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Meta-Analysis
. 2018 Apr 5;4(4):CD012271.
doi: 10.1002/14651858.CD012271.pub2.

Daikenchuto for reducing postoperative ileus in patients undergoing elective abdominal surgery

Nobuaki Hoshino  1 , Toshihiko Takada, Koya Hida, Suguru Hasegawa, Toshi A Furukawa, Yoshiharu Sakai
Affiliations
Meta-Analysis

Daikenchuto for reducing postoperative ileus in patients undergoing elective abdominal surgery

Nobuaki Hoshino et al. Cochrane Database Syst Rev. .

Retraction in

Abstract

Background: Postoperative ileus is a major complication for persons undergoing abdominal surgery. Daikenchuto, a Japanese traditional medicine (Kampo), is a drug that may reduce postoperative ileus.

Objectives: To assess the efficacy and safety of Daikenchuto for reducing prolonged postoperative ileus in persons undergoing elective abdominal surgery.

Search methods: We searched the following databases on 3 July 2017: CENTRAL, MEDLINE, Embase, ICHUSHI, WHO (World Health Organization) International Clinical Trials Registry Platform (ICTRP), EU Crinical Trials registry (EU-CTR), UMIN Clinical Trials Registry (UMIN-CTR), ClinicalTrials.gov, The Japan Society for Oriental Medicine (JSOM), American Society of Clinical Oncology (ASCO), Society of American Gastrointestinal and Endscopic Surgeons (SAGES). We set no limitations on language or date of publication.

Selection criteria: We included randomised controlled trials (RCTs) comparing Daikenchuto with any control condition in adults, 18 years of age or older, undergoing elective abdominal surgery.

Data collection and analysis: We applied standard methodological procedures expected by Cochrane. Two review authors independently reviewed the articles identified by literature searches, extracted data, and assessed risk of bias of the included studies using the Cochrane software Review Manager 5.

Main results: We included seven RCTs with a total of 1202 participants. Overall, we judged the risk of bias as low in four studies and high in three studies. We are uncertain whether Daikenchuto reduced time to first flatus (mean difference (MD) -11.32 hours, 95% confidence interval (CI) -17.45 to -5.19; two RCTs, 83 participants; very low-quality evidence), or time to first bowel movement (MD -9.44 hours, 95% CI -22.22 to 3.35; four RCTs, 500 participants; very low-quality evidence) following surgery. There was little or no difference in time to resumption of regular solid food following surgery (MD 3.64 hours, 95% CI -24.45 to 31.74; two RCTs, 258 participants; low-quality evidence). There were no adverse events in either arm of the five RCTs that reported on drug-related adverse events (risk difference (RD) 0.00, 95% CI -0.02 to 0.02, 568 participants, low-quality evidence). We are uncertain of the effect of Daikenchuto on patient satisfaction (MD 0.09, 95% CI -0.19 to 0.37; one RCT, 81 participants; very low-quality of evidence). There was little or no difference in the incidence of any re-interventions for postoperative ileus before leaving hospital (risk ratio (RR) 0.99, 95% CI 0.06 to 15.62; one RCT, 207 participants; moderate-quality evidence), or length of hospital stay (MD -0.49 days, 95% CI -1.21 to 0.22; three RCTs, 292 participants; low-quality evidence).

Authors' conclusions: Evidence from current literature was unclear whether Daikenchuto reduced postoperative ileus in patients undergoing elective abdominal surgery, due to the small number of participants in the meta-analyses. Very low-quality evidence means we are uncertain whether Daikenchuto improved postoperative flatus or bowel movement. Further well-designed and adequately powered studies are needed to assess the efficacy of Daikenchuto.

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Conflict of interest statement

Nobuaki Hoshino has received writing fees from Igaku‐Shoin and Kanehara publishers.

Suguru Hasegawa has received lecture fees from Olympus, Johnson & Johnson, Covidien Japan, Stryker, Chugai, Taiho, Yakult. He has received grant or research support from the Japanese Ministry of Education, Culture, Sports, Science and Technology, and Taiho.

Toshihiko Takada has received a grant from St. Luke's Life Science Institute.

Koya Hida has received grants for research about the treatment of rectal cancer from the Japanese Society of Clinical Oncology, The Japanese Foundation for Research and Promotion of Endoscopy. He has received writing fees from the Medical View Company and the Nanko‐do Company.

Toshi A Furukawa has received lecture fees from Eli Lilly, Janssen, Meiji, Mitsubishi‐Tanabe, MSD, and Pfizer and consultancy fees from the Takeda Science Foundation. He has received royalties from Igaku‐Shoin and Nihon Bunka Kagaku‐sha publishers. He has received research support from Mochida and Mitsubishi‐Tanabe.

Yoshiharu Sakai has received lecture fees from Olympus, Johnson & Johnson, Covidien Japan, Stryker, Chugai, Taiho, Yakult, Takeda, Terumo. He has received grant or research support from the Japanese Ministry of Education, Culture, Sports, Science and Technology, Tsumura, Daiichisankyo, Taiho, Chugai, Yakult, Shionogi, Otsuka and Sanofi.

Figures

Figure 1
Figure 1
Study flow diagram
Figure 2
Figure 2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
Figure 3
Figure 3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
Figure 4
Figure 4
Trial Sequential Analysis for time from completion of operation to first bowel movement
Analysis 1.1
Analysis 1.1
Comparison 1 Daikenchuto versus control, Outcome 1 Time from completion of operation to first flatus (hours).
Analysis 1.2
Analysis 1.2
Comparison 1 Daikenchuto versus control, Outcome 2 Time from completion of operation to first bowel movement (hours).
Analysis 1.3
Analysis 1.3
Comparison 1 Daikenchuto versus control, Outcome 3 Time from completion of operation to resumption of regular solid food intake (hours).
Analysis 1.4
Analysis 1.4
Comparison 1 Daikenchuto versus control, Outcome 4 Any drug‐related adverse events.
Analysis 1.5
Analysis 1.5
Comparison 1 Daikenchuto versus control, Outcome 5 Patient satisfaction.
Analysis 1.6
Analysis 1.6
Comparison 1 Daikenchuto versus control, Outcome 6 Incidence ratio of any re‐interventions before leaving hospital.
Analysis 1.7
Analysis 1.7
Comparison 1 Daikenchuto versus control, Outcome 7 Length of postoperative hospital stay (days).
See this image and copyright information in PMC

References

References to studies included in this review

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References to studies excluded from this review

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References to ongoing studies

    1. Akamatsu H. Clinical effectiveness of daikenchuto (TJ‐100) on gastrointestinal symptom after colectomy in colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder [腹痛，腹部膨満感を有する便通障害患者における大腸癌手術後の腹痛，腹部膨満感等の消化器症状に対する大建中湯（TJ‐100）の臨床的効果の検討]. UMIN Clinical Trials Registry 2012;UMIN000008348.
    1. Eguchi T. Exploratory study of daikenchuto for nutritional management following colectomy of colon cancer [大腸癌術後の栄養管理法についての検討～大建中湯の探索的検討～]. UMIN Clinical Trials Registry 2011;UMIN000006413.
    1. Jensen C. Effect of TU‐100 in patients undergoing laparoscopic colectomy (TU100P2T3). ClinicalTrials.gov 2014;NCT02232893.
    1. Kaido T. Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation [成人肝臓移植術後の消化管障害に対するTJ‐100ツムラ大建中湯（医療用）の有効性に関する検討 ‐多施設共同による二重盲検無作為化比較臨床試験‐]. UMIN Clinical Trials Registry 2014;UMIN000014326.
    1. Mochida S. A tolerability and efficacy study of TU‐100 for the treatment of postoperative ileus. ClinicalTrials.gov 2005;NCT00266461.

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