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Rev Neurol. 2003 Aug 1-15;37(3):214-20
Cabrera Gomez JA, Echazabal Santana N, Porrero Martin PJ, Valenzuela Silva C, Rodriguez CA, Fuentes Suarez I, Perez Ruiz L, Ramos Cedeño AM, Cabrera Nuñez JA.
Centro Internacional de Restauracion Neurologica (CIREN), Cubanacan, Playa. La Habana, Cuba.
Some experimental, Phase II clinical trials and the preliminary reports of the Cuban Phase III clinical trial indicate that alpha IFN (IFN) may be useful in relapsing remitting (RR) multiple sclerosis (MS).
The reports in Cuba showed that 70% of the MS patients have cognitive dysfunction.
To assess the efficacy of IFN alpha 2b recombinant in the cognitive dysfunction of RR MS.
PATIENTS AND METHODS.
57 RR MS clinical definite (Poser et al) patients from the randomised, double blind, placebo controlled study of 225 patients with RR MS and brain MRI confirmed.
Patients were randomly assigned to receive intramuscular IFN alpha 2b (Heberon R ) 10 million IU (high dose), 3 million IU (low dose) or placebo twice week for 2 years.
Outcome results were blinding evaluated considering changes in the following tests: Luria, WAIS, Benton and PASAT 3.
Adverse events and side effects were not evaluated to maintain physician blinding.
The initial comparison of the groups did not show any differences among the placebo (n= 20), low dose (n= 18) and high dose (n= 19) considering age (p= 0.234), gender, ethnic group (p= 0.012), years ill (p= 0.787), EDSS (p=0.203) and rate of relapses (p= 0.432).
The Luria s Test showed an improved in the low dose group from 2.50 1.34 to 1.39 1.85 (p= 0.029) and in the high dose group from 3.22 1.89 to 2.17 1.50 (p= 0.006) vs placebo 2.85 1.66 to 2.90 1.97 (p=0.723).
The results of the Benton s test demonstrated that the low dose group had an improved from 5.50 1.10 to 6.22 1.31 (p= 0.047), in the high dose group from 4.87 1.85 to 5.78 1.35 (p= 0.005) where as in the placebo group worse from 5.15 1.76 to 5.05 2.11 (p= 0.893).
The WAIS test showed the same results, the low dose group increased from 5.17 1.34 to 6.06 1.21 (p= 0.022), the high dose group from 4.56 1.38 to 5.39 1.29 (p= 0.007) and the placebo group worse from 5.25 1.25 to 5.05 1.57 (p=0.354).
Finally, the PASAT 3 test increased in the IFNs groups: from 45.72 10.61 to 49.94 11.68 (p= 0.015) in the low dose group, from 42.67 11.04 to 48.72 8.84 (p= 0.03) in the high dose group, but in the placebo group worse from 44.55 10.86 to 41.95 13.74 (p= 0.655).
IFN alpha improved the cognitive dysfunction in RR MS patients.
The higher dose is more beneficial.