Efficacy of daikenchuto, a traditional Japanese Kampo medicine, for postoperative intestinal dysfunction in patients with gastrointestinal cancers: meta-analysis.

BACKGROUND: The Japan Society for Oriental Medicine makes a compilation of structured abstracts of randomized controlled trials (RCTs) of Kampo medicines available on its Evidence Reports of Kampo Treatment (EKAT) website. METHODS: Using EKAT, we conducted a systematic review and meta-analysis on the efficacy of using daikenchuto ( https://mpdb.nibiohn.go.jp/stork ) for bowel dysfunction after surgery for gastrointestinal cancer. The primary outcomes were the time to first postoperative flatus and the time to first postoperative bowel movement (BM). RESULTS: We found nine relevant RCTs. The mean differences between the daikenchuto group and control group (daikenchuto was not administered) were - 0.43 (95% CI: - 0.77 to - 0.09) days for the time to first postoperative flatus, - 0.29 (95% CI: - 0.59 to 0.01) days for the time to first postoperative BM, and - 0.95 (95% CI: - 1.70 to - 0.21) days for the length of postoperative hospital stay, and the risk ratio of the incidence of intestinal obstruction was 0.60 (95% CI: 0.35-1.03). The time to first postoperative flatus and the length of postoperative hospital stay were significantly shorter in the daikenchuto group than those in the control group (P = 0.01). However, only double-blind studies were evaluated; the results turned to be non-significant. CONCLUSION: As a result of meta-analysis by all retrieved according to the registered protocol, daikenchuto was efficacious in improving postoperative bowel dysfunction in patients with gastrointestinal cancers. However, limiting to articles with description of COI and blindness, significance disappeared.

[The Japanese legal system and the applicability of laws and regulations on private information protection and research ethics relating to medical research].

Objectives　To clarify the structure, applicability, and objectives of the current Japanese legislation for private information protection and research ethics and to examine the clauses of the related laws/regulations for academic research purposes.Methods　The research design is a descriptive study based on a systematic literature review. Using the "e-Gov" database, the laws/regulations relating to private information protection and research ethics that apply to medical research involving human subjects and human genome/gene analysis research were included in the research. The Drugs Law (Law No. 145 of 1960) and related GCP/GPSP regulations and laws/regulations on administrative organizations, management, and procedures were excluded. Furthermore, the guidelines and Q&A relating to these laws/regulations and all 47 prefectural regulations on private information protection have been selected from the websites of the related ministries, government organizations, and prefectures.Results　Our study demonstrated that the current legal system on private information protection consists of three layers and that the applicability of the laws/regulations in this area varies according to the type of research organization. Additionally, the applicability of the laws/regulations on research ethics is different depending on the research area. While the Private Information Protection Law (PIPL) for the private sector contains two objectives, PIPL for administrative organizations and PIPL for independent administrative organizations both include three objectives. For academic research purposes, PIPL for the private sector sets out a holistic exemption clause, whereas the other two PIPLs stipulate three specific exemption clauses. Furthermore, our research revealed that the clauses of the prefectural regulations demonstrated many variances.Conclusion　This study suggests that the current Japanese legal system relating to private information protection could be defined as a "mixed model," wherein the laws/regulations concerned are not necessarily consistent. The protection of medical information is solely regulated by a few specific laws with a narrow scope of application; the ethical guidelines are not directly based on any laws; and identifying applicable laws/regulations, depending on the category of research organization, is complicated, especially in the case of collaborative research involving researchers from various organizations. Therefore, in the larger framework of legislation, it is indispensable to reconsider the protection of private medical information and its effective use, including the ethics of this process because of the sensitive and useful nature of private medical information.

Maternal and neonatal outcomes in birth centers versus hospitals among women with low-risk pregnancies in Japan: A retrospective cohort study.

AIM: In order for low-risk pregnant women to base birth decisions on the risks and benefits, they need evidence of birth outcomes from birth centers. The purpose of this study was to describe and compare the maternal and neonatal outcomes of low-risk women who gave birth in birth centers and hospitals in Japan. METHODS: The participants were 9588 women who had a singleton vaginal birth at 19 birth centers and two hospitals in Tokyo. The data were collected from their medical records, including their age, parity, mode of delivery, maternal position at delivery, duration of labor, intrapartum blood loss, perineal trauma, gestational weeks at birth, birth weight, Apgar score, and stillbirths. For the comparison of birth centers with hospitals, adjusted odds ratios for the birth outcomes were estimated by using a logistic regression analysis. RESULTS: The number of women who had a total blood loss of >1 L was higher in the midwife-led birth centers than in the hospitals but the incidence of perineal lacerations was lower. There were fewer infants who were born at the midwife-led birth centers with Apgar scores of <7, compared to the hospitals. CONCLUSION: This study was the first to compare important maternal and neonatal outcomes of birth centers and hospitals. Additional research, using matched baseline characteristics, could clarify the comparisons for maternal and neonatal outcomes.