-Original-

Efficacy of Rikkunshito for Functional Heartburn: A Prospective Pilot Study

Noriyuki Kawami, Shintaro Hoshino, Yoshimasa Hoshikawa, Tomohide Tanabe, Mai Koeda, Eri Momma, Nana Takenouchi, Yuriko Hanada, Mitsuru Kaise and Katsuhiko Iwakiri

Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan

Background: Although rikkunshito was reported to be effective for treatment-resistant nonerosive gastroesophageal reflux disease (NERD), it is unclear which Rome IV subgroups of NERD patients benefit from rikkunshito. This study investigated the efficacy of rikkunshito in patients with functional heartburn.
Methods: Ten patients with functional heartburn who experienced symptoms of dyspepsia were enrolled and received rikkunshito for 8 weeks. The Frequency Scale for Symptoms of GERD (FSSG), the Japanese translation of the Quality of Life in Reflux and Dyspepsia (QOLRAD-J) questionnaire, and the Hospital Anxiety and Depression Scale (HADS) before, and 4 and 8 weeks after, administration were evaluated. Overall treatment efficacy (OTE) was evaluated at 8 weeks after administration.
Results: One patient voluntarily withdrew from treatment at 4 weeks. 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 was higher 8 weeks after treatment or at discontinuation than before treatment, the difference was not significant different. HADS score was not significantly lower 8 weeks after treatment or at discontinuation, as compared with before treatment. However, total FSSG and HADS anxiety scores were positively correlated (correlation coefficient: 0.684, P = 0.027).
Conclusions: The findings from this first study of the efficacy of rikkunshito for functional heartburn suggest that it might be effective in such patients.

J Nippon Med Sch 2022; 89: 56-65

Keywords
rikkunshito, functional heartburn, nonerosive gastroesophageal reflux disease, potassium-competitive acid blocker-resistant, multichannel intraluminal impedance-pH monitoring

Correspondence to
Noriyuki Kawami, MD, PhD, Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
s5038@nms.ac.jp

Received, October 29, 2020
Accepted, February 3, 2021