Tag Archives: natural medications

Maqui berry is the latest trendy super food

Maqui berry (pronounced “mah-kee”) is one of the hottest new berries being marketed for “weight loss,” “detoxification,” and for “general health.” But, does it work? Or not? Continue reading

Isoflavones reduce postmenopausal insomnia, hot flashes

In a past blog, Natural Medications (Herbs, Vitamins, and Supplements) for Menopausal Symptoms, I discussed the data supporting a trial of isoflavones in women with menopausal symptoms. However, there was not a lot of data. Now, Medscape is reporting, “Isoflavones may reduce insomnia symptoms” in postmenopausal women, according to a small study in the journal Menopause. Continue reading

FDA advises against purchasing drinks sold as supplements for sexual enhancement

It seems that there are new warnings almost weekly from the FDA regarding potential dangers of certain over-the-counter natural medications (herbs, vitamins, or supplements). The reason is that these substances are virtually unregulated here in the United States and unscrupulous manufacturers constantly take advantage of this to make money at your expense. Continue reading

Less Than 25% of Valerian Herbal Sleep Supplements Pass Tests For Quality

Long-time readers of this blog know of my admiration for ConsumerLab.com, a leading provider of consumer information and independent evaluations of natural medications (herbs, vitamins and supplements). In fact, I use their findings almost daily in my practice to recommend natural medications to my patients.

In its most recent evaluation of a natural medication, valerian, ConsumerLab found that MOST of the valerian herbal supplements tested contained less of the herb than expected and/or were contaminated with lead.

Valerian is a popular herbal sleep aid used by approximately 6% of the U.S. population. Valerian accounted for $68 million in sales in the U.S. in 2009, up 10% from the prior year, according to Nutrition Business Journal.

Among nine leading and best-selling products selected by ConsumerLab.com for review, only TWO passed testing.

Of the seven that failed, one contained no detectable key valerian compounds and four others had only 26.7% to 82.5% of amounts expected from ingredient listings.

One of these products was found to be contaminated with lead, as were two other products. These results were confirmed in independent laboratories. Lead is a heavy metal that can impair mental functioning and may affect blood pressure. The amounts of lead found in the products (which ranged up to 3.5 mcg of lead per daily serving) are not likely to cause toxicity alone, but it is best to avoid unnecessary lead exposure.

Lead contamination was found to be an issue in products consisting primarily of valerian root powder as opposed to valerian root extract. The extraction process removes heavy metals.

“Valerian may help some people with sleep problems, although the evidence is mixed,” said Tod Cooperman, M.D., President of ConsumerLab.com. “Unfortunately, it appears that many people may not be giving valerian a fair try because the brand they buy lacks the expected ingredient. And some brands unnecessarily increase one’s exposure to lead.”

ConsumerLab.com found similar problems in earlier reviews of valerian supplements in 2001, 2004, and 2006. Dr. Cooperman added, “If you use valerian, it would seem prudent to choose a product that passed ConsumerLab.com’s testing.”

The complete report is available here. The report includes results for ten products. ConsumerLab.com selected nine. One other product was tested at the request of its manufacturer through CL’s Voluntary Certification Program and is included for having passed testing.

Brands included are:

  • A. Vogel (Bioforce),
  • Bluebonnet,
  • CVS,
  • Douglas Laboratories,
  • Genestra (Seroyal),
  • Mason,
  • Nature’s Answer,
  • Shaklee,
  • Solaray, and
  • Solgar.

Another of my favorite Internet-based sites for information on natural medications, the Natural Medicines Comprehensive Database, rates valerian as POSSIBLY EFFECTIVE for insomnia. The Database says:

Most research shows that taking valerian orally reduces the time to sleep onset (sleep latency), and improves subjective sleep quality. The greatest benefit is usually seen in patients using 400-900 mg valerian extract up to 2 hours before bedtime.

Valerian does not relieve insomnia as fast as benzodiazepines. Continuous nightly use for several days to four weeks might be needed for significant effect.

Some research suggests that valerian is not as effective as temazepam (Restoril) or diphenhydramine (Benadryl) for causing sedation in elderly people.

Valerian is often used in combination with other sedative herbs. Taking a combination product containing valerian extract 187 mg plus hops extract 41.9 mg per tablet, two tablets at bedtime, seems to modestly improve subjective sleep measures including subjective sleep latency compared to placebo after 28 days of treatment; however it was not significantly better than placebo after only 14 days of treatment (15018). A combination of valerian with lemon balm might also improve the quality and quantity of sleep in healthy people.

Valerian also seems to improve the sleep quality of insomniacs who have recently withdrawn from benzodiazepines. After tapering the benzodiazepine over two weeks, 300 mg valerian extract in three divided daily doses might subjectively improve sleep quality.

There is also preliminary clinical research that suggests valerian also might help improve sleep in intellectually impaired children.

Not all evidence is positive. Some evidence suggests that valerian does not significantly improve insomnia compared to placebo.

Valerian does not relieve insomnia as fast as benzodiazepines (6480). Continuous nightly use for several days to four weeks might be needed for significant effect (6249,10209).
Some research suggests that valerian is not as effective as temazepam (Restoril) or diphenhydramine (Benadryl) for causing sedation in elderly people (10424).
Valerian is often used in combination with other sedative herbs. Taking a combination product containing valerian extract 187 mg plus hops extract 41.9 mg per tablet, two tablets at bedtime, seems to modestly improve subjective sleep measures including subjective sleep latency compared to placebo after 28 days of treatment; however it was not significantly better than placebo after only 14 days of treatment (15018). A combination of valerian with lemon balm might also improve the quality and quantity of sleep in healthy people (10423).
Valerian also seems to improve the sleep quality of insomniacs who have recently withdrawn from benzodiazepines. After tapering the benzodiazepine over two weeks, 300 mg valerian extract in three divided daily doses might subjectively improve sleep quality (8006).
There is also preliminary clinical research that suggests valerian also might help improve sleep in intellectually impaired children (10207).
Not all evidence is positive. Some evidence suggests that valerian does not significantly improve insomnia compared to placebo (15046).

The Natural Medicines Database also rates valerian as POSSIBLY SAFE “when used orally and appropriately, short-term. Clinical studies have reported safe use of valerian for medicinal purposes in over 12,000 patients in trials lasting up to 28 day.” However, “the safety of long-term use is unknown.”

So, for my patients with occasional insomnia, I simply print off the ConsumerLab.com list of valerian products that have passed quality testing and say, “Buy the least expensive one and don’t use it more than a month at a time.”

The three products on the current “approved” list include:

  • Bluebonnet Herbals Valerian Extract (1 vegetable capsule, 1 per day)
  • Shaklee® Gentle Sleep Complex (3 tablets, 3 per day)
  • Solgar® Standardized Valerian Root Extract (1 vegetable capsule, up to 3 per day)

Problems Persist With Ginseng Supplements

Long-time readers know of my fondness for ConsumerLab.com. Their independent testing of natural medications (herbs, vitamins, and supplements) guides my teaching and my prescribing. Now, a review by ConsumerLab.com finds 45% of ginseng products don’t provide the full amount of the ingredient indicated on the label, or worse, are contaminated.

ConsumerLab.com is now reporting that five out of eleven of the most popular ginseng supplements in the U.S. were selected for testing and contained less ginseng than expected from their labels or were contaminated with lead and/or pesticides.

Problems with the quality of ginseng supplements have been reported by ConsumerLab.com since 2000. Ginseng is a popular herb with U.S. sales last year of $83 million according to Nutrition Business Journal.

“Consumers need to be wary of the quality of ginseng supplements” said Tod Cooperman, MD, President of ConsumerLab.com.

“People should also recognize that there is enormous variation in the amount of ginsenosides — key ginseng compounds — in marketed supplements. We found most products to provide approximately 10 to 40 mg of ginsenosides per day, but some yielded much higher amounts, including one that delivered a whopping 304 mg.  We are not aware of human studies with the higher amounts. The effects might certainly differ from one product to another.”

Ginseng has often been promoted for increasing vitality. While there is not much clinical evidence to support an energy boosting effect, studies indicate that that certain preparations may help prevent colds and flus or keep blood sugar levels down in people with diabetes. A range of other uses have been suggested but lack strong evidence.

The new Product Review of Ginseng Supplements provides test results for fifteen supplements – eleven selected by ConsumerLab.com and four tested at the request of their manufacturers/distributors that passed the same testing through CL’s Voluntary Certification Program.

Also listed are two products similar to one that passed testing but sold under different brand names.

Brands included are Action Labs, Bluebonnet, Good Neighbor Pharmacy, Imperial (GINCO), Nature Made, Nature’s Bounty, Nature’s Plus, NSI (Vitacost), Pharmanex, Puritan’s Pride, Solgar, Spring Valley (Walmart), TruNature, Vitamin Shoppe, Vitamin World, and Whole Foods.

ConsumerLab.com is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. The company is privately held and based in Westchester, New York.

Of importance, it has no ownership from, or interest in, companies that manufacture, distribute, or sell consumer products.

My Recommendations for Glucosamine, Chondroitin, and SAMe for Osteoarthritis

Several readers have requested that I post the advice that I both use in practice and teach other healthcare professionals when it comes to a topic on which I frequently teach, Natural Medications for Osteoarthritis: An evidence-based evaluation.

This year I’ve given this talk in several hospitals and to state and national gatherings of physicians and PAs. Let’s start with the take home recommendations:

The Bottom Line

Take Home Point #1

All patients with osteoarthritis should take part in an active exercise regimen and reduce weight (if overweight or obese). I also recommend they begin a diet high in fruits, vegetables, and low in unsaturated fats. Antioxidants in pill form probably won’t help. Instead, I advise patients to boost consumption of vegetables and fruits that provide lots of vitamin C, vitamin E, and beta-carotene as high dietary intake of foods that contain these antioxidants might slow progression of osteoarthritis and have other benefits.

Take Home Point #2

I recommend starting with a a dose of glucosamine sulfate, 1500 mg once daily; however if this dose is not tolerated, I suggest switching to 500 mg three times daily with food. I do NOT recommend glucosamine hydrochloride (glucosamine HCL) or N-acetyl glucosamine (NAG). The evidence generally supports using glucosamine SULFATE for pain and possibly slowing disease progression. But, keep in mind that glucosamine has primarily been studied for osteoarthritis of the knee.

It might not be as effective in other joints.

Take Home Point #3

You need to give the glucosamine 4-8 weeks to see if it will help or not. If not effective, or only partially effective, then change to DONA Glucosamine Sulfate or Xicil Glucosamine Sulphate (both by Rotta Pharmaceuticals). According to the Natural Medicine Comprehensive Database, “This product has been studied in clinical research. Based on this research, this product’s Effectiveness Rating is: LIKELY EFFECTIVE for osteoarthritis. You can find DONA here. (BTW, I have no financial or other ties to sites like this that I recommend to you.)

Take Home Point #4

Chondroitin sulfate appears to be effective for osteoarthritis when combined with conventional treatments (either glucosamine sulfate or glcosamine HCL – using ConsumerLab.com approved combination products such as Cosamine-DS, Spring Valley, Member’s Mark, or Elations Healthier Joints); however, there is more and better evidence for glucosamine SULFATE – and a significant cost differential. I recommend these combinations only for patients who have not responded to 8 weeks of the DONA glucosamine sulfate.

Take Home Point #5

Combination products of glucosamine plus chondroitin or glucosamine plus MSM or glucosamine plus chondroitin plus MSM are probably effective, but there is no reliable evidence that the combination is better than treatment with just glucosamine SULFATE alone.

Take Home Point #6

Based on research to date, SAMe sounds like a great alternative. But two things keep SAMe from moving into primetime: (1) poor product quality and (2) high cost.

Take Home Point #7

Other products look promising … cat’s claw, devil’s claw, stinging nettle. However, since these products work through the same antiinflam-matory mechanisms as current NSAIDs, they may not prove to offer any advantage. It’s way too soon to recommend them.

Products such as avocado-soybean unsaponifiables and cetylated fatty acids also look interesting and appear to hold some promise for improving symptoms. But, I think it’s still a bit premature to recommend them. I’ll be watching closely for more solid evidence.

Now, here are some of the details that I share with healthcare professionals. Thanks to the Natural Medicines Comprehensive Database and ConsumerLab.com for their websites which provide great information for me to share.

Abstract

This presentation will discuss an evidence-based evaluation supporting or refuting the use of a variety of natural medications (herbs, vitamins, and supplements) for joint symptoms, joint health, and bone health. In addition, we’ll review clinically useful and evidence-based sources of information for natural medications, as well as how to find and recommend quality substances.

Learning Objectives

After this discussion, attendees should be able to:

  1. Describe the natural medications used for osteoarthritis symptoms,
  2. Describe an evidence-based, trustworthy source of information for natural medications,
  3. Describe a independent quality testing lab of natural medications that can be used to recommend safe products, and
  4. Describe the evidence supporting or refuting the use of several natural medications for arthritis.

Osteoarthritis

Osteoarthritis can be very frustrating for patients because it can significantly interfere with an active lifestyle. Treatment choices are limited in range of options and in effectiveness. Ideally, non-drug therapies should be implemented first, when disease severity is mild.

These therapies can include:

  • exercise and weight loss,
  • dietary changes, and
  • physical therapy, braces, wraps/rubs, and other orthopedic devices.

Drug therapy should be considered for patients with moderate to severe symptoms or multi-joint disease.

Commonly Used Medicines for Osteoarthritis

Conventional Medicines

  • Acetaminophen (Tylenol)
  • Non-steroidal Anti-inflammatory Drugs (NSAIDs) — prescription and OTC (such as ibuprofen [Advil] or naproxen [Aleve])
  • Prescription COX-2 Inhibitors such as celecoxib (Celebrex)

Despite treatment with these agents, most patients often only achieve partial pain relief. And these approaches do nothing to slow down the disease process.

Some patients also worry about potential side effects related to taking these drugs, particularly after all the press generated by the COX-2 inhibitors and cardiovascular disease risk.

As a result, many patients turn to natural medicines with the hope of finding something that might:

  • relieve their pain,
  • be safe, and
  • help slow down the disease process.
  • In short … improve their condition.

As such, osteoarthritis is the most common condition for which patients turn to alternative medicines.

Commonly Used Natural Medicines for Osteoarthritis

  • Capsicum
  • Capsicum species
  • Cat’s claw
  • Uncaria guianensis
  • Devil’s claw
  • Harpagophytum procumbens
  • Ginger
  • Zingiber officinale
  • Indian frankincense
  • Boswellia serrata

Commonly Used Structure Modifying Agents for Osteoarthritis

  • Chondroitin sulfate
  • Glucosamine hydrochloride
  • Glucosamine sulfate
  • N-acetyl glucosamine

Commonly Used Natural Medicines containing Antioxidants for Osteoarthritis

  • Beta-carotene (supplements/foods)
  • Superoxide dismutase (SOD)
  • Vitamin C (supplements or foods)
  • Vitamin E (supplements or foods)

Commonly Used Miscellaneous Natural Medicines for Osteoarthritis

  • Avocado (Persea americana)
  • Cetylated fatty acids
  • Methylsulfonylmethane (MSM)
  • S-adenosylmethionine (SAMe)
  • Soybean oil (Glycine max)

Balancing Safety and Effectiveness — My Recommendations for Various Products

Recommend Against — Possibly Ineffective, even though likely safe

  • Vitamin E

Recommend Against — Insufficient Evidence of Safety or Effectiveness

  • N-acetyl glucosamine
  • Phellodendron

Don’t Recommend — Likely or possibly safe, but in-sufficient evidence of effectiveness

  • Ginger
  • Indian frankincense
  • Limbrel
  • MSM
  • Stinging nettle
  • Turmeric
  • Willow bark

Don’t Recommend — Possibly Safe and Possibly Effective

  • Avocado (with soybean oil)
  • Cetylated fatty acids
  • Beta-carotene containing foods
  • Cat’s claw
  • Devil’s claw
  • Glucosamine hydrochloride
  • SOD (injectable)

Caution — Likely Safe and Possibly Effective

  • Chondroitin sulfate
  • Vitamin C  containing foods

Recommend — Effective and likely safe

  • Capsicum (topical)
  • Glucosamine sulfate
  • SAMe

Now, for more details on these products.

Capsicum (topical)

Capsicum peppers contain the constituent “capsaicin.” It’s this compound that makes the peppers fiery hot. Capsaicin is approved by FDA and Health Canada as an OTC drug. Capsaicin is the active ingredient in Zostrix and other OTC products used topically for pain. Topical capsaicin is effective for temporary symptom relief of pain related to osteoarthritis

Repeated use of capsaicin works as a counterirritant, depleting and inhibiting the reaccumulation of substance P (associated with the process of pain transmission in OA) in sensory nerves.

Practice Pearl: I tell patients to allow at least 3 days of multiple daily capsaicin applications to achieve significant pain relief.

Glucosamine sulfate

An optimal treatment for osteoarthritis would be one that modifies the joint structure and returns the joint to its normal, healthy state. So far, medicine has not been able to produce such a therapy. Some researchers think glucosamine might be a candidate.

There’s a lot of hype generated about supplements. In the case of glucosamine, some of it is deserved. But the research has been conflicting and confusing. Over 20 clinical studies lasting up to 3 years and enrolling over 2500 patients have been conducted, evaluating glucosamine for OA. The vast majority of these studies evaluated glucosamine SULFATE for osteoarthritis of the KNEE.

Overall, when the findings of these studies are pooled, glucosamine appears to reduce pain scores by 28% to 41%, and to improve functionality scores by 21% to 46%.

Also, for pain relief, GS 1500 mg qd appears to be comparable to

  • … ibuprofen 1200 mg daily.
  • … piroxicam (Feldene) 20 mg daily …
  • … acetaminophen 1000 mg three times daily.

The effects of GS appear to last longer than these analgesics, but the analgesics work much faster. NSAIDs relieve symptoms within 2 weeks. GS takes 4-8 weeks.

Researchers have speculated for years that GS could potentially modify joint structure and possibly reverse or slow disease progression.

  • In 2001, a study published in Lancet showed that GS might have this effect. Researchers measured joint space narrowing in patients taking glucosamine sulfate. After 3 years of treatment, these patients did not have further joint space narrowing, suggesting that GS might have slowed or stopped disease progression.
  • In 2002, a similar 3-year study published in the  Archives of Internal Medicine showed that patients taking GS did not have increased narrowing of the joint space, again suggesting that GS slows disease progression.
  • A meta-analysis of study results suggests that patients taking glucosamine sulfate 1500 mg/day have 54% reduced risk of osteoarthritis disease progression.
  • A retrospective analysis of patients who took glucosamine sulfate for 1-3 years also showed that glucosamine sulfate is associated with a 57% decreased risk of total knee replacement.

Although most of the research has been positive, especially related to glucosamine sulfate, some research findings have been negative. The reason for the discrepancies is not completely known; however, some experts suspect that different methodologies for assessing improvement, different product formulations, and perhaps different patients have contributed.

The vast majority of glucosamine sulfate research with positive outcomes has been done using a specific brand of glucosamine sulfate called Dona (Rotta Pharmaceuticals, Italy), which costs about $1 per day.

In fact, according to one analysis, when findings from studies using the Dona formulation are pooled, GS appears to be effective; however, when findings using other formulations are pooled, GS appears to be ineffective.

Practice Pearls:

  • Glucosamine does not have a significant effect on insulin sensitivity and does not seem to increase A1C in type 2 diabetes.
  • Glucosamine is derived from the exoskeletons of shrimp, lobster, and crabs, so there is concern that glucosamine products might cause allergic reactions in people who are sensitive to shellfish.
  • There are no documented reports of allergic reaction to glucosamine in shellfish allergic patients.
  • There is also some evidence that patients with shellfish allergy can safely take glucosamine products.

Chondroitin Sulfate

Like glucosamine, chondroitin appears to serve as a substrate for the formation of the joint matrix structure. Chondroitin sulfate alone seems to be effective for improving symptoms of OA when used in conjunction with analgesics.

Trials evaluating a specific blend of glucosamine hydrochloride plus chondroitin sulfate (CosaminDS, Nutramax) have also been positive.

Preliminary evidence also suggests that chondroitin might slow joint space narrowing. However, a 2006 study in the New England Journal of Medicine (GAIT) found that glucosamine HCL or chondroitin or the combination of both was ineffective for relieving symptoms of osteoarthritis.

In a subgroup of patients with more severe osteoarthritis, the combination provided modest relief, while the single agents did not. Some have interpreted this study to suggest that the COMBINATION of glucosamine hydrochloride plus chondroitin could be used for more severe osteoarthritis.

SAMe

You’ve probably been asked about SAMe (s-adenosylmethionine). It’s most often considered a natural medication for depression. But it is also commonly used for joint pain and osteoarthritis.

SAMe is significantly more effective than placebo, and as effective as NSAIDs, including the COX-2 inhibitor celecoxib (Celebrex), for improving symptoms of OA.

Based on research to date, SAMe sounds like a great alternative. But two things keep SAMe from moving into primetime:

  • poor product quality and
  • high cost.

Tests on SAMe products show that many contain little or none of the active ingredient. Furthermore, patients taking the typical dose (200 mg tid) would have to pay up to $120 per month.

For patients who try SAMe, the butanedisulfonate salt has the highest bioavailability (5%) and is more stable than the tosylate salt which only has 1% bioavailability and there are concerns about stability.

Practice Pearl: SAMe has serotonergic effects. Advise caution in patients with bipolar disorder … it can cause them to convert from depression to manic state. Also, combining SAMe with other serotonergic agents such as antidepressants might lead to symptoms of serotonin syndrome.

How do you find clinically useful, evidence-based, and trustworthy information on natural medications? How do you find safe natural medications to recommend? Especially since natural medications are NOT regulated in the United States

So, how do you find product:

  • that actually contains what the label claims?
  • that is bioavailable?
  • that is NOT contaminated?

ConsumerLab.com Findings:

  • Although prior testing has shown the vast majority of glucosamine products to meet label claims, glucosamine from shellfish such as shrimp and crabs may potentially be contaminated with lead. Among the 21 glucosamine supplements ConsumerLab.com selected and tested, only 16 (64%) met quality standards and FDA labeling requirements. In other words, 36% FAILED testing.
  • Chondroitin is an ingredient with which ConsumerLab.com has found problems in the past — with products not always providing the amount claimed of this expensive ingredient.
  • Among the 19 products claiming to contain MSM, glucosamine, and/or chondroitin, 5 (26%) FAILED testing.
  • Failed for providing less ingredient than labeled, lead contamination, failure to properly break apart, or other mislabeling.
  • All eight of the SAMe supplements that CL selected for testing passed the evaluation. This is considerably better than results in 2003, in which one product was found with only 30% of its listed amount, and in 2000, when nearly half of the products were short on SAMe.

Conclusion

  • There are limited options for patients with osteoarthritis.
  • Many experts, including myself, now consider glucosamine SULFATE a first-line treatment. Others remain skeptical.
  • Nonetheless, the evidence generally supports using glucosamine SULFATE for pain and possibly slowing disease progression.
  • Don’t recommend glucosamine HYDROCHLORIDE or NAG.
  • Keep in mind that glucosamine has primarily been studied for osteoarthritis of the knee. It might not be as effective in other joints.
  • SAMe and perhaps chondroitin also seem to be effective. However, due to product quality control problems and high costs, they may not be as practical an option for most patients.
  • Other products look promising … cat’s claw, devil’s claw, stinging nettle. However, since these products work through the same antiinflam-matory mechanisms as current NSAIDs, they may not prove to offer any advantage. It’s way too soon to recommend them.
  • Products such as avocado-soybean unsaponifiables and cetylated fatty acids also look interesting and appear to hold some promise for improving symptoms. But, it’s still a bit premature to recommend these. I’ll be watching closely for more solid evidence.
  • Antioxidants in pill form probably won’t help. Instead, I advise patients to boost consumption of vegetables and fruits that provide lots of vitamin C, vitamin E, and beta-carotene. High dietary intake of foods that contain these antioxidants might slow progression of osteoarthritis and have other benefits.

Bibliography

Dietary supplements found to contain prescription drugs (once again)

Instant Access to All Product Review Reports Covering Latest Test Results for Over 900 Products
Quality Ratings and Product Comparisons by Brand
Expert Tips on Using Supplements
Price Checks on Popular Brands
Encyclopedia of Natural Products
e-Newsletter with Updates and Alerts
New and Archived Recalls and Warnings

As I’ve told you in many past blogs, U.S. law prevents the regulation of natural medications (herbs, vitamins, and supplements). Such regulations could protect consumers from purchasing product with all types of contamination. You can read more about this in my book, Alternative Medicine: the options, the claims, the evidence, how to choose wisely. Anyway, it’s past time for this sort of regulation to be enacted. Here’s another example why:

The Los Angeles Times “Booster Shots” blog reported, “Here are two recalls that might not have consumers rushing to get their money back.”

The FDA “announced in July that a lab analysis of Joyful Slim Herb Supplement was found to contain desmethyl sibutramine. Most people know sibutramine as Meridia, a prescription weight-loss drug.”

In another case, the FDA “announced that some batches of Good Health’s Vialipro had been found to contain sulfoaildenafil, a cousin of sildenafil. Most people know that drug as Viagra.”

The additions “might be one way to counter criticism that many supplements are ineffective. Nonetheless, the FDA is far from pleased.”

And, we as consumers should be displeased also.

So, since these products are unregulated in the U.S., what can we as healthcare consumers do to protect ourselves if we choose to take a natural medication (herb, vitamin, or supplement)? Here’s what I recommend to my patients, check first with ConsumerLab.com to see if they’ve tested the class of natural medication you’re considering.

If so, you can then find approved brands that this independent quality testing lab has found are (1) to contain in the bottle what the label says is there, (2) to contain in the bottle what should be there (the right substance in the right amount from lot to lot and bottle to bottle, (3) to NOT contain contaminants, (4) and to be absorbable in your body.

They charge about $12 per review (for 30 days access) or about $30 for a one-year subscription ($50 for a two-year subscription) … but, given the cost of natural medications, I think it’s worth every penny to find natural medicines that are safe.

By the way, here’s what you get with a subscription:

  • Access to All Product Review Reports Covering Latest Test Results for Over 900 Products
  • Quality Ratings and Product Comparisons by Brand
  • Expert Tips on Using Supplements
  • Price Checks on Popular Brands
  • Encyclopedia of Natural Products
  • e-Newsletter with Updates and Alerts
  • New and Archived Recalls and Warnings

Also, you should know I have NO relationship or financial ties with ConsumerLab. They’re just a great source of information for me and my patients.

Parents cautioned about giving children dietary supplements

On the front of its Personal Journal section, the Wall Street Journal reports that increasingly, Americans are giving their children dietary supplements. However, groups such as the American Academy of Pediatrics and the American Dietetic Association, caution that food is the best source of nutrition.

In addition, many supplements, if taken in excess, can prove dangerous.

Nevertheless, physicians concede that children who are picky eaters may need certain supplements, although experts urge parents to be wary of nutrition claims, particularly since the FDA does not regulate supplements to the same extent that it does drugs.

I have much more information about natural medicines (herbs, vitamins, and supplements), in general, and giving natural medicines to children, in particular, in my best-selling book, Alternative Medicine: the options, the claims, the evidence, how to choose wisely.

  • You can order a signed copy of the book here.
  • You can read the Table of Contents here.
  • You can read the First Chapter here.

A hot product on the Internet, but should you consider L-methylfolate instead of plain old folic acid?

My favorite natural medicines website is the Natural Medicines Comprehensive Database. The NMCD has new information about L-methylfolate which is being heavily promoted, especially on the Internet, by some manufacturers as a more active form of folic acid. Are they telling the truth? Here’s the information from NMCD:

L-methylfolate is in many prenatal vitamins such as Optinate, Neevo DHA, Prenate Elite; and regular vitamin supplements including Optimized Folate, MegaFolinic, and others. It’s also being used in medical foods for memory loss or depression, in products such as CerefolinNAC and Deplin.

According to the NMCD, “folates” are a mixture of different forms of the vitamin that occur naturally in food. Most supplements contain folic acid, a synthetic form of the vitamin. In the body, all of these forms are converted to L-methylfolate before entering the bloodstream and being stored by the body.”

The Database reports, “It is true that L-methylfolate is slightly better absorbed than folic acid. You’ll hear claims that L-methylfolate is a better alternative than folic acid because many patients have reduced activity of an enzyme that metabolizes folic acid to L-methylfolate. “

However, “so far there’s no proof that this makes a clinical difference.”

For example, studies show that equivalent doses of folic acid and L-methylfolate raise folate levels in pregnant women equally well.

Also, there is also no proof that L-methylfolate is any better than folic acid for preventing neural tube defects.

The NMCD tells us physicians, “Explain to patients that L-methylfolate is just as safe as folic acid for supplementation, but there is no reliable evidence that it’s more efficacious.”

Also, keep in mind that doses in some products are very high. Deplin contains 7500 mcg and CerefolinNAC contains 5600 mcg. These amounts are much higher than the 1000 mcg/day that has been linked to a higher cancer risk in some patients.

The NMCD webstite cautions, “Clinical research shows that taking folic acid daily in doses of 800-1200 mcg for 3-10 years significantly increases the risk of developing cancer and adverse cardiovascular effects compared to placebo.” This has been reported in studies in 2004 and 2006 studies in the New England Journal of Medicine, a 2009 study in the Journal of the National Cancer Institute, and a 2009 study in the Journal of the American Medical Association.

Also, according to the NMCD, researchers have recommended that “Doses above 1000 mcg per day should be avoided if possible to prevent precipitation or exacerbation of neuropathy related to vitamin B12 deficiency. However, there is some evidence that doses of 5 mg per day orally for up to 4 months can be used safely if vitamin B12 levels are routinely measured.

So, the bottom line, from my perspective, is that it’s likely safer and as or more effective to just use old time folic acid.

Stricter government oversight of dietary supplements may be moving closer – thank goodness

Whenever I give talks on natural medications (herbs, vitamins, and supplements), whether to healthcare professionals or laypersons, people seem shocked to learn that these substances are virtually unregulated in the United States. I’ve written about the many problems this causes healthcare professionals and consumers in my book, Alternative Medicine: The options, the claims, the evidence, how to choose wisely. So, I was very happy to read an AP article reporting “Stricter government oversight of dietary supplements is moving closer, thanks to an agreement among senators to include guidelines in” the Dietary Supplement Safety Act.

The report says that in a letter sent to Sen. Tom Harkin (D-IA), chairman of the Senate Health, Education, Labor and Pensions Committee, Sens. John McCain (R-AZ) and Byron Dorgan (D-ND) outlined “four key areas of ‘common ground,'” two of which include “requiring all dietary supplement manufacturing, processing, and holding facilities to register with the Secretary of Health and Human Services,” and “giving the Food and Drug Administration authority to issue a mandatory recall order if a dietary supplement is adulterated or misbranded.”

I hope they are successful. If so, it will go a long way toward protecting consumers from the deceptive practices and advertising used by some manufacturers or natural medications.

Herbal remedies need real regulation

In my best-selling book, Alternative Medicine: The Christian Handbook, I explain the reasons that natural medications (herbs, vitamins, and supplements) received so little regulation in the United States, and the many problems this causes for health consumers.

Now, David Frum, a resident fellow at the American Enterprise Institute, the author of six books, including “Comeback: Conservatism That Can Win Again,” and the editor of frumforum.com, has weighed in with a thoughtful article on CNN:

Did you know that there exists an all-natural remedy for memory loss? Weight gain? Macular degeneration? Prostate enlargement? These products are so successful that clinical testing has already begun! Just listen to the following testimonial from an unidentified person …

As these ads blare at you from your favorite AM radio station, perhaps you wonder: How can this be legal? Since the late 1960s, aspirin makers have been trying to win the right to tell the public that a daily low-dose tablet can help prevent heart disease. They have been told no, and no, and no again.

Federal regulators are so nervous about over-selling aspirin’s benefits that they have restricted statements about aspirin to the most bland and basic. Yet while the statements about aspirin have to be cushioned in the vaguest generalities, snake oil flim-flam can be huckstered in the most truth-defying way, thanks to a 1994 law coaxed through Congress by the people who make these drugs.

The law bears the long title of the Dietary Supplement Health and Education Act of 1994. It was sponsored in House of Representatives by Rep. Dan Burton, R-Indiana, and in the Senate by Orrin Hatch, R-Utah, and Dick Durbin, D-Illinois.

The DSHEA law draws a line between synthesized medicines like aspirin and remedies made from herbs, minerals, vitamins and amino acids. This latter group was recategorized as “dietary supplements” — that is, as foods rather than drugs.

“Drugs” are subjected to exacting scientific trial to prove them both safe and also effective. Sellers of dietary supplements are not required to prove that their remedies work. They are not even required to prove them safe — as “foods” they are presumed safe unless shown otherwise. “Drugs” must disclose any risk of side effect. (That’s why those erectile dysfunction ads terrify TV audiences with their references to four-hour erections.)

Dietary supplements bear no such burden — which is why St. John’s wort can be sold as an anti-depressant, without any mention of the disturbing indications that the herb weakens the effectiveness of birth control pills.

“Drug” advertising must be pre-approved by the Food and Drug Administration, which minutely reviews the ads’ accuracy. Dietary supplement advertising is regulated by the Federal Trade Commission.

So long as supplements avoid promises to cure a specific disease, their sellers can say pretty much whatever they want, provided only that they have some kind of supporting evidence on file.

That evidence does not have to meet any kind of scientific test: pretty much any pattern of ink on paper will do the job. I cannot say, “My rosemary-sage-thyme-and-oregano tablets cure AIDS.” But if I pay my cousin $100 to do a few experiments, I can claim, “My tablets boost the immune system — and clinical trials are under way!”

(There is an exception to the permissive rules about advertising natural products: wine. There is substantial evidence that a glass of red wine a day reduces the risk of heart attack. The laws of most states forbid any hint or suggestion that moderate alcohol use might confer health benefits. Still, if you ask the scientists, wine has better grounds to call itself a health food than does, say, echinacea!)

Fifteen years after receiving the favor of Congress, dietary supplements have grown into a $24 billion a year industry. Most of the products sold by the industry are merely useless.

For those who eat a balanced diet, scientists have found no quantifiable benefit from taking multivitamins. On the other hand, multivitamins probably won’t do any harm. It would be better to give the $10 you spend on a jar of pills to the Salvation Army, but at least you are not poisoning yourself.

The same could not be said, alas, for the unfortunate customers of a Belgian herbal dispensary who bought a supplement that contained the herb Aristolochia fangi. The A. fangi herb is rich in aristolochic acid, a carcinogen — and users experienced an outbreak of urinary tract cancers. A. Fangi has since been banned in the European Union. It remains legal in the United States.

As outrages go, Congress’ special favor to the herbal supplement industry might seem relatively small stuff: a splash in the torrent of the $2 trillion per year that Americans spend on health and wellness.

And yet in the midst of a great national debate over health care, this small outrage has some serious implications. Advocates for the herbal supplement industry justify their special sweet deal by championing the right of consumers to make their own “health choices.”

Individual choice certainly sounds like the American way. But the fact is that most of us are not well positioned to make intelligent health choices. If we try to play our own doctor, we are going to expose our health — and our money — to risk and exploitation.

As individuals, we have trouble distinguishing between anecdotes: “My neighbor took zinc for her cold and she said it really helped,” and data: Most colds last four days, so you could smoke yak-dung cigarettes on day three and feel better on day four.

We are poor balancers of risk: Look at the rising number of Americans who resist taking vaccines because of astronomically remote chances that something might go wrong.

We are vulnerable to placebos: “Hey — I took the 30-day free sample and I feel sure my vision did improve!”

We are swayed by prejudice and ideology: The film-maker Spike Lee wrote in Rolling Stone in 1992: “I’m convinced AIDS is a government-engineered disease.”

The reason we should defer to experts is not that the experts know everything. Of course they don’t. It’s just that they know more than non-experts do.

It’s not that science has all the answers. It doesn’t. It’s just that astrologers, shamans, and natural healers have none of them.

Americans spend over 50 percent more per person on their health than anyone else on earth. For all that extra money, Americans see very little benefit. Americans rank 42nd on earth in life expectancy, 29th in infant mortality.

Improving and rationalizing this costly and dysfunctional system is a gigantic, maybe impossible, task. But one small reform could strike a meaningful blow for reason and cost-effectiveness: Apply the rules governing the advertising of aspirin to the advertising of oregano tablets. Repeal the DSHEA law and give the Food and Drug Administration full authority over every manufactured substance that purports to promote health or relieve illness.

You can purchase an autographed copy of my book, Alternative Medicine: The Christian Handbook here. You can see the Table of Contents here, and read a sample chapter here.

Some herbal supplements associated with dangerous blood lead levels in women

Reuters Health carried a very interesting report indicating that some herbal supplements may boost the levels of lead in the blood of women.

A study, published in November showed that among 12,807 men and women age 20 and older, by Dr. Catherine Buettner, at Beth Israel Deaconess Medical Center in Boston, Massachusetts, and colleagues found blood lead levels about 10 percent higher in women, but not men, who used specific herbal supplements.

When they examined herbal supplement use among women of reproductive age (age 16 to 45 years old), “the relationship with lead levels was even stronger, with lead levels 20 percent higher overall, and up to 40 percent higher among users of select herbal supplements compared to non-users,” they report in the Journal of General Internal Medicine.

Lead accumulates in the body over time and may pass from a woman’s placenta and breast milk to developing fetuses and infants. The U.S. Food and Drug Administration does not specify safe lead limits, or even routinely test for this toxin in herbal supplements — but the state of California has established such levels.

Buettner’s team found that women using Ayurvedic or traditional Chinese medicine herbs had lead levels 24 percent higher than non-users, while those using St. John’s wort and “other” herbs had lead levels 23 percent and 21 percent higher, respectively, than non-users.

When combined with prior studies hinting at excess lead in specific supplements, the evidence strongly suggests use of specific herbal supplements may result in higher lead levels among women, Buettner said.

In the current study, Buettner was reassured to find “no evidence of lead toxicity,” she told Reuters Health in an email.

The researchers point out that the use of some herbal supplements among study participants was low, which limited the power to detect associations among specific herbal supplements.

They also emphasize that the current study does not prove that herbal supplements cause higher lead levels. They urge further studies to analyze how other lead exposures, calcium intake, or use of other dietary supplements alter lead levels.

Dr. Adriane Fugh-Berman, at Georgetown University Medical Center in Washington, D.C. concurs in an editorial on the study, and also cautions, “let us not use too broad a brush to tar all herbal products.”

Specific analyses of specific herbal products or the blood of users, Fugh-Berman writes, should be used to establish products containing problematic amounts of lead.

SOURCE: Journal of General Internal Medicine, November 2009

No Science to Back Actress Somers’ Potentially Harmful Menopause Advice

Miserable in menopause, Elizabeth Alsgaard pondered an awful choice: Drenching hot flashes or hormone therapies that might raise the risk of cancer. What former actress Suzanne Somers raved about held much more appeal — custom-mixed “bioidentical” hormones, just like ones the body makes.
“Anything I can put into my body that’s natural has to be better,” said Alsgaard, a California audiologist who admitted having “no knowledge base to go on other than fear” when she took Somers’ advice.
Millions of women have tried custom-compounded hormones or herbal supplements like black cohosh and red clover since 2002, when a big federal study found risks from traditional hormone replacement therapy, or HRT.
Alternative remedies are especially popular with upscale, educated women who like to research and find their own solutions to medical problems. They like the idea of personalized treatments versus off-the-shelf prescription drugs.
However, instead of a safer option, they are getting products of unknown risk that still contain the estrogen many of them fear, women’s health experts say.
“Misinformation is rampant” about bioidenticals, said Dr. JoAnn Manson, preventive medicine chief at Harvard-affiliated Brigham and Women’s Hospital in Boston. “It really is buyer beware.”
She and other experts explain:
—”Bioidentical” is a marketing term that has no accepted medical meaning. Its implied benefit is not unique to alternative remedies; many prescription drugs contain hormones that chemically match estrogens and progesterones made naturally by the body.
—Custom-compounded hormones are not approved by the federal Food and Drug Administration and have not been proved safe or effective. They may carry the same cancer and heart risks as traditional treatments and have had even less testing to find out.
—Hormone preparations do not need to be customized for each woman; a few standard doses work for almost everyone, medical experts say. The saliva tests that some women are given to tailor formulas are of dubious value because hormone levels fluctuate widely throughout the day.
—Compounding pharmacists use such different methods that a customized prescription can contain widely varying amounts of hormones depending on who fills it.
—Many compounders use estriol, a form of estrogen not approved for sale in the United States. The FDA is in a battle with compounding pharmacies over its use.
The bottom line?
“Women need to understand there’s no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy. In fact, there’s much less evidence for efficacy and very little research on long-term safety,” said Manson, who has no industry ties and was a key researcher in the big federal study that warned women in 2002 of the health risks from long-term hormone use.
For years, medical groups have warned against custom-compounded hormones. The American College of Obstetricians and Gynecologists has denounced claims about their safety. The American Medical Association has urged more FDA oversight. The Federal Trade Commission has filed complaints against online sellers who made health claims for natural progesterone creams without supporting evidence.
In 2001, the government tested 29 products from compounding pharmacies and found that one-third did not meet standard quality benchmarks, including potency problems, Manson writes in her book, “Hot Flashes, Hormones and Your Health.”
That has not stopped their popularity, and Somers has promoted them in several best-selling books and on “The Oprah Winfrey Show” earlier this year.
“I laugh when they call me a quack,” said Somers, who rubs hormones on her arms, injects them vaginally and takes some 60 supplement pills each day. In a phone interview, Somers said she is not trying to play doctor but to share with women what worked for her.
The issue flared last year, when the FDA declared that custom-mixed hormones were no safer than traditional treatments and warned pharmacies to stop using estriol, which is not approved in the United States for any use. (Most traditional menopause therapies use a different form of estrogen with a similar name — estradiol.)
The industry claimed it was being persecuted and fought back. In full-page ads in major newspapers, several alternative medicine groups claimed that estriol is safe, criticized “synthetic, hyper-expensive” prescription drugs, and asked, “Why is the FDA so hostile to ‘natural’ medicine?”
There are several thousand compounding pharmacies in the United States and hormones are a significant part of their business, said L.D. King, executive director of the International Academy of Compounding Pharmacists in Missouri City, Texas. No one knows how many women use these products, but “we believe the FDA action on the estriol issue would have affected hundreds of thousands of women,” King said.
A group of nine compounding pharmacies sued the FDA. After a murky ruling by a federal court in Louisiana centering on federal versus states’ authority, neither side appealed, King said.
“It gets complicated and there’s not a win,” he said. “We continue to advocate that FDA’s action is wrong.”
Alsgaard was not aware of the flap. She was 52 and living in San Diego when she stopped taking birth control pills, and menopause symptoms “hit me like a brick wall.” Her doctor, a specialist in women’s health, urged traditional hormone replacement therapy.
“She was just so aggressive it really flipped me out,” said Alsgaard, who feared a cancer risk from the pills. After reading one of Somers’ books, Alsgaard went to a different doctor specializing in bioidentical hormones.
“She spoke at a physician’s level, talked about metabolic things I didn’t understand and sold me a couple hundred dollars of supplements I never took,” Alsgaard said. “I was so desperate it was like, ‘OK, OK, just give me whatever I need.”‘
Although Alsgaard did not use the supplements, she did spend about $1,000 for saliva tests, hormone creams and custom-compounded hormone pills the doctor prescribed. Six months later, she was still miserable.
Disgusted with the doctor and in the middle of moving to Los Angeles, she found a new doctor and asked again for a natural remedy, believing those are safer than traditional hormone pills.
“He did a lot more extensive workup on me and put me on a bioidentical implant, a pellet implanted into the hip,” she said.
Pellets containing estrogen, testosterone or both are the latest craze in this field. They are implanted just under the skin every few months under a local anesthetic, and are not FDA-approved for treating menopause. Problems that have been reported include difficulty removing the pellets if the therapy has to be discontinued, infection or pain at the injection site and fluctuating blood levels of estrogen, including a potentially high cumulative effect over several years.
Alsgaard did not know the pellets lack FDA approval. Her first, implanted in April, has done the trick, she said.
“I feel awesome. I have no night sweats, no hot flashes, no mood swings. After feeling so terrible, I’d forgotten how good it feels to feel normal,” she said.
Whether her estrogen pellet is any safer than traditional estrogen pills is unknown.
Her physician, Dr. Kevin Pimstone, an internist at UCLA, said hormone pellets are “a very small part of my practice” — a few patients a month.
“I’m a really conventional doctor who offers this to patients who ask for it,” he said. “I don’t think there’s any evidence that bioidentical hormones are any safer than conventional hormones.”
———
On the Net:
FDA on hormone compounds: http://tinyurl.com/kv7sqb
Federal alternative medicine center: http://nccam.nih.gov/health/menopause/menopausesymptoms.htm
The AP is carrying a story about a woman who was miserable in menopause, Elizabeth Alsgaard, who “pondered an awful choice:” Drenching hot flashes or hormone therapies that might raise the risk of cancer. What former actress Suzanne Somers raved about held much more appeal — custom-mixed “bioidentical” hormones, just like ones the body makes. But, is there any science to support Somers’ claims? And, could her claims be potentially harmful to women? Continue reading

Physician calls for increased FDA regulation of dietary supplements

In my book, Alternative Medicine: The Christian Handbook, I lament the lack of regulation of dietary supplements in the U.S. Because of this lack, it’s very difficult for consumers to know, when it comes to herbs, vitamins, and supplements, if what they purchase actually contains what the label says. It’s almost impossible to know if the natural medication is contaminated or not. As a result, there are now other voices beginning to call out for at least some regulation of these substances. Continue reading

The Ten Commandments of Preventive Medicine – Part 8 – Alternative Medicine

In my latest book, 10 Essentials of Happy, Healthy People, I teach people how to utilize these ten essentials that are necessary to live a happy and highly healthy life. Under The Essential of Self-Care, teach what I call “The 10 Commandments of Preventive Medicine. Here’s the eighth installment of this ten-part series. Continue reading

Two dietary supplements used by high school athletes contain illegal and dangerous steroids

Two over-the-counter dietary supplements that anti-doping officials say are popular among high school football players contain steroids, according to court papers filed by federal authorities.

More Information: Continue reading

Trustworthy consumer websites for NATURAL MEDICATION info (herbs, vitamins, and supplements)

How can you make informed choices about natural medications (herbs, vitamins, and supplements)? For one thing, don’t get your information from ads or labels! There is almost no regulation in the U.S. on these products. So, where can you turn?

More Information: Continue reading

Is Prince Charles Endorsing Quackery? His Herbal Detox Products Stir Controversy

In an unusual turn of events, a prominent scientist in the United Kingdom is accusing Prince Charles of contributing to the “ill health of the nation” by backing with his name an herbal detox product that sells for about $13.75 per bottle and that he says is “outright quackery.”

More Information: Continue reading

Study Links Herbal Medicines to Lead Poisoning. How can you find safe herbs?

Fox News is commenting on a study published in the August 27 issue of JAMA in which medical researchers say that one-fifth of Ayurvedic herbal medicines sold on the Internet contain dangerously high levels of lead, arsenic and mercury. How’s a consumer to protect themselves?

My Take? Continue reading