Although “coldness” exaggerates chronic pain in the lower back and extremities in patients who experience it, there is no western-style medicine focusing on “coldness” Therefore, we investigated the efficacy and safety of a Kampo medicine that improves “coldness”. In the present study, we retrospectively reviewed medical chart records on the prescription of tokishigyakukagoshuyushokyoto 7.5 g/day (dry weight) to patients who had subjective coldness in their lower extremities. We performed pre- to 1 month post tokishigyakukagoshuyushokyoto treatment comparisons with regard to Visual Analogue Scale (VAS), axillary temperature, dorsal foot temperatures, Ankle-Brachial pressure Index (ABI), Pulse Wave Velocity (PWV) and patient satisfaction. The records of 21 patients with lower back pain and “coldness” were evaluated. VAS, and both axillary and dorsal foot temperatures were significantly improved, and satisfaction score was increased. Subjective coldness was alleviated in 7 patients ; however, objective temperatures were increased in all patients. In summary, we noted that tokishigyakukagoshuyushokyoto increased axillary and the dorsal foot temperatures, and objectively contributed to pain relief as well as patient satisfaction.

Shigyakusan, a traditional Japanese prescription, has been prescribed for chronic diseases including gastritis, upper respiratory tract infection, hepatitis, irritable colon and so on. The effectiveness of shigyakusan against pain, however, has only been rarely reported. Here we report that shigyakusan was effective on pain such as intractable chronic and acute pain in 26 patients. Shigyakusan is composed of 7.5 g (dry weight/day) : saiko, shakuyaku, kijitsu and kanzo. Shigyakusan and kososan mimic the composition of saikosokanto. Pain alleviation periods were 3-90 days (26 ± 19). Pains were recognized in various regions including side of the flank and the thorax, the back, the tongue, the perineum, the elbow joint, the head and plantar areas. Abdominal findings as tension of the rectus abdominis, kyokyokuman (discomfort of the hypochondrium area) and sinkahiko (tenderness of the hypochondrium area) were recognized 58%, 46% and 38%, respectively. All patients were recognized with depressive conditions. Shigyakusan alleviated acute and chronic pain that had not been improved with Western medicine. Therefore, shigyakusan may be considered for prescription in patients with incurable pain.