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Journal ArticleDOI

Intravenous secretin for autism spectrum disorders (ASD).

TL;DR: There is no evidence that single or multiple dose intravenous secretin is effective and as such currently it should not be recommended or administered as a treatment for ASD.
Abstract: BACKGROUND: In 1998 secretin, a gastrointestinal hormone, was suggested as an effective treatment for autism spectrum disorders (ASD) based on anecdotal evidence. OBJECTIVES: To assess whether intravenous secretin improves the core features of ASD, other aspects of behaviour or function such as self-injurious behaviour, and the quality of life of affected individuals and their carers. We also assessed whether secretin causes harm. This is an updated version of our review of this topic originally published in 2005. SEARCH METHODS: We searched CENTRAL (2010 Issue 1), MEDLINE (1950 to January 2010) , EMBASE (1980 to 2010 Week 2), PsycINFO (1806 to 2010 Week 2), CINAHL (1938 to January 2010), ERIC (1966 to January 2010), Sociological Abstracts (1952 to January 2010). Sociofile and HealthStar were searched in March 2005 when this review was first published, but were not available for this update. Records were limited to studies published since 1998 as this is when secretin was first proposed as a possible treatment for ASD. We searched reference lists of trials and reviews; we also contacted experts and trialists to find unpublished studies. SELECTION CRITERIA: Randomised controlled trials of intravenous secretin compared to a placebo treatment in children or adults diagnosed with ASD, where at least one standardised outcome measure was reported. DATA COLLECTION AND ANALYSIS: Sixteen studies met the inclusion criteria but for two of these, conducted by Repligen, the only available multisite data were reported in press releases. All outcome data from the other 14 trials were continuous. Where trials used cross-over designs, we conducted analysis on results from the first treatment phase. Where mean change from baseline was reported, we used this in preference to post-treatment scores for meta-analyses or forest plots. Meta-analysis was able to be attempted for only one outcome (Childhood Autism Rating Scale). Insufficient data were available to conduct sensitivity or subgroup analyses to assess the impact of study quality, clinical differences in the intervention or clinically relevant differences between groups, such as age or presence of gastrointestinal symptoms. MAIN RESULTS: Over 900 children were recruited for the secretin trials. Twenty-five established standardised outcome measures were reported to assess core features of ASD, communication, behaviour, visuospatial skills, affect and adverse events. One standardised measure of global impression was also used. No more than four studies used any one outcome measure similarly. When duration from the start of the intervention to outcome assessment was known, outcomes were reported at between three and six weeks. Meta-analysis of data was not possible but there is now consistency of findings, with RCTs of the efficacy of secretin in autism not showing improvements for core features of ASD. AUTHORS' CONCLUSIONS: There is no evidence that single or multiple dose intravenous secretin is effective and as such currently it should not be recommended or administered as a treatment for ASD. Further experimental assessment of secretin's effectiveness for ASD can only be justified if there is new high-quality and replicated scientific evidence that either finds that secretin has a role in neurotransmission in a way that could benefit all children with ASD or identifies important subgroups of children with ASD who could benefit from secretin because of a proven link between the action of secretin and the known cause of their ASD, or the type of problems they are experiencing.

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Journal ArticleDOI
TL;DR: The data suggest that clinical trials in patients with severe cognitive deficits are influenced by the certainty of receiving genuine medication, and open-label design should thus not be used to evaluate the effect of pharmacologic treatments in ID, as the results will be biased by an enhanced placebo component.
Abstract: Objective: To determine the placebo component of treatment responses in patients with intellectual disability (ID). Methods: A statistical meta-analysis comparing bias-corrected effect sizes (Hedges g ) of drug responses in open-label vs placebo-controlled clinical trials was performed, as these trial types represent different certainty of receiving genuine treatment (100% vs 50%). Studies in fragile X, Down, Prader-Willi, and Williams syndrome published before June 2015 were considered. Results: Seventeen open-label trials (n = 261, 65% male; mean age 23.6 years; mean trial duration 38 weeks) and 22 placebo-controlled trials (n = 721, 62% male; mean age 17.1 years; mean trial duration 35 weeks) were included. The overall effect size from pre to post treatment in open-label studies was g = 0.602 ( p = 0.001). The effect of trial type was statistically significant ( p = 0.001), and revealed higher effect sizes in studies with 100% likelihood of getting active drug, compared to both the drug and placebo arm of placebo-controlled trials. We thus provide evidence for genuine placebo effects, not explainable by natural history or regression toward the mean, among patients with ID. Conclusions: Our data suggest that clinical trials in patients with severe cognitive deficits are influenced by the certainty of receiving genuine medication, and open-label design should thus not be used to evaluate the effect of pharmacologic treatments in ID, as the results will be biased by an enhanced placebo component.

14 citations

Journal ArticleDOI
TL;DR: The prevailing challenges in low resource setting in designing and testing the efficacy of behaviour interventional model that is generalizable to primary care settings are discussed.

14 citations

Patent
20 Apr 2012
TL;DR: In this paper, a method for treating an individual with a neuropsychiatric disorder using digestive enzymes and their derivatives to alleviate the symptoms of neuropsychological disorders is described, which comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of the neuropsychial disorder.
Abstract: Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of a neuropsychiatric disorder. Also described herein is a method for treating an individual with a neuropsychiatric disorder using digestive enzymes and their derivatives to alleviate the symptoms of neuropsychiatric disorders. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of the neuropsychiatric disorder.

13 citations

Journal ArticleDOI
TL;DR: This work is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License, which permits noncommercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages.
Abstract: Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits noncommercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Commentary

13 citations


Cites background from "Intravenous secretin for autism spe..."

  • ...Currently, secretin is not to be recommended as an evidence-based treatment for individuals with ASD.7 Another such example is hyperbaric oxygen therapy (HBOT)....

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  • ...Dravet syndrome and Lennox-Gastaut are 2 forms of treatment-resistant epilepsy that are associated with intellectual disability, and are commonly comorbid with ASD.17 This association is further supported by the coexistence of both epilepsy and ASD in individuals with Rett, Angelman, Dup15q, and Landau Kleffner syndromes.18 Thus, it is not surprising that studies conducted in the treatment-resistant epilepsy population have observed the potential benefit of CBD on behavioral symptoms of ASD.19 The US FDA urges caution when interpreting anecdotal reports of use of CBD in children with ASD....

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  • ...We urge physicians to be familiar with the current state of the evidence, be able to have conversations with families and patients about the level of support, and be aware of the limitations that exist if choosing to recommend CBD as a treatment for children with ASD....

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  • ...The role of cannabis in seizure disorders dates back thousands of years, yet it was not until recently that RCTs have demonstrated the safety and efficacy of cannabidiol using Epidiolex (oral cannabidiol).14-16 It is important to mention that it is estimated that 25% of children with treatment-resistant epilepsy have comorbid ASD....

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  • ...Weak recommendations imply that a parent’s choices will vary according to their beliefs and preferences.26 As of today, the existing evidence does not support that CBD should be recommended as a treatment for ASD....

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Journal ArticleDOI
TL;DR: The TED prototypique as discussed by the authors is a set of troubles envahissants du developpement (TED) constituent un ensemble of troubles d’apparition precoce, caracterises par des deficits severes and une alteration envahisante de plusieurs secteurs du deVELOPEMENT, venant perturber de facon majeur de l’enfant.
Abstract: Resume Les troubles envahissants du developpement (TED) constituent un ensemble de troubles d’apparition precoce, caracterises par des deficits severes et une alteration envahissante de plusieurs secteurs du developpement, venant perturber de facon majeure le developpement de l’enfant, notamment dans les domaines de la communication et de la socialisation. Le TED prototypique est le trouble autistique qui est caracterise par l’atteinte, avant trois ans, des domaines de la communication, de la socialisation, et la presence de comportements et interets restreints et stereotypes. D’autres troubles developpementaux (cognitifs, moteurs) sont souvent associes. Il n’existe aucun traitement pharmacologique curatif des TED. Pour autant, certains traitements pharmacologiques ont un bon niveau de preuve dans la prise en charge de certains symptomes associes aux TED. Il s’agit essentiellement des antipsychotiques (risperidone et aripiprazole, efficaces sur les troubles du comportement, l’irritabilite), et dans une moindre mesure, des psychostimulants (methyphenidate efficace sur les symptomes d’inattention et d’hyperactivite) et des inhibiteurs selectifs de la recapture de la serotonine (fluoxetine et fluvoxamine, efficaces sur les comportements repetitifs et stereotypes). D’autres traitements retiennent l’attention, mais leur niveau de preuve d’efficacite reste insuffisant. Le cas de l’ocytocine est une piste interessante car, si son efficacite etait prouvee par des etudes ulterieures, il s’agirait de la premiere molecule efficace sur les deficits de la socialisation et de la communication retrouves dans les TED.

12 citations

References
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Journal ArticleDOI
13 Sep 1997-BMJ
TL;DR: Funnel plots, plots of the trials' effect estimates against sample size, are skewed and asymmetrical in the presence of publication bias and other biases Funnel plot asymmetry, measured by regression analysis, predicts discordance of results when meta-analyses are compared with single large trials.
Abstract: Objective: Funnel plots (plots of effect estimates against sample size) may be useful to detect bias in meta-analyses that were later contradicted by large trials. We examined whether a simple test of asymmetry of funnel plots predicts discordance of results when meta-analyses are compared to large trials, and we assessed the prevalence of bias in published meta-analyses. Design: Medline search to identify pairs consisting of a meta-analysis and a single large trial (concordance of results was assumed if effects were in the same direction and the meta-analytic estimate was within 30% of the trial); analysis of funnel plots from 37 meta-analyses identified from a hand search of four leading general medicine journals 1993-6 and 38 meta-analyses from the second 1996 issue of the Cochrane Database of Systematic Reviews . Main outcome measure: Degree of funnel plot asymmetry as measured by the intercept from regression of standard normal deviates against precision. Results: In the eight pairs of meta-analysis and large trial that were identified (five from cardiovascular medicine, one from diabetic medicine, one from geriatric medicine, one from perinatal medicine) there were four concordant and four discordant pairs. In all cases discordance was due to meta-analyses showing larger effects. Funnel plot asymmetry was present in three out of four discordant pairs but in none of concordant pairs. In 14 (38%) journal meta-analyses and 5 (13%) Cochrane reviews, funnel plot asymmetry indicated that there was bias. Conclusions: A simple analysis of funnel plots provides a useful test for the likely presence of bias in meta-analyses, but as the capacity to detect bias will be limited when meta-analyses are based on a limited number of small trials the results from such analyses should be treated with considerable caution. Key messages Systematic reviews of randomised trials are the best strategy for appraising evidence; however, the findings of some meta-analyses were later contradicted by large trials Funnel plots, plots of the trials9 effect estimates against sample size, are skewed and asymmetrical in the presence of publication bias and other biases Funnel plot asymmetry, measured by regression analysis, predicts discordance of results when meta-analyses are compared with single large trials Funnel plot asymmetry was found in 38% of meta-analyses published in leading general medicine journals and in 13% of reviews from the Cochrane Database of Systematic Reviews Critical examination of systematic reviews for publication and related biases should be considered a routine procedure

37,989 citations

Journal ArticleDOI
TL;DR: It is concluded that H and I2, which can usually be calculated for published meta-analyses, are particularly useful summaries of the impact of heterogeneity, and one or both should be presented in publishedMeta-an analyses in preference to the test for heterogeneity.
Abstract: The extent of heterogeneity in a meta-analysis partly determines the difficulty in drawing overall conclusions. This extent may be measured by estimating a between-study variance, but interpretation is then specific to a particular treatment effect metric. A test for the existence of heterogeneity exists, but depends on the number of studies in the meta-analysis. We develop measures of the impact of heterogeneity on a meta-analysis, from mathematical criteria, that are independent of the number of studies and the treatment effect metric. We derive and propose three suitable statistics: H is the square root of the chi2 heterogeneity statistic divided by its degrees of freedom; R is the ratio of the standard error of the underlying mean from a random effects meta-analysis to the standard error of a fixed effect meta-analytic estimate, and I2 is a transformation of (H) that describes the proportion of total variation in study estimates that is due to heterogeneity. We discuss interpretation, interval estimates and other properties of these measures and examine them in five example data sets showing different amounts of heterogeneity. We conclude that H and I2, which can usually be calculated for published meta-analyses, are particularly useful summaries of the impact of heterogeneity. One or both should be presented in published meta-analyses in preference to the test for heterogeneity.

25,460 citations

Book
23 Sep 2019
TL;DR: The Cochrane Handbook for Systematic Reviews of Interventions is the official document that describes in detail the process of preparing and maintaining Cochrane systematic reviews on the effects of healthcare interventions.
Abstract: The Cochrane Handbook for Systematic Reviews of Interventions is the official document that describes in detail the process of preparing and maintaining Cochrane systematic reviews on the effects of healthcare interventions.

21,235 citations

Book
01 Jun 1991

12,618 citations


"Intravenous secretin for autism spe..." refers background in this paper

  • ...Behaviour scales (for example, the Child Behavior Checklist (Achenbach 1991)) 5....

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