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.