Introduction
Complementary and alternative medicine is a fascinating area for me. My first educational experience occurred in the 1980s while on a trip to China with a group of health professionals. Witnessing the effectiveness of acupuncture needles in providing complete anesthesia to a patient whose abdomen was wide open instantly made me a believer! Seeing acupuncture and a variety of other alternative techniques in action taught me to think about options outside of conventional medicine. In Chinese university-based hospitals, the doctors used a hybrid of Western and traditional Chinese medicine to treat their patients.
My personal experience with chronic back pain has led me to use many alternative medicines and complementary techniques. I had an open mind, which made me more receptive to alternative solutions. The pursuit of pain relief is always a strong motivating factor. With pain, you receive immediate feedback, and you will know whether the remedy is working. However, dealing with your bones, the problem is that you do not have the benefit of knowing the result for a long time.
We use complementary and alternative medicine therapies quite often, maybe even more often in my state—California. The problem is that evidence is scant or nonexistent for so many of the treatments. It is difficult to know what are the real benefits and risks of these alternative treatments.
The good news is that, just as I observed in China some twenty-five years ago, the increasing integration of the “two worlds” is happening here and now. The National Institutes of Health (NIH) established the National Center for Complementary and Alternative Medicine to foster research and provide information about this area. Many major hospitals and universities have set up integrative medicine centers. In the future, as conventional medicine broadens its view to encompass a more integrated approach, nothing will be “outside the mainstream.” Meanwhile, more research is needed to provide answers on safety and effectiveness of alternative medicine.
Fosteum: A Food Product by Prescription
Fosteum® is a unique product that is categorized as a “medical food” and requires a prescription from your doctor. Fosteum's main ingredient is genistein, which is an isoflavone (one of the estrogen-like compounds in soy products). Each capsule contains 27 mg of genistein, a bioavailable form of zinc, which provides approximately 4 mg of elemental zinc and 200 IU of vitamin D (cholecalciferol). The prescribed dose is one capsule twice a day, approximately every twelve hours.
WHAT IS A MEDICAL FOOD?
Prior to learning about Fosteum, I thought medical foods were only nutrition products given to ill patients who could not take in regular foods, for example, special nutrient-rich liquids given through a tube directly into the stomach when someone is unable to swallow or eat solid food.
As defined by the Food and Drug Administration (FDA) under the Orphan Drug Act, “the term ‘medical food' refers to a food that is formulated to be consumed or administered internally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
Originally, medical foods were designed for patients with rare, inherited metabolic diseases who needed special diets. These foods were considered drugs because they are used for medicinal purposes and were referred to as “orphan drugs” because so few individuals are affected.
To promote development of these types of products, the FDA reclassified them from drugs to foods. The FDA does not approve medical foods, but they are intended for use by patients under a doctor's supervision.
SOURCE: www.fda.gov
Effectiveness
Fosteum has only been studied in Italy, in two small, randomized trials of post-menopausal women. No study subjects had osteoporosis.
One study enrolled ninety women who were on average six to seven years past menopause. Subjects were randomly divided into one of three groups that received either Fosteum, continuous estrogen therapy pill, or a dummy placebo pill. At the end of one year, bone density increases of three to four percent were observed in both the Fosteum and estrogen groups. Therefore, in this small study, Fosteum appeared to protect against bone loss to a similar degree as estrogens. Hot flashes were reported by 40 percent of subjects in the placebo group, by 20 percent of those in the Fosteum group, and by only one woman taking estrogen. Information is not given about the percent of women reporting hot flashes at the start of the study. Therefore, the actual decrease in occurrence of hot flashes is not known.
The largest study started with 389 postmenopausal women, age fifty-four on average, with low bone density at the hip. They were randomized to groups that took either Fosteum or a dummy placebo pill. The study was planned to last for two years and about one-third continued in a one-year extension for a total of three years. At the end of two years, bone density for those in the Fosteum group increased 5 percent at the neck region of the hip and 6 percent at the spine. The placebo group had the same magnitude of loss at both sites. In the smaller extension group, at the end of three years bone density increased in the Fosteum group while the placebo group had a mirrored loss of 7 percent at the hip and 10 percent at the spine.
Since it is unlikely that women who were more than five years past menopause would have had such rapid bone loss, it raises questions about the results of this small study. In addition, the modest effect of Fosteum on bone turnover does not explain the observed robust increase of bone density.
Digestive complaints were more common with Fosteum. By the end of two years, one in five participants in the Fosteum group discontinued the study due to adverse events. The lining of the womb (endometrium) did not change with two years of use. The report of this study did not include any mention of hot flashes.
It is nice to see randomized clinical trials with Fosteum. However, the two studies combined have a total of just fewer than five hundred subjects. Since the main ingredient is genistein, other soy studies can be looked at to put the results of these two studies into perspective. Fosteum clearly has an estrogenic effect, which may be why the number and intensity of hot flashes are lower. Even so, one of the small Italian studies showed that Fosteum was less effective than estrogen in decreasing the frequency and intensity of hot flashes. Do not use Fosteum if you have a history of breast cancer or have other reasons you cannot take estrogen products.
Fosteum
(genistein)
Category
Antiresorptive
Phytoestrogen
Manufacturer
Primus Pharmaceuticals
Pivotal Fracture Trial
none
Fracture Reduction
none
Indications for Osteopenia and Osteoporosis
Prescription medical food product
Dose
1 capsule twice a day
Each capsule contains
27 mg genistein aglycone
20 mg citrated zinc bisglycinate
200 IU cholecalciferol
Additional Information
May increase bone density
May decrease hot flashes
Not for use in women with history of breast cancer
If you have hot flashes and good bone density to begin with, soy products may be helpful in reducing the number and intensity of those power surges. It may be the total daily dose amount of isoflavones in soy that is important rather than just the genistein. If that is indeed the case, you can get all you need in other less expensive soy products.
If you have established osteoporosis or have a history of broken bones and are looking for something else, you cannot rely on Fosteum to reduce your risk of fractures. I recommend that you look at FDA-approved medicines that show reduction in the risk of fractures in studies of thousands of people.
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The Bare Bones
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Soy: Pass the Tofu?
I did not pay attention to soy until I reached menopause. I switched to a soy latte in the morning and increased the soy in my diet with the hope that my hot flashes and sweats would diminish. Plenty of other women are doing the same thing. Soy is everywhere. It's a common dairy substitute in the form of soy milk, soy cheese, or soy yogurt. Soy protein is in all types of products on the grocery shelves. Tofu has increased in popularity beyond use in Asian dishes. The whole soybean in its young, green stage is called edamame, its Japanese name, and is served as a healthy appetizer.
Soy is commonly used by postmenopausal women for health benefits, whether as a supplement or as a regular part of their diets. There is tremendous interest in the use of soy foods for protecting the bone.
A Natural SERM?
Soybeans are high in protein that is rich in isoflavones. Isoflavones belong to a class of plant compounds called phytoestrogens. Depending on the target tissue, these compounds have the ability to mimic or block the actions of estrogen. Their action is similar to the designer estrogens or SERMs, like Evista, which has both estrogen-like and anti-estrogen effects.
The soy isoflavones are genistein, daidzein, and glycitein. Like Evista, soy isoflavones bind to estrogen receptors. Therefore, you might expect similar effects: Benefit to the bone without causing stimulation of breast tissue or the lining of the uterus (endometrium). Research has focused on whether you actually get these effects with soy.
Effectiveness
Looking at women in Japan and China, where soy foods are consumed in large amounts, suggests that a diet high in soy is beneficial for bone health, since rates of fracture are lower there than in Western countries. Trying to pinpoint the key factor is the difficulty. Most likely a combination of factors that make up the Asian lifestyle contributes to the lower risk of fracture, not just a single factor. For those of us on Western diets, it is difficult to change our diets to match those of Asian women. In the research setting, the approach has been to try tablets or supplements to see if they result in bone density changes.
Several analyses of multiple small studies (meta-analyses) have shown mixed results regarding bone-protective effects of soy. Regardless of the findings, the results cannot be applied to US women because the majority of the studies included in the meta-analyses were based on Asian women. However, recent results from larger, well-designed, randomized clinical trials show little, if any, effect. The following are recent randomized placebo-controlled trials conducted for a year or longer in European or American women.
PHYTOS
The PHYTOS study used isoflavone-enriched biscuits and cereal bars in more than two hundred healthy, early postmenopausal Caucasian women for one year. The foods were enriched with a total daily dose of 110 mg of isoflavones from soy concentrate, which consisted of 60 to 75 percent genistein. Consumption of enriched foods containing 110 mg per day of soy isoflavone did not prevent bone loss and did not affect bone turnover in early postmenopausal women.
Soy and Bone Mineral Density in Older Women
This study looked at the addition of dietary soy protein and isoflavone in tablet form separately and in combination versus placebo. A total of 131 women with an average age of seventy-three began the clinical trial and three-quarters of the women successfully completed the study. In a group of late postmenopausal women, the addition of soy for one year did not affect bone density or bone turnover markers.
OPUS: Osteoporosis Prevention Using Soy
OPUS was a two-year study with daily supplementation of 80 or 120 mg of soy isoflavones in the form of a tablet versus an inactive placebo tablet. A total of four hundred healthy early postmenopausal women, average age fifty-five, participated. At the end of two years, bone density decreased in the 3 percent range at the spine and the 2 percent range at the total hip in all groups. Bone density declined regardless of soy treatment.
SIRBL: Soy Isoflavones for Reducing Bone Loss
SIRBL was a three-year study of daily 80 or 120 mg doses of soy isoflavones in 224 postmenopausal women, average age fifty-four. The soy isoflavones were extracted from soy protein and compressed into tablets. Approximately 2 percent loss in bone density was observed at the hip and spine with the 80 mg dose. However, the 120 mg daily dose showed a slowing of bone loss at the neck region of the hip only. No treatment effect was seen on bone turnover markers. These doses had no effect on the lining of the womb (endometrial thickness) and there were no reports of any adverse events.
The study interventions included the use of isolates of soy protein, isoflavone supplements, extracts from soy foods, and soy integrated into foods. Even though the studies used different types and dosages of supplements, the results are underwhelming. Although the active component of soy is considered to be the isoflavone component and not its protein, no significant differences were found. Older studies with the synthetic ipriflavone up to doses of 200 mg three times a day also failed to show bone benefits.
The effects of soy on bone may depend on the dose. A daily dose higher than 80 to 90 mg appeared to be required for any effect, and that was only minimal. This is considerably higher than the average soy dietary intake of 50 to 60 mg in Asia and the estimated 25 to 30 mg needed for heart benefits. Overall, the intervention trials examining the effect of soy isoflavones on bone density and bone turnover markers in Western population groups do not confirm the findings of the population studies and clinical trials involving Asian women.
The wide variability in response may relate to the ability to produce equol, which is a byproduct of the isoflavone daidzein. Only an estimated 30 to 50 percent of those in Western populations are able to produce equol. In contrast, Asians, who consume soy products with greater regularity, are more likely to be equol producers. The presence of equol may be a key factor in the positive effects of a diet rich in soy. Since this is not fully proven and has been contradicted, the verdict is still out on the production-of-equol theory.
Because soy protein and isoflavones (either alone or together) did not affect bone mass, they should not be considered an effective therapy for preserving skeletal health in postmenopausal women.
Is there a downside to use of soy supplements? Because they deliver levels of isoflavones that exceed the usual dietary intakes from soy, the safety of soy isoflavone supplements may be a concern. Soy products were well tolerated in short-term studies. The overall long-term effects on the breast and uterine lining are not known. However, if soy works like a SERM, you would not expect stimulation of breast tissue or the uterine lining. Also, Asian women have low rates of breast and endometrial cancer.
Right now there are two opposing lines of research on breast cancer and soy: Soy or its isoflavones may either protect against breast cancer or promote breast cancer. For heart disease, the benefits and risks are also being debated.
Remember, the research studies are based on soy protein or isoflavones, not the whole food. Just like any other nutrient, dietary soy is preferable to supplements.However, the few studies on dietary intervention did not show prevention of bone loss. Soy isoflavones in higher doses appear to suppress bone loss rather than induce bone gain.
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The Bare Bones
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Strontium Citrate:
Is It the Same as Ranelate?
Because strontium ranelate is not available in the US, many women have turned to the other strontium sources on the pharmacy shelves. The over-the-counter supplement strontium citrate is the most common. Strontium may be available in other salt forms. You may also find strontium carbonate, strontium chloride, or strontium gluconate. A totally different form, a radioactive isotope of strontium, is used as a treatment for bone pain caused by cancer in the bone. I mention that in case you hear of someone being treated with strontium in the hospital.
You cannot take strontium citrate at the same time as anything else. You must be very fastidious about taking it on an empty stomach. That means having no food, drink, or any other medicines or supplements for at least two hours before. The most convenient time is usually at bedtime. The doses of strontium citrate vary from a few micrograms to 1,000 milligrams in a multivitamin and mineral packet. The most widely available formulations of strontium citrate only contain 226 mg or 340 mg per pill, and the supplement dose is two a day for a total of 452 or 680 mg daily.
The above doses equate to about a quarter to a third of the amount of strontium in the strontium ranelate sachet. At those fractions of the prescription medicine dose, the strontium citrate is probably not going to work. The 2 gram or 2,000 milligrams daily dose of strontium ranelate only decreases bone turnover a small amount. Therefore, you are unlikely to see any changes with over-the-counter strontium citrate. Although a systematic study has not been done, colleagues who have followed patients taking strontium citrate have not seen any changes in bone turnover or bone density.
Effectiveness
What are the data for strontium citrate? At the present time, almost nothing. One small study at the University of California, Davis, will answer a few questions, but it will not be definitive. Researchers there are conducting a study titled “Effects of Strontium Citrate on Bone Health in Women.” They are evaluating the 680 mg formulation taken daily for three months. A total of two hundred early postmenopausal women are being recruited and randomized to strontium citrate or placebo pills. Measures of bone markers and bone density will be done at baseline. However, because of the brief duration of the study, only bone markers will be followed.
The many curious patients who want to know if strontium citrate works will find that the UC Davis study will provide only limited results. The study's three-month duration will be too short to allow researchers adequate time to evaluate strontium citrate's effects on bone density. What we really want to know is whether strontium citrate decreases fractures. But that would require a huge study of thousands of people for at least three years. Such a study is unlikely.
The UC Davis study will only provide results for bone turnover markers collected in a controlled environment. If this study verifies what has been seen in the clinic, you should leave the strontium citrate on the pharmacy shelf and not waste your money.
Cannot Live without Strontium?
If you decide you cannot live without strontium and have absolutely no other option, take the medicine that has been used in clinical trials. Read the section titled “Other Medicines: Available Elsewhere But Not in the United States” (page 263) to get more information about strontium ranelate. If you are still interested after reading that summary, talk to your doctor about this medicine.
If you have a valid prescription, canadadrugs.com will fill your prescription and send it to a US address. If you and your doctor agree that strontium ranelate is a reasonable next step, ask him to write the prescription. The brand Protelos, which contains a dose of 2 grams of strontium ranelate, is stocked in boxes of twenty-eight sachets. Be sure to understand that you will need to find a DXA center that knows how to measure your bone density and adjust the measurement for the presence of strontium.
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The Bare Bones
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Natural Products:
Still More Questions to Be Answered
In this section, you will find a list of supplements that is by no means complete, though it does cover the names of the majority of supplement components you may encounter. One problem with listing them separately is that many are used in combination with other supplements. Trying to isolate which one or two ingredients may be responsible for the main effect hampers studies of the natural health products. For instance, traditional Chinese herbal medicines tend to rely on the joint actions of many herbs mixed together.
The natural health products listed below include most products that are promoted as “effective” for bone health. However, there is little scientific evidence on the effectiveness of these various products for boosting bone health. Many of the natural medicines advocated for bone protection are used for reducing menopausal symptoms. You get immediate feedback when trying to quell hot flashes. In contrast, you just do not know if the treatment is effective for bone, since there is no relief of symptoms and you need to wait a longer time interval to see results.
This laundry list of natural health products is organized for discussion into the following groups: products with estrogen-like effects, oils, trace elements, and Chinese herbal remedies.
Estrogen-like Effects
These products may have effects like estrogen and theoretically, if strong enough, they may protect bone. Some may act like a “natural SERM.” They are estrogen-like at the bone, inhibit estrogen at the breast, and may have other anticancer properties. Others may work by increasing circulating levels of estrogens. The products with the most scientific evidence are covered first.
Dehydroepiandrosterone, or DHEA, is a hormone made naturally by the adrenal glands, which sit atop each kidney. Levels of DHEA fall progressively after about thirty years of age. Since these hormone levels decrease with aging and diseases of aging, including osteoporosis, DHEA is touted as an effective “anti-aging” hormone supplement.
Does increasing DHEA to youthful concentrations improve or preserve bone health? Estrogen levels increase as a result of taking DHEA. Small positive changes in bone density were observed with use for one or two years at a daily dose of 50 mg for older women and 75 mg for men. However, these small changes were not consistently seen in the hip, spine, or forearm or in both men and women.
Since DHEA is converted into testosterone and estrogen, the long-term effects, especially risks of breast cancer or prostate cancer, are not known. In addition, DHEA has also been shown to decrease levels of “good” (HDL) cholesterol in women, and this could potentially increase the risk of heart disease. In the absence of long-term studies and with a potential for harmful effects, DHEA is not recommended until further information in known.
Red clover is a legume like soybeans. It contains large amounts of plant estrogens, or phytoestrogens, with the active isoflavone compounds genistein and daidzein, which are similar to soy, as well. Based on dry weight, red clover is said to contain ten times the phytoestrogens found in soy. Supplements made from extracts of red clover are increasingly popular as alternative therapies for hot flashes. One brand, Promensil®, contains 40 mg of red clover isoflavones in the standard tablet preparation.
The bone-preserving effects of red clover have also been examined, but the evidence is very limited. In a one-year clinical trial using a red clover-derived supplement, bone density was better than placebo at the spine. No difference was observed at the hip.
Flaxseed in a dose of 40 grams daily was given in a small clinical trial for three months. Flaxseed improved cholesterol but did not change bone turnover markers in postmenopausal women. In a longer one-year study in two hundred postmenopausal women, bone density was similar between the treatment and placebo groups.
Other plants, including alfalfa, horsetail, hops, and licorice root, have similar isoflavone properties, which may be responsible for their reported estrogenlike effects.
Black cohosh and wild yam are used as a “natural alternative” for estrogen therapy. The mechanism of action for black cohosh is not clear, and there is no information on its effect on bone. In a small study of Taiwanese women, wild yams increased levels of estrone, which is an estrogen produced in fat cells. No direct study has been done on its effect on bone. However, estrone positively correlates with bone mass in postmenopausal women in other studies.
Ginseng is used for a myriad of health reasons. The estrogen-like effects of ginseng are controversial. Estrogen activity is suggested by the fact that with large doses in postmenopausal women, vaginal bleeding may occur.
OILS
Plant-based and fish oils are essential fatty acids. These fatty acids are necessary for health, but your body does not make them so you must get them through food. The two types are called omega-3 fatty acids and omega-6 fatty acids. Some studies suggest that people who do not get enough of some essential fatty acids are more likely to have bone loss. The ratio of the fatty acids is also implicated. A higher ratio of omega-6 to omega-3 fatty acids is associated with lower hip bone density in both men and women.
Evening primrose oil and black currant seed oil, taken as supplements, contain an omega-6 fatty acid called gamma-linolenic acid. In a small pilot study using evening primrose oil in combination with fish oils and calcium, subjects showed less bone loss over three years than those who took placebo. In this study, after the first eighteen months, the placebo group switched to active therapy and all subjects had small increases in bone density.
Fish oils have a long list of benefits. I take fish oil for its purported heart effects. Dietary studies suggest that the omega-3 fatty acids are important for bone density. In five small supplemental fish oil studies, the effect of omega-3 fatty acids on bone density was variable. Small or no effects were observed.
TRACE MINERALS
In addition to calcium and vitamin D, certain minerals are required for the maintenance of healthy bone. Trace amounts, as the name implies, are all that is needed. Unless you are malnourished, your diet should be supplying what you need.
Copper, manganese, and zinc work with enzymes that manufacture the collagen fiber of bone as well as many other essential reactions in the body. In epidemiology studies pinpointing one element, zinc showed a correlation with higher bone mass. But if more is given in supplements, will that make a difference? No clinical trials have looked at this.
In the early 1990s, a colleague at the University California, San Diego, Dr. Paul Saltman, looked at a “cocktail” of trace minerals with and without calcium in a small group of women for two years. Since this study is widely cited as “proof,” I am providing more detail. Each active supplement contained 15 mg of zinc, 2.5 mg of copper, and 5 mg of manganese. The calcium was 1,000 mg in the form of calcium citrate malate. A total of fifty-nine older women with an average age of sixty-six were divided into four groups. Bone density at the spine was evaluated at the end of two years:
Trace mineral only: slowed bone loss
Calcium only: slowed bone loss
Combination trace minerals and calcium: maintained stable bone density
Placebo: bone loss
Only the combination versus placebo comparison showed statistical difference.
Do you need more than a trace for “good measure”? There is no evidence to suggest that supplementation is needed or beneficial for people eating a normal diet. If you think you need more of one of these minerals, eat food rich in that nutrient. The food will supply it in balance with other essential nutrients.
Boron and its usefulness became a topic of discussion following my very first public lecture on the topic of bone health. The first question asked was, “Do I need boron in my calcium tablets?” There was no guiding data then, and more than twenty years later, there is still no evidence from clinical trials. In fact, its biological function has not been clearly established. Again, it is a “trace” element, and a trace is all you should need.
Silicon may confer bone benefits. In one observational study, higher dietary intake of silicon was associated with higher bone density. Beer was recently found to be high in silicon content. This finding led to many headlines, like “Beer, A New Treatment for Your Bones?” Just don't make a steady diet of it.
Horsetail also contains significant amounts of silicon. Horsetail contains an enzyme (thiaminase) that can cause deficiency of the B vitamin, thiamine. Some horsetail products may specify that they are “thiaminase-free,” but there is not enough information to know if thiaminase-free products are safe. You may want to stay clear of this product.
Stinging nettle is a root that contains both silicon and boron. It is better known for its use as a diuretic.
Fluoride has a high affinity for calcium, so it can easily become part of the bone mineral structure. Years of research and development have investigated fluoride as a potential prescription medicine. There were high hopes for its success because it stimulates the bone-forming cells, osteoblasts. In 1993, three preparations were in final stages of clinical trials. Large increases in bone density, particularly at the spine, were achieved. The problem turned out to be that the denser bone was more prone to fracture. Fluoride did not prevent fractures. The mineral structure it created was more brittle.
Dr. David Baylink, at Loma Linda University in California, believes that there may be a small window of opportunity for fluoride. He uses it with a very special patient who needs a bone formation boost but cannot take Forteo. He must fastidiously follow blood levels of fluoride to get “just the right amount.” He cautions people not to try this on their own.
TRADITIONAL CHINESE MEDICINES
Even though I am fascinated by Chinese medicine, I cannot begin to interpret the dozens of Chinese herbs that go into different concoctions. These prescriptions were produced by trial and error literally over centuries.
In general, the kidney is viewed as the controlling system for the bone. Therefore, stimulating the kidney with traditional medicines is thought to provide beneficial bone effects. However, it is unclear how the herbs actually influence the bone tissue. Many “tonics” are a combination of multiple botanicals.
Dong quai or Angelica sinensis is a common ingredient in prescriptions for bone fractures and osteoporosis. Clinical data has shown that these prescriptions reduce fracture healing time. This observation suggests that Dong quai speeds up bone formation. Researchers in the laboratory have shown that Dong quai increased production of proteins in cell culture, which may, in turn, increase bone formation.
Deer velvet from deer antlers is another product in common use. It contains ferulic acid, which seems to have estrogenic activity. In cell cultures, ferulic acid stimulates breast cancer cells. You should avoid using deer velvet if, for example, you are restricted from using estrogen because of a history of breast cancer.
Researchers are working to demonstrate the effectiveness of traditional remedies beyond the cell cultures. Usually, traditional prescriptions combine many herbal and mineral medicines. Although only one or two are responsible for the central effect, the supplemental ingredients may also be important in achieving the goal of a remedy.
WORDS OF CAUTION
These products do not require evaluation for safety and effectiveness by the FDA. The FDA has no requirements for the composition of supplements. As a result, some products may contain different amounts than stated on the label. For example, in a study of commercially available DHEA preparations, only half of products tested matched the stated ingredient amount on the package. The other half ranged from none to 150 percent of the claimed amount.
Under the Dietary Supplement Health and Education Act of 1994, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Good Manufacturing Practices (GMPs) for dietary supplements are modeled after those for food. They are designed to help prevent super-potent or sub-potent products, wrong ingredients, contaminants, or foreign materials in the supplements.
Natural products are not always innocuous. There is a false perception that these remedies are safer than manufactured medicines. An analysis of 251 Asian herbal products bought in the United States identified arsenic in 36 of them, mercury in 35, and lead in 24 of the products. Yikes!
Taking a blood thinner? Don't take these. If you are taking Coumadin, Plavix, Effient®, or anything else to thin your blood, do not take any of these products. It is playing Russian roulette with your body; some increase bleeding, others decrease blood-thinning effectiveness. Dong quai has blood-thinning properties like Coumadin. Other herbs including ginseng and red clover, may also increase bleeding. Others can reduce the effects of your blood thinning medicine, such as alfalfa, which contains a large amount of vitamin K. The American Society of Anesthesiologists recommends stopping all herbal medicines at least two weeks before surgery because of the risks of herbal and drug interaction as well as an increased chance of bleeding.
If you use these supplements, be aware that the data, if any, do not show support for bone health. Some supplements, like fish oil, may have other benefits for your general health, which may make them good choices to include in your daily regimen. However, your diet is the best way to get the nutrients you need and in the right proportion. Although many of these products may help diminish menopausal symptoms, longer-term effects on bone health have not been seen. Overall, clinical evidence is presently lacking to support their use as effective supplements for bone health.
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The Bare Bones
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Vibration Therapy:
Good, Good, Good, Good Vibrations
Like the Beach Boys, Dr. Clinton Rubin has been delivering good vibrations for years in his laboratory experiments. Dr. Rubin's research at the State University of New York (SUNY) at Stony Brook focuses on how vibration affects bone. He and his team have been responsible for the lion's share of research in this area. Prior to his research, vibration was most often viewed as harmful to bone and muscle, particularly for generating low back problems among those who were regularly exposed to vibration in the workplace. As a result of those concerns, international safety standards were established to define thresholds for human tolerance of vibration.
Dr. Rubin's laboratory experiments started with “buzzing” turkeys with low levels of vibration. A true buzz was created at an international bone meeting when he showed the effect of low-intensity, high-frequency vibration on bone. Adult female sheep were treated for twenty minutes a day with low-level mechanical vibration at high-frequency, 30 cycles per second, for one year. The treated sheep showed a marked increase of 30 percent in the density and volume of the leg bone (femur) in comparison to the untreated. That is a tremendous amount of bone formation.
Vibration therapy is being explored as a drug-free intervention for preventing bone loss and building bone. Similar to drug development, a low-intensity version of whole body vibration has been tested in animals and small groups of subjects with promising results. Now, larger studies in high-risk individuals are being done, and the exact mechanism of action of how vibration is causing these changes is being worked out.
A SUBSTITUTE FOR EXERCISE?
This low intensity mechanical vibration at high frequency of 30 cycles per second may offer the benefits of exercise (without having to exercise) plus other positive effects. It would be a welcome addition to the “medicine chest” for treatment of osteoporosis, particularly in older individuals with fragile skeletons. The additional benefits of building muscle mass and improving balance in this high-risk group, who are prone to muscle loss and falls with aging, are particularly attractive. The recent findings that these low magnitude signals direct the bone marrow stem cell population to make more osteoblasts, or bone-forming cells, instead of becoming fat cells, is equally exciting.
Mechanical signals are critical to achieving and retaining bone health. The benefit of exercise is achieved through this mechanism. The bone's adaptation to mechanical signals can be influenced by a very few higher magnitude strain events or by many thousands of low magnitude strain events. Low-magnitude vibration signals basically mimic muscle contraction similar to maintaining a standing posture. The low-intensity mechanical signals produced by the vibration platform can change the fate of stem cells to become bone-forming cells instead of fat cells. This process is similar to what happens with higher impact signals from weight-bearing exercises.
Dr. Rubin and his team elegantly showed the ability of low-intensity signals to increase bone formation and at the same time decrease fat formation in several animal experiments. In one experiment, the overall number of stem cells was increased by almost 50 percent and more became bone-forming cells than fat cells. The end result was better bones, less fat, and more stem cells.
In another theory of how vibration may increase bone formation, experiments in the absence of weight bearing suggest that shaking back and forth causes fluid changes that can be sensed by bone cells. Dr. Janet Rubin, a professor of medicine at the University of North Carolina at Chapel Hill, is helping to work out the precise mechanism of action. (It is a family affair for the Rubins—they are brother and sister.)
EFFECTIVENESS
Several small pilot studies evaluated whether the observations seen in animal studies would also occur in humans. In the first clinical trial, seventy post-menopausal women were randomly assigned to either a treatment group that used a vibration platform delivering low-level mechanical vibration at high frequency, 30 cycles per second, or a control group that used an inactive platform. Subjects in each group stood on their platform for ten minutes twice a day for twelve months. At the end of one year, the treatment group maintained bone mass while the control group lost bone. The greatest benefit was seen in women weighing 143 pounds or less. In contrast to those in the vibration-active group, who had essentially stable bone density, those in the control group experienced bone density losses that averaged about 3 percent at the spine and 2 percent at the neck region of the hip.
One study looked at vibration therapy as an intervention for twenty children with conditions that limit exercise, such as cerebral palsy. The children stood on platforms five days a week for ten minutes each day; half of them received the active vibration. After six months, the treatment group gained 6.3 percent on measurements of the shinbone and the placebo group lost 12 percent. An 18 percent difference in just a half a year is huge. Keep in mind that this study looked at only a handful of subjects.
A one-year trial of fifty young women, ages fifteen to twenty, with a history of a fracture and bone density lower than the average for their peers was also done. Subjects were randomized to an active or an inactive vibration platform. At the end of one year, spine bone density in the active group, measured by CT scan, increased almost 4 percent. The muscle next to the spine showed a 10 percent increase; and a small increase in abdominal fat was noted. In contrast, women in the control group failed to increase their bone density or muscle area and had an almost 6 percent increase in abdominal fat formation.
Although this may all sound too good to be true, we are anxiously awaiting the outcomes of the current randomized clinical trials that use these low intensity vibration platforms for treatment of frail older patients with osteoporosis. Because falls, muscle strength, and balance problems raise the fracture risk in seniors, this intervention would be a boon for this population. Anyone who is unable to exercise may benefit; the applications may be boundless. Based on the animal research, you may be able to jump-start stem cells to make osteoblasts instead of fat cells.
Positive results would open a whole new approach, especially for the high-risk older patient. The mantra “no pain, no gain” may be trumped by this approach. How vibration therapy might interface with individuals on medicines for osteoporosis is another area for further research. Be on the lookout for the results of the clinical trials and the FDA approval of this low intensity vibration platform, which looks like an oversized laptop computer and weighs seventeen pounds. Availability of this device is anticipated in late 2011.
Not All Vibration Platforms Are the Same
A word of caution about those whole-body vibration platforms in your fitness center; they are different from the ones used in Dr. Rubin's experiments. Do you need to hang on for dear life while you are on the vibration machine? All that shaking is probably too much force. The high intensity whole body machines were developed to give elite athletes an extra edge. For us mere mortals, more is not necessarily better.
Just like there is a “therapeutic window” for many medicines and nutritional supplements, research indicates that a “mechanical window” also exists. Too little or too much may cause harm rather than good. Those platforms developed for use by elite athletes should not be used by anyone with a fragile skeleton. If you have good bone density and do decide to use one, make sure to bend your knees.
The potential to use low-intensity vibration in place of strenuous exercise to improve bone quality and quantity is an exciting new horizon. In addition, the stimulation of signals to the bone marrow to produce more of the bone-forming cells that tend to decline with aging may truly be the “Fountain of Youth” for bone and muscles. We will know soon from results of well-designed clinical trials whether Dr. Rubin has found the sweet spot with his device that delivers low-intensity vibrations at high frequency. If so, this portable low-intensity vibration platform will be a surefire blockbuster.
If more research demonstrates that low-intensity vibration results in a remarkable decrease in production of abdominal fat in preference for making bone, we will all be making a beeline to get this device. And we will look forward to idly standing around for fifteen to twenty minutes a day while good vibrations do their thing.
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The Bare Bones
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Physical Measures: Integrating Movement
Picture daybreak in a city. Hundreds of people are moving yet it is eerily quiet. That was my experience on a trip to China in 1988, where millions and millions of people practice tai chi. Just after dawn, parks and street corners filled with men and women moving slowly and fluidly through a complete range of motion over their natural center of gravity. When I looked closer, I discovered that most of the participants were older and some were quite elderly. They all moved gracefully, floating from side to side. It was an amazing sight—I was transfixed—and I witnessed the same scenes, again and again, in the early morning light, in every city I visited.
Tai chi is just one of the meditative mind-body exercises growing in popularity in the US. Yoga, Pilates®, and Feldenkrais® are other common low impact forms of exercise that focus on the mind-body link. You will find that most fitness clubs provide classes or individual instruction in yoga or Pilates. However, you may need to search for a Feldenkrais practitioner in your area if you wish to learn that method, as there are currently only eight to ten thousand in the United States. Health departments often sponsor free tai chi classes, and local tai chi societies also offer introductory sessions.
TAI CHI
Tai chi has been practiced in China for more than a thousand years. Tai chi has its roots in martial arts, but it has developed into a practice of flowing meditative movements. Some styles of tai chi retain more of a martial arts focus with the sharp release of power. Slow and smooth movements that involve all the major muscle groups characterize this low-impact weight-bearing exercise. The sway of movement is centered with constant shifting of body weight, which improves leg and core strength as well as balance. The body's weight is transferred back and forth between the legs with both knees slightly bent at all times. I like to visualize the expressive names of the movements, like “white crane spreads wings” or “carry tiger to the mountain.”
Tai chi has been touted to have health benefits for just about every ailment. Tai chi is based on the same principles as acupuncture and herbal therapies—to balance the yin and yang and the flow of life force called qi or chi. For bone health, tai chi is helpful for balance, posture, muscle strength, and flexibility.Studies of tai chi's effects on bone density have been mixed. From the bone perspective, tai chi's real value is in fall prevention, which plays an important role in decreasing fracture risk.
Tai chi practiced in the controlled environment of trials has shown a positive impact on older people, including frail adults. The observed benefits included directly reducing the risk of falls and fear of falling and improving muscle strength, balance, and flexibility, as well as performance of usual activities of day-to-day life. The benefit lasts only so long as tai chi is being regularly performed.
YOGA
“Yoga” means something different to each of us, probably because the variations seem innumerable. Yoga is a systemic exercise that combines posture, breathing, and stretching to promote physical and mental well-being. Some types are very strenuous and difficult while others are gentler, with more of a focus on alignment and stretching. According to yoga master B. K. S. Iyengar, “Words cannot convey the value of yoga—it has to be experienced.” In his book, Light on Life, Iyengar writes, “Physical health is not a commodity to be bargained for. Nor can it be swallowed in the form of drugs and pills. It has to be earned through sweat. It is something that we must build up.”
As with any exercises or movement, if you have already had a spine fracture or are at high risk for one, you will need to adapt some of the exercises that involve flexion or bending forward, since that would increase forces on your spine. Therefore, the emphasis should be on maintaining a neutral spine position that is neither bent forward nor extended back.
PILATES
Pilates studios and classes at fitness centers have sprouted up like mushrooms everywhere. Joseph Pilates was a German rehabilitation specialist who developed the exercise in the 1920s. The Pilates regimen offers neuromuscular reeducation via exercises integrated with a yoga-like conscious breathing pattern. Pilates may be done as a series of floor-mat exercises or by working with specialized machines. There are many adapted regimens, as well. The emphasis on centering and breathing is akin to the concepts in yoga and tai chi.
The focus in Pilates is on contracting muscle for power and developing a strong core. Pilates is also valuable for improving balance. Maneuvers on the Pilates machines are designed to lengthen and stretch the spine. Initially, focus is on posture of the spine and learning to use core muscles during controlled breathing. After one learns to maintain control of the spine, exercises gradually progress to incorporate arm and leg movements while maintaining control of the spine. Mat classes are similar but are done without the resistance of the machines. There are certain positions in Pilates that should be avoided if you have osteoporosis of the spine or history of spine fractures. The best approach would be to work first with an individual instructor before joining any group class. Ask your instructor to help you modify exercises so that they are appropriate and can be done safely.
Pilates is a whole body exercise that emphasizes core strength and correct body mechanics via specific exercises. These may help with balance, muscle strength, and reducing fall risk. Pilates has not been studied systematically in formal research studies on bone health. Modified programs have been adapted for use in older women at risk for fracture.
FELDENKRAIS
Feldenkrais focuses more on the brain to orchestrate movement. You are taught to think about any movement before you make the actual physical motion. By practicing Feldenkrais you learn to visualize your movement and to make the changes necessary for improving action and alignment. You create a new pattern of movement.
The best way to explain this method is by telling the story of its inventor, Moshe Feldenkrais. He applied his knowledge as a physicist and Judo master to “fix” his own knee injury by reteaching himself how to walk. He focused on the links between his brain and the rest of his nervous system in an effort to “rewire” his muscle responses. Based on this work, which he extended to therapy on others, he formulated the method known by his name in the 1950s. Now practitioners are taught and certified by the Feldenkrais Guild.
The technique has two major forms, group classes or individual sessions. A series of guided exercises in a class with a Feldenkrais instructor is called “awareness through movement.” If you observe a class, you will see participants rolling from hip to hip with fluid movements. These and other simple movements that involve standing or sitting rewire the brain to direct correct movement.
The other approach, called “functional integration,” involves the Feldenkrais practitioner making a series of gentle manipulations with movement. The practitioner's role is to look at how you move and to teach your brain to make the muscles move in the right directions. I call this “bodywork.” You lie fully clothed on a massage-like table for about an hour while the practitioner moves you. This works on breaking habitual patterns of movement that may be the cause of problems like neck or back pain.
Anyone who has limitations as a result of fractures, illness, or just plain bad habits may benefit. Several small studies with guided exercises over short periods of time showed improvement in balance and mobility and decreased fear of falling. Keeping your body more finely tuned will help with muscle strength, balance, vitality, and decreasing risk of falling.
WANT TO BEGIN ONE OF THESE
PROGRAMS BUT YOU'RE NOT SURE HOW?
Most of the people who practice one form or another of these techniques usually become strong advocates for their method of choice. However, at present there is not much science available on these mind-body physical measures in the area of bone health. Any activity that helps you improve strength, balance and coordination, posture, mental outlook, and overall vitality makes sense. It will complement and enhance your other efforts.
Participating in any form of these physical measures or exercises is always a good idea; doing so may be your road to longevity. If you are interested, check out the opportunities available in your community and take an introductory class.
I have tried all four of these methods. As a geriatrician, I was so fascinated with the vitality of the older Chinese who practice tai chi that I took up the practice of tai chi myself and continued for a couple of years after I returned from my trip to China. Now that I have reminded myself of its benefits, it is time to restart! The other techniques were recommended to me for relief of back pain. I am most familiar with Feldenkrais. A wonderful and insightful Feldenkrais practitioner treated me for years, but unfortunately she moved away. I was unable to replace her experience and expert eye with another practitioner.
Finding the right person with the right touch is a challenge, just like finding an expert in anything. The fit many times depends on the individual instructor, so it might take a bit of trial and error. Whatever your fitness level and interest, you will be able to find a class or instructor to fit your level and needs. If you have osteoporosis or previous spine fractures, some programs will need to be modified. There are positions in Pilates and yoga, particularly forward bending with a rounded back, which should be avoided.
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The Bare Bones Physical measure that utilize the mind-body link complement other therapies and are beneficial for:
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