A Double-Blind, Placebo-Controlled Trial of Oral Human Immunoglobulin for Gastrointestinal Dysfunction in Children with Autistic Disorder

Handen, Benjamin L.; Melmed, Raun D.; Hansen, Robin; Aman, Michael G.; Burnham, David L.; Bruss, Jon B.; McDougle, Christopher J.

doi:10.1007/s10803-008-0687-y

Cited by 40 publications

(21 citation statements)

References 35 publications

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“…As in a number of pharmacological studies in ASD, a robust placebo effect was noted (Handen et al 2009;King et al 2009). In the current study, this may be attributable to learning effects following multiple exposures to the assessment tools.…”

Section: Discussionmentioning

confidence: 86%

Safety and Efficacy of Donepezil in Children and Adolescents with Autism: Neuropsychological Measures

Handen

Johnson²,

McAuliffe-Bellin³

et al. 2011

Journal of Child and Adolescent Psychopharmacology

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Objective: There has been recent interest in the use of cognitive enhancing drugs, such as cholinesterase inhibitors, as a possible treatment for executive functioning (EF) deficits in autism spectrum disorder (ASD). The goal of this study was to assess the tolerability, safety, and efficacy of donepezil on EF in a sample of children and adolescents with ASD. Method: Thirty-four children and adolescents with ASD (age range 8-17 years; IQ >75) were enrolled in a 10-week, doubleblind, placebo-controlled trial of donepezil (doses of 5 and 10 mg), followed by a 10-week open label trial for placebo nonresponders. Results: The effect of donepezil treatment on EF was examined. Despite improvement on a number of EF measures, no statistically significant between-group differences were found (with gains observed for both the placebo and donepezil groups). Conclusions:The results suggest that short-term treatment with donepezil may have limited impact on cognitive functioning in ASD. Future controlled trials may need to consider a longer treatment period to detect significant gains on EF measures.

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Section: Discussionmentioning

confidence: 86%

Safety and Efficacy of Donepezil in Children and Adolescents with Autism: Neuropsychological Measures

Handen

Johnson²,

McAuliffe-Bellin³

et al. 2011

Journal of Child and Adolescent Psychopharmacology

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“…A large, double-blind placebo-controlled trial of oral Ig did not yield significant differences in GI dysfunction or autism symptoms. 123 IVIG can have serious adverse effects, and 3-15% of recipients experience a systemic reaction to infusion. 121 This expensive therapy should be limited to treating conditions with sufficient evidence of efficacy to support its use.…”

Section: Biologically Based Practicesmentioning

confidence: 99%

Complementary and Alternative Medicine in Autism: An Evidence-Based Approach to Negotiating Safe and Efficacious Interventions with Families

2010

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Summary: This review focuses on helping clinicians identify resources and develop strategies they may use to effectively negotiate safe and effective use of complementary and alternative medicine (CAM) treatments with families of children with autism spectrum disorders (ASD), as well as other neurodevelopmental disorders. Since new types of CAM continue to be introduced into the autism community, emphasis is placed on providing clinicians with tools to help families negotiate the myriad of available treatments and make decisions based on current safety and efficacy data, while remaining mindful of the reasons families may be considering these treatments.We familiarize readers with high-quality, evidence-based resources that providers and families may use to ascertain current information about specific types of CAM, verify the content of biologically-based treatments, identify ongoing CAM research and obtain toolkits designed to help healthcare providers raise the topic of CAM usage and facilitate disclosure and discussion of CAM use with patients and their families. Key Words: Complementary and alternative medicine, autism, integrative medicine, gluten-free casein-free diet, melatonin, chelation, hyperbaric oxygen treatment, evidence-based medicine.

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“…After 2 years, the Pentoxifylline Nausea, vomiting, low blood pressure, and headache [70] Pentoxifylline Limited to the gastrointestinal tract [72] Luteolin Increased irritability [86] Prednisolone Cushing syndrome, irritability. Gastrointestinal bleeding and hypercalcemia (both self-limited) [90] Minocycline Gastrointestinal and upper respiratory symptoms, pica, hematuria, weight gain, hyperactivity, urinary tract infection, otitis media, epistaxis, teeth staining, increased aggression, head-banging, sensitivity to light, appetite loss, and ritualistic behavior [125] Pioglitazone Transitory and self-limited elevations in white blood count, glucose levels, and liver enzymes [133] Oral human immunoglobulin Skin and subcutaneous tissue disorders [103] Oral human immunoglobulin Vomiting, skin rash [103] Intravenous immunoglobulin Mild headaches and infusion-site reactions [108] Mononuclear cells and mesenchymal stem cells Self-limited low-grade fever [110] Autologous cord blood Allergic reaction, skin changes, agitation, and childhood infections [115] Autologous bone marrow-derived mononuclear cells…”

Section: Sulforaphanementioning

confidence: 99%

“…Similarly, Handen et al [103] tested oral human immunoglobulin efficacy for GI symptoms in ASD. One hundred and twenty-five ASD children were treated with different doses of immunoglobulin (140, 420, or 840 mg/ day) or placebo.…”

Section: Oral Immunoglobulinmentioning

confidence: 99%

Immunological Dysfunction in Autism Spectrum Disorder: A Potential Target for Therapy

Marchezan

Santos

Deckmann

et al. 2018

Neuroimmunomodulation

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Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder with an unknown etiology and currently few effective therapies. Immune system alterations have being demonstrated in ASD, both in humans and via animal models; immune imbalance thus arises as a possible pathway for drug intervention. In this review, the studies were classified into 2 major groups: (1) clinical research whose authors classify therapies with primary anti-inflammatory and immunomodulatory actions, making use of: sulforaphane, celecoxib, lenalidomide, pentoxifylline, spironolactone, flavonoid luteolin, corticosteroids, oral immunoglobulin, intravenous immunoglobulin, cell therapy, dialyzable lymphocyte extracts, minocycline, and pioglitazone; and (2) other ASD therapies already used or currently under study whose initial characteristics were neither anti-inflammatory nor immunomodulatory initially, but displayed a capacity for immunomodulation throughout the treatment: risperidone, vitamin D, omega-3, Ginkgo biloba, L-carnosine, N-acetylcysteine, and microbiome restoration. These studies used various data acquisition methodologies. Questions arose such the need for randomized and placebo-controlled studies with greater numbers of participants as well as the use of biomarkers to refine the treatment of autistic subjects.

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A Double-Blind, Placebo-Controlled Trial of Oral Human Immunoglobulin for Gastrointestinal Dysfunction in Children with Autistic Disorder

Cited by 40 publications

References 35 publications

Safety and Efficacy of Donepezil in Children and Adolescents with Autism: Neuropsychological Measures

Safety and Efficacy of Donepezil in Children and Adolescents with Autism: Neuropsychological Measures

Complementary and Alternative Medicine in Autism: An Evidence-Based Approach to Negotiating Safe and Efficacious Interventions with Families

Immunological Dysfunction in Autism Spectrum Disorder: A Potential Target for Therapy

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