The objective of present study was to assess the safety and efficacy of nanocurcumin as an anti-inflammatory and antioxidant agent in adults with amyotrophic lateral sclerosis (ALS). We conducted a 12-month, double-blind, randomized, placebo-controlled trial at a neurological referral center in Iran. Eligible patients with a definite or probable ALS diagnosis were randomly assigned to receive either nanocurcumin (80 mg daily) or placebo in a 1:1 ratio. A computerized random number generator was used to prepare the randomization list. All patients and research investigators were blinded to treatment allocation. The primary outcome was survival, and event was defined to be death or mechanical ventilation dependency. Analysis was by intention-to-treat and included all patients who received at least one dose of study drug. A total of 54 patients were randomized to receive either nanocurcumin (n = 27) or placebo (n = 27). After 12 months, events occurred in 1 patient (3.7%) in the nanocurcumin group and in 6 patients (22.2%) in the placebo group. Kaplan-Meier analysis revealed a significant difference between the study groups regarding their survival curves (p = 0.036). No significant between-group differences were observed for any other outcome measures. No serious adverse events or treatment-related deaths were detected. No patients withdrew as a result of drug adverse events. The results suggest that nanocurcumin is safe and might improve the probability of survival as an add-on treatment in patients with ALS, especially in those with existing bulbar symptoms. Future studies with larger sample sizes and of longer duration are needed to confirm these findings.

Diabetic neuropathy (DN) is the most common complication of diabetes mellitus (DM) and also the major cause of morbidity and mortality in diabetic patients. There have been recent speculations that circulating 25-hydroxyvitamin D (25(OH)-D) could be involved in DN development and progression. This study explored the association between serum 25(OH)-D and DN in diabetic subjects by performing strict matching of possible confounders. Overall, 33 diabetic subjects with DN and 29 controls matched in terms of age, sex, BMI, height and disease duration entered this study. Nerve conduction velocity (NCV) was performed to determine the existence and severity of large fiber neuropathy. 25(OH)-D had significantly lower value in DN group (21.2 ± 11.5 vs. 13.5 ± 5.1 ng/mL, P = 0.001). None of the other observed variables showed a significant association with existence and severity of DN. After adjustment for all studied variables, serum vitamin D had an independent and inverse association with both DN presence and severity, as each 1 ng/mL increase in serum 25(OH)-D was correlated with 2.2 and 3.4 % decrease in the presence and severity of NCV impairment, respectively. While adjusted for demographic variables, comorbidities and treatment of DM, our results imply that decreased levels of circulating 25(OH)-D may contribute to increased risk of large fiber neuropathy in type 2 diabetic subjects.

Infliximab therapy for patients with refractory PM and DM was well tolerated and may benefit a subset of patients.