The discussion about my text on the Mollii Suit at the end of last year was interesting. After the publication of the text, some of my patients approached me and showed me videos of their positive experiences with the product, also to convince me of the effectiveness of the device.This once again made it clear to me how important it is to constantly remind ourselves of the principles of good scientific practice – for which I stand and which you can rely on in the DocBlog texts: I can only assume a specific effect of an intervention (such as the Mollii Suit) and communicate its effectiveness when I have examined this intervention in a controlled experimental setup and was able to provide positive evidence of its effectiveness. Case reports are interesting and can contribute to hypothesis generation, but they are not a suitable means for scientifically valid proof of efficacy.
The Placebo Effect
The demand for a scientific approach is related to the placebo effect, which can be very potent and therefore must be excluded by a suitable experimental setup. The placebo effect refers to the positive changes in health or well-being of a person when they receive a placebo, i.e. a substance/intervention that is actually ineffective.
However, equating this effect with “imagination” – as is sometimes done – falls significantly short. It has been shown that the expectations, beliefs and psychological attitude of a person can have a significant influence on the effectiveness of placebos and that placebos can cause physiological changes. Neurobiological studies have shown, for example, that the placebo effect is associated with changes in the brain, especially in regions associated with pain perception and reward. So it is by no means a matter of imagination, but rather the unique human ability to make use of the “body’s own pharmacy” – as neuroscientist Prof. Dr. Ulrike Bingel from the University Hospital Essen, who researches the placebo effect intensively, puts it. Here is a reference to a report from 3sat that summarizes and illustrates what has been said very nicely.
Placebo Effect in Science
Due to its potency, the placebo effect is currently of interest to neuroscience. It is now known that the driving force of the placebo effect is expectation – the greater the expectation of efficacy, the greater the effect – and expectations can be generated by different mechanisms and measures such as social interaction, emotions, but also advertising. This brings us back to the example of Mollii Suit: what expectations are raised by the emotionality, the case studies and the choice of words (“superhero suit”) when reading the homepage.
In order to evaluate the actual effectiveness of interventions, as already mentioned above, the placebo effect must be taken into account and excluded by a cleverly chosen study design: If one group of patients receives a real medical intervention and another group a placebo intervention, it can be assessed whether the observed improvements are due to the specific effect of the treatment or to the placebo effect. Such studies for multiple sclerosis have never been conducted by the manufacturer of the Mollii Suit for their product and this is the reason for my criticism.
Now one could argue: It doesn’t matter, as long as it gets better, even if it’s “just” the placebo effect. However, I consider this ethically questionable – because ultimately such a “deception” represents a violation of the principle of informed consent. Patients should always be fully informed about the nature of an intervention. Do you think that this principle is respected with the Mollii Suit, for example? And ultimately, the manufacturer wants to sell its product at the expense of statutory health insurance. Do you think it’s correct to burden the solidarity community in view of such data?
I am looking forward to your answers in the comments…
