ColdSore-FX is a new topical product promoted for cold sores. Is it worth considering? Continue reading
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
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
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),
- Douglas Laboratories,
- Genestra (Seroyal),
- Nature’s Answer,
- Solaray, and
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.
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)
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.
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.
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.
After this discussion, attendees should be able to:
- Describe the natural medications used for osteoarthritis symptoms,
- Describe an evidence-based, trustworthy source of information for natural medications,
- Describe a independent quality testing lab of natural medications that can be used to recommend safe products, and
- Describe the evidence supporting or refuting the use of several natural medications for arthritis.
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
- 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 species
- Cat’s claw
- Uncaria guianensis
- Devil’s claw
- Harpagophytum procumbens
- 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
Don’t Recommend — Likely or possibly safe, but in-sufficient evidence of effectiveness
- Indian frankincense
- Stinging nettle
- 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
Now, for more details on these products.
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.
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.
- 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.
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.
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?
- 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.
- 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.
- O’Mathuna, Donal, Larimore, Walt. Alternative Medicine: the options, the claims, the evidence, how to choose wisely. Zondervan Publishers, Grand Rapids, MI. 2008. Signed copies available here.
- University of Iowa – Herbalinks
- Natural Medicines Comprehensive Database
- USP Verified Dietary Supplement Program
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.
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
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