الفهرس 
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Abstract
The pervasive developmental disorders (PDD) are a group of neuropsychiatric disorders that include autistic disorder, Asperger’s disorder, childhood disintegrative disorder, Rett’s disorder, and PDD not otherwise specified. PDD are characterized by severe and pervasive deficits in several areas of development. These include reciprocal social interaction skills; communication skills; or the presence of stereotyped behavior, interests, and activities. Children with PDD may present with difficult behaviors including hyperactivity, inattention, impulsivity, stereotypies, screaming, children with autism frequently have serious behavioral disturbances, such as self-injurious behavior, aggression, and tantrums in response to routine environmental demands. Recent evidence indicates that atypical antipsychotics represent a promising option for the treatment of autistic disorder. In particular, risperidone appears to be effective in treating aggressiveness, hyperactivity, irritability, stereotypies, social withdrawal, and lack of interests. Risperidone is the only medication approved by US Food and Drug Administration for irritability in youth with autism.There is increasing evidence that fatty acid deficiencies or imbalances may contribute to childhood neurodevelopmental disorders, including attention-deficit/ hyperactivity disorder, dyslexia, dyspraxia, and autistic spectrum disorders. Omega-3 polyunsaturated fatty acids are considered to be a promising therapeutic for autistic children, the best evidence currently available to support this claim comes from research showing that autistic children have lower DHA levels in blood than children with mental retardation.This study was conducted on 50 child attending Psychiatric Clinic at Unit of Special Needs, Institute of postgraduate Childhood Studies-Ain Shams University [25 cases treated with Risperidone and 25 cases treated with Efalex Efamol Omega-3& Omega-6] . All children were diagnosed with autism spectrum disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) without severe mental retardation, aged 5- 12 years. Children had to be free of serious medical disorders or other psychiatric disorders requiring medication.Treatment with an anticonvulsant agent for seizure control was allowed if the dose had been unchanged for at least four weeks and if there had been no seizures for at least six months. Past and current treatments for PDD were reviewed (a drug free interval of at least 6 weeks was required before baseline assessments were conducted). Children receiving a psychotropic drug that was deemed effective for the treatment of aggression, tantrums, or self-injurious behavior were excluded. Also Children had serious medical disorders, other psychotic disorders (schizophrenia), clinically significant laboratory abnormalities (abnormalities in CBC or liver function) or children had seizure disorder for which they were receiving >1 anticonvulsant or if they had a seizure in the last 6 months were excluded.Group of patients treated with Risperidone consisted of 17(68%) males and 8 (32%) females. Their ages ranged between 60 - 144 months , with a mean value ( 77.56 ± 19.78 ) . Nine ( 36%) of them had normal EEG and 16 (64%) had abnormal EEG in the form of: Frontal 6 cases ( 24 % ), Right temporal 2 cases ( 8 % ) and Left temporal 8 cases ( 32 % ). IQ ( Intelligence Quotient ) ranged between 51-108 with a mean value ( 73.1 ± 17.4 ). IQ: average: 6 (24%), low average: 1(4%), border line IQ: 4 (16%), mild MR: 13 (52%) and 1 case moderate MR (4%).
Group of patients treated with Efalex Efamol Omega-3& Omega-6 consisted of 21 males (84%) and 4 females (16%). Their ages ranged between 60 – 144 months, with a mean value ( 74.5 ± 22.7 ). 12 (48%) of them had normal EEG and 13 (52%) had abnormal EEG in the form of: Frontal 5 cases( 20 % ), Right temporal 3 cases (12 % ), Left temporal 4 cases (16 % ) and Right tempro-occipital 1 case (4%). IQ ( Intelligence Quotient ) ranged between 36 - 104 with a mean value
( 72.2 ± 18.9 ). IQ: average: 6 (24%), low average: 5 (20%), border line IQ: 4(16%) , mild MR: 6 (24%) and 4 case (16%) moderate MR.The daily dose was 1- 2 capsule per day [ Fish oil : 294mg (Of which omega 3: 91mg,of which DHA: 65mg, EPA: 17mg) and Efamol Pure Evening Primrose Oil: 110mg (Of which omega 6: 90mg,of which GLA: 12mg, AA: 5mg), Vitamin E(dl-alpha tocopheryl acetate) : 5mg and Thyme Oil: 1mg] according to the age and the case need. Or 1 teaspoon (5ml) - 2 teaspoons (10 ml) daily with food according to the case.
Risperidone should be initiated at 0.5 mg once daily, and can be increased after 4 weeks according to the case response to reach minimum effective dose. All cases will be subjected to:1-Full psychiatric history taking including medical history.2- Physical examination (general and local).
3- Measurement of height, weight, vital signs (pulse, blood pressure).4- Routine laboratory test, complete blood picture (CBC) and liver function test.
5- Electroencephalogram (EEG).6- IQ intelligence testing (Stanford-Binet intelligence Scale).7- Autism Treatment Evaluation Checklist (ATEC) at (baseline & after 8 weeks).
Scores of ATEC before and after treatment with Efalex
Speech/language/communication subscale score ranged between 6 – 27 with a mean value of ( 17.5 ± 5.1 ) before treatment and subscale score ranged between 6 – 26 with a mean value of ( 15.8 ± 4.7 ) after treatment.
- Sociability subscale score ranged between 8 – 35 with a mean value of ( 20.7 ± 7.7 ) before treatment and subscale score ranged between 2 - 30 with a mean value of ( 14.9 ± 7.8 ) after treatment.- Sensory and cognitive awareness subscale score ranged between 4 - 34 with a mean value of ( 15.4 ± 7.3 ) before treatment and subscale score ranged between 2 - 32 with a mean value of ( 13.3 ± 7.3 ) after treatment. - Health / physical / behavior subscale score ranged between 12 - 51
with a mean value of (28 ± 11.1 ) before treatment and subscale score ranged between 10 – 49 with a mean value of ( 24.2 ± 11.2 ) after treatment.-Total score ranged between 48 – 136 with a mean value of ( 81.7 ± 23.7) before treatment and total score ranged between 41 - 126 with a mean value of ( 68.2 ± 24.3 ) after treatment.In our study, omega-3 FAs showed statistical significant improvement in case treated with O-3 FAs in sociability subscale as resulted by student t-test [ before ttt 21.32 ± 8.18 and after ttt 15.08± 5.67, t: 2.57 , p< 0.05]. There were also improvement in the other 3 subscales ( speech-language-communication/ sensory and cognitive/ health-physical-behavior) and the total score however, the differences between before and after treatment were not statistically significant by using student-t test. In our study by using chi-square statistical analysis showed that Efalex caused change in speech/language/communication subscale of ATEC more than 10% in 13 cases (52%), change less than 10% in 8 cases (32%) and no change in 4 cases (16%), P< 0.05 which means that Efalex is effective in improving speech problems in children with autism. In sociability subscale, chi-square test showed change more than 10% in 19 cases (76%), change less than 10% in 5 cases (20%) and no change in one case (4%), P< 0.0001 which is highly significant. So Efalex is effective in improving social problems associated with autism According to chi-square statistical analysis for sensory and cognitive awareness subscale of ATEC improvement more than 10% in 13 cases (52%), less than 10% in 5 cases (20%), and no change in 7 cases (28%), P< 0.05, which is statistically significant. So Efalex is effective in improving sensory and cognitive problems associated with autism.
Statistical analysis of health/ physical/ behavior subscale of ATEC scores by using chi-square test showed improvement more than 10% change in 16 cases (64%), less than 10% in 6 cases (24%) and no change in 3 cases (12%), P< 0.0001, which is highly significant and suggesting that Efalex is effective in treating health/ physical/ behavior problems associated with autism. Health/ physical/ behavior problems associated with autism including hyperactivity, lethargy, self or others injuries, destruction, sound sensitive, anxious, fearful, unhappy, crying, seizures, obsessive speech, rituals, sameness, shouts or screams, agitation, sensitivity to pain, fixation on certain objects or topics, repetitive movement and other health problems as bed wetting, wet or soils pants, diarrhea, constipation, sleep problems and eats too much or too little or extremely limited diet.Statistical analysis of total score of ATEC, more than 10% change in 19 cases (76%) , less than 10% in 6 cases ( 24%), P< 0.0001, which is highly statistically significant proving that Efalex is an effective treatment for autistic children and targeting core symptoms deficit in autism.
Scores of ATEC before and after treatment with Risperidone - Speech / language / communication subscale score ranged between
10 - 28 with a mean value of ( 18.7 ± 5.4 )before treatment and subscale score ranged between 9 - 25 with a mean value of ( 17.3 ± 4.6 ) after treatment.
- Sociability subscale score ranged between 2 – 36 with a mean value of ( 23.3 ± 12.0 ) before treatment and subscale score ranged between 1 - 33 with a mean value of ( 17.8 ± 10.4 ) after treatment.
- Sensory and cognitive awareness subscale score ranged between 1 - 36 with a mean value of (19.6 ± 10.4 ) before treatment and subscale score ranged between 0 - 32 with a mean value of ( 15.9 ± 8.2 ) after treatment. - Health / physical /behavior subscale score ranged between 12 - 53with a mean value of ( 31.4 ± 12.3 ) before treatment and subscale score ranged between 7 – 51 with a mean value of ( 26.7 ± 12.7 ) after treatment.- Total score ranged between 35 - 137 with a mean value of ( 93.0 ± 35.4 ) before treatment and total score ranged between 26-125 with a mean value of 77.7±32.1 after treatment. In our study there was statistically significant improvement in the social subscale of ATEC by using student t-test [before ttt with Risperidone mean±SD: 23.32±9.05, after ttt 17.84±7.35, t: 2.40, P< 0.05], there were improvement in the other 3 subscales (speech-language-communication/ sensory and cognitive/ health- physical- behavior) and the total score, however, the differences between before and after treatment were not statistically significant by this test. According to chi-square statistical analysis percent of change in speech/ language/ communication subscale of ATEC in our study was 6 cases (24%) no change, 7 cases (28%) change was less than 10% and 12 cases (48%) was more than 10 % change, P> 0.05 which is not statistically significant. So from this results we concluded that Risperidone is not effective to improve speech in autistic children. In sociability subscale of ATEC no change was happened in 1 case (4%), 4 cases (16%) changes less than 10 % occurred and 20 cases (80%) changes more than10% occurred, P< 0.0001 which means that Risperidone is highly significant in improving sociability in autistic children.
Statistical analysis to sensory and cognitive subscale of ATEC by using chi-square, it was found that no change was happened in 7 cases (28%), change less than 10% occurred in 2 cases (8%) and change more than 10% occurred in 16 cases (64%), P< 0.0001 which means that Risperidone is highly significant in sensory and cognitive improvement in autistic children. By using chi-square to test effect of Risperdal in improvement of health/ physical/ behavior problems subscale in autistic children, it was found that no change was happened in 4 cases (16%), changes less than 10% occurred in 6 cases (24%) and 15 cases (60%) was change more than 10%, P< 0.0001 which means that Risperidone is effective in treating health/ physical/ behavior problems in autistic children. Analysis of total score of ATEC, 5 cases (20%) was less than 10% change and 20 cases (80%) was more than 10% change, P< 0.0001. So Risperidone is effective in treating core symptoms of autism. Comparison between Risperidone and Omega-3 fatty acids on autistic disorders
By comparing the use of Risperidone and Efalex in treatment of AD in our study, it was found that both improving sociability in autistic children as proven by student t-test ( t: 2.40 for Risperidone and t: 2.57 for Efalex) and chi-square test ( X2: 32.4 for Risperidone and X2: 29.1 for Efalex), and their results are nearly the same.
Other problems associated by AD as speech differed as Risperidone was not effective in treating speech problems in autistic children (X2: 3.24), but Efalex is effective in treating it ( X2: 7.29).Sensory and cognitive awareness in Risperidone treated group change more than 10% was 16 cases (64%) and change less than 10% was found in 2 cases (8%), while in Efalex treated group change more than 10% was found in 13 cases (52%),and change less than 10% was found in 5 cases (20%) in both groups no effect were happened in 7 cases (28%).
In health/ physical/ behavior problems associated with AD, results of both drugs are near to each other. As Risperidone treated group shown improvement more than 10% change in 15 cases (60%), and no change in 4 cases (16%), while Efalex treated group shown improvement more than 10% in16 cases (64%) and no change in 3 cases (12%), both had the same % change less than 10 in 6 cases (24%).
By comparing the total score results of Risperidone and Efalex, it was found that Risperidone shown improvement more than 10% in 20 cases (80%), and change less than 10% in 5 cases (20%), while Efalex shown improvement more than 10% in 19 cases (76%), and change less than 10% in 6 cases (24%).
These results concluded than Efalex and Risperidone are nearly similar in treating core symptoms in autistic children except speech problems which responded to Efalex only. It seems that risperidone was not improving speech in children with autism. Risperidone was more effective than omega-3 fatty acids in improving cognitive and sensory problems associated with autistic disorders.According to the previous, we concluded the use of omega-3 fatty acids in treating autistic children as it is effective in improving core symptoms of autism with minimal side effect in comparison to risperidone which has more side effects as regard that autism treatment needs long duration of treatment with more exposure to risperidone side effects. So, we recommend use of omega-3 fatty acids as it seems more safe in young children with autistic disorders.