N-of-1 Trials: A New Clinical Research Methodology Appropriate for Homeopathic Supportive Care in Oncology

Context: The significant financial and human cost of randomized controlled studies make them difficult to access outside the university hospital environment and/or partnership with the pharmaceutical industry. Many homeopathic physicians, grouped within the International Homeopathic Society for Supportive Care in Oncology (IHSSCO), practice outside hospital oncology departments. To evaluate and scientifically validate their practice, new research methodologies enabling the generation of conclusive studies appropriate for Homeopathic Supportive Care in Oncology (HSCO) are essential.

Methods: We relied on the publications of clinical studies in HSCO and on the research methodology publications specific to complementary medicine. We compared the opinion of experts in clinical research with the experience of IHSSCO’s experts. We also looked for the most suitable IT tools.

Results: Publications of clinical cases remain useful provided they comply with the recommendations of the Homeopathic Clinical Case Reports and the MOdified NARanjo Criteria for Homeopathy (MONARCH). They are most often retrospective and offer a fairly low level of proof. On the other hand, single-case experimental studies of the N-of-1 type or Single Case Experimental Studies (SCED) present ‘Level 1 Evidence’. They make it possible to choose and evaluate the optimal homeopathic treatment for a given patient more powerfully than with group studies. This type of study, where patients are their own witnesses, is well suited to homeopathy, whether classical or clinical. Adding the risk of bias in N-of-1 Trials (RoBiNT) scale increases its scientific value. For the collection and analysis of data, the use of software which keeps health data secure makes it possible to invite several doctors to work on the same project in complete confidentiality.

Conclusion: We will present N-of-1 trial projects, supported by IHSSCO, focused on chronic diarrhea, trauma, fatigue, and joint pain induced by aromatase inhibitors in HSCO.

Keywords: N-of-1 studies, oncology, supportive care

Publication History

Article published online:
30 January 2024