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Updated: Mar 23, 2026

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The Difference between the Two Representative Kampo Formulas for Treating Dysmenorrhea: An Observational Study.

Tetsuhiro Yoshino¹, Kotoe Katayama², Yuko Horiba¹

¹Center for Kampo Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.

Evidence-Based Complementary and Alternative Medicine : Ecam

|March 24, 2016

Summary

This study developed a predictive model to help specialists choose between tokishakuyakusan and keishibukuryogan for dysmenorrhea treatment. The model accurately distinguishes patient profiles for each Kampo formula, aiding clinical decision-making.

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Area of Science:

Integrative Medicine
Pharmacology
Women's Health

Background:

Kampo medicine offers two effective formulas for dysmenorrhea: tokishakuyakusan and keishibukuryogan.
Current clinical criteria for selecting between these formulas are not well-defined, leading to potential inconsistencies in treatment.

Purpose of the Study:

To compare patient characteristics treated with tokishakuyakusan versus keishibukuryogan.
To develop and validate a predictive model for selecting the appropriate Kampo formula for dysmenorrhea patients.

Main Methods:

A comparative study involving 168 primary and secondary dysmenorrhea patients.
Logistic regression analysis was used to identify significant predictors differentiating the two treatment groups.
Internal and external validation of the predictive model was performed.

Main Results:

Distinct clinical factors were identified for each formula: tokishakuyakusan (lightheadedness, low BMI, weak abdomen) and keishibukuryogan (sweating tendency, heat intolerance, leg numbness, cold lower back, strong abdomen, paraumbilical tenderness).
The predictive model demonstrated high accuracy: 81.2% internal, 80.5% via cross-validation, and 85.0% in external validation.

Conclusions:

A validated predictive model can aid in the selection of tokishakuyakusan or keishibukuryogan for dysmenorrhea based on specific patient symptoms and physical findings.
Further prospective trials are recommended to confirm the clinical utility of this predictive model.