Preprint Communication Version 1 Preserved in Portico This version is not peer-reviewed

Rikkosan’s Short-term Analgesic Effect of Burning Mouth Syndrome: A single-arm cohort study

Tatsuki Itagaki
ORCID logo ,
Keisuke Nakamura
,
Tougo Tanabe
,
Takumi Shimura
,
Yu Nakai
,
Ken-ichiro Sakata
* ORCID logo ,
Jun Sato
,
Yoshimasa Kitagawa
Version 1 : Received: 8 January 2024 / Approved: 8 January 2024 / Online: 8 January 2024 (16:57:52 CET)
Version 2 : Received: 23 January 2024 / Approved: 24 January 2024 / Online: 24 January 2024 (09:47:20 CET)
Version 3 : Received: 14 February 2024 / Approved: 14 February 2024 / Online: 14 February 2024 (11:31:21 CET)

How to cite: Itagaki, T.; Nakamura, K.; Tanabe, T.; Shimura, T.; Nakai, Y.; Sakata, K.; Sato, J.; Kitagawa, Y. Rikkosan’s Short-term Analgesic Effect of Burning Mouth Syndrome: A single-arm cohort study. Preprints 2024, 2024010639. https://doi.org/10.20944/preprints202401.0639.v1 Itagaki, T.; Nakamura, K.; Tanabe, T.; Shimura, T.; Nakai, Y.; Sakata, K.; Sato, J.; Kitagawa, Y. Rikkosan’s Short-term Analgesic Effect of Burning Mouth Syndrome: A single-arm cohort study. Preprints 2024, 2024010639. https://doi.org/10.20944/preprints202401.0639.v1

Abstract

Burning mouth syndrome (BMS) is a chronic oral pain disorder. There is a theory that BMS is nociplastic pain. Standard treatment for BMS has not yet been established. Kampo medicine is a traditional oriental medicine. The purpose of this study is to validate the effectiveness of rikkosan—a traditional Japanese herbal medicine (Kampo)—in the treatment of BMS. The average effect of rikkosan was estimated to be a two-level reduction in NRS, and the sample size was designed with a standard deviation of 2.6, alpha error of 5%, and power of 90%. The required sample size was calculated as 20 people. A single-center retrospective study was conducted in 20 patients who were diagnosed with BMS and treated with rikkosan alone (7.5 g) three times daily. Patients were asked to evaluate their pain using a numerical rating scale (NRS) or a visual analogue scale (VAS) at the time of the initiation of rikkosan and at 1 month after. No side effects were observed in patients. NRS or VAS/10 scores decreased significantly between the time of the initiation of rikkosan (5.6 ± 2.5) and the one-month after (3.8 ± 2.2) (p < 0.05). Treatment with rikkosan was effective for BMS in the short term. Rikkosan has a short-term effect of reducing NRS by two levels in BMS patients.

Keywords

Burning mouth syndrome; Nociplastic pain; Pharmacotherapy; Kampo medicine

Subject

Medicine and Pharmacology, Clinical Medicine

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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