November 28, 2017
Keio University School of Medicine
A multi-center collaborative research group from 33 institutions across Japan, led by Professor Takanori Kanai and Associate Professor Makoto Naganuma of the Department of Internal Medicine (Gastroenterology) at the Keio University School of Medicine, has scientifically demonstrated in a placebo-controlled clinical trial that a plant-derived dye is effective in treating active ulcerative colitis.
This indigo dye is a crude drug called Seitai. Professor Kanai's team had previously suggested in a small-scale, single-center study that oral administration of Seitai could show high efficacy in patients with active ulcerative colitis through a mechanism different from conventional treatments. In this study, a clinical trial including a placebo with stepwise dosing of Seitai, Seitai demonstrated a high efficacy rate of 70–81%.
As this study has demonstrated the high efficacy of Seitai, we will promote the development of this treatment to ensure its safe use by conducting further research, including additional animal experiments.
This achievement is expected to provide a clear path toward elucidating the pathology of ulcerative colitis with the aim of a complete cure and developing new treatment methods. The results of this research were published in the online advance edition of the American scientific journal "Gastroenterology" on November 22, 2017 (U.S. Eastern Time).
Separately from this research, the existence of ulcerative colitis patients who personally obtain Seitai based on unreliable information from sources like the internet and use it as a folk remedy has become a concern. Following cases where patients who ingested Seitai unrelated to this study developed pulmonary arterial hypertension, the Ministry of Health, Labour and Welfare issued a warning to relevant academic societies on December 27, 2016, advising them to instruct patients not to ingest Seitai based on their own judgment and to always consult a physician.
The study conducted by our research group was a trial aimed at evaluating safety and efficacy, and we believe that patients should not use Seitai based on their own judgment. Following this warning, we prioritized safety, suspended this clinical trial, and have now published the results.
For the full press release, please see below.