A validation study of the WHO analgesic ladder: a two-step vs three-step strategy.
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.
Maltoni
Marco
M
Palliative Care Unit, Forlimpopoli Hospital, Via Duca d'Aosta 33, 47034 Forlimpopoli (FC), Italy. ma.maltoni@ausl.fo.it
Scarpi
Emanuela
E
Modonesi
Caterina
C
Passardi
Alessandro
A
Calpona
Sebastiano
S
Turriziani
Adriana
A
Speranza
Raffaella
R
Tassinari
Davide
D
Magnani
Pierantonio
P
Saccani
Denis
D
Montanari
Luigi
L
Roudnas
Britt
B
Amadori
Dino
D
Fabbri
Laura
L
Nanni
Oriana
O
Raulli
Paola
P
Poggi
Barbara
B
Fochessati
Francesca
F
Giannunzio
Donatella
D
Barbagallo
Maria Lucia
ML
Minnotti
Vincenzo
V
Betti
Maura
M
Giordani
Stefano
S
Piazza
Elena
E
Scapaticci
Roberto
R
Ferrario
Sabrina
S
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
D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal