A Placebo-Controlled Surgical Trial of the Treatment of Migraine Headaches

Guyuron, Bahman; Reed, Deborah; Kriegler, Jennifer S.; Davis, J. Kelly; Pashmini, Nazly; Amini, Saeid B.

doi:10.1097/prs.0b013e3181adcf6a

Cited by 242 publications

(252 citation statements)

References 44 publications

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“…Effective preventive migraine treatments include antiepileptic drugs (Vikelis and Rapoport, 2010), antidepressants (Nagata, 2009;Koch and Ju¨rgens, 2009), b-adrenoceptor blockers (Evers et al, 2006(Evers et al, , 2009, calcium channel blockers (Negoro, 2009), botulinum toxin (Taylor, 2008;Mathew and Jaffri, 2009) and surgery (Guyuron et al, 2009). The antiepileptic drug ''topiramate'' is approved for the prophylaxis of migraine headache in adults.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of combined topiramate/thioctic acid therapy in migraine prophylaxis

Ali

Awad

Al-Adl

2010

Saudi Pharmaceutical Journal

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Migraine cannot be cured and the aim, shared with the patient, is to minimise the impact of the illness on the patient's life and lifestyle. The aim of prophylaxis is to reduce the number of migraine attacks. Prophylaxis should be considered when appropriately used acute management gives inadequate control of symptoms. The efficacy and safety of topiramate 50 mg/d and thioctic acid (α-lipoic acid) 300 mg/d either as monotherapy or in combination were investigated as migraine prophylactic agents. Forty secondary school migraineur girls were enrolled in the study. The study was conducted in two phases, a prospective baseline phase and 1-month treatment phase. Combined topiramate/thioctic acid therapy was more effective than either topiramate or thioctic acid monotherapy as a migraine-preventive treatment. Combined topiramate/thioctic acid therapy decreased the mean monthly migraine frequency from 5.86 ± 1.2 to 2.6 ± 0.98 (p ⩽ 0.05), topiramate (50 mg/d) from 5.71 ± 1.4 to 4.75 ± 1.5 and thioctic acid (300 mg/d) from 5.68 ± 1.6 to 5.22 ± 1.8. Reduction in mean monthly migraine days was also significantly greater in the group receiving combined topiramate/thioctic acid (from 12.32 ± 1.85 to 5.74 ± 1.1) compared to those receiving either topiramate 50 mg/d (from 12.7 ± 1.34 to 11.85 ± 1.35) or thioctic acid 300 mg/d (from 12.5 ± 1.72 to 11.65 ± 1.44). The responder rate (% of patients showing ⩾50% reduction in monthly migraine frequency) was 85% in patients receiving combined topiramate/thioctic acid therapy compared to 30% and 20% in patients receiving either topiramate or thioctic acid, respectively. The incidence of adverse events was higher in patients receiving topiramate (50 mg/d) monotherapy. The most common adverse events were nausea, fatigue, paraesthesia and taste perversion. We conclude that combined topiramate/thioctic acid therapy is more effective and better tolerated than topiramate monotherapy. The combination has lower monthly medication costs compared to the traditionally used topiramate 100 mg monotherapy.

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Section: Introductionmentioning

confidence: 99%

Efficacy of combined topiramate/thioctic acid therapy in migraine prophylaxis

Ali

Awad

Al-Adl

2010

Saudi Pharmaceutical Journal

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“…In the seminal trials on internal mammary artery ligation 31, 32 a skin incision was made to expose the arteries in all patients but no ligation was made in the placebo group. Similarly, Guyuron and colleagues used a skin incision to expose superficial nerves and muscles, which were cut during the active surgery but, in the placebo group, the integrity of these structures was maintained 33 . Trials investigating transplantation of dopaminergic neurones as a treatment for Parkinson’s disease not only required skin incision but also burr holes in the skull 34, 35 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

Blinding in trials of interventional procedures is possible and worthwhile

2017

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In this paper, we have used evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible, and that many creative methods can be used to make the active and the placebo procedure as similar as possible. We give examples of ingenious strategies used to simulate the active procedure and make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and the types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.

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“…Mit einem solchen Patientenkollektiv soll jetzt nochmals eine randomisierte Studie durchgeführt werden. Fragwürdiger Höhepunkt der nicht medikamentösen Therapie war ein chirurgischer Ansatz zur "Heilung" der Migräne [51]. Die Arbeitsgruppe um den plastischen Chirurgen an der Cleveland-Klinik schloss 75 Patienten mit Migräne ein, bei denen sich die Migräne nach lokaler Injektion von Botulinumtoxin in die Stirnmuskulatur, in den M. temporalis oder in die Okzipitalregion besserte.…”

Section: Nicht Medikamentöse Verfahren Der Migräneprophylaxeunclassified