***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    ***EXAMPLES*** 
    Input: Background — Patent foramen ovale ( PFO ) is prevalent in patients with migraine with aura . Observational studies show that PFO closure result ed in migraine cessation or improvement in ≈80 % of such patients . We investigated the effects of PFO closure for migraine in a r and omized , double-blind , sham-controlled trial . Methods and Results — Patients who suffered from migraine with aura , experienced frequent migraine attacks , had previously failed ≥2 classes of prophylactic treatments , and had moderate or large right-to-left shunts consistent with the presence of a PFO were r and omized 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 r and omized . 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 ; P=0.51 ) . 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 ( P=0.027 ) . 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 United States and Europe Abstract The present investigation examined the efficacy of two types of imaginal strategy treatments relative to a placebo control group  on  cold pressor pain and migraine .  One imaginal strategy group ( response group ) was trained to imagine pleasant scenes which included their own responses ( e.g. , muscular relaxation , deep breathing ) . The other imaginal strategy group ( stimulus group ) was trained to imagine scenes with many stimulus details . All imagery subjects were instructed to use their strategies if they had a headache , felt a headache coming on , or found themselves engaged in a negative line of thinking ( catastrophizing ) . The imagery treatments were clearly superior to the  placebo control group both on experimentally produced pain , and a general measure of headache activity , but were not different from each other . Improvement was maintained through a 2 month follow‐up . Successful treatment outcome was predicted by the frequency of imaginal strategy use . Possible underlying mechanisms for the treatments ' efficacy and issues for future research were discussed Background and Purpose Behavioral medicine interventions that directly reduce arousal and negative emotions , such as relaxation training ( RT ) , are conceptually different from interventions that temporarily increase negative emotions , such as written emotional disclosure ( WED ) , but no studies have directly compared their efficacy . We compared the effects of RT and WED on people with tension or migraine headaches . Methods College students with either tension ( n = 51 ) or migraine ( n = 90 ) headaches were r and omized to one of three groups : RT , WED , or a neutral writing control condition ; four sessions were held over 2 weeks . Mood was measured before and after each session , and outcomes ( headache frequency , severity , disability , and general physical symptoms ) were assessed at baseline and at 1-month and 3-month follow-ups . Results As expected , RT led to an immediate increase in calmness , whereas WED led to an immediate increase in negative mood , for both headache sample s. Intent-to-treat analyses showed that , for the tension headache sample , RT led to improved headache frequency and disability compared to both WED and the control group , but WED had no effect . For migraine headaches , RT improved pain severity relative to the control group , but WED again had no effect . Conclusions A brief RT protocol was effective for tension headaches , but WED had no effect on health status for either tension or migraine headaches . Modifications to WED , such as targeting people with unresolved stress , providing guidance to enhance the potency of the writing , or including additional at-home writing and exposure exercises , may improve its efficacy for people with headaches and other health problems Evidence that placebo acupuncture is an effective treatment for  chronic pain  presents a puzzle : how do placebo needles appearing to patients to penetrate the body , but instead sitting on the skin 's surface in the manner of a tactile stimulus , evoke a healing response ? Previous accounts of ritual touch healing in which patients often described enhanced touch sensations ( including warmth , tingling or flowing sensations ) suggest an embodied healing mechanism . In this qualitative study , we asked a subset of patients in a singleblind r and omized trial in irritable bowel syndrome to describe their treatment experiences while undergoing placebo treament . Analysis focused on patients ' unprompted descriptions of any enhanced touch sensations ( e.g. , warmth , tingling ) and any significance patients assigned to the sensations . We found in 5/6 cases , patients associated sensations including " warmth " and " tingling " with treatment efficacy . The conclusion offers a " neurophenomenological " account of the placebo effect by considering dynamic effects of attentional filtering on early sensory cortices , possibly underlying the phenomenology of placebo acupuncture The efficacy of the combination of dihydroergotamine ( 10 mg ) with acetylsalicylic acid ( 80 mg ) ( DHE + ASA ) in the prophylaxis of migraine was studied in a double-blind , placebo-controlled crossover trial ( 8 weeks twice ) . Of 45 patients who entered the study , 38 completed it . The number of attacks was significantly ( p = 0.003 ) reduced during active treatment ( 11.5 ± 6.2 ) compared with placebo ( 16.6 ± 9.9 ) . The mean duration , the mean severity , and the mean score for symptomatic acute medication of attacks did not differ significantly . The overall assessment made by the patients themselves was in favor of DHE + ASA ( p = 0.001 ) . These results indicate a moderately beneficial effect of the dihydroergotamine/low-dose acetylsalicylic acid combination in migraine prophylaxis In order to evaluate the specific effects of blood volume pulse ( BVP ) biofeedback in the treatment of migraine headaches , 21 female migraine patients were r and omly assigned to one of three experimental conditions : temporal artery constriction feedback , temporal artery dilation feedback , or waiting list . Biofeedback training consisted of 15 sessions over an 8-week period . All patients completed 5 weeks of daily self-monitoring of headache activity and medication before and after treatment . Results showed that constriction and dilation biofeedback were equally effective in controlling migraines and produced greater benefits than the waiting-list condition . No significant relationships were found between therapeutic gains and BVP self-regulation skills . However , further analyses revealed that changes in headache activity and medication were associated with changes in vasomotor variability . The current rationale for the use of BVP biofeedback in the treatment of migraine is question ed and a new one is proposed OBJECTIVE Migraine is still an unsolved problem . This clinical trial investigates the efficacy and tolerance of Petasites hybridus in the prophylaxis of  migraine .  METHODS A r and omized , group-parallel , placebo-controlled , double-blind clinical study was carried out with a special CO2 extract from the rhizome of Petasites hybridus . Following a four-week run-in phase , 60 patients received either the special Petasites hybridus extract Petadolex or placebo at a dosage of two capsules ( each capsule contains 25 mg ) twice daily over 12 weeks . Outcome variables included the frequency , intensity and duration of migraine attacks as well as any accompanying symptoms . RESULTS The frequency of migraine attacks decreased by a maximum of 60 percent compared to the baseline . This reduction in migraine attacks with Petadolex was significant ( p < 0.05 ) compared to placebo . No adverse events were reported . Petasites was exceptionally well tolerated . CONCLUSIONS The results suggest that migraine patients can benefit from prophylactic treatment with this special extract . The combination of high efficacy and excellent tolerance emphasizes the particular value that Petasites hybridus has for the prophylactic treatment of migraine All combinations of cooling versus warming and finger versus temporal artery were used in the present study , the aim of which was to identify an optimal biofeedback training site and to assess the specific effects of skin temperature biofeedback upon migraine . After an initial 4-week baseline phase , during which daily records of headache activity and medication were kept , 24 migraine patients were r and omly assigned to one of the four experimental conditions . Training sessions for all patients were of 50-min duration and occurred once per week for 8 weeks . The headache charts were completed for another 4 weeks after treatment was terminated and again at 6-month follow-up . The results showed significant reductions in migraine activity and drug usage . However , self-regulation of skin temperature in different directions at different sites did not in fact result in significantly different magnitudes of change in migraine activity across groups . The role of nonspecific factors is discussed and a physiological model is proposed to explain how warming and cooling may produce clinical improvement in migraine CONTEXT Small open-label and controlled trials suggest that the antiepileptic drug topiramate is effective for  migraine prevention  . OBJECTIVE To assess the efficacy and safety of topiramate for migraine prevention in a large controlled trial . DESIGN , SETTING , AND PATIENTS A 26-week , r and omized , double-blind , placebo-controlled study was conducted during outpatient treatment at 52 North American clinical centers . Patients were aged 12 to 65 years and had a 6-month history of migraine ( International Headache Society criteria ) and 3 to 12 migraines a month but no more than 15 headache days a month during a 28-day prospect i ve baseline phase . INTERVENTIONS After a washout period , patients meeting entry criteria were r and omized to topiramate ( 50 , 100 , or 200 mg/d ) or placebo . Topiramate was titrated by 25 mg/wk for 8 weeks to the assigned or maximum tolerated dose , whichever was less . Patients continued receiving that dose for 18 weeks . MAIN OUTCOME MEASURES The primary efficacy measure was change from baseline in mean monthly migraine frequency . Secondary efficacy measures included responder rate ( proportion of patients with > or = 50 % reduction in monthly migraine frequency ) , reductions in mean number of monthly migraine days , severity , duration , and days a month requiring rescue medication , and adverse events . The month of onset of preventive treatment action was assessed . RESULTS Of 483 patients r and omized , 468 provided at least 1 postbaseline efficacy assessment and comprised the intent-to-treat population . Mean monthly migraine frequency decreased significantly for patients receiving topiramate at 100 mg/d ( -2.1 , P = .008 ) and topiramate at 200 mg/d ( -2.4 , P<.001 ) vs placebo ( -1.1 ) . Statistically significant reductions ( P<.05 ) occurred within the first month with topiramate at 100 and 200 mg/d . The responder rate was significantly greater with topiramate at 50 mg/d ( 39 % , P = .01 ) , 100 mg/d ( 49 % , P<.001 ) , and 200 mg/d ( 47 % , P<.001 ) vs placebo ( 23 % ) . Reductions in migraine days were significant for the 100-mg/d ( P = .003 ) and 200-mg/d ( P<.001 ) topiramate groups . Rescue medication use was reduced in the 100-mg/d ( P = .01 ) and 200-mg/d ( P = .005 ) topiramate groups . Adverse events result ing in discontinuation in the topiramate groups included paresthesia , fatigue , and nausea . CONCLUSION Topiramate showed significant efficacy in migraine prevention within the first month of treatment , an effect maintained for the duration of the double-blind phase A novel calcium entry blocker , nicardipine , has been tested using a dosage of 20 mg twice a day against placebo on 30 patients suffering from migraine without aura , according to a double-blind , cross-over design ; overall duration of the study was four months ( two with nicardipine and two with placebo ) . Migraine parameters such as monthly frequency , mean intensity and mean duration of attacks were monitored . Two indexes were also calculated : index A ( monthly frequency x mean intensity ) and index B ( monthly frequency x mean intensity x mean duration ) . All the parameters considered and the two indexes showed a marked and significant improvement after nicardipine treatment in comparison to both placebo and pre- study scores . Detailed analysis of the cross-over results showed that improvement obtained with nicardipine lasted some time after the drug was discontinued . Nicardipine did not alter the blood and attention tests performed and caused few side effects The effects and side‐effects in migraine prophylaxis of placebo , Divascan ® ( 1‐isopropylnoradrenochrome‐5‐monosemicarbazone ) and pizotifen were compared in a double‐blind cross‐over study . The dosage was for Divascan 15 mg a day and for pizotifen 3 mg a day . Data from the last 6 weeks of each test period of 8 weeks were used to assess the effect of the treatment . Thirty patients entered the trial . Data from 28 patients treated with placebo and Divascan and 27 patients treated with pizotifen  were used for 
    Output:
    
AND RELEVANCE Sham acupuncture and sham surgery are associated with higher responder ratios than oral pharmacological placebos .