F E AT U R E S
The Effects of Flaxseed on Menopausal Symptoms and Quality of Life ■
Nuray Egelioglu Cetisli, PhD, RN ■ A. Saruhan, PhD, RN ■ B. Kivcak, PhD The purpose of this study was to analyze the effects of flaxseed on menopausal symptoms and quality of life throughout the menopausal period. The empirical research was conducted in an obstetrics and gynecology outpatient department of a university hospital and involved 140 menopausal women who were divided into 4 groups. The menopausal symptoms decreased and the quality of life increased among the women who used flaxseed for 3 months. KEY WORDS: flaxseed, menopause, menopausal symptoms, nurses, nursing, quality of life Holist Nurs Pract 2015;29(3):151–157
Menopause is natural and physiological for women; it is not a disease. However, it is a period that can negatively affect the quality of a woman’s life because of the intensity and length of the symptoms and potential risks and pathologies. Herbal estrogens taken in the diet increase the estrogen level that decreases during the menopausal period, and their estrogenic properties can avert menopausal symptoms. Because of its estrogenic, antiestrogenic, antioxidant, and antiproliferative properties, a diet of phytoestrogenic herbs can decrease the frequency of vasomotor symptoms by increasing the estrogen level and changing the hormonal balance.1-5 Phytoestrogenic agents are chemicals that can act as a natural estrogen in the human body. There is no synthesis or deposit of these compounds in the body, and their only source is an intensive herbal diet containing these compounds. Phytoestrogens can be found in grains, vegetables, and fruits. The most well-known and enriched sources of phytoestrogens are flaxseed and soy. Phytoestrogens, such as flaxseed and soy, have been shown to affect menopausal symptoms within 12 weeks.6-9
Author Affiliations: Department of Obstetric and Gynecologic Nursing, Faculty of Health Sciences, Izmir Katip Celebi University, Izmir, Turkey (Cetisli); and Faculty of Nursing (Saruhan), and Faculty of Pharmacy (Kivcak) Ege University, Izmir, Turkey. The authors have disclosed that they have no significant relationships with, or financial interest in, any commercial companies pertaining to this article. Correspondence: Nuray Egelioglu Cetisli, PhD, RN, Obstetric and Gynecologic, Faculty of Health Science, Izmir Katip Celebi University, Cigli 35620, Izmir, Turkey ([email protected]). DOI: 10.1097/HNP.0000000000000085
Intensive observation, support, care, and health training are needed during menopause. To increase the quality of life in terms of physical, mental, and social lives, women need to know the potential health problems that might arise during menopause in order to take proper precautions. Women need support, consultation, and information about menopause. Because they have important roles in increasing the quality of the lives of women, the general goals of menopausal care nurses are to ensure that women and their families understand that menopause is a natural period of a life. These nurses are key people for enabling women to cope with social, physical, and emotional problems. Informing women and their families about menopause, correcting misunderstood beliefs and perceptions, and planning the sexual lives, aliments, practices, and social activities of the women are also other roles of the nurses. Nurses who study women’s health should be the main group that provides complementary methods to cope with menopausal symptoms due to their scientific knowledge about the protection, development, and sustainment of the health of menopausal women.10,11 The number of studies in the literature related to the efficacy of training and complementary treatment methods for decreasing menopausal symptoms to affect the quality of life is very limited. Brzezinski et al12 sought to determine the effects of a diet heavy in phytoestrogen on the menopausal complaints of women in the climacteric period. In this study, these authors provided a diet heavy in phytoestrogen to an experimental group (n = 78) over 12 weeks while not performing any manipulations in the control group 151
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(n = 36). At the end of 3 months, the complaints of the women in the phytoestrogen group related to symptoms such as hot flashes, vaginal dryness, and menopausal symptoms were significantly decreased compared with their pretreatment scores, whereas the differences in the control group were not significant.12 In a random controlled study by Lewis et al,13 the effects of soy flour and flaxseed on the quality of life and the frequency and strength of hot flashes in women in the postmenopausal period who ate biscuits containing wheat flour were reviewed. In this study, flaxseed was given to 28 women and soy flour was given to 31 women. The biscuits were given for 4 months, and the authors found that the strength of the hot flashes of the group that was given biscuits containing flaxseed was weaker than that of the group that was given biscuits containing wheat flour.13 Studies of the efficacy of training and complementary treatment methods that can be used to decrease the effects of menopausal symptoms on quality of life are notably limited. This study was undertaken to determine the effects of using flaxseed and training throughout the menopausal period on women’s menopausal symptoms and quality of life.
METHODS Sample and design This study was planned to analyze the differences of in the quality of life and experiences of menopausal symptoms between women who used flaxseed and received training and hormone replacement therapy (HRT) and a control group. This experimental research was planned to be composed of pretests, posttests, and a control group. The research was conducted with participants who were being treated in the obstetrics and gynecology outpatient department of a university hospital and had provided consent to participate in the study. Women who had experienced their last menstrual bleeding at least 1 year before (ie, diagnosed as menopausal), had not received hormone treatment in the last year, and who had not used vitamins, minerals, or phytoestrogens were accepted into the study. Women with a diagnosis of surgical menopause, diabetes, hypertension, cancer, hypo/hyperthyroidism, hyperlipidemia, or gastrointestinal system disease and those who did not want to participate were excluded from the study.7 The study was conducted with 140 women. Seventy women were in the experimental groups (experimental
group 1 and experimental group 2), 35 women were in the experimental variable group, and 35 women were in the control group. Using the data obtained from the study, a power analysis was completed with the Minitab statistical software, and the test results of this study were found to be 99% powerful. The groups were homogenized in terms of the women’s age, length of menopause, and frequency of menopause symptoms. In the design of the study, an expert advised regarding the issue of securing the patients. Only flax seed that was analyzed in terms of its content and certified as dependable were used. The study included a provision to remove any participants from their group if any anomalies were observed in their biochemical or anthropometric test results at the end of the first month. However, no variations were observed in the anthropometric or biochemical test results, and all participants completed the study. The women who participated in the study were categorized into 2 groups according their quality of life and menopausal symptoms. Experimental group: This group had 2 subgroups. Experimental group 1: Thirty-five women who did not receive HRT or for whom HRT was contraindicated were included in this group. This group received 5 g of flaxseed daily. Experimental group 2: This group was identical to experimental group 1, with the exception of the training that was given to the participants The participants in both groups were asked to complete a patient assessment questionnaire by answering questions from a Menopause Rating Scale and the SF-36 Quality-of-Life Scale at the first visit. Doses for 1 month (150 g) were given to all participants in the experimental groups, and they were asked to use 5 g per day. To control for the possible side effects of flaxseed, anthropometric and biochemical tests were performed at the first and second (after 1 month of flaxseed use) visits. The doses for the second month (300 g) were given to the participants whose test results were normal at the second visit. At the final visit, the participants were asked to answer the questions from the Menopause Rating Scale and the SF-36 Quality-of-Life Scale. The women were given detailed instructions regarding how to use and store flaxseed. Furthermore, a brochure that was prepared by the researcher was given to the participants.
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Effects of Flaxseed on Menopausal Symptoms and Quality of Life
Training and an informative booklet about menopause, its symptoms and treatments, and techniques for coping with menopause were given after the first visit to the participants in experimental group 2 but not to the participants in experimental group 1. The participants in the study were telephoned (every 15 days) to inquire whether they had any problems using the flaxseed. Moreover, the researcher provided her phone number to the participants with instructions to call her if they had any problem using the flaxseed. Experimental variable group This group consisted of 35 women who had begun HRT or were approved for HRT by the doctor in the gynecology policlinic of a university hospital (typically, drug treatment with 2 mg of estradiol hemihydrate + 1 mg of norethindrone acetate was given). At the first visit, the participants were asked to complete a patient assessment form that includes questions about sociodemographic data and questions from a Menopause Rating Scale and the SF-36 Quality-of-Life Scale. At the final visit, all measurements were repeated. Control group This group consisted of 35 women who did not receive any medical or complementary treatment. The participants in this group were asked to complete a patient assessment form that included questions about sociodemographic data and questions from the Menopause Rating Scale and the SF-36 Quality-of-Life Scale. At the final visit, all of the measurements were repeated.
Instruments Patient assessment form This form had 8 questions that were used to collect data about the women who participated in the research. These data were age, education, profession, data about menopause (age and length of menopause, complaints about menopause, and when those complaints began and their frequency), blood pressure anthropometric data (ie, weight, height, body mass index, waist size, hip size, and waist/hip ratio), and biochemical values (ie, fasting blood glucose, total triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein, very high-density lipoprotein, aspartate aminotransferase, and alanine aminotransferase). The form was prepared by the researcher after examining the reference literature and similar studies.3,6,7,14
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Menopause Rating Scale This scale was first developed in German in 1992 by Schneider et al to measure the strength of menopausal symptoms and their effects on quality of life and was subsequently adapted to English in 1996 and tested for validity and reliability. Both validity and reliability for the Turkish version were tested by Can Gurkan in 2005, who reported a Cronbach α value of 0.84.15 In the present study, the Cronbach α value was 0.82. Eleven items evaluating menopausal complaints were rated on a Likert-type scale with the following 4 options: 0, none; 1, weak; 2, medium; 3, strong; and 4, very strong. Scores were given for each item, and the total score of the scale was calculated. There was no cutoff point for the scale. The minimum score was 0, and the maximum score was 44. The results were categorized as follows: weak, 0-11; medium, 12-23; strong, 24-33; and very strong, 34-44. Higher scores indicated stronger complaints. The scale has 11 items related to menopausal complaints in the following 3 subdivisions: 1) Somatic complaints: These included items related to hot flashes (sweating attacks), cardiac diseases, sleeping problems, and joint and muscle complaints. 2) Psychological complaints: These included items such as dispiritedness, nervous derangement, apprehension, and physical and mental fatigue. 3) Urogenital complaints: These included sexual problems (changes in sensuality, sexual intercourse, and satisfaction), urinary problems (difficulty urinating, frequent urinating), and vaginal problems.15 SF-36 Quality-of-Life Scale This scale was developed by Ware in 1987 to analyze the quality of life in terms of health and to measure the general results of treatment independently of age, illness, and treatment. Validation and reliability tests of this scale were performed in Turkey by Pınar in 2005, and scale’s reliability coefficient for repeated testing is 0.94 and the Cronbach α value, which defines the structural coherence, is 0.92.16 The SF-36 Quality-of-Life Scale is composed of 36 questions and 8 subscales. The second question of the scale is related to the perception of changes in health in the previous 12 months, and the other questions evaluate the previous 4 months. The Physical and Mental Health score is calculated by summing the weighted scores of the questions involving the
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subscales of SF-36 Quality-of-Life Scale. There is no total score calculation. The calculated scores and subscale scores are expressed as continuous variables that range between 0 and 100. “Zero” indicates unhealthy, whereas “100” indicates good health. There is no intersection point of the scale. The aim of calculating the score is to ease comparison and interpretation.16 Physical functionality, physical roles, and pain are assessed in the calculation of the physical health score, whereas mental roles and mental functionality are assessed in the calculation of the mental health score. The overall health perception, vitality, and social functionality supplement both scores in the same manner. The second question was not included in the evaluation because it is related to changes in health perception in the previous 12 months.16 Flaxseed education brochure The researcher prepared a literature-referenced brochure for the women who used the flaxseed in the experimental groups (ie, experimental groups 1 and 2) to inform the participants about the ingredients of flaxseed, its benefits, usage, side effects, and points of caution related to its use.1-3,6,9,17 Menopause education brochure The researcher prepared a literature-referenced brochure for the women in experimental group 2 that informed them about menopause, common symptoms, diagnosis and treatment methods, digestion, sexuality, and techniques for coping with menopause.10,11,17 The researcher abstained from using medical terminology while preparing the brochure, and the opinions of 10 experts were sought out. Revisions were performed on the basis of the experts’ evaluations. The revised brochure was then given to 10 women to determine the clarity of the final brochure, and feedback was acquired. These 10 women did not participate in the study.
Ethical considerations Before the data were collected, the study was approved by the institutional review board of the study site, which was a university hospital in Turkey. The researcher explained the aim of the study to participants, and their written consent was obtained prior to the study.
Statistical analysis The survey forms used in the study were first examined by the researcher for the presence of errors, and the data were then entered and processed using a computer. The data analyses were performed with the SPSS 11.00 software. Chi-square homogeneity tests were applied to the women’s demographic characteristics (ie, age, menopausal period, and the frequency of menopausal symptoms). One-way analyses of variance were used to analyze the women’s SF-36 Quality-of-Life Scale score averages and Menopause Rating Scale score averages for the first and final visits. Variance analysis was performed with repeated measurements to analyze the variation in the scale scores average between the visits. Tukey (HSD) tests and correlation analyses were used to determine the relationships between the average SF-36 Quality-of-Life Scale scores and the women’s Menopause Rating Scale scores.
FINDINGS All 4experimental groups were found to be homogeneous; no significant differences were found (P > .05) between the groups in terms of the women’s average ages, average ages of menopause, or average menopause periods (Table 1). Regarding the visits, the difference between the Menopause Rating Scale total score averages was statistically significant (Wilks λ = 0.84, P < .05). The strength of menopause symptoms that the women experienced decreased between the first and the last visits in experimental group 1, group 2, and the experimental variable group. The decreases were 8.7% in experimental group 1, 9.8% in experimental group 2, and 10% in the experimental group variable. The strength of menopausal symptoms experienced by the women in control group increased by 6.9%, and the difference in the average scores was statistically significant (Table 2). Regarding the visits, the differences between SF-36 Quality-of-Life Scale Physical and Mental Health score averages were statistically significant (Wilks λ = 0.70, P < .05; Wilks λ = 0.92, P < .05). The SF-36 Quality-of-Life Scale Physical and Mental Health score averages seemed to be similar to those of the first visit, whereas at the last visits of experimental group 1 (who were given flaxseed for 3 months) and experimental group 2 (who were given information
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Effects of Flaxseed on Menopausal Symptoms and Quality of Life
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TABLE 1. Characteristics of the Subjects Experimental Group 1, X ± SD
Characteristics
Age average
47.88 ± 2.63
Age of menopause average, y
47.25 ± 2.45
Menopause period average, mo
Experimental Group 2, X ± SD
Experimental Variable Group, X ± SD
47.91 ± 2.44 47.80 ± 2.69 F = 0.69; P = .74 47.37 ± 2.19 46.85 ± 2.86 F = 0.36; P = .96 6.85 ± 3.55 6.68 ± 3.87 F = 0.29; P = .91
6.80 ± 4.02
Control Group, X ± SD
47.37 ± 2.83 46.62 ± 2.93 6.88 ± 3.94
TABLE 2. Total Score Averages on the Menopause Rating Scale for the Women According to Visit Menopause Rating Scale Total Score Average Monitors
First monitor Last Monitor Change, %
Experimental Group 1
18.71 ± 7.02 14.88 ± 4.78 −8.7
Experimental Group 2
Experimental Variable Group
21.00 ± 5.31 21.54 ± 5.22 16.71 ± 4.01 17.14 ± 6.17 Wilks λ = 0.84; P = .00 −9.8 −10.0
about menopause after the first visit and given flaxseed for 3 months), the Physical and Mental Health score averages for the SF-36 Quality-of-Life Scale increased. In the experimental variable group (given HRT for 3 months), the Physical Health score average decreased whereas the Mental Health score average increased. In the control group to which none of the treatments were applied, both the Physical and Mental Health score averages decreased (Table 3). Across all groups, a weak negative relation was observed (P < .05) between the total average score on the Menopause Rating Scale and the Physical Health average score of the SF-36 Quality-of-Life Scale. Regarding these results, the women’s SF-36 Quality-of-Life Scale Physical Health score average decreased as their complaints about menopausal symptoms increased (Table 4).
Control Group
18.88 ± 7.50 22.85 ± 5.85 +6.9
DISCUSSION The frequency and strength of complaints about menopause depend on the woman. Some women feel these complaints strongly, others do not, and all are affected at different levels. In the literature, excess amounts of weak estrogenic compounds in women’s diets are mentioned as a possible important factor that affects this variation. It is emphasized that the problems arising from menopause can be prevented by increasing the consumption of herbal estrogen and increasing serum concentrations of compounds with estrogenic activity that acts as selective estrogen receptor modulators. Phytoestrogens have received increasing amounts of attention as natural treatments that solve the problems of menopause.1,2 Brzezinski et al12 performed another study to determine the effects of a diet rich in phytoestrogen on
TABLE 3. Physical and Mental Health Score Averages on the SF-36 Quality-of-Life Scale According to Visit SF-36 Quality-of-Life Scale Physical Health Score Average Visits
Experimental Group 1
Experimental Variable Group
38.63 ± 7.07 41.69 ± 4.58 Wilks λ =0.70; P = .00 SF-36 Quality-of-Life Scale Mental Health score average First visit 40.63 ± 8.01 40.61 ± 7.35 Last visit 42.39 ± 5.00 43.36 ± 4.63 Wilks’ λ = 0.92; P = .01
First visit Last visit
38.93 ± 8.53 49.00 ± 8.55
Experimental Group 2
Control Group
37.29 ± 5.98 34.65 ± 6.71
34.94 ± 6.15 33.82 ± 5.29
40.02 ± 6.62 41.13 ± 7.08
41.37 ± 6.99 39.29 ± 7.18
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TABLE 4. Correlations Between the SF-36 Quality-of-Life Scale Physical and Mental Health Score Averages and the Menopause Rating Scale Score Average Menopause Rating Scale SF-36 Quality-of-Life Scale
Physical Health Mental Health a
Experimental Group 1
Experimental Group 2
Experimental Variable Group
Control Group
−0.45a −0.62a
−0.48a −0.60a
−0.36a −0.56a
−0.35a −0.39a
P < 0.05.
the complaints of women in the climacteric period. The women in the experimental group were given a diet rich in phytoestrogen (flaxseed, soy) for 12 weeks (n = 78) and nothing was given to the control group (n = 36). At the end of 3 months, the scores of the women in the menopausal group for menopausal symptoms, hot flashes, and vaginal dryness were significantly decreased, whereas the variation in the control group was insignificant.12 In a randomized controlled study by Lewis et al,13 the effects of soy flour and flaxseed on quality of life and the frequency and strength of hot flashes in postmenopausal women were studied. Over 4 months, flaxseed were given to 28 women, soy flour was given to 31 women, and cookies made of wheat flour were given to 28 women. At the end of the study, the strength of the hot flashes was reduced in the women who ate flaxseed compared with the women who ate wheat flour.13 In another randomized controlled study conducted by Dodin et al6 on postmenopausal women, 40 g of flaxseed per day was given to the experimental group (n = 101) for 12 months and wheat seed was given for 12 months to the control group (n = 98). At the end of the study, no difference was found in the decreases in vasomotor symptoms.6 In a study by Simbalista et al,9 who analyzed the effects of flaxseed on climacteric symptoms, no differences were observed between the control group and the experimental group (to whom 25 g of flaxseed per day was given for 12 weeks).9 Across the literature, the results of studies of alternative herbal treatment of menopausal symptoms are variable and inconsistent.5,8,17-21 It has been hypothesized that this variation is due to nonstandardized application periods and amounts of flaxseed used. In the present study, a significant decrease in menopausal symptoms was observed in the experimental groups that were given 5 g per day over 12 weeks. Notably, similar decreases in menopausal symptoms were observed in the experimental group that received HRT (10%) and the experimental groups (group 1, 8.7%; group 2, 9.8%) that were given
flaxseed. Women prefer to use flaxseed because of ease of use and the absence of side effects compared with HRT. Kang et al8 found that women prefer complementary treatments to HRT because they find the complementary treatments dependable and do not want HRT due to its cancer risk and the bleeding it causes. In this study, the authors found that menopausal symptoms can be treated with complementary treatment methods and that 80% of women aged between 45 and 60 years used complementary treatments without any recipe to cope with menopausal complaints.8 In study by MacLennan et al22 in Australia, the authors found that 48.5% of women used complementary treatments and that the women who most frequently used complementary treatments were in their premenopausal period.22 In this study, the greater decrease in the average score on the Menopause Rating Scale observed in experimental group 2 (9.8%) is hypothesized to be due to the training given to them by the researcher. This training was given to the women to inform them about menopause, to help them cope with symptoms, minimize their risk of illness triggered by menopause, and develop preventive behavior regarding these issues. The researcher hypothesizes that the training given to experimental group 2 allowed the women to cope with the symptoms. In a study of climacteric women, Ertem10 found a significant difference in menopause knowledge between an experimental group that was given training and a control group.10 Ergol11 found a positive relation between knowledge about treatment methods and the application of those methods to menopausal complaints. Thus, through training, women can be thought to cope with menopausal complaints and these complaints can be decreased.11 Moreover, it is likely that the questions that were asked of the control group on the first visit caused the women to be being aware of the symptoms and thus increased the strength of their complaints.
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Effects of Flaxseed on Menopausal Symptoms and Quality of Life
In the present study, experimental groups 1 and 2 exhibited increases in the average mental and physical health scores on SF-36 Quality-of-Life Scale (P < .05). Lewis et al13 found that quality of life increased due to flaxseed use and that hot flash complaints decreased.13 No significant difference was found in the changes in the quality of life change at the end of 12 weeks between the experimental group that was given 40 g of flaxseed per day and the control group that was given wheat seeds in the study of Dodin et al.6 In this study, the reason for the increase in the quality of life in the experimental group was likely due to the flaxseed use and the training that was given on the phone regarding coping with complaints by the researcher. On the phone, the women spoke about their complaints comfortably with the researcher and their questions were answered. Women who are aware of the menopause period and its associated changes and complaints and know techniques for coping with the changes and complaints can welcome menopause with more ease and develop techniques to cope with it. The significant increase in the mental health score averages of the women in experimental group 2 (who were given training about menopause) supports this theory. The greater increase in the mental health score averages observed in experimental group 2 is hypothesized to be due to the use of flaxseed for 3 months, training, and the phone-based assistance. In this study, a weak or medium strength negative relation was found between the total score average Menopause Rating Scale score and the SF-36 Quality-of-Life Scale Mental and Physical Health score average (P < .05). This result indicates that the SF-36 Physical and Mental Health Quality-of-Life Scale score decreased as the women’s complaints about menopause increased.
CONCLUSIONS In this study, a decrease in menopausal symptoms and an increase in the quality of life among the women who used flaxseed for 3 months were observed. This difference was found to be greater among the women who used flaxseed and also received training about the menopausal period. These results can serve as a reference for clinical care providers to apply to women in the menopausal period.
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REFERENCES 1. Adlercreutz H. Lignans and human health. Crit Rev Clin Lab Sci. 2007;44(5/6):483-525. 2. Cornwell T, Cohick W, Raskin I. Dietary phytoestrogens and health. Phytochemistry. 2004;65(8):995-1016. 3. Duvan CI, Ozturk Turhan N, Boklan F. Phytoestrogens. J Turk Ger Gynecol Assoc. 2005;6(3):12-17. 4. Geller SE, Studee L. Botanical and dietary supplements for menopausal symptoms: what works, what doesn’t. J Womens Health. 2005;14(7):634-649. 5. Hill A, Hill S. Counseling patients about hormone therapy and alternatives for menopausal symptoms. Am Fam Physician. 2010;82(7): 801-807. 6. Dodin S, Lemay H, Jacques F, Legare JC, Masse FB. The effects of flaxseed dietary supplement on lipid profile, bone mineral density, and symptoms in menopausal women: a randomized, double-blind, wheat germ placebo-controlled clinical trial. J Clin Endocrinol Metabol. 2005;90(3):1390-1397. 7. Hallund J, Ravn-Haren R, B¨ugel S, Tholstrup T, Tetens I. A lignan complex isolated from flaxseed does not affect plasma lipid concentrations or antioxidant capacity in healthy postmenopausal women. J Nutr. 2006;136(1):112-116. 8. Kang HJ, Ansbacher R, Hammoud MM. Use of alternative and complementary medicine in menopause. Int J Gynecol Obstet. 2002;79(3): 195-207. 9. Simbalista RL, Sauerbronn AV, Aldrighi JM, Areas JAG. Consumption of a flaxseed-rich food is not more effective than a placebo in alleviating the climacteric symptoms of postmenopausal women. J Nutr. 2010;140(2):293-297. 10. Ertem G. To determine the life quality of women climacterium period. Int J Hum Sci. 2010;7(1):469-483. 11. Ergol S. The knowledge, application and attitudes for health practices of women climacterium period. Health Soc. 2001;1:49-57. 12. Brzezinski A, Adlercreutz H, Shaoul R, et al. Short-term effects of phytoestrogen-rich diet on postmenopausal women. Menopause. 1997;4(2):89-94. 13. Lewis JE, Nickell LA, Thompson LU, Szalai JP, Kiss A, Hilditch JR. A randomized controlled trial of the effect of dietary soy and flaxseed muffins on quality of life and hot flashes during menopause. Menopause. 2006;13(4):631-642. 14. Ewies AA. Phytoestrogens in the management of the menopause: up-to-date. Obstet Gynecol Surv. 2002;57(5):306-313. 15. Can G¨urkan O. The validity and reliability of Turkish version of Menopause Rating Scale. Nurs Forum. 2005;3(3):30-35. 16. Pınar R. Reliability and construct validity of the SF-36 in Turkish cancer patients. Qual Life Res. 2005;4(1):259-264. 17. Carroll DG, Pharm D. Nonhormonal therapies for hot flashes in menopause. Am Fam Physician. 2006;73(3):457-464. 18. Kochman RH, Celnikier DH. Hot flashes revisited: pharmacological and herbal options for hot flashes management. What does the evidence tell us?. Acta Obstet Gynecol Scand. 2005;84(10):972-979. 19. Lethaby A, Marjoribanks J, Kronenberg F, Roberts H, Eden J, Brown J. Phytoestrogens for vasomotor menopausal symptoms (review). Cochrane Database Syst Rev 2007;(4):CD001395. 20. Loprinzi CL, Reame NK. Treatment of menopause-associated vasomotor symptoms: position statement of the North American Menopause Society. Menopause. 2004;11(1):11-33. 21. Kronenberg F, Berman AF. Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials. Ann Intern Med. 2002;137:805-813. 22. MacLennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes [review.] Cochrane Database Syst Rev. 2004;(4):CD002978.
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The Effects of Flaxseed on Menopausal Symptoms and Quality of Life ■
Nuray Egelioglu Cetisli, PhD, RN ■ A. Saruhan, PhD, RN ■ B. Kivcak, PhD The purpose of this study was to analyze the effects of flaxseed on menopausal symptoms and quality of life throughout the menopausal period. The empirical research was conducted in an obstetrics and gynecology outpatient department of a university hospital and involved 140 menopausal women who were divided into 4 groups. The menopausal symptoms decreased and the quality of life increased among the women who used flaxseed for 3 months. KEY WORDS: flaxseed, menopause, menopausal symptoms, nurses, nursing, quality of life Holist Nurs Pract 2015;29(3):151–157
Menopause is natural and physiological for women; it is not a disease. However, it is a period that can negatively affect the quality of a woman’s life because of the intensity and length of the symptoms and potential risks and pathologies. Herbal estrogens taken in the diet increase the estrogen level that decreases during the menopausal period, and their estrogenic properties can avert menopausal symptoms. Because of its estrogenic, antiestrogenic, antioxidant, and antiproliferative properties, a diet of phytoestrogenic herbs can decrease the frequency of vasomotor symptoms by increasing the estrogen level and changing the hormonal balance.1-5 Phytoestrogenic agents are chemicals that can act as a natural estrogen in the human body. There is no synthesis or deposit of these compounds in the body, and their only source is an intensive herbal diet containing these compounds. Phytoestrogens can be found in grains, vegetables, and fruits. The most well-known and enriched sources of phytoestrogens are flaxseed and soy. Phytoestrogens, such as flaxseed and soy, have been shown to affect menopausal symptoms within 12 weeks.6-9
Author Affiliations: Department of Obstetric and Gynecologic Nursing, Faculty of Health Sciences, Izmir Katip Celebi University, Izmir, Turkey (Cetisli); and Faculty of Nursing (Saruhan), and Faculty of Pharmacy (Kivcak) Ege University, Izmir, Turkey. The authors have disclosed that they have no significant relationships with, or financial interest in, any commercial companies pertaining to this article. Correspondence: Nuray Egelioglu Cetisli, PhD, RN, Obstetric and Gynecologic, Faculty of Health Science, Izmir Katip Celebi University, Cigli 35620, Izmir, Turkey ([email protected]). DOI: 10.1097/HNP.0000000000000085
Intensive observation, support, care, and health training are needed during menopause. To increase the quality of life in terms of physical, mental, and social lives, women need to know the potential health problems that might arise during menopause in order to take proper precautions. Women need support, consultation, and information about menopause. Because they have important roles in increasing the quality of the lives of women, the general goals of menopausal care nurses are to ensure that women and their families understand that menopause is a natural period of a life. These nurses are key people for enabling women to cope with social, physical, and emotional problems. Informing women and their families about menopause, correcting misunderstood beliefs and perceptions, and planning the sexual lives, aliments, practices, and social activities of the women are also other roles of the nurses. Nurses who study women’s health should be the main group that provides complementary methods to cope with menopausal symptoms due to their scientific knowledge about the protection, development, and sustainment of the health of menopausal women.10,11 The number of studies in the literature related to the efficacy of training and complementary treatment methods for decreasing menopausal symptoms to affect the quality of life is very limited. Brzezinski et al12 sought to determine the effects of a diet heavy in phytoestrogen on the menopausal complaints of women in the climacteric period. In this study, these authors provided a diet heavy in phytoestrogen to an experimental group (n = 78) over 12 weeks while not performing any manipulations in the control group 151
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(n = 36). At the end of 3 months, the complaints of the women in the phytoestrogen group related to symptoms such as hot flashes, vaginal dryness, and menopausal symptoms were significantly decreased compared with their pretreatment scores, whereas the differences in the control group were not significant.12 In a random controlled study by Lewis et al,13 the effects of soy flour and flaxseed on the quality of life and the frequency and strength of hot flashes in women in the postmenopausal period who ate biscuits containing wheat flour were reviewed. In this study, flaxseed was given to 28 women and soy flour was given to 31 women. The biscuits were given for 4 months, and the authors found that the strength of the hot flashes of the group that was given biscuits containing flaxseed was weaker than that of the group that was given biscuits containing wheat flour.13 Studies of the efficacy of training and complementary treatment methods that can be used to decrease the effects of menopausal symptoms on quality of life are notably limited. This study was undertaken to determine the effects of using flaxseed and training throughout the menopausal period on women’s menopausal symptoms and quality of life.
METHODS Sample and design This study was planned to analyze the differences of in the quality of life and experiences of menopausal symptoms between women who used flaxseed and received training and hormone replacement therapy (HRT) and a control group. This experimental research was planned to be composed of pretests, posttests, and a control group. The research was conducted with participants who were being treated in the obstetrics and gynecology outpatient department of a university hospital and had provided consent to participate in the study. Women who had experienced their last menstrual bleeding at least 1 year before (ie, diagnosed as menopausal), had not received hormone treatment in the last year, and who had not used vitamins, minerals, or phytoestrogens were accepted into the study. Women with a diagnosis of surgical menopause, diabetes, hypertension, cancer, hypo/hyperthyroidism, hyperlipidemia, or gastrointestinal system disease and those who did not want to participate were excluded from the study.7 The study was conducted with 140 women. Seventy women were in the experimental groups (experimental
group 1 and experimental group 2), 35 women were in the experimental variable group, and 35 women were in the control group. Using the data obtained from the study, a power analysis was completed with the Minitab statistical software, and the test results of this study were found to be 99% powerful. The groups were homogenized in terms of the women’s age, length of menopause, and frequency of menopause symptoms. In the design of the study, an expert advised regarding the issue of securing the patients. Only flax seed that was analyzed in terms of its content and certified as dependable were used. The study included a provision to remove any participants from their group if any anomalies were observed in their biochemical or anthropometric test results at the end of the first month. However, no variations were observed in the anthropometric or biochemical test results, and all participants completed the study. The women who participated in the study were categorized into 2 groups according their quality of life and menopausal symptoms. Experimental group: This group had 2 subgroups. Experimental group 1: Thirty-five women who did not receive HRT or for whom HRT was contraindicated were included in this group. This group received 5 g of flaxseed daily. Experimental group 2: This group was identical to experimental group 1, with the exception of the training that was given to the participants The participants in both groups were asked to complete a patient assessment questionnaire by answering questions from a Menopause Rating Scale and the SF-36 Quality-of-Life Scale at the first visit. Doses for 1 month (150 g) were given to all participants in the experimental groups, and they were asked to use 5 g per day. To control for the possible side effects of flaxseed, anthropometric and biochemical tests were performed at the first and second (after 1 month of flaxseed use) visits. The doses for the second month (300 g) were given to the participants whose test results were normal at the second visit. At the final visit, the participants were asked to answer the questions from the Menopause Rating Scale and the SF-36 Quality-of-Life Scale. The women were given detailed instructions regarding how to use and store flaxseed. Furthermore, a brochure that was prepared by the researcher was given to the participants.
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Effects of Flaxseed on Menopausal Symptoms and Quality of Life
Training and an informative booklet about menopause, its symptoms and treatments, and techniques for coping with menopause were given after the first visit to the participants in experimental group 2 but not to the participants in experimental group 1. The participants in the study were telephoned (every 15 days) to inquire whether they had any problems using the flaxseed. Moreover, the researcher provided her phone number to the participants with instructions to call her if they had any problem using the flaxseed. Experimental variable group This group consisted of 35 women who had begun HRT or were approved for HRT by the doctor in the gynecology policlinic of a university hospital (typically, drug treatment with 2 mg of estradiol hemihydrate + 1 mg of norethindrone acetate was given). At the first visit, the participants were asked to complete a patient assessment form that includes questions about sociodemographic data and questions from a Menopause Rating Scale and the SF-36 Quality-of-Life Scale. At the final visit, all measurements were repeated. Control group This group consisted of 35 women who did not receive any medical or complementary treatment. The participants in this group were asked to complete a patient assessment form that included questions about sociodemographic data and questions from the Menopause Rating Scale and the SF-36 Quality-of-Life Scale. At the final visit, all of the measurements were repeated.
Instruments Patient assessment form This form had 8 questions that were used to collect data about the women who participated in the research. These data were age, education, profession, data about menopause (age and length of menopause, complaints about menopause, and when those complaints began and their frequency), blood pressure anthropometric data (ie, weight, height, body mass index, waist size, hip size, and waist/hip ratio), and biochemical values (ie, fasting blood glucose, total triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein, very high-density lipoprotein, aspartate aminotransferase, and alanine aminotransferase). The form was prepared by the researcher after examining the reference literature and similar studies.3,6,7,14
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Menopause Rating Scale This scale was first developed in German in 1992 by Schneider et al to measure the strength of menopausal symptoms and their effects on quality of life and was subsequently adapted to English in 1996 and tested for validity and reliability. Both validity and reliability for the Turkish version were tested by Can Gurkan in 2005, who reported a Cronbach α value of 0.84.15 In the present study, the Cronbach α value was 0.82. Eleven items evaluating menopausal complaints were rated on a Likert-type scale with the following 4 options: 0, none; 1, weak; 2, medium; 3, strong; and 4, very strong. Scores were given for each item, and the total score of the scale was calculated. There was no cutoff point for the scale. The minimum score was 0, and the maximum score was 44. The results were categorized as follows: weak, 0-11; medium, 12-23; strong, 24-33; and very strong, 34-44. Higher scores indicated stronger complaints. The scale has 11 items related to menopausal complaints in the following 3 subdivisions: 1) Somatic complaints: These included items related to hot flashes (sweating attacks), cardiac diseases, sleeping problems, and joint and muscle complaints. 2) Psychological complaints: These included items such as dispiritedness, nervous derangement, apprehension, and physical and mental fatigue. 3) Urogenital complaints: These included sexual problems (changes in sensuality, sexual intercourse, and satisfaction), urinary problems (difficulty urinating, frequent urinating), and vaginal problems.15 SF-36 Quality-of-Life Scale This scale was developed by Ware in 1987 to analyze the quality of life in terms of health and to measure the general results of treatment independently of age, illness, and treatment. Validation and reliability tests of this scale were performed in Turkey by Pınar in 2005, and scale’s reliability coefficient for repeated testing is 0.94 and the Cronbach α value, which defines the structural coherence, is 0.92.16 The SF-36 Quality-of-Life Scale is composed of 36 questions and 8 subscales. The second question of the scale is related to the perception of changes in health in the previous 12 months, and the other questions evaluate the previous 4 months. The Physical and Mental Health score is calculated by summing the weighted scores of the questions involving the
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subscales of SF-36 Quality-of-Life Scale. There is no total score calculation. The calculated scores and subscale scores are expressed as continuous variables that range between 0 and 100. “Zero” indicates unhealthy, whereas “100” indicates good health. There is no intersection point of the scale. The aim of calculating the score is to ease comparison and interpretation.16 Physical functionality, physical roles, and pain are assessed in the calculation of the physical health score, whereas mental roles and mental functionality are assessed in the calculation of the mental health score. The overall health perception, vitality, and social functionality supplement both scores in the same manner. The second question was not included in the evaluation because it is related to changes in health perception in the previous 12 months.16 Flaxseed education brochure The researcher prepared a literature-referenced brochure for the women who used the flaxseed in the experimental groups (ie, experimental groups 1 and 2) to inform the participants about the ingredients of flaxseed, its benefits, usage, side effects, and points of caution related to its use.1-3,6,9,17 Menopause education brochure The researcher prepared a literature-referenced brochure for the women in experimental group 2 that informed them about menopause, common symptoms, diagnosis and treatment methods, digestion, sexuality, and techniques for coping with menopause.10,11,17 The researcher abstained from using medical terminology while preparing the brochure, and the opinions of 10 experts were sought out. Revisions were performed on the basis of the experts’ evaluations. The revised brochure was then given to 10 women to determine the clarity of the final brochure, and feedback was acquired. These 10 women did not participate in the study.
Ethical considerations Before the data were collected, the study was approved by the institutional review board of the study site, which was a university hospital in Turkey. The researcher explained the aim of the study to participants, and their written consent was obtained prior to the study.
Statistical analysis The survey forms used in the study were first examined by the researcher for the presence of errors, and the data were then entered and processed using a computer. The data analyses were performed with the SPSS 11.00 software. Chi-square homogeneity tests were applied to the women’s demographic characteristics (ie, age, menopausal period, and the frequency of menopausal symptoms). One-way analyses of variance were used to analyze the women’s SF-36 Quality-of-Life Scale score averages and Menopause Rating Scale score averages for the first and final visits. Variance analysis was performed with repeated measurements to analyze the variation in the scale scores average between the visits. Tukey (HSD) tests and correlation analyses were used to determine the relationships between the average SF-36 Quality-of-Life Scale scores and the women’s Menopause Rating Scale scores.
FINDINGS All 4experimental groups were found to be homogeneous; no significant differences were found (P > .05) between the groups in terms of the women’s average ages, average ages of menopause, or average menopause periods (Table 1). Regarding the visits, the difference between the Menopause Rating Scale total score averages was statistically significant (Wilks λ = 0.84, P < .05). The strength of menopause symptoms that the women experienced decreased between the first and the last visits in experimental group 1, group 2, and the experimental variable group. The decreases were 8.7% in experimental group 1, 9.8% in experimental group 2, and 10% in the experimental group variable. The strength of menopausal symptoms experienced by the women in control group increased by 6.9%, and the difference in the average scores was statistically significant (Table 2). Regarding the visits, the differences between SF-36 Quality-of-Life Scale Physical and Mental Health score averages were statistically significant (Wilks λ = 0.70, P < .05; Wilks λ = 0.92, P < .05). The SF-36 Quality-of-Life Scale Physical and Mental Health score averages seemed to be similar to those of the first visit, whereas at the last visits of experimental group 1 (who were given flaxseed for 3 months) and experimental group 2 (who were given information
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Effects of Flaxseed on Menopausal Symptoms and Quality of Life
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TABLE 1. Characteristics of the Subjects Experimental Group 1, X ± SD
Characteristics
Age average
47.88 ± 2.63
Age of menopause average, y
47.25 ± 2.45
Menopause period average, mo
Experimental Group 2, X ± SD
Experimental Variable Group, X ± SD
47.91 ± 2.44 47.80 ± 2.69 F = 0.69; P = .74 47.37 ± 2.19 46.85 ± 2.86 F = 0.36; P = .96 6.85 ± 3.55 6.68 ± 3.87 F = 0.29; P = .91
6.80 ± 4.02
Control Group, X ± SD
47.37 ± 2.83 46.62 ± 2.93 6.88 ± 3.94
TABLE 2. Total Score Averages on the Menopause Rating Scale for the Women According to Visit Menopause Rating Scale Total Score Average Monitors
First monitor Last Monitor Change, %
Experimental Group 1
18.71 ± 7.02 14.88 ± 4.78 −8.7
Experimental Group 2
Experimental Variable Group
21.00 ± 5.31 21.54 ± 5.22 16.71 ± 4.01 17.14 ± 6.17 Wilks λ = 0.84; P = .00 −9.8 −10.0
about menopause after the first visit and given flaxseed for 3 months), the Physical and Mental Health score averages for the SF-36 Quality-of-Life Scale increased. In the experimental variable group (given HRT for 3 months), the Physical Health score average decreased whereas the Mental Health score average increased. In the control group to which none of the treatments were applied, both the Physical and Mental Health score averages decreased (Table 3). Across all groups, a weak negative relation was observed (P < .05) between the total average score on the Menopause Rating Scale and the Physical Health average score of the SF-36 Quality-of-Life Scale. Regarding these results, the women’s SF-36 Quality-of-Life Scale Physical Health score average decreased as their complaints about menopausal symptoms increased (Table 4).
Control Group
18.88 ± 7.50 22.85 ± 5.85 +6.9
DISCUSSION The frequency and strength of complaints about menopause depend on the woman. Some women feel these complaints strongly, others do not, and all are affected at different levels. In the literature, excess amounts of weak estrogenic compounds in women’s diets are mentioned as a possible important factor that affects this variation. It is emphasized that the problems arising from menopause can be prevented by increasing the consumption of herbal estrogen and increasing serum concentrations of compounds with estrogenic activity that acts as selective estrogen receptor modulators. Phytoestrogens have received increasing amounts of attention as natural treatments that solve the problems of menopause.1,2 Brzezinski et al12 performed another study to determine the effects of a diet rich in phytoestrogen on
TABLE 3. Physical and Mental Health Score Averages on the SF-36 Quality-of-Life Scale According to Visit SF-36 Quality-of-Life Scale Physical Health Score Average Visits
Experimental Group 1
Experimental Variable Group
38.63 ± 7.07 41.69 ± 4.58 Wilks λ =0.70; P = .00 SF-36 Quality-of-Life Scale Mental Health score average First visit 40.63 ± 8.01 40.61 ± 7.35 Last visit 42.39 ± 5.00 43.36 ± 4.63 Wilks’ λ = 0.92; P = .01
First visit Last visit
38.93 ± 8.53 49.00 ± 8.55
Experimental Group 2
Control Group
37.29 ± 5.98 34.65 ± 6.71
34.94 ± 6.15 33.82 ± 5.29
40.02 ± 6.62 41.13 ± 7.08
41.37 ± 6.99 39.29 ± 7.18
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TABLE 4. Correlations Between the SF-36 Quality-of-Life Scale Physical and Mental Health Score Averages and the Menopause Rating Scale Score Average Menopause Rating Scale SF-36 Quality-of-Life Scale
Physical Health Mental Health a
Experimental Group 1
Experimental Group 2
Experimental Variable Group
Control Group
−0.45a −0.62a
−0.48a −0.60a
−0.36a −0.56a
−0.35a −0.39a
P < 0.05.
the complaints of women in the climacteric period. The women in the experimental group were given a diet rich in phytoestrogen (flaxseed, soy) for 12 weeks (n = 78) and nothing was given to the control group (n = 36). At the end of 3 months, the scores of the women in the menopausal group for menopausal symptoms, hot flashes, and vaginal dryness were significantly decreased, whereas the variation in the control group was insignificant.12 In a randomized controlled study by Lewis et al,13 the effects of soy flour and flaxseed on quality of life and the frequency and strength of hot flashes in postmenopausal women were studied. Over 4 months, flaxseed were given to 28 women, soy flour was given to 31 women, and cookies made of wheat flour were given to 28 women. At the end of the study, the strength of the hot flashes was reduced in the women who ate flaxseed compared with the women who ate wheat flour.13 In another randomized controlled study conducted by Dodin et al6 on postmenopausal women, 40 g of flaxseed per day was given to the experimental group (n = 101) for 12 months and wheat seed was given for 12 months to the control group (n = 98). At the end of the study, no difference was found in the decreases in vasomotor symptoms.6 In a study by Simbalista et al,9 who analyzed the effects of flaxseed on climacteric symptoms, no differences were observed between the control group and the experimental group (to whom 25 g of flaxseed per day was given for 12 weeks).9 Across the literature, the results of studies of alternative herbal treatment of menopausal symptoms are variable and inconsistent.5,8,17-21 It has been hypothesized that this variation is due to nonstandardized application periods and amounts of flaxseed used. In the present study, a significant decrease in menopausal symptoms was observed in the experimental groups that were given 5 g per day over 12 weeks. Notably, similar decreases in menopausal symptoms were observed in the experimental group that received HRT (10%) and the experimental groups (group 1, 8.7%; group 2, 9.8%) that were given
flaxseed. Women prefer to use flaxseed because of ease of use and the absence of side effects compared with HRT. Kang et al8 found that women prefer complementary treatments to HRT because they find the complementary treatments dependable and do not want HRT due to its cancer risk and the bleeding it causes. In this study, the authors found that menopausal symptoms can be treated with complementary treatment methods and that 80% of women aged between 45 and 60 years used complementary treatments without any recipe to cope with menopausal complaints.8 In study by MacLennan et al22 in Australia, the authors found that 48.5% of women used complementary treatments and that the women who most frequently used complementary treatments were in their premenopausal period.22 In this study, the greater decrease in the average score on the Menopause Rating Scale observed in experimental group 2 (9.8%) is hypothesized to be due to the training given to them by the researcher. This training was given to the women to inform them about menopause, to help them cope with symptoms, minimize their risk of illness triggered by menopause, and develop preventive behavior regarding these issues. The researcher hypothesizes that the training given to experimental group 2 allowed the women to cope with the symptoms. In a study of climacteric women, Ertem10 found a significant difference in menopause knowledge between an experimental group that was given training and a control group.10 Ergol11 found a positive relation between knowledge about treatment methods and the application of those methods to menopausal complaints. Thus, through training, women can be thought to cope with menopausal complaints and these complaints can be decreased.11 Moreover, it is likely that the questions that were asked of the control group on the first visit caused the women to be being aware of the symptoms and thus increased the strength of their complaints.
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Effects of Flaxseed on Menopausal Symptoms and Quality of Life
In the present study, experimental groups 1 and 2 exhibited increases in the average mental and physical health scores on SF-36 Quality-of-Life Scale (P < .05). Lewis et al13 found that quality of life increased due to flaxseed use and that hot flash complaints decreased.13 No significant difference was found in the changes in the quality of life change at the end of 12 weeks between the experimental group that was given 40 g of flaxseed per day and the control group that was given wheat seeds in the study of Dodin et al.6 In this study, the reason for the increase in the quality of life in the experimental group was likely due to the flaxseed use and the training that was given on the phone regarding coping with complaints by the researcher. On the phone, the women spoke about their complaints comfortably with the researcher and their questions were answered. Women who are aware of the menopause period and its associated changes and complaints and know techniques for coping with the changes and complaints can welcome menopause with more ease and develop techniques to cope with it. The significant increase in the mental health score averages of the women in experimental group 2 (who were given training about menopause) supports this theory. The greater increase in the mental health score averages observed in experimental group 2 is hypothesized to be due to the use of flaxseed for 3 months, training, and the phone-based assistance. In this study, a weak or medium strength negative relation was found between the total score average Menopause Rating Scale score and the SF-36 Quality-of-Life Scale Mental and Physical Health score average (P < .05). This result indicates that the SF-36 Physical and Mental Health Quality-of-Life Scale score decreased as the women’s complaints about menopause increased.
CONCLUSIONS In this study, a decrease in menopausal symptoms and an increase in the quality of life among the women who used flaxseed for 3 months were observed. This difference was found to be greater among the women who used flaxseed and also received training about the menopausal period. These results can serve as a reference for clinical care providers to apply to women in the menopausal period.
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