Medline ® Abstract for Reference 29
of 'Cancer pain management: General principles and risk management for patients receiving opioids'
Randomized Trial of Low-Dose Morphine Versus Weak Opioids in Moderate Cancer Pain.
Bandieri E, Romero M, Ripamonti CI, Artioli F, Sichetti D, Fanizza C, Santini D, Cavanna L, Melotti B, Conte PF, Roila F, Cascinu S, Bruera E, Tognoni G, Luppi M
J Clin Oncol. 2016 Feb;34(5):436-42. Epub 2015 Dec 7.
PURPOSE: The WHO guidelines on cancer pain management recommend a sequential three-step analgesic ladder. However, conclusive data are lacking as to whether moderate pain should be treated with either step II weak opioids or low-dose step III strong opioids.
PATIENTS AND METHODS: In a multicenter, 28-day, open-label randomized controlled study, adults with moderate cancer pain were assigned to receive either a weak opioid or low-dose morphine. The primary outcome was the number of responder patients, defined as patients with a 20% reduction in pain intensity on the numerical rating scale.
RESULTS: A total of 240 patients with cancer (118 in the low-dose morphine and 122 in the weak-opioid group) were included in the study. The primary outcome occurred in 88.2% of the low-dose morphine and in 57.7% of the weak-opioid group (odds risk, 6.18; 95% CI, 3.12 to 12.24; P<.001). The percentage of responder patients was higher in the low-dose morphine group, as early as at 1 week. Clinically meaningful (≥30%) and highly meaningful (≥50%) pain reduction from baseline was significantly higher in the low-dose morphine group (P<.001). A change in the assigned treatment occurred more frequently in the weak-opioid group, because of inadequate analgesia. The general condition of patients, which was based on the Edmonton Symptom Assessment System overall symptom score, was better in the morphine group. Adverse effects were similar in both groups.
CONCLUSION: In patients with cancer and moderate pain, low-dose morphine reduced pain intensity significantly compared with weak opioids, with a similarly good tolerability and an earlier effect.
Elena Bandieri and Fabrizio Artioli, UnitàSanitaria Locale, Modena; Marilena Romero, Daniela Sichetti, Caterina Fanizza, and Gianni Tognoni, Fondazione Mario Negri Sud, Santa Maria Imbaro, Chieti; Carla Ida Ripamonti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Istituto Nazionale Tumori, Milan; Daniele Santini, Unitàdi Oncologia Medica, UniversitàCampus Bio-Medico, Rome; Luigi Cavanna, Ospedale di Piacenza, Piacenza; Barbara Melotti, Unitàdi Oncologia Medica, Ospedale Sant'Orsola-Malpighi, Bologna; Pier Franco Conte, Istituto Oncologico Veneto, IRCCS, Universitàdi Padova, Padova; Fausto Roila, Ospedale "S.Maria", Terni; Stefano Cascinu, Azienda Ospedaliero Universitaria Ospedali Riuniti, UniversitàPolitecnica delle Marche, Ancona; Mario Luppi, Universitàdegli Studi di Modena e Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Modena, Italy; and Eduardo Bruera, MD Anderson Cancer Center, Houston, TX.