Many osteopaths (and chiropractors) use their treatments for babies even though there is no good evidence that these treatments benefit any infant condition. Osteopaths are desperate to find some evidence to support these treatments so that they can promote them more widely. They have therefore undertaken a study called CUTIES, which stands for Crying, Unsettled, disTressed Infants: Effectiveness Study. The first mention I found of this was in an edition of The Osteopath (magazine produced by the regulator, the General Osteopathic Council). There are a number of serious issues with this research that means the outcomes are unlikely to tell us anything about whether osteopathy is actually effective for unsettled babies. Let’s look at these issues in more detail.
When conducting research, it is inevitable that some level of bias will exist even in the best designed and conducted study. Good researchers work really hard to remove as much bias as possible in order to improve the accuracy of results from their study. However, that is not the case here. The introduction to the study states that the aim is “to build an evidence base for osteopathy in the care of infants”. The researchers are actually setting out to try and provide justification for osteopathic treatment of infants. Research should instead set out to find out IF a treatment works rather than to try and show that it does. This research was therefore deeply flawed before it even started.
Study design, lack of plausibility and “birth trauma” nonsense
This is described as an effectiveness study. This is putting the cart before the horse. Before undertaking an effectiveness study, it is normal to start with a feasibility study to ensure that the treatment is feasible and acceptable to patients. In the published protocol for this study, the authors claim that a pilot trial was conducted to assess feasibility. However, no reference was provided which suggests that it was unpublished. This is a serious concern. Moving to an effectiveness study without first publishing the pilot trial means that it’s not possible for anyone else to assess the basis for the approach used in the effectiveness study (e.g. sample size, recruitment, blinding, etc). This is not the way that good research should be conducted.
In actual fact the main technique used by osteopaths on babies, cranial osteopathy, is based on a series of illogical unfounded ideas and therefore it is entirely infeasible. Even the protocol for this very trial states “There is little evidence to support the mechanism of action underpinning this approach with the rationale for treatment being theoretically driven”. The reason for the lack of evidence to support the mechanism of action is that it is biologically implausible and makes no sense in the context of a modern understanding of the human body.
Within this protocol paper we also see the same claimed justification for these treatments used by many osteopaths and chiropractors, i.e. “birth trauma”. This is something that isn’t recognised by conventional medicine. That’s because “birth trauma” is something that osteopaths and chiropractors have literally made up in order to try and justify their treatments. It’s not a real thing.
The study hypothesis is that “specific targeted osteopathic light touch usual care is superior to non-specific light touch”. The trouble is that is very hard to actually test. In practice, the osteopaths are likely to behave differently (whether intentionally or not) when they deliver the osteopathic intervention. It is this non-specific effect that is the most likely explanation for any difference between the intervention group and control group. In other words, any detected apparent benefit for the osteopathic intervention is very likely to be due to the behaviour of the osteopaths rather than the intervention itself. This doesn’t mean that osteopathy works, just that having the right approach when dealing with patients is important.
The outcome measures for this study are: effectiveness of osteopathic care on crying time, confidence in parenting, overall perceived change, and parental satisfaction and experience with osteopathic care. It’s noticeable that these are subjective self-reported measures that are very prone to bias. I’d also suggest that outcome measures such as “parental satisfaction and experience with osteopathic care” have no place in a trial that is intended to measure treatment effectiveness.
Popularity of osteopathic care for babies is very concerning
Although not related to the study itself, the lead for the study suggests that one in every eight / nine infants go to see an osteopath. Personally, I find this very concerning. There is no evidence that osteopathy provides any benefits for any infant condition and osteopaths lack the specialist expertise to treat babies. Any osteopath who is asked see a baby should instead refer them to a more qualified practitioner.
There are many serious issues with this study including an unpublished pilot trial, a treatment approach that lacks plausibility and a biased approach. I would therefore like to make a prediction in which I’m very confident. I predict that this study will produce positive results. How can I possibly know this before the study has been completed? That’s very simple. The study has been designed to generate a positive outcome. It is heavily biased throughout to the point that the person leading the study describes the aim as “to build an evidence base for osteopathy in the care of infants”. Will my prediction turn out to be correct? Let’s wait until the results are published and we’ll see. I’d be very pleased if I was proven wrong because that would indicate a rigorous approach to this research. Unfortunately, I think that’s very unlikely to happen.