PMID- 30863474
OWN - NLM
STAT- MEDLINE
DCOM- 20190610
LR  - 20200225
IS  - 1918-1523 (Electronic)
IS  - 1203-6765 (Print)
IS  - 1203-6765 (Linking)
VI  - 2019
DP  - 2019
TI  - Gabapentin versus Transdermal Fentanyl Matrix for the Alleviation of Chronic 
      Neuropathic Pain of Radicular Origin: A Randomized Blind Multicentered 
      Parallel-Group Noninferiority Trial.
PG  - 4905013
LID - 10.1155/2019/4905013 [doi]
LID - 4905013
AB  - A number of studies have been published proposing various approaches to the 
      treatment of neuropathic pain; however, to our knowledge, no attempts have been 
      made to compare gabapentin and fentanyl in patients with lumbar radiculopathy. We 
      evaluated the relative efficacy and safety of fentanyl matrix and gabapentin for 
      the treatment of chronic neuropathic pain of radicular origin. The study was 
      designed as a randomized blind multicentered parallel-group noninferiority trial. 
      A total of 108 patients with moderate-to-severe pain (>/=4 intensity on an 11-point 
      numeric rating scale) were randomly prescribed either fentanyl matrix or 
      gabapentin over a period of 56 days. In the primary analysis, the noninferiority 
      of fentanyl matrix treatment was evaluated in relation to the efficacy of 
      gabapentin based on the pain intensity difference (PID) at 56 days after the 
      first dose of the drugs. Secondary endpoints included pain relief, improvement in 
      functional status (the Korean-Oswestry Disability Index (K-ODI)), improvement in 
      depressive symptoms (Korean-Beck Depression Index (K-BDI)) between the 28th and 
      56th day, and adverse events (AEs). Analysis of the primary efficacy endpoint 
      established the noninferiority of fentanyl matrix compared with gabapentin, with 
      no statistically significant difference observed in the PID after 56 days for the 
      two treatment groups. Similarly, analysis of pain relief revealed no significant 
      differences between the groups on days 28 and 56. There was no difference in the 
      K-ODI and K-BDI between the groups during the study period. The overall incidence 
      of at least one AE was similar for fentanyl matrix (67.3%) and gabapentin 
      (69.6%). The most commonly reported AEs for patients treated with fentanyl matrix 
      and gabapentin included dizziness (30.8% vs. 44.6%, respectively), somnolence 
      (26.9% vs. 35.7%), and constipation (15.4% vs. 17.9%). This study demonstrated 
      that the analgesic effect of fentanyl matrix is noninferior in comparison with 
      gabapentin and supports the use of fentanyl matrix as an effective and safe 
      treatment for moderate-to-severe chronic neuropathic pain. This trial is 
      registered with NCT01127100.
FAU - Hwang, Chang Ju
AU  - Hwang CJ
AUID- ORCID: 0000-0001-5666-3135
AD  - Department of Orthopaedic Surgery, Asan Medical Center, University of Ulsan 
      College of Medicine, Seoul, Republic of Korea.
FAU - Lee, Jae Hyup
AU  - Lee JH
AUID- ORCID: 0000-0002-2141-0266
AD  - Department of Orthopaedic Surgery, Seoul National University College of Medicine, 
      Seoul, Republic of Korea.
FAU - Kim, Jung-Hoon
AU  - Kim JH
AUID- ORCID: 0000-0002-9997-0263
AD  - Department of Orthopaedic Surgery, Inje University Ilsan Paik Hospital, Inje 
      University College of Medicine, Goyang, Republic of Korea.
FAU - Min, Sang Hyuk
AU  - Min SH
AD  - Department of Orthopaedic Surgery, Dankook University Hospital, Cheonan, Republic 
      of Korea.
FAU - Park, Kun-Woo
AU  - Park KW
AD  - Department of Orthopaedic Surgery, Bundang Chuk Hospital, Seongnam, Republic of 
      Korea.
FAU - Seo, Hyoung-Yeon
AU  - Seo HY
AD  - Department of Orthopaedic Surgery, Chonnam National University Hospital, Gwangju, 
      Republic of Korea.
FAU - Song, Kwang-Sup
AU  - Song KS
AD  - Department of Orthopaedic Surgery, Chung-Ang University College of Medicine, 
      Seoul, Republic of Korea.
LA  - eng
SI  - ClinicalTrials.gov/NCT01127100
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20190204
PL  - United States
TA  - Pain Res Manag
JT  - Pain research & management
JID - 9612504
RN  - 0 (Analgesics)
RN  - 6CW7F3G59X (Gabapentin)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Analgesics/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Fentanyl/*administration & dosage
MH  - Gabapentin/*therapeutic use
MH  - Humans
MH  - Low Back Pain/drug therapy
MH  - Male
MH  - Middle Aged
MH  - Neuralgia/*drug therapy
MH  - Pain Measurement
MH  - Radiculopathy/drug therapy
MH  - Transdermal Patch
PMC - PMC6378801
EDAT- 2019/03/14 06:00
MHDA- 2019/06/14 06:00
PMCR- 2019/02/04
CRDT- 2019/03/14 06:00
PHST- 2018/08/16 00:00 [received]
PHST- 2019/01/09 00:00 [revised]
PHST- 2019/01/15 00:00 [accepted]
PHST- 2019/03/14 06:00 [entrez]
PHST- 2019/03/14 06:00 [pubmed]
PHST- 2019/06/14 06:00 [medline]
PHST- 2019/02/04 00:00 [pmc-release]
AID - 10.1155/2019/4905013 [doi]
PST - epublish
SO  - Pain Res Manag. 2019 Feb 4;2019:4905013. doi: 10.1155/2019/4905013. eCollection 
      2019.