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Leo Greene: Reaction from local medical authority on Italian lithium trial
Leo Greene, Columnist
Article Created: 02/05/2008 09:04:43 PM PST

Editor's note: Inland Valley Daily Bulletin reporter and videographer Leo Greene has been documenting his journey since being diagnosed with ALS, Lou Gehrig's disease, in August 2006.

The dramatic findings from an Italian clinical trial published Feb. 5 in the Proceedings of the National Academy of Sciences online journal earned praise from the Loma Linda University Medical Center ALS Clinic medical director.

ALS patients given the mood stabilizing drug lithium over the course of a 15 month trial experienced a significant slowing of disease progression.

"These results are fascinating and exciting," said Dr. Laura Nist.

A group of patients taking only Riluzole, the one drug approved for treating ALS, showed a nearly 40-percent decline in their ALSFRS-R score, which is used to measure ALS progression. Meanwhile, patients taking both Riluzole and Lithium had their scores drop an only an average 14-percent.

Below is Dr. Nist's e-mailed response to the journal publication:

"These results are fascinating and exciting. The study design is appropriate and straightforward. The evaluation methods are both function reporting by the patient and testing by the doctor, which is good.

"The more objective eval(uation) methods seem to decrease (worsen) more than the patient

(self-evaluation) over the study. But, in each method of

evaluation there is a clear difference in those taking lithium compared to those not taking lithium. Those taking lithium had some decline. But it doesn't seem significantly different from the beginning of the study to 15 months and how they are doing is significantly different (better) than those not taking lithium who worsened measurably.

"Negatives of the study are that the patients knew if they were taking lithium or not which raises the concern that those taking lithium would over-report they are doing well, and the small number of people in the study. The small number raises the concern that the results are more

likely due to chance (happened to have 16 slow progressing PALS) than to true effect. It is also not shown if those in the study were predominant upper motor neuron (tend to progress more slowly) or lower motor neuron.

"So, how does this data translate to others? It is encouraging, but it needs to be verified in a large trial so it is less likely the findings are due to chance and to verify the findings in another population. For me, this means in the US with PALS here."

- Dr. Laura Nist, Medical Director, Loma Linda University Medical Center ALS Clinic

Leo Greene can be reached via e-mail at l_greene@dailybulletin.com

http://www.dailybulletin.com:80/ci_8180100