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Peer-reviewedCC BY 4.0PLOS One

A Kampo medicine, kamishoyosan, ameliorates menstruation-associated symptoms in patients with premenstrual syndrome: An exploratory open-label, randomized controlled trial

  • Jun Chikumi1
  • Eri Sato2
  • Ai Ikebuchi3
  • Yohei Tokita4
  • Mitsuto Fukushige5
  • Mayu Yamamoto6
  • Hiroshi Sunada
  • Yusuke Endo
  • Hisashi Noma
  • Tasuku Harada
  • Fuminori Taniguchi
6 affiliations
  1. 1Tottori University Faculty of Medicine, Obstetrics and Gynecology, Tottori, Japan
  2. 2Tottori University Faculty of Medicine, Health Service Center, Tottori, Japan
  3. 3TSUMURA Kampo Research Laboratories, Research & Development Division, TSUMURA & CO., Tokyo, Japan
  4. 4Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital, Tottori, Japan
  5. 5Organization for Research Institute and Promotion, Tottori University, Tottori, Japan
  6. 6Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan
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Abstract

Premenstrual syndrome (PMS) is a psychological or physical symptom. We conducted an open-label, randomized, exploratory trial with the aim of evaluating the efficacy and safety of kamishoyosan (KSS) for PMS. KSS was administered orally during three menstrual cycles. The primary endpoint was the change in the premenstrual Menstrual Distress Questionnaire (MDQ) total score. The secondary endpoints included MDQ total and subscale scores, a daily symptom questionnaire, the Work Productivity and Activity Impairment (WPAI) Questionnaire, overall impressions, sleep status, and heart rate. A total of 50 patients were enrolled. The primary endpoint, the premenstrual MDQ total score, was significantly ameliorated after KSS treatment. Furthermore, KSS reduced MDQ scores during the menstrual cycle. Among the MDQ subscales, KSS decreased score of pain, concentration, behavioral change, and negative feelings during the premenstrual cycle. In addition, hyperthymia reduced during the menstrual cycle. The results of the daily symptom questionnaire indicated that KSS treatment alleviated irritability, easy anger, anxiety, emotional instability, abdominal distension, coldness, and stiff shoulders.The WPAI activity impairment score was lower in the KSS group, and overall impression favoured in KSS treatment.. The only adverse event related to KSS was headache in one case. These exploratory findings suggest that KSS may improve menstrual-related symptoms in PMS.

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Cite

BibTeXRIS
BibTeX
@article{chikumi2026kampo,
  title = {{A Kampo medicine, kamishoyosan, ameliorates menstruation-associated symptoms in patients with premenstrual syndrome: An exploratory open-label, randomized controlled trial}},
  author = {Jun Chikumi and Eri Sato and Ai Ikebuchi and Yohei Tokita and Mitsuto Fukushige and Mayu Yamamoto and Hiroshi Sunada and Yusuke Endo and Hisashi Noma and Tasuku Harada and Fuminori Taniguchi},
  journal = {PLOS One},
  year = {2026},
  month = nov,
  doi = {10.1371/journal.pone.0362303},
  url = {https://doi.org/10.1371/journal.pone.0362303},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - A Kampo medicine, kamishoyosan, ameliorates menstruation-associated symptoms in patients with premenstrual syndrome: An exploratory open-label, randomized controlled trial
AU  - Jun Chikumi
AU  - Eri Sato
AU  - Ai Ikebuchi
AU  - Yohei Tokita
AU  - Mitsuto Fukushige
AU  - Mayu Yamamoto
AU  - Hiroshi Sunada
AU  - Yusuke Endo
AU  - Hisashi Noma
AU  - Tasuku Harada
AU  - Fuminori Taniguchi
PY  - 2026
DA  - 2026/11/06
JO  - PLOS One
DO  - 10.1371/journal.pone.0362303
UR  - https://doi.org/10.1371/journal.pone.0362303
AB  - Premenstrual syndrome (PMS) is a psychological or physical symptom. We conducted an open-label, randomized, exploratory trial with the aim of evaluating the efficacy and safety of kamishoyosan (KSS) for PMS. KSS was administered orally during three menstrual cycles. The primary endpoint was the change in the premenstrual Menstrual Distress Questionnaire (MDQ) total score. The secondary endpoints included MDQ total and subscale scores, a daily symptom questionnaire, the Work Productivity and Activity Impairment (WPAI) Questionnaire, overall impressions, sleep status, and heart rate. A total of 50 patients were enrolled. The primary endpoint, the premenstrual MDQ total score, was significantly ameliorated after KSS treatment. Furthermore, KSS reduced MDQ scores during the menstrual cycle. Among the MDQ subscales, KSS decreased score of pain, concentration, behavioral change, and negative feelings during the premenstrual cycle. In addition, hyperthymia reduced during the menstrual cycle. The results of the daily symptom questionnaire indicated that KSS treatment alleviated irritability, easy anger, anxiety, emotional instability, abdominal distension, coldness, and stiff shoulders.The WPAI activity impairment score was lower in the KSS group, and overall impression favoured in KSS treatment.. The only adverse event related to KSS was headache in one case. These exploratory findings suggest that KSS may improve menstrual-related symptoms in PMS.
SN  - 1932-6203
ER  -