Incorrect methods
"The results of many studies of psychedelics are overestimated"
Georgy Golovanov, Hi-tech+
To what extent does it distort the results of clinical trials of psychedelic drugs that their participants can easily determine whether they have received an active agent or a placebo? New Zealand researcher psychopharmacologist Suresh Muthukumaraswamy is sure that the distortions are significant. In his opinion, the conclusions of many recent scientific articles on the benefits of psychedelics need to be revised, since the results of almost all such studies are biased.
For about half a century, randomized controlled trials (RCTs) have been considered the gold standard for evaluating the effectiveness of treatment methods. In the process of such an experiment, scientists collect participants with certain qualities and randomly divide them into at least two groups.
One group undergoes experimental treatment, while the other – the control group – receives a placebo. In order to exclude an error, RCTs are ideally carried out blindly, that is, the distribution of participants into groups takes place in secret not only from themselves, but also from researchers. All this should lead to reliable empirical evidence of the effectiveness of therapy.
The blind method of research also allows minimizing the placebo effect when taking a "dummy" leads to positive therapeutic results. Previous experience has shown that this effect significantly distorts the results if participants already have some expectations about therapy. For example, if ten of them are given a sugar pill and told that this is an innovative remedy for headaches, one or two will really have the pain disappear.
This problem hinders the development of the modern field of psychedelic therapy. And it is so serious that, according to Suresh Muthukumaraswamy, a psychopharmacologist from The University of Auckland, requires a review of the results of almost all clinical studies on this topic. He believes that science does not have enough data to consider any psychotropic drug ready for use for medical purposes.
Article by Muthukumaraswamy et al. Blinding and expectation confounds in psychedelic randomized controlled trials is published in the journal Expert Review of Clinical Pharmacology – VM.
The problem of the lack of blind studies is compounded by the fact that usually modern trials of psychedelics take place in parallel with therapeutic sessions that last several weeks or months. All this time, the participants from the control group know that they are receiving a placebo, and they are experiencing not just a one-time disappointment. Their motivation to achieve positive results during routine therapy decreases.
In addition, the therapist himself understands this. Will he try as hard as when working with a placebo patient, Muthukumaraswamy asks. And in psychotherapy, one of the most important success factors is the emergence of a positive connection between the patient and the doctor.
The scientist does not propose to stop the research of psychedelics. But it is necessary, he believes, to change the approach to testing. For example, try to circumvent the placebo problem by giving the control group reduced doses of the drug. But in general, he calls for greater scientific rigor and transparency in tests and reports.
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