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

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Abstract

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.

Methods

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.

Results

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.

Conclusions

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.

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Acknowledgements

The co-authorship of all the following group members is acknowledged: Laura Fabbri (Palliative Care Unit, Forlimpopoli Hospital, Forlimpopoli), Oriana Nanni (Unit of Biostatistics and Clinical Trials, Istituto Oncologico Romagnolo, Forlì), Paola Raulli (Palliative Care Unit, Bassini Hospital, Cinisello Balsamo), Barbara Poggi and Francesca Fochessati (Department of Oncology, Infermi Hospital, Rimini), Donatella Giannunzio and Maria Lucia Barbagallo (Palliative Care Unit, Azienda Istituti Ospitalieri, Cremona), Vincenzo Minotti and Maura Betti (Department of Oncology, Monteluce Polyclinic, Perugia), Stefano Giordani (Hospice-ADO Casa della Solidarietà, Ferrara), and Elena Piazza, Roberto Scapaticci, and Sabrina Ferrario (Department of Oncology, Luigi Sacco Hospital, Milan). We thank Gráinne Tierney for editing the manuscript.

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Authors and Affiliations

  1. Palliative Care Unit, Forlimpopoli Hospital, Via Duca d’Aosta 33, 47034, Forlimpopoli (FC), Italy

    Marco Maltoni & Caterina Modonesi

  2. Unit of Biostatistics and Clinical Trials, Istituto Oncologico Romagnolo, Forlì, Italy

    Emanuela Scarpi

  3. Division of Oncology and Diagnostics, Morgagni-Pierantoni Hospital, Forlì, Italy

    Alessandro Passardi, Sebastiano Calpona & Dino Amadori

  4. Villa Speranza Hospice, Catholic University of the Sacred Heart, Rome, Italy

    Adriana Turriziani

  5. Palliative Care Unit, Bassini Hospital, Cinisello Balsamo, Italy

    Raffaella Speranza

  6. Department of Oncology, Infermi Hospital, Rimini, Italy

    Davide Tassinari & Britt Roudnas

  7. Casa Madonna dell’Uliveto Hospice, Palliative Care Residential Center, Montericco di Albinea, Italy

    Pierantonio Magnani

  8. Reggio Emilia Local Health and Social Services, Reggio Emilia, Italy

    Denis Saccani

  9. Oncology Unit, Lugo Hospital, Lugo, Italy

    Luigi Montanari

Authors
  1. Marco Maltoni
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  2. Emanuela Scarpi
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  3. Caterina Modonesi
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  4. Alessandro Passardi
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  5. Sebastiano Calpona
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  6. Adriana Turriziani
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  7. Raffaella Speranza
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  8. Davide Tassinari
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  9. Pierantonio Magnani
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  10. Denis Saccani
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  11. Luigi Montanari
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  12. Britt Roudnas
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  13. Dino Amadori
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Corresponding author

Correspondence to Marco Maltoni.

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Maltoni, M., Scarpi, E., Modonesi, C. et al. A validation study of the WHO analgesic ladder: a two-step vs three-step strategy. Support Care Cancer 13, 888–894 (2005). https://doi.org/10.1007/s00520-005-0807-6

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  • DOI: https://doi.org/10.1007/s00520-005-0807-6

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