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. Author manuscript; available in PMC: 2014 Dec 4.
Published in final edited form as: Lancet Neurol. 2012 May 16;11(6):521–534. doi: 10.1016/S1474-4422(12)70065-0

Table 2.

Published class I and class II evidence of pharmacological treatment for DNP

Drugs Trial size Dosage Study design Result NNT EFNS AAN
Pregabalin 146 300 mg Parallel, 8 weeks Pregabalin > placebo103 3.9 I I
338 75, 300, 600 mg Parallel, 5 weeks Pregabalin (300, 600 mg) > placebo104 300 mg: 3.6
600 mg: 3.3
I I
246 150, 600 mg Parallel, 6 weeks Pregabalin (600 mg) > placebo105 600 mg: 4.2 I I
338 Fixed or Flexible: 150 – 600 mg Parallel, 12 weeks Fixed and flexible > placebo106 3.6 II
167 600 mg Parallel, 13 weeks Pregabalin (600 mg) > placebo107 I I
396 150, 300, 600 mg Parallel, 12 weeks Pregabalin (600 mg) > placebo108 600 mg: 6.3
Gabapentin 165 < 3600 mg Parallel, 8 weeks Gabapentin > placebo109 4 I I
40 900 mg Crossover, 2×6 weeks Gabapentin = placebo70 II
Lamotrigine 59 < 400 mg Parallel, 8 weeks Lamotrigine > placebo72 4 I II
360 200, 300, 400 mg Parallel, 19 weeks Lamotrigine = placebo71 I I
53 200 mg vs amitriptyline 75 mg Parallel, 6 weeks Lamotrigine = amitriptyline110 II
Valproate 52 600–>1200 mg Parallel, 4 weeks Valproate > placebo73 II II
39 500 mg Parallel, 16 weeks Valproate > placebo74 II II
31 1500 mg Parallel, 4 weeks Valproate = placebo75 I
Amitriptyline 29 ≤ 150mg Crossover, 2×6 weeks Amitriptyline > placebo78 2.1 II
24 25–75 mg Crossover, 2×6 weeks Amitriptyline > placebo111 II
19 75 mg 3-phase, crossover amitriptyline and maprotiline Amitriptyline > Maprotiline > placebo80 I
Desipramine 20 Average 201 mg Crossover, 2×6 weeks Desipramine > placebo112 2.2 II
Venlafaxine ER 244 150–225 mg Parallel, 6 weeks Venlafaxine > placebo113 4.5 I I
60 75–150 mg Parallel, 8 weeks Venlafaxine > placebo114 II
Venlafaxine + gabapentin 11 and 42 Parallel, 2×8 weeks Venlafaxine+gabapentin > placebo in gabapentin unresponsive patients115 II and III
Duloxetine 457 20, 60, 120 mg Parallel, 12 weeks Duloxetine (60mg, 120 mg) > placebo116 60 mg: 4.3
120 mg: 3.8
I II
348 60 mg, 120 mg Parallel, 12 weeks Duloxetine (60mg, 120 mg) > placebo117 60 mg: 11
120 mg: 5
I I
334 60 mg, 120 mg Parallel, 12 weeks Duloxetine (60mg, 120 mg) > placebo118 60 mg: 6.3
120 mg: 3.8
I II
Oxycodone CR 159 10–100 mg Parallel, 6 weeks Oxycodone > placebo119 N/A I II
338 10–80 mg with gabapentin (100–3600 mg) Parallel, 12 weeks Oxycodone + gabapentin > placebo + gabapentin120 I I
Morphine sulfate 57 120 morphine, 60 mg morphine +2400 mg gabapentin, 3600 mg gabapentin Crossover, 4×4 weeks Morphine + gabapentin>morphine>gabapentin>placebo81 I II
Tramadol 127 100–400 mg (mean 210 mg) Parallel, 6 weeks Tramadol > placebo121 3.1 II
45 200–400 mg Crossover, 2×6 weeks Tramadol > placebo122 4.3 II
311 37.5 mg + 325 mg acetaminophen Parallel, 8 weeks Tramadol/APAP > placebo123 I
Dextromethorphan 19 400 mg Crossover, 2×9 weeks Dextromethorphan > placebo124 3.2 I I
14 Mean 381 mg Crossover, 2×6 weeks Dextromethorphan > placebo125 4 I II
Capsaicin 0.075% 252 0.075% qid Parallel, 8 weeks Capsaicin > placebo126 NA
22 0.075% qid Parallel, 8 weeks Capsaicin > placebo82 I
Isosorbide dinitrate 22 30 mg Crossover, 2×4 weeks Isosorbide dinitrate > placebo84 I
Glyceryl trinitrate 48 Crossover, 2×4 weeks Glyceryl trinitrate> placebo85 II
ABT-594 266 150, 225, 300 mg bid Parallel, 7 weeks ABT-594>placebo86 I
Botulinum toxin 18 Fifty units of subtype A in 1.2 mL 0.9% saline intradermally into each foot, each injection 4 U subtype A Crossover, 12×12 weeks Botulinum toxin > placebo127 II
Levodopa 25 100 mg levodopa plus benserazide 25 mg tid Parallel, 28 days Levodopa + benserazide > placebo128 II

DNP = Diabetic neuropathic pain