UNLABELLED: SUMMARY AIM: The aim of this study was to evaluate the efficacy and safety of combined transdermal buprenorphine and pregabalin in chronic low back pain. PATIENTS & METHODS: A total of 45 patients with chronic low back pain were recruited into the study. For an initial 3-week period, all patients received transdermal buprenorphine 35 µg/h. After 3 weeks of only transdermal buprenorphine 35 µg/h, patients were randomized (single-blind) to receive transdermal buprenorphine 35 µg/h plus pregabalin 300 mg/day (group A) or transdermal buprenorphine 35 µg/h plus placebo (group B), and were observed for a further 3-week period. Efficacy parameters were weekly mean Visual Analog Scale (VAS) scores, the Pain Rating Index (PRI) of the Short-Form McGill Pain Questionnaire (SF-MPQ), the Present Pain Index (PPI) of the SF-MPQ and sleep interference. We also evaluated the use of rescue medication (paracetamol [acetaminophen]) and the presence of adverse events. RESULTS: A total of 44 patients were evaluated for efficacy and safety parameters. Pain relief, as assessed by VAS, PPI and PRI, improved significantly (p < 0.05) in all patients after the first week of treatment with only transdermal buprenorphine. Following randomization, only patients in group A showed further reductions in the mean VAS, PPI and PRI scores. Moreover, patients in group A had a lower consumption of rescue medication than those in group B. There was a low incidence of mild adverse events in both group A and group B, with no serious adverse events in either group. CONCLUSION:Pregabalin 300 mg/day as an add-on to transdermal buprenorphine 35 µg/h led to significant pain reduction and a significant reduction of interference with sleep quality in patients with chronic low back pain.
RCT Entities:
UNLABELLED: SUMMARY AIM: The aim of this study was to evaluate the efficacy and safety of combined transdermal buprenorphine and pregabalin in chronic low back pain. PATIENTS & METHODS: A total of 45 patients with chronic low back pain were recruited into the study. For an initial 3-week period, all patients received transdermal buprenorphine 35 µg/h. After 3 weeks of only transdermal buprenorphine 35 µg/h, patients were randomized (single-blind) to receive transdermal buprenorphine 35 µg/h plus pregabalin 300 mg/day (group A) or transdermal buprenorphine 35 µg/h plus placebo (group B), and were observed for a further 3-week period. Efficacy parameters were weekly mean Visual Analog Scale (VAS) scores, the Pain Rating Index (PRI) of the Short-Form McGill Pain Questionnaire (SF-MPQ), the Present Pain Index (PPI) of the SF-MPQ and sleep interference. We also evaluated the use of rescue medication (paracetamol [acetaminophen]) and the presence of adverse events. RESULTS: A total of 44 patients were evaluated for efficacy and safety parameters. Pain relief, as assessed by VAS, PPI and PRI, improved significantly (p < 0.05) in all patients after the first week of treatment with only transdermal buprenorphine. Following randomization, only patients in group A showed further reductions in the mean VAS, PPI and PRI scores. Moreover, patients in group A had a lower consumption of rescue medication than those in group B. There was a low incidence of mild adverse events in both group A and group B, with no serious adverse events in either group. CONCLUSION:Pregabalin 300 mg/day as an add-on to transdermal buprenorphine 35 µg/h led to significant pain reduction and a significant reduction of interference with sleep quality in patients with chronic low back pain.
Authors: Joseph V Pergolizzi; Robert B Raffa; Charles Fleischer; Gianpietro Zampogna; Robert Taylor Journal: J Pain Res Date: 2016-10-31 Impact factor: 3.133