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. 2017 Aug 5;2017(8):CD012536. doi: 10.1002/14651858.CD012536.pub2
Study Treatment Adverse events Withdrawals
Arnold 2016 Intervention group (N = 54):
flexible‐dose pregabalin 75 to 450 mg/day
Control group (N = 53):
flexible‐dose placebo 75 to 450 mg/day
Study duration: 15 weeks' duration involving 4 phases: doses were optimised over 3 weeks based on efficacy and tolerability to 75, 150, 300, 450 mg/day. Remaining at that dose for 12 weeks.
Total adverse events:
Pregabalin: 167
Placebo: 132
No. participants with any adverse event:
Pregabalin: 38/54
Placebo: 34/53
No. participants with serious adverse events:
Pregabalin: 1/54
Placebo: 0/53
Total all‐cause withdrawals:
Pregabalin: 10/54
Placebo: 17/53
Withdrawals due to adverse events:
Pregabalin: 4/54
Placebo: 4/53
Brown 2016 Intervention group (N = 17):
oral gabapentin 900 mg/day (300 x 3)
Control group (N = 17):
oral amitriptyline 10 mg/day
Study duration: 6 weeks
Total adverse events:
Gabapentin: 2/17
Amitriptyline: 1/17
No. participants with any adverse event:
Gabapentin: 2/17
Amitriptyline: 1/17
No. participants with serious adverse events:
Gabapentin: 0/17
Amitriptyline: 0/17
Total all‐cause withdrawals:
Gabapentin: 2/17
Amitriptyline: 3/17
Withdrawals due to adverse events:
Gabapentin: 2/17
Amitriptyline: 1/17
CI: confidence interval; m: mean; N: number of participants; SD: standard deviation