di Michele Ciabatti* is Frank Cecchi**
According to the Ministry of Health, the terms "drug", "medicine" and "medicinal product" have been used synonymously over the years. However, recently the term has been preferred medicinal. What is a medicine:
- any substance or combination of substances presented as having curative or prophylactic properties of human diseases;
- any substance or combination of substances that can be used on humans or administered to humans for the purpose of restoring, correcting or modifying physiological functions, exercising a pharmacological, immunological or metabolic action, or establishing a medical diagnosis.
All medicines consist of active ingredients and various excipients. The active principle it is the component of medicines on which its healing action depends, the actual medicine.
- excipients they are instead inactive components of the medicine, devoid of any pharmacological action. They have the function of protecting the active ingredient from external agents that could damage it (heat, cold, humidity or other chemical substances).
The effect “placebo" it is a well-known phenomenon that determines a perceived or real benefit on the part of the patient who, despite taking a medicine without active properties, i.e. a pill that does not contain "healing" substances, believes he is undergoing an effective treatment for his clinical condition.
However, the effect "nocebo” (from the Latin “I will cause harm”), which can lead to a reduction in clinical effectiveness or the perception of side effects related to negative expectations prior to taking the drug or starting treatment.
This phenomenon has important biological bases and has been the subject of numerous studies and scientific publications. A typical example of an effect nocebo it is the one potentially generated by the uncritical reading of the list of possible side effects described in the leaflet included in the package of a drug, the so-called "leaflet". The patient may feel and recognize one or more of these disorders after taking the medicine, even in the case of extremely rare adverse events or those described only in the case of taking toxic doses of the same.
In the cardiological field, a well-known example is the case of muscle pain ("myalgia") reported after taking a category of drugs for reducing cholesterol, "statins". This is a class of drugs that has been shown to lead to a marked reduction in stroke, myocardial infarction and mortality, over time, in patients who take them consistently. These drugs have led to a profound improvement in the lives of patients with cardiovascular disease and a clear reduction in hospitalizations, hospital procedures and related costs. Cases of real muscle damage related to statin therapy are very rare according to data deriving from large studies in the literature. However, many patients report myalgia after taking these drugs even in the absence of objective demonstration of muscle damage on blood tests (increased CPK). This phenomenon can in fact be explained by the effect nocebo, since this side effect has been described by doctors and by word of mouth from patients. An important study published in one of the major international cardiology journals (“Journal of The American College of Cardiology”) examined a group of patients who took statins consecutively for 4 months, and subsequently tablets without active drug (which are defined as “ placebo”) for another 4 months and subsequently did not take any tablets. Patients reported an increased percentage of side effects regardless of the type of pill taken (active statin or "placebo" i.e. absence of statin). These results, therefore, confirmed that the majority of side effects associated with statins are actually mediated by an important effect component nocebo.
Another important demonstration of the importance of the effect placebo is the one deriving from studies on anesthetic drugs, which demonstrated how the perception of pain resulting from the injection of the drug before an operating procedure was significantly influenced by the description provided by the doctor. In cases where it was described as “the worst part of the procedure,” patients reported a significant increase in pain, compared to cases where the benefit of anesthesia during the procedure was emphasized.
At this point the problem arises of how to provide correct information on the possible side effects of a treatment without generating a serious effect nocebo on the one hand, but at the same time still allowing a complete understanding of the possible related problems. Effective and sincere communication between doctor and patient is therefore essential in order to create a climate of trust and understanding regarding diagnostic and therapeutic strategies. Recent studies on the effects of psychotherapy have demonstrated how the patient's perception of the doctor's degree of empathy and competence is able to significantly modulate the effectiveness of the treatment itself. Even small measures such as placing emphasis on the expected benefits rather than on possible unwanted effects or emphasizing the benefit on the subject himself rather than on the general population could help to limit the effect nocebo of a therapy. The building of a trusting relationship and a greater understanding of the clinical consequences of the therapy should therefore lead to the patient's involvement in the shared therapeutic strategy.
In order to achieve this goal it is important to provide the subject with more information about their clinical condition and the strategies available for treatment. This issue is particularly delicate in the current complexity of the information universe, often populated by "fake news" and non-scientific information, conveyed by non-accredited and authoritative sources as can happen in various social networks (facebook, instagram, etc) or google news. In this sense, patient associations such as AICARM APS play a fundamental role in providing the tools and methods for understanding prescribed drugs and sharing the therapeutic paths proposed to patients.
*Cardiovascular Department, San Donato Hospital, Arezzo
**President of AICARM APS