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Anti-Fatigue and Hypnotic Effects of a Traditional Herbal Extract on Multiple Sclerosis Patients : A Double Blind Randomized Clinical Trial

Objectives: Multiple Sclerosis (MS) is a chronic inflammatory and neurodegenerative disorder of the central nervous system. The aim of this study was to investigate the effects of a Persian herbal medicine treatment including Crocus sativus, Hypericum perforatum, Cinnamon verum, and Vitis vinifera on fatigue and sleep disorders in MS patients. Methods: In this controlled, double-blinded, clinical trial, 52 patients with MS suffering from fatigue or sleep disorders were randomly divided into two groups (herbal remedy or the placebo). Fatigue symptoms were quantified by means of Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS). The Insomnia Severity Scale (ISI) and Pittsburgh Sleep Quality Index (PSQI) were used to assess sleep difficulties. Results: There was a significant reduction in FSS and MFIS scores in both groups, but the mean change rate in FSS and MFIS scores in the drug group was significantly higher compared to the placebo group. In both the drug and placebo groups, ISI and PSQI scores decreased significantly after four weeks, but the change rate in ISI and PSQI scores in the drug group was significantly more than the placebo group (p=0.00). Conclusion: The present study suggests that herbal extract treatment may improve sleep disorder and fatigue symptoms in MS patients. Further investigations are needed to know the exact mechanism of actions.