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Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal symptoms in patients with a history of colon and rectosigmoid cancer surgery: a randomized crossover study

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Abstract

Purpose

This randomized crossover trial investigated the effects of Daikenchuto (DKT: TJ-100) on gastrointestinal symptoms of patients after colon and rectosigmoid cancer surgery.

Methods

Among patients who had completed surgery for colon cancer, including rectosigmoid cancer, over 6 months ago, 20 who complained of gastrointestinal symptoms were enrolled. Subjects were randomly assigned to two sequences: sequences: A and B. In period 1, sequence A subjects were orally administered DKT, whereas sequence B subjects were untreated for 28 days. After a 5-day interval, in period 2, sequences A and B were reversed. Quality-of-life markers (GSRS and VAS), the Sitzmark transit study, the orocecal transit time (lactulose hydrogen breath test) and Gas volume score were evaluated before and after each period with findings compared between the presence of absence of DKT administration.

Results

Between sequences, there were no significant differences in clinicopathological characters or any evaluations before randomization. There was no carryover effect in this crossover trial. The administration of DKT significantly ameliorated the GSRS in total, indigestion, and diarrhea, although the planned number of subjects for inclusion in this trial was not reached.

Conclusions

DKT may ameliorate subjective symptoms for postoperative patients who complain of gastrointestinal symptoms.

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Data availability

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

The authors have no acknowledgments to report.

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Authors and Affiliations

  1. Department of Gastroenterological Surgery and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan

    Haruki Sada, Hiroyuki Sawada, Masakazu Tokunaga, Manabu Shimomura, Hiroyuki Egi, Hideki Ohdan & Takao Hinoi

  2. Department of Surgery, Kure Medical Center and Chugoku Cancer Center, National Hospital Organization, 3-1 Aoyama-cho, Kure, 737-0023, Japan

    Haruki Sada

  3. Department of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine, 454 Shizukawa, Toon, Ehime, 791-0295, Japan

    Hiroyuki Egi

  4. Center for Medical Education, Institute of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan

    Minoru Hattori

  5. Department of Infectious Disease, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan

    Hiroki Ohge

  6. Department of Clinical and Molecular Genetics, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan

    Takao Hinoi

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  1. Haruki Sada
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  2. Hiroyuki Sawada
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Correspondence to Takao Hinoi.

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Sada, H., Sawada, H., Tokunaga, M. et al. Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal symptoms in patients with a history of colon and rectosigmoid cancer surgery: a randomized crossover study. Surg Today 53, 873–881 (2023). https://doi.org/10.1007/s00595-022-02640-2

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