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Abstract: The International League Against Epilepsy (ILAE) Psychiatry and Treatment Strategies Commissions (Sub-commission on Non-pharmacological treatment) jointly convened a conclave on the neuropsychiatric aspects of epilepsy. A systematic assessment of CAM, listing the therapies and examining evidence of possible efficacy of these therapies based on our current research methods may be of benefit to determine their current status and stimulate research in this area for possible treatments for epilepsy. A systematic review to examine the evidence from randomized controlled trials investigating psychological treatments for epilepsy was carried out and discussed. Better designed and larger studies are imperative if researchers are to address whether behavioral interventions can positively influence seizure frequency and psychological functioning. One design consideration could be if NPT is used as an adjunctive to ongoing antiepileptic drugs or pending surgery in subjects who are on AEDs. The outcome that needs to be evaluated should be well defined and may either be seizures index (mostly cannot be separated from AED effects) or QOL or behavioral scale (for the adjunctive NPT intervention). In conclusion, psychological interventions are used in attempts to reduce seizure frequency, improve the quality of life and avoid adverse effects of drugs among people with epilepsy and need further RCTs to assess their role in epilepsy care and in improving the life of persons with epilepsy.
Keywords: epilepsy, treatment, nonpharmacological treatment (NPT), psychotherapy, behavioral interventions, outcomes
A significant number of people with epilepsy in the developing & developed world use complementary and alternative medicines (CAM) therapies and may not disclose this fact to their treating physicians. The therapies encompassed in CAM are diverse in nature and include herbal remedies, psychological interventions, educational therapy, and relaxation therapies of various forms such as progressive relaxation, meditation, Yoga, music therapy, diet modification and various other modalities. Health seeking behaviors may be diverse in that the alternative therapies may be used alone or as adjunct to allopathic treatments for epilepsy. Contributors to CAM utilization may include cultural mores, economic difficulties and a large epilepsy treatment gap, especially in the developing world. A systematic assessment of CAM, listing the therapies and examining evidence of possible efficacy of these therapies based on our current research methods may be of benefit to determine their current status and stimulate research in this area for possible treatments for epilepsy.
The International League Against Epilepsy (ILAE) convened a conclave on the neuropsychiatric aspects of epilepsy in Chennai, India in February 2008. One of the charges for this group was to focus on nonpharmacologic interventions for epilepsy, specifically focusing on psychological therapies. Herbal and diet therapies have been covered elsewhere (ref) and were considered outside the scope of the objectives of this task force. Previously published critical reviews on the use of psychological treatments for epilepsy have highlighted the methodological deficiencies in many of these studies(1,2,3,4) (Goldstein 1990; Goldstein 1997; Krafft 1982; Mostofsky 1993). These limitations include recruiting too small a number of participants, poor operational definitions, lack of controls, randomization or blinding, highly selected patient groups, lack of documentation of inter-observer agreements and poor description of interventions. In this paper, we present a systematic review to examine the evidence from randomized controlled trials investigating psychological treatments for epilepsy.
Rationale for using psychological therapies to treat epilepsy:
Psychological interventions have been studied in epilepsy with two main areas of focus, addressing: (1) the comorbidities of epilepsy, and (2) the precipitants of epilepsy. People with epilepsy (PWE) are at increased risk of anxiety and depression, of experiencing low self esteem, and of suffering from the stigma attached to having epilepsy. A recent, large community study (based on responses by 696 adults) showed the importance of frequency of current seizures in determining anxiety, depression, and perceived life fulfillment (8). Factors other than frequency of seizures may influence ability to cope psychologically. In addition, psychological factors have become increasingly recognised as playing a part in the occurrence of seizures. Psychological interventions might consider, therefore, both the psychological disturbances that accompany poorly controlled seizures, and the occurrence of the seizures themselves. For example, psychological interventions such as relaxation therapy, cognitive behaviour therapy (CBT), bio-feedback and educational interventions have been used alone or in combination in the treatment of epilepsy, to reduce the seizure frequency and improve the quality of life.
It has been postulated that there is a relationship between behavioural, physiological and psychological states and the probability of seizure occurrence (5) (Fenwick 1991). Epilepsy is often associated with anxiety, depression, behaviour problems and cognitive dysfunction. This co-morbidity may reflect a common single cause, or be due to the stigma and social handicaps associated with epilepsy or a combination of both. Psychological interventions such as psychotherapy, individual, group or family counseling, progressive relaxation therapy and cognitive behaviour therapy have been used to treat psychopathology associated with epilepsy(6,7) (Davis 1984; Miller 1994). Anecdotal reports reveal that such treatments not only alleviate anxiety, depression and behaviour problems but also reduce seizure frequency(8,9) [ref].
Environmental external triggers are known to precipitate epileptic seizures, as is seen in the reflex epilepsies. Internal triggers are also known to precipitate epileptic seizures. In reflex epilepsies such as musicogenic, photogenic, movement induced, eating or reading epilepsy, external factors may precipitate a seizure. Self induction of seizures by some people with epilepsy (waving the hand in front of eyes or blinking inducing photosensitive seizures) provides evidence that some people are aware of stimuli that precipitate their seizures (10,11)[ref]. Epileptic seizures have also been known to be precipitated by psychological triggers (internal precipitants) such as stress, anxiety, anger and emotions, as well as by mental tasks and thoughts (12,13,14,15)(Betts 1992; Fenwick 1994; Temkin 1984 Woods RJ,2006) . In studies examining precipitants of epileptic seizures, stress is cited as one of the most frequent precipitants (16) (Nakken KO 2005)
Anecdotal reports exist documenting people with epilepsy using behavioural methods to avoid seizures, for example an individual may recognize precipitating factors or prodromal symptoms of a seizure and initiate countermeasures (17,18,19)(Fenwick 1994; Pritchard 1985; Wolf 1997). Hence the question arises as to whether psychological and behavioural methods can be used to treat epilepsy
MEDLINE search (1966-2009) and PsycINFO search (1887-2009) of behavioral interventions for epilepsy was performed in June 2009, using the individual terms: epilepsy, combined with psychotherapy, cognitive behavioral therapy, biofeedback and educational therapy. When the search revealed epilepsy and psychotherapy articles, the article bibliographies were reviewed. A review of neurology and epilepsy specialized textbooks with chapters on behavioral treatment of epilepsy was also conducted. For inclusion criteria, we incorporated studies or case reports that determined the diagnosis of epilepsy and behavioral treatments.
In this review, the following aspects of various trials were assessed:
(1) Study methods
(a) Design (egg. parallel or crossover design).
(b) Randomization method (allocation concealment and list generation).
(c) Blinding method.
(a) Number (total/per group).
(b) Age and gender distribution.
(c) Seizure type and epilepsy syndrome.
(d) Duration of epilepsy.
(e) Aetiology of epilepsy.
(f) Presence or absence of learning disability.
(3) Type of intervention and control.
(4) Duration of follow up.
(5) Outcome data as described earlier.
We did not undertake comparing a formal meta-analysis across studies.
A large number of case reports and other studies referring to epilepsy and psychotherapy were identified. To summarize the findings of the literature review, we describe 1) the approaches of the behavioral interventions, 2) the design of the studies, and 3) the outcomes of the studies.
The broad aims of psychological approaches for treating epilepsy include:
(1) Increasing the seizure threshold by modulating electroencephalogram (EEG) activity or altering the level of arousal;
(2) Modulating seizure precipitating factors;
(3) Preventing the spread of epileptic activity and thus the generalization of the seizure.
The psychological methods of treatment of epilepsy that have been experimentally studied include:
(1) Reward management: overt reward; covert reward; denial of reward; punishment programmers and relief avoidance.
(2) Self control strategies allow the individual to gain control of seizure activity by using cognitive processes(20,21) (Cabral 1976; Dahl 1988) and comprise:
(a) "self (patient) identified strategies" to inhibit seizure activity;
(b) relaxation (progressive muscle relaxation);
(c) desensitization to the occurrence of a seizure by exposure to seizure-provoking situations;
(d) avoidance of seizure precipitating stimuli;
(e) psychotherapy - individual, group or family;
(3) Psycho-physiological approaches that have been attempted include:
(a) classical conditioning, habituation and extinction of seizure precipitating factors(22) (Forster 1969; Forster 1968);
(b) EEG bio-feedback training to modulate 12-16 Hz sensorimotor rhythm, or alpha activity or slow cortical potentials(23,24,25,26) (Kuhlman 1978; Lubar 1981; Quy 1979; Sterman 1980a)
(c) diaphragmatic breathing with end-tidal percent CO2 bio-feedback (27)(Fried 1990).
(4) Miscellaneous: stress-management programs; physical training (16)(Nakken 1990); neck or body massage; assertive therapy; rational emotive therapy; psychotherapy and counseling pertaining to the vocational; educational; genetic and marital problems of the individual.
(5) A combination of the above measures individualized to a particular individual (28, 29) (Andrews 1992; Reiter 1987).
(6) Acceptance and commitment therapy - a form of short course psychotherapy (30a)Lundgren
(7) Yoga consisting of breathing control, postures and its resultant splanchnic stimulation (30c) has been evaluated in RCT (30b) and compared to acceptance and commitment Therapy
Description of studies
Five main modalities were used in behavioral interventions for epilepsy: Relaxation Therapy, Cognitive Behavioral Therapy, Biofeedback, Educational Interventions, and combined interventions, which are described below. We also review the effect of the various interventions on specific psychological measures.
Relaxation therapy and epilepsy
Three studies investigated the effect of relaxation therapy on seizure control(31,32,33) (Dahl 1987; Puskarich 1992; Rousseau 1985). In total these studies included 50 adults with uncontrolled epilepsy (23 to the treatment group and 27 controls; 18 men and 32 women). One study enrolling 32 individuals (age, gender composition not stated) evaluated the effect of relaxation therapy on psychosocial functioning (34)(Snyder 1983).
(1) Relaxation therapy and seizure control: design
Two studies used a quasi random method, one using sequential alternation(33) (Rousseau 1985) and the other alternating blocks of five (32)(Puskarich 1992). In the third study (31) (Dahl 1987), the randomization method is not mentioned in the published report. There is considerable variation in the seizure frequencies at baseline among the randomized groups in all the three studies, which may be a reflection of the small sample size and/or the randomization method.
(2) Relaxation therapy and psychosocial functioning
The randomization was by alternate allocation in the study by Snyder and only 50% of enrolled participants completed the study.
Relaxation therapy: outcomes
(a) Relaxation therapy and seizures
The publications by Dahl, Rousseau and Puskarich provided sufficient seizure frequency data to calculate 50% responder rates. Results for two studies suggest a non-significant advantage for relaxation therapy, with Peto odds ratio (OR) with 95% confidence intervals (CIs) of 2.56 (95% CI 0.45 to 14.44) (3) and 2.54 (95% CI 0.17 to 37.01) (33) (Rousseau 1985). One study (31) (Dahl 1987) found a significant advantage for relaxation therapy, with a Peto OR of 15.64 (95% CI 1.57 to 155.75). However, the confidence intervals are wide and given the methodological limitations of the study, these findings are limited. In total, only one participant in the relaxation therapy group (in the study by Rousseau) and none among the controls were seizure free.
For the outcome percentage reduction in seizure frequency (compared to attention control group), there was a non significant advantage for treatment in all three studies, with weighted mean differences of 358.96 (95% CI -49.33 to 767.25), 27.08 (95% CI -10.49 to 64.65) and 32.68 (95% CI -5.56 to 70.92) respectively for the three studies.
(b) Relaxation therapy and psychosocial functioning
Snyder found no significant difference in WPSI scores between the treatment and control groups after relaxation therapy; no data regarding the seizure frequency are available.
Cognitive behaviour therapy and epilepsy
We found two studies evaluating the effect of CBT on seizure control and or psychological functioning (6, 35) (Davis 1984; Tan 1986). Davis studied the effect of cognitive behaviour therapy among 15 adults with epilepsy who were also depressed. Tan investigated the efficacy of group cognitive behaviour therapy for the alleviation of psychosocial problems and reduction of seizures, among 30 adults with epilepsy. We are awaiting the details of the method of randomization and effects of the stress management training program on seizure control and quality of life in another study (Berger 2001).
Cognitive behaviour therapy and epilepsy: design
The randomization method is not mentioned in either of the two studies (6, 35) (Davis 1984; Tan 1986). In the study by Tan, two individuals in each group had "probable to definite" co-existing non-epileptic seizures and the mean baseline weekly seizure frequency in the three groups differed considerably. In a study, assessing the efficacy of cognitive behaviour therapy in people with epilepsy and a depressed affect (6) (Davis 1984), the concomitant antidepressant therapy and the intervention given to controls, have not been described.
(a) Cognitive behaviour therapy: seizure outcomes
No statistically significant advantage was found for cognitive behavioural therapy. Tan (35) found a greater than 67% reduction in seizure frequency in 1 of the 10 participants in the treatment group and in 2 of the 10 in the attention control group and 1 of the 10 controls. The Peto OR for CBT versus attention control is 0.47 (95% CI 0.04 to 5.19) and for CBT versus controls Peto OR is 1.0 (95% CI 0.06 to 17.25). One of the 10 participants in the treatment group and 1 in each of the 2 control groups were seizure free giving a Peto OR 1.0 (95% CI 0.06 to 17.25).
(b) Cognitive behaviour therapy and psychosocial outcomes
No statistically significant advantage was found for cognitive behavioural therapy. Tan found no significant differences between the treatment group and two control groups for the WPSI, MMPI and BDI. Only the therapists' global ratings of psychological adjustment improved for both the CBT and control groups. In a study of the use of cognitive behaviour therapy in people with epilepsy and a depressed affect, Davis, found significantly greater reduction in dysphoria/depression in the treatment group, compared to controls. There was also a significant decrease in self reported anxiety/ stress and anger. There was increased involvement in social activities for individuals in the treatment group as measured by the 'Community Adjustment Questionnaire'. The study does not report the effect of treatment on seizures.
Bio-feedback and epilepsy
Lantz 1988(36) studied the effect of EEG bio-feedback on 24 adults randomized to three groups: contingent EEG bio-feedback, non-contingent feedback and no intervention controls. (37) Nagai 2004 investigated the effects of galvanic skin response (GSR) biofeedback training or sham feedback on seizure frequency in 18 patients with treatment resistant epilepsy
Bio-feedback and epilepsy: design
The published report of the study by Lantz does not state the randomization method. The study on GSR biofeedback (Nagai) was a single blind (patients were blinded) randomized controlled study, where the allocation was by random number tables, determined at trial onset.
(a) EEG bio-feedback and seizures
Lantz reported a statistically significant reduction in seizure frequency following contingent training (p < 0.005). The median seizure reduction in the treatment group was 61%. However the data for the control group are not available and hence we are unable make a comparison between treatment groups.
(b) EEG bio-feedback and neuropsychological and quality of life measures
These outcomes were reported by Lantz, who found no significant difference between treatment and control groups for the MMPI and the WPSI.
(c) GSR BIO-FEEDBACK AND SEIZURES
Nagai found that six of the 10 patients in the treatment group had 50% or greater reduction in seizure frequency, compared to none among the eight in the sham feedback group (Peto OR 12.81 95%CI 1.88 to 87.06; p=0.009).
Yoga and Epilepsy comparison with Acceptance and Commitment therapy (ACT):
Yoga for epilepsy and studies on its effects on physiology, psychology and EEG was reviewed by Yardi. (30 C)
Two studies comparing Yoga with Acceptance and commitment therapy short course psychotherapy) have been reported, one of these was comparing ACT with Attention control group. Yardi, Dahl and Lundgren reported as study whose design consisted of a randomized controlled trial with repeated measures (N = 18). All participants had an EEG-verified epilepsy diagnosis with drug-refractory seizures. Participants were randomized into one of two groups: ACT or yoga. Therapeutic effects were measured using seizure index (frequency Ã- duration) and quality of life (Satisfaction with Life Scale, WHOQOL-BREF). The treatment protocols consisted of 12 hours of professional therapy distributed in two individual sessions, two group sessions during a 5-week period, and booster sessions at 6 and 12 months post treatment. Seizure index was continuously assessed during the 3-month baseline and 12-month follow-up. Quality of life was measured after treatment and at the 6-month and 1-year follow-ups
The results indicate that both ACT and yoga significantly reduce seizure index and increase quality of life over time. ACT reduced seizure index significantly more as compared with yoga. Participants in both the ACT and yoga groups improved their quality of life significantly as measured by one of two quality-of-life instruments. The ACT group increased their quality of life significantly as compared with the yoga group as measured by the WHOQOL-BREF, and the yoga group increased their quality of life significantly as compared with the ACT group as measured by the SWLS.
Lundgren, Dahl et al studied ACT and attention control in an RCT in South Africa, the purpose of this study was to develop and evaluate a psychological treatment program consisting of acceptance and commitment therapy (ACT) together
With some behavioral seizure control technology shown to be successful in earlier research. The method consisted of a randomized controlled
trial group design with repeated measures (n = 27). All participants
had an EEG verified epilepsy diagnosis with drug refractory
Seizures. Participants were randomized into one of two
Conditions, ACT or supportive therapy (ST). Therapeutic effects
were measured by examining changes in quality of life (SWLS
and WHOQOL) and seizure index (frequency Ã- duration). Both
treatment conditions consisted of only nine hours of professional
therapy distributed in two individual and two group sessions during
a four-week period. The results showed significant effects over all of the
dependent variables for the ACT group as compared to the ST
group at six- and twelve-month follow-ups. The results from this study suggest that a
short-term psychotherapy program combined with anticonvulsant
drugs may help to prevent the long-term disability that occurs from drug refractory seizures
Educational interventions and epilepsy
Four studies(38,39,40,41) (Helgeson 1990; Lewis 1990; May 2002; Olley 2001) assessed the outcome of educational interventions on psychosocial functioning . Helgeson tested the effect of a two-day psycho-educational program (Sepulveda Epilepsy Education) among 100 adults with epilepsy. Lewis investigated the effect of a child centered, family focused, and educational program on 252 children with epilepsy aged between 7 to 14 years. Self competence, changes in the children's knowledge about seizures, changes in the children's and in their parents' behaviour were studied. Olley evaluated the efficacy of a two-day modular didactic psycho- educational program on adjustment to epilepsy, stigma, psychoneurotic traits, depression and knowledge of epilepsy among adult Nigerian patients. May studied the effect of a modular didactic educational program (MOSES - Modular Service Package Epilepsy) on health related quality of life, self esteem, depression, restriction in daily life, epilepsy related fear, stigma, mobility and leisure, knowledge of epilepsy, coping with epilepsy, adaptation to epilepsy and contentedness with drug therapy among adult German speaking patients from 22 epilepsy centers in Germany, Austria and Switzerland. Apart from one study(40) (May 2002) which assessed the seizure frequency categorized in a 0 to 5 scale (0 = no seizures, 5 = 1 or more seizure/day) the other studies did not investigate the outcome of their interventions on seizures.
Educational interventions and epilepsy : design
In the study by Helgeson , 100 individuals with epilepsy were randomized, 50 to each group but the method of randomization was not described. However, only 23 in the treatment group and 20 in the control group actually participated and 20 in the treatment group and 18 in the control group completed the study. In the study by Lewis , randomization was by random number assignment. The randomization in the third study (Olley ) was by alternate allocation matched according to seizure type and frequency of seizures. The randomization method was not described in the study by May , which randomized 383 individuals among whom only 250 completed the study and the results of 242 participants were analyzed (excluding 8 protocol violators).
Educational interventions: outcomes
Helgeson found significant differences between the treatment and control groups for the three major subscales of the 50 item Sepulveda Epilepsy Education (SEE) true-false list. The treatment group demonstrated a significant increase in overall understanding of epilepsy, significant decrease in fear of seizures, significant decrease in hazardous medical self management practices. Serum antiepileptic drug levels indicated better drug compliance in the treatment group. There was no statistically significant difference between treatment and control groups for the WPSI, except that the control group's level of adjustment appeared to decrease over the course of the trial. Lewis found statistically significant improvements in the treatment group for participants' knowledge about epilepsy, specifically regarding what not to do during a seizure (no objects in the mouth, do not restrain, emergency room visit not required); the purpose of the EEG and the minimal restriction of activities required. Children in the treatment group were more likely to participate in normal activities compared to controls.
Children's perceived competencies in scholastic achievement, social skills and behaviour also improved. The anxiety of these children's parents also decreased. Olley found significant improvement in depression, neurotic disorders and knowledge of epilepsy in the treatment group compared to the control group after a 2 day psycho-educational program. May found that MOSES educational program resulted in a significant improvement in knowledge and coping with epilepsy with the treatment group feeling more satisfied with therapy, better tolerability and fewer side effects of AEDs. However there was no significant improvement in the SF-36 questionnaire, depression or other epilepsy specific measures such as self esteem, fear, stigma, mobility and leisure.
Relaxation and behaviour therapy and epilepsy
The combined use of relaxation and behaviour therapy was evaluated in two studies. (42)Dahl 1985 investigated the effect of a broad spectrum behaviour modification therapy on seizures among 18 children with uncontrolled epilepsy, randomized to three groups: behaviour modification, attention control and control groups.(43) Sultana 1987 studied 150 adults with uncontrolled epilepsy randomized into a treatment group which received Jacobson's muscle relaxation and behaviour therapy and a control group in a 2:1 ratio. The outcomes studied included seizure frequency as well as psychological measures.
Relaxation and behaviour therapy and epilepsy: design
The method of randomization is not described in the published report of the study by Dahl . The randomization was by sequential allocation of participants to the treatment and control groups in a 2:1 ratio in the study by Sultana .
Combined use of relaxation and behaviour therapy: outcomes
(a) Relaxation and behaviour therapy and seizures
Dahl reported only median seizure frequencies with ranges and a seizure index calculated by multiplying seizure frequency by the seizure duration (seconds). The authors found a sustained reduction in the median seizure index for the behaviour modification group at the end of one year and eight years follow-up, while in the two control groups there was an increase in seizure index at the end of one year. The published report does not provide the actual values for these observations. The study by Sultana , reported mean seizure frequencies for each seizure type (number in each category not stated) and reported the mean seizure frequencies for those individuals who had less than 20 seizures per month at baseline and those who had greater than 20 per month separately. These data were however skewed and we were therefore unable to undertake analyses of effect size using reported data.
(b) Relaxation and behaviour therapy and psychological outcome
Sultana found significant improvements in state anxiety, trait anxiety and adjustment (home, health, social and emotional). There was also subjective improvement in inferiority feelings and fear of attack.
Effects of behavioral interventions on specific psychological measures
(a) Effect of anxiety
Sultana found a significant reduction in state and trait anxiety scores in the treatment group with combined relaxation and behaviour therapy, while Helgeson who employed a psycho-educational approach found no significant change in state-trait anxiety. Olley found that a 2 day educational program, showed a significant decrease in overall neurotic disorders (assessed by Crown-Crisp experiential index - formerly called as Middlesex Hospital Questionnaire) in the treated group compared to control group.
(b) Effect on depression
Davis found a significant reduction in depression among people with epilepsy and depressed affect treated with cognitive behaviour therapy, as assessed by the BDI, Generalized Contentment Scale (GCS) and Lubin's Depression Adjective Check List (DACL). Tan found no significant improvement in the BDI or MMPI-D scales for individuals receiving cognitive behavioural therapy. Sultana found a marginal but non significant reduction in depression at one year for a combination of relaxation and behavioural therapy. Helgeson found no significant reduction in depression between the group receiving the psycho-educational program and the control group for the BDI or DACL. Olley found significant reduction in depression with a two-day psychoeducational program (both for intergroup and within group pre and post intervention analysis) as assessed by BDI. May found no significant benefit on depression (assessed by depressive mood scale) with the MOSES educational program.
(c) Adujustment to epilepsy
Tan found that only the therapists' global ratings of psychological adjustment improved with cognitive behaviour therapy and supportive counseling. Adjustment to seizures, emotional adjustment, vocational adjustment, interpersonal adjustment did not change with therapy. Helgeson found no significant difference between the treatment and control group for adjustment to seizures (WPSI) or for emotional, vocational and interpersonal adjustment. Sultana observed significant improvement for treatment group in home, health, social and emotional adjustment, whilst controls worsened in home adjustment.
(d) Effect on WPSI
Helgeson used a psycho-educational program and found no significant change in WPSI scores. Tan did not find any change in WPSI after CBT. Lantz found no change in WPSI following either the control period or contingent EEG bio-feedback training. Snyder found no significant changes in the overall mean WPSI scores after relaxation therapy.
(e) Effect on MMPI
Lantz found no significant differences in the MMPI between EEG bio-feedback and control groups. Tan found no significant change in MMPI after cognitive behaviour therapy.
Other therapies and epilepsy
We found no randomized studies that investigated the effects of counselling, suggestion, hypnotherapy, conditioning, systematic desensitization, behavioural countermeasures, physical therapies, massage, aromatherapy, music or dance therapy on epilepsy, either seizure frequency or on comorbidities of epilepsy.
According to Cochrane style evaluation, design must follow certain criteria as a standard but as found in this review, most NPT do not have many RCTs and /or do not meet the design criteria adequately.
Implications for practice
(1) Behavioral interventions and seizure control
(a) Relaxation therapy and seizure control
The studies presently available indicate a possible beneficial effect on reduction of seizure frequency. However, in view of methodological limitations and the small number of individuals enrolled, definite conclusions cannot be made, and further studies are needed.
(b) Cognitive behaviour therapy, EEG or GSR bio-feedback, educational interventions and combined use of relaxation and behaviour therapy
No reliable conclusions can be drawn regarding their efficacy in controlling seizures. Though one study of GSR biofeedback reported beneficial effect on seizure frequency, no definite conclusions can be drawn due to the small sample size and wide confidence intervals.
(2) Psychological treatments and psychological outcomes
No reliable conclusions can be drawn at present regarding the effects of psychological interventions upon the quality of life in people with epilepsy. However, it appears that educational interventions may be of value, improving the person's knowledge and understanding of epilepsy, adjustment to seizures and medication compliance.
Implications for research: consensus of a meeting held in Chennai in Feb 2008.
Better designed and larger studies are imperative if researchers are to address whether behavioral interventions can positively influence seizure frequency and psychological functioning. Methodological issues- Finding a suitable placebo, and blinding of the subject and /or investigator is not always possible in NPT. Therefore, the traditional double blind, randomized placebo controlled treatment trial used in AED epilepsy trials may be difficult to conduct using behavioral interventions for epilepsy. In addition, controlling for the potential treatment effect of nonspecific factors such as empathy and attention will be important.
Acknowledging the limitations of the non-pharmacological studies and examining the impact of the non-specific factors that affect outcomes will be essential in designing NPT epilepsy trials. This can be achieved by attempting to minimize the non-specific factors associated with placebo effect and maximize the nonspecific factors in clinical actions.
Trials may have different areas of focus, which may include studying the mechanism of action or alternatively, focusing on specific outcome measures, such as quality of life, symptoms, or medical utilization/cost benefit. It may be important to look for behavioural change using appropriate instruments and address the elements that have effect on behavior. Therefore it is suggested to operationalise the variables so that the trials have external validity and can be duplicated in a multicentric setting.
It is debatable which model is best for evaluation of NPT - one may either marry the non-pharmacological interventions approach to the scientific -based model of randomized blinded clinical trials with special modifications or dismiss the scientific blinded RCT model altogether and evaluate the outcome of standardized intervention where nonspecific factors have been minimized to fullest possible extent.
The end point in most studies focus on seizures control but the focus of NPT may really be in addition or alone, to change behavior or quality of life or co morbid conditions associated with epilepsy. However these studies need an appropriate scientific standardized outcome measure and adequate power of the sample to reach a conclusion. One design consideration could be if NPT is used as an adjunctive to ongoing antiepileptic drugs or pending surgery in subjects who are on AEDs. The outcome that needs to be evaluated should be well defined and may either be seizures index (mostly cannot be separated from AED effects) or QOL or behavioral scale (for the adjunctive NPT intervention)
Conducting trials enrolling patients with medically refractive epilepsies defined by a standard definition, and adding the intervention to AEDs , while noting all adverse effects in the study may be a beneficial design.
The Quality of Life in Epilepsy Survey (QOLIE), (44)Devinsky O 1993)
is a commonly used adjunctive measure in AED trials, but whether it will work as well in psychological therapies is not certain. Defining some other outcome measures depending on the co- morbidity targeted will also be important.
Including qualitative answers that patients report, to account for richness of outcomes such as fear of next seizure, dependence on family, feelings of uncertainty/gloom while doing daily activities, etc. could be assessed. In this way, disability focused outcome measures may cover important endpoints not accounted for by seizure index.
Knowledge of subject expectations are most important to successfully complete the trials and to retain subjects, e.g. Japanese people believe that Herbal therapy cannot replace AEDs and may exit trials early or the experience of Indian herbal nootropic in one study, leading to good recruitment but high attrition rates in studies conducted in the past [ref].
Antiepileptic drugs adequately treat only 60% of patients with epilepsy. Given the limited control of epilepsy AEDs provide, addressing epilepsy with a broader perspective may be of benefit. Chronic disease models are used in diabetes, dementia and other disorders. Providing an NPT intervention such as, "Coping with Seizures" (as opposed to Curing Epilepsy) could be beneficial, as it is in other diseases. Promoting this approach, however, acknowledges a different focus altogether, as multiple drugs of polypharmacy may have failed to control seizures adequately in a number of out patients with refractory epilepsy.
There is a precedent in the "Management of Depression" study at Brown University that addresses living with the persistent symptoms of depression (in a treatment resistant population). It is important to note that helping a patient to cope with chronic illness does not preclude the continued search for cure. The fact is that we have very few cures for many of the diseases we treat. As neurologists, we may have to, therefore, change the treatment providers' culture to address persistent symptoms in epilepsy and other chronic diseases.
Transcultural issues need to be addressed during the design of these - what is the cultural climate in the institute and academy vs. the patient, and spell out what are the patient expectations and clinician expectations from these studies. Develop this paragraph.
By using the broader outlook married to scientific methodology as much as is applicable for the intervention (e.g. it is easier to apply to Biofeedback than Yoga), one may have sufficient and acceptable data that can be used to evaluate the usefulness of NPT in epilepsy care. The findings may be used to empower the patient and their families to use these methods in an attempt to reduce the treatment gap and change the way they look at life and allow them to cope with epilepsy.
In conclusion, psychological interventions are used in attempts to reduce seizure frequency, improve the quality of life and avoid adverse effects of drugs among people with epilepsy. Of the trials found and reviewed, some were of poor methodological quality, whilst others had contradictory results. It was concluded that there was no evidence that relaxation therapy, cognitive behaviour therapy, EEG or galvanic skin response biofeedback used alone or in combination have an impact on seizures or quality of life. Educational interventions may reduce anxiety, improve medication compliance and social competency, but further well designed trials are needed. Yoga and ACT seem promising but further studies are needed.