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A large population-based study has recently shown that the prevalence of painful diabetic neuropathy (PDN) is ∼21%, and painful symptoms are more prevalent in patients with type 2 diabetes, females, and South Asians.
The results from the current study suggest that a single high-dose intramuscular injection of vitamin D3 provides significant relief in painful diabetic neuropathy by improving the associated symptoms.
A large population-based study has recently shown that the prevalence of painful diabetic neuropathy (PDN) is ∼21%, and painful symptoms are more prevalent in patients with type 2 diabetes, females, and South Asians. PDN is characterized by symmetrical lower limb paresthesiae, dysesthesiae, lancinating pains and allodynia, with nocturnal exacerbation and significant sleep disturbance, with a reduced quality of life. National and international guidelines advocate a range of therapies for symptom relief. However, the therapeutic efficacy for all recommended medications is at best ∼50% pain relief and is limited due to unwanted side effects. Several recent observational studies in patients with diabetes have demonstrated a significant association between vitamin D deficiency, and paraesthesiae and numbness, but also between neurological deficits and electrophysiology as well as parasympathetic dysfunction. Furthermore, a recent systematic review and meta-analysis of 1484 patients with type 2 diabetes has demonstrated a highly significant association (OR −2.68) between vitamin D deficiency and the development of diabetic peripheral neuropathy. In relation to a mechanistic link between vitamin D and pain, a recent study has shown that nociceptive calcitonin gene-related peptide-positive neurons have a distinct vitamin D phenotype with hormonally regulated ligand and receptor levels. In relation to the potential therapeutic benefits of vitamin D therapy, studies are limited. An open-label prospective study in 51 patients with type 2 diabetes and painful neuropathy showed that ∼2000 IU of cholecalciferol daily for 3 months resulted in an ∼50% decrease in the visual analog scale (VAS). Given the mechanistic link between vitamin D and neuropathy, and the known prevalence of vitamin D deficiency, this single-center open-label clinical trial was conducted to determine the effects of a single high-dose administration of intramuscular vitamin D on symptoms of PDN.
Rationale behind research:
In relation to the potential therapeutic benefits of Vitamin D therapy, studies are limited.
Therefore, this single-center open label clinical trial was conducted to determine the effects of a single high-dose administration of intramuscular vitamin D on symptoms of painful diabetic neuropathy.
Objective:
To assess the effect of high-dose vitamin D in patients with painful diabetic neuropathy.
Study outcomes
Time Points: Baseline and on four subsequent visits every 5±1 week
Outcomes:
Figure 1: Total McGill pain location from baseline to final visit
Figure 2: McGill pain score from baseline to final visit
A single intramuscular dose of 600 000 IU of vitamin D appears to be a safe and efficacious treatment for painful diabetic neuropathy.
The administration of 600 000 IU of vitamin D results in a modest but significant increase in 25(OH)D levels measured at 20 weeks. This improvement in 25(OH)D levels was associated with an improvement in several independent measures of PDN, which became significant at Visit 3, approximately 10 weeks after administration of vitamin D. This would argue against a placebo effect, as this would have been expected to manifest immediately or at least at V2. Furthermore, a maximal placebo response from baseline of 33–36% has been shown in double-blind randomized controlled trials and our data show improvement of pain far in excess of a placebo response. However, we cannot exclude a placebo response particularly as patients received regular follow-up after a known active intervention.
Treatment options for PDN are currently limited due to the side effects from many of the current therapies. A single dose of vitamin D was found to be safe and effective. However, a longer placebo controlled study with more frequent assessment of vitamin D levels and objective measures of neuropathy is required to assess the optimal frequency, dose safety, and overall efficacy of Vitamin D in PDN, and perhaps, in diabetic neuropathy.
The major limitation of the current study was the lack of placebo group.
The results from the present study suggest that treatment with a single intramuscular dose of 600 000 IU of vitamin D in patients with painful diabetic neuropathy is associated with a significant decrease in the symptoms of painful diabetic neuropathy
BMJ Open Diabetes Research and Care 2016;4: e000148
Vitamin D for the treatment of painful diabetic neuropathy
Abdul Basit et al.
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