Open Access低剂量纳曲酮治疗疼痛性糖尿病神经病变的疗效和安全性:一项随机、双盲、主动对照、交叉临床试验
Author(s) -
Srinivasan Anand,
Dutta Pinaki,
Bansal Dipika,
Chakrabarti Amitava,
Bhansali Anil Kumar,
Hota Debasish
Publication year - 2021
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.13202
Subject(s) - medicine , naltrexone , anesthesia , adverse effect , visual analogue scale , amitriptyline , diabetic neuropathy , somnolence , randomized controlled trial , clinical trial , crossover study , diabetes mellitus , placebo , opioid , receptor , endocrinology , alternative medicine , pathology
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/d) 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 2 weeks for a total of 6 weeks. Up‐titration was done (to 4 mg naltrexone or 25/50 mg amitriptyline) if the pain reduction was less than 20% on the visual analog scale (VAS) 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 washout period, the participants were crossed over to receive the comparator drug for another 6 weeks with similar evaluations. Results The difference (confidence interval) in the change in VAS score 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 fifty‐two adverse events were reported in the naltrexone and amitriptyline groups, respectively ( P < .001). The most common adverse events were mild diarrhea with naltrexone and somnolence with amitriptyline. Conclusions Low‐dose naltrexone exhibited similar efficacy and a superior safety profile compared with amitriptyline in painful diabetic neuropathy.