Clinical trials of integrative medicine: testing whether magic works?

[n2doc]

David H. Gorskiemail, Steven P. Novella

A new phenomenon in clinical trials has arisen over the past 20 years. Complementary and alternative medicine (CAM) or integrative medicine (IM) modalities based on principles that bespeak infinitesimally low prior probability of success or that even violate well-established laws of physics and chemistry are being tested in randomized clinical trials (RCTs). CAM proponents frequently justify such RCTs by arguing that they will finally settle once and for all which CAM or IM modalities do and do not work. Our response is that this is a misguided viewpoint that has led to the infiltration of pseudoscience in academic medicine. We begin with a thought experiment.

Imagine that someone were to describe to you a treatment modality based on two principles. The first principle states that symptoms should be treated with compounds that cause the same symptoms in asymptomatic subjects and the second principle states that serially diluting such a remedy makes the action of that remedy stronger. These remedies are often diluted 1060-fold and beyond, many orders of magnitude beyond Avogadro's constant, meaning that the chance that a single molecule of original compound remains behind is infinitesimal. Would it be reasonable to believe that such remedies have a sufficient chance of being efficacious and that it would be worthwhile and ethical to test them in RCTs?

This is not a made-up example. What is being described is homeopathy, a 200-year-old system of medicine based on vitalism and prescientific ideas invented by Samuel Hahnemann [1] that has been tested in multiple RCTs. Indeed, a recent search of PubMed for ‘homeopathy randomized clinical trial’ turned up over 400 references. Although many of these were review articles, many were RCTs. Of these, perhaps the most famous (and notorious) are two randomized, double blind, placebo-controlled clinical trials testing homeopathic remedies to treat acute childhood diarrhea in Nicaragua [2] and Honduras [3]. Depending on the trial, the specific homeopathic remedies tested consisted of 1060-fold dilutions of mixtures containing substances including arsenicum album (arsenic trioxide), calcarea carbonica (carbonate of lime), chamomilla (German chamomile), podophyllum (Mayapple), and mercurious vivus (quicksilver, metallic mercury). One trial reported a questionable benefit [2]; the other, a later more rigorous study, found no benefit at all [3]. Yet both trials were performed even though the ingredients in the homeopathic remedies tested were not known to be effective against childhood diarrhea, two ingredients, arsenic and mercury, are definitely toxic, and the ingredients were diluted away to nonexistence. These two trials serve as examples of this trend of testing CAM and IM treatments that have a very low to nonexistent pre-test probability of producing a true positive RCT. There are many more such clinical trials of homeopathy, to the point where systematic reviews and meta-analyses are becoming common. Not surprisingly, they tend to be inconclusive or negative [4].

More common in the USA is reiki: ‘energy medicine’ that involves using hand and touch to direct into the patient's ‘healing energy’ from what reiki masters call the ‘universal source’. It is closely related to therapeutic touch (TT), which makes similar claims. For such modalities, the pre-trial likelihood of a positive effect greater than placebo is negligible, if not zero, given that there is no evidence that this healing energy even exists, much less that humans can manipulate it. Nonetheless, numerous hospitals, including prestigious hospitals [5], have reiki programs and carry out RCTs [6], resulting in at least one systematic review [7], which, not surprisingly, concluded that there is no evidence that reiki has specific therapeutic effects for any condition. Yet RCTs to test whether reiki, TT, homeopathy, reflexology, craniosacral therapy, acupuncture, and other modalities equally lacking in preclinical plausibility are ongoing, as is easily verified by a search of www.ClinicalTrials.gov.

more

http://www.cell.com/trends/molecular-medicine/fulltext/S1471-4914%2814%2900103-8

[valerief]

1. Prayer gets the most money from the govt via faith-based handouts. nt

[ChairmanAgnostic]

2. sorry but lumping acupuncture in with the rest is really unfair.

Acupuncture works, it is not make believe, it is not some touchy feely POS approach.

[Warpy]

4. This is where I point out

that studies showed that random dry needling worked nearly as well as following Chinese meridians. Nobody knows why shoving fine needles into the dermal skin layer does things, especially for pain, but it does.

I'm the biggest skeptic on the planet but it worked on me.

[ChairmanAgnostic]

5. same here.

Yet it does seem to work, even under clinical testing.

[KT2000]

3. I am noticing

an all-out effort to stop all research into anything and everything considered alternative and complementary medicine. Just let it play out and see what happens. Wasting research dollars is the usual complaint but that cost is nothing in the big picture.

I see a doctor who also does chelation treatments for cardio issues and mercury - considered alternative. More than a few cardiac patients I have talked with have told me their mainstream doctors advise them to keep doing what they are doing, knowing they are doing chelation treatments, because their numbers and overall condition are much improved. A mainstream doctor will not prescribe such treatment but rather communicate subtly - as in this case. These patients have avoided major surgery.

I am afraid these attack articles are meant to throw the baby out with the bathwater.