Most trials of alternative treatments are fundamentally flawed: an example based on paediatric osteopathy

Much of the research published on alternative therapies is of very poor quality and is often focused on trying to market a therapy rather than actually assessing whether it has benefits or not. There are many issues with the trials conducted in this area and in this post I would like to focus on two key problems:

  1. Trialling a treatment for which there is no plausible way it could provide any benefit for the given condition.
  2. Trying to show efficacy from a small pilot study.

Getting these two points right is, in my view, beginner level study design. They are often done incorrectly in trials of alternative therapies. Paediatric osteopathy, much like paediatric chiropractic, is mired in pseudoscience and wildly unrealistic treatment claims. I’d like to use this trial of paediatric osteopathy as an example of the points above.

Overview of the study

The title of the study was “Efficacy and Feasibility of an Osteopathic Intervention for Neurocognitive and Behavioral Symptoms Usually Associated With Fetal Alcohol Spectrum Disorder”. The intervention in this case was 4 weeks of osteopathic manipulative treatment (OMT). It was a pilot study with just 32 patients split between intervention (OMT) and a control (standard support measures).


Looking at the first criteria I highlighted above, is there a plausible way that osteopathic manipulative treatment (OMT) could influence neurocognitive and behavioural symptoms? The short answer is a very resounding “no”. There is just no reasonable way that performing manipulations could have an impact on behaviour or the functioning of the brain in any health condition.

It is, however, worth looking a bit more closely at the treatments used in the osteopathic approach to understand just how ridiculous they are. According to the paper “Somatic dysfunctions were detected by physical examination, based on tissue texture changes, asymmetry, limitation in normal range of motion, and tissue tenderness parameters (TART), which guided the osteopathic evaluation and OMT intervention”. Firstly, some degree of asymmetry is normal in everyone and, in spite of claims by many chiropractors and osteopaths, there is no evidence that trying to “correct” this provides any benefit. Secondly, what possible relationship could a limitation in range of motion or tissue tenderness have to behaviour or brain function? This just makes no sense. They go on to say “Using OMT techniques, the identified somatic dysfunctions were corrected one by one in the whole body”. Again, how could any of this possibly have any effect on the symptoms they are trying to treat?

Efficacy and pilot studies

The purpose of a pilot study is to assess feasibility of a treatment approach and understand associated parameters in preparation for a fully powered efficacy trial. A pilot study should NEVER be used to determine efficacy of a treatment. In trials of alternative therapies this very basic rule is often broken with many pilot studies trying to claim that the tested treatment is “effective”. This is exactly what we see with this study: “The main primary objective of this pilot study was to evaluate the efficacy and feasibility of a 4-week planned OMT intervention” (emphasis mine). No, no, no and again no! The authors recognise that this is a pilot study but then claim the primary objective is to evaluate efficacy. If the people conducting a pilot study don’t understand the purposes of such a study they probably shouldn’t be doing the research in the first place!

Other issues

Besides these two very fundamental issues with this study, there are other problems too. For instance, they are trying to develop a treatment for fetal alcohol spectrum disorder. However, in this study they recruited patients that DO NOT have this condition. The patients recruited were “Children aged 3 to 6 years without a FASD diagnosis but with symptoms usually present in FASDs”. If you want to see whether a treatment works for a particular health problem then a pretty basic starting point is recruiting people with that condition.

These sorts of very basic problems are all too common in studies of alternative therapies.


Like many alternative therapies, paediatric osteopathy is mired in pseudoscience and misleading claims. The research conducted into these approaches is often focused on marketing the particular pet therapy rather than genuinely researching it. Using a trial of paediatric osteopathy as an example, I have highlighted two very basic flaws that are common in many studies of alternative therapies:

  1. Trialling a treatment for which there is no plausible way it could provide any benefit for the given condition.
  2. Trying to show efficacy from a small pilot study.

Studies like this are a waste of time and money and, in my view, are unethical because they involve testing biologically implausible treatments on unsuspecting members of the public. The results from these sorts of trials shouldn’t be trusted and they certainly shouldn’t be used to inform treatment choices.

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