title: Comparison of the effectiveness between generic and original form of gabapentin for pain relief in suspected neuropathic component of low back pain.
abstract: OBJECTIVE
  To compare effectiveness of the generic form of gabapentin with its original form.
  
  
  METHODS
  A single-blind evaluation randomized controlled trial (RCT) of patients that were diagnosed with low back pain with suspected neuropathic component at the Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital were included in the present study. Patients were randomized into two treatment groups. The first group received gabapentin generic form (GGF) or Gabapentin Sandoz, whereas the other received gabapentin original form (GOF) or Neurontin. The primary endpoint was the VisualAnalogue Scale (VAS) pain score. The secondary endpoints were the Thai version of the Oswestry low back pain disability index (ODI) score, lumbar spine's range ofmotion, safety profiles, and average medical cost. Non-inferiority was pre-specified at 20%. The amount of medication was increased to maintain VAS less than 40 mm and tapered off in case of adverse event.
  
  
  RESULTS
  Forty-one patients, GGF 21 and GOF 20, had completed the study. At 8th week, the visual analogue scale (VAS) and ODI scores significantly decreased in both groups. Mean and standard deviation (SD) of VAS improvement were 31.4+/- 22.1 mm for the GGF group versus 34.3 +/- 22.6 mm for the GOF group (p = 0.69), within pre-specified 20% non-inferiority margin (difference 2.9 mm 95% CI-17.7 mm, 11.8 mm). Mean ODI improvement was 1.1% for the GGF group versus 7.6%for the GOF group (p = 0.42), within pre-specified 20% non-inferiority margin, (difference 3.5, 95% CI = -12.3%, 5.3%). Both groups have significantly gainedflexion of the lumbar spine. Both groups revealed similar safety profiles. The GGF group showed significantly lower average cost for medications (2,844 baht).
  
  
  CONCLUSIONS
  In comparison with the GOF (Neurontin) group, the non-inferior effectiveness for pain reduction and improvement of back function has been revealed in the GGF (Gabapentin Sandoz) group. Similar safety profiles were demonstrated in both groups. The average medication cost of GGF is much lower than GOF (4.67 times).
authors.forename: Supattra
authors.initials: S
authors.lastname: Kantito
authors.forename: Supattra
authors.initials: S
authors.lastname: Kantito
authors.forename: Natthiya
authors.initials: N
authors.lastname: Tantisiriwat
authors.forename: Krisna
authors.initials: K
authors.lastname: Piravej
mesh_terms: D000328:Adult; D000368:Aged; D000588:Amines / Q000008:administration & dosage* / Q000627:therapeutic use; D000700:Analgesics / Q000008:administration & dosage* / Q000627:therapeutic use; D003509:Cyclohexanecarboxylic Acids / Q000008:administration & dosage* / Q000627:therapeutic use; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D000077206:Gabapentin; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D016037:Single-Blind Method; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D000588:Amines; D000700:Analgesics; D003509:Cyclohexanecarboxylic Acids; D016568:Drugs, Generic; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin