Poulain, P., Denier, W., Douma, J., Hoerauf, K., Samija, M., Sopata, M., & Wolfram, G. (2008). Efficacy and safety of transdermal buprenorphine: A randomized, placebo-controlled trial in 289 patients with severe cancer pain. Journal of Pain and Symptom Management, 36(2), 117–125.doi: 10.1016/j.jpainsymman.2007.09.011
To investigate the analgesic efficacy and safety of a transdermal buprenorphine patch used by patients with chronic severe cancer pain
Eligible patients participated in an open-label two-week phase in which they stopped drug therapy with previously prescribed analgesics. In this phase patients started drug therapy that consisted of a 70 mcg buprenorphine (BUP) transdermal (TDS) patch applied every three days. Pain intensity scores and intake of rescue medication, sublingual BUP, indicated whether a patient responded to BUP TDS. At the end of two weeks, patients who responded to BUP TDS were assigned to the BUP TDS group or the placebo group for a two-week maintenance phase. Patients used rescue medication for breakthrough pain as needed. BUP and placebo patches were identical in appearance and adhesive properties. Twice daily patients reported current pain on a 10-point scale. Authors evaluated the amount of BUP rescue medication taken and patients’ global satisfaction with treatment. At each visit the patient was asked to report any new adverse event.
Randomized double-blind, placebo-controlled trial following an initial two-week open-label phase
Findings suggest that, for some patients, transdermal buprenorphine may be effective in the treatment of chronic cancer pain.
Transdermal buprenorphine may be helpful to some patients, but in this study more than one-third of cases did not respond to the treatment. The relevance of the findings of a placebo-controlled trial such as this one are questionable; patients with chronic pain would be expected to respond better to any pain medication than to placebo. Authors provide no information about the value of transdermal buprenorphine compared to the value of other analgesics.