title: Evaluating the Role of Corticosteroid Pulse Therapy in Patients With Secondary Progressive Multiple Sclerosis Receiving Mitoxantrone: A Double Blind Randomized Controlled Clinical Trial.
abstract: BACKGROUND
  Multiple sclerosis (MS) is a central nervous system disorder with periods of recurrence and recovery. Mitoxantrone has been approved for secondary progressive MS (SPMS) treatment but data lacks the role of corticosteroid pulse therapy in SPMS.
  
  
  OBJECTIVE
  To evaluate the role of corticosteroid pulse therapy in patients with SPMS receiving mitoxantrone.
  
  
  METHODS
  A double blind randomized controlled clinical trial was performed on 71 patients with SPMS referred to Shahid Sadoughi Hospital (Yazd, Iran) for receiving mitoxantrone in two groups. The first group (35 patients) received 20 mg mitoxantrone plus 500 mg methylprednisolone monthly for six months. The second group (36 patients) received the same dosage of mitoxantrone plus 100 CC of 5% dextrose water monthly for six months. Expanded disability status scale (EDSS), MRI plaques in both groups before and after the treatment completion and six months after the end of trial were compared together.
  
  
  RESULTS
  28 men and 43 women enrolled in the study. MRI plaques number reduced in groups significantly (2.29 vs. 2.17) without significant difference between the groups (P = 0.782). Six months after trial completion, plaques number increased in groups without significantly difference (0.72 vs. 0.77, P = 0.611). The mean value of EDSS showed significant reduction at the end of treatment in groups (0.79 and 0.53) without significant difference between the groups (P = 0.953). Six months after trial completion, EDSS increased in groups without significant difference (0.35 vs. 0.43, P = 0.624).
  
  
  CONCLUSIONS
  Corticosteroid pulse therapy in SPMS was effective in inflammatory process, but could not postpone or decline the neurodegenerative process and besides the imposing side effects could not result in significant improvement in EDSS and MRI plaques number in long term.
authors.affiliation: Neurology Department, Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, IR Iran.
authors.forename: Abolghasem
authors.initials: A
authors.lastname: Rahimdel
authors.affiliation: Neurology Department, Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, IR Iran.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Zeinali
authors.affiliation: Neurology Department, Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, IR Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Mellat
keywords: Methylprednisolone; Mitoxantrone; Secondary Progressive Multiple Sclerosis, MS therapy