Evidence map›Paper›PMID 31231974›Full record

Observational studyCancer medicine2019

Incidence of opioid-induced constipation in Japanese patients with cancer pain: A prospective observational cohort study.

Akihiro Tokoro, Hisao Imai, Soichi Fumita, Toshiyuki Harada, Toshio Noriyuki, Makio Gamoh, Yusaku Akashi, Hiroki Sato, Yoshiyuki Kizawa

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05216328 (OMAMA-study - Prevention of Opioid-induced Constipation in Patients With Advanced Cancer), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05216328 phase4recruitingnot on this mapstarted 2022, after this paper: background citation

OMAMA-study - Prevention of Opioid-induced Constipation in Patients With Advanced Cancer

TypeinterventionalSponsorAmsterdam UMC, location VUmcRan2022 to 2025Enrolled330ConditionsConstipation, Opioid-InducedArmsMacrogol Only Product in Oral Dose Form, Magnesium hydroxide 724mg
3 · Its place in the literature

Who cites it

28 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Naldemedine for Opioid-Induced Constipation in Patients With Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  4. Article
  5. Dose-dependent association of naldemedine and magnesium oxide in the management of opioid-induced constipation.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Observational
  6. Article
  7. Article
  8. Article
  9. Efficacy of prophylactic laxatives against opioid-induced constipation: retrospective propensity score matching analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Akihiro TokoroDepartment of Psychosomatic Internal Medicine and Supportive and Palliative Care Team, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.ORCID 0000-0002-0635-7647
Hisao ImaiDivision of Respiratory Medicine, Gunma Prefectural Cancer Center, Gunma, Japan.ORCID 0000-0003-3097-4255
Soichi FumitaDepartment of Medical Oncology, Kindai University Nara Hospital, Nara, Japan.ORCID 0000-0003-0253-0681
Toshiyuki HaradaCenter for Respiratory Diseases, JCHO Hokkaido Hospital, Sapporo, Japan.ORCID 0000-0003-0825-5166
Toshio NoriyukiDepartment of Surgery, Onomichi General Hospital, Onomichi, Hiroshima, Japan.
Makio GamohDepartment of Medical Oncology, Osaki Citizen Hospital, Miyagi, Japan.
Yusaku AkashiDepartment of Medical Oncology, Kindai University Nara Hospital, Nara, Japan.
Hiroki SatoMedical Affairs, Shionogi & Co., Ltd, Osaka, Japan.ORCID 0000-0002-3346-5053
Yoshiyuki KizawaDepartment of Palliative Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.ORCID 0000-0003-2456-5092

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multicenter, prospective, observational cohort study assessed opioid induced constipation (OIC) in Japanese patients with cancer. Eligible patients had stable cancer and an ECOG PS of 0-2. OIC incidence based on the Rome IV diagnostic criteria was determined by patient diary entries during the first 14 days of opioid therapy. The proportion of patients with OIC was calculated for each 1-week period and the overall 2-week study period. Secondary measurements of OIC included the Bowel Function Index (BFI) score (patient assessment administered by physician), spontaneous bowel movements (SBMs) per week (patient assessment), and physician assessments. Medication for constipation was allowed. Two hundred and twenty patients were enrolled. The mean morphine-equivalent dose was 22 mg/day. By Rome IV criteria, the cumulative incidence of OIC was 56% (95% CI: 49.2%-62.9%); week 1, 48% (95% CI: 40.8%-54.6%); week 2, 37% (95% CI: 30.1%-43.9%). The cumulative incidence of OIC was lower in patients who received prophylactic agents for constipation (48% [95% CI: 38.1%-57.5%]) than in patients who did not (65% [95% CI: 55.0%-74.2%]). The cumulative incidences of OIC were 59% (95% CI: 51.9%-66.0%), 61% (95% CI: 54.3%-68.1%), and 45% (95% CI: 38.0%-51.8%) based on BFI scores, physician assessments, and SBM frequency, respectively. Frequency of BMs/week before starting opioids was the most influential factor for the occurrence of OIC. Utilization of prophylactic agents for constipation was associated with a modest effect on reducing the incidence of OIC. The incidences of OIC reported were variable depending on the diagnostic tool involved.

Indexed as

AdultAgedAnalgesics, OpioidCancer PainCohort StudiesFemaleHumansIncidenceJapanMaleMiddle AgedMorphineOpioid-Induced ConstipationProspective StudiesYoung AdultAnalgesics, OpioidMorphinecancer painopioidopioid-induced constipationprophylacticspontaneous bowel movements

Identifiers

PMID31231974
PMCPMC6712473

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.