Here’s a compelling op-ed from a chemistry PhD about the problem with randomized clinical trials. RCTs are the gold standard for testing effectiveness and safety. The problem, however, is that a randomized clinical trial puts the substance in question in a bubble. Remove the substance from its context, this writer argues, and you aren’t going to get an accurate picture.
Hang on, all ye fans of the FDA. I’ll explain. Randomized clinical trials are essential for food and drugs. But the piece points out that the value is not so cut and dried when it comes to vitamin supplements.
Supplements, of course, have been all over the news lately. Recently a spate of stories came out condemning antioxidants. Another called vitamins into question. I’m used to drug companies funding studies and releasing statements about the dangers of vitamins, and Sara and Aaron addressed the whole issue in a scathing little parody at Healthbolt (for adult eyes and a sense of humor only). The FDA will begin requiring supplement manufacturers to test their products and prove that they contain what they say they contain. This is a good thing as far as I’m concerned, though it’ll be 2010 before everything takes full effect, and the policing will be an honor system not unlike the current setup Big Pharma enjoys. So it remains to be seen just how much good this will do in stopping bogus supplements…
At this point in the antioxidant debacle, though, I can tell you that I’m really tired of certain interests truckin’ out the same old scare, and I said as much in a flare at Technorati. Typically, a substance, such as a single antioxidant, is given to a group. Placebos are given, all is randomized, time passes. Sounds great, but it’s not. Thus far, the results from many RCTs have been dismally unconvincing, leading experts to assert that antioxidants are worthless despite loads of observational studies. I won’t regurgitate the whole op-ed here, but consider a worthy criticism of RCTs:
Frequently the supplement is given to an unhealthy population – even terminally diseased groups. Should we really expect miracles here? I’m interested in the etiology of disease and chronic health conditions. I think it’s obvious enough that a combination of risk factors, diet, genetics and environmental conditions are at play in most health issues. Can we reasonably expect a year of, say, vitamin E supplementation to offset 20 or 40 years of cumulative damage from a host of factors?
My advice? Take a broad spectrum of different antioxidants for prevention and overall health, not in a misguided attempt to cure a disease. Nutritional supplements are fundamentally different from drugs in their approach. The former supports prevention; the latter targets specific symptoms and eliminates or mitigates them. In the best cases, and only occasionally, drugs cure disease. In the worst cases, they merely mask pain or alleviate symptoms that indicate an unhealthy lifestyle.
To me, RCTs may be missing the big picture with antioxidants: synergy, baby.
WORKER BEES’ DAILY BITES
Aspirin and fish are two health topics that get plenty of coverage. Just when you read the latest studies that command you to shun all things pill and pisces, another round tells you to take the opposite tack. We’re dishing all the latest research. And for simultaneous comic relief and health insights, you’ll enjoy the link to a debunker who is taking on…the debunkers.
Aspirin: What a Pill
Plenty of authoritative medical studies and organizations recommend taking aspirin for various health issues ranging from heart disease to cancer. Other studies find fault with this OTC drug. Today, European scientists are calling for better investigation into the dangers of aspirin. One problem with OTC drugs is that they are often taken in excess of the recommended dosages. Our observation (certainly not original, but worth stating): OTC drugs are still drugs, and it’s vital to exercise caution and do your homework. Many hospital visits are due to overdoses and interactions from “harmless” OTC drugs.
Fish: Scientists Still Flip-Flopping
While fish consumption does present concerns (mercury! sustainable harvesting!) one thing is now conclusive: fish oil is a more effective source of essential fatty acids than olive oil, nuts and plant oils.
This is Laurelfan’s Flickr Photo. We enjoy wild-caught salmon, too!
But Who Will Debunk the Debunkers?
Anssi Manninen, that’s who (via Bodybuilding.com). This is a pretty interesting and entertaining piece calling nutritional “debunkers” on the their own apparently misguided advice.
Worker Bees’ Daily Bites:
What’s shakin’, Apples? I’m here to highlight the best links to get your week off to an informed and healthy start:
Do you trust Big Pharma? You shouldn’t. (I know we said we’d lay off those guys for a while, but this is pretty important news. Official laying-off begins now.)
Dairy Ads Pulled
More Scams Debunked
Deer velvet is my personal favorite. Come on, gimme a break! This site is no-frills but nicely summarizes some popular supplement scams. I disagree with the last one. What do you think?
Buy Milk in the Dark
This milk advice is one of the most odd, but useful, health tips I’ve seen yet. Buying milk that’s been exposed to fluorescent light destroys precious nutrients. (As you’ll note from reading our assorted research into Big Moo, I think your best bet is to buy raw milk from a reputable local source, but this is not recommended by the federal government.)
Mother’s Milk Vs. Nestle
To say I’m bothered by the fact that Nestle pushes baby formula on new mothers in regions that lack potable water would be an understatement. Breast-feeding is the obvious choice for nourishing infants in impoverished areas where clean water and good food are scarce for mom, let alone baby, but apparently Nestle would rather turn a quick profit and shove sugary formula (deficient in EFAs) down newborns’ throats. Thousands of babies are dying as a result. Read about it here. I for one am boycotting Nestle. They make a LOT of products – they’re the biggest food company in the world. Fortunately, they don’t typically make healthy food, so it’s easy to avoid supporting them.
I’ve gotten so many great health questions from you all this week, I’m still working through several of the emails. (Sorry for the delay – I haven’t forgotten you! I encourage you to post your questions in the Forum, so that along with my tips, you’ll get the whole gang to help you out.) There were a few questions this week regarding various quack products and FDA warnings that I’ve been asked a number of times over the years, so let’s set the record straight here at MDA.
1. Sandra recently asked me about transfer factor supplements – do they work, and should we be taking them?
“Transfer factor” is derived from bovine colostrum and is said to enhance immunity and muscle performance, among other claims. Like glandulars, this is a product without much to back it up. Not only is there no reputable scientific evidence, but it really doesn’t make much common sense. Cow’s milk is for baby cows, after all, and is designed by nature to be perfect for little calves’ growing immune systems, not ours. Although that’s even debatable, as most dairy cows these days are so crowded, sick and drugged up, I doubt they’re passing on much of anything beneficial to their offspring, whom they never meet anyway. A better way to boost your immunity? Reduce stress! Get exercise! Eat mostly vegetables! Enjoy yourself! Honest.
2. Lisa wants to know if oxygenated water is healthier than regular tap or bottled water.
Nope. I wrote a fun piece debunking these much-hyped “mock waters” some time ago, and it was published over at my good friend Gabrielle Reece’s site. You can also read it here. I’ve gotten some questions about reverse osmosis, bottled water safety (it’s coming, Evelyn!), and other H20 issues, so I’ll be posting a more in-depth look at all things liquid very soon.
3. I’ve also gotten a lot of questions about the current web controversy (no, not the Digg debacle): CAM regulation from the FDA.
Joe Mercola, no stranger to controversy, did what I felt was a very fair job of setting the record straight on this issue. (Note: I certainly don’t endorse all that he has to say, but this is a very balanced look at the current panic over CAM). The very knowledgeable Cindy Hebbard of Wisdom of Healing, politely refuted Mercola’s point of view after I recommended she check out his exploration of this issue. I encourage you to read both points of view if you’re curious.
The blogosphere is certainly hopping all over this issue. People’s response to this issue has been overwhelming – with the FDA extending, then short-changing, the public comment period. Health Ranger Mike Adams of NewsTarget ponders: will juice be banned? Will massage oil be available by prescription only? (Here’s what this science blogger I admire has to say).
I am a big proponent of being a squeaky wheel - nothing works better when it comes to getting governments and corporations to change. (That, and voting with your wallet.) And it’s no secret that the FDA is hardly a friend of natural living and often uses obscenely aggressive tactics against perfectly innocent naturopaths, herbal therapists and the like (just read Cindy’s response to me at her blog). Honestly, I’m glad everyone is picking up on this, because it’s a healthy sign of actively involved citizens.
That said, what the FDA is issuing is simply a (rather repetitive) guidance letter, not a regulation. The FDA doesn’t have legislative power, so this is more of a slap in the face than anything. Given that the rules aren’t being changed, it’s annoying, perhaps, and it’s indicative of the FDA’s attitude towards natural health, but it’s not really a “new” threat. Those of us who have been in the natural health industry have been aware of this issue for quite some time, and there’s just nothing scary here. Yes, the wording of “modalities” – meaning therapies – has been changed to “medicines”. But again, there is no cause for grave alarm. (And as you loyal readers know, I harbor no great and abiding love for the FDA. The FDA is the brunt of many a roast here at MDA).
Here’s the deal: as before, as long as any supplement or natural therapy isn’t making a claim of medical treatment or cure, you can expect things to be business as usual. For example, Mike Adams brings up cranberry juice in his blogging about this issue. In accordance with the FDA’s “new” guidance, cranberry juice can’t be marketed as a cure for bladder infections. It can be marketed as being beneficial for urinary tract health. But…this is nothing new.
Tell the FDA you’re unhappy with where they’re putting their attention and resources – but don’t panic. (This doesn’t mean we shouldn’t keep an eagle-eye on the FDA, of course. These are the folks who have a problem with stevia, after all. I’ve long noticed that new guidance issuances and sudden press releases about the “danger” of vitamins typically coincide with Big Pharma and FDA scandals. Trucking out sensational scares always makes for a nice distraction from the bigger issues.)
Stick around for a look at the environment and food packaging from Sara and a healthy recipe for your weekend brought to you by Aaron. Have a wonderful weekend, Apples!
Most Popular Posts
The Buckler Brief
Bringing you the latest in supplement analysis!
Use: natural migraine relief
The verdict: worth a try
I don’t normally recommend a lot of herbs, especially the trendier ones, unless they have some serious scientific backing. Butterbur passes my test. Depending on which recent study you check out, Butterbur (taken twice daily at 75 mg a pop) reduces the frequency of migraines by as much as 60 per cent. Supplement News Blog reports that in a double-blind study from Neurology, butterbur was twice as effective as a placebo in offering migraine relief. Personally, I have seen many cases of migraine suffering clear up with a good daily dose of Omega-3′s, a multivitamin, and elimination of sugar from the diet. However, if you’ve done these things and still suffer the agony of migraines, you might want to try butterbur.
Source: Supplement News
Note on the source: I do not endorse melatonin, nor does Mark. The use of hormone supplement therapy is controversial and I believe you’re better off finding natural ways to stimulate the production of your own melatonin through nutrition and exercise, rather than create an artificial dependency. Supplementing frequently with melatonin (other than for recovering from jet lag or other short-term sleep interferences) can cause the body to produce less on its own, therefore triggering a rather vicious cycle of hormone depletion.
Use: where do I start?
The verdict: absolutely essential and often overlooked!
Magnesium is vital to mental and emotional health, proper sleep, healthy cell function, bone health and, according to new research, reduction of inflammation. Those of you who know me know that inflammation is perhaps my biggest health concern for people. It’s the common culprit behind diabetes, arthritis, heart disease, obesity and many other conditions. I believe the DV for magnesium is much too low. (Here’s some interesting research to get you started if you are curious to learn more. Here’s another handy link.) I’m including these statements on magnesium today because I think this is a critically overlooked nutrient.
Though not a “trendy” supplement (and look for me to debunk plenty of those in future Briefs), I believe we really need to focus our current attention on the importance of magnesium. Many of our current health problems indicate possible magnesium deficiency, and it’s a big enough issue that the WHO has even published their concerns (the WHO is quite conservative and typically doesn’t promote supplementation beyond basic necessity, so when they talk about deficiency issues, you know it’s a big deal. The sad thing is that our Western diet, which is so potentially rich in nutrition, is in practice creating a very deficient, unhealthy population. You may remember we reported on this issue recently.)
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