Clinical trials that evaluate experimental treatment for patients with epilepsy often produce large placebo effects, but a recent database analysis suggests that what appears like a placebo effect may in fact result from the natural variability in patients’ response to treatment.
- Researchers conducted clinical trial simulations using data from sources including a large patient-managed seizure tracking diary database called SeizureTracker.com, a clinical trial that looked at transcranial magnetic stimulation, and a seizure diary dataset called NeuroVista, which tracks longitudinal intracranial monitoring.
- The analysis measured 50% responder rates and median percentage change.
- The clinical trial simulations were performed in 2 directions; it measured outcomes with time running forward and in reverse, ie, moving backwards from baseline through titration, to treatment.
- The analysis found that temporal reversal didn’t prevent large 50% responder rates, suggesting that what appears to be a placebo effect in clinical trials is in fact normal variability in the way patients respond to active treatment.
A multi-dataset time-reversal approach to clinical trial placebo response and the relationship to natural variability in epilepsy. Seizure. 2017; 53:31-36. DOI: http://dx.doi.org/10.1016/j.seizure.2017.10.016.