**1. Introduction**

According to the World Health Organization (WHO), TM consists of knowledge, skills, and practices used for protection from physical and mental illnesses, diagnosis, improvement, and treatment of these diseases, as well as maintaining the health well, which is based on theories, beliefs, and experiences indigenous to different cultures, whether explicable or not. TM practices have a long history [1]. In general terms, the use of supplementary methods in addition to modern medicine in the patient treatment process is called "complementary medicine," while the use of other methods instead of modern medicine is called "alternative medicine." Similar terms had also been used in Turkey for a long time. However, as a result of the evaluations done based on the definition of WHO, it has been

concluded that medicine cannot have an alternative, only the treatment can have one. Accordingly, the definition, "traditional and complementary medicine," has come to the fore [2].

People resort more to TM and CAM applications because these applications have low cost, are easy to access, are often free of invasive procedures, are considered promising in some chronic and terminal stage diseases, and some side effects of new treatment options can cause distrust. Also, in countries where TM and CAM applications are covered by public insurance, the inclination toward these applications will inevitably increase [3]. Friends talk about the solution to certain problems and articles about TM and CAM are frequently seen in the printed media. Many hospitals include these treatment methods in their care plans. Courses on TM and CAM are placed in the curriculum of medicine, pharmacy, and nursing faculties [4].

When the literature is evaluated, TM and CAM applications are observed to become widespread all over the world, and especially the increase in the use of TM and CAM in the western world in the last decade has increased the need for field-specific evidence-based research [5]. Although CAM has an effect, there are many unknown points about these treatments regarding scientific research that will convincingly reveal the value of individual treatments.

#### **1.1 Scientific research and clinical research on TM and CAM**

Scientific knowledge reveals the cause and effect relationship logically based on experiments. It aims to clarify the cause and effect link between events investigated as a result of accepted, proven, and reproducible experiments. Scientific research should be planned in a way to show useful results and healing in patient care. Clinical research consists of scientific studies that are carried out with the participation of volunteer people and aim to obtain medical information. For new drugs, medical devices, and other treatment methods to be beneficial to humans, scientific information should be provided on topics such as showing their safety and effectiveness, developing new treatment methods, and determining the side effects of medications and medical devices employed in treatment before they are used widely. After all treatments have been shown to be successful in the laboratory and on laboratory animals, the effects/side effects on human volunteers are investigated. Answers to questions such as the effectiveness of treatment, suitable doses for treatment, and the possible side effects can be found with clinical research results.

Medical research is carried out systematically using scientific methods based on a plan to obtain scientific information. Medical research that is conducted on humans is carried out systematically with scientific methods based on a protocol by staff (physicians) who are authorized to perform their profession in the field of medicine on patients or healthy volunteers by doing physical, chemical, or psychological medical interventions, or using biological samples taken from these people, or utilizing other personal data of these people. Medical research on humans primarily aims to obtain new and generalizable scientific data. On the other hand, its effects on the human body may not be foreseen precisely [6].

Researchers should know and apply common methods, measures, and standards so that necessary evidence can be produced and interpreted to make their decision on the use of TM and CAM treatments. Scientific thinking must remain within the ethical framework while focusing on the solution of problems. Scientific research that can be carried on human volunteers should be designed with great scientific and ethical sensitivity. Each stage of the research should be applied in a way that will protect human rights and dignity and will not cause permanent harm for future generations.

**77**

*Ethical Evaluation of Clinical Research on Complementary and Alternative Medicine*

*1.2.1 Clinical research into traditional and complementary medicine practices*

**1.2 Traditional medicine and complementary alternative medicine health** 

Research carried out in the field of TM and CAM can be handled under two

These are studies carried out on human beings to reveal or verify the clinical or pharmacological effects of one or more products and/or methods falling within the field of traditional and complementary medicine applications, to identify their adverse events or reactions, and to investigate their safety and effectiveness.

These can be defined as traditional and complementary medicine applications that will be carried out using methods that will not require direct attention or intervention of a physician or dentist provided that observational studies, survey studies, retrospective studies, and traditional and complementary medicine applications are administered under conditions that are specified within the legal

In studies to be conducted in the field of TM and CAM, natural, synthetic, or biotechnology-rooted active substance or combination of substances administered to human beings to prevent, diagnose, or treat diseases, correct, regulate, or change a physiological function can be defined as a drug or human medicinal product. To ensure that studies are conducted in international scientific and ethical standards, good clinical practice titles consist of rules that should be obeyed by parties participating in the research and cover regulations about topics such as designing, conducting, following, budgeting, evaluating and reporting the research, protecting all rights of the volunteer and body integrity, providing the reliability of

Randomized clinical trials, which are shown as a source of evidence for the applicability of a particular intervention, provide important data for making practical decisions. They were accepted as the gold standard by A. Hill. Although the level of evidence is evaluated according to the type of the research, each study should

While randomized controlled studies are considered as the gold standard of evidence for treatment effectiveness, other research models will be needed about the activity field of CAM when randomized controlled trials cannot be conducted. These models may include studies meeting randomized and nonrandomized conditions, observational cohort studies, case-control studies, studies evaluating the effectiveness of certain treatment packages as a whole, and studies measuring

Evidence-based medicine (EBM) can be defined as the systematic approach where physicians make their decisions by combining their experiences, preferences, and patient characteristics in light of the best available evidence. Today, opinionbased decision-making approach referring to individual clinical experience has been replaced by evidence-based decision-making practice because the former causes variations and inconsistencies among clinical practices, it leads to disconnections between clinical practice and medical research, and it has become difficult to follow all the sources in the rapidly growing medical literature as a result of the ever-increasing number of studies in the field of medicine [8]. EBM practices, which have replaced TM practices, necessitate that decisions should be supported

*DOI: http://dx.doi.org/10.5772/intechopen.93094*

*1.2.2 Noninvasive clinical studies*

regulations of countries.

placebo or add-on effects [4].

research data, and maintaining their confidentiality.

also be evaluated in terms of strengths and weaknesses [7].

**surveys**

headings.

*Ethical Evaluation of Clinical Research on Complementary and Alternative Medicine DOI: http://dx.doi.org/10.5772/intechopen.93094*

#### **1.2 Traditional medicine and complementary alternative medicine health surveys**

Research carried out in the field of TM and CAM can be handled under two headings.

#### *1.2.1 Clinical research into traditional and complementary medicine practices*

These are studies carried out on human beings to reveal or verify the clinical or pharmacological effects of one or more products and/or methods falling within the field of traditional and complementary medicine applications, to identify their adverse events or reactions, and to investigate their safety and effectiveness.

#### *1.2.2 Noninvasive clinical studies*

*Bioethics in Medicine and Society*

come to the fore [2].

faculties [4].

concluded that medicine cannot have an alternative, only the treatment can have one. Accordingly, the definition, "traditional and complementary medicine," has

When the literature is evaluated, TM and CAM applications are observed to become widespread all over the world, and especially the increase in the use of TM and CAM in the western world in the last decade has increased the need for field-specific evidence-based research [5]. Although CAM has an effect, there are many unknown points about these treatments regarding scientific research that will

Scientific knowledge reveals the cause and effect relationship logically based on experiments. It aims to clarify the cause and effect link between events investigated as a result of accepted, proven, and reproducible experiments. Scientific research should be planned in a way to show useful results and healing in patient care. Clinical research consists of scientific studies that are carried out with the participation of volunteer people and aim to obtain medical information. For new drugs, medical devices, and other treatment methods to be beneficial to humans, scientific information should be provided on topics such as showing their safety and effectiveness, developing new treatment methods, and determining the side effects of medications and medical devices employed in treatment before they are used widely. After all treatments have been shown to be successful in the laboratory and on laboratory animals, the effects/side effects on human volunteers are investigated. Answers to questions such as the effectiveness of treatment, suitable doses for treatment, and the possible side effects can be found with clinical research results. Medical research is carried out systematically using scientific methods based on a plan to obtain scientific information. Medical research that is conducted on humans is carried out systematically with scientific methods based on a protocol by staff (physicians) who are authorized to perform their profession in the field of medicine on patients or healthy volunteers by doing physical, chemical, or psychological medical interventions, or using biological samples taken from these people, or utilizing other personal data of these people. Medical research on humans primarily aims to obtain new and generalizable scientific data. On the other hand,

convincingly reveal the value of individual treatments.

**1.1 Scientific research and clinical research on TM and CAM**

its effects on the human body may not be foreseen precisely [6].

Researchers should know and apply common methods, measures, and standards so that necessary evidence can be produced and interpreted to make their decision on the use of TM and CAM treatments. Scientific thinking must remain within the ethical framework while focusing on the solution of problems. Scientific research that can be carried on human volunteers should be designed with great scientific and ethical sensitivity. Each stage of the research should be applied in a way that will protect human rights and dignity and will not cause permanent harm for future

People resort more to TM and CAM applications because these applications have low cost, are easy to access, are often free of invasive procedures, are considered promising in some chronic and terminal stage diseases, and some side effects of new treatment options can cause distrust. Also, in countries where TM and CAM applications are covered by public insurance, the inclination toward these applications will inevitably increase [3]. Friends talk about the solution to certain problems and articles about TM and CAM are frequently seen in the printed media. Many hospitals include these treatment methods in their care plans. Courses on TM and CAM are placed in the curriculum of medicine, pharmacy, and nursing

**76**

generations.

These can be defined as traditional and complementary medicine applications that will be carried out using methods that will not require direct attention or intervention of a physician or dentist provided that observational studies, survey studies, retrospective studies, and traditional and complementary medicine applications are administered under conditions that are specified within the legal regulations of countries.

In studies to be conducted in the field of TM and CAM, natural, synthetic, or biotechnology-rooted active substance or combination of substances administered to human beings to prevent, diagnose, or treat diseases, correct, regulate, or change a physiological function can be defined as a drug or human medicinal product.

To ensure that studies are conducted in international scientific and ethical standards, good clinical practice titles consist of rules that should be obeyed by parties participating in the research and cover regulations about topics such as designing, conducting, following, budgeting, evaluating and reporting the research, protecting all rights of the volunteer and body integrity, providing the reliability of research data, and maintaining their confidentiality.

Randomized clinical trials, which are shown as a source of evidence for the applicability of a particular intervention, provide important data for making practical decisions. They were accepted as the gold standard by A. Hill. Although the level of evidence is evaluated according to the type of the research, each study should also be evaluated in terms of strengths and weaknesses [7].

While randomized controlled studies are considered as the gold standard of evidence for treatment effectiveness, other research models will be needed about the activity field of CAM when randomized controlled trials cannot be conducted. These models may include studies meeting randomized and nonrandomized conditions, observational cohort studies, case-control studies, studies evaluating the effectiveness of certain treatment packages as a whole, and studies measuring placebo or add-on effects [4].

Evidence-based medicine (EBM) can be defined as the systematic approach where physicians make their decisions by combining their experiences, preferences, and patient characteristics in light of the best available evidence. Today, opinionbased decision-making approach referring to individual clinical experience has been replaced by evidence-based decision-making practice because the former causes variations and inconsistencies among clinical practices, it leads to disconnections between clinical practice and medical research, and it has become difficult to follow all the sources in the rapidly growing medical literature as a result of the ever-increasing number of studies in the field of medicine [8]. EBM practices, which have replaced TM practices, necessitate that decisions should be supported

#### *Bioethics in Medicine and Society*

with qualified and current researches with a systematic approach to make the right decisions in the diagnosis and treatment processes. It is very important to reach information about evidence by following a conscious approach in the process of EBM applications. Evidence is determined by carefully selecting from the findings of clinical trials carried out by using real patients as subjects and applying original, powerful research methods [9].
