A feasibility study of transdermal buprenorphine versus transdermal fentanyl in the long-term management of persistent non-cancer pain.

OBJECTIVE: Buprenorphine and fentanyl transdermal patches are used widely for the management of persistent malignant and nonmalignant pain. Buprenorphine and fentanyl transdermal patches, both potent opioids, are considered to be equally efficacious in managing persistent pain. Various retrospective studies comparing dosage changes of buprenorphine and fentanyl patches in persistent pain patients have been completed; however, no long-term prospective, randomized, clinical study has compared the effectiveness of these patches. The objective of the present study was to satisfy this need. AIMS: This study aims to compare prospectively the long-term efficacy, acceptability, and side effects of both of these patches in patients with persistent pain. This study would examine the feasibility and lay the groundwork for a larger, multicenter study where such efficacy and safety outcomes of the two medications can be adequately assessed.
DESIGN: The participants were 46 adults (range 22-80 years.) with nonmalignant persistent pain (mean = 11 years), predominantly with lower back pain. Data were obtained monthly for 12 months. Participants recruited were opioid-naïve patients, having pain for the greater part of the day and night, and appropriate for treatment with transdermal patches. After initial assessment, participants were randomly allocated to either buprenorphine or fentanyl patch treatment. Participants were then titrated to optimal doses of medication. Patients with adverse effects or unsatisfactory pain relief were treated alternatively and discontinued from the study.
RESULTS: Nearly one-third of all patients, 41% (8 of 22) of the transdermal buprenorphine (TDB) group and 37.5% (8 of 24) of the transdermal fentanyl (TDF) group stopped treatment due to unacceptable side effects or inadequate pain relief. The remaining participants showed a similar trend in the improvement of pain intensity, physical activity, sleep, and mood throughout the study. Significant relief in the intensity of pain was achieved for the initial 6 months and the effects stabilized in the remainder of the study in both groups. There were no significant group differences over time. However, a higher equipotent dose of fentanyl was required for comparable pain relief. Compared with TDF group, the TDB group initially experienced relatively less side effects. However, a greater number of buprenorphine users suffered from local skin reactions. Buprenorphine users had significant improvement in mood. Thirty-one percent (5 of 16) of the buprenorphine group and 57% (8 of 14) of the fentanyl users needed additional pain relief medications by the end of 3 months. By the end of 12 months, a significant number 78% (7 of 9) of buprenorphine users but comparatively fewer 44% (4 of 9) of the fentanyl group used rescue medicines. Both had more doctor visits in the latter half of the study.
CONCLUSION: Thirty percent of the total number of patients discontinued treatment because of side effects or unsatisfactory pain relief. For those continuing treatment, clinical improvements were seen in the initial 6 months in both groups. Fifty percent of the TDB and 43% of TDF groups had significant relief in 3 months, which persisted up to 6 months. Only 11% and 13% of patients, respectively, had sustained relief after 6 months. Twenty percent more patients in the TDB group benefited significantly in symptoms of depression from TDB compared with the TDF group. Interestingly, switching of patches seemed to increase acceptability by preventing adverse effects and tolerance. Confirmation of these effects should be studied in future with a multicenter study and larger sample. Wiley Periodicals, Inc.

RCT Entities:   Population Interventions Outcomes