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Controversy abounds concerning the use of lithium in amyotrophic lateral sclerosis (ALS). The announcement in November 2007 that none of 16 patients with ALS (PALS) treated with lithium carbonate had died during 15 months of treatment compared to 8 of 28 untreated patients1 resulted in unprecedented pressure from patients to receive this treatment, despite expressed concerns regarding the generalizability of the finding.2 PALS and their physicians generated several responses to this concern (table e-1 on the Neurology® Web site at www.neurology.org). PatientsLikeMe—a remarkable, patient-generated, Web-supported database—sounded a discordant note in December 2008 when it reported that after 4–6 months' observation of 162 patients, lithium failed to slow decline in self-reported scores on the ALS Functional Rating Scale–Revised (ALSFRS-R). The ALSFRS-R is a composite measure of 12 items reflecting key motor functions. Further, no difference was noted on comparison with controls matched for prognostic factors. Some patients, however, stopped lithium after approximately 4 months because of side effects or lack of perceived efficacy.3 The result was unchanged in a refined analysis.4
This presented a quandary, as PALS and physicians were uncertain whether to forgo a treatment based on unrandomized observational data, using a self-assessed, self-reported outcome measure, with controls selected based on a risk factor algorithm. …
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