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Should the Kibosh be Put on Black Cohosh?

Jordan White

February 16, 2009

Macintosh HD:Users:jordanwhite:Desktop:SevenDwarfsOfMenopause1.jpg

Image from: http://www.d-a-l.com/help/after-hours-chat-room-adult/29495-seven-dwarfs-menopause.html

An evaluation of the effectiveness of the non- traditional form of treatment on menopausal symptoms…

Introduction: What is Menopause?

::art.menopause.graphic.felker.jpgCravings, bloating, cramps, mood swings… “that time of the month” is dreaded by millions of women around the world. Fortunately, there is an end to this nagging, yet necessary cycle. It is known as menopause. Occurring in women around the ages of 50 to 52, menopause is characterized by a decline in the production of the female sex hormone, estrogen, and a stop in the generation of eggs from the ovaries. It marks the permanent end to the menstrual cycle and thus the ability of the woman to reproduce (http://www.healthscout.com/ency/68/141/main.html). During menopause, the woman finally has relief from the irritations associated with the menstrual cycle, but is this relief in fact fortunate?

Image from: http://www.cnn.com/2008/HEALTH/conditions/04/18/hfh.menopause/index.html

The Symptoms of Menopause

For some this relief is in fact fortunate. For others, the tradeoff for night sweats, anxiety, loss of sex drive or sexual pleasure, insomnia, irritability, mood swings, vaginal dryness, headaches or migraines, mouth discomfort, heart palpitations, poor concentration and memory function, tenderness of the breasts, and fatigue is far from fortunate (http://www.healthscout.com/ency/68/141/main.html). In addition to these possible symptoms of menopause, nearly 75% of menopausal women experience hot flashes, or sudden sensations of warmth, particularly in the face and neck regions. Increased heartbeat, feelings of dizziness, and sweating often coincide with the hot flashes. Although the duration of hot flashes is usually only between a few seconds and a few minutes, for some women the occurrences can number upwards of 50 times per day (http://www.qualityhealth.com/heat-wave-understanding-hot-%20%20%20%20%20flashes-340/featuredArticle). With this high frequency of occurrences, it is not surprising that many women seek liberation from the disruptive, vexing symptoms. Some elect to use estrogen or hormone replacement therapies but “after a federally sponsored study was halted due to concerns about increase risk of heart attacks, strokes, and breast cancer” (http://www.qualityhealth.com/heat-wave-understanding-hot-%20%20%20%20%20flashes-340/featuredArticle), many more women are turning to alternatives such as perscription drugs, non- drug measures, and non- traditional forms of treatment (http://www.healthscout.com/ency/68/141/main.html). Consequentially, in the past few years, the popularity of alternative and complementary medicine has been increasing, and an estimated $21.2 billion has been spent on it as many believe it to “offer a more “natural” and less toxic alternative than “synthetic” drugs“ (Pockaj et al., 2004). One of the newer, non- traditional forms of treatment that has demonstrated such an increase in popularity is an herb known as black cohosh. 

Black Cohosh as a Non- traditional Form of Treatment: What is Black Cohosh?

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Image from: http://nccam.nih.gov/health/blackcohosh/ataglance.htm

Black cohosh, also known as black snakeroot, bugwort, rattleroot, rattleweed, bugbane, macrotys, Actaea racemosa, or Cimicifuga racemosa, is an herbaceous perennial plant that is indigenous to North America. A member of the buttercup family, it has its history in Native American medicine and home remedies of 19th century America. Black cohosh was previously utilized in treating the ailments of rheumatism, menstrual irregularities, premenstrual symptoms and the induction of labor. Its more current use is in the treatment of menopausal symptoms, in particular hot flashes. Teas, capsules, solid extracts, and liquid extracts are all made using the subterranean roots and stems of black cohosh in fresh or dried form (http://nccam.nih.gov/health/blackcohosh/ataglance.htm).

How Does Black Cohosh Work?

As estrogen production decreases during menopause, it was previously believed that black cohosh’s effectiveness laid in its ability to stimulate estrogenic activity. However, a more recent study by researchers from the University of Illinois at Chicago has refuted this belief.  In the study, researchers separated rats, whose ovaries had been taken out, into groups. The groups received varying amounts of black cohosh extract each day for fourteen days. To determine possible estrogenic effects, researchers recorded any changes in the weight of the uteruses of the rats and any evidence of proliferation of their vaginal cells. No changes were recorded and thus the researchers concluded that black cohosh does not stimulate estrogenic activity. Researchers performed further studies on the rats that exhibited the binding ability of the black cohosh extract to other receptors. Serotonin receptors that help control body temperature had previously been linked to the occurrence of hot flashes and researchers found that the black cohosh extract was in fact able to bind to these specific receptors.  “Researchers still do not know the specific chemical or chemicals in black cohosh that target the serotonin receptors” but this seems to be a plausible mechanism by which black cohosh treats menopausal symptoms, in particular hot flashes (http://www.aphroditewomenshealth.com/news/20030808031634_health_news.shtml).    

What Claims are Being Made?

Several well-established medical institutions, as well as some less-reputable, profit- driven herbal supplement companies, have made claims regarding black cohosh. While most claims regarding black cohosh are claims of advocacy, recognition of mixed study results is often cited within the claims.

The American College of Obstetricians and Gynecologists, the nation’s leading health care provider for women, cites black cohosh as an herbal product that may help to relieve menopausal symptoms for some women. As the ACOG is private, voluntary, and nonprofit, its primary goal of helping women to better understand medical care is rather unbiased. Thus the ACOG acknowledges that the mechanism by which black cohosh works is not fully known, that “results of studies on how well it works are mixed” and that side effects may occur (http://www.acog.org/publications/patient_education/bp158.cfm).

The North American Menopause Society, another nonprofit organization, is also committed to helping women, in particular those who are suffering from menopause.  Allowing no commercial advertising on their website and thus eliminating potential biases, NAMS defines black cohosh as “an herb, typically used in nonprescription supplement form. Among its uses is relieving mild hot flashes, although most studies show no better relief than a placebo”. Although the studies were acknowledged as showing no better relief than a placebo, in the North American Menopause Society “Change One Thing Challenge”, women were recommended to fix a hot flash with black cohosh, particularly in the form of Remifemin, and according to NAMS, they “guarantee it’ll be worth the effort” (http://www.menopause.org/1changehotflash.aspx).

The National Institutes of Health is the primary Federal agency for conducting and supporting medical research. Composed of twenty-seven branches, the expansive NIH works to provide the most current and accurate information regarding medical discoveries. In the key points of the black cohosh fact sheet, the Office of Dietary Supplements (one of the twenty-seven branches) stresses that “although preliminary evidence is encouraging, the currently available data are not sufficient to support a recommendation on the use of black cohosh for menopausal symptoms” (http://ods.od.nih.gov/factsheets/BlackCohosh.asp). Black cohosh is noted for its use in treating menopausal symptoms but its use is not yet supported by the National Institutes of Health. The National Center for Complementary and Alternative Medicines, another branch of the National Institutes of Health, is currently “funding a rigorous scientific study to determine whether treatment with black cohosh reduces the frequency and intensity of hot flashes, and other menopausal symptoms” (http://ods.od.nih.gov/factsheets/BlackCohosh.asp).

Capitalizing on the mixed health claims of black cohosh are the less- reputable businesses ranging from large, commercial companies such as Enzymatic Therapy and Alvita Tea Company, to smaller, private companies such as Moon Branch Botanicals. Enzymatic Therapy is the primary manufacturer of the popular black cohosh product Remifemin. Remifemin, with its slogan “control the things you can (like hot flashes, night sweats and irritablility)“, advertises up to 70% symptom reduction. However, the product does contain a disclaimer reading “this statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” (http://www.enzymatictherapy.com/Remifemin/home.aspx). Black cohosh root tea bags can be purchased from the Alvita Tea Company (http://www.alvita.com/) and black cohosh cut root is available from Moon Branch Botanicals (http://www.moonbranch.com/blackcohosh.html). Both products are marketed for their treatment of menopausal symptoms and contain disclaimers very similar to that of Remifemin. Consumers should be very cautious when evaluating the claims made by these websites as most are profit- driven and seek to capitalize on claims that may be based only in theory and not statistics.

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Images from: http://www.alvita.com/ http://www.morethanalive.com/Bulk_Herbs http://www.enzymatictherapy.com/Remifemin/Product-Details.aspx?p=07520&cid=1885

What Do Relevant Clinical Trials Say About These Claims?

Study results have been mixed as to whether black cohosh is in fact an effective treatment for menopausal symptoms. As black cohosh is a relatively new form of treatment, research has been limited, yet significant results have been taken into account.

In a study by Jacobson et al. (2005), a randomized, double- blind, placebo-controlled trial was done in 85 breast cancer survivors as many experience hot flashes and elect to use non- traditional forms of treatment. The 85 women were divided into two groups. Forty- two of the participants were assigned to the black cohosh tablet group and forty- three were assigned to the placebo group. Participants were instructed to take one tablet, twice daily with meals, for 60 days. At the start of the trial, participants completed a questionnaire pertaining to demographic factors and menopausal symptoms. In a subset of the patients, follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels were measured at the first and final visits. At the conclusion of the trial, another questionnaire about menopausal symptoms was completed. Participants also kept 4-day hot flash diaries at three different intervals during the study. Before starting the study, from days 27 to 30, and from days 57 to 60, the participants recorded the number and intensity of hot flashes experienced. The hot flashes were given scores of 1,2, or 3, which corresponded to mild, moderate, and severe, respectively. Of the 85 original patients, nine elected to stop participation for personal reasons, and only 69 completed all three of the four- day hot flash diaries. Of the 69 women that completed the study, both groups reported declines in number and intensity of hot flashes, with the overall reduction of hot flash activity being 27%. Both groups showed improvements in menopausal symptoms and changes in blood levels of FSH and LH also did not differ in the two groups. Thus black cohosh did not prove to be significantly more effective than the placebo in treating menopausal symptoms, although excessive sweating did decrease significantly more in the treatment group. Problems with this study include the inclination of women to report fewer hot flashes than the actual number being experienced, especially when they believe they are receiving “treatment”. The short duration of the study and the possible confusion of symptoms of nervousness for hot flashes were also cited as possible hindrances to the accuracy of this study (Jacobson et al., 2001).

In a second study by Pockaj et al. (2004), women were enrolled in a pilot study on the criteria that they were above 18 years of age, experienced hot flashes at least fourteen times per week, and either had breast cancer previously, were at a risk for the development of breast cancer, or elected not to use estrogen or hormone replacement therapies. In the descriptive study, participants completed hot flash diaries during a one- week baseline prior to the start of the study. The women then began taking one tablet of a black cohosh supplement in the form of Remifemin, twice a day, orally for the subsequent four weeks. Participants recorded their hot flash experiences on the criteria of the number of daily hot flashes experienced each week, and the average hot flash score. The average hot flash score was computed by taking the number of mild hot flashes experienced and adding twice the number of moderate hot flashes experienced, three times the number of severe hot flashes and four times the number of very severe hot flashes experienced each week. Of the 23 women who originally enrolled in the study, 21 completed the study. An average of 8.3 hot flashes per day were reported during the baseline week and after only one week, the mean number of hot flashes experienced per day dropped to 6.6. By the final week of the study, comparisons with the baseline week were as follows. Reduction in mean daily hot lash frequency was 50%. The weekly hot flash scores were reduced 56% and severity was decreased by 22%. In addition, during the four- week period, participants recorded any experiences regarding sleepiness, changes in mood, feelings of nervousness, fatigue or tiredness, loss of appetite, sleeping trouble, constipation or loss of weight. At the conclusion of the study these symptoms also seemed to decrease in frequency and severity. Thus in this study, black cohosh appeared to be effective in reducing hot flashes and other menopausal symptoms. It should be noted, however, that the researchers “do not currently feel comfortable claiming that black cohosh clearly is better than a placebo for alleviating hot flashes” and feel that further exploration is necessary (Pockaj et al., 2004).

In a third nine- week study by Loprinzi et al. (2006), women were enrolled on the same criteria as the above study. 132 women were initially enrolled in the study but cancellations and failure to complete the diaries resulted in only 99 women being eligible for data collection. As in the above study, the first week served as a baseline in which no treatment was given. The women were split into two groups with one group taking one tablet of black cohosh twice daily and the other group taking one tablet of placebo twice daily. During this four- week time period, both groups of women completed diaries in which they utilized a 1 to 10 scale to individually rate symptoms of excessive sweating, leg heaviness, pain in joints or muscles pain, chills, headache, feelings of nervousness, stomach cramps, nausea, feelings of dizziness, negative mood swings, quality of life, the interference of hot flashes on life quality, and satisfaction of hot flash control. After four weeks, the two groups switched treatments. The group previously taking black cohosh began taking the placebo and the group previously taking the placebo began taking black cohosh. There was no significant difference in reduction of symptoms and the mean decreases for frequency of hot flashes, as compared to the baseline week, were 17% and 26% for participants receiving black cohosh or placebo, respectively. Mean decreases for hot flash score, as compared to the baseline week, were 20% and 27% for participants receiving black cohosh or placebo, respectively. In addition, at the conclusion of the study, the participant’s preferences regarding treatment were recorded. 34% preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment.  Black cohosh was reported as not being significantly more effective than the placebo against most menopausal symptoms and thus the results of this double-blind randomized study contradict the claim that black cohosh is more effective than the placebo in treating menopausal symptoms. Researchers suggest this discrepancy may “be due to placebo effects, as have been seen repeatedly in clinical trials. It may be that the enthusiasm regarding the promise of natural products can enhance the usual 20% to 30% placebo effect”. However, they do acknowledge that “this trial does not in and of itself prove that there is not a black cohosh dose or schedule that might help relieve hot flashes or other menopausal symptoms” and suggest further research and studies (Loprinzi et al., 2006).

Marketing Safety and Side Effects: How is Black Cohosh Marketed?

In addition to conflicting study results, black cohosh has many controversial safety and marketing issues. As black cohosh is marketed as an herbal, dietary supplement, rather than a drug, it is considered a food. However, the Food and Drug Administration does not have to be informed by the manufacturers that black cohosh is, in any way safe or effective, before it is marketed. Furthermore, the composition of dietary supplements may fluctuate greatly as testing for manufacturing consistency is only loosely regulated (http://ods.od.nih.gov/factsheets/blackcohosh.asp#h5). Therefore consumers should use caution when evaluating the claims of herbal, dietary supplements, such as black cohosh, as they may be misleading and have possible negative side effects.

What are the Possible Side Effects?

Even with the above knowledge, a great number of women continue to use black cohosh in the treatment of their menopausal symptoms. Statements have been released asserting the possible side effects of stomach problems, heaviness in legs, weight problems, and headaches. A few individuals have reported liver damage and one case of hepatitis, requiring a liver transplant, has also been reported. Millions of women have taken the herb without any of the above- mentioned negative side effects but women should be aware that black cohosh is a relatively new non- traditional form of treatment for menopausal symptoms that has only been studied in a very limited manner (http://ods.od.nih.gov/factsheets/blackcohosh.asp#h5).  

Most of the studies conducted have only been for durations of six months or less. Thus the long-term effects of black cohosh remain unknown. . A study following postmenopausal women taking combined estrogen and progestin for an average of 5.2 years demonstrated a slight increase in the risk of a few diseases that may not have been apparent if the study had been of a shorter duration. Likewise, black cohosh may also demonstrate a slight increase in health risks such as liver disorders or breast cancer if studies were to be conducted for longer durations (http://ods.od.nih.gov/factsheets/blackcohosh.asp#h5).

::images-5.jpeg::images-5.jpegConclusion: Is Black Cohosh an Effective Non- traditional Form of Treatment for Menopausal Symptoms?

Menopause is a natural part of the life- cycle and is certain to befall all women around the ages of 50 to 52. As it is associated with many unfavorable symptoms that have the capacity to disrupt daily life, many women turn to supplements that will relieve the nagging symptoms. For those who prefer alternative, non- drug forms of treatment, black cohosh appears to be a suitable alternative as it has demonstrated, in some studies, an ability to effectively reduce, and even relieve menopausal symptoms, in particular hot flashes. However, studies have been limited in both number and duration and results regarding the effectiveness in treating menopausal symptoms have been mixed. As there is a lack of long-term studies, as well as possible negative side effects associated with the use of black cohosh, the herb should be used with extreme caution. Until further research becomes indicative of fewer possible negative side effects and studies demonstrate greater coherence in results, black cohosh should perhaps not be used at all to effectively treat the symptoms of menopause.

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References

Black cohosh. Retrieved February 15, 2009, from National Institutes of Health Web site: http://ods.od.nih.gov/factsheets/BlackCohosh.asp

Black cohosh- actaea/ cimicifuga racemosa. Retrieved February 15, 2009, from  Moon Branch Botanicals Web site: http://www.moonbranch.com/blackcohosh.html

Black cohosh not estrogenic says new study. Retrieved February 14, 2009, from Aphrodite Women's Health Web site: http://www.aphroditewomenshealth.com/news/20030808031634_health_news.shtml

Black cohosh root tea bags. Retrieved February 15, 2009, from Alvita Tea Company Web site: http://www.alvita.com/

Change one thing challenge: 5 ways to fix a hot flash. Retrieved February 14, 2009, from The North American Menopause Society Web site: http://www.menopause.org/1changehotflash.aspx

Health encyclopedia- diseases and conditions. Retrieved February 15, 2009, from HealthScout Network Web site: http://www.healthscout.com/ency/68/141/main.htm

Heat wave: understanding hot flashes. Retrieved February 12, 2009, from Quality Health Web site: http://www.qualityhealth.com/heat-wave-understanding-hot-%20%20%20%20%20flashes-340/featuredArticle

Herbal products for menopause. Retrieved February 14, 2009, from The American College of Obstetricians and Gynecologists Web site: http://www.acog.org/publications/patient_education/bp158.cfm

Herbs at a glance. Retrieved February 12, 2009, from National Institutes of Health Web site: http://nccam.nih.gov/health/blackcohosh/ataglance.htm

Jacobson, J.S., Troxel, A.B., Evans, J., et al. (2001). Randomized trial of blackcohosh for the treatment of hot flashes among women with a history of breast cancer. Journal of Clinical Oncology. 19(10), 2739-2745.

Loprinzi, C.L., Gallagher, J.G., Stella, P.J., et al. (2006). Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG trial N01CC1. Journal of Clinical Oncology. 24(18), 2836-2841.

Pockaj, B.A., Loprinzi, C.L., Sloan, J.A., et al. (2004). Pilot evaluation of black cohosh for the treatment of hot flashes in women. Cancer Ivestigation. 22(4), 515-521.

Remifemin menopausal relief. Retrieved February 15, 2009, from Enzymatic Therapy Web site: http://www.enzymatictherapy.com/Remifemin/home.aspx

 

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