The World Health Organization (WHO) guidelines for the treatment of
cancer pain recommend
nonopioid analgesics as first-line
therapy, so-called "weak"
analgesics combined with
nonopioid analgesics as second-line
therapy, and so-called "strong"
opioids (with
nonopioid analgesics) only as third-line
therapy. However, these guidelines can be questioned with regard to the extent of efficacy as well as the rationale for not using strong
opioids as first-line treatment, especially in terminal
cancer patients. The purpose of this randomized study was to prospectively compare the efficacy and tolerability of strong
opioids as first-line agents with the recommendations of the WHO in terminal
cancer patients. One hundred patients with mild-moderate
pain were randomized to treatment according to WHO guidelines or to treatment with strong
opioids. Evaluated outcomes included
pain intensity, need for change in
therapy, quality of life, Karnofsky Performance Status, general condition of the patient, and adverse events. No between-treatment differences were observed for changes in quality of life or performance status, but patients started on strong
opioids had significantly better
pain relief than patients treated according to WHO guidelines (P=0.041). Additionally, patients started on strong
opioids required significantly fewer changes in
therapy, had greater reduction in
pain when a change was initiated, and reported greater satisfaction with treatment than the comparator group (P=0.041). Strong
opioids were safe and well-tolerated, with no development of tolerance or serious adverse events. These data suggest the utility of strong
opioids for first-line treatment of
pain in patients with terminal
cancer.