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Natural Products INSIDER


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Navigating the Confusing Menopause Market

Somlynn Rorie

References

“Forty is the old age of youth; fifty the youth of old age.” ~Victor Hugo

Aging is the sign above the fork in the road, and is a fact every individual must contemplate at some point in her life. Today’s society has become fearful of getting older and obsessed with staying eternally young. A study from the non-profit organization, YWCA, found 80 percent of women are unhappy with their physical appearance and are willing to invest in plastic surgery, and spend about $100 a month on beauty products.¹ One only needs to look at the popularity of anti-aging products and the increase in plastic surgery procedures (a 446 percent increase since 1997) that are said to remove wrinkles, lines, make skin taut and “take years of the face” to realize the notion of aging gracefully is out of touch.

For many women, menopause is just one of the many transitions to be reckoned with as they come to terms with getting older. For example, old age brings with it an increased risk for chronic diseases. Researchers from Rush University Medical Center, Chicago, recently found as women begin to enter menopause, risk factors associated with heart disease appear to climb.² They also found the risk of developing metabolic syndrome increased during perimenopause, the transition the woman body makes into menopause. High blood pressure, abdominal obesity, high blood sugar, low levels of “good” high-density lipoprotein (HDL) cholesterol and high triglycerides are risk factors for heart disease, stroke and diabetes; and metabolic syndrome usually consists of three or more of these traits.

Menopause also marks the end of the fertile phase of life and the shutting down of the reproductive system. Every woman is affected by menopause differently, both physically and mentally. One woman may consider it a “medical condition” or a negative sign of old age; another may view the change as a natural process that requires no medical intervention and is a liberating period that ends the concern of pregnancy and anxiety about menstruation. According to the North American Menopause Society (NAMS), “Menopause is a natural biologic event, not a disease or an estrogen deficiency disease. … Menopause is a psychosocial passage.”

The term menopause comes from the Greek words “month” and “cessation” and refers to a woman’s last menstrual period. Usually this occurs when the ovaries no longer make enough estrogen to produce and support a menstrual cycle; but, other reasons can induce menopause such as medical intervention, surgical removal of both ovaries or cancer treatments. Natural menopause kicks in around the age of 52, although women can experience it between the ages of 40 and 55 years. Premature menopause occurs in women less than 40 years old; perimenopause is the time during or around menopause (usually during a woman’s 40s and sometimes in her later 30s), when the symptoms most associated with menopause occur. During this time, estrogen levels are erratic; they can become highly elevated or stoop as low as 10 percent of normal reproductive highs. Simultaneous life stresses associated with midlife and the effects of aging can also increase the amount of distress menopause changes can cause.

As the Baby Boomer generation ages, an unprecedented number of women have become postmenopausal; an estimated 6,000 U.S. women reach menopause every day (more than 2 million per year, NAMS noted). The experience varies widely. Woman who experience induced menopause usually have a greater need for treatment to control the associated symptoms than women who undergo natural menopause. Many women who have natural menopause report no physical changes during the perimenopausal years except irregular menstrual periods, which eventually end when menopause is reached. Other women experience hot flashes, vaginal dryness, difficulty sleeping, mood changes and other discomforts. Associated health-related risks include osteoporosis and a higher prevalence of cardiovascular risk factors.

Lifestyle changes such as exercise, diet modification, weight management and not smoking can help reduce menopause-related discomforts. Dr. R. Chattha and colleagues from the Swami Vivekananda Yoga Anusandhana Samsthana in Bangalore, India, studied 120 menopausal women, 40 to 55 years old, who did yoga or simple stretching and strengthening exercises five days a week for eight weeks.³ The program also included listing to lectures on using yoga to manage stress and mastering postures, breathing and meditation. The control group heard lectures on diet, exercise, the physiology of menopause and stress. After eight weeks, the women in the yoga group showed significant reduction in hot flashes, night sweats and sleep disturbances, while the women in the control group did not.

In tandem with a healthy lifestyle, dietary supplements and alternative therapies are increasingly being used to relieve symptoms associated with menopause, especially since studies have raised concerns regarding the safety of hormone replacement therapy (HRT), especially in women with a family history of cancer or cardiovascular disease (CVD). In a national study of 4,975 women aged 35 to 64 years old, regarding their attitudes toward menopause and concerns about the menopause experience, 71 percent said they experienced at least one menopause symptom; the most common was hot flashes (84 percent), followed by mood swings (53 percent) and night sweats (52 percent).⁴ About 40 percent of respondents felt comfortable choosing over-the-counter (OTC) or herbal remedies to treat their menopause discomforts; soy products (41 percent) and vitamin E were the most commonly discussed and tried products. The most important factor for choosing a treatment: safety (54 percent), symptom relief (39 percent) and few side effects (29 percent).

More women are turning to natural solutions to ease the discomfort of menopause, and manufacturers are offering products that range from blends of classic herbal ingredients extensively studied for menopausal symptoms, products that offer new herbal combinations, and products that help ease the effects either by cream, patch or spray. “The [menopause] market is active,” said David Winston, RH (AHG), founder of Herbalist & Alchemist. “About four to five years ago, a large long term study found HRT, although effective in relieving menopausal symptoms, also increased risk of breast and uterine cancers. At that point there was a significant increase in interest in natural alternatives.”

Lauren Clardy, COO, Sprunk-Jansen, added: “The consumer base for alternatives to HRT has exploded. Coupled with the aging population and more women entering menopause every year who are combating brain fog, hot flashes, decreased libido, sleep disruption and decreased lubrication, the range of related products offers a lot of opportunity for the educated retailer to make suggestions to customers.”

More women are turning to the Internet, their friends and neighbors, and mainstream media to get their information and ideas for alternatives; however, this can be potentially problematic. “All too often, women learn about their options from their neighbors or the media, which, unless their neighbor is a clinician, is not really a good source,” Winston said. “And the mainstream media does a poor job at communicating knowledgeable and balanced information while they are trying for attention grabbing headlines. They often make little or no attempt to separate truth from falsehoods; they do not review study design issues or the dosage or quality of products used. There is quite a bit of confusion and misinformation in information available online or in print.”

For retailers, the Internet also plays a valuable role in finding information to share with consumers. Clardy recommended retailers check out manufacturers’ Web sites and visit industry-sponsored Web sites such as SupplementInfo.org. She added, “Have your staff looks at these so they can further their knowledge in order to make good recommendations.”

Winston also encouraged retailers to look for products designed by experienced clinical practitioners. “There are too many products that have just been thrown together by someone who has ‘theoretical’ knowledge, but has not worked with botanical or nutrients in practice,” he said. “The companies should also be reputable and follow all established federal GMPs (good manufacturing practices).”

The potential for herbal and alternative remedies for the menopause market is huge, but conflicting messages, incomplete science and quality products marketed alongside bunk products can create consumer confusion. Scientific studies can be useful if the study is done well; unfortunately, there are many poorly designed studies and products that use poor quality materials. This situation places further pressure on retailers to do their research on menopause products.

But how does a retailer navigate and understand the science of menopause ingredients and offerings when there is so much conflicting or shaky evidence? “It is a challenge,” Winston acknowledged. “Many studies are poorly done both in design construction and in quality of materials used. One must often really read the study, not just the abstract, to find out whether an herb is really effective. For example, there was a study done on Dong Quai, which concluded it had no estrogenic effects; therefore, it had no benefit for menopause. Sadly, researchers never looked into traditional use; this herb has never been used for estrogenic activity. Dong Quai enhances cardiovascular health, bowel and liver function and uterine blood flow. The reason it has been included in traditional menopausal formulas for hundreds for years was for support to these organs. No one botanical will be a one-for-one replacement for a pharmaceutical such as HRT, but a well-constructed formula can be very helpful in supporting a woman as she goes through menopause.”

Retailers who have a clinician on staff can put that person’s experience to work in reviewing the research; if there is no one on staff, consider working with a local practitioner to ensure you’re delivering the best quality advice to consumers. Winston said, “Have someone in the store or on call that can be a reference. There are many excellent sources of information and training programs available from top clinicians.”

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The most common menopause-related discomfort is hot flashes (or hot flushes). They are thought to be the result of changes in the hypothalamus, the part of the brain that regulates the body’s temperature. If the hypothalamus senses a woman is too warm, it starts a chain of events to cool her down. Blood vessels near the surface of the skin begin to dilate (enlarge), increasing blood flow to the surface in an attempt to dissipate body heat. It may also increase perspiration to cool the body. An increased pulse rate and a sensation of rapid heart beating may also occur. Some hot flashes are followed by a cold chill. For women with frequent hot flashes, clinicians may suggest isoflavone supplements at about 40 to 80 mg/d or whole soy foods. Isoflavones are well-known phytoestrogens, active substances derived from plants that have a weak-estrogen-like action. Isoflavones are commonly found in soy and red clover.

Isoflavones from soy have been shown to provide several benefits ranging from heart health and maintaining good bone health in postmenopausal women. In a double blind prospective study, 60 postmenopausal women were randomly assigned to receive 60 mg/d of isoflavones (from soybean) or placebo for three months.5 In the women who received isoflavones daily, hot flashes and night sweats were reduced by 57 percent and 43 percent, respectively. The study implied isoflavones could be used to relieve acute menopausal symptoms. A study from the Beth Deaconess Medical Center in Boston found consuming soy nuts three or four times throughout the day, along with therapeutic lifestyle changes, decreased incidence of hot flashes and improved menopausal symptoms.⁶ Research from Harvard Medical School, Boston, found a dietary supplement rich in the soy isoflavone daidzein could reduce the incidence of hot flushes by 52 percent.⁷

The efficacy of soy isoflavones to ease symptoms of menopause, specifically hot flashes, continues to be debated. A study published in Maturitas found supplementation of soy isoflavones does ease hot flushes.⁸ A meta-analysis from Griffith University School of Medicine reviewed 17 randomized, controlled studies and found isoflavone supplementation was associated with a 20 percent reduction in the amount of flushes in women experiencing 10 or more flushes every day.⁹ And, a study out of Italy confirmed in a larger population study of postmenopausal women that taking 56 mg/d of phytoestrogen aglycone genistein can reduce the number and severity of hot flushes without exerting adverse effects on the endometrium.¹⁰

On the opposite end of the spectrum, a Cochrane Database System Review concluded there is no evidence of effectiveness in the alleviation of menopausal symptoms with the use of phytoestrogen treatments (including dietary soy, soy extracts, red clover extracts and other types of phytoestrogens).¹¹ A systemic review from the University of Minnesota evaluated research from the Cochrane Library and Medline from 1966 to March 2004 and, based on the available evidence, found phytoestrogens from soy and red clover did not improve hot flushes.¹²

However, a report published in Menopause said concluding isoflavone supplements do not significantly reduce hot flash symptoms may be incorrect, adding the lack of discrimination between individual isoflavones contained in heterogeneous isoflavone mixtures from differing sources can be misleading when designing studies, interpreting results and conducting reviews.¹³

It appears the conflicting messages are not affecting consumer interest in soy products. The Packaged Facts report “Soy Foods and Beverages” estimated total retail sales of soy products reached $2.1 billion in 2007, up 7 percent from 2006. The report also noted one out of every five consumers report they believe consuming soy-based foods and beverages provides, heart health function (16 percent), cholesterol-lowering properties (11 percent) and potential for menopause symptom relief (10 percent).

Isoflavones can come from other plant sources as well. Red clover extract, for example, contains various isoflavones, which makes it a popular option for easing menopausal changes. And much like soy, evidence is inconsistent on whether it is effective in helping menopausal hot flashes. In one 12-week double blind controlled trial of 30 postmenopausal women, 80 mg/d of red clover isoflavones was found to significantly reduce hot flashes.¹⁴ A randomized, double blind study from Guayaquil, Ecuador, supported the notion that 80 mg/d of red clover supplementation in post menopausal women significantly decreased menopausal symptoms.¹⁵

One of the largest studies that included 252 women discredited the potential of red clover and its effects on menopause symptoms.16 Known as the Isoflavone Clover Extract study, researchers revealed the reduction of daily hot flashes from red clover extract at 12 weeks were similar to placebo.

The root Kwao Krua or Pueraria mirifica (PM), from areas in Northeastern Thailand and Myanmar, contains a number of isoflavones and has been shown to have promising benefit for menopausal symptoms. A randomized, double blind study investigated 71 postmenopausal women who randomly received 20, 30 or 50 mg/d of PM or placebo for 24 weeks.¹⁷ Vaginal dryness in the PM group decreased after 12 weeks of treatment. Researchers from the Hat Yai Regional Hospital, Songkhla, Thailand, found PM relatively alleviated climacteric symptoms such as hot flushes and night sweats in perimenopausal women; however optimal doses need to be clinically assessed.¹⁸ The same researchers compared PM to conjugated equine estrogen (CEE), and found the root possesses a similar estrogenic effect as CEE and can alleviate menopause-related changes.¹⁹ In another study, they looked at the efficacy and safety of PM and found it to be relatively safe for the alleviation of climacteric symptoms; however, data is insufficient to draw definite conclusions on its estrogenic effect.²⁰

One of the most accepted herbal supplements for menopause is black cohosh, a member of the buttercup family native to the rich woods of North America and grown commercially in Europe. In Germany, black cohosh preparations are commonly used to improve symptoms such as hot flashes, depression and sleep disturbance and is covered by a positive monograph of the German Commission E., which allows such products to be labeled for "premenstrual discomfort, dysmenorrhea or climacteric (menopausal) neurovegetative ailments." Recent studies on the herb have attempted to support its benefits. A 12-week double blind, placebo-controlled trial of 304 women with menopausal symptoms found that black cohosh was more effective than placebo.²¹ A three-month study of 120 menopausal women comparing black cohosh to Prozac found black reduced the incidence of hot flashes more effectively than Prozac; however, the drug was more effective than the herb for menopause-related mood changes.²²

Systematic reviews have also shed light on the herb's effectiveness and safety. A review from the University of Exter, United Kingdom, concluded black cohosh is a safe herbal medicine; however, a slight risk of mild transient adverse events are rare, but may occur if taken for a limited amount of time.²³

Conflicting science also exists for black cohosh. A review from the University of Naples Federico II, Naples, Italy looked at data from Medline, Embase, Amed, Phytobase and Cochrane Library.²⁴ Investigation of double blind, randomized clinical trials revealed black cohosh did not consistently demonstrate an effect on menopausal conditions, and efficacy of the herb as a treatment is uncertain and further rigorous trials are warranted. Another review out of Poland concluded 32 papers showed contradictory results and adverse symptoms are rare (5.4 percent), mild and reversible.²⁵

The conflicting science on this herb has opened doors for black cohosh alternatives, such as EstroG, a natural phyto-estrogen supplement. “Continued negative data on black cohosh and a review by the FDA of black cohosh concerning the risk of liver damage to women taking the extract in pure form, and an NIH study continues to bear down on women who view a market category with few choices,” said Michael Jeffers, vice president of marketing, JLM Marketing Inc. EstroG is a combination of three herbal extracts; a randomized, double-blinded 11-month study from Samsung Jeil Hospital in Korea found the supplement offered improvements for night sweats, hot flashes and vaginal dryness.²⁶ After three months, the improvements were said to be five times greater than the placebo group.

In addition to the physiologic symptoms such as hot flashes and night sweats, other commonly reported symptoms include psychological symptoms such as mood changes (increased sadness, depression and/or anxiety). Researchers combed through MEDLINE and EMBASE databases from 1966 to April 2006, as well as the Commission E reports and the German Regulatory Health Authority, looking for botanical and dietary supplements that were used for treatment of mood and anxiety disorders by middle aged peri- and postmenopausal women.²⁷ The authors concluded St. John’s wort (Hypericum perforatum) and black cohosh were the most useful in alleviating mood and anxiety changes during menopause; Asian ginseng holds promise but needs more research; kava “holds promise for decreasing anxiety but should be used carefully;” and Ginkgo biloba and valerian do not appear to reduce depression or anxiety in menopausal women.

Another area of interest for women entering menopause is maintaining a healthy sex life. Some of the effects of menopause include decreased libido, sleep disruption and decreased lubrication. Sprunk-Jansen has introduced Feminine™, a product used for centuries in Greek-Arabic medicine for menopausal symptoms. It contains two unique herbs: the roots of Asofoetida (ferula asafetida), which has been used for tiredness and to increase libido, and caper buds (capparis spinosa) that has been used historically to increase libido and lubrication. “Modern scientific methods indicate that the principal effect of the herbs is to increase blood supply to the genital area while relaxing muscles,” Clardy said. “We carried out a clinical study in 60 women who had problems with their sexual activity or infertility but were otherwise healthy. We asked each to maintain her normal activities and to take one table of Feminine per day for six months. Of these, 80 percent noticed an improvement in libido after only one month of taking Feminine.”

Ayurvedic herbs can also offer menopausal support. In Ayurvedic medicine, Shatavari is traditionally used by women for overall health, vitality and as an aphrodisiac; it has also been said to lessen the imbalances caused by menopause. "Shatavari contains natural phyto-estrogen hormone precursors that help women to maintain a healthy reproductive system and optimum energy even as they age," said Vinay Kynadi, president and CEO of Herbz International."For the aging woman, Shatavari is clinically reported to enhance immunity by boosting defense functions like the production of white blood cells and neutrophils. It is also used for libido and menstrual irregularities. Its demulcent action also restores the dry membranes of the vagina, which normally cause severe discomfort during the post-menopausal period." Herbz International recently launched Vivacy, a Shatavari-based blend of herbs, said to help in hormone level optimization, the prevention of post-menopausal dryness, and balancing the cervical pH level.

The concern for the issues surrounding HRT and the desire to find natural alternatives to calm the changes of menopause is widening the gap for new offerings and innovation. For example, Clardy predicted the use of new delivery systems such as topicals, patches, liquids and nasal mists, as well as companies utilizing nutrigenomics.

Winston mentioned botanicals with a long traditional history of use for treating menopausal issues will take center stage, especially when they are formulated with other botanicals; classic market staples in the menopause category will continued to be studied and new botanical hopefuls may make it into the next generation of menopausal formulas. Chaste tree, motherwort, sage, white peony and Dong Quai (as part of a formula) are just a few garnering attention.

He added: “The classic Chinese formula Si Wu Tang, which contains Dong Quai, processed Rehmannia, Ligusticum and white peony, has been used for hundreds of years to treat what the Chinese call ‘blood deficiency’, indication of which include hot flashes and dry skin. A formula we make for vaginal dryness includes extracts of fresh milky oat seed, white pond lily, Chinese asparagus and licorice. Another formula is our Osteoherb bone density formula containing nettle leaf, alfalfa, dandelion leaf, horsetail, oat straw and a bit of black pepper for absorption.”

When asked about other herbal products that could possibly offer relief in conditions associated with menopause, Winston listed the following:

• Brain Fog- holy basil, rosemary, white peony
• Osteoporosis – vitamin D, Osteoherb, Boron, resveratrol,
• Atherosclerosis, Heart Disease – hawthorn, Dong Quai, Tienqi ginseng, Dan Shen (salvia miltiorrhiza), blueberry/pomegranate/cranberry to protect against atherosclerosis
• Cancer Prevention – ginger, milk thistle, green tea, tumeric, resveratrol

Other new ingredient offerings include Phytostrol N-ERr 731, a Rhaponticum rhubarb root extract for menopause conditions. The herb has been available in Germany since 1993, and several trials have found a reduction in menopause symptoms. A study published in the 2007 issue of Menopause claimed rhubarb extract ERr 731 decreases anxiety and improves health state and general well-being in perimenopausal women.²⁸ In a 12-week double blind, placebo-controlled trial of 109 women, researchers found the use of the extract could significantly reduces the occurrence and severity of climacteric complaints in perimenopause.²⁹

Maca has been used by the native people in Peru as a traditional remedy to treat various female-related disorders. A pilot study on early postmenopausal women found an organic maca preparation exhibited hormone-balancing effects, leading researchers to suggest the herb may reduce the discomfort experienced by women in the early postmenopausal stage.³⁰

Traditional Chinese Medicine (TCM) has also been studied as a possible replacement for HRT. A study of 31 peri- and postmenopausal Dutch women in a double blind and double-dummy randomized placebo-controlled pilot trial found placebo reduced hot flashes 30 percent, TCM had a 29 percent higher average score, and HRT had a 50 percent average score.³¹ Sen Ten Pharmaceuticals Cool Vital Mover product utilizes TCM herbs. The dried root of Bupleurum, for example, is a classic herb used in the treatment of mood swing and hot flashes.

Vitamin E has also made its way into the category. A study out of the Tarbiat Modarres University, Tehran, Iran reported vitamin E (400 IU/d) was more effective than placebo in the treatment of hot flashes.³² Another study conducted at the Mayo Clinic and May Foundation found in 120 breast cancer survivors given vitamin E (800 IU/d) a reduction in hot flash frequency (25 percent versus 22 percent from the placebo group). The researchers noted the clinical magnitude of the hot flash reduction was marginal.³³

Winston noted resveratrol has extremely interesting clinical evidence. “It has been shown to strengthen cardiovascular function, decrease atherosclerosis, increase bone density and prevents cancers. While it does not affect hot flashes or vaginal dryness, it can certainly be interesting as part of an overall protocol,” he said.

The passage into menopause can be a daunting phase of life for many women, especially as they contend with other associated health issues and the perceived burden of getting older. Retailers can help ease her worry by effectively providing her with the tools to make effective decisions. By navigating her through storm, educating her with good science and putting her in touch with a naturopath or trained clinician for individual assistance, the passage through his potentially complex time can effectively become smooth sailing.

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