title: A validation study of the WHO analgesic ladder: a two-step vs three-step strategy.
abstract: OBJECTIVE
  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 > 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.
  
  
  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.
authors.affiliation: Palliative Care Unit, Forlimpopoli Hospital, Via Duca d'Aosta 33, 47034 Forlimpopoli (FC), Italy. ma.maltoni@ausl.fo.it
authors.forename: Marco
authors.initials: M
authors.lastname: Maltoni
authors.forename: Emanuela
authors.initials: E
authors.lastname: Scarpi
authors.forename: Caterina
authors.initials: C
authors.lastname: Modonesi
authors.forename: Alessandro
authors.initials: A
authors.lastname: Passardi
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Calpona
authors.forename: Adriana
authors.initials: A
authors.lastname: Turriziani
authors.forename: Raffaella
authors.initials: R
authors.lastname: Speranza
authors.forename: Davide
authors.initials: D
authors.lastname: Tassinari
authors.forename: Pierantonio
authors.initials: P
authors.lastname: Magnani
authors.forename: Denis
authors.initials: D
authors.lastname: Saccani
authors.forename: Luigi
authors.initials: L
authors.lastname: Montanari
authors.forename: Britt
authors.initials: B
authors.lastname: Roudnas
authors.forename: Dino
authors.initials: D
authors.lastname: Amadori
authors.forename: Laura
authors.initials: L
authors.lastname: Fabbri
authors.forename: Oriana
authors.initials: O
authors.lastname: Nanni
authors.forename: Paola
authors.initials: P
authors.lastname: Raulli
authors.forename: Barbara
authors.initials: B
authors.lastname: Poggi
authors.forename: Francesca
authors.initials: F
authors.lastname: Fochessati
authors.forename: Donatella
authors.initials: D
authors.lastname: Giannunzio
authors.forename: Maria Lucia
authors.initials: ML
authors.lastname: Barbagallo
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Minnotti
authors.forename: Maura
authors.initials: M
authors.lastname: Betti
authors.forename: Stefano
authors.initials: S
authors.lastname: Giordani
authors.forename: Elena
authors.initials: E
authors.lastname: Piazza
authors.forename: Roberto
authors.initials: R
authors.lastname: Scapaticci
authors.forename: Sabrina
authors.initials: S
authors.lastname: Ferrario
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000145:classification / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010166:Palliative Care / Q000592:standards*; D017060:Patient Satisfaction; D015203:Reproducibility of Results; D014944:World Health Organization
chemical_list: D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal