Since many months, I have noticed a proliferation of so-called pilot studies of alternative therapies. A pilot study (also called feasibility study) is defined as a small scale preliminary study conducted in order to evaluate feasibility, time, cost, adverse events, and improve upon the study design prior to performance of a full-scale research project. Here I submit that most of the pilot studies of alternative therapies are, in fact, bogus.
To qualify as a pilot study, an investigation needs to have an aim that is in line with the above-mentioned definition. Another obvious hallmark must be that its conclusions are in line with this aim. We do not need to conduct much research to find that even these two elementary preconditions are not fulfilled by the plethora of pilot studies that are currently being published, and that proper pilot studies of alternative medicine are very rare.
Three recent examples of dodgy pilot studies will have to suffice (but rest assured, there are many, many more).
The aim of this study was to evaluate the effects of foot reflexotherapy on pain and postural balance in elderly individuals with low back pain. And the conclusions drawn by its authors were that this study demonstrated that foot reflexotherapy induced analgesia but did not affect postural balance in elderly individuals with low back pain.
The aim of this study was to investigate the effect of Tai Chi training on dual-tasking performance that involved stepping down and compared it with that of conventional exercise among stroke survivors. And the conclusions read: These results suggest a beneficial effect of Tai Chi training on cognition among stroke survivors without compromising physical task performance in dual-tasking.
The aim of this study was to evaluate the efficacy [of acupuncture] over 12 weeks of treatment and 12 weeks of follow-up. And the conclusion: Acupuncture decreases WC, HC, HbA1c, TG, and TC values and blood pressure in MetS.
It is almost painfully obvious that these studies are not ‘pilot’ studies as defined above.
So, what are they, and why are they so popular in alternative medicine?
The way I see it, they are the result of amateur researchers conducting pseudo-research for publication in lamentable journals in an attempt to promote their pet therapies (I have yet to find such a study that reports a negative finding). The sequence of events that lead to the publication of such pilot studies is usually as follows:
- An enthusiast or a team of enthusiasts of alternative medicine decide that they will do some research.
- They have no or very little know-how in conducting a clinical trial.
- They nevertheless feel that such a study would be nice as it promotes both their careers and their pet therapy.
- They design some sort of a plan and start recruiting patients for their trial.
- At this point they notice that things are not as easy as they had imagined.
- They have too few funds and too little time to do anything properly.
- This does, however, not stop them to continue.
- The trial progresses slowly, and patient numbers remain low.
- After a while the would-be researchers get fed up and decide that their study has enough patients to stop the trial.
- They improvise some statistical analyses with their results.
- They write up the results the best they can.
- They submit it for publication in a 3rd class journal and, in order to get it accepted, they call it a ‘pilot study’.
- They feel that this title is an excuse for even the most obvious flaws in their work.
- The journal’s reviewers and editors are all proponents of alternative medicine who welcome any study that seems to confirm their belief.
- Thus the study does get published despite the fact that it is worthless.
Some might say ‘so what? no harm done!’
But I beg to differ: these studies pollute the medical literature and misguide people who are unable or unwilling to look behind the smoke-screen. Enthusiasts of alternative medicine popularise these bogus trials, while hiding the fact that their results are unreliable. Journalists report about them, and many consumers assume they are being told the truth – after all it was published in a ‘peer-reviewed’ medical journal!
My conclusions are as simple as they are severe:
- Such pilot studies are the result of gross incompetence on many levels (researchers, funders, ethics committees, reviewers, journal editors).
- They can cause considerable harm, because they mislead many people.
- In more than one way, they represent a violation of medical ethics.
- The could be considered scientific misconduct.
- We should think of stopping this increasingly common form of scientific misconduct.