Safety and Efficacy of Nanocurcumin as Add-On Therapy to Riluzole in Patients With Amyotrophic Lateral Sclerosis: A Pilot Randomized Clinical Trial

Abstract

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.

<p>Curcumin-loaded nanoparticles: a novel therapeutic strategy in treatment of central nervous system disorders</p>

“…No significant difference was observed in ALSFRS-R score, muscle strength, and CMAP amplitude decrements between the nano-curcumin and placebo groups. 94…”

Randomized, double‐blind, placebo‐controlled phase II trial of nanocurcumin in prostate cancer patients undergoing radiotherapy

“…A possible component involved in the nanocurcumin failure in this randomized trial is the duration of its pretreatment before the RT course initiation. Recently, several clinical trials on SinaCurcumin® have had favorable results for the clinical application of curcumin after long‐term administration (Ahmadi et al, ; Alizadeh et al, ; Dolati, Aghebati‐Maleki, et al, ). Based on these randomized trials, we assumed that a longer duration of supplementation seems to produce a better outcome.…”

“…SinaCurcumin® as a novel nanoformulation of curcuminoids has recently demonstrated considerable efficacy in different clinical settings. Some favorable results have been shown in patients with amyotrophic lateral sclerosis, multiple sclerosis, ulcerative colitis, HTLV‐1 associated myelopathy/tropical spastic paraparesis (HAM/TSP), type 2 diabetes, nonalcoholic fatty liver disease, and as well as infertile patients (Ahmadi et al, ; Alizadeh et al, ; Dolati, Aghebati‐Maleki, et al, ; Dolati, Ahmadi, et al, ; Jazayeri‐Tehrani et al, ; Masoodi et al, ; Mohammadi et al, ; Rahimi et al, ). The main underlying mechanisms included the modulation of some inflammatory factors, posttranscriptional activities, and total antioxidant capacity (Alizadeh et al, ; Dolati, Aghebati‐Maleki, et al, ; Dolati, Ahmadi, et al, ).…”

Antioxidant Alternatives in the Treatment of Amyotrophic Lateral Sclerosis: A Comprehensive Review

“…It binds to the pre-fibrillar aggregates of SOD1, altering its amyloidogenic pathway and decreasing cytotoxicity (Bhatia et al, 2015). Curcumin may improve survival in patients with ALS, especially those with bulbar involvement (Ahmadi et al, 2018). In a double-blind therapeutic trial, treatment with curcumin showed a decrease in ALS progression and a reduction of oxidative damage (Chico et al, 2018) (Table 1).…”