migraine is a highly prevalent illness , and women of reproductive ages are more affected by it than men or women in other age groups ( 1 ) .
many researchers have supported the view that behavioral interventions such as biofeedback and relaxation , either alone or in combination , can be effective for the treatment of headache ( 2 - 7 ) . especially , thermal biofeedback with or without combined autogenic training
is known to be effective for the treatment of migraine headache ( 5 , 8) .
in addition , some studies showed that the effect of the behavioral treatment is durable ( 9 , 10 ) .
there have been no controlled studies about the efficacy of biofeedback and relaxation training for patients with migraine in korea , and few studies have been conducted to investigate the direct association between mood states , including anxiety or depression , and headache activity .
the mechanism underlying the efficacy of biofeedback treatment and the role of psychological factors in migraine treatment are still unclear , though various mood states , including anxiety and depression , and some cognitive factors are known to be related to pain regulation ( 11 - 13 ) .
psychological conditions including anxiety and depression have been reported to have a strong association with migraine ( 12 - 14 ) .
thus , in this study , we examined the hypothesis that biofeedback - assisted autogenic training is effective for the treatment of korean female patients with migraine and that the improvement of psychological factors , such as anxiety and depression , is associated with the reduction of headache activity in migraine patients who are given biofeedback treatment .
thirty - two patients , who had migraine headache with or without aura , as defined by the international headache society criteria ( 15 ) , participated in this study , from march 2003 until december 2006 .
the patients were female subjects aged 20 to 40 yr who had a body mass index ( bmi ) ranging from 18 to 27.5 .
the patients were randomly allocated to one of two patient groups , consisting of a treatment group receiving biofeedback - assistant relaxation treatment ( n=17 ) and a monitoring group in which the headache activities and biofeedback parameters of the patients were simply measured ( n=15 ) .
these two groups did not show any significant difference in the duration of headache , headache index , duration of medication use , or other headache - related variables at the baseline ( table 1 ) .
twenty - one normal female volunteers were recruited by advertisement and were matched with the migraine patients by age ( treatment group : 31.125.49 yr , monitoring group : 31.874.70 yr , normal control group : 29.384.64 yr ) , and mood states and mean skin temperature of the patients before the biofeedback treatment were compared with those of the normal control subjects .
each subject underwent a comprehensive medical and psychiatric assessment including careful history taking , physical examination , neurological examination , mental status examination , and electrocardiography .
those patients who seemed to suffer from secondary headache due to medical or psychiatric illnesses were not included in the study .
they did not take regular medications for migraine headache , and only pro re nata ( p.r.n . )
this study was approved by the institutional review board of samsung medical center , and all of the subjects gave their written informed consent .
the patients in the treatment group received 8 sessions of biofeedback - assisted autogenic training ( two sessions per week ) during a period of 4 weeks , while those in the monitoring group received no active intervention except for simple biofeedback measurements ( 1st , 4th , and 8th session ) during the treatment - waiting period .
biofeedback treatment was administered with the patient sitting on a comfortable arm - chair in a quiet room in the psychiatric outpatient clinic of samsung medical center .
a procomp+system and biograph version 2.1 program ( thought technology ltd . , quebec , canada ) were used for the biofeedback treatment and measurements .
the autogenic training procedures consisted of 6 standard exercises combining both relaxation and auto - suggestion ( limb heaviness exercise , limb warmth exercise , cardiac exercise , respiration exercise , solar plexus warmth exercise , and " forehead cooling " exercise ) ( 16 ) . during the 1st session , after the baseline profiles were obtained , education in relaxation techniques was given to the patients in the treatment group . during the 2nd to 8th sessions , thermal biofeedback combined with autogenic training
for the first 15 - 20 min , after collecting the headache diary data , the patients were rated on psychological variables and headache severity .
the patients were trained to increase their skin temperature by an experienced biofeedback therapist for about 15 min according to the procedures described in a treatment manual . during the last 15 min ,
they were instructed to continue the relaxation exercise by themselves , while listening to a prerecorded tape .
the headache severity was rated on a 6-point rating scale with 0 representing " no pain " and 5 representing " pain as severe as it can be " .
the average frequency , duration , and intensity of pain during the 7 consecutive days were compiled as headache indexes .
headache indexes at baseline , after 2 weeks , and after 4 weeks of biofeedback treatment were used to compare the two groups .
secondary outcomes were evaluated using the mpq ( 17 ) and the clinical global impression severity scale ( cgi - s ) administered by the therapist .
the baseline headache variables were recorded for the previous 1 week before the treatment and the follow - up headache variables as the mean of the symptoms during the previous week . due to the possibility of there being a change in the perception of pain according to the menstrual cycle ( 18 ) ,
the menstruation phase was determined by asking the subjects the onset of their last menstruation . before the biofeedback treatment
, there were no differences in the headache indices and mood states between the treatment group and monitoring group according to the menstruation phase .
the psychological assessments for anxiety and depressive symptoms were performed using the hamilton rating scales for anxiety ( ham - a ) ( 19 ) and depression ( ham - d ) ( 20 ) , and the spielberger state anxiety inventory ( stai - s ) ( 21 ) .
the cgi - s , ham - a , and ham - d were performed by a well - trained psychiatrist who was blind to the patients ' clinical states . to compare the baseline values , chi - square test , fisher 's exact test , and analysis of variance ( anova ) were used .
. repeated measures anova was performed to analysis mean changes of skin temperature , psychological variables , and secondary pain outcomes .
student 's t - test with bonferroni 's correction was performed for post hoc analysis .
univariate and multivariate logistic regression analyses were used to whether the baseline or changes of depression and anxiety level could predict the treatment outcome .
thirty - two patients , who had migraine headache with or without aura , as defined by the international headache society criteria ( 15 ) , participated in this study , from march 2003 until december 2006 .
the patients were female subjects aged 20 to 40 yr who had a body mass index ( bmi ) ranging from 18 to 27.5 .
the patients were randomly allocated to one of two patient groups , consisting of a treatment group receiving biofeedback - assistant relaxation treatment ( n=17 ) and a monitoring group in which the headache activities and biofeedback parameters of the patients were simply measured ( n=15 ) .
these two groups did not show any significant difference in the duration of headache , headache index , duration of medication use , or other headache - related variables at the baseline ( table 1 ) .
twenty - one normal female volunteers were recruited by advertisement and were matched with the migraine patients by age ( treatment group : 31.125.49 yr , monitoring group : 31.874.70 yr , normal control group : 29.384.64 yr ) , and mood states and mean skin temperature of the patients before the biofeedback treatment were compared with those of the normal control subjects .
each subject underwent a comprehensive medical and psychiatric assessment including careful history taking , physical examination , neurological examination , mental status examination , and electrocardiography .
those patients who seemed to suffer from secondary headache due to medical or psychiatric illnesses were not included in the study .
they did not take regular medications for migraine headache , and only pro re nata ( p.r.n . )
this study was approved by the institutional review board of samsung medical center , and all of the subjects gave their written informed consent .
the patients in the treatment group received 8 sessions of biofeedback - assisted autogenic training ( two sessions per week ) during a period of 4 weeks , while those in the monitoring group received no active intervention except for simple biofeedback measurements ( 1st , 4th , and 8th session ) during the treatment - waiting period .
biofeedback treatment was administered with the patient sitting on a comfortable arm - chair in a quiet room in the psychiatric outpatient clinic of samsung medical center .
a procomp+system and biograph version 2.1 program ( thought technology ltd . , quebec , canada ) were used for the biofeedback treatment and measurements .
the autogenic training procedures consisted of 6 standard exercises combining both relaxation and auto - suggestion ( limb heaviness exercise , limb warmth exercise , cardiac exercise , respiration exercise , solar plexus warmth exercise , and " forehead cooling " exercise ) ( 16 ) . during the 1st session , after the baseline profiles were obtained , education in relaxation techniques was given to the patients in the treatment group . during the 2nd to 8th sessions , thermal biofeedback combined with autogenic training
for the first 15 - 20 min , after collecting the headache diary data , the patients were rated on psychological variables and headache severity .
the patients were trained to increase their skin temperature by an experienced biofeedback therapist for about 15 min according to the procedures described in a treatment manual . during the last 15 min ,
they were instructed to continue the relaxation exercise by themselves , while listening to a prerecorded tape .
the headache severity was rated on a 6-point rating scale with 0 representing " no pain " and 5 representing " pain as severe as it can be " .
the average frequency , duration , and intensity of pain during the 7 consecutive days were compiled as headache indexes .
headache indexes at baseline , after 2 weeks , and after 4 weeks of biofeedback treatment were used to compare the two groups .
secondary outcomes were evaluated using the mpq ( 17 ) and the clinical global impression severity scale ( cgi - s ) administered by the therapist .
the baseline headache variables were recorded for the previous 1 week before the treatment and the follow - up headache variables as the mean of the symptoms during the previous week . due to the possibility of there being a change in the perception of pain according to the menstrual cycle ( 18 ) ,
the menstruation phase was determined by asking the subjects the onset of their last menstruation . before the biofeedback treatment
, there were no differences in the headache indices and mood states between the treatment group and monitoring group according to the menstruation phase .
the psychological assessments for anxiety and depressive symptoms were performed using the hamilton rating scales for anxiety ( ham - a ) ( 19 ) and depression ( ham - d ) ( 20 ) , and the spielberger state anxiety inventory ( stai - s ) ( 21 ) . the cgi - s , ham - a , and ham - d were performed by a well - trained psychiatrist who was blind to the patients ' clinical states .
to compare the baseline values , chi - square test , fisher 's exact test , and analysis of variance ( anova ) were used . treatment outcome analysis in terms of headache index was preformed using chi - square test .
repeated measures anova was performed to analysis mean changes of skin temperature , psychological variables , and secondary pain outcomes .
student 's t - test with bonferroni 's correction was performed for post hoc analysis .
univariate and multivariate logistic regression analyses were used to whether the baseline or changes of depression and anxiety level could predict the treatment outcome .
the fisher 's exact test revealed a significant difference in the response rate in terms of headache index between the two groups ( =4.979 , df=1 , p=0.029 ) .
ten of the 17 patients ( 58.9% ) in the treatment group showed a significant improvement in their headache index corresponding to a 50% or greater reduction in their headache activity , whereas only 3 of the 15 subjects ( 20% ) in the monitoring group achieved a significant improvement ( fig .
1 ) . repeated measures anova indicated that there were significant interactions between time and group in the mpq - s ( f=6.994 , p=0.014 ) , mpq - a ( f=9.978 , p=0.006 ) , and cgi - s ( f=16.160 , p=0.001 ) .
mean resting skin temperatures did not show any differences between the treatment and monitoring group , nor pre- and post - treatment ( all p values > 0.1 ) .
the results of the comparisons of the psychological states of the three groups are shown in table 2 . the anxiety and depression levels in the migraine patients
were significantly higher than those in the normal control subjects at the baseline ( all p values < 0.001 ) .
there were no group differences between the biofeedback - assisted autogenic training group and the monitoring group .
significant interactions between time and group were found for the ham - a ( f=10.560 , p=0.003 ) , ham - d ( f=8.161 , p=0.013 ) , and stai - s ( f=12.320 , p=0.002 ) .
post hoc analysis revealed that there were significant between - group differences at the endpoint ( p=0.002 , 0.032 , 0.001 , respectively ) .
age , bmi , the baseline ham - d , ham - a , and stai - s were not associated with treatment response in terms of headache index ( all p values > 0.1 ) in the biofeedback - assisted training group
. however , the multivariate logistic regression revealed that the greater reduction of the ham - a score was associated with the treatment response controlling for age , bmi , and the baseline ham - a in the biofeedback - assisted autogenic training group ( or=1.52 , ci=1.01 - 2.33 , p=0.048 ) whereas the reduction of the ham - d score nor that of the stai - s were not ( p=0.088 and p=0.080 , respectively ) .
we found that biofeedback - assisted autogenic training is effective in management of female migraine patients in korean population .
they also exhibited significant differences in their mood states measured by the ham - a , ham - d , stai - s , as compared with the normal healthy women .
this finding is consistent with the results of previous studies which showed that migraine patients had high levels of anxiety and depression ( 12 , 14 , 22 ) .
it is also consistent with a previous report ( 23 ) that negative mood states such as anxiety and depression are related to physical complaints and headache .
the anxiety and depression scores in the migraine patients were reduced after 4 weeks of biofeedback treatment .
furthermore , the reduction in anxiety level after the biofeedback treatment was related to the treatment response of the patients . to our knowledge , there have been no reports about the association between mood states , including anxiety and depression , and improvements in headache activity in migraine patients receiving biofeedback treatment .
our result is also consistent with the finding of previous studies ( 24 - 27 ) that mood states might affect the experience of pain through the cognitive processing of nociceptive information , although this hypothesis has not been directly examined in headache patients .
the present result is in contrast with the previous report ( 2 ) that decreased depression level rather than anxiety was related to the outcome of biofeedback - assisted training in patients with chronic tension - type headache . taken together , reduction of anxiety may be related to the biofeedback treatment response of migraine headache , whereas reduction of depression may be related to the biofeedback treatment response of chronic tension - type headache .
further studies will be necessary to confirm this difference between migraine and tension type headache .
mean skin temperatures between the pre- and post - treatment changes were not statistically different .
our finding also suggests that the reduction of anxiety rather than depression level is more important in the biofeedback treatment of migraine .
this result appears to confirm the previous findings that the treatment mechanism of biofeedback is mediated by an indirect process rather than a direct physiological change ( 28 , 29 ) .
cognitive factors such as increased self - efficacy belief or coping style can affect the success of biofeedback treatment , and anxiety is known to be closely associated with cognitive factors ( 11 ) .
however , since migraine is known to be inter - related to anxiety ( 30 ) , our tentative finding has the limitation that it does not confirm whether an improvement in anxiety causes a decrease in headache activity .
further studies are needed to examine the relationship among mood states , cognitive factors , and headache .
migraine is an illness with a fluctuating course in which the symptoms wax and wane , and psychophysiological treatment may have a delayed effect .
secondly , the severity of headache in the recruited patients was relatively low and the patients in this study may not represent the general population with migraine headache .
however , to the best of our knowledge , this is the first controlled study to examine the efficacy of biofeedback treatment and the relationship between mood states and headache activity in korean migraine patients . in conclusion ,
biofeedback treatment was found to cause an improvement of headache and mood states such as anxiety and depression in female migraine patients .
in addition , the reduction of anxiety level was related to the biofeedback treatment response .
these results suggest that biofeedback treatment can be an effective non - pharmacological treatment for migraine patients and that the improvement of the anxiety states afforded by biofeedback treatment may play a key role in reducing headache activity .
 biofeedback with or without combined autogenic training is known to be effective for the treatment of migraine . 
 this study aimed to examine the effect of biofeedback treatment on headache activity , anxiety , and depression in korean female patients with migraine headache . 
 patients were randomized into the treatment group ( n=17 ) and monitoring group ( n=15 ) . 
 mood states including anxiety and depression , and psychophysiological variables such as mean skin temperature of the patients were compared with those of the normal controls ( n=21 ) . 
 we found greater treatment response rate ( defined as 50% reduction in headache index ) in patients with biofeedback - assisted autogenic training than in monitoring group . 
 the scores on the anxiety and depression scales in the patients receiving biofeedback - assisted autogenic training decreased after the biofeedback treatment . 
 moreover , the decrease in their anxiety levels was significantly related to the treatment outcome . 
 this result suggests that the biofeedback - assisted autogenic training is effective for the treatment of migraine and its therapeutic effect is closely related to the improvement of the anxiety level . 
INTRODUCTION
MATERIALS AND METHODS
Subjects
Procedure & Treatment
Measures of pain and psychological variables
Data analyses
RESULTS
DISCUSSION