Considerations for Indigo Naturalis: Safety and Perspectives

While the scientific observations on Indigo Naturalis (IN) in relation to Ulcerative Colitis (UC) are intriguing, as detailed in our previous posts, it is crucial to understand its safety profile and the ongoing considerations for its potential clinical application. 

Safety Observations from Preclinical Study: In the rat study, IN treatments exhibited a generally favorable safety profile within the experimental context. Notably, the high-dose IN group showed significantly reduced levels of serum alanine transaminase (ALT) and aspartate transaminase (AST) – common indicators of liver function – compared to the UC model group. This observation suggests a favorable impact on liver enzymes in the animal model. Furthermore, the historical use of IN for over 1,000 years traditionally attests to its safety, reliability, and tolerability in its traditional context.

Safety Observations from Human Clinical Trial (Important Nuance): The multicenter human trial, despite yielding positive efficacy results, was terminated prematurely due to an external report of pulmonary arterial hypertension (PAH) in a patient who had used self-purchased IN for six months. It is critical to note that no serious adverse events were observed within the clinical trial itself. However, mild liver dysfunction was observed in 10 patients receiving IN during the trial, a finding separate from the external PAH case that led to the trial's termination.

Current Recommendation and Future Outlook: Due to the potential for adverse effects, including the externally reported PAH, the authors of the human clinical trial concluded that IN should not yet be used clinically without further investigation. This underscores the paramount importance of thorough safety evaluations, especially for traditional substances that are gaining scientific attention in modern clinical settings.

The traditional use of IN aligns with the Eastern medical approach, which often focuses on addressing underlying causes and promoting holistic well-being, contrasting with Western medicine's typical focus on immediate symptom relief. While IN has a long-standing reputation for safety and tolerability based on its extensive historical use, modern scientific rigor demands a comprehensive understanding and validation of its safety profile.

Future research is vital to delve deeper into IN's mechanisms, particularly how it modulates cytokines and tight junctions, and its association with intestinal flora and the inflammatory immune response.

In conclusion, Indigo Naturalis is a subject of scientific inquiry for its properties relevant to UC, due to its observed modulatory effects on inflammation and potential role in mucosal repair. However, until more definitive safety data is established and clear clinical guidelines are developed, its use warrants extreme caution and should only be considered under strict medical supervision to ensure patient safety and maximize potential benefits, especially given the concerns about potential serious adverse effects like PAH raised by external reports.