Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

Kiyoshi Takamatsu; Mariko Ogawa; Tsuyoshi Higuchi; Takashi Takeda; Kunihiko Hayashi; Hideki Mizunuma

doi:10.1155/2020/9285317

Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

Evid Based Complement Alternat Med. 2020 Jul 11:2020:9285317. doi: 10.1155/2020/9285317. eCollection 2020.

Authors

Kiyoshi Takamatsu¹, Mariko Ogawa¹, Tsuyoshi Higuchi², Takashi Takeda³, Kunihiko Hayashi⁴, Hideki Mizunuma⁵

Affiliations

¹ Department of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital, Sugano 5-11-13, Ichikawa-City, Chiba 272-8513, Japan.
² Department of Nursing Science, Hirosaki University Graduate School of Health Sciences, Zaifu-cho 5, Hirosaki-City, Aomori 036-8562, Japan.
³ Division of Women's Health, Research Institute of Traditional Asian Medicine, Kindai University, Oonohigashi 377-2, Osaka-sayama-City, Osaka 589-8511, Japan.
⁴ Department of International/Community Health Laboratory Sciences, Graduate School of Health Sciences, Gunma University, Showa-Machi 3-39-22, Maebashi-city, Gunma 371-8514, Japan.
⁵ Fukushima Medical Center for Children and Women, Fukushima Medical University, Hikariga-oka 1, Fukushima-City, Fukushima 960-1295, Japan.

Abstract

Objective: Kampo medicine, a traditional Japanese medicine, is widely used in Japan, especially in the field of menopause medicine. However, few studies have shown evidence-based effects. This study aimed to confirm the effects of kamishoyosan on menopausal symptoms with a randomized, placebo-controlled, double-blind clinical trial.

Methods: Subjects were randomly allocated to groups that received either kamishoyosan (n = 101) or a placebo resembling kamishoyosan (n = 104). The primary outcomes were the change in the number of hot flashes, depression scores, improvements of anxiety, quality of life (QOL), and menopausal symptoms before and 4 and 8 weeks after initiation of treatment with the study drug. The secondary outcome was drug safety.

Results: After 8 weeks, the number of hot flashes decreased after treatment in both groups, but there was no significant difference between the two groups. The changes in SDS scores showed the same results. Moreover, no significant differences were observed between the two groups in assessments with the STAI, SF-36, and JSOG menopausal index. No serious adverse effect was reported.

Conclusions: This first placebo-controlled double-blind randomized trial with kamishoyosan demonstrated that it was safe and had some effects on climacteric symptoms, but not significant compared with placebo. Some problems, such as placebo effects, in the study of Kampo therapy for menopausal symptoms, were revealed. This trial is registered with the trial registration number. UMIN 000006042.