Cancer pain treatment following the World Health Organization guidelines is
effective and feasible. However, the evidence supporting the use of opioid
s for mild to moderate pain on the second step of the analgesic ladder is w
idely discussed. The present evaluation compares the efficacy and safety of
high doses of oral tramadol (greater than or equal to 300 mg/d) with low d
oses of oral morphine (less than or equal to 60 mg/d). Patients were includ
ed in this nonblinded and nonrandomized study if the combination of a nonop
ioid analgesic and up to 250 mg/d of oral tramadol was inadequate. 810 pati
ents received oral tramadol for a total of 23,497 days, and 848 patients re
ceived oral morphine for a total of 24,695 days. The average dose of tramad
ol was 428 +/- 101 mg/d (range 300-600 mg/d); the average dose of morphine
was 42 +/- 13 mg/d (range 10-60 mg/d). Additional nonopioid analgesics were
given on more than 95% of days. Antiemetics, laxatives, neuroleptics, and
steroids were prescribed significantly more frequently in the morphine grou
p; the use of other adjuvants was similar in both groups.
The mean pain intensity on a 0-100 numerical rating scale (NRS) was 27 +/-
21 (95% CI 26-29) in the tramadol and 26 +/- 20 (95% CI 24-27) in the morph
ine group (NS). The analgesic efficacy was good in 74% and 78%, satisfactor
y in 10% and 7%, and inadequate in 16% and 15% of patients receiving tramad
ol and morphine, respectively (NS). Constipation, neuropsychological sympto
ms, and pruritus were observed significantly more frequently with low-dose
morphine; other symptoms had similar frequencies in both groups. These data
suggest that tramadol can be used for the treatment of cancer pain, when n
onopioids alone are not effective. High doses of tramadol are effective and
safe. (C) U.S. Cancer Pain Relief Committee, 1999.