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Pharmacy Times

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Alternatives to Hormone Replacement Therapy

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Publicity surrounding a women?s study that linked hormone replacement therapy (HRT) to increased risk of heart disease has sent women scrambling to OTC aisles to find alternative therapies.

"Since the disappointing results of the Heart and Estrogen?Progestin Replacement Study were published, women have certainly become more interested in using dietary supplements for the relief of menopausal symptoms," said Mar-cus Laux, a licensed naturopathic physician at the National College of Naturopathic Medicine in Portland, Ore, and author of Natural Woman, Natural Menopause. "In fact, it was estimated that one third of all women who were taking hormone replacement therapy in July 2002 immediately stopped taking these drugs in response to these findings." Within 1 month after publication of the study, sales of prescription hormone replacement drugs dropped nearly 37%, according to IMS Health.

Rebecca Kurth, MD, director of Columbia Eastside Prime-care in Manhattan, believes some of her patients were almost relieved to hear negative press on hormone replacement. "Many women feel they are getting a lot of quality-of-life benefits from being on estrogen," she said. "But for many others, estrogen therapy is a hassle, and they are happy to have a concrete reason to stop hormone replacement therapy." That does not mean women are happily willing to accept the unpleasant effects of menopause. "Hot flashes are the number-1 concern, followed by vaginal dryness, then concerns about moods and forgetfulness," Dr. Kurth said. "OTC products can address many of these issues." Women may also experience cramping, bloating, and constipation, according to Dr. Ronald Boyer, medical director of Boiron USA. He said that homeopathic products can be very effective in treating these symptoms as well as the more common symptoms of menopause. "Homeopathy is one of the most compelling therapies for these conditions because of its ability to alleviate discomfort without hormones, side effects, toxicity, or danger of interference with other drugs or medical conditions," he said. Dr. Boyer stressed that the homeopathic approach does not seek to replace estrogen. "Menopause is not a disease," he said. "Homeopathic medicines can help eliminate the symptoms that occur when the level of estrogen in the body decreases." Pharmacists should make patients aware of the fact that it may take a few weeks before the effects of nutritional supplements are felt. "A woman may need to be a little patient before she decides that something does not work," Dr. Laux said. Pharmacists should also caution patients to stick to a dosing schedule and not to exceed recommended dosage guidelines.

Questions Answered About Black Cohosh Pharmacists are likely to field a growing number of questions from consumers about black cohosh (Cimicifuga race-mosa)?a form of phytoestrogen?that has been in the news since studies with favorable outcomes have surfaced in the media."Black cohosh has been used to reduce the number and severity of hot flashes for many, many years," Dr. Laux said. "Several clinical studies have demonstrated that black cohosh is as effective as estrogen in reducing hot flashes and vaginal dryness." Adelaide Nardone, MD, a professor of obstetrics and gynecology at the University of Rhode Island, does not give black cohosh the same unqualified thumbs up. Although she believes it can be effective, she said that because black cohosh is an estrogenic herb, there is some concern that if used unopposed by a progestin it may lead to endometrial hyperplasia, although she allows that this has not been well documented in literature."As with most herbal remedies, there is little or no evidence of its long-term safety," she said. She added that pharmacists should be sure to caution patients that the use of black cohosh is contraindicated in pregnancy and lactation and should not be used in conjunction with other hormonal products, such as HRT or oral contraceptives. "If a woman has an allergic reaction to aspirin, she should take black cohosh with caution," she said.Although Dr. Nardone said she has seen black cohosh cause nausea, vomiting, dizziness, visual disturbances, and bradycardia, Dr. Kurth said her patients have never experienced side effects with the use of black cohosh. The usual dose for black cohosh is 20 mg to 40 mg, 2 times a day.Promising Results from SoyA number of studies have indicated that soy isoflavones not only help relieve hot flashes, but also can be used in the prevention of bone loss as well as heart disease."Soy has helped many women get through menopause," Dr. Laux said. "The isoflavones in soy (genistein and diadzein) are categorized as phyto-estrogens, which literally means ?estrogens from plant sources.? However, in soy?s case, this description is fairly misleading. While genistein and diadzein act like estrogen in some organs, they appear to block estrogen in others. A more accurate term for soy phytoestrogens would be phyto-SERMS, or ?plant-based selective estrogen receptor modifiers.?" For menopausal women, a daily dose of 60 mg of dietary soy is sufficient. Dr. Nardone suggests the best sources of soy are, soymilk (30 mg or 8 oz), tofu (35 mg or 33 cup), tempeh (35 mg or 33 cup), roasted soy nuts, (60 mg or 33 cup), and soy protein powder (60 mg or 2 scoops).Soy is also available in supplement form. "For best results, patients should make sure that products contain at least 50 mg of soy isoflavones or 40 mg of red clover isoflavones a day and that those amounts have been independently verified to contain these amounts," said Tod Cooperman, president of ConsumerLab.com, an independent group that tests vitamins and minerals. Cooperman cautions that because products vary significantly in their suggested daily serving size, ranging from as little as 8 mg to as much as 100 mg of isoflavones per day, pharmacists can help patients select products for which amounts claimed on packaging have been independently verified.Help for Vaginal DrynessAnother unpleasant postmenopausal side effect is vaginal dryness. Dr. Nardone, who serves as a medical advisor to the Vagisil Women?s Health Center, estimates that 90% to 100% of post-menopausal women suffer from vaginal dryness and atrophy and seek products to relieve this painful symptom."Women can greatly benefit from a hormone-free and safe product such as Vagisil Intimate Lubricant," she said. "When used regularly on the external genitalia, this moisturizer will help restore water and moisture to these tissues." Dr. Kurth said pharmacists also can recommend KY Jelly or Vaseline.Recently, a number of new personal lubricants have been introduced to the market, including Church & Dwight?s Trojan Personal Lubricant in 2 flavors and Ansell?s LifeStyles Personal Lubricants in 2 flavors as well.

Relief for Mood Symptoms

When it comes to mood and energy symptoms, there is far less consensus on which products are helpful. There is little proven research on these herbal products; much of the "buzz" surrounding these products comes from anecdotal data.

Dr. Kurth said her patients have experienced success with B-complex vitamins. "Pharmacists can recommend that patients looking to relieve stress symptoms can try B-complex supplements," she said.

Dr. Nardone recommends her patients try magnesium. "Magnesium, taken at ~400 mg daily, can be beneficial to muscles and help with irritability and nervousness and fatigue," she said.

Other herbs/supplements that have been used to relieve symptoms of irritability are evening primrose oil, dong quai, and ginseng.

Pharmacists should use caution in recommending these products to patients; many can cause severe interactions when taken with prescription?or even OTC?drugs. Pharmacists can play a key role in researching contrain-dications and cautioning patients to always consult with their physicians before taking herbal supplements.

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