A STUDY TO ASSESS THE EFFECTIVENESS OF SOYABEAN CONSUMPTION ON THE MENOPAUSAL SYMPTOMS AMONG WOMEN BETWEEN 45-56 YEARS IN SELECTED VILLAGES AT
COIMBATORE DISTRICT.
By 30083221
DISSERTATION SUBMITTED TO THE TAMIL NADU Dr. M.G.R. MEDICAL UNIVERSITY, CHENNAI, IN PARTIAL FULFILMENT OF THE REQUIREMENT
FOR THE DEGREE OF
MASTER OF SCIENCE IN NURSING 2008-2010
CERTIFIED THAT THIS IS THE BONAFIDE WORK DONE
BY
30083221
CHERRAAN’S COLLEGE OF NURSING, COIMBATORE, TAMILNADU.
SUBMITTED IN PARTIAL FULFILLMENT OF REQUIREMENT FOR THE DEGREE OF MASTER OF SCIENCE IN NURSING TO THE TAMIL NADU
Dr. M.G.R. MEDICAL UNIVERSITY, CHENNAI.
COLLEGE SEAL: Mrs. RANI IRUDAYARAJ. MSc(N)., Mphil., MBA, PRINCIPAL, CHERRAAN’S COLLEGE OF NURSING COIMBATORE.
A STUDY TO ASSESS THE EFFECTIVENESS OF SOYABEAN CONSUMPTION ON THE MENOPAUSAL SYMPTOMS AMONG WOMEN BETWEEN 45-56 YEARS IN SELECTED VILLAGES AT
COIMBATORE DISTRICT.
Approved by the Dissertation Committee on ____________
RESEARCH GUIDE………..
Mrs. Rani Irudayaraj. M.Sc(N) Mphil, MBA, Principal,
Cherraan’s College of Nursing Coimbatore.
CLINICAL GUIDE ………..
Mrs. Muthukarupayee, M.Sc. (N)., OBG., Vice principal,
Cherraan’s College of Nursing, Coimbatore.
MEDICAL EXPERT ………..
Dr.Rajini Sivakumar, M.B.B.S, D.G.O, Obstetrics & Gynaecologists,
Alankrita Clinic, Kovai Pudur Pirivu, Coimbatore.
A DISSERTATION SUBMITTED TO THE TAMILNADU Dr. M.G.R. MEDICAL UNIVERSITY, CHENNAI IN PARTIAL FULFILMENT OF THE REQUIREMENT
FOR THE DEGREE OF
MASTER OF SCIENCE IN NURSING MARCH - 2010.
ACKNOWLEDGEMENT
First and the foremost, I extremely thank The Lord Almighty for his help and blessing on me during my study period. He is the source of the strength and inspiration in every walk of my life and the foundation of my knowledge and wisdom.
I render my thanks to Mr. K.C.PALANISAMY, B.E., (Agri),Chairman of Cherraan’s Institute of Health Science who gave an opportunity to complete my master degree in this esteemed institution.
It’s privilege to express thanks to Mrs.RANI IRUDAYARAJ. MSc(N)., Mphil., MBA, Principal, Cherraan’s College of Nursing Coimbatore who has given precious advice, valuable suggestion for the completion of the thesis with in the stipulated period.
I express my heartfelt gratitude to one of the most important person that is rememberable in my research study the counsellor and guide, Mrs. MUTHUKURUPAI, Vice principal, MSc (N)., for her expert guidance, creative and valuable suggestions, correction and advice to carry out this study. It is my great privilege to have worked under her.
My sincere gratitude and whole hearted thanks to Mrs. LINDSIE, MSc.(N)., Lecturer, Cherraan’s College of Nursing, Coimbatore, who helped me from the beginning to the completion of this study with her valuable suggestion and guidance.
I express my special sense of gratitude and thanks to our class co-ordinator Mr.
SURESH, MSc (N)., professor, Cherraan’s college of nursing for his support through out the course of my study.
My heartfelt thanks to Ms. GANGA ESWARI MSc (N), Lecturer, Cherraan’s college of nursing for her support and guidance during the study.
I extend my sincere thanks to Dr.Rajini Sivakumar, M.B.B.S, D.G.O, for her guidance and valuable suggestions.
With immense pleasure I thank Mr. SILENDARAN, MSc., PhD, for his extended help in all the statistical analysis.
I express my sincere thanks to librarian Mrs. VASANTHI Cherraan’s college of nursing Coimbatore, and Dr. M.G.R. Medical university, Chennai for their co-operation.
My heartfelt thanks to all faculty members and students of Cherraan’s college of Nursing.
I extend my thanks to Array Computer for supporting me in my entire thesis work.
I owe my special thanks all the women who have actively participated in this study with out their co-operation the study would not have materialized.
I am very grateful to Mrs.Sapanasatheesam MA., BEd., English lecturer for her valuable editorial support.
I express my sincere thanks to the experts who have done the content validity and given suggestion in the modification of the tool.
My sincere thanks to Mr. Prabhu P.MA., M.phil (Tamil) Lecturer SMS College for his co-operation in translating the tool in Tamil.
Its my pleasure to thank my beloved parents, brother for their love, support and valuable prayers in all the way of my study.
At the time of prosperity friends are plentiful. My indebtedness to my friends for their encouragement, constant moral support and co-operation are beyond everything.
Words are not enough to thank them.
Its my pleasure to thank my beloved kids MANAS MADHU AND MANAV MADHU.
I am grateful to my father-in-law and mother-in-law for their constant support in my life.
Expressing my deep gratitude to my husband MADHU for all his support, that words can not express.
ABSTRACT
A study to assess the effectiveness of soyabean consumption on menopausal symptoms among women between 45-56 years in selected villages at Coimbatore district ,was conducted by 30083221 as a partial fulfilment of requirements for the degree of Master of Science in Nursing at Cherraan’s College of Nursing ,Coimbatore district under the Tamilnadu Dr.M.G.R. Medical university, Chennai during the year 2008-2010.
OBJECTIVES
To evaluate the effectiveness of soyabean consumption on menopausal symptoms among women between 45-56 yrs in experimental group.
To evaluate the effectiveness of soyabean consumption on post test menopausal symptoms among women between 45-56 yrs among experimental and control group.
To find out the association between post test menopausal symptoms with selected demographic variables among experimental group.
To find out the association between post test menopausal symptoms with selected demographic variables among control group.
HYPOTHESIS
H1: There will be a significant difference between the menopausal
symptoms before and after soy bean consumption among women between 45-56 yrs in experimental group.
. H2: There will be a significant difference in post test score of menopausal symptoms among women between 45-56 yrs in experimental group and control group.
H3: There will be a significant association between post test menopausal score with their selected demographic variable among experimental group.
H4 : There will be a significant association between post test menopausal score with their selected demographic variable among control group.
Conceptual frame work for the study was based on the “KENNY’S OPEN SYSTEM MODEL”.
Research design used for this study was quasi experimental design. The study was conducted in Ramachettipalayam and Sundakamuthur at Coimbatore district. The population for this study consisted of menopausal women, age between45-56 yrs. Convenient sampling was used to select the sample .The sample size was 60 menopausal women age between 45-56yrs.
Data collection tool consisted of demographic variables ,self administered questionnaire, to assess the signs and symptoms of menopause.
Reliability was established through test re-test method. The co-efficient correlation score was ‘r’ = 0.9876.The tool was found to be reliable. Data collection was done for 4 week. The collected data was analysed using descriptive and inferential statistics.
MAJOR STUDY FINDINGS FINDING - 1 :
Revealed that post test mean 11.5 was lesser than pre test mean 14.5 in experimental group. The obtained ‘t’ value 7.761 was highly significant at 0.05 level.
Soya bean consumption was effective on menopausal symptoms among women between 45-56 year.
FINDING – 2 :
The study findings revealed that the mean score of experimental group was 11.5 the mean score of control group 14.57. The obtained ‘t’ value 2.5 was not significant at 0.05 level(p=0.05).
FINDING – 3 :
The association between post test menopausal score and demographic variables of menopausal women between 45-56 years age, religion, education,
occupation, family type, income, marital status, and dietary pattern among experimental group were not significant at 0.05 level.
FINDING – 4 :
The association between post test menopausal score and demographic variables of menopausal women between 45-56 years age, religion, education, occupation, family type, income, marital status, and dietary pattern among control group were not significant at 0.05 level.
Based on the above findings the implications drawn for nursing service ,nursing administration, nursing education and nursing research. Limitation and recommendation were stated adequately.
TABLE OF CONTENTS
S.No. Content Page No.
I INTRODUCTION
Background of the study Need for the study Statement of the problem Objectives of the study Hypothesis
Operational definitions Assumption
Delimitations
1- 6 1 2 5 5 5 6 6 6 II REVIEW OF LITERATURE
Study related to soyabean on menopause Study related to menopause
Study related soyabean consumption
10-32 10 21 28 III RESEARCH METHODOLOGY
Research approach Research design Variables
Setting of the study
Population of the study
Sample and Sample size
Sampling technique
Sampling criteria
Development of tool
Description of the tool
33-40 33 33 36 36 36 36 37 37 37 38
S.No. Content Page No.
III Validity of the tool
Content validity of the tool
Reliability of the tool Data collection procedure
Plan for data analysis Ethical consideration
38 38 39 39 39 40
IV DATA ANALYSIS AND INTERPRETATION 41-57
V FINDINGS AND DISCUSSION 58-59
VI SUMMARY CONCLUSION, IMPLICATION,LIMITATION AND RECOMMENDATION
Summary of the study Major study findings Conclusion
Implications of the study Limitation
Recommendations REFERENCES
APPENDICES
60-63
60 61 62 62 63 63
LIST OF TABLES
S.No. Title Page No.
1.
2.
3.
4.
5.
Mean, standard deviation and ‘t’ value of menopausal symptoms of experimental group.
Mean, Standard Deviation and ‘t’ value of menopausal symptoms of control group.
Mean, standard deviation and ‘t’ value of post test menopausal symptom score among experimental group and control group.
Frequency, percentage distribution and χ2 value of demographic variable with post test menopausal symptoms of experimental group.
Frequency, percentage distribution and χ2 value of demographic variable with post test menopausal symptom among control group.
50
51
52
53
55
LIST OF FIGURES
S.No. Title Page No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Conceptual frame work.
Diagrammatic representation of research design.
Percentage Distribution of Age of Menopausal Women Percentage Distribution of Religion of Menopausal Women Percentage Distribution of Education of Menopausal Women.
Percentage Distribution of Occupation of Menopausal Women.
Percentage Distribution of Family Type of Menopausal Women.
Percentage Distribution of Income of Menopausal Women.
Percentage Distribution of Marital Status of Menopausal Women.
Percentage Distribution of Dietry Pattern of Menopausal Women.
9 35 42 43 44 45 46 47 48 49
LIST OF APPENDICES
Appendices Title
I II III.
IV.
V.
Letter requesting expert’s opinion for content validity of the tool.
Name list of experts who validated the tool.
Letter seeking permission to conduct study.
Letter granting permission for conducting study.
Tool structured questionnaire
1
CHAPTER I
INTRODUCTION
“As people begin to look for alternative therapies for themselves, they search for them, for their pet too”.
- Alyssa Erlandson BACK GROUND OF THE STUDY
Menopause is derived from two Greek words, “Meno” means month and
“Pause” means stop. Thus menopause is the permanent cessation of menstruation.
A around 130 million Indian women are expected to live beyond the menopause into old age by 2015. Menopause is emerging as an issue owing to rapid globalization, urbanization, awareness and increased longevity in urban middle aged Indian women.
World Menopause Day is celebrated on 18th October every year. World Menopause Day started all the way back in 1984 and was instituted by the International Menopause Society and the World Health Organization (WHO).
The Menopause day is devoted to creating awareness about one of the most difficult time in a women’s life. Every woman experiences menopause in her lifetime.
Yet most of them feel uncomfortable while talking about the changes they are going through.
At about the age of 45 to 56 years, the ovaries stop making estrogen and the withdrawal of the hormone results in stoppage of the monthly menstrual periods. It happens naturally to all women sooner or later but may also be induced if the ovaries are removed or stop functioning for any other reason. The most common symptoms of menopause include, irregular bleeding, hot flushes, vaginal thinning and dryness, mood changes, decreased sex drive, osteoporosis (thinning or weakening of bones), heart disease etc.
With all that we know about the pitfalls of conventional medicine's treatment of women in menopause, it makes sense that women are turning to natural approaches to relieve menopausal discomforts. The beneficial effects of estrogen on these discomforts are indisputable, but as women become more informed they see that the risks
2
(especially of breast cancer) may be too great to justify its use. Others stop using conventional hormone replacement therapy because of side effects.
When symptoms appear in menopause, many women look to the natural world for help even though many pharmacological options are available for a woman during pre menopausal and menopausal period, soya is considered as “super food” for relieving menopausal symptoms. Because soya bean contains hormones phyto estrogen (phyto means plant) that mimics the action of natural female estrogen.
Soya bean (Glycine max) belongs to the legume family. Legumes feature phyto nutrients that lend some unique benefits to women during menopause. The soya bean is especially rich in isoflavones. Of the three main types of soya bean isoflavones, the ones which are most effective for menopausal symptom relief are genistein and daidzein. Recently a third isoflavone, glycitein, is also being studied to determine its health benefits.
In addition to the healing power of isoflavones, soya is also high in antioxidants, omega-3’s, and protein. Plus, it’s low on the glycemic index.
Soya is a high quality protein. It is one among two known plant foods which contain all the essential amino acids, and some soya products can be a source of calcium and iron. Other benefits of soya are :
Lowered blood pressure
Improvements to blood vessels, such as greater elasticity of artery walls
Reduced risk of osteoporosis
Protection against various cancers, including those of the breast, colon, prostate and skin
Management of endometriosis.
NEED FOR THE STUDY
As more and more women reach the age of menopause there has been a growing interest in ways of combating the metabolic and physiologic changes that occur during this time. The debate that ranges about the benefits and risks of ’medical treatments‚ such as hormone replacement therapy often reaches the conclusion that
3
each woman must decide for herself. Many women are looking to other more natural ways to deal with the drop in estrogen production that accompanies ageing.
In Japan, there is no word for menopause and it is widely believed that in that country women do not suffer from the effects of this change of life. Explanations for this have centered mainly on diet. The differences are between the Japanese more generally the Asian diet. and a typical western diet. The most obvious difference is the high consumption of soya bean and soya bean products.
Women in China typically have fewer hot flushes during menopause than their Western counterparts. This observation has led research into dietary differences, including the fact that Asian women tend to have soya-rich diets, while Western women have meat-rich diets.
Women who eat foods rich in soya protein are also doing a big favor for their hearts. According to a comprehensive review of the literature by the FDA in the late 1990’s, eating 25 g of soya protein daily is enough to gain soya’s heart-healthy benefits.
A study on post-menopausal women between 45-56 years released during 2006 also showed a reduced mark for the risk of cardiovascular problems, by balancing homocysteine and C-reactive protein level in the body.
Not only is soya high in protein (38% of the bean) but it’s also low in carbohydrates, making it a low glycemic (index - glycemic index) food that can support us in keeping our weight at a healthy level. Choosing foods with a low Glycemic Index helps your blood sugar and insulin levels remain stable over time, helping you feel full for longer duration, with fewer hunger cravings and fewer calories being stored as fat.
American Society conducted a study (2007) on association between higher levels of all isoflavones in the blood and lower risk for breast cancer. The strongest evidence for a decrease in risk was seen for the isoflavone genistein, suggesting that this compound may be most protective against breast cancer development. Isoflavones are present in soya bean abundantly.
4
Even newer research lends mounting evidence to the observation that the protective effect of genistein is strongest when a woman’s diet is high in soya during the adolescence and childhood.
Effective doses of individual soya isoflavones in menopause vary according to which soya foods and products are chosen. Target range of 40–80 mg of isoflavones per day is needed for adequate relief. Women with severe menopause symptoms may see quicker results with a daily intake. Women suffering from hot flushes and night sweats may have to use soya consistently in higher quantity to obtain good long-term results.
Soya phytoestrogens have very little effect on vasomotor symptoms such as hot flushes, night sweats and vaginal dryness. Bowman Gray School of Medicine in North Carolina,conducted a comparative study regarding the effectiveness of soya phytoestrogens on women aged 45 to 56 with menopausal symptoms. They reported that women who took a phytoestrogen-rich soya supplement reported a 50 percent decrease in the severity of their hot flushes.
Quun W. et.al (2009) have done a study on soya isoflavones have an anti estrogenic effect. Thirty four healthy menopausal women between 45-56 years were selected randomly. They took 40mg to 140 mg isoflavones daily. This work provides novel insight into estrogenic and mathylatin effects of dietary isoflavones.
Ishiwata N (2009) conducted a study on major role in the health benefits of soya bean. They examined the effect of a new S-equal supplement on menopausal symptom and mood stages. 134 Japanees women were selected aged 40 – 59 years, they were randomly assigned in to 3 groups. In conclusion soya supplement improved mood related symptoms in perimonopausal/ post menopausal women.
Finally, we want to share with every woman in menopause regarding the good news of soya isoflavones. It helps to promote better bone health and have a positive effect on bone density. Because of menopause, women can lose up to 20% of their bone density, so this is a particularly important time to consider adding soya to their diet.
5
This motivated the investigator to undertake the study on the effect of soya on menopausal symptoms.
STATEMENT OF THE PROBLEM
A study to assess the effectiveness of soya bean consumption on the menopausal symptoms among women between 45-56 yrs in selected villages at Coimbatore district.
OBJECTIVES OF THE STUDY
To evaluate the effectiveness of soya bean consumption on menopausal symptoms among women between 45-56 yrs in experimental group.
To evaluate the effectiveness of soya bean consumption on post test menopausal symptoms among women between 45-56 yrs among experimental and control group.
To find out the association between post test menopausal symptoms with selected demographic variables among experimental group.
To find out the association between post test menopausal symptoms with selected demographic variables among control group.
HYPOTHESIS
H1: There will be a significant difference between the menopausal symptoms before and after soya bean consumption among women between 45-56 yrs in experimental group.
. H2: There will be a significant difference in post test score of menopausal symptoms among women between 45-56 yrs in experimental group and control group.
H3: There will be a significant association between post test menopausal score with their selected demographic variable among experimental group.
H4 : There will be a significant association between post test menopausal score with their selected demographic variable among control group.
6
OPERATIONAL DEFINITION
Effectiveness : Outcome of soya bean consumption on menopausal symptoms among women between 45-56 yrs.
Soya bean : Soya bean belonged to legume family, rich in calcium, high in fibre and protein, low in saturated fat, cholesterol free, lactose free a good source of omega 3 fatty acid high in phyto estrogens that mimic the action of the hormone estrogens.
Menopausal symptoms: Symptom associated with menopause ( hot flushness, night sweat, weight gain ,drowsiness, head ache, tension, dryness of vagina, skin dryness).
ASSUMPTION
Women between 45 – 56 years will suffer from menopausal symptoms.
Women those who are taking soya bean will experience less menopausal symptoms.
DELIMITATION
Study was delimited to the women age between 45-56 years.
The study was delimited to sample from Sundakamuthur and Ramachettipalayam.
7
CONCEPTUAL FRAME WORK
KENNY’S OPEN SYSTEM MODEL
A conceptual frame work deals with the concepts assembled together by virtue of their relevance to the research problem which provides a certain frame work of reference for clinical practice, research and education.
Conceptualization is the process of framing ideas, designs and plan.
- Treece (1986) The study is based on KENNY”S OPEN SYSTEM MODEL. All the living system are open, in that there is continuous exchange of matter, energy and information. Open system has changing degree of interaction with the environment from which the system receives input and gives back out put in the form of matter, energy and information. For survival all systems of nursing receive varying type and amount of matter energy and information.
The main concept of open system model are input, through put, output and feed back. In open system theory input refers to matter, energy and information that are processed. After processing the input the system returns to output (matter, energy and information to the environment in an altered state). Feed back refers to environment response to the systems output used by the system in adjustment correction and accommodation to the interaction with the environment.
The study is under taken to determine the effect of soya beans consumption on the menopausal symptoms.
Pre test conducted to assess the signs and symptoms of menopause like hot flushness, sleeplessness, night sweat etc.
Input - Provide soya beans for reducing the menopausal symptoms.
Through put – Through put is the process of soya bean consumption on menopausal symptom among women who consumed soya bean.
Post test – Again assessing the signs and symptoms of menopause .
8
Out put – Refers to effect of soya bean consumption on
menopausal symptom by post test. This modules of Kenny’s Open System is best suited to this study.
9
Fig 1: CONCEPTUAL FRAME WORK BASED ON J.W.KENNY’S OPEN SYSTEM MODEL
INPUT OUTPUT
Assessing the Signs
and Symptoms
of Menopause
among women between age
group 45 – 56 yrs.
P R E T E S T
Experimental Group Providing Soy beans
on Menopausal
symptoms
Process of consumption of soy beans
P O S T T E S T
Menopausal Signs and Symptoms
Reduced
Menopausal Signs and Symptoms
Not Reduced THROUGH PUT
Control Group With out intervention
Feed Back
10
CHAPTER II
REVIEW OF LITERATURE
Review of literature is an essential component of the research process. It is a critical examination of publication related to the topic of interest. Review should be comprehensive and evaluative. It helps to plan and conduct the study in a systematic and scientific manner.
Nursing research may be considered as a continuing process in which knowledge from earlier studies is an integral part. Capitalizing on the review of expert research can be fruitful in providing helpful ideas and suggestions.
( Treece and Treece – 1986 ) For the present study the related literature was reviewed and organized in the following:
Section 1
Studies related to soya bean on menopause.
Section 2
Studies related to menopause.
Section 3
Studies related to soya bean consumption.
STUDIES RELATED TO SOYA BEAN ON MENOPAUSE
Qinw, Zhuw et.al (2009) conducted a study on Soya Isoflavones have an atiestrogenic effect and aiter mammary promoter hypermethylation in healthy premenopausal women between 45-56 years. 34 healthy post menopausal women between 45-56 years were randomized to 40mg or 140mg Isoflavones daily through one menstrual cycle. This work provides novel insight into estrogenic and methylation effect of dietary Isoflavones.
Kupfever EM, Darmirc SL et.al (2009) conducted a study on complementary and alternative medicine MC for vasomoter symptoms among women, who have discontinued hormone therapy. A sample of 563 menopausal women between 45-56 years who had discontinued the use of hormone therapy completed a questionnaire describing their experiences with the use of complementary and alternative medicine.
11
The most common choice complementary and alternative medicine were (a) multi vitamin and calcium, (b) black cohosh, (c) soya supplement food, (d) homeopathy, (e) meditation and relaxation. They find out the increasing adoption of complementary and alternative medicine, it is important for a health care provider to be familiar with the various method so they are comfortable discussing the benefits and risk with their patients to assist them in making informed decision.
Melby et. al (2009),conducted a study on new equal supplement for relieving menopausal sumpotoms; randomized placebo controlled trial of Japanese women.
They conducted a randomizedclonble-blind, placebo- controlled trial with equal suppliment for 12 weeks with 134 japanese women aged 40-59 years. They were randomly assigned to three group placebo (n=4) 10mg of equal per day (Eq:1 n=44) and 10mg of equal three times per day (Eq : 3 n=46). Habitual Isoflovones intake was limited to 20 mg Id. They find out that S. equal supplement improved mood related symptoms in premenopausal and post menopausal women.
Kavandith K, John Kc et. al (2008) conducted a study on high Isoflavones soya diet increases insulin secretion with out decreasing insulin sensitivity in pre menopausal non human primates. They studied insulin sensitivity in 15 peremenopausal non human primates consuming either a high Isoflavones soya diet or soya free casein/ lactalbumin diet for 4 months. These study result demonstrate that consumption of soya containing high isoflavone level is not associated with changes in insulin sensitivity in the high estrogen mimic of the premenopausal female.
July, Nascamm, Zhon JR et.al (2008) conducted a study on effect of soya nuts on adhesion molecules and markers of inflammation in hypertensive post menopausal women between 45-56 years. Sixty healthy post menopausal women between 45-56 years (48 narmotensive and 12 with hypertension) were randomized in a crossover design to a TIC diet alone or a TLC diet in which 0.5 cup of soya nuts (259 soya protein and 101 mg aglycone isoflavones) replaced 259 of non soya protein daily.
Each diet was followed for a week. Comparing it with the RLC diet alone level of soluble vascular cell adhesion molecule were significantly lower as the soya diet in
12
women with hypertension (623. 6+1-153.8 vs 553.8+1-114.4 ng/ml despectively p=0.003) were as no significant difference were observed in nonmotensive women. In that they find out the reduction in soluble vascular cell adhesions molecule with soya nuts in women with hypertension suggests an improvement in endothelial function that may reflect an over all improvement in the underlying inflammatory process underlying arteriosclerosis.
Jon HJ, Wu. Sc et.al (2008) conducted a study on effect of intestinal production of equal as menopausal symptoms in women treated with soya isoflavones. A randomized double blind, placebi- controlled clinical trial was conducted over 6 months with 96 healthy menopausal women between 45-56 years. After taking 135 mg of isoflavones daily for 1 week the women in the study group were assigned the equal- producing or the non EP group according to the presence or absence of equal in their urine. Result is compared with the placebo group, the sources for hot flashes and excessive sweating were significantly after 3 months and the scores for weakness, palpitation limp paresthesia and total symptoms after 6 months, in the EP group only.
They find out isoflavones supplementation improves menopausal symptoms only in women with the ability to produice equal.
ADPT,S, Clarkson TB et.al (2008) conducted a study as equal production capacity is associated with favorable vascular function in post menopausal women between 45-56 years using toboline : no effect with soya supplement. They screened 110 women using tiboline for -3-60 month for high equal production capacity with a one week soya challenge.post menopausal tiboline user’s endogenous equal production capacity is associated with favorable vascular function. This phenomena was not affected by soya and thus equal producing capacity may be an independent vascular health marker at least in post menopausal women between 45-56 years using tiboline.
Kim HW, Khil JM et.al (2007) conducted a study on isoflavones intake from soya food and premenstrual symptoms. This study was conducted to explore the relationship between isoflavones intake from soya food and premenstrual symptom among women. Subject considered of 243 women living in Korea aged 19 – 49 years.
13
Result was suggested some positive health effect of isoflavones from soya food on premenstrual symptoms. More accurate objective measurement need to be applied and more investigation of soya isoflavones effect on many aspects of women’s health need to be done in a future study.
Cohen LA, Crepsin JS,et.al (2007) conducted a study on soya isoflavones intake and estrogen excretion patterns in young women effect of probiotic administration. It was measured in 36 healthy premenstrual women before and after the injection of soya protein formula containing 120mg of isoflavones daily for one month, result was soya isoflavones injections include qualitative differences in urinary excretion of estrogen metabolites and isoflavones but failed to alter 20 HE1/16 alpha OHEI ratios.
They find out that isoflavones rich soya protein administration alone or with probiotic supplement, did not alter urinary excretion of estrogen metabolites in premenopausal women between 45-56 years. However adding concentrated probiotics may alter isoflavones bio availability.
Nahar CA, et . al (2007) conducted a study on efficiency and safety of a soya isoflavones extract in post menopausal women between 45-56 years. In this double blind randomized placebo – controlled study a total of 80 women ( Mean age = 55.1 years) who reported 5 or more hot flushed episodes per day were randomized to receive either 250 mg of standardized soya extract a total of 100 mg/ day of isoflavones (n=40) or placebo (m=40). The mean number of hot flushness was 9.6 + 1-3.9 per day in the isoflavones group and 10.1 + 1-4.9 in the placebo group (p70.05) after 10 months there was a significant reduction in both group. The soya isoflavones extract exerted favorable effect as vasomotor symptoms and good compliance providing a safe and effective alternative therapeutic for post menopausal women between 45-56 years.
HSU I P et . al (2007) conducted a study on effect of soya germ extracts on blood lipo proteins, anti oxidative capacity and urinary estrogen metabolites in post menopausal women between 45-56 years as hormones therapy. A1 subject received 6g of soya germ extract per day for 4 weeks. It is inferred that plasma HDL/C level increased markedly with significant decrease of plasma LDL-C/ HDL-C ratio and LDL-
14
T4 levels. That concluded soya germ extract may improve serum lipid profile in post menopausal Taiwanese women who receive HT, and probably provide a favorable effect on estrogen metabolism.
Welty F K, et . al (2007) conducted a study on association between soya nut consumption and decrease menopausal symptoms. Sixty health post menopausal women between 45-56 years were randomized in a cross over design to a therapeutic life style changes. TLC diet alone and TIC diet of similar energy, fat and protein content in which one half cup of soya nuts divided into three or four portions spaced throughout a day containing (259 of soya protein during each 8 week diet period). Subjects recorded the number of hot flushes and amount of exercise daily. It is inferred that compared to the TLC diet alone the TLC diet plus soya nuts was associated with a 45%
decrease in hot flushes (7.5+1 – 3.6 VS. 4.1+/-2.6 hot flushes day respectively, p<0.001) in women with >4.5 hot flushes/day at baseline and 41% in those = 4.5 hot flushes/day (2.2+1-1.2 vs 1.3+1-1.1, respectively, p<0.001) soya nut intake was also associated with significant improvement in score on the menopausal symptoms quality of life questionnaire 19% decrease in vasomotor score (p=0.004) 12.9% reduction in psychosocial score (p=0.01) 7.9% decrease in physical score (p=0.045) and trends towards improvement in the sexual score with a 17.7% reduction in symptoms (p=0.129). Substituting soya nuts for non soya protein in a TIC diet and consumed three or four times throughout the day is associated with a decrease in hot flushness and improve in menopausal symptoms.
Ma DF et . al (2008) conducted a study on soya isoflavones intake inhibits bone resorption and stimulates bone formation in menstrual women. They identified randomized controlled trial related to urinary deoxypyridinoline and serums bone specific alkaline phosphatase, nine studies with a total of 432 subjects were selected for meta analysis. The urinary D & Pyr concentration in subjects who consumed Isoflavones decreased significantly by -2.08 (95% c/=0.22 – 2.75 mugli) decrease in the urinary DPyr concentration with isoflavones intake of <90 mg/day and with treatment lasting less than 12 weeks were -2.34 n mollmmol (95% c/: -4.46 to -0.22 n mollmmol)
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and (-2.03 n mollmmol 95% c/: -3.20 to -0.85 n mollmmol), respectively isoflavone intervention significantly inhibits bone resumption and stimulates bone formation. These favorable effect occur even if <90 mg/day of isoflavones are consumed or the intervention lasts less than 12 weeks.
Azadbaknt . L. et . al (2007) conducted a study on soya including diet improving the features of the metabolic syndrome. This randomized crossover clinical trial was undertaken in 42 post menopausal women between 45 - 56 years with the metabolic syndrome. Participants were randomly assigned to consume a control diet or a soya protein diet or soya nut diet each for 8 weeks. It is inferred that the soya nut regimes decreased the homeostasis model of assessment – insulin resistance score significantly compared with the soya protein (different in percentage change – 7.4 +(=0.8; p< 0.01) or control (-12.9+ 1- 0.9; p<0.01) diet consumption of soya also reduced fasting plasma glucose more significantly than did the soya protein (-5.3 + 1- 0.5% p<0.01) or control (-5.1 + 1- 0.6%; p<0.01) diet. The soya nut regimes decreased LDL cholesterol more than did the soya protein period (-5.0 +. – 0.6% p<0.01) and the control (-9.5+/-0.6% p<0.01) diet soya nut consumption significantly reduced serum c- peptide concentrations compared with control diet (-8.0+/ - 2.1: p <0.01) short term soya nut consumption improved glycemic control and lipid profiles in post menopausal women between 45-56 years with the metabolic syndrome.
Malsta N. et . al (2007) conducted a study on effects of soya protein and resistance exercise on body composition and blood lipid in post menopausal women between 45-56 years. In a controlled trial 46 post menopausal women between 45-56 years were randomized to one of four group 25g of soya protein (SP n=10) 25g of soya protein plus resistance exercise (SPE n=14) 25g of metadextrine (placebo) (Pl n=11) or placebo plus resistance exercise (PLE, n+11) progressive resistance training was held three times a week. For 16 weeks and included 8 exercise C3 series of 8-12 repetition at baseline and after 16 weeks, body mass index, waist circumference, body fat, muscle mass and serum lipid levels were measured. Subject were classified as over weight and showed android fat distribution. Urinary isoflavones excretion indicates compliances to
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soya protein treatment. After 16 weeks of intervention both SPE and PLE groups showed significant increase of 1.3 kg in muscle mass and reduction in weight of -1.4 and – 2.1 cm respectively (p<0.05) significant decrease in the mean value of total cholesterol and LDL (-29.0 and – 24.0 mg/dl, p< 0.001 and p<0.006, respectively soya protein supplementation with out composition. However it exerted possible favorable effects on lipid profile in post menopausal women between 45-56 years. The increase in muscle mass and reduction in abdominal fat were corrected with resistance training.
Tsangalis D et . al (2007) conducted a study on urinary excretion of equal by post menopausal women between 45-56 years consuming soya milk fermented by probiotic bifidobacteria. Subject randomized into two groups consuming either fermented or non-fermented soya milk, ingested three daily dosages of daidzein via soya milk and collected pooled urine specimens. Daidzein and equal were quantified using high performance liquid chromatography. After 14 days supplementation six women (38%) excreted equal (>1 micromol equal/ day) including four from the FS group, two of whom were classified as non producers at day 4.
Teede HJ, Dalais FS et . al (2005) Dietary soya containing phytoestrogens does not activate the hemostatic system in postmenopausal women.40 healthy postmenopausal women of age 50-75 yr received soya protein isolate (40g soya protein, 118 mg isoflavones) (n = 19) or casein placebo (n = 21). Plasma markers of coagulation, fibrinolysis, and endothelial dysfunction were measured at baseline and 3 months. The baseline characteristics of the two groups were similar. Compared with casein placebo, soya decreased triglycerides (P < 0.005) and low-density lipoprotein/high-density lipoprotein ratio (P < increased lipopratein, (a) (P < -001) and increased lipoprotein (a) (p<0.05). activity of coagulation factor VII (VVIc) decreased similarly in both groups (P < 0.005). Prothrombin fragments 1 + 2 (a marker of thrombin generation) decreased in the soya group (P < 0.005), but the change was not different from the casein group. There was no effect of soya on soluble fibrin (a marker of fibrin production), plasminogen activator inhibitor-1 (a marker of fibrinolytic inhibitory potential), D-dimer.
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File SE, Hartley DE et . al (2005) Cognitive improvement after 6 weeks of soya supplements in postmenopausal women is limited to frontal lobe function. In a double-blind, placebo-matched parallel groups study,^50 postmenopausal women (aged 51-66 y) were randomly allocated to receive daily treatment with a soya supplement (Novasoya, 60 mg total isoflavone equivalents/day) or matching placebo capsules. They were tested at baseline before treatment began and after 6 weeks of treatment in tests of attention, memory, and frontal lobe function, and completed questionnaires to assess sleepiness, mood, and menopausal symptoms. After 6 weeks of treatment, there was a significant (P < 0.02) reduction in - somatic menopausal symptoms in the group taking soya supplements, but there were no other significant effects of soya on menopausal symptoms or mood. On the test of nonverbal short-term memory, the soya group showed greater improvement than the placebo group (P <
0.03), but there were no effects of soya on long-term memory, category generation, or sustained attention. However, the soya treatment produced significantly better performance on the two tests of frontal lobe function, those of mental flexibility (simple rule reversal, P < 0.05; complex rule reversal, P < 0.03) and of planning ability (P <
0.05).
West SG, Hilpert Kf, et . al (2005) Effect of concluding soya protein in a blood cholesterol – lowering diet on markers of cardiac risk in men and in postmenopausal women with and without hormone replacement therapy. We tested whether adding soya protein to a low-fat, high-fiber, Step I diet improved cardiac risk markers in 18 postmenopausal women and 14 men with hypercholesterolemia and examined whether concurrent use of HRT altered diet responsiveness. Diets were matched for macronutrient content, and all food was provided. After 3 weeks on the Step I diet, subjects were randomized to diets (6 weeks) containing 25 g/day protein isolate from soya or cow's milk, with crossover. The soya treatment contained 90 mg/day isoflavones. Lipids, vascular cell adhesion molecule-1 (VCAM-1), p-selectin, and urinary isoflavonoids were measured at the end of each diet. In men and HRT- women only, there were significant reductions in LDL-C (-17.330", high-density
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lipoprotein cholesterol (HDL-C) (-15.3%), and triglycerides (-11.5%) during the Step I diet, and soya had no additional effects. At study entry, HRT+ women had lower LDL- C and higher triglycerides than men. Their LDL-C was unchanged, and triglycerides were significantly reduced (-15.1%) by the Step I diets. Isoflavonoid excretion was unrelated to diet response or HRT status. In men and HRT- women, the diets significantly lowered LDL-C, independent of soya intake. In HRT+ women, the diets improved triglycerides without lowering HDL-C.
Wu AH, Stanczyk FZ et . al (2005) A controlled 2-mo dietary fat reduction and soya food supplementation study in postmenopausal women. Fifty-seven postmenopausal women participated in a randomized, controlled, dietary intervention study. The subjects consumed a very-low-fat diet (VLFD; 11% of energy as fat), a Step I diet (25% of energy as fat) supplemented with soya food (SFD; 50 mg isoflavones/d), or a control Step I diet (CD; 27% of energy as fat) with no soya food. All diets were prepared at the General Clinical Research Center of the University of Southern California. Serum hormones and other markers were measured at baseline and every 2 wk during the 8 wk of intervention. There were no significant differences in total estradiol and sex hormone binding globulin at the completion of the intervention between women in the SFD and VLFD groups and those in the CD group. Serum insulin decreased significantly in the SFD group, and leptin decreased significantly in the SFD and VLFD groups; however, these changes, did not differ significantly from the changes in the CD group. This study does not provide evidence that ingestion of soya food or a VLFD significantly reduces estrogen concentrations in postmenopausal women. However, short-term changes in diet may have significant and beneficial effects on blood insulin and leptin concentrations.
Teede HJ, Dalais FS,et.al (2004) Dietary soya containing phytoestrogens does not have detectable estrogenic effects on hepatic protein synthesis in postmenopausal women. Fifty healthy postmenopausal women aged 50-75 y participated in a double- blind, placebo-controlled trial in which they received either soya protein isolate (40 g soya protein, 118 mg isoflavones) or casein placebo. Measurements were made at
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baseline and at 3 mo. Urinary isoflavone excretion was measured to reflect compliance.
Baseline characteristics were not significantly different between the soya and placebo groups. Urinary isoflavone excretion increased in the soya group and the end of 3 mo was higher in the soya group than in the placebo group. In plasma samples from both groups, C-reactive protein increased significantly over the 3-mo treatment period, whereas sex hormona-binding globulin and thyroid-binding globulin decreased significantly. However, there were no significant differences between the groups in hepatic protein synthesis (change over 3 mo +/- SEM in the soya and placebo groups, respectively): C-reactive protein, 0.42 +/- 0.2 and 0.48 +/- 0.2 U/mL; sex hormona- binding globulin, -6.9+/- 1.5 and -10.0 +/- 2.1 micro g/ml; thyroid-binding globulin, - 16 +/- 8 and – 26 +/- 7 nmol/l. furthermore, gonadotropin and dehydroepiandrosterone sulfate concentrations did not change significantly in
Acharya S, Maskarinec G et . al (2004) Nutritional changes among premenopausal women undertaking a soyaa based dietary intervention study in Hawaii.
In this analysis of 10® intervention and 106 control subjects, women completed a validated food-frequency questionnaire at baseline; throughout the study, they participated in at least three unannounced 24-h recalls. At randomization, both groups were similar in age and body weight, reported low soyaa intake, and did not differ by intake of major nutrients and foods. According to the 24-h recalls, women in the intervention group consumed nearly two servings of soyaa per day, while the control women remained at 0.2 servings. In comparison with the control group, the intervention group consumed fewer dairy products, primarily milk, but also less meat, nuts and seeds. As a result of the dietary modification, the intervention women consumed less- saturated fat and cholesterol and more protein, dietary fibre, calcium and vitamins than the control group. These results suggest that women in the intervention group improved the overall quality of their diet by adding two servings of soyaa per day.
Balk JL, Whiteside DA, A pilot study of the effects of phytoestrogen supplementation on postmenopausal endometrium. Performed a prospective, double- blinded, randomized, placebo-controlled trial comparing the effects of 6 months of
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dietary phytoestrogen supplementation versus placebo in postmenopausal women.
Baseline endometrial biopsies were performed and, if adequate, nonhyperplastic, noncancerous, and nonovulatory, subjects were randomly assigned to receive daily placebo or soya cereal supplementation for 6 months. Subjects were recruited from January 1998 through June 2000. Twenty-seven subjects were randomized, and 19 completed the study. One (3.7%) baseline endometrial sample was weakly proliferative.
All other baseline and final biopsies were consistent with atrophic, inactive endometrium. The maximum risk of endometrial stimulation with phytoestrogens is 35%. Hot flushes, night sweats, and vaginal dryness were significantly less severe at the final week of the study compared with baseline in the placebo group. Insomnia was more common in the treated group. There were no other statistically significant differences in symptoms or side effects.
Arjmandi BH, Khalil DA, et . al (2003) Soya protein has a greater effect on bone in postmenopausal women not on hormone replacement therapy, as evidenced by reducing bone resorption and urinary calcium excretion. A total of 71 women were randomly assigned to either soya protein (SP) or milk-based protein (MBP), 40 g daily for 3 months, in a double-blind parallel design. Forty-two women completed the study (20 on SP and 22 on MBP. Overall, both protein supplements positively influenced serum IGF-T, known to correlate with bone formation. However, SP had a more pronounced effect on IGF-I than MBP. Urinary deoxypyridinoline (Dpd) excretion, a specific biomarker of bone resorption, was significantly reduced by SP, but not by MBP when all women were included. Furthermore, women on MBP experienced a 33%
increase in urinary calcium excretion, whereas SP did not have such an effect. To evaluate whether SP affects women differently on the basis of their HRT status, data from women on HRT (n = 22) and those not on HRT (n = 20) were analyzed separately.
The subanalysis of the data indicated that SP had the greatest impact on serum IGF –I (an increase of 97%) in the women not on HRT. The changes in urinary Dpd due to SP were only observed in women not on HRT, indicating that the overall decrease in Dpd occurred with SP in the absence of HRT. These results indicate that soya protein may
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positively influence bone and calcium homeostasis in post menopausal women, particularly those not on HRT.
Ho SC, Woo J, Lam S et.al (2003) Soya protein consumption and bone mass in early postmenopausal Chinese women. The sample comprised 454 healthy Chinese women (mean age 55.1 +/- 3.57) within the first 12 years of postmenopause. We estimated the dietary intake of soya protein and isoflavones, and other key nutrients, including dietary protein and calcium, using the quantitative food frequency method.
Noted a dose-response relationship with increasing higher BMD values at the trochanter, intertrochanter as well as the total hip and total body with increasing soya protein intake quartiles (P<0.05 from tests for trend). The BMD values differed by about 4-8% between the first and fourth soya protein intake quartiles. Though women from the fourth intake quartile had a 2.9% higher BMD value compared with those from the first intake quartile, the difference was not statistically significant. The effects of soya protein and soya isoflavones on, bone health should be further explored in populations with habitual dietary soya intake.
Chiechi LM, Putignano G, et.al (2003) The effect of a soya rich diet on the vaginal epithelium in postmenopausal analyzed double blind trial. In this study, we analyzed the effects of a 6-month soya-rich diet on the vaginal epithelium of asymptomatic postmenopausal women in a randomized clinical trial. 187 women were recruited for the study and divided into three groups: a phytoestrogen rich diet group; a hormonal replacement group, and a control group. A vaginal sample for hormonal cytology was taken before and at the end of the study, and sent unnamed to a cytologist.
STUDIES RELATED TO MENOPAUSE.
AK Datta et.al (2008) conducted a study on Female Hormone Replacement Therapy in Postmenopausal. Our knowledge of beneficial role of female sex hormone in postmenopausal women between 45-56 years is expanding rapidly. Apart from the relief of menopausal symptoms, oestrogens have proved to be effective in prevention of cardiovascular disease and osteoporotic fractures – the two leading causes of death in
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geriatric age. There is growing evidence that these hormones improve cognitive functions and thus, may arrest Alzheimers dementia. While oestrogen replacement therapy in elderly women is gaining momentum, the risk of breast and endometrial carcinoma, albeit small, exists. Venous thrombo-embolism is another concern.
Judicious use of the hormones by appropriate route along with regular monitoring and screening programme, however, minimizes the risk. Advent of other related compounds like tibolone and new generation selective oestrogen receptor modulators (SERMs) have made the choice wider, particularly in those who are not suitable candidates for oestrogen therapy.
Nancy E et.al (2008), Conducted a study on acupuncture treatment for menopausal hot flashes. To investigate the feasibility of conducting a randomized trial of the effect of acupuncture in decreasing hot flashes in peri- and postmenopausal women between 45-56 years. Fifty-six women ages 44 to 55 with no menses in the past 3 months and at least four hot flashes per day were recruited from two clinical centers and randomized to one of three treatment groups: usual care (n = 19), sham acupuncture (n = 18), or Traditional Chinese Medicine acupuncture (n = 19).
Acupuncture treatments were scheduled twice weekly for 8 consecutive weeks. The sham acupuncture group received shallow needling in nontherapeutic sites. The Traditional Chinese Medicine acupuncture group received one of four treatments based on a Traditional Chinese Medicine diagnosis. Usual care participants were instructed to not initiate any new treatments for hot flashes during the study. Daily diaries were used to track frequency and severity of hot flashes. The mean daily index score was based on the number of mild, moderate, and severe hot flashes. Follow-up analyses were adjusted for baseline values, clinical center, age, and body mass index. There was a significant decrease in mean frequency of hot flashes between weeks 1 and 8 across all groups (P = 0.01), although the differences between the three study groups were not significant. However, the two acupuncture groups showed a significantly greater decrease than the usual care group (P < 0.05), but did not differ from each other.
Results followed a similar pattern for the hot flash index score. There were no
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significant effects for changes in hot flash interference, sleep, mood, health-related quality of life, or psychological well-being. These results suggest either that there is a strong placebo effect or that both traditional and sham acupuncture significantly reduce hot flash freque.
Chattha et.al (2008) conducted a study on Treating the climacteric symptoms in Indian women with an integrated approach to yoga therapy: a randomized control study. To study the effect of yoga on the climacteric symptoms, perceived stress, and personality in perimenopausal women between 45-56 years. One hundred twenty participants (ages 40-55 years) were randomly divided into two study arms, ie, yoga and control. The yoga group practiced an integrated approach to yoga therapy comprising surya namaskara (sun salutation) with 12 postures, pranayama (breathing practices), and avartan dhyan (cyclic meditation), whereas the control group practiced a set of simple physical exercises under supervision of trained teachers for 8 weeks (1 h daily, 5 days per week). The assessments were made by Greene Climacteric Scale, Perceived Stress Scale, and Eysenck's Personality Inventory before and after the intervention. Of the three factors of the Greene Climacteric Scale, the Mann-Whitney test showed a significant difference between groups (P < 0.05) in the vasomotor symptoms, a marginally significant difference (P = 0.06) in psychological factors but not in the somatic component. Effect sizes were higher in the yoga group for all factors.
There was a significantly greater degree of decrease in Perceived Stress Scale scores (P < 0.001, independent samples t test) in the yoga group compared with controls (between-group analysis) with a higher effect size in the yoga group (1.10) than the control (0.27). On the Eysenck's Personality Inventory, the decrease in neuroticism was greater (P < 0.05) in the yoga group (effect size = 0.43) than the control group (effect size = 0.21) with no change in extroversion in either the yoga or control group. Eight weeks of an integrated approach to yoga therapy decreases climacteric symptoms, perceived stress, and neuroticism in premenopausal women between 45-56 years better than physical exercise.
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Elhelw, et.al (2006) conducted a study on Non-hormonal therapies for the treatment of menopausal symptoms. Hot flushes affect approximately 75% of postmenopausal women between 45-56 years and are one of the most distressing symptoms that women experience as they enter the menopause. The treatment of hot flushes is a common clinical challenge. Hormone replacement therapy (HRT) effectively reduces vasomotor symptoms by 80-90%, however, many patients may be unable or unwilling to undergo hormonal treatment. Publication of the results of the Women’s Health Initiative (WHI) and the Million Women Study (MWS) has led to considerable uncertainties about the role of HRT among health professionals and women. The estrogen and progestin arm of the Women's Health Initiative and other recent reports suggest that HRT may increase the risk for coronary heart disease events, strokes, venous thromboembolism, and invasive breast cancer. Many expert groups recommend that combination hormonal therapy for the management of vasomotor symptoms should be limited to the shortest duration consistent with treatment goals and benefits versus risks for individual women. All of these concerns have generated interest in non- hormonal treatment of hot flushes. Such therapies, readily available for the menopausal patient could become a therapeutic nightmare -especially when taken without physician supervision. Data for these therapies are limited, and most of the studies have been conducted in women with a history of breast cancer. In this review we discuss the evidence underlying the commonly used non-hormonal therapies for hot flushes in terms of efficacy and safety.
Sarah P et .al (2006) Life After the Women's Health Initiative: Evaluation of Postmenopausal Symptoms and Use of Alternative Therapies After Discontinuation of Hormone Therapy. To determine the number of women who have menopausal symptoms after discontinuing hormone therapy, to determine how many of these women subsequently require non hormonal alternatives to manage their symptoms, and to assess the effectiveness of those therapies. One-year retrospective study.
Department of Family Medicine outpatient clinic at a university medical center. From 378 postmenopausal women between 45-56 years who discontinued hormone therapy
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between August 1, 2002, and August 31, 2003, we randomly selected 78 using electronic medical records to provide a sample with a 95% confidence interval and a 10% margin of error. Measurements and Main Results: Reasons why the women discontinued therapy and any non hormonal alternative therapies that they may have used to manage subsequent menopausal symptoms were recorded. The primary investigator contacted the 78 women to complete a telephone survey. In most women, at least one menopausal symptom recurred. Vasomotor symptoms (hot flashes) were most common and occurred in 41 (53%) women. In addition, 59 (76%) women reported using non hormonal alternative therapies, and 40 (68%) of this group deemed the alternatives helpful. We strongly believe that health care providers, including pharmacists, must continue to communicate with and educate women regarding treatment options for menopausal symptoms. Clinical pharmacists are ideally suited to contribute to ongoing research in this area.
Cohen .et.al (2003) Conducted a study on Acupuncture Ease the Symptoms of Menopause. In a randomized, 2-group clinical study, acupuncture was used for the relief of menopausal hot flushes, sleep disturbances, and mood changes. The experimental acupuncture treatment consisted of specific acupuncture body points related to menopausal symptoms. The comparison acupuncture treatment consisted of a treatment designated as a general tonic specifically designed to benefit the flow of Ch'i (energy). Results from the experimental acupuncture treatment group showed a decrease in mean monthly hot flush severity for site-specific acupuncture. The comparison acupuncture treatment group had no significant change in severity from baseline over the treatment phase. Sleep disturbances in the experimental acupuncture treatment group declined over the study. Mood changes in both the experimental acupuncture treatment group and the comparison acupuncture treatment group showed a significant difference between the baseline and the third month of the study.
Acupuncture using menopausal-specific sites holds promise for non hormonal relief of hot flushes and sleep disturbances. Menopausal symptoms impact the lives of individual women, their families, their productivity, and their lives within their
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communities. 1-4 While hormone replacement therapy (HRT), now known as hormone therapy (HT), is the most often cited remedy for menopausal symptoms, non hormonal interventions are preferred by some women and by nearly all women with menopausal symptoms induced or accelerated by breast cancer treatment. 5 Previous small-sample studies indicate that non hormonal treatments are effective in relieving the symptoms associated with menopause. 6 Non hormonal therapies for menopause symptom relief include pharmacologic therapies 7,8 (eg, clonidine, veralipride, metaclopramide, sulpride, venlafaxine), herbs (E. Robinson and S.M. Cohen, unpublished data, 1999) (black cohosh, red clover), dietary alterations 9-11 (phytoestrogens), paced respirations, 12 physical activity, 13,14 and acupuncture. Acupuncture holds promise for short-term management (3-5 years) of menopausal symptoms, and this study was conducted to explore the efficacy of acupuncture for menopausal symptom relief.
Misra, D.N. et.al (2003). Conducted a study on Clinical Trial to Evaluate the Efficacy of Menopausal Syndrome. Postmenopausal syndrome is characterised by manifestations of hot flushes, insomnia, night sweating, irritability and mood swings and anxiety-depression. Anxiolytic drugs along with hormone replacement therapy (HRT) are the palliative treatments of choice in modern drug therapy. However, HRT has several limitations. M-3119, a herbomineral preparation administered to 42 women with signs and symptoms of postmenopausal syndrome at a dose of 2 tablets twice daily for 6 months, cured the symptoms in 53% of women, improved in 31% and remaining 16%
did not respond to the therapy. From the various parameters taken for clinical analysis, it may be concluded that M-3119 would be an effective therapy for the control of symptoms of menopausal syndrome.
Carpenter et.al (2002) conducted a study on Magnetic Therapy for Hot Flashes After Breast Cancer. The purpose of this randomized placebo-controlled crossover pilot study was to evaluate the effectiveness and acceptability of magnetic therapy for hot flashes among breast cancer survivors. Participants completed a 24-hour baseline hot- flash monitoring session, wore the magnetic devices or placebo for 3 days, completed an after-treatment hot-flash monitoring session, experienced a 10-day washout period,
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and then crossed over to the opposite study arm. Magnetic devices and placebos were placed on 6 acupressure sites corresponding to hot-flash relief. Complete data were available from 11 survivors of breast cancer. Results indicated magnetic therapy was no more effective than placebo in decreasing hot-flash severity, and contrary to expectations, placebo was significantly more effective than magnets in decreasing hot- flash frequency, bother, interference with daily activities, and overall quality of life.
Implications for clinical practice and future research include the need to explore alternative interventions aimed at alleviating hot flashes in this population.
Newton et.al (2002) conducted a study on Use of Alternative Therapies for Menopause Symptoms: Results of a Population-Based Survey. From the Center for Health Studies, Group Health Cooperative, Seattle, Washington; Department of Epidemiology, University of Washington, Seattle, Washington; and Centers for Disease Control and Prevention, Atlanta, Georgia. To describe self-reported prevalence of the use of alternative therapies for menopause symptoms and subject characteristics associated with their use. A telephone survey of 886 women aged 45-65 years (87.2%
response rate) was conducted at Group Health Cooperative in Washington state.
Women were asked about eight alternative therapies and their use for menopause symptoms. The proportion of women who used each therapy was 76.1% for any therapy, 43.1% for stress management, 37.0% for over-the-counter alternative remedies, 31.6% for chiropractic, 29.5% for massage therapy, 22.9% for dietary soya, 10.4% for acupuncture, 9.4% for naturopath or homeopath, and 4.6% for herbalists. The proportion of women who used it to manage menopause symptoms was 22.1% for any therapy, 9.1% for stress management, 13.1% for over-the-counter alternative remedies, 0.9% for chiropractic, 2.6% for massage therapy, 7.4% for dietary soya, 0.6% for acupuncture, 2.0% for naturopath or homeopath, and 1.2% for herbalists. Among women who used these therapies, 89-100% found them to be somewhat or very helpful.
A history of breast cancer was associated with a six-fold increase in use of dietary soya for menopause symptoms (odds ratio 6.23, 95% confidence limits 2.54, 15.28). Current users of hormone replacement therapy were half as likely to use alternative remedies or
