The studies in this part are distinguished by taking patients who were not in an acute relapse.
The effectiveness of steroids in the long-term treatment of MS was investigated in one systematic review (Ia), six RCTs (Ib) and one CCT (IIa). The review117 included four placebo-controlled RCTs comparing the effects of ACTH (n = 1), prednisolone (n = 1) and methyl-prednisolone (n = 2) given for 9-18 months. It reported no significant effect on long-term functional improvement or on relapse occurrence. The review also reported the occurrence of both major and minor side effects including herpes simplex, herpes zoster, severe ankle oedema, femur fracture, acute anxiety and severe depression.117 Four of the controlled trials also compared steroids to placebo. Two RCTs, one of ACTH and the other of two different doses of zinc hydroxide corticotrophin, found no effect of treatment on any of the outcomes investigated.142,143 One reported a greater incidence of adverse effects including steroid diabetes, increased blood pressure, oedema, acne and hirsutism in the intervention groups.142 A placebo-controlled RCT144 of methylprednisolone daily for five days followed by oral prednisone for a further four days reported beneficial effects for four (pyramidal function, cerebellar symptoms, sensitivity disorders and overall EDSS scores) of the eight outcomes investigated. This study only included patients with primary progressive MS. A second placebo-controlled RCT investigated a combination treatment of prednisolone, azathioprine and antilymphocyte globulin. This study found no effects on relapse rate or EDSS score but did report a positive effect on VEP latency.145 One RCT and one CCT compared the regular administration of intravenous methylprednisolone to treatment with methylprednisolone during relapses.146,147 Both studies included only patients with relapsing remitting MS, and both reported positive effects of treatment. It should be noted that the CCT was of very poor quality,146 and the RCT was only of average quality.147 The CCT reported only mild side effects, however, the RCT reported two serious adverse effects (acute glomerulonephritis and severe osteoporosis) in the group receiving regular steroid treatment.
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