Qimei Granules Alleviate Symptoms in Chronic Pancreatitis with Jueyin Disease: A Randomized Double-Blind Placebo-Controlled Trial

INTRODUCTION: Chronic pancreatitis (CP) remains a challenging gastrointestinal disorder with limited treatment options. Qimei Granules, a modified formulation derived from the classical Wumei Pill, were developed to relieve clinical symptoms of CP. This study evaluated the efficacy and safety of Qimei Granules in treating CP patients with Jueyin disease. METHODS: This was a randomized, double-blind, placebo-controlled clinical trial. A total of 102 diagnosed CP patients with the cold-heat complex syndrome of Jueyin disease were recruited to receive standard Western CP treatment, supplemented with either Qimei Granules or a placebo for six weeks. Primary outcomes included improvement in major symptoms, TCM syndrome scores, and overall clinical efficacy. Secondary outcomes included pancreatic endocrine and exocrine function and nutritional status. Safety was evaluated based on liver and kidney function indicators and adverse event monitoring. RESULTS: Qimei Granules significantly improved abdominal pain, abdominal distension, and diarrhea in patients with CP (clinical efficacy rate of 74.4% vs. 47.1%, P<0.05). TCM syndrome scores were also significantly improved (P<0.05). Fasting blood glucose and glycosylated hemoglobin levels were significantly reduced after treatment with Qimei Granules (P<0.05). No significant differences were observed in serum amylase, lipase, or hemoglobin levels between the control and intervention groups. CONCLUSION: This study demonstrates the clinical efficacy of Qimei Granules in alleviating core symptoms in CP patients with the cold-heat pattern of Jueyin disease. Based on TCM theoretical principles of syndrome differentiation and treatment and supported by the specific components of Qimei Granules that address mixed cold and heat manifestations, this formula is recommended for CP patients with Jueyin disease.