Does every bizarre concept require a clinical trial?

Researchers from the ‘Complementary and Integrative Medicine Research, Primary Medical Care, University of Southampton’ conducted a study of Professional Kinesiology Practice (PKP) What? Yes, PKP! This is a not widely known alternative method.

According to its proponents, it is unique and a complete kinesiology system… It was developed by a medical doctor, Dr Bruce Dewe and his wife Joan Dewe in the 1980s and has been taught since then in over 16 countries around the world with great success… Kinesiology is a unique and truly holistic science and on the cutting edge of energy medicine. It uses muscle monitoring as a biofeedback system to identify the underlying cause of blockage from the person’s subconscious mind via the nervous system. Muscle monitoring is used to access information from the person’s “biocomputer”, the brain, in relation to the problem or issue and also guides the practitioner to find the priority correction in order to stimulate the person’s innate healing capacity and support their physiology to return to normal function. Kinesiology is unique as it looks beyond symptoms. It recognizes the flows of energy within the body not only relate to the muscles but to every tissue and organ that make the human body a living ever changing organism. These energy flows can be evaluated by testing the function of the muscles, which in turn reflect the body’s overall state of structural, chemical, emotional and spiritual balance. In this way kinesiology taps into energies that the more conventional modalities overlook and helps remove all the guesswork, doubt and hard work of subjective diagnostics. This is a revolutionary way to communicate with the body/mind connection. Through muscle monitoring and the use of over 300 fingermodes we can detect and correct the cause of the problem and effect a long lasting change for better health and wellbeing. Our posture could be considered to be the visual display unit from our internal bio-computer. Our posture / life energy improves as we upgrade the way we respond to life’s constant challenges and demands.

You do not understand? Let me make it crystal clear by citing another PKP-site:

PKP is a phenomenological practice – this means practitioners use manual muscle testing to demonstrate to the client how much or how little they are able to move in relation to their problem. PKP practitioners have tests for more than 100 muscles, and dozens of other tests that they do so they can clearly show you how your movement is affected by your problem. This muscle story shows a person how their life is unfolding, and it also helps to guide on how to transcend the situation and design a future which is more in alignment with nature and the laws of the cosmos… PKP is about living life more wisely.

In case you still have not understood what PKP is, you might have to watch this youtube clip. And now that everyone knows what it is, let us have a look at the new study.

According to its authors, it was an exploratory, pragmatic single-blind, 3-arm randomised sham-controlled pilot trial with waiting list control (WLC) which was conducted in the setting of a UK private practice. Seventy participants scoring ≥4 on the Roland and Morris Disability Questionnaire (RMDQ) were randomised to real or sham PKP receiving one treatment weekly for 5 weeks or a WLC. WLC’s were re-randomised to real or sham after 6 weeks. The main outcome measure was a change in RMDQ from baseline to end of 5 weeks of real or sham PKP.

The results show an effect size of 0.7 for real PKP which was significantly different to sham. Compared to WLC, both real and sham groups had significant RMDQ improvements. Practitioner empathy (CARE) and patient enablement (PEI) did not predict outcome; holistic health beliefs (CAMBI) did, though. The sham treatment appeared credible; patients did not guess treatment allocation. Three patients reported minor adverse reactions.

From these data, the authors conclude that real treatment was significantly different from sham demonstrating a moderate specific effect of PKP; both were better than WLC indicating a substantial non-specific and contextual treatment effect. A larger definitive study would be appropriate with nested qualitative work to help understand the mechanisms involved in PKP.

So, PKP has a small specific effect in addition to generating a sizable placebo-effect? Somehow, I doubt it! This was, according to its authors, a pilot study. Such an investigation should not evaluate the effectiveness of a treatment but the feasibility of the protocol. Even if we disregard this detail, I assume that the results indicate the effects of PKP to be essentially due to placebo. The small effect which the authors label as “specific” is, in my view, almost certainly caused by residual confounding and hidden biases.

One could also go one step further and say that any treatment that is shrouded in pseudo-scientific language and has zero plausibility is an ill-conceived candidate for a clinical trial of this nature. If it should be tested at all – and thus cost money, effort and patient-participation – a rigorous study should be designed and conducted not by apologists of the intervention but by more level-headed scientists.