Imagine if you will that you’re in the throes of labor (there is a point to this exercise in unplanned parenthood, so bear with me).
Between contractions, there’s a nattering in your ear about the use of local anesthesia prior to the epidural that friends swear will allow you to actually consider doing this again.
The injection is announced by someone saying either, "We are going to give you a local anesthetic that will numb the area so that you will be comfortable during the procedure" or "You are going to feel a big bee sting; this is the worst part of the procedure."
Not surprising, the perceived pain was found to be significantly greater after the latter statement.
German investigators highlight this experiment as part of a detailed and fascinating look at the nocebo phenomenon, or the opposite of the placebo phenomenon, in medicine.
The topic has apparently been given the short shrift by scientists and clinicians. A recent PubMed search by the Germans revealed roughly 2,200 studies penned on the placebo effect, but only 151 publications on the nocebo effect, with the vast majority of these being editorials, commentaries, and reviews, rather than empirical studies.
Dr. Winfried Häuser of the Klinikum Saarbrücken and his associates, nail the crux of the issue with a quote from cardiologist and Nobel laureate Dr. Bernard Lown that "Words are the most powerful tool a doctor possesses, but words, like a two-edged sword, can maim as well as heal."
The article touches on the neurobiological mechanisms of the nocebo effect, which like those for the placebo effect, center around conditioning and reaction to expectations – albeit in this case negative expectations.
There is a discussion about who might be at risk of nocebo responses (yes, ladies he’s speaking to us), and an amusing array of clinical studies illustrating the nocebo effect.
There’s a randomized controlled trial (RCT) of finasteride in benign prostate hyperplasia, in which sexual dysfunction was reported by 44% of patients informed of this possible side effect, compared with only 15% of those not informed.
Similarly, there’s another RCT of the beta-blocker atenolol in coronary heart disease. Rates of sexual dysfunction jumped from 3% of patients not told of the drug or side effect to 31% of those treated to complete details about both the drug and the possible sexual dysfunction
Where the review really hits its stride, however, is in the discussion of ethical problems that arise in everyday clinical practice where the nocebo phenomenon may be triggered by verbal and non-verbal communications by physicians and nurses.
The authors note that physicians are obliged to inform patients about the possible adverse events of a proposed treatment so they can make an informed decision, but also have a duty to minimize the risks of a medical intervention, including those induced by the patient briefing.
Strategies are offered to reduce this dilemma with the most obvious being patient education and communications training for medical staff.
Clinicians are also advised to focus on the proportion of patients who tolerate a procedure or drug rather than the proportion experiencing adverse events.
The most controversial suggestion is the concept of "permitted non-information." Patients agree not to receive information on mild and/or transient side effects, but must be briefed about severe and/or irreversible side effects. To respect their autonomy and preferences, patients could pick and chose what side effects they want to briefed on (or forego) from a list of categories of possible side effects for a drug or procedure.
When the German Medical Association gets round to updating its 1990 recommendations on patient briefing, the authors say there needs to be discussion on "whether it is legitimate to express a right of the patient not to know about complications and side effects of medical procedures and whether this must be respected by the physician."
There should also be debate on whether some patients might be left confused or uncertain by their inability to follow the comprehensive adverse event information found on package inserts or consent forms.
Such a strategy could be problematic in the United States, where nearly half of all adults (90 million people) have difficulty understanding and acting upon health information, according to the Institute of Medicine report "Health Literacy: A Prescription to End Confusion."
Throw in the wracking pain of childbirth, the instability of bipolarity, or the confusion of Parkinson’s, and you’ve just made the lawyers of America incandescently happy.
Dr. Häuser reports reimbursement for training and travel costs from Eli Lilly and the Falk Foundation, and lecture fees from Lilly, the Falk Foundation and Janssen-Cilag. A co-author reports research funds from Sorin, Italy.