Aim: Hormone replacement therapy (HRT) for climacteric symptoms is effective for vasomotor symptoms, such as hot flushes and sweating, but not for various psychological symptoms, such as anxiety, depression, and irritability. In such cases, prescribing Kampo, traditional herbal medicine, is sometimes considered. However, the effectiveness of Kampo has not been clearly shown. We examined the clinical effect of Kami-shoyo-san, a herbal formula commonly prescribed for climacteric symptoms in a Japanese Kampo clinic.
Methods: There were 180 patients who initially consulted our Kampo Outpatient Clinic due to the absence of a response to HRT or unsatisfactory improvement. Out of 180 patients, 45 patients received a Kami-shoyo-san extract for 4 weeks based on patient-centered Kampo diagnosis. We evaluated the severity of climacteric symptoms based on the visual analogue scale (VAS) score before and after 4 weeks of Kami-shoyo-san administration. Furthermore, the severity of each symptom before treatment was compared between the responders and non-responders.
Results: Kami-shoyo-san was effective in 33 (73.3%) of the 45 patients. After treatment, on the whole, the VAS score significantly decreased (P < 0.0001). Concerning vasomotor symptoms and psychological symptoms, each VAS score significantly decreased (P < 0.0001). When comparing the severity of pretreatment symptoms between responders and non-responders, symptoms, such as ‘insomnia’, ‘depression’, and ‘vertigo’ were significantly more marked in the responders (P < 0.05).
Conclusion: The results of this study suggest that Kami-shoyo-san relieved both vasomotor and psychological symptoms, and especially in patients with marked psychological symptoms, it exhibited potent effects.