Methodological and Ethical Challenges for the Implementation of Complementary and Alternative Medicine-Related Clinical Trials: Review of Reviews

Abstract

Background and Objectives: The implementation of Complementary and Alternative Medicine (CAM) has increased in recent decades. Due to the positive effects of CAM interventions, 5 to 74.8% of people use these treatments worldwide. However, implementing CAM-related clinical trials is associated with challenging issues. Failure to address these challenges can lead to poor quality of studies, publication of non-scientific findings, and ultimately disregard for human rights and ethics. This review aims to comprehensively review the literature focusing on methodological and ethical challenges for implementing CAM-related clinical trials. Material and Methods: This review of reviews was conducted via international databases, including PubMed/MEDLINE, Web of Science, and Scopus using keywords extracted from medical subject headings such as “Methods”, “Methodological Study”, “Methodological Studies”, “Ethics”, “Complementary Therapies”, “Complementary Medicine”, “Alternative Medicine”, “Clinical Trial”, and “review” from the earliest to May 1, 2022. Results: In general, challenging issues for the implementation of CAM-related clinical trials can be divided into two categories: 1) methodological and 2) ethical. Methodological challenges included: Risk of bias, Lack of knowledge of researchers, and Blinding. On the other hand, ethical challenges in clinical trial studies are divided into two categories: patients' rights and placebo use. Conclusion: Overall, the present study emphasizes the need for special attention to the quality of CAM-related clinical trials. Also, this study can pioneer the introduction of critical challenging issues in CAM-related clinical trials and provide appropriate suggestions for researchers to solve these issues in future studies.

Keywords

• methods
• complementary therapies
• ethics
• clinical trial