Supportive Care in Cancer

, Volume 13, Issue 11, pp 888–894

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


    • Palliative Care UnitForlimpopoli Hospital
  • Emanuela Scarpi
    • Unit of Biostatistics and Clinical TrialsIstituto Oncologico Romagnolo
  • Caterina Modonesi
    • Palliative Care UnitForlimpopoli Hospital
  • Alessandro Passardi
    • Division of Oncology and DiagnosticsMorgagni-Pierantoni Hospital
  • Sebastiano Calpona
    • Division of Oncology and DiagnosticsMorgagni-Pierantoni Hospital
  • Adriana Turriziani
    • Villa Speranza HospiceCatholic University of the Sacred Heart
  • Raffaella Speranza
    • Palliative Care UnitBassini Hospital
  • Davide Tassinari
    • Department of OncologyInfermi Hospital
  • Pierantonio Magnani
    • Casa Madonna dell’Uliveto HospicePalliative Care Residential Center
  • Denis Saccani
    • Reggio Emilia Local Health and Social Services
  • Luigi Montanari
    • Oncology UnitLugo Hospital
  • Britt Roudnas
    • Department of OncologyInfermi Hospital
  • Dino Amadori
    • Division of Oncology and DiagnosticsMorgagni-Pierantoni Hospital
Original Article

DOI: 10.1007/s00520-005-0807-6

Cite this article as:
Maltoni, M., Scarpi, E., Modonesi, C. et al. Support Care Cancer (2005) 13: 888. doi:10.1007/s00520-005-0807-6


Goals of work

The 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.


Patients 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.


Fifty-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 ≥5 (22.8 vs 28.6%, p<0.001) and ≥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.


Our 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.


Cancer painAnalgesic ladderWHO guidelinesOpioidsPain assessment

Copyright information

© Springer-Verlag 2005