Autism Therapy: placebo

definition of placebo: False drug, often consisting of a sugar pill with no active medicine, used for comparison with drugs being tested in a study. Usually the person taking the placebo is not told that they are only taking a sugar pill.

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J Am Acad Child Adolesc Psychiatry, by Marcus, RN, Owen R., Kamen L., Manos G., McQuade RD, Carson WH, and Aman MG, published in 2009, summarized May 13, 2010

Aripiprazole may help to treat irritability in children with autism.

This double-blind, placebo-controlled study compared the atypical antipsychotic aripiprazole with placebo in terms of being able to reduce irritability in children (aged 6 to 17 years) with autism. This eight week study found that aripiprazole was able to reduce irritability in children with autism. Children who received aripiprazole also had decreased hyperactivity. There was a high placebo response rate of 35% on this study. The authors also note that this was a fixed-dose study and therefore doctors were not able to change the dose of the drug based upon the patient’s response to the drug.


Expert Opinion, by Kavirajan, H., published in 2009, summarized Dec 21, 2009

Memantine may be helpful for people with moderate-to-severe autism disorders.

The glutamate pathway may be out of balance in brains of people with autism. Memantine is a medication that reduces certain brain activities by blocking glutamate receptors in the brain. Two clinical trials of memantine in people with autism had different results. One trial reported that memantine was helpful for improving language and social interactions in people with pervasive developmental disorder-not otherwise specified (PDD-NOS). Another trial reported improvements in memory, irritability, and other behaviors for people with PDD. However, language was not affected in the second trial. Neither of these studies included a placebo control. Better studies are needed to find out if memantine may be helpful for people with autism.


Research in Developmental Disabilities, by Sturmey, P., published in 2005, summarized Oct 13, 2009

Secretin therapy may result in short term improvement of language and social problems in children with autism.

Secretin is a hormone produced by the gastrointestinal tract that helps the body to digest food. Secretin has been proposed as a therapy to treat autism This review article includes 15 studies of secretin therapy for children with autism. All 15 studies were double-blind, randomized, and placebo-controlled. None of the studies showed that secretin therapy could help children with autism. Some of the studies showed that language and social skills did get better, but the improvements did not last long. Four studies said that secretin may help children with autism who also have gut problems, but the data in these studies were not strong.


Mental Retardation and Developmental Disabilities Research Reviews, by Sandler, A., published in 2005, summarized Sep 18, 2009

Placebo (sugar pill) effects seen in some studies of autism drug therapy need to be explored more, and may be helpful for autism therapy.

In placebo-controlled studies, patients on drug therapy are compared to patients taking a placebo. Often the patient and the researcher do not know who gets the placebo (double-blind). Usually researchers expect that the placebo will be a control, and will have no effect. But placebo groups have shown improvements in several studies of brain disorders in children. Secretin studies are a good example. From early studies, researchers thought that secretin may have been helpful for people with autism. But later, 10 placebo-controlled studies showed that secretin was no better than placebo. In those studies, the groups given placebo showed improvements as well. Researchers are trying to understand why some people taking placebo show improvements. They hope to understand this so that they can find ways to help people use less medication.


Michala Riggle of Kentucky may only be 12, but she has raised awareness for an alternative treatment that has helped her little brother's autism. Along with awareness of glutathione, she has raised funds - nearly $300,000 - making beaded bracelets and getting donations. Kosair Children's Hospital is now studying the use of glutathione - "a tri-peptide of amino acids that help detoxify our body." The study uses glutathione for some children and a placebo for others. One mother, who does not know whether her child is on the glutathione or a placebo says that her child is no longer in a stroller, but walking and holding her hand.

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Citalopram: No Effect in Autism

Dec 3, 2009 by Anonymous

Does citalopram help children with autism? A Citalopram (Cilexa®) study made a big splash in the autism community this month. Citalopram is an antidepressant that has been prescribed off-label for children with autism. Doctors thought it might reduce repetitive behaviors (rocking, hand flapping, etc.) in children with autism. A new study suggests that it probably won’t make a difference.  

Citalopram is a selective serotonin reuptake inhibitor (SSRI) which is a class of drugs that are FDA-approved for depression. SSRIs are said to be widely prescribed off-label for children with autism, but hard numbers are not known because of the off-label use. They are prescribed off-label for other conditions, including obsessive compulsive disorder (OCD) in children.  

King et al (2009) reported results of a large randomized, placebo-controlled, double-blind study of citalopram with 149 children (5-17 years old). The children had autism, Asperger syndrome, or pervasive developmental disorder not otherwise specified (PDD-NOS). All of the children had moderate to severe compulsive or repetitive behaviors. They received citalopram therapy (10-20 mg/day) or placebo for 12 weeks. 

Citalopram therapy did not reduce repetitive behaviors or improve any other behaviors that they measured more than placebo. The authors tested more than 11 behaviors and skills using 3 different standard clinical tests.  

Why is this important? For one thing, citalopram may be commonly prescribed for children with autism, though it is tough to know just how often. Pair that tidbit with the solid design study. The design is quite solid for this kind of study. They had 149 children in the study, placebo controls, double-blinded design, 12 weeks of drug therapy, and 3 standardized tests for 11 different behaviors. And they found no effect.  

The second reason it is important is that this study also showed a noticeable “placebo effect.” The placebo effect is when people who take placebo in the study report having a response (either better or worse). In this study, 34% of children taking placebo showed improvement in the behavioral test scores. The patients and the researchers didn’t know which they were receiving (hence the term “double-blind”). So about 1/3 of the patients showed improvements, whether they took the placebo or the drug


 

Can nutrition help verbal skills in children with autism? A study reported the August 2009 issue of Alternative Therapies says yes, for some children. Combined vitamin E and omega 3 therapy may help a type of verbal apraxia (a type of speech problem) that may be linked to food allergies and nutritional problems.

 Children with verbal apraxia have trouble pronouncing words and may have severe speech problems. Many scientists have thought that verbal apraxia is a brain disorder. This study suggests that verbal apraxia may also be related to metabolism differences and nutritional problems.

 Metabolism is the process of making energy from food. Metabolism is a complex system of enzymes, proteins, fats, and carbohydrates that work together to digest food and turn it into energy that the body can use. People likely have a wide range of metabolic differences. Some of those differences can be quite large for some individuals. In this study, they suggest that some children with autism may have metabolism differences that affect how they process foods, and how their brain works.

 What did the study show? This study tested 187 children with verbal apraxia, and many of them also had autism. All of the children took 400-3,000 International Units of vitamin E daily. They also took 1-3 grams of polyunsaturated fats (including omega 3 fatty acids) per day.

 Almost all of the families (97%) reported improvements in speech, imitation, coordination, eye contact, and other skills with vitamin E and omega-3 therapy. There were few side effects reported during the length of the study.

 The authors also described blood test results for nutritional information about 26 of the children. They reported low carnitine levels, high anti-gluten antibodies (suggesting a gluten allergy), low vitamin D levels, and fat absorption problems in most of the children they tested. They described how nutrition and metabolism might be different in some children with autism.

 What do these results mean for children with verbal apraxia and autism? The results are exciting because 97% of the children showed improvements, and there were few side effects. Sounds perfect, doesn’t it? But it’s not quite as perfect as it sounds.

 There are some major limitations of this study. First of all, the researchers asked parents to give their subjective opinion of improvements. The parents knew they were in a study. Although they were given specific improvements to look for, there is a possibility of bias in favor of reporting a good result.

 Secondly, they did not use placebo controls. All of the parents and children knew they were getting the supplements. There is the possibility of the “placebo effect” which is when people taking placebo (“sugar pills”) report feeling better or actually show improvements. Many think it is the power of the mind/body connection that somehow influences how they feel or even how their body physically responds. There is scientific evidence for brain connections to the immune and endocrine systems to support these observations. It is possible that, in this study, the children and/or parents were hopeful that the supplements would work, and that influenced the outcome. There was a placebo effect observed in a recent study of citalopram and autism in children.

 Third, the supplements may be helpful for only a subset of children with verbal apraxia. The researchers chose children with verbal apraxia who also had metabolism differences….

 What is the bottom line for omega-3 and vitamin E from this study? In spite of the shortcomings of this study, the results are very promising. Children with verbal apraxia may benefit from vitamin E and omega-3 supplements, which may get their metabolism on a better track. And researchers will continue to explore the nutrition/metabolism link with brain function. Good nutrition is likely to be important for many brain functions, not just verbal apraxia.



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