Efficacy of rikkunshito in patients with functional heartburn: a prospective pilot study.

BACKGROUND Although the efficacy of rikkunshito in patients with treatment-resistant non-erosive gastroesophageal reflux disease (NERD) has been reported, it is unclear for which subgroups of NERD patients (per the Rome IV criteria) rikkunshito is effective. The objective of this study was to investigate the efficacy of rikkunshito in patients with functional heartburn. METHODS Ten patients with functional heartburn who experienced symptoms of dyspepsia were enrolled. The patients were administered rikkunshito for 8 weeks. The frequency scale for the symptoms of GERD (FSSG), Japanese translation of quality of life in reflux and dyspepsia questionnaire (QOLRAD-J), and hospital anxiety and depression scale (HADS) were evaluated before and 4 and 8 weeks after administration. Overall treatment efficacy (OTE) was evaluated 8 weeks after administration. RESULTS One patient was discontinued 4 weeks after administration because of voluntary withdrawal. Total FSSG score was significantly (P = 0.039) lower 8 weeks after treatment or at discontinuation (13.2 ± 8.0) than before treatment (18.3 ± 10.7). Although QOLRAD-J score tended to increase 8 weeks after treatment or at discontinuation compared with before treatment, no significant difference was observed. HADS score did not decrease significantly 8 weeks after treatment or at discontinuation compared with before treatment. However, a correlation was found between total FSSG and HADS anxiety scores (correlation coefficient: 0.684, P = 0.027). CONCLUSIONS This was the first study to investigate the efficacy of rikkunshito in patients with functional heartburn. Rikkunshito may be effective in these patients.