electroconvulsive therapy ( ect ) is one of the most efficacious treatment of major depressive disorder ( mdd ) .
it is used as a rapid and efficacious treatment in emergent and/or treatment resistant forms of other psychiatric disorders .
the cognitive aspects which are influenced immediately after ect are : orientation , information processing , retrograde and anterograde amnesia , visuospatial capacity and word finding .
donepezil in a case report study galantamine in study without control group , a glucocorticoid antagonist ( cort108997 ) in another study , thyroid hormones , antihypertensive , poropofol , physosigmine , naloxone , piracetam showed some benefits in preventing ect - induced cognitive impairment ; but many of those have not enough reliability because were not statistically significant , or were case reports , unblanded , uncontrolled or on animals .
the other studies did not show efficacy of the used drugs in prevention of memory impairments . considering these non sufficient and controversial data , more structured studies with control group on human samples are necessary .
so , we chose the so - called memoral herbal for our this preventive new study , which has never been used for this propse .
the memoral herbal capsules , each contains 360 mg of boswellia oleo - gum resin and 36 mg of zimgiber rhizome . the most important constituent of boswellia is gum resin 60% , mosilage 20 - 23% and essence 5 - 9% , which contains a - b - thujon , p - cymen and linanol .
boswellia serrata has boswellic acid and acetyl- 11- keto - beta boswellic acid too , which are responsible for many therapeutic effect .
the volatile oils in boswellia dilate the vasculator of the brain thus can increase the blood passage through the brain .
boswellia extract has been demonstrated by a battery of rigorous tests to have anti - inflammatory effect .
the mechanism by which boswellia can improve memory is through its anti - inflammatory effect on the brain .
the aim of this study is to compare memoral herbal with placebo in prevention of ect - induced cognitive impairments .
this study is a randomized and controlled clinical trial which was done during 9 months of 2011 at noor hospital ( isfahan , iran ) .
the sample size was 70 patients , based on 80% power and 95% confidence interval . each consequent patient placed randomly in intervention ( memoral ) or control ( placebo ) group , i.e. , 35 patients in each group .
the inclusion criteria were : 15 - 65ys / o , diagnosis of major depressive disorder ( mdd ) or bipolar disorder ( bd ) according to the impression of therapist ( academic member ) documented in the patient file , prescribed at least 4 ect sessions by the therapist and informed consent for participation .
exclusion criteria were : mental retardation ( mr ) or dementia as documented in hospital file by psychiatrist , discontinuation of ect before fourth sessions , discontinuation of participation before the end of study , and arising delirium during the course of study .
the ethical issues of this study was approved by ethical committee of behavioral sciences research center ( bsrc ) of isfahan university of medical sciences ( iums ) , iran .
the study process registered at iranian registering of clinical trials office , with irct i d : irct201102072232n2 .
the study was illustrated to patients and an informed consent form was signed by each patient or his / her first degree related person who was supporting him / her ( in cases the patient was unable to decide ) .
each patient received three capsules ( tid ) of either memoral or placebo from the day before first ect session until 2 months after the last session of ect .
memoral and placebo capsules were produced by goldaru pharmaceutical manufactory ( isfahan , iran ) .
the capsules were labeled by only  a  or  b  brand and were taken to patients by a nurse .
this scale was developed through extension of mini mental status examination ( mmse ) memory , language and visuospacial ability subscales , and adding verbal fluency subscale to it .
it is translated to persian and validated by pouretemad h.r.(2006 ) . its sensitivity and specificity for screening normal persons from mild cognitive impairment ( mci ) is 93% and 91% , respectively ; for screening alzheimer patients from mci patients is 73% and 93% , respectively , and for screening normal persons from alzheimer patients is 100% and 96% , respectively .
it has five subscales : attention and orientation , memory , language , verbal fluency , visuospatial ability .
also it has the capacity for scoring based on the past so - called mmse scale .
the patients cognitive function was assessed at four occasions : before the first ect session , before the 4 ect session , 1 month and 2 months after the last ect session , by a psychologist
. the probable side effects of memoral were also evaluated at those occasions , using a checklist .
the findings were analyzed by repeated measure of analysis of variance ( anova ) and pearson chi - square , using spss18 .
this study is a randomized and controlled clinical trial which was done during 9 months of 2011 at noor hospital ( isfahan , iran ) .
the sample size was 70 patients , based on 80% power and 95% confidence interval . each consequent patient placed randomly in intervention ( memoral ) or control ( placebo ) group , i.e. , 35 patients in each group .
the inclusion criteria were : 15 - 65ys / o , diagnosis of major depressive disorder ( mdd ) or bipolar disorder ( bd ) according to the impression of therapist ( academic member ) documented in the patient file , prescribed at least 4 ect sessions by the therapist and informed consent for participation .
exclusion criteria were : mental retardation ( mr ) or dementia as documented in hospital file by psychiatrist , discontinuation of ect before fourth sessions , discontinuation of participation before the end of study , and arising delirium during the course of study .
the ethical issues of this study was approved by ethical committee of behavioral sciences research center ( bsrc ) of isfahan university of medical sciences ( iums ) , iran .
the study process registered at iranian registering of clinical trials office , with irct i d : irct201102072232n2 .
the study was illustrated to patients and an informed consent form was signed by each patient or his / her first degree related person who was supporting him / her ( in cases the patient was unable to decide ) .
each patient received three capsules ( tid ) of either memoral or placebo from the day before first ect session until 2 months after the last session of ect .
memoral and placebo capsules were produced by goldaru pharmaceutical manufactory ( isfahan , iran ) .
the capsules were labeled by only  a  or  b  brand and were taken to patients by a nurse .
this scale was developed through extension of mini mental status examination ( mmse ) memory , language and visuospacial ability subscales , and adding verbal fluency subscale to it .
it is translated to persian and validated by pouretemad h.r.(2006 ) . its sensitivity and specificity for screening normal persons from mild cognitive impairment ( mci ) is 93% and 91% , respectively ; for screening alzheimer patients from mci patients is 73% and 93% , respectively , and for screening normal persons from alzheimer patients is 100% and 96% , respectively .
it has five subscales : attention and orientation , memory , language , verbal fluency , visuospatial ability .
also it has the capacity for scoring based on the past so - called mmse scale .
the patients cognitive function was assessed at four occasions : before the first ect session , before the 4 ect session , 1 month and 2 months after the last ect session , by a psychologist
. the probable side effects of memoral were also evaluated at those occasions , using a checklist .
the findings were analyzed by repeated measure of analysis of variance ( anova ) and pearson chi - square , using spss18 .
of 70 patients , two patients from memoral group and five patients from placebo group were excluded because of premature discontinuation of ect and discharge from the hospital , causing disruption of participation .
so 33 patients in memoral group , and 30 patients in placebo group remained and there was not any significant difference between two groups ( p = 0.95 ) . considering educational levels , there was not any significant difference between two groups ( p = 0.18 ) : including 6 ( 9.5% ) patients had primary school studies , 23 ( 36.5% ) guidance school , 24 ( 38.1% ) high school , 10 ( 15.9% ) had university studies .
the frequency of patients diagnosis was : 26 ( 41.3 ) patients with bd manic or mixed episode , 13 ( 20.6% ) patients bd depressive episode , 24 ( 38.1% ) patients with mdd .
there was not any significant difference between memoral and placebo group about diagnoses distribution ( p = 0.09 ) .
also there was no significant difference between the number of ect sessions in two groups ( pv=0.95% ) ; included 2 ( 3.2% ) patients received five ect sessions,25 ( 39.7% ) received six sessions , four ( 6.3% ) received seven sessions , 17 ( 26.9% ) received eight sessions , two ( 3.2% ) patients received nine sessions , 8 ( 12.7% ) received 10 sessions , two ( 3.2% ) patients received 11 sessions , two ( 3.2% ) patients received 12 sessions , and one ( 1.6% ) patient received 14 ect sessions .
the mean energy of ect used in memoral group was 25.8 joule in memoral group , and 25.9 joule in placebo group ( p = 0.98).the mean age of patients in memoral group was 33.8 ys / o , and 32.8 ys / o in placebo group , with no significant difference between them ( p = 0.17).we did not find any important side effects that could exclude patients from the study , and there was not any significant difference between two groups for this issue ( p = 0.30 ) .
there was not any significant difference between two groups between total score of ace of memoral group ( 76 ) and placebo group ( 79.4 ) before intervention ( p = 0.32 ) .
also , there was not any significant difference between two groups for the scores of attention and orientation subscales ( p = 0.64 ) , memory ( p = 0.75 ) , verbal fluency ( pv = 0.35 ) , language ( p = 0.11 ) , and mmse subscales ( p = 0.40 ) before intervention .
table 1 shows the mean sd of the total score of ace and the scores of ace subscales in memoral and placebo groups at four assessment occasions , i.e. , before intervention , before the 4 ect session , 1 month and 2 months after the last ect sessions [ figure 1 ] .
the mean  sd of the total score of ace and the scores of ace subscales in memoral and placebo groups at four assessment occasions : before intervention , before 4 ect session , 1 month and 2 months after last ect sessions the mean of the total score of ace in memoral and placebo groups at four assessment occasions : before intervention , before 4 ect session , 1month and 2months after last ect sessions repeated measure of anova showed that the total score of ace and the scores of attention and orientation subscale , memory , verbal fluency and mmse subscales were significantly higher in memoral group than in placebo group after intervention , and also were uprising , unlike placebo group [ table 1 , figure 2 ] .
but the scores of the language , and visuospatial ability subscales did not show any significant difference between two groups , although these were uprising in memoral group , unlike in placebo group [ table 1 ] .
the paired comparison of each subscales in two groups also showed significant difference at each stage .
the mean of the memory subscale score of ace in memoral and placebo groups at four assessment occasions : before intervention , before 4 ect session , 1month and 2 months after last ect sessions
this study assessed the efficacy of memoral herbal on prevention of ect - induced cognitive impairments , using ace scale .
the total score of ace and the subscales of memory , attention and orientation , verbal fluency and mmse in memoral group were significantly higher than in placebo , and did not declined by ect unlike in placebo group .
the noticeable finding was the largest amount of difference for memory subscale in this intervention [ table 1 , figure 2 ] .
this study showed that memoral herbal prevents ect - induced memory impairment more rapidly and more impressively than other drugs used in previous similar studies.[313 ] unlike previous studies[313 ] in this intervention , we assessed cognitive status in more detailed and itemized description .
so these data may have more reliability and scrupulosity than previous findings , and may somehow interpret the inconsistency of some previous findings.[1215 ] .
the sample size of this study is another precedence of this study over previous ones .
this was some deal because of the blinding goals and the independence of researchers from therapists .
the future studies on prevention of ect - induced cognitive impairments may comprise memoral herbal with other drugs in a research , and on patients with other diagnoses .
our work showed the effective prevention of ect - induct cognitive impairment by using memoral herbal .
the memory , attention and orientation , verbal fluency , and mmse of patients showed improvement by memoral use .
 background : electroconvulsive therapy ( ect ) is one of the most efficacious treatment for major depressive disorder ( mdd ) , it is also used as a rapid and efficacious treatment for other psychiatric disorders , especially treatment resistant ones . 
 the cognitive impairment is one of the most important side effects of ect . 
 this study examined the memoral herbal efficacy in prevention of ect - induced memory impairment.methods:in a randomized clinical trial , 70 patients with mood disorders who were candidates for ect enrolled in either memoral or control group , and received either memoral or placebo . 
 the memory was assessed by addenbrook cognitive examination ( ace ) , and the findings were analyzed by anova under spss18.results:the memoral group patients showed significantly higher total ace scores than placebo group ( p < 0.001 ) . 
 the scores of attention and orientation , verbal fluency and memory subscales not only never decreased during the study in memoral group , but also increased . 
 there was no significant difference between these scores of memoral and placebo groups for the subscales of language and visuospacial ability.conclusion:the memoral herbal is an efficacious and safe choice in prevention of ect- induced cognitive impairment . 
INTRODUCTION
METHODS
Study design
Intervention
Assessment
RESULTS
DISCUSSION
CONCLUSIONS