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Maltoni, M., Scarpi, E., Modonesi, C., Passardi, A., Calpona, S., Turriziani, A., . . . Amadori, D. (2005). A validation study of the WHO analgesic ladder: A two-step vs. three-step strategy. Supportive Care in Cancer, 13, 888–894.
To determine if, on the WHO analgesic ladder, passing directly from step 1 to step 3 is more effective than the traditional three-step strategy for treating chronic cancer pain; to evaluate the tolerability and therapeutic index of both strategies
Intervention Characteristics/Basic Study Process
Over 24 months, patients were monitored at home by telephone or a home health nurse. The study design included two arms: in one, patients moved from step 1 to step 3 (with treatment with strong opioids); in the other, patients moved from step 1, to step 2 (with treatment with weak opioids), to step 3.
Sample Characteristics
The sample was composed of 54 patients.
Patients were age 18 and older.
The sample was composed of patients with multiple visceral or bone metastases or locally advanced disease.
Setting
Italy
Study Design
Randomized controlled trial
Measurement Instruments/Methods
Numeric Rating Scale (NRS), 0–10, to measure pain
Five-step scale, 0–4, to measure other symptoms
Five-step scale, 0–4, to measure degree of patient satisfaction
Use of coanalgesics, adjuvants, and other treatments (as established by a yes/no answer)
Results
Going from step 1 to step 3 resulted in a statistically significant advantage over the traditional progression. Authors did not report the P value.
Authors noted that all patients needed prophylactic treatment of constipation.
Conclusions
Preliminary data suggest that a direct move to the third step is feasible and could reduce some pain scores. The two-step strategy this study supports requires careful management of side effects.