“Results: Six studies that met the inclusion criteria were identified and included in the meta-analysis. Two of these reported a significantly greater improvement in mood symptoms in the treatment versus the sham group. When combined in the meta-analysis, the overall weighted mean difference was –1.1 [on the HAM-D] (95% confidence interval –4.5 to 2.3), and the results of a test for heterogeneity were not significant (χ2 = 5.81, p = 0.33). Conclusions: This meta-analysis suggests that rapid-rate rTMS is no different from sham treatment in major depression; however, the power within these studies to detect a difference was generally low. Randomized controlled trials with sufficient power to detect a clinically meaningful difference are required.”
There were some legitimate criticisms of her method, which you can read here along with her reply. Couturier’s reply seems to have addressed the criticisms aptly.
Since that time, two studies have shown greater efficacy for rTMS over sham therapy (here and here). To my knowledge, there has not been a meta-analysis that has accounted for these new studies. The effects seemed reasonably large, though I’ve only read the abstracts at this point.
So what’s the story with rTMS? It’s pretty murky. FDA may approve it because it seems to have two studies showing efficacy yet there are a fair number of studies showing no efficacy. All told, it is going to be one controversial decision that I look forward to discussing more as it develops. I'm certain the folks at Neuronetics are crossing their fingers!