An international, open-label, randomised trial comparing a two-step approach versus the standard three-step approach of the WHO analgesic ladder in patients with cancer.

Autor:	Fallon M; Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh. Electronic address: Marie.Fallon@ed.ac.uk., Dierberger K; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK., Leng M; Makerere University, Kampala, Uganda., Hall PS; Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK., Allende S; Instituto Nacional de Cancerologia, Mexico City, Mexico., Sabar R; Sabar Health, Even Yehuda, Israel., Verastegui E; Instituto Nacional de Cancerologia, Mexico City, Mexico., Gordon D; Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh., Grant L; Global Health Academy, Usher Institute, University of Edinburgh, Edinburgh, UK., Lee R; Makerere University, Kampala, Uganda., McWillams K; NHS Lanarkshire, Glasgow, UK., Murray GD; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK., Norris L; Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh., Reid C; NHS Lothian, Edinburgh, UK., Sande TA; Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh., Caraceni A; Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy., Kaasa S; European Palliative Care Research Centre (PRC) Oslo University Hospital, Oslo, Norway; University of Oslo, Oslo, Norway., Laird BJA; Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh; St Columba's Hospice, Edinburgh, UK.
Jazyk:	angličtina
Zdroj:	Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2022 Dec; Vol. 33 (12), pp. 1296-1303. Date of Electronic Publication: 2022 Aug 30.
DOI:	10.1016/j.annonc.2022.08.083
Abstrakt:	Background: Worldwide, cancer pain management follows the World Health Organization (WHO) three-step analgesic ladder. Using weak opioids (e.g. codeine) at step 2 is debatable with low-dose strong opioids being potentially better, particularly in low- and middle-income countries where weak opioids are expensive. We wanted to assess the efficiency, safety and cost of omitting step 2 of the WHO ladder. Patients and Methods: We carried out an international, open-label, randomised (1 : 1) parallel group trial. Eligible patients had cancer, pain ≥4/10 on a 0-10 numerical rating scale, required at least step 1 (paracetamol) of the WHO ladder and were randomised to the control arm (weak opioid, step 2 of the WHO ladder) or the experimental arm (strong opioid, step 3). Primary outcome was time to stable pain control (3 consecutive days with pain ≤3). Secondary outcomes included distress, opioid-related side-effects and costs. The primary outcome analysis was by intention to treat and the follow-up was for 20 days. Results: One hundred and fifty-three patients were randomised (76 control, 77 experimental). There was no statistically significant difference in time to stable pain control between the arms, P = 0.667 (log-rank test). The adjusted hazard ratio for the control arm was 1.03 (95% confidence interval 0.72-1.49). In the control arm, 38 patients (53%) needed to change to a strong opioid due to ineffective analgesia. The median time to change was day 6 (interquartile range 4-11). Compared to the control arm, patients in the experimental arm had less nausea (P = 0.009) and costs were less. Conclusion: This trial provides some evidence that the two-step approach is an alternative option for cancer pain management. (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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