Prevalence and impact of constipation and bowel dysfunction induced by strong opioids: a cross-sectional survey of 520 patients with cancer pain: DYONISOS study

Abstract

Objective:

To describe the prevalence of opioid-induced constipation (OIC) in patients with cancer pain according to the Knowles-Eccersley-Scott symptom score (KESS), the different symptoms of opioid-induced bowel dysfunction (OIBD), and to assess the impact of OIBD on patient’s quality-of-life.

Methods:

A cross-sectional observational study, using the KESS questionnaire and the physician’s subjective assessment of constipation, and other questionnaires and questions on constipation, OIBD, and quality-of-life, carried out on 1 day at oncology day centres and hospitals.

Results:

Five hundred and twenty patients were enrolled at 77 centres in France; 61.7% of patients (n = 321) showed a degree of constipation that is problematic for the patient according to KESS (between 9–39). Even more patients, 85.7% (n = 438), were considered constipated according to the physician’s subjective assessment—despite laxative use (84.7% of patients). Quality-of-life was significantly reduced in constipated vs non-constipated patients for both PAC-QoL (p < 0.0001 for total score and each dimension) and the SF-12 questionnaires (statistically significant for all dimensions except physical state and role physical). OIC and OIBD led to hospitalization (16% of patients), pain (75% of patients), and frequent changes in opioid and laxative treatment.

Key limitations:

This cross-sectional study, in a selected population of cancer patients, has measured prevalence and impact of OIBD. Further confirmation could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids

Conclusions:

Cancer patients taking opioids for pain are very frequently constipated, even if they are prescribed laxatives. This leads to relevant impairments of quality-of-life.

Keywords::

• Prevalence
• Opioid-induced constipation
• Bowel dysfunction
• Quality-of-life

Transparency

Declaration of funding

This study was designed and financed by Mundipharma SAS France and conducted under the sponsorship of Mundipharma SAS France.

Declaration of financial/other relationships

LA and SP were principal co-ordinators of this study and received fees from Mudiphama SAS France for participation to the study. LA has been a momentary board member and SP has been a board member for Mundipharma SAS. NB, LL, and VG participated as investigators in this study. NB has received honoraria as a speaker for Mundipharma symposium. LL has received honoraria as a speaker for Mundipharma meetings. BC was an employee of Mundipharma SAS France. CC is an employee of Mundipharma SAS France. All authors were involved in the development and writing of the manuscript. JME Peer Reviewers on this manuscript have no relevant financial relationships to disclose.

Acknowledgments

Written with the assistance of Hazel Olway, a Medical Writer at Mundipharma Research Ltd., and Catharina Buschmann-Kramm, R&D Communication Manager at Mundipharma Research GmbH & Co.KG. Petra Leyendecker, Michael Hopp, Catharina Buschmann-Kramm, and Björn Bosse (Mundipharma Research GmbH & Co. KG) gave expert input into the discussion of the results.

Notes

†BFI Copyright 2002, Mundipharma GmbH, City, Country; BFI is subject of European Patent Application Publication No. EP 1,860,988 and corresponding patents and applications in other countries.

*PAC-QOL, Janssen Global Services, LLC, City, State, Country, USA.