Skip to main content
. Author manuscript; available in PMC: 2014 Dec 17.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Apr 18;4:CD001430. doi: 10.1002/14651858.CD001430.pub3

Menon 2007.

Methods Method of randomization: coin toss followed by alternating group assignment
Number randomized: 21
Exclusions after randomization: no exclusions after randomization
Losses to follow up: no loss to follow up reported
Method of allocation concealment: Not specified
Participant masking: Yes (author communication)
Provider masking: Unknown
Outcome assessor masking: Yes (author communication)
Intention to treat analysis:Unknown
Participants Country and period of study: Tertiary care center in India (Period unknown)
Age: 7 to 53 (mean Group I 31.2 + 10.1 years, mean Group II 26.6 + 11.5 years)
Sex: Overall, 57% were male (Group I 55% male, Group II 60% male)
Inclusion:

  1. Subjects with previously untreated acute optic neuritis within 8 days of onset;

  2. Visual acuity < 20/60 in affected eye;


Exclusions:

  1. Known systemic disease other than multiple sclerosis;

  2. Prior history of optic neuritis attacks;

  3. Prior diagnosis of multiple sclerosis where subject received corticosteroids;

  4. Evidence of optic disc pallor in affected eye;

  5. Pre-existing ocular abnormalities that affect assessment of visual function;


Evidence of systemic condition for which corticosteroids would be contraindicated
Interventions Group I (11 subjects) - Intravenous dexamethasone 200mg (in 150ml 5% dextrose solution) given over 1.5-2 hours once a day for 3 days
Group II (10 subjects) - Intravenous methylprednisolone 250mg/six hourly (in 150ml 5% dextrose solution) given over 1.5-2 hours once a day for 3 days followed by oral prednisolone for 11 days
Outcomes Visual acuity (ETDRS at 4 m distance and Snellen at 6 m distance)
Visual field (Goldmann perimeter)
Contrast sensitivity (Pelli-Robson chart at 1 m)
Color vision (Ishihara pseudoisochromatic color vision plates)
Stereoacuity (Randot stereoacuity test, Wirt circle)
Visually evoked response (Lace electronica EREV m99 machine at 33cm)
Other: hemogram, fasting blood glucose, Venereal diseases research laboratory, immuno-histocytological analysis for toxoplasmosis, chest X-ray, X-ray paranasal sinuses, aerobic and anaerobic blood cultures, orbital ultrasound and neuroimaging for cases not showing any improvement with standard therapy in either group
Notes The study investigators were contacted for the proportion of patients with normal visual acuity, visual field, and contrast sensitivity, but no additional data were available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk According to the published report: “The patients were randomized into two groups by block randomization”. However, in correspondence with the author “The first case was decided by a toss of a coin. All subsequent were by rotation of patients (patients were alternatively assigned to group 1 and group 2)”
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported
Masking (performance bias and detection bias) Low risk Both patients and outcome assessors were masked (blinded) to the treatment assignment. - author correspondence
Incomplete outcome data (attrition bias) All outcomes Low risk No loss to follow-up reported
Selective reporting (reporting bias) Low risk Results for all outcomes were reported
Other bias Low risk