Comparison of granule and traditional decoction of Gancao Xiexin for cold-heat complex pattern recurrent oral ulcer: a randomized controlled trial

TL;DR

This study compares the effectiveness and safety of granule and traditional decoction forms of Gancao Xiexin for treating recurrent oral ulcers with a cold-heat complex pattern.

Contribution

The study provides a direct comparison of clinical efficacy and safety between granule and traditional decoction forms of a TCM formula for ROU.

Findings

Both granule and traditional decoction forms showed significant clinical improvements in ROU patients.

Granules had significantly lower heavy metal content compared to traditional decoction.

No significant differences were found in inflammatory factors, immune indicators, or pain scores between the two formulations.

Abstract

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.

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.

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).

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.

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