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Efficacy of Daikenchuto in the prevention of bowel obstruction in patients with colorectal cancer undergoing laparoscopic surgery: An observational study using a Japanese administrative claims database

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Abstract

Purpose

Daikenchuto is an herbal medicine widely used in Japan without clear evidence to prevent bowel obstruction after abdominal surgery. We evaluated the efficacy of Daikenchuto in laparoscopic surgery for colorectal cancer (CRC).

Methods

We included patients from the medical claims databases diagnosed with CRC between January 2012 and December 2019 and treated with laparoscopic surgery. We compared the Daikenchuto and control groups to evaluate early bowel obstruction (EBO) events for 1 year. The Daikenchuto group included patients prescribed Daikenchuto on postoperative day (POD) 0 or 1. An EBO event was defined as the use of a nasogastric tube, transnasal ileus tube, endoscopic balloon dilatation, or the requirement of reoperation for bowel obstruction from PODs 1 to 364.

Results

In total, 46,458 patients met the eligibility criteria; 2407 and 44,051 patients were included in the Daikenchuto and control groups, respectively. Some of the patient’s characteristics were significantly different between the groups. The frequencies of EBO events in the Daikenchuto and control groups were 5.7% (95% confidence interval: 4.8–6.7) and 4.6% (4.4–4.8), respectively. The most frequent events were nasogastric tube (3.1%, 2.9%) and transnasal ileus tube insertions (1.4%, 0.8%) in the Daikenchuto and control groups, respectively. The hospital stay was significantly shorter in the Daikenchuto group than in the control; this trend was confirmed in the sensitivity analysis.

Conclusions

Daikenchuto did not demonstrate efficacy for EBO. It might be adequate for shortening patient’s hospital stay. Further studies are warranted.

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Acknowledgements

We would like to thank Editage (www.editage.com) for English language editing. Taiho Pharmaceutical Co., Ltd. took no part in this study.

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Authors and Affiliations

  1. Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshida Konoecho, Sakyoku, Kyoto, 606-8501, Japan

    Yuji Kunitomi, Masayuki Nakashima, Masato Takeuchi & Koji Kawakami

  2. Department of Data Science, Taiho Pharmaceutical Co., Ltd., 1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo, 101-8444, Japan

    Yuji Kunitomi

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  1. Yuji Kunitomi
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Contributions

Y. K. contributed to the study conception and all authors contributed to the development and improvement of the protocol and study design. Y. K. performed data analysis. The first draft of the manuscript was written by Y. K., and all authors read, revised on previous versions of the manuscript, and approved the final manuscript.

Corresponding author

Correspondence to Koji Kawakami.

Ethics declarations

Ethics approval

This study was approved by the Ethics Committee of the Graduate School and Faculty of Medicine, Kyoto University (approval number: R3038; date: July 1, 2021). This study was performed in accordance with the ethical guidelines for medical and health research involving human subjects by the Ministry of Health, Labor, and Welfare.

Consent to participate

The need for informed consent was waived because anonymized data were used.

Consent for publication

Not applicable.

Conflict of interests

Y. K. is a company employee of Taiho Pharmaceutical Co., Ltd. M. T. received a consultation fee from Eisai Co., Ltd. K. K. received consultation fees from LEBER, Inc., JMDC Inc., Shin Nippon Biomedical Laboratories, Ltd., and Advanced Medical Care Inc.; executive compensation from Cancer Intelligence Care Systems, Inc.; honoraria from Mitsubishi Chemical Holdings Corporation, Mitsubishi Corporation, Pharma Business Academy, and Toppan Inc.; research funds from Eisai Co., Ltd., Kyowa Kirin Co., Ltd., Sumitomo Pharma Co., Ltd., Mitsubishi Corporation., and Real World Data, Co., Ltd.; and held stock in Real World Data, Co., Ltd. The other authors have no direct or indirect conflicts of interest.

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Kunitomi, Y., Nakashima, M., Takeuchi, M. et al. Efficacy of Daikenchuto in the prevention of bowel obstruction in patients with colorectal cancer undergoing laparoscopic surgery: An observational study using a Japanese administrative claims database. Support Care Cancer 31, 133 (2023). https://doi.org/10.1007/s00520-023-07599-5

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