Perhaps consideration of an adaptive clinical strategy using NSAIDs daily as a daily initial treatment for a month to reduce headache frequency and then adding triptans secondarily as episodic acute treatment to capitalize on improved 2-hour efficacy in subsequent months might be considered in future studies. Clearly, furthermore rigorous studies are required to understand the appropriate
use of acute interventions in CM. There are numerous and significant limitations to this study. The most obvious is the small sample size of subjects completing the study per protocol and the high dropout rate in group B (naproxen sodium group). Ganetespib clinical trial Another potential limitation is the fact that patients were not naive to the study medications, which may have compromised the blinding of the study medication, and this too could have been a possible factor in the high dropout rate for naproxen sodium. In this study, subjects were BI 6727 cost surveyed at discharge and 45% (9/20)
correctly identified the medication they were taking, which is close to random guessing. However, assuming this did unblind the study and might in part explain the high early dropout rate in group B, it is not a likely explanation for the efficacy in those subjects completing the study per protocol. Regardless, blinding will be an issue for future studies of acute medications in CM, as subjects will undoubtedly have tried most acute treatments before evolving into a diagnosis of CM. Another limitation might be that patients entering the study were overusing acute medications prior to and during the baseline period and were in unrecognized MOH. When randomized to the active phase of the study, those in group B eliminated triptans, and this may have
improved their migraine frequency. In the naproxen sodium group (group B), 4 out of 5 subjects (80%) used more than 10 doses of triptans during baseline. In the group randomized to SumaRT/Nap (group A), 53% (8/15) were taking triptans during baseline more than 10 days per month. It is possible that stopping triptan usage in group B was a factor in the observed reduction in migraine frequency and the continuation (-)-p-Bromotetramisole Oxalate of a triptan in group A largely nullified the benefit of naproxen sodium. It should be noted that subjects were not judged as being in MOH prior to randomization, and response to naproxen sodium was early in month 1 and without evidence of “rebound headache” or a temporary worsening of underlying migraine. Small underpowered studies and even case reports have often provided insights and solutions for patients seeking relief of migraine. While it is unwarranted to suggest this study will do either, it is warranted to suggest these data support a hypothesis that there might be a differential response for naproxen sodium and SumaRT/Nap in treatment attributes as described in this study for subjects with CM.