Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS
This double-blinded, placebo-controlled trial looked at the effects of Bacille Calmette-Guérin (BCG) after clinically isolated syndrome (CIS).
Patients were randomly assigned to receive either BCG (33 patients) or a placebo (40 patients). The patients were monitored monthly with brain MRI for six months. Then both groups entered a pre-planned phase with IM interferon-β-1a for 12 months. From month 18 onwards, the patients took disease modifying therapies as recommended by their treating neurologist in an open-label extension lasting up to 60 months.
The results showed that during the first six months, the number of cumulative lesions was significantly lower in the vaccinated group. The relative risk was 0.541 for gadolinium-enhancing lesions, 0.364 for new and enlarging T2-hyperintense lesions and 0.149 for new T1-hypointense lesions. The total number of T1-hypointense lesions was lower in the vaccinated group at months 6, 12 and 18. After 60 months the researchers found that the probability of clinically definite MS was lower in the BCG and DMT arm and those subjects that were vaccinated were more likely not to be using disease modifying therapy.
: Ristori G, Romano S
: Neurology. 2013 Dec 4. [Epub ahead of print]
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