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Buprenorphine transdermal system compared with placebo reduces interference in functioning for chronic low back pain.
Postgrad Med. 2015 Jan; 127(1):38-45.PM

Abstract

OBJECTIVE

This study examines the efficacy of the buprenorphine transdermal system (BTDS) for reducing the interference of pain on physical and emotional functioning associated with chronic low back pain (CLBP).

METHODS

A post-hoc analysis used data from a randomized, placebo-controlled, double-blind trial of patients with moderate-to-severe CLBP. The Brief Pain Inventory (BPI) measured pain interference at screening, following a run-in period, and during the 12-week double-blind treatment phase. Statistical analyses examined treatment arm differences (BTDS vs placebo) for the following: BPI Interference subscale items and subscale scores at the trial end point (week 12); patterns of change in the Interference subscale scores over time; proportions of patients indicating mild or no interference following treatment; and proportions of patients showing improvement (30%, 50%, 2-point, or 4-point change in score from screening to week 12) for each item and subscale.

RESULTS

Mean scores for BPI Interference items and Interference subscale were significantly lower (ie, indicated less interference) for BTDS than for placebo (all P < 0.001). Treatment arm differences in Interference subscale scores emerged within 4 weeks of treatment. The BTDS patients were significantly more likely to indicate mild/no interference on 5 of 7 Interference subscale items following treatment (P < 0.05). For most comparisons, BTDS patients were significantly more likely to show criterion-level improvements in Interference item and subscale scores (P < 0.05 for differences).

DISCUSSION

Results indicate the efficacy of BTDS treatment, compared with placebo, for reducing the interference of pain on physical and emotional functioning in patients with moderate-to-severe CLBP. The advantage of BTDS was observed within 4 weeks of treatment, and was maintained throughout the 12-week treatment phase.

Authors+Show Affiliations

Optum , Lincoln, RI.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25526229

Citation

Yarlas, Aaron, et al. "Buprenorphine Transdermal System Compared With Placebo Reduces Interference in Functioning for Chronic Low Back Pain." Postgraduate Medicine, vol. 127, no. 1, 2015, pp. 38-45.
Yarlas A, Miller K, Wen W, et al. Buprenorphine transdermal system compared with placebo reduces interference in functioning for chronic low back pain. Postgrad Med. 2015;127(1):38-45.
Yarlas, A., Miller, K., Wen, W., Lynch, S. Y., Munera, C., Pergolizzi, J. V., Raffa, R., & Ripa, S. R. (2015). Buprenorphine transdermal system compared with placebo reduces interference in functioning for chronic low back pain. Postgraduate Medicine, 127(1), 38-45.
Yarlas A, et al. Buprenorphine Transdermal System Compared With Placebo Reduces Interference in Functioning for Chronic Low Back Pain. Postgrad Med. 2015;127(1):38-45. PubMed PMID: 25526229.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Buprenorphine transdermal system compared with placebo reduces interference in functioning for chronic low back pain. AU - Yarlas,Aaron, AU - Miller,Kate, AU - Wen,Warren, AU - Lynch,Shau Yu, AU - Munera,Catherine, AU - Pergolizzi,Joseph V,Jr AU - Raffa,Robert, AU - Ripa,Steven R, Y1 - 2014/12/15/ PY - 2014/12/20/entrez PY - 2014/12/20/pubmed PY - 2015/9/16/medline KW - Butrans KW - buprenorphine transdermal system KW - chronic low back pain KW - opioid treatment KW - pain interference SP - 38 EP - 45 JF - Postgraduate medicine JO - Postgrad Med VL - 127 IS - 1 N2 - OBJECTIVE: This study examines the efficacy of the buprenorphine transdermal system (BTDS) for reducing the interference of pain on physical and emotional functioning associated with chronic low back pain (CLBP). METHODS: A post-hoc analysis used data from a randomized, placebo-controlled, double-blind trial of patients with moderate-to-severe CLBP. The Brief Pain Inventory (BPI) measured pain interference at screening, following a run-in period, and during the 12-week double-blind treatment phase. Statistical analyses examined treatment arm differences (BTDS vs placebo) for the following: BPI Interference subscale items and subscale scores at the trial end point (week 12); patterns of change in the Interference subscale scores over time; proportions of patients indicating mild or no interference following treatment; and proportions of patients showing improvement (30%, 50%, 2-point, or 4-point change in score from screening to week 12) for each item and subscale. RESULTS: Mean scores for BPI Interference items and Interference subscale were significantly lower (ie, indicated less interference) for BTDS than for placebo (all P < 0.001). Treatment arm differences in Interference subscale scores emerged within 4 weeks of treatment. The BTDS patients were significantly more likely to indicate mild/no interference on 5 of 7 Interference subscale items following treatment (P < 0.05). For most comparisons, BTDS patients were significantly more likely to show criterion-level improvements in Interference item and subscale scores (P < 0.05 for differences). DISCUSSION: Results indicate the efficacy of BTDS treatment, compared with placebo, for reducing the interference of pain on physical and emotional functioning in patients with moderate-to-severe CLBP. The advantage of BTDS was observed within 4 weeks of treatment, and was maintained throughout the 12-week treatment phase. SN - 1941-9260 UR - https://www.unboundmedicine.com/medline/citation/25526229/Buprenorphine_transdermal_system_compared_with_placebo_reduces_interference_in_functioning_for_chronic_low_back_pain_ L2 - http://www.tandfonline.com/doi/full/10.1080/00325481.2014.992715 DB - PRIME DP - Unbound Medicine ER -