Intravenous secretin for autism spectrum disorder

 

Abstract

Background

Secretin is a gastro-intestinal hormone which has been presented as an effective treatment for autism based on anecdotal evidence.

Objectives

To determine if intravenous secretin:
1. improves the core features of autism (social interaction, communication and behaviour problems);
2. improves the non-core aspects of behaviour or function such as self injurious behaviour;
3. improves the quality of life of affected individuals and their carers;
4. has short term and long term effects on outcome;
5. causes harm.

Search methods

Results of electronic searches of CENTRAL, MEDLINE, EMBASE, PsycINFO, CINAHL, ERIC, HealthStar and Sociofile (1998 - March 2005) were independently examined by two authors. Reference lists of trials and reviews were searched; experts and trialists were contacted to find unpublished studies.

Selection criteria

Randomised controlled trials of intravenous secretin comparing secretin with a placebo treatment in children or adults diagnosed with autism spectrum disorders, where at least one standardised outcome measure was reported.

Data collection and analysis

Fourteen studies met inclusion criteria. All outcome data were continuous. Where trials used cross-over designs, analysis was conducted on results from first treatment phase, allowing combined analysis with parallel design trials. Where standardised assessment tools generated scores as outcome measures, comparisons were made between means of these scores. Where baseline means were reported, differences between treatment and control were determined to assess possible bias. Where mean change from baseline was reported, this was used in preference to post-treatment scores for meta-analyses or forest plots. As meta-analysis was possible for only one outcome (Childhood Autism Rating Scale), it was impossible to use sensitivity or subgroup analyses to assess 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

Twenty-five established standardised outcome measures were reported to assess core features of autism, communication, behaviour, visio-spatial skills, affect and adverse events within fourteen included studies. No more than four studies used any one outcome measure similarly. Outcomes were reported between three and six weeks. RCTs of efficacy of secretin in autism have not shown improvements for core features of autism.

Authors' conclusions

There is no evidence that single or multiple dose intravenous secretin is effective and as such it should not currently be recommended or administered as a treatment for autism. Further experimental assessment of secretin's effectiveness for autism can only be justified if methodological problems of existing research can be overcome.

 

Plain language summary

Intravenous secretin for autism spectrum disorder

Secretin is a gastro-intestinal hormone which has been presented as an effective treatment for autism based on anecdotal evidence. This review of thirteen randomised studies found no evidence that single or multiple dose intravenous secretin is effective across a range of outcomes, and concludes that as such it should not currently be recommended or administered as a treatment for autism. Further experimental assessment of secretin's effectiveness for autism can only be justified if methodological problems of existing research can be overcome.

 

摘要

背景

自閉症疾患之靜脈內注射分泌激素 (secretin)

分泌激素是某種腸胃道賀爾蒙，根據非正式的證據顯示，可有效的治療自閉症疾患。

目標

探討靜脈內注射分泌激素是否: 1.改善自閉症的核心特徵 (社交互動，溝通與行為問題) 2.改善非核心方面的行為或功能，例如自傷行為 3.改善被影響的個案和他們的照護者之生活品質 4.在預後方面，短期和長期的效果 5.造成的傷害。

搜尋策略

電子搜尋CENTRAL、MEDLINE、EMBASE、PsycINFO、CINAHL、ERIC、HealthStar和Sociofile (從1998年至2005年3月) 的結果，由兩名作者分別獨立檢驗。搜尋參考文獻與回顧之名單。聯絡專家和執行試驗者，以找出未發表的試驗。

選擇標準

關於靜脈內注射分泌激素的隨機對照試驗，比較被診斷為自閉症疾患的兒童或成人，接受分泌激素與安慰劑治療的差別。至少要報告一項標準化的結果量測。

資料收集與分析

共有14個試驗符合選擇標準。所有的結果資料為連續性的。這些試驗使用交叉設計，而分析是基於第一段治療期間的結果，這樣可允許平行試驗的合併分析。標準化的評估工具用分數做為結果的量測，再利用分數的平均值來做比較。基準的平均值分數出來之後，再決定出治療組與控制組織間的差異，以評估可能的誤差。和基準差異的平均值出來之後，會優先用於更適合用於統合分析或森林圖(forest plots)的治療後分數。但統合分析只能用於一項結果 (孩童自閉症評估量表，而不能使用敏感度或次分群體分析，來評估試驗品質、介入方式的臨床差異、或是組別間臨床相關的差異，例如年紀和腸胃道症狀的存在與否，所造成的影響。

主要結論

在14個包括的試驗中，共有25個已建立的標準化的結果量測，以評估自閉症的核心特徵、溝通、行為、視覺空間技能、情感、與負向事件。結果量測相似的，不超過4個試驗。結果被報告的時間在3到6周不等。關於分泌激素對自閉症效果的隨機對照試驗，並沒有顯示在自閉症的核心症狀有改善的狀況。

作者結論

沒有證據顯示，單一或多重劑量靜脈注射分泌激素是有效果的，這個方法不應該做為現階段對自閉症的治療建議。分泌激素對自閉症治療效果的進一步試驗性評估，只有在目前現存的研究克服方法學上的問題之後，才有辦法證明。

翻譯人

本摘要由成功大學附設醫院紀美宏翻譯。

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

分泌激素是某種腸胃道賀爾蒙，根據非正式的證據顯示，可有效的治療自閉症疾患。這篇包含13個隨機試驗的文獻回顧發現，沒有證據顯示，單一或多重劑量靜脈注射分泌激素，對各類型的結果是有效果的；作者建議，這個方法不應該做為現階段對自閉症的治療建議。分泌激素的治療功效，只有在目前現存的研究克服方法學上的問題之後，才有辦法證明。