The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
Large population-based study has shown that the prevalence of painful diabetic neuropathy
(PDN) is around 21%, and painful symptoms are more prevalent in patients with type 2
diabetes, females, and Asians. PDN is characterized by symmetrical lower limb paresthesiae,
dysesthesiae, lancinating pains and allodynia, with nocturnal exacerbation. PDN cause sleep
disturbance and reduce quality of life. The international guidelines advocate a range of
therapies for symptom relief. The therapeutic efficacy for all recommended medications is at
best around 50% pain relief and is limited due to unwanted side effects. Apart from
peripheral and central alterations, metabolic alterations such as increased glycemic influx,
and elevated plasma methylglyoxal levels have been implicated in the pathogenesis of PDN.
Several treatment options for PN are available, including pharmacological,
non-pharmacological, and alternative options. Patients suffering from severe and disabling
symptoms (e.g. NeP) may require guideline treatments like pregabalin, duloxetine, or
gabapentin initially until the symptoms are under control. These medications can
symptomatically relieve NeP; however, they do not address the underlying cause. Other options
such as neurotropic B vitamins (B1, B6, and B12) do not only target the symptoms, but also
improve nerve health and contribute to nerve regeneration. The B vitamins are commonly used
for PN treatment in clinical practice worldwide, this treatment option is most suitable
before the patient suffers from chronic NeP. However, co-treatment with neurotropic B
vitamins is also appropriate in NeP patients, to ensure the restoration of nerve health.