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Efficacy and safety of low-dose naltrexone in painful diabetic neuropathy: A randomized, double-blind, active-control, crossover clinical trial

Efficacy and safety of low-dose naltrexone in painful diabetic neuropathy: A randomized, double-blind, active-control, crossover clinical trial
Publication Type
Journal Article
Research Type
Reported as
Clinical Trial
May 20, 2021
Anand Srinivasan, Pinaki Dutta, Dipika Bansal, Amitava Chakrabarti, Anil Kumar Bhansali, Debasish Hota
All India Institute of Medical Sciences, Postgraduate Institute of Medical Education and Research, National Institute of Pharmaceutical Education and Research

BACKGROUND: There is a need for newer therapies for chronic painful diabetic neuropathy as the existing drugs have their own limitations. Clinical trials on low-dose naltrexone (1-5 mg/day) showed efficacy and safety in certain chronic painful conditions, but not in painful diabetic neuropathy. Hence the present study was planned.

METHODS: Sixty-seven participants with painful diabetic neuropathy were randomized to receive either 2 mg naltrexone or 10 mg amitriptyline daily following a 2-week run-in period. The participants were followed up every two weeks for total 6 weeks. Up-titration was done (to 4 mg naltrexone or 25 /50 mg amitriptyline) if the pain reduction was less than 20% on visual analogue scale (VAS) score during the next follow-up visit. Efficacy was assessed using the change in VAS score at the end of 6 weeks from baseline. Safety was evaluated at each follow-up visit. After 2 weeks of wash-out period, the participants were crossed over to receive the comparator drug for another six weeks with similar evaluations

RESULTS: The difference (confidence interval) in the change in VAS between groups from baseline was 1.64 (-0.92 to 4.20) in per-protocol analysis and 1.5 (-1.11 to 4.13) in intention to treat analysis. Eight and 52 adverse events were reported in the naltrexone and amitriptyline groups, respectively (P < 0.001). The most common adverse events were mild diarrhea with naltrexone and somnolence with amitriptyline.

CONCLUSIONS: Low-dose naltrexone exhibited similar efficacy and superior safety profile compared to amitriptyline in painful diabetic neuropathy.

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