Safety and Efficacy of Bhutanese Traditional Herbal Drug Formulary for Gastritis-Related Problems (SEDRU): a Nationwide Observational Study

Abstract

Background Gastritis-related symptoms, often manifesting as stomach disorders, are among the top ten diseases diagnosed and treated in traditional medicinal units (TMU) in Bhutan. This study evaluated the safety and potential efficacy of the currently used medications for stomach disorders in Bhutan. Methods This prospective observational study was conducted across all 63 TMUs in Bhutan over a six-month period in 2019. Patients presenting with gastritis-related symptoms were enrolled and monitored throughout the study. Adverse reactions were assessed using the Naranjo algorithm. The Severity of Dyspepsia Assessment (SODA) scores, both overall and recipe-specific, were recorded at baseline and at weekly follow-up visits. The changes in SODA scores over time were analyzed using repeated measures ANOVA to assess the efficacy of the herbal treatments. Results A total of 152 patients were included in the study, with baseline information available for 109 patients. Follow-up data were collected for 100 patients at one week, 88 patients at two weeks, 72 patients at three weeks, and 51 patients at four weeks. The most common prescribed herbal drugs were Sedru 5, Ruta 6 and Zhijay 6. The baseline SODA score averaged 54.4 (± 8.8), which decreased progressively to 50.0 (± 8.3) at week 1, 46.9 (± 8.0) at week 2, 42.7 (± 12.0) at week 3 and 38.9 (± 13.7) at week 4, with a statistically significant improvements (p < 0.001). Nine adverse drug events were reported, but there were no definite adverse drug reactions. Patient satisfaction with the traditional formulations also showed a significant improvement. Conclusion The study found significant improvements in both pain and non-pain symptoms of gastritis, as well as patient satisfaction, with the use of traditional Bhutanese herbal medicines. The absense of definite adverse drug reactions indicates a favorable safety profile for these treatments. This study marks the first time the traditional medicine system in Bhutan has adopted scientific measures to promote evidence-based clinical practice, demonstrating a significant step forward in integrating traditional knowledge with modern research methodologies. Trial registration : Thai Clinical Trials Registry TCTR20180430004 dated 30 April 2018.