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Evaluating Efficacy and Safety of Saffron Add-On Treatment in Improvement of Motor and Depressive Symptoms of Patients With Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Publisher



Lalezari V1 ; Aghamollaii V1 ; Moslehi A2 ; Najafi A2 ; Parsaei M3 ; Beikmarzehei A2 ; Moghaddam HS1 ; Abdolghaffari AH4 ; Akhondzadeh S2
Authors

Source: Journal of Herbal Medicine Published:2024


Abstract

Aim: Evidence has highlighted neuroprotective effects of saffron in animal models of Parkinson's disease (PD). The present study investigated the efficacy and safety of add-on saffron on motor and depressive symptoms of patients with PD. Methods: This study was an 8-week, randomized, double-blind, and parallel-group clinical trial. Known cases of PD with depression were randomized to receive either a routine treatment (levodopa or levodopa-equivalent dose of a dopamine agonist) plus saffron capsule (15 mg bid) or routine treatment plus placebo. All participants were assessed using the Hamilton Depression Rating Scale (HAMD), Geriatric Depression Scale-30 (GDS-30), item 3 of Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 1, MDS-UPDRS part 3, and H and Y scale at baseline and at week 8. Results: A total of 52 patients (25 in saffron and 27 in placebo groups) were included. Our results demonstrated that saffron could not improve motor symptoms of PD patients (F=0.53, df=1, p=0.424). However, repeated-measures analysis showed a significant effect of time × treatment (F=8.24, df=1, p=0.006) on HAMD scores, indicating a greater improvement of depressive symptoms in saffron compared to placebo groups. Our study showed nonsignificant findings regarding the secondary outcome measures (GDS-30, item 3 of MDS-UPDRS part 1, and H and Y scale). We showed that treatment with saffron is safe in PD. Conclusion: We substantiated that add-on treatment with saffron significantly improved depression, but not motor symptoms, in PD. Further trials with larger sample sizes and longer follow-ups are needed to confirm our findings. © 2024 Elsevier GmbH
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