Meta AnalysisID 2462
N-乙酰半胱氨酸在孤独症谱系障碍中的有效性：一项随机对照试验的Meta分析
CRD42019138299
Patients: Autism spectrum disorders (ASDs) are a group of neurodevelopment disorders defined by two core symptoms - a deficit in social communication and the presence of repetitive behaviors and/or restricted interests (
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Record Fields
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- Meta Analysis Id
- 2462
- Evidence Id
- 11020
- Core Evidence Id
- 11020
- Source Meta Analysis Id
- 2411
- Herb2 Meta Analysis Id
- HBMA002411
- Crd Id
- CRD42019138299
- Title
- Effectiveness of N-acetylcysteine in Autism Spectrum Disorders: A Meta-analysis of randomized Controlled Trials
- Review Question
- Patients: Autism spectrum disorders (ASDs) are a group of neurodevelopment disorders defined by two core symptoms - a deficit in social communication and the presence of repetitive behaviors and/or restricted interests (Diagnostic Statistical Manual of Mental Disorders V).Recently, new evidence has led to the hypotheses of excessive oxidative stress and glutamatergic dysfunction in the development of ASDs. Intervention and comparison: N-acetylcysteine (NAC) is an orally bioavailable prodrug of cysteine that restores GSH levels and scavenges oxidants such as hydroxyl radical and hydrogen peroxide. It is initially used to compromise acetaminophen overdose and as mucolytics in chronic obstructive pulmonary disease and currently, widely used for preventing contrast-induced nephropathy during imaging with contrast. NAC permeates the blood-brain barrier and has good bioavailability. It converts L-cysteine to cysteine, facilitating its uptake by glial cells and consequently allowing glutamate release which in turn stimulates the inhibitory glutamate receptors. Study design: Recent systematic reviews of clinical trials have examined the effectiveness of NAC in ASDs However, so far, no meta-analysis has been conducted to investigate the pooled effects of these trials. We plan to conduct a meta-analysis to examine the treatment effects of NAC in ASDs in randomized controlled trials (RCTs).
- Study Type Included
- The type of study eligible for inclusion in this review is randomized controlled trials.
- Condition Being Studied
- We examine the common outcomes used in clinical practice including the abberant behavior checklist (ABC), Social Responsiveness Scale (SRS), and the Repetitive Behavior Scale – Revised (RBS-R).
- Participant
- We adopt broader inclusion criteria in this study, namely, trials that included patients diagnosed with ASDs based on DSM-IV-TR criteria or other official diagnostic criteria. The exclusion criteria are: (1) ASDs with secondary diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified; (2) patients taking antioxidant agents, glutathione prodrugs, or concomitant medications with glutamatergic effects before enrollment.
- Animal
- Human Disease Modelled
- Intervention
- N-acetylcysteine (NAC) is an orally bioavailable prodrug of cysteine that restores GSH levels and scavenges oxidants such as hydroxyl radical and hydrogen peroxide. Several trials have investigated the effectiveness of orally administrated NAC in ASDs. In our study, we will examine the effectiveness of NAC reducing the symptoms of ASDs.
- Comparator Control
- Risperidone and apriprazole are the only two medications approved by the US Food and Drug Administration (FDA) to treat ASDs patients indicated for irritability and disruptive behaviors, aggression, and self-injurious behaviors. That means these two drugs are commonly prescribed to manage ASDs. On the other hand, some ASDs patients are managed by non-pharmapeutics approaches. Accordingly, another intervention or a non-exposed control group will be compared. A variety of comparators are expected in our included trials. The comparators that to be included in our study include no treatment, placebo, and standard psychiatric therapeutics with NAC-placebo.
- Main Outcome
- The outcomes are primarily psychiatric symptoms and behavioral disturbance across 5 domains: irritability, agitation, and crying, lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech measured by using the abberant behavior checklist (ABC). The secondary outcome are the social skills as measured by the Social Responsiveness Scale (SRS) and the Repetitive Behavior Scale – Revised (RBS-R). Measures of effect Timing: 8-12 weeks Effect measures: total score and subscale scores.
- Outcome Measure
- Additional Outcome
- Drug safety: adverse effects in intervention and comparator groups are generally reported in clinical trials. However, this information is generally described in diverse formats. We will report the frequency of adverse effects if possible or otherwise, summarize the findings. Measures of effect Timing: 8-12 weeks Effect measures: frequency
- Study Method
- Meta-analysis, Systematic review
- Keyword
- Acetylcysteine; Autism Spectrum Disorder; Humans
- Contact
- El-Wui Loh [email protected]
- Organisational Affiliation
- Center for Evidence-Based Health Care, Shuang Ho Hospital, Taipei Medical University
- Funding Source
- This study is not supported by any funding agent.
- Other Selection Criteria
- Final Publication
- Lee TM, Lee KM, Lee CY, Lee HC, Tam KW, Loh EW. Effectiveness of N-acetylcysteine in autism spectrum disorders: A meta-analysis of randomized controlled trials. Aust N Z J Psychiatry. 2021 Feb;55(2):196-206. doi: 10.1177/0004867420952540. https://journals.sagepub.com/doi/10.1177/0004867420952540?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub0pubmed&
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Taiwan
- Review Stage
- Review Completed published
- First Submission Date
- 2019-06-07
- Registration Date
- 2019-08-08
- Anticipated Start Date
- 2019-08-31
- Anticipated Completion Date
- 2019-09-30
- Title Cn
- N-乙酰半胱氨酸在孤独症谱系障碍中的有效性：一项随机对照试验的Meta分析
- Title En
- Effectiveness of N-acetylcysteine in Autism Spectrum Disorders: A Meta-analysis of randomized Controlled Trials
- Bilingual Status
- complete