contain two sample groups, one group containing women defined as perimenopausal and one group defined as postmenopausal. Each group will contain ten participants and each participant will ingest six grams of Asparagus racemosus daily over the six month period. Asparagus racemosus is presented in capsule form to remove the possibility of participants exceeding or under achieving the three gram dosage in the morning and in the evening. The capsules will be weighed and the total amount of capsules that equals three grams will be ingested at every time that Asparagus racemosus is to be ingested. There will be no control group used in this research project.
The choice of both quasi-experimental design and qualitative research allows for not only the personal experience of the participant taking Asparagus racemosus to be recorded and analyzed but also allows for experience based results to be compared with clinical findings. There is no need for control in this project as results from both sample groups can be compared to each other and can be compared to the trend in the population. This paper is a pilot study in to the effects of Asparagus racemosus and as such the need for a control and the need for larger sample groups are reduced.
Advertising in local Auckland community papers, natural health clinics and shops will be conducted in order to find participants for the sample groups. A contact phone number will be given for interested prospective participants to ring. An answer phone will record all replies and the participants will be phoned back and an introduction interview will be arranged. This interview will help to establish first contact with the participants but will also be an opportunity to explain the research topic with the prospective participant. Participants will be selected from women who have indicated that they have been experiencing menopausal symptoms such as hot flushes, night sweats, insomnia, anxiety, fatigue, vaginal dryness and amenorrhea. Women experiencing over six months of amenorrhea will be placed in the sample group indicating postmenopausal women. Women either having irregular periods or having had menses during the six months prior to the study will be placed in the perimenopausal group. A hormone assay of the participants will confirm the postmenopausal and perimenopausal condition.
The participants will be advised of the topic and an informed consent will be obtained that outlines the nature and safety of Asparagus racemosus. The participant will be made aware that they can terminate their involvement at any stage of the research project. Participants will agree to regular blood tests during the course of the study and complete an online questionnaire every week. They will be shown a questionnaire before the study begins to understand the type of questions that are going to be directed to them.
It is important for natural medicine to be tested or measured against the very same systems that have been used to record the effect of allopathic medicine. This in turn will help to eliminate variables that may influence the outcome and most importantly will help to establish credibility of natural medicine and research into natural medicine in the modern medical system. The WHQ questionnaire has been chosen for this very purpose. The questionnaire that is most likely to be used is “The Women’s Health Questionnaire” (WHQ) one of the most frequently utilized measures in the assessment of quality of life in mid-aged populations of women. 54 This questionnaire covers nine areas of women’s physical and emotional health issues using a four point rating system. Questions contained in the WHQ cover such areas as memory, vasomotor symptoms, sleep problems, sexual behaviour, menstrual symptoms, and anxiety. The WHQ is used in clinical trials of hormone preparations for menopausal and postmenopausal women 54 and has demonstrated to be able to show changes to women’s health experiences that were undergoing treatment in HRT. 55 The typical time frame that it takes to complete the questionnaire is 5 minutes and it’s self-administration make it ideal to use as a questionnaire that does not interfere unnecessarily into the participant’s life.
The participants will be given a participant number that will act as an account log on number for an online questionnaire form. The participants will be asked to log on to a website that contains this form once a week to answer the questions presented to them in regards to women’s health and menopausal symptoms. An automatic reminder via e-mail will be sent to the participants prior to the deadline for completed weekly questionnaires. The participants will be advised that keeping a daily diary of their menopausal symptoms in regards to frequency, severity and any changes in physical or mental health will help them answer the questionnaire accurately. The information collected from this online questionnaire will be analyzed by a computer program at the end of the study.
The use of an online questionnaire not only allows the least disruption to be made to the participant lives but also removes the chance of participants being coached in their response by an interviewer. There is also the possibility due to the sensitive nature of some of the possible questions that the participant may not give a true answer because of embarrassment. Because the use of online questionnaire forms and the use of account number instead of names the privacy and dignity of the participant remains at all times. The drawback is that all participants will need access to a personal computer, have an e-mail address and be computer literate. There is the strong possibility that some participants will not fill the weekly questionnaire out on regular basis due to lack of compliance to the program. Where as if the participants are scheduled a weekly interview with a female interviewer to go through the questionnaire then there may be less chance of non-compliance.
Hormone assays of each participant will be conducted prior to the research to confirm that the individual is either postmenopausal of perimenopausal. Women having a FSH reading of between 8-120 IU/L and a LH reading between 15-100 IU/L are classed as being postmenopausal and as such will be part of the postmenopausal sample group. Normal range of hormones for women not experiencing menopause vary during the ovarian cycle, during the follicle and luteal phase of the cycle FSH levels are between 1-8 IU/L and LH is between 2-15 IU/L. At the mid-cycle ovulatory peak FSH is between 6-26 IU/L and LH is between 20-120 IU/L.56 Women not having FSH and LH levels that diagnosis postmenopausal condition yet are experiencing menopausal symptoms will be allocated to the perimenopausal sample group. This assay will also act as a marker for the level of FSH and LH in the participant’s serum before the introduction of Asparagus racemosus. Over the period of the research the participant will be asked to submit to further blood test so as further hormone assays can be undertaken during the course of the research and a final assay performed at the end of the research. This information received over the period of six months will give a profile of any changes to the level of FSH and LH. Further research into the hormonal cycle and the importance of hormone cycles in regards to affecting hormone assays will have to be established before time and frequency of hormone assays are finalized. At this time hormone assays will be conducted at the beginning of the research, every two months into the study and at the end of the six months. The frequency may change depending on the finding of further research into hormone cycles and hormones assays and if the ethics board disapproves with the frequency of assay testing.
Data collected from both the questionnaire and the hormone assays will be presented as descriptive statistics. The information will be graphed according to the question and the result from the different groups measured against group responses at the start of the study-ie before – after. Both groups will be presented together to compare any difference between the groups that may have taken place.
Resource requirements: Based on the calculation that 1.008 kilo grams of Asparagus racemosus will be ingested per person for the six month period, access to 20.16 kg supply of organic Asparagus racemosus from a trusted organic source will be required. Accessing Wellpark College's dispensary the price for 20.16 kg of Asparagus racemosus is $ 857.80. Capsules to contain the Asparagus racemosus will also have to be purchased. A computer, computer program that analyzes information and a computer programmer to establish the web based questionnaire, including a web domain if the research unit does not have access to the college domain. The WHQ can be used for academic/non-profit research but written consent must be given first from the legal owners of the questionnaire. At this point in time I am still awaiting a reply to an e-mail that I sent to the contact address for the WHQ asking for permission to use the questionnaire for this particular proposal.
A Medlab account will have to be set up for the hormone assays to be undertaken including wages for a nurse to take the blood samples which is around $17.00 an hour. To help with the compliance of filling in the weekly questionnaire $15.00 dollars a month will be paid towards an internet account for each participant for the six months that the research project is running which equates to $1800.00. Printing of the initial advertisement flyers and printing of the findings will have to be ascertained. An estimate having yet to finalise cost of procedures and unforeseen expense I would suggest that a figure of fifty thousand to be a reasonable figure to start with.
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