The Main Differences in the Knowledge between Conventional Medicine and Complementary Medicine and Ethical Evaluation of these Differences in Terms of Patients’ Informed Consent

To ensure the presence of medical indications and informed consent from the patient, which are the conditions for a medical intervention to be ethically and legally valid in conventional medicine, the information given to the patient must be accurate to a certain level and understandable. Considering the structure of the knowledge used both to determine medical indications and inform patients, there is a significant difference between conventional medicine and complementary and alternative medicine (CAM).

According to the hierarchy of evidence in the evidence-based medicine (EBM) approach, which seeks a more scientific understanding of therapeutic knowledge, the methodological strength of the research methods used to obtain evidence is graded, with randomised controlled studies and meta-analyses at the top. In the EBM approach, the ‘promotion of health’, a value-laden goal, emphasises the importance of protecting the patient from unnecessary and dangerous interventions. Although evidence-based knowledge plays an important role in clinical encounters, the ultimate decision-making power rests with autonomous patients who have their own value systems.

According to the principalist approach in medical ethics, in order for the patient to be autonomous in decision-making processes, the expected benefits and possible risks of an intervention should be communicated clearly and in a way that they can understand, using the best available evidence. Regarding the difficulty in applying the empirical testability criterion to CAM, informing the patient is considered a problem as the benefits and risks are not clearly known. In accordance with the principle of respect for autonomy (principal ethics), the patient is expected to give his consent by being informed within the framework of this information.

The above mentioned “using the best available evidence” can generally be understood as using only positive randomized-controlled trials (RCT) results to inform the patient. Whereas, considering using the best available evidence, "giving transparent information about the best available evidence", I will conduct this discussion on whether such an informing process in CAM can provide a valid consent from the patient. For instance, even in the absence of strong evidence based on positive empirical data, is it possible for the patient to understand the context of the intervention, risks, and expected benefit to some extent, by explaining the quality level of the available evidence?

From an ethical and legal perspective, there is nothing literally defined as to what information physicians are required to disclose to their patients, in terms of the requirements for informed consent. Therefore, as there are no clear guidelines to use for the informed consent process, when obtaining full and valid informed consent from patients, the decision on how much necessary information should be provided, and how much it is sufficient to discuss what is known about the expected benefits and risks with the patient, will be made within its context, in line with basic principles, in clinical scenarios with different levels of complexity. This decision-making process is the only one between physician and patient for each individual clinical scenario. The basic principles of informed consent mentioned above are: (1) the patient giving consent must have capacity (2) the consent must be freely given (3) the consent must be sufficiently specific to the procedure or treatment proposed (4) the consent must be informed. Principles 3 and 4, which refer to the content of the information, imply that the patient must have understood what she is consenting to in order for consent to be intervention-specific.

CAM modalities are known to fail to reasonably meet the standards of evidence for effectiveness. So, is this determination sufficient to make a directly negative assessment of the legitimacy of CAM interventions. Considering the “understanding condition” for the validity of the informed consent, is it possible for the patient to have an understanding about the intervention without knowing the detailed information about the intervention? In the absence of positive results from empirical studies known as “the best available external evidence”, can we say that the condition of understanding the informed consent cannot be fulfilled in any way? Regardless of the ongoing theoretical debates around the concept of evidence, these interventions are already being implemented, which requires us to pay attention to patients’ well-being. Thus, the following ethical questions need answers: In these interventions, can patients’ autonomy be realised? Can patients be informed of non-evidence-based knowledge?

In response to these questions, there are some radical arguments that it would not be appropriate to judge CAM using biomedical ethical principles, such as autonomy, assuming that CAM has inherently different values from conventional medicine. Because CAM’s purpose is healing, it has been argued that the power of therapy is more important than knowledge and informing the patient. In addition, the patient may not want to be informed and may give uninformed consent. If the patient only wants to heal, can requirement to inform be overridden in CAM? Is a different type of informed consent model possible for CAM? Is there a need for a new understanding of autonomy and different ethical principles for CAM? Is it possible to go beyond the classical epistemological standards in CAM?

In the context mentioned above, I will conduct an inquiry regarding the possibility of informing the patient and obtaining valid consent in CAM. First, I will explain the differences in the structure and content of knowledge between conventional medicine and CAM. Then, I will define the ethics problem associated with this issue and discuss various approaches, arguing that the information required to make conventional medicine interventions legitimate is not available in CAM.