Those of us on the industry side of healthcare may dismiss today’s news as another headline doing damage to an industry that delivers benefit to millions. But in claiming “The difference in improvement between patients taking placebos and patients taking anti-depressants is not very great”, lead researcher Professor Irving Kirsch raises some undeniably challenging questions.
For one thing, the “effect” is not limited to mental health trials. One RCT in patients with acute duodenal ulcer (Lanza et al. 1994) consisted of three treatment arms: the then-new drug lansoprazole (Zoton/ Pravacid), an older drug, ranitidine (Zantac) and placebo. As per experimental law, the 44 patients receiving placebo had the same diagnosis as the other patients and were examined alongside them. After two weeks about a third of the placebo patients were healed, and after four weeks just under half of them were healed.
Here’s another in angina: (Boissel et al 1986) 35 patients with severely limited functional status were treated for 6 months only with placebo and short-acting nitroglycerin. The placebo dosage was blindly titrated over this time until an “optimal” response was seen. Twenty seven of the 35 patients showed substantial improvements over this period. Overall the number of angina attacks dropped from 10.3 to 2.4 a week with a corresponding decrease in nitroglycerin tablets used. It seems unlikely that these people would have simply gotten better had they stayed at home and had no treatment. But, with inert treatment in a clinical trial, they did get better.
Let’s not forget that a placebo isn’t necessarily a tablet. In two studies (Cobb et al, NEJM 1959. Dimond et al, J of Cardio. 1960) surgeons were only informed once in the operating room which patients were to have a complete internal-mammary artery operation, and which were to receive sham surgery. Both studies showed that most of the patients were much better after “surgery” regardless of whether they had actually received it or not.
These examples of a high response rate in a placebo arm are not uncommon. For centuries, it has been known that sick people frequently get better when administered an inert intervention by a healer or medicine man. It’s hard to account for the substantial improvement in these patients.
Increasingly, the term “placebo effect” has been a dismissive one, given to justify a response that cannot really be understood. To me, it seems that at some point the role of the patient’s ‘mind-over-illness’ must be considered. Indeed, the word “placebo” is being challenged by medical anthropologists, who ask how placebos, an inert substance by definition, can have any effect at all. If it does something, it is not inert. There must be something else at play driving this change.
Daniel Moerman in his excellent book Meaning, medicine, and the “placebo effect”, suggests a very different approach to this problem. He uses the term “Meaning response” and defines this as “the psychological and physiological effects of meaning in the treatment of illness”. The meaning response can be applied to most of the results traditionally attributed to placebo effect. As a definition it gathers the elements of the non-physiological into treatment success, aiming at a better understanding of this phenomenon.
Once you acknowledge that treatment ‘meaning’ exists alongside mode of action and plays a role, it’s only a short distance to another important realisation. This is directly relevant to us: by understanding meaning in the eyes of the end user, we can feed this insight into the HCP strategy. Adapting and optimising our communications can only help drive a better brand experience, a better consultation and perhaps better outcomes.
What do you think?