A Baffling Mystery: Treating Pain and Depression

We definitely treat a lot of patients with chronic pain and chronic depression at WholeHealth Chicago. I could list the potential sources of all this pain, all this depression, but why bother? If pain or depression melt away your joie de vivre, we try to help.

Depending on personal preferences, we offer a variety of treatment combinations: prescription medication if needed, along with complementary therapies such as chiropractic, massage, mind-body therapy, acupuncture, Healing Touch, homeopathy, herbs, psychotherapy, and so forth. We’re no fans of the take-a-pill-for-every-ill philosophy so prevalent in medicine today.

Myself, along with Drs. Kelley and Donigan at WholeHealth Chicago are the ones with access to prescription pads, and we all keep abreast of the newer medications as they’re tested, approved by the FDA, and released to the general public. Whether or not an insurer will foot the bill is another issue altogether. These days it seems we need to get prior approval for even the least expensive generics.

Random clinical trials

Like all new drugs, pain meds (called analgesics) and antidepressants are clinically tested by random clinical trials (RCTs), in which a large group of patients with a common condition (such pain or major depressive disorder) are divided into two groups. One group receives the actual drug being tested and the other a placebo, or sugar pill. Even investigators don’t know who gets what.

After a few weeks, patients report what they’ve experienced, and then everybody switches pills, again anonymously, so someone who unknowingly received the placebo now gets the actual med and vice versa. Again, after a few weeks they report the effects: positive (feeling better), negative (side effects), or nothing at all.

The whole process is called a randomized placebo-controlled crossover clinical trial and there are literally thousands of these studies being performed around the world. Generally, they’re subsidized by Big Pharma, mightily praying that its drug is a winner. If so, the FDA gives a thumbs up and the profits pour in.

With some RCTs, though, there’s no financial gain for anyone. These trials mainly test techniques (“Does acupuncture help back pain?”) or natural products (“Does ginger help nausea?”) and are supported by medical schools or even by interested physicians.

A strange turn of events

In recent years, two very interesting phenomena about RCTs have emerged, leaving investigators utterly flummoxed. Ready for this?

• In RCTs involving both pain medications and antidepressants, the pain/depression-relieving effect of the placebo is almost the same as the effect of the medications themselves. In other words, patients who are unknowingly receiving sugar pills are reporting good results for pain/depression relief, while patients receiving the actual pain drug/antidepressant are reporting good results as well. Hmm…
• This strange phenomenon is occurring exclusively in clinical trials based in the US. It’s not being observed in foreign clinical drug trials. Double Hmm…

When the results of an expensive clinical trial prove a med is no better than the placebo, the FDA denies approval and millions of Big Pharma research dollars (and potentially billions in profits) go down the drain. Thus, trying to figure out what’s happening among American RCTs becomes pretty important. The most educated guesses are just that—guesses, but most investigators think the scenario looks something like the following.

People in the US do take a lot of medication, more than anyone else on the planet. Currently, 59% of people over 20 are taking one or more prescription drugs and 15% are taking five or more, a significant increase since 2000 and especially over the last decade.

The increase is attributed to our skyrocketing rates of obesity. Right now, almost 40% of Americans are in the clinically obese range. Because of this, Americans take more prescription drugs than ever for obesity-related diabetes, high blood pressure, and heart disease.

Unrealistic expectations

Because Americans rely on medications to treat just about everything, we’ve developed unrealistic expectations about anything in pill form. In addition, most of us know at least something about randomized clinical trials. So when we’re told by an authority figure “We’re testing a new medication for your particular problem,” we sign up to participate, drink the Kool-Aid, and in our hearts believe it’s going to work.

“Well,” we mumble to ourselves, “I’m already taking X pill for Y problem and it works, Z pill for A problem, and it works, so this new pill I’m testing is going to work, too.” And lo! it does.

There are a few very important lessons to learn from this phenomenon:

1. Physicians and patients alike are too reliant on pharmaceuticals to treat ailments. We’ve all been brainwashed, I by my drug rep or reading some biased, self-serving clinical trial published in JAMA and you by the latest TV commercial or unquestioning acceptance of your doctor’s hastily written prescription. Yes, undeniably, you may have pain and, yes, you might feel seriously depressed, but if placebos are proven to relieve these symptoms, then all of us need to think twice before I prescribe and you swallow more pills. We (the entire medical profession) need to consider alternative therapies instead.
2. Doctors must develop the same belief system in alternative therapies that we currently have in pharmaceuticals. Since physicians are enamored of clinical trials, then let’s run them on alternative therapies, but they must be done correctly. Smoke emerges from my ears when I read a clinical trial proving something like acupuncture doesn’t work when the technique used in the study is blatantly incorrect.
3. We need to let it sink in that we’re spending billions of dollars on drugs that in many cases are no better than sugar pills.
4. We’re going to lose if our thinking goes along these lines: “I don’t have time to work with a nutritionist so I’ll just increase my insulin.” “My insurance won’t cover acupuncture or yoga therapy, so I’ll just take some more Vicodin.” “I don’t have time for counseling, so I’ll increase my Zoloft.”

Yikes.

Be well,
David Edelberg, MD