Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study.
A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p=0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p=0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p=0.0016). Both the Patient (p=0.023) and Clinician (p=0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness.
Gordh
Torsten E
TE
Multidisciplinary Pain Center, Uppsala University Hospital, S-751 85 Uppsala, Sweden Department of Anaesthesiology, University of Oslo, Rikshospitalet University Hospital, 0027 Oslo, Norway Department of Neurology, Danish Pain Research Centre, Aarhus University Hospital, Aarhus Sygehus Noerrebrogaede 44, Aarhus 8000, Denmark Pain Clinic, Department of Anaesthesiology, Karolinska University Hospital, Solna, S-171 76 Stockholm, Sweden Department of Anaestesiology, Umeå University Hospital S-901 85 Umeå, Sweden Department of Neurology, Linköping University Hospital, S-581 85 Linköping, Sweden Multidisciplinary Pain Center, Department of Medicine, Sahlgrenska University Hospital, Östra 41685 Göteborg, Sweden Department of Rehabilitation, Lund University Hospital S-221 85 Lund, Sweden Pain Clinic, Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Central Hospital, Haartmaninkatu 2A, 00029 HUS, Finland.
Stubhaug
Audun
A
Jensen
Troels S
TS
Arnèr
Staffan
S
Biber
Björn
B
Boivie
Jörgen
J
Mannheimer
Clas
C
Kalliomäki
Jarkko
J
Kalso
Eija
E
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000588:Amines / Q000494:pharmacology / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003509:Cyclohexanecarboxylic Acids / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D000077206:Gabapentin; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy* / Q000473:pathology; D010147:Pain Measurement / Q000187:drug effects / Q000379:methods; D059348:Peripheral Nerve Injuries; D010525:Peripheral Nerves / Q000187:drug effects* / Q000473:pathology; D020196:Trauma, Nervous System / Q000188:drug therapy / Q000473:pathology; D005680:gamma-Aminobutyric Acid / Q000494:pharmacology / Q000627:therapeutic use*
D000588:Amines; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin