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C ritical Appraisal

C ritical Appraisal. Done by : Fatimah Al- Shehri . King Abdul-Aziz university . Supervised by : Dr.Omar Jamjoom. Introduction. 1-What's autism? 2-Causes . 3-Symptoms. 4-Diagnosis. 5- Treatment. Introduction :. Definition :

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C ritical Appraisal

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  1. Critical Appraisal Done by :Fatimah Al-Shehri. King Abdul-Aziz university . Supervised by : Dr.OmarJamjoom.

  2. Introduction 1-What's autism? 2-Causes . 3-Symptoms. 4-Diagnosis. 5- Treatment.

  3. Introduction : Definition : Is known as a complex developmental disability. It results of a neurological disorder that has an effect on normal brain function, affecting development of the person's communication and social interaction skills.

  4. introduction Causes of autism : 1-Genetic predisposition. 2Maternal illness during pregnancy. 3-Difficulty during pregnancy. 4-Neurological &metabolic factors. 5-Impared immune system.

  5. introduction Pathophysiology: There is an imbalance of oxidative stress and anti-oxidative stress in children with autism.

  6. Introduction Symptoms: 1-Social-interaction difficulties. 2-Communication challenges. 3-Repetitive behaviors. 4-Speech problems.

  7. Introduction Diagnosis: 1-No medical test that can diagnose autism. 2-Parents are the first to notice that their child is showing unusual behaviors. 3-The Modified Checklist of Autism in Toddlers (M-CHAT): is a list of informative questions about your child.

  8. M-CHAT:

  9. M-CHAT:

  10. Introduction Treatment: 1-Behavioral treatments. 2-Medicines . 3-Treatment of the additional medical conditions.

  11. The Study of the critical appraisal.

  12. Background: The aim of the study : To examined the efficacy and safety of N-Acetylcysteine(NAC) augmentation for treating irritability in children & adolescents with (ASD). Thesis of the study: Glutathione plays a significant role in defense against oxidative stress in autism.The level of glutathione in the cerebellum and temporal cortex of patients with autism are markedly decreased . The levels of reduced glutathione is lowered in autistic patients.

  13. Background Thesis of the study: N-acetylcysteine(NAC) is an antioxidant precursor to Glutathione .Considering the role of glutathione in autism and the effect of NAC on glutathione level, it is hypothesized that NAC as an augmentation agent decreases irritability score.

  14. Method: A- Diagnosis of autism: was made using DSM-IV-TR criteria. All interviewers were conducted by an experts child and adolescent psychiatrist. Assessments were performed by resident of psychiatry trained to use the questionnaire an checklist.

  15. Method: B- Study design : It was a randomized double blinded study with two parallel groups . C- Allocation: the patients were randomly allocated into one of the two groups using a random number generator. .

  16. Method: D-Intervention: Resperidone started at 0.5mg/day and it was titrated up to 2g/day during 3 weeks for children less than 30kg. The dose of children more than 30kg was up to 3mg/day. The dose of resperidone was not fixed and it could be changed considering clinical symptoms and adverse effects . E-Blinding: Double blinded ,both NAC and placebo tablets were administered in the form of effervescent. The other group received risperidone plus placebo tablets. The shape ,size ,taste & color of NAC &placebo were identical.

  17. Method:

  18. Concomitant medications during the trial

  19. Method: Statistical analysis:

  20. Results Flow chart for the clinical trial N-Acetylcysteine + risperidone versus Placebo+risperidone.

  21. Results The primary outcome was :Irritability. The secondary outcomes : the adverse effects (Extrapyramidal symptoms).

  22. Comparison of irritability scores between(NAC+Risperidone) group with (Placebo +Risperidone) group.

  23. Side effects :

  24. Conclusion: NAC+risperidone decreased irritability in this trial. This improvement in the NAC+risperidone group was more than that of the placebo+risperidone group. Future trials with larger sample sizes, longer durations, and higher doses are required in order to examine the possible effects of NAC on autism Competing interests: The authors declare that they have no competing interests.

  25. Limitation of this study: 1-The sample size was small . 2-The duration of current trial was very short. 3-It is not clear whether the symptom will relapse after the discontinuation of NAC. 4-It is not examined whether this effect will be stable in long term. In order to have a more homogenous group, further studies should not include a wide range of children. Finally, the concomitant use of risperidone may limit the efficacy of obtained results. Therefore, the efficacy of higher doses of NAC should be investigated in further trials.

  26. Validity:

  27. Validity:

  28. Validity:

  29. Results

  30. Results The mean (SD) scores of ABC subcsale in (NAC +risperdone) group and (Placebo+risperdone )group.

  31. Results How are the results expressed ? Day time drowzness: EER=(Events in E group/total in E-group)=4/20=0.2 CER=(Events in C group/total in C group)=2/20=0.1 RR=EER/CER=0.2/0.1=2 100%))RRR=1-RR=1-2=1 ARR=CER-EER=0.1(10%) NNT=100/ARR=100/10=10 For every 10 patients treated with NAC one patient will experince daytime drowzness.

  32. Applicability:

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