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Low Dose Aspirin for Ms-Related Fatigue: Results of a Pilot, Double-Blind, Randomized Trial Publisher



Sadeghinaini M1 ; Ghazizadeh Esslami G2 ; Fayyazi S2 ; Nabavi SM3 ; Morsali D4 ; Ghaffarpour M5
Authors
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Authors Affiliations
  1. 1. Clinical Trial Center, Tehran University of Medical Science (TUMS), Tehran, Iran
  2. 2. Exceptional talent Development center (ETDC), Tehran University of medical science (TUMS), Tehran, Iran
  3. 3. Center for Neuroscience and Cognition, Neurology Group, Royan Institute for Stem Cell Biology and Technology, Tehran, Iran
  4. 4. Neurology Department, Texas Medical School, Houston, Texas, United States
  5. 5. Department of Neurology, Imam Khomeini Hospital, Iranian Centre of Neurological Research, Tehran University of Medical Sciences, Tehran, Iran

Source: Neurology Psychiatry and Brain Research Published:2017


Abstract

Context Fatigue is one of the most common and disabling symptoms in Multiple Sclerosis (MS). Aims We aimed to evaluate the effects of low dose Aspirin (80 mg) in primary fatigue in MS patients. Settings and design This is a single-center, randomized, double-blind and parallel trial with 1:1 ratio allocation of two treatment groups of low dose Aspirin (80 mg) and placebo in outpatients with MS-related fatigue. Methods and material Treatment strategy was applied for 8 weeks in definitely diagnosed MS patients. Patients were assessed by means of modified fatigue impact scale (MFIS) and fatigue severity scale (FSS). Patients were also evaluated for side effects and tolerability of the drug. Results One hundred and twenty patients with MS were randomized. Among them, 100 patients entered final analysis. No significant effect in FSS and MFIS was found regarding intervention arms using ANOVA for repeated measure. Independent sample T-test, examining absolute changes for FSS score (Endpoint − Baseline), reveals Aspirin supremacy against placebo which was statistically significant. Conclusions Aspirin in 80 mg did not convey a significant difference in either group. However the absolute changes among the two treatment arms appeared meaningful in FSS but not in MFIS. Therefore, the probability of Aspirin effectiveness exists, however it is not provable in repeated measure analysis as a result of substantial drop out and relatively short treatment period. © 2016 Elsevier GmbH
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