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Immune Globulins and Autism Ranking: Mildly Hazardous Limited negative evidence

Current Research

Current Research Studies

We have identified seven studies of immunoglobulins as a treatment for autistic people published in English-language, peer-reviewed journals. These studies included more than 190 individuals aged from 2-17.

  • Three studies (Boris et al, 1996; Gupta et al, 1996; Schneider, 2006) reported significant improvements in a range of areas including an increase in social communication skills (such as speech), a decrease in gastrointestinal symptoms (such as diarrhoea), and a reduction in challenging behaviours (such as irritability).
  • Three studies (DelGiudice-Asch et al, 1999; Handen et al, 2009; Plioplys, 1998) reported no effects.
  • One study (Niederhofer et al 2003; reported limited/mixed results). 

The most rigorous of these studies was Handen et al (2009) which stated that “Endpoint analysis revealed no significant differences across treatment groups on a modified global improvement scale (validated in irritable bowel syndrome studies), number of daily bowel movements, days of constipation, or severity of problem behaviors.”

Status of Current Research Studies

There are a number of limitations to all of the research studies published to date. For example,

  • Four of the studies (DelGiudice-Asch et al, 1999; Niederhofer et al, 2003; Plioplys, 1998; Schneider et al 2006)) had less than 20 participants. 
  • Four of the studies (Boris et al 2006; DelGiudice-Asch et al, 1999; Plioplys, 1998; Schneider et al 2006) were open label, that is non-blinded trials, and none of them had a comparison control group. 
  • One of the studies (Gupta et al, 1996) was a retrospective case series which used arbitrary, non-standard outcome measures.
  • The study by Niederhofer et al, 2003 was reported in a letter to a journal, rather than being a detailed write up of the intervention. 
  • In one of the studies (Schneider et al, 2006) the participants were taking a wide range of other substances including various vitamins, minerals and other dietary supplements, making it difficult to know what caused the reported benefits. 
  • The authors of the single, large, randomised trial (Handen et al, 2009) listed a number of potential limitations to their study including the lack of evaluation by a gastroenterologist at the start of the study.

For a comprehensive list of potential flaws in research studies, please see ‘Why some autism research studies are flawed’.

 

Updated
16 Jun 2022
Last Review
31 May 2018
Next Review
01 Jun 2024