Find us on:


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.

vape no A Tag

is rice good for weight loss keto diet foods weight loss does gemfibrozil cause weight loss fast weight loss diet plans low carb weight loss per week weight loss surgery mn weight loss programs on line abnormal weight loss icd 10 what can cause sudden weight loss diet pills that lose weight fast methodist weight loss program b12 injections vs pills weight loss weight loss pills from india weight loss pills prescribed chinese diet pills 2014 otc weight loss pills reviews 14 day weight loss diet walking for weight loss plan cat diet weight loss tips for fasting weight loss

cbd gold cbd oil atomic structure grassroots cbd joe manganiello buy cbd in nj cbd oil elixinol benefits of cbd pills post it notes cvs essential oils kratom and cbd oil cbd oil and magnesium purchase pure cbd oil what does no que no mean myriad pro web safe que meaning line perscription cbd oil new york medicaid marijuana salve arthritis ejuice clones act on reviews define dosage

enhancer libido giant cock growth how to get a sex drive how much does the average penis weigh how to take viagra for best results do i have low testosterone fildena 100 mg for sale how to get a viagra prescription online increase blood to penis male enlargement pills side effects photos of male penises viagra empty stomach best free testosterone supplement p6 chrome reviews fast hard sex cbd oil for erectile dysfunction real sex act how to turn a woman on in bed progentra before and after progentra pills