• Support Care Cancer · Nov 2005

    Randomized Controlled Trial

    A validation study of the WHO analgesic ladder: a two-step vs three-step strategy.

    • Marco Maltoni, Emanuela Scarpi, Caterina Modonesi, Alessandro Passardi, Sebastiano Calpona, Adriana Turriziani, Raffaella Speranza, Davide Tassinari, Pierantonio Magnani, Denis Saccani, Luigi Montanari, Britt Roudnas, Dino Amadori, Laura Fabbri, Oriana Nanni, Paola Raulli, Barbara Poggi, Francesca Fochessati, Donatella Giannunzio, Maria Lucia Barbagallo, Vincenzo Minnotti, Maura Betti, Stefano Giordani, Elena Piazza, Roberto Scapaticci, and Sabrina Ferrario.
    • Palliative Care Unit, Forlimpopoli Hospital, Via Duca d'Aosta 33, 47034 Forlimpopoli (FC), Italy. ma.maltoni@ausl.fo.it
    • Support Care Cancer. 2005 Nov 1; 13 (11): 888-94.

    Goals Of WorkThe aims of the present study were to verify whether an innovative therapeutic strategy for the treatment of mild-moderate chronic cancer pain, passing directly from step I to step III of the WHO analgesic ladder, is more effective than the traditional three-step strategy and to evaluate the tolerability and therapeutic index in both strategies.MethodsPatients aged 18 years or older with multiple viscera or bone metastases or with locally advanced disease were randomized. Pain intensity was assessed using a 0-10 numerical rating scale based on four questions selected from the validated Italian version of the Brief Pain Inventory. Treatment-specific variables and other symptoms were recorded at baseline up to a maximum follow-up of 90 days per patient.ResultsFifty-four patients were randomized onto the study, and pain intensity was assessed over a period of 2,649 days. The innovative treatment presented a statistically significant advantage over the traditional strategy in terms of the percentage of days with worst pain > or =5 (22.8 vs 28.6%, p < 0.001) and > or =7 (8.6 vs 11.2%, p = 0.023). Grades 3 and 4 anorexia and constipation were more frequently reported in the innovative strategy arm, although prophylactic laxative therapy was used less in this setting.ConclusionsOur preliminary data would seem to suggest that a direct move to the third step of the WHO analgesic ladder is feasible and could reduce some pain scores but also requires careful management of side effects.

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