Combining Fluoxetine and rTMS in Poststroke Motor Recovery: A Placebo-Controlled Double-Blind Randomized Phase 2 Clinical Trial.
Camila Bonin Pinto, Leon Morales-Quezada, Polyana Vulcano de Toledo Piza and 14 others
PMID 31286828WHAT IT FOUND
Combining low-frequency rTMS with fluoxetine improved hand function speed significantly more than either fluoxetine or placebo alone.
However, the fluoxetine-only group actually performed worse than the placebo group. The benefit likely came from rTMS overcoming potential negative effects of the drug, not from synergy.
Key findings
01The combined group (fluoxetine plus rTMS) showed significantly greater improvement in hand function speed (JTHF) compared to both the fluoxetine-only and placebo groups.
02Patients receiving fluoxetine alone had significantly less improvement in hand function and motor impairment scores compared to those receiving placebo.
03There were no significant differences in mood scores between the groups, suggesting the motor effects were not driven by changes in depression.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTs
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What it does not show
The sample size was very small (27 patients), making the results exploratory and prone to error. There was no rTMS-only group, so it is impossible to know if the combined benefit was due to the interaction of the two treatments or simply rTMS working while fluoxetine was ineffective or harmful. The placebo group had slightly better baseline motor scores and a different distribution of stroke types (more posterior cerebral artery strokes), which may have influenced the results despite statistical adjustments. The study did not include a long-term follow-up to see if the benefits persisted after treatment ended.
Declared interests
The study was funded by the National Institutes of Health (N.I.H., Extramural). No commercial conflicts of interest were declared in the provided text.
The easy way to misread this
Do not conclude that fluoxetine aids motor recovery. In this trial, the group receiving fluoxetine alone performed significantly worse than the placebo group. The improvement seen in the combined group was likely driven by rTMS, potentially masking negative effects of the drug.