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Premedicated Mask May Hold Promise for Migraine Patients

Update of open-label study of a treatment for migraine and/or tension headaches
Editor’s Note: This column highlights innovations in pain management developed by our physician-readers. Although these reports are preliminary case studies, the editors encourage innovation that has the potential to improve patient outcomes.

The use of topical treatment modalities for migraine and/or tension-type headaches holds the promise of providing a safe alternative or adjunct to systemic medications. Such treatment also may reduce narcotic dependence and the incidence of rebound headaches. This article is a continuation of an earlier study of the efficacy of an anticephalgic photoprotective mask with a topical cream containing bryonia and rhus toxicodendron.1 In the current open-label study, we combined a photoprotective mask with a topical medication containing menthol (1.40%) in the treatment of migraine and/or tension headache.

Participants and Methods
Sixty patients who suffer from migraine and/or tension headaches were enrolled in the open-label study. None of the patients reported significant head trauma and none were pregnant. All participants were patients of a neurologist and were seeking treatment for severe headaches. The patients ranged in age from 20 to 65 years. All reported suffering from headaches for at least 1 year and all were prescribed either prophylactic and/or abortive oral medications and/or parenteral medications for headaches. The patients all suffered from at least one severe headache per month and all had associated photophobia.

The participants received an opaque anticephalgic mask and were given five packets (3 mL per packet) of topical cream containing menthol. At the onset of headache, the patients were instructed to apply the cream to their frontalis and/or temporalis regions, put on the anticephalgic mask, and lie down They also were advised to take their customary oral and/or parenteral medications, if needed.

Using a visual analog scale, the patients were asked to rate the degree of relief that they attributed to the topical medication and the mask. The treatment was rated on a 0- to 10-point scale: 0 if ineffective, 10 if totally effective in the treatment of headache. At the interview following completion of study participation, the patients also were asked whether this form of treatment helped. All headaches were rated 3 to 4 in severity prior to treatment, with 0 meaning no headache and 4 indicating an extremely severe headache. Improvement was defined as reduction of at least two points.

Of the 60 patients enrolled, 50 completed the study. Results of the study are summarized in the Table. Of the patients completing the study, 41 (82%) stated that the mask and topical cream were effective in treating their headaches (P=0.001). The remaining 9 patients (18%) said the system was ineffective in treating their headaches. The mask and cream were used a total of 250 times by all of the participants. The average number of uses per patient was 8.2. The average time to relief was 33.2 minutes. No significant side effects and/or allergic reactions were associated with the medication and mask. Many of the patients began using the mask and cream preventatively every night.

The use of topical modalities for the relief of headaches has been around since ancient Egypt. In fact, applying pressure to the head during headaches is an ancient remedy. In Sumeria and ancient Egypt, binding the head was a commonly used treatment. This also was a commonplace treatment long afterward, as illustrated by Shakespeare who had Desdemona say, upon hearing from Othello that he had a headache, “Let me bind it hard. Within this hour it will be well.”2 More recently, Blau and Dexter found that 28 of 50 migraine sufferers gained some relief from occluding the scalp circulation with fingers or a blood pressure cuff.3 Drummond and Lance noted that one-third of their 66 patients with migraine experienced relief by compression of the temporal artery.4 Lance also employed a machine that pulls the circumference of the head and neck to 2°C and one with a vertex of 41°C. He reported that of 20 migraine sufferers, 15 had less severe headaches using this “Migra-Lief” apparatus.5

The anticephalgic photoprotective premedicated mask (APPM) is a benign delivery system for transdermal analgesic medication, which provides simultaneous photo relief and pressure on distended extracranial arteries. Its excellent safety profile affords many advantages over systemic medications. The system can be used frequently, despite nausea or vomiting from the headache. There is minimal, if any, systemic absorption. The APPM is ideal in treating peripheral sensitization and photophobia. Because of its transdermal delivery system, the APPM has a relatively quick onset of response. The average time for relief in our study participants was 
33.2 minutes.

This form of delivery system can be used in the cardiac risk population. It is nonaddicting and has no affect on blood pressure or on the gastrointestinal, renal, hepatic, or pulmonary systems. The APPM can be used abortively or prophylactically. It can be used on an empty stomach.

The majority of patients treated with APPM and menthol cream demonstrated relief of headache symptoms. The open-label study demonstrates the effectiveness of the APPM used in conjunction with menthol cream as an adjunctive treatment of migraines and/or tension-type headaches. This form of treatment can be used in conjunction with currently available oral and parenteral medications. It is an ideal treatment for patients with photophobia and peripheral sensitization.

Last updated on: December 9, 2011
First published on: September 1, 2011