Lessons from placebo effects in migraine treatment

Antonaci, Fabio; Chimento, Pierluigi; Diener, Hans‐Christoph; Sances, Grazia; Bono, Giorgio

doi:10.1007/s10194-007-0360-4

Cited by 44 publications

(32 citation statements)

References 18 publications

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“…The lack of objective measures of migraine and the known placebo effect seen in previous pharmacological studies 20 meant that adequate blinding of both patients and headache physicians was an important element in the design of the MIST trial. Although not assessed formally, we believe blinding was achieved with the sham procedure.…”

Section: Discussionmentioning

confidence: 99%

Migraine Intervention With STARFlex Technology (MIST) Trial

Dowson¹,

Mullen²,

Peatfield³

et al. 2008

Circulation

507

145

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Background-Patent foramen ovale (PFO) is prevalent in patients with migraine with aura. Observational studies show that PFO closure resulted in migraine cessation or improvement in Ϸ80% of such patients. We investigated the effects of PFO closure for migraine in a randomized, double-blind, sham-controlled trial. Methods and Results-Patients who suffered from migraine with aura, experienced frequent migraine attacks, had previously failed Ն2 classes of prophylactic treatments, and had moderate or large right-to-left shunts consistent with the presence of a PFO were randomized to transcatheter PFO closure with the STARFlex implant or to a sham procedure. Patients were followed up for 6 months. The primary efficacy end point was cessation of migraine headache 91 to 180 days after the procedure. In total, 163 of 432 patients (38%) had right-to-left shunts consistent with a moderate or large PFO. One hundred forty-seven patients were randomized. No significant difference was observed in the primary end point of migraine headache cessation between implant and sham groups (3 of 74 versus 3 of 73, respectively; Pϭ0.51). Secondary end points also were not achieved. On exploratory analysis, excluding 2 outliers, the implant group demonstrated a greater reduction in total migraine headache days (Pϭ0.027). As expected, the implant arm experienced more procedural serious adverse events. All events were transient. Conclusions-This trial confirmed the high prevalence of right-to-left shunts in patients with migraine with aura. Although no significant effect was found for primary or secondary end points, the exploratory analysis supports further investigation. The robust design of this study has served as the model for larger trials that are currently underway in the

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Section: Discussionmentioning

confidence: 99%

Migraine Intervention With STARFlex Technology (MIST) Trial

Dowson¹,

Mullen²,

Peatfield³

et al. 2008

Circulation

507

145

View full text Add to dashboard Cite

show abstract

“…In migraine trials, the placebo response is high, in terms of both efficacy and side effects. 1 Thus, a proper control group to assess the placebo effect in our study would have been appropriate, consisting of patients with placebo treatment for their trigger points. Unfortunately, as already mentioned, a true placebo treatment for TrP infiltration does not exist, since dry needling, or injection of saline, is per se an effective therapeutic approach for TrP release.…”

Section: Discussionmentioning

confidence: 99%