Abstract
OBJECTIVE: To compare the clinical efficacy and metabolites of Gancao Xiexin Decoction (GXD) granules versus traditional decoction in patients with recurrent oral ulcers (ROU) and cold-heat complex syndrome. METHODS: A randomized trial of 79 patients evaluated the clinical efficacy of both formulations for recurrent oral ulcers (ROU) with cold-heat complex syndrome. HPLC-ICP-MS was used to analyze metabolites and heavy metals. RESULTS: The Traditional Chinese Medicine (TCM) group, granule group and biomedicine group all showed significant improvements in clinical efficacy, inflammatory factors, and immune markers (P < 0.05). However, no significant differences were found between granules and decoction in salivary inflammatory factors, immune indicators, pain VAS scores, or TCM syndrome scores (P > 0.05). HPLC-ICP-MS analysis showed 60.4% common peak ratio in decoction and 68.1% in granules, with significantly lower heavy metal levels (Cu, As, Cd, Hg, Pb) in granules (P < 0.01). CONCLUSION: GXD granules and traditional decoction showed comparable clinical efficacy in managing ROU with cold-heat complex syndrome. Notably, granule formulations exhibited lower heavy metal content, suggesting potential advantages in safety profile.