Abstract
Introduction: Fatigue is one of the most common and debilitating symptoms experienced by multiple sclerosis (MS) patients. This study aimed to evaluate the effects of combination of hydroalcoholic extracts of Nigella sativa and Linum Usitatissimum on general health, fatigue and its contributing factors in patients with relapsing-remitting MS (RRMS).
Methods: In this parallel-group, randomized, double-blind, placebo-controlled pilot clinical trial, patients diagnosed with RRMS based on the 2017 McDonald criteria, with Expanded Disability Status Scale (EDSS)<4.5, and experiencing fatigue were enrolled. Participants were randomly assigned to receive the either the herbal supplement (n=25) or placebo (n=25). Capsules were administered twice daily over a period of three months. Fatigue and its contributing factors were assessed using the Comprehensive Fatigue Assessment Battery for Multiple Sclerosis (CFAB-MS) at baseline and at the end of the interventions.
Result: A total of 35 patients completed the trial, 17 in the intervention group and 18 in the placebo group. Based on the visual analogue scale (VAS) for general health, the intervention group showed a statistically significant improvement in nutritional status(p-value:0.009). However, no significant differences were observed between the groups in terms of physical, mental, and social fatigue, pain, sleep disturbances, stress, mood, anxiety and worry, nutrition, environmental interactions, or fatigue management indices (p-values>0.05).
Conclusion: Based on this preliminary research, three months of supplementation with a combination of hydroalcoholic extracts of N. sativa and L. Usitatissimum did not produce a significant improvement in fatigue and its associated factors among patients with RRMS.