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. Author manuscript; available in PMC: 2012 Feb 1.
Published in final edited form as: Ther Adv Endocrinol Metab. 2011 Feb;2(1):27–38. doi: 10.1177/2042018810391900

Table 1.

Basis of Recommendation Medications Randomized Placebo Controlled Trials
Tier I

  • Supported by evidence from three or more randomized clinical trials in painful diabetic neuropathy

  • Safety profile

  • Tolerability

  • Number of significant drug interactions

  • Cost

 Tricyclic Antidepressants:
Amitriptyline Max 1987
Max 1992
Bansal 2009
Morello 1999
Desipramine Max 1991
Max 1992
Sindrup 1990
Imipramine Sindrup 1989
Kvinesdal 1984
Young 1985
Duloxetine Goldstein 2005
Raskin 2005
Wernicke 2006
Armstrong 2007
Pregabalin Freeman 2008
Rosenstock 2004
Arezzo 2008
Lesser 2004
Richter 2005
Freynhagen 2005
Bansal 2009
Gabapentin Backonja 1998
Backonja 1999
Morello 1999
Sandercock 2009 1
Tier II

  • Supported by evidence from two or more randomized clinical trials in painful diabetic neuropathy

  • Safety profile

  • Tolerability

  • Number of significant drug interactions

  • Cost

 Venlafaxine Rowbotham 2004 2
Kadiroglu 2008
Sindrup 2003 3
Carbamazepine Wilton 1974
Rull 1969
Gomez-Perez 1996
Valproate Kochar 2002
Kochar 2004
Agrawal 2009 4
Tier III Medications Supportive Randomized Controlled Trials Conflicting Randomized Trials

  • Supported by evidence from two or more randomized clinical trials in painful diabetic neuropathy but with conflicting data

  • Safety profile

  • Tolerability

  • Number of significant drug interactions

  • Cost

 Lamotrigine Eisenberg 2001
Jose 2007 5 		McCleane, 1999 6
Vinik 2007 7
Oxcarbazepine Dogra 2005 8
Beydoun 2006 9 		Grosskopf 2006 10
Alpha-Lipoic Acid Ruhnau 1999
Ziegler 2006
Ametov 2003 		Reljanovic 1999
Ziegler 1999
Breakthrough Pain Medications Randomized Placebo Controlled Trials
Supported by evidence from randomized clinical trials including painful diabetic neuropathy
To be used as adjuvant therapies 		Tramadol Freeman 2007
Harati 1998
Sindrup 1999 11
Lidocaine Galer 2002 12
Capsaicin The Capsaicin Study Group 1991
Scheffler 1991
Tandan 1992
1

This study examined use of Gabapentin ER which is not currently commercially available

2

This study examined use of Venlafaxine ER

3

This was a randomized control trial of carbamazepine in neuropathic pain but and included sixteen patients with painful diabetic neuropathy. These patients responded better that the remainder of the cohort to carbamazepine

4

This was a double-blind randomized placebo-controlled trial in diabetic neuropathy which found that both valproate and a combination of valproate plus glyceryl trinitrate spray improved pain control.

5

This was a randomized control trial comparing Lamotrigine to amytriptiline and placebo for the treatment of painful diabetic neuropathy.

6

This study examined lamotrigine dosing at 200 mg/day

7

This study examined lamotrigine doses up to 400 mg/day

8

This study examined oxcarbazepine dosing of 1800 mg/day

9

This study examined oxcarbazepine dosing of 1200 mg/day

10

This study examined oxcarbazepine dosing of 600 mg/day, 1200 mg/day and 1800 mg/day. The primary efficacy variable did not reach statistical significance, however patients with diabetic neuropathy who received the 1200 mg/day or 1800 mg/day dosing did have improvements in pain when compared to the placebo group and 600 mg/day dosing group.

11

This was a placebo control trial examining tramadol with acetaminophen in the treatment of painful diabetic neuropathy

12

This was a placebo controlled study of lidocaine patches in the treatment of multiple types of painful neuropathy including diabetic neuropathy