Fifty-six patients who complained of dysmenorrhea received different Kampo medicines for eight weeks or more according to the therapeutic practices of oriental medicine. With patients in their teens and 20s, there was more functional dysmenorrhea than organic dysmenorrhea. The frequency of organic dysmenorrhea increased with patients in their 30s and 40s.
Thirty-six of the patients had functional dysmenorrhea. The improvement rate was very high (over 90 percent) in those who continued to take the medicine for eight weeks. Twenty patients had organic dysmenorrhea. The improvement rate in this group was about 70 percent. Kampo medicine proved to be very useful for the patients with functional and organic dysmenorrhea.
Five typical cases, three functional and two organic, were analyzed in this paper.

Approximately 40% of women during the course of their menstrual cycles suffer from premenstrual syndrome (PMS). The cause of this syndrome is unknown, furthermore diagnostic criteria and treatments have not been established. Kampo medicines were applied using Kami-shoyo-san as a first choice, and several other alternative Kampo medicines, to 33 PMS patient cases. To evaluate the effectiveness of this therapy, PMS scores were recorded prior to treatment. Patients' scores were recorded as; score 0 (symptomless), score 1 (endurable), score 2 (unbearable without medicine), as well as the five major characteristics of PMS, 1) psychiatric symptoms, 2) headache, 3) breast pain, 4) swelling, 5) lower abdominal pain or lumbago. The scores were verified subsequent to two menstrual cycles. Kampo medicine was found to be effective in 24 cases, with scores declining in average from 4.4 to 1.5. Further treatments were requested in 4 cases, moreover, 5 cases were discounted altogether. Thus Kampo medicine proved to be a very useful method for patients suffering from PMS.

Hyperextension injuries of the ankylosed thoracolumbar spine, particularly those with preexisting kyphotic deformity, present significant therapeutic challenges. The authors viewed that such injuries without displacement or fractures of the posterior elements are reasonable candidates for standalone percutaneous vertebroplasty (PVP). In such cases, the posterior tension band is spared; thus, fractures are unstable not in the lateral direction, which would lead to the translation of the fracture, but in the vertical direction. Such vertical instability of the fracture can be stabilized if the open mouth-type vertebral cleft is adequately filled with a sufficiently large amount of polymethylmethacrylate (PMMA) cement. Our three patients receiving standalone PVP received injections of 12 mL, 16.5 mL, and 18 mL of PMMA cement. This minimally invasive surgical procedure achieved both short-term (immediate pain relief and mobilization) and long-term (fracture healing) goals.

Monitoring of the safety profile for the approved medical products consists of routine pharmacovigilance activities for all drugs and additional pharmacovigilance activities for product-specific concerns. Signal management is an important part of routine pharmacovigilance activities, so EMA and FDA have published the guidelines for signal management in various documents. The AMED Risk Management Plan （RMP） research group, which started its activities in 2018 to enhance risk management plan in Japan, reviewed the guidelines and related articles and then put together the principles of signal management. The guidelines in EU and US describes the signal detection and evaluation methods including points to consider when conducting them, responsibilities of each action, and the procedures that the regulatory authorities disclose the outcome of their activities, in addition to the principles and procedures of signal management. Through the guidelines, they establish transparency for public including pharmaceutical industry. Our group first created the Japanese definitions of signal-related terms. Based on them, we created high-level concept for a series of activities from signal detection to risk identification and discussed the future vision of signal management in Japan.