OBJECTIVE: To assess the efficacy of oral high-dose methylprednisolone in acute optic neuritis (ON). BACKGROUND: It has been determined that oral high-dose methylprednisolone is efficacious in attacks of MS. METHODS: A total of 60 patients with symptoms and signs of ON with a duration of less than 4 weeks and a visual acuity of 0.7 or less were randomized to treatment with placebo (n = 30) or oral methylprednisolone (n = 30; 500 mg daily for 5 days, with a 10-day tapering period). Visual function was measured and symptoms were scored on a visual analog scale (VAS) before treatment and after 1, 3, and 8 weeks. Primary efficacy measures were spatial vision and VAS scores the first 3 weeks (analysis of variance with baseline values as the covariate), and changes in spatial vision and VAS scores after 8 weeks. A significance level of p < 0.0125 was employed. RESULTS: The VAS score (p = 0.008) but not the spatial visual function (p = 0.03) differed in methylprednisolone- and placebo-treated patients during the first 3 weeks. After 8 weeks the improvement in VAS scores (p = 0.8) and spatial visual function (p = 0.5) was comparable with methylprednisolone- and placebo-treated patients. A post hoc subgroup analysis suggested that patients with more severe baseline visual deficit and patients treated early after onset of symptoms had a more pronounced response to treatment. The risk of a new demyelinating attack within 1 year was unaffected by treatment. No serious adverse events were seen. CONCLUSION:Oral high-dose methylprednisolone treatment improves recovery from ON at 1 and 3 weeks, but no effect could be demonstrated at 8 weeks or on subsequent attack frequency.
RCT Entities:
OBJECTIVE: To assess the efficacy of oral high-dose methylprednisolone in acute optic neuritis (ON). BACKGROUND: It has been determined that oral high-dose methylprednisolone is efficacious in attacks of MS. METHODS: A total of 60 patients with symptoms and signs of ON with a duration of less than 4 weeks and a visual acuity of 0.7 or less were randomized to treatment with placebo (n = 30) or oral methylprednisolone (n = 30; 500 mg daily for 5 days, with a 10-day tapering period). Visual function was measured and symptoms were scored on a visual analog scale (VAS) before treatment and after 1, 3, and 8 weeks. Primary efficacy measures were spatial vision and VAS scores the first 3 weeks (analysis of variance with baseline values as the covariate), and changes in spatial vision and VAS scores after 8 weeks. A significance level of p < 0.0125 was employed. RESULTS: The VAS score (p = 0.008) but not the spatial visual function (p = 0.03) differed in methylprednisolone- and placebo-treated patients during the first 3 weeks. After 8 weeks the improvement in VAS scores (p = 0.8) and spatial visual function (p = 0.5) was comparable with methylprednisolone- and placebo-treated patients. A post hoc subgroup analysis suggested that patients with more severe baseline visual deficit and patients treated early after onset of symptoms had a more pronounced response to treatment. The risk of a new demyelinating attack within 1 year was unaffected by treatment. No serious adverse events were seen. CONCLUSION: Oral high-dose methylprednisolone treatment improves recovery from ON at 1 and 3 weeks, but no effect could be demonstrated at 8 weeks or on subsequent attack frequency.
Authors: P Rieckmann; K V Toyka; C Bassetti; K Beer; S Beer; U Buettner; M Chofflon; M Götschi-Fuchs; K Hess; L Kappos; J Kesselring; N Goebels; H-P Ludin; H Mattle; M Schluep; C Vaney; U Baumhackl; T Berger; F Deisenhammer; F Fazekas; M Freimüller; H Kollegger; W Kristoferitsch; H Lassmann; H Markut; S Strasser-Fuchs; K Vass; H Altenkirch; S Bamborschke; K Baum; R Benecke; W Brück; D Dommasch; W G Elias; A Gass; W Gehlen; J Haas; G Haferkamp; F Hanefeld; H-P Hartung; C Heesen; F Heidenreich; R Heitmann; B Hemmer; T Hense; R Hohlfeld; R W C Janzen; G Japp; S Jung; E Jügelt; J Koehler; W Kölmel; N König; K Lowitzsch; U Manegold; A Melms; J Mertin; P Oschmann; H-F Petereit; M Pette; D Pöhlau; D Pohl; S Poser; M Sailer; S Schmidt; G Schock; M Schulz; S Schwarz; D Seidel; N Sommer; M Stangel; E Stark; A Steinbrecher; H Tumani; R Voltz; F Weber; W Weinrich; R Weissert; H Wiendl; H Wiethölter; U Wildemann; U K Zettl; F Zipp; R Zschenderlein; G Izquierdo; A Kirjazovas; L Packauskas; D Miller; B Koncan Vracko; A Millers; A Orologas; M Panellus; C J M Sindic; M Bratic; A Svraka; N R Vella; Z Stelmasiak; K Selmaj; H Bartosik-Psujik; K Mitosek-Szewczyk; E Belniak; A Mochecka; A Bayas; A Chan; P Flachenecker; R Gold; B Kallmann; V Leussink; M Mäurer; K Ruprecht; G Stoll; F X Weilbach Journal: J Neurol Date: 2004-11 Impact factor: 4.849