Going for the Gold

Mainstream physicians and medical scientists like to talk about the “gold standard” in research. The randomized, placebo-controlled, double-blinded clinical trial. And it is indeed the gold standard for collecting evidence about drugs.

The problem is, the placebo effect can actually play a tremendous role in healing. And it shouldn’t be discounted when it comes to conducting research that will actually move modern medicine forward…

Back when medical practice was still more art than science, people actually appreciated the power of the placebo effect. Perhaps the greatest physician of the late 19th to early 20th centuries, Sir William Osler, wrote about this topic in his standard textbook of medicine. He certainly presented all the science that was known at the time. But he was also sure to include a serious discussion about benefits of the placebo effect.

Unfortunately, all that changed with the start of pharmaceutical-based medicine. You see, the placebo effect is so powerful that the method of conducting clinical trials had to be designed around it. Otherwise, researchers can’t tell whether benefits are coming from the drug itself or simply from the fact that the patient is being treated at all.

In fact, under the current standards of clinical trials, if a drug offers just 20 percent improvement over the placebo, it’s considered effective by the FDA. That still seems somewhat “iffy” to me. But the clinical trial approach for drugs was brought forward as the gold standard for everything in medicine. Which is extremely short-sited and limiting.

For example, consider the following study from Harvard. Researchers tested the effects of an herb (St. John’s wort) vs. a drug (SSRI) vs. a placebo for mild-moderate depression. Participants in the trial also received 15 hours of intensive interaction with a highly-skilled mental health professional. This was done for ethical reasons. They didn’t want people who were only getting the “ineffective” treatments—the herb or the placebo—to suffer alone. This Harvard study represented the “gold standard” of both medical science and ethics in conducting human trials.

But researchers were amazed when the study showed no benefits for the treatments over placebo. Of course, they were quick to trumpet that the herb “did not work.” You had to dig harder to find out the drug didn’t work either

What no one talked about was the obvious benefit of the hands-on mental health support provided to everyone in the study. It completely washed over the ability of any substance—drug or herb.

So, here’s what this study really proved: You can’t replace human caring with a drug—or a plant. Of course, no modern-day, statistic-worshipping, number-crunching scientist would ever be able to come to such a conclusion.

But this experience shows just one of many reasons why clinical trials are not the only standard.

Now, so-called “evidence-based” medicine (EBM) has come into fashion. However, EBM is being exposed as nothing more than statistical shenanigans that provide a cloak of credibility for expensive Big Pharma research and for physicians intimidated by all the numbers. (See my report The Secret to Spotting the Truth Behind the Headlines for more on the façade of EBM.)

That said, there is now a huge volume of research from around the world proving the safety and effectiveness of complementary and alternative medicine. Particularly dietary supplements. Yes, even using the “gold standard” approach of clinical trials.

But what these studies usually miss in their quest for “data,” is true advancement in patient-based medicine. Which should, after all, be the ultimate goal of research. To find real patient-based results, there are many other things that must be taken into account:

  1. Is it biologically plausible? In other words, does it make sense in terms of how human biology works?
  2. Is there an underlying hypothesis? Or is it just a statistical “fishing expedition?”
  3. Does it apply to my patient as a unique individual (and not just a statistic)?
  4. Do the “experts” doing the research know anything at all about how the particular non-drug therapy is actually used and practiced?
  5. Can you even trust the data at all? Given the inherent biases in funding, career interests, and academic and political correctness, and outright fraud in up to half of today’s published research, this concern is a very real consideration for recent studies.

But even beyond the research rhetoric, there must be knowledge and understanding of the traditional and historic uses of herbal remedies. This source is another treasure trove of information that is usually overlooked by modern, mainstream medical science. (Which is actually proud of their view that history is irrelevant to our present “golden age” of medical science). It’s even ignored by too many in the nutritional products industry itself.

If researchers don’t understand the historical use of a particular supplement (or, let’s be honest—even basic human nutrition and metabolism), there is simply no way they can accurately design the study in the first place. Wasting money, time, and misdirecting the consumer.

Germany, which has been no slouch in using the best, cutting-edge sciences for generations, nonetheless knows to recognize and approve herbal remedies in human medicine based upon their historical use.

And CAM therapies—including herbal and nutritional supplements—are holding their own during modern research. Even in “gold standard” clinical trials that completely disregard their rich histories.

But what’s sorely lacking in this country is an approach that brings all of this together. The best of science, and nature, and history. To truly move modern, patient-based medicine forward.

It’s become a sort of personal mission of mine. And tomorrow, I’ll share some exciting news about how this dream is finally becoming a reality. Until then…