The synergistic effect of vitamin D supplement and mindfulness training on pain severity, pain-related disability and neuropathy-specific quality of life dimensions in painful diabetic neuropathy: a randomized clinical trial with placebo-controlled.

PURPOSE: This study aimed to examine the synergistic effect of Vitamin D (VD) Supplement and mindfulness on neuropathic pain severity, Pain-Related Disability and Neuropathy-Specific Quality of Life (QOL) dimensions in painful diabetic neuropathy.
METHODS: In this randomized controlled trial, 225 patients with painful diabetic neuropathy were randomly allocated to five groups: (1) mindfulness and placebo, (2) placebo, (3) mindfulness, (4) VD, and (5) mindfulness and VD. Mindfulness training includes twelve sessions, and VD patients received a daily four thousand IU oral dosage (four capsules) with 28,000 IU vitamin D weekly for 12 weeks. Laboratory analyses, Sun exposure time, Vitamin D intake, BMI and physical activity were measured in pre-test and post-test. Pain-Related Disability measured with The Pain Disability Index (PDI). For other outcome variables, Neuropathy, a Specific QOL questionnaire and Neuropathic pain severity scale were utilized. Data were analyzed using one-way repeated-measures analysis of variance (ANOVA), Scheffe Post-hoc test and paired sample t-test.
RESULTS: In baseline, measures were not different among the groups. At the end-of-treatment, results showed improvement in all groups except the "placebo only" group for outcome variables. There was no difference between VD and mindfulness groups (within and not combined with placebo) in posttest. However, "VD + mindfulness" has a greater improvement rather than VD and mindfulness groups (P < 0.05). Moreover, both protocols have no significant effects on FBS, BMI and energy intakes (P > 0.05).
CONCLUSION: Combining VD and mindfulness can reduce pain severity and pain-related disability, so with these changes, patients experience improve in their quality of life. © Springer Nature Switzerland AG 2021.