Health and Beauty

Evidence behind autism drugs may be biased: study

NEW YORK | Mon Apr 23, 2012 5:11pm EDT

(Reuters Health) - Doctors' belief that certain antidepressants can help to treat repetitive behaviors in kids with autism may be based on incomplete information, according to a new review of published and unpublished research.

The drugs, which include popular selective serotonin reuptake inhibitors (SSRIs), are sometimes used to treat repetitive behaviors in people with obsessive-compulsive disorder (OCD).

"The main issue to emphasize is that SSRIs are perhaps not as effective at treating repetitive behaviors as previously thought. Further research will help confirm these findings in the long run," said Melisa Carrasco, the study's lead author, in an email.

For their analysis, Carrasco, a researcher at the University of Michigan in Ann Arbor, and her colleagues examined PubMed and ClinicalTrials.gov for randomized, double-blind and placebo-controlled trials -- considered the gold standard in medical research -- supporting the use of SSRIs and similar antidepressants in children with autism.

Their search yielded 15 trials. Five studies were excluded because they did not meet the researchers' criteria. Another five were listed as completed but never published.

Carrasco's team emailed the researchers on the unpublished trials to request their data. One researcher complied and sent the findings.

Of the six studies, three showed a benefit from SSRIs and three -- including the unpublished study -- reported some or no benefit.

Overall, the 365 participants in the six studies showed a small response to the SSRIs, but that association disappeared when the researchers accounted for the studies that were completed but never published.

When only positive findings get published, and negative ones never see the light of day, the evidence on a topic is said to be subject to "publication bias."

As a result of including the unpublished data, "The research made it clear that the effects of (serotonin receptor inhibitors) treatment of (autism spectrum disorders) are considerably overrated," Carrasco and colleagues wrote in the journal Pediatrics.

She told Reuters Health, however, that the new study does not mean the drugs are not useful for treating other conditions related to autism spectrum disorders.

"There is compelling data available, for example, in regards to their use in treating anxiety in autism, and there may still be potential... in treating additional aspects of autism as well," she said.

The new study also had limitations, including there being limited data on the topic and a lack of a unified system to measure repetitive behaviors.

In an accompanying commentary, Dr. Scott Denne, at the Indianapolis University School of Medicine, wrote that the paucity of data "results in physicians being unable to make rational informed decisions" about the benefits and risks of using SSRIs to treat children with autism.

"You come to completely different conclusions based on the information you have," Denne told Reuters Health. "There is a mechanism to make those data available and that data should be available on ClinicalTrials.gov whether it's published or not."

As a result of the 1997 FDA Modernization Act, ClinicalTrials.gov was created as by the United States' National Institutes of Health and the U.S. Food and Drug Administration. The website serves as a listing of trials involving human subjects.

Several bodies including the NIH, Congress and an association of academic journal editors have passed guidelines and regulations encouraging -- and in some cases requiring -- researchers to register their clinical trials on the website.

In a separate study also published in the journal Pediatrics, researchers found the results for the majority of clinical trials involving children are unavailable.

Specifically, of 2,400 completed studies involving children and registered on ClinicalTrials.gov between 2000 and 2010, only 29 percent were ever published. On average, they were not published until two years after the study was completed.

Those researchers also found that only 53 percent of studies funded through the NIH were ever published.

"The problem is that existing clinical research policy does not guarantee availability of the results of all clinical studies and leads to biased health care decisions based on highly selected and incomplete information," said the study's lead author, Dr. Tatyana Shamiliyan of the Division of Health Policy and Management at the University of Minnesota in Minneapolis, in an email.

Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, told Reuters Health that children are sometimes prescribed drugs for uses that are not approved by the FDA. It's called off-label prescribing.

Pharmaceutical companies cannot market a drug for an off-label use, but nothing stops a doctor from prescribing it.

Wolfe said, when children are prescribed medicines because of publication bias, it can be "very dangerous."

Regarding the people who went through clinical trials that were never published, Denne told Reuters Health, "I think the public ought to demand that the results of their data, of what they really sacrificed for, should be available so other people can benefit."

SOURCE:, and Pediatrics, online April 23, 2012.


Published on 25/04/2012 04:00:00

More on Health and Beauty
 Vegan Health and Beauty | Vegan Shopping
 Daybreak wants to recognise and celebrate the nation’s Health Heroes - nominate an unsung hero here...
 Tools to help yourself and your kids
 Coping With a Sensitive Stomach
 Ding Dong Merrily on High.....
 What is autism and Asperger syndrome?
 Children with autism lack visual skills required for independence
 Take Five.....
 A day in the life of a Support Worker...
 Please sign Act Now Petition
 Food for the brain
 SENSORY PROBLEMS AND AUTISM
 Noelle Hartnett – Speech & Language Therapist
 Austin Hughes
 Natural remedies for tinnitus
 If you need any help or advice with over 20 years experience I am here for you. I am also a trained advocate for the NAS.
 Felicia Higgins claims her prize at the Vitality Show
 If you have an autistic child and are looking towards Martial Arts for help,
 About ANXIETY UK
 Fish oil helps hyperactive kids
 Controlling the Physical Symptoms of Anxiety
 Happiness and Emotional Well-Being
 The Truth About Lies and Longevity
 Louise Infante writes for Anna Kennedy Online 'Become a Vegetarian'
 What is Rebound Therapy?
 Recognizing the Types of ADHD
 How Exercise Eases Anxiety
 How are food and mental health related?
 Understanding Anxiety Disorders
 St John's Wort - Hypericum perforatum
 David Feakes - Ancient Art of Reiki
 Understanding Atypical Depression
 Sensory diet suggestions for autism
 When Life Gets You Down: Coping With Situational Depression
 The truth about diet and Autism
 What Do Sensory Integration Therapists Do for Children with Autism?
 Autism And Allergies: What Can Your Child Eat?
 How do you know if you're at risk for adult ADHD?
 How Much Sleep Do You Need?
 Physical Exercise and Autism
 Aromatherapy and Autism
 Who do you see when you look in the mirror....
 Quick and Refreshing Fixes for Your Hair
 Hippotherapy’ proves an effective treatment for local autistic boy
 Aromatherapy in Central London
 Keeping children and young people safe
 The Best Natural Treatments for Depression
 Staying Healthy as a Caregiver
 Sensory Interventions
 Epsom Salts to Detox, Relieve Pain
 Autism and Dentistry: Dental Challenges for Families and Treating Dentists
 The Great Weight Debate
 Tony Attwood
 Looking after our Bodies...
 Creative Thinking on Brain Gain
 Autism and trips to the hospital
 SIGN LANGUAGE AND AUTISM – PERFECT TOGETHER?
 Eliminating Stress Brings Pain Relief
 Swine Flu - Your questions answered
 Caring for Yourself While You Care for Others....
 Children and Adults with autism seem to have troubles in the bathroom.
 Back to basics: skincare essentials
 Mental health support
 Help Manage Adult ADHD
 Afro Caribbean Skin Tips
 Adult ADHD
 Guide to Sex
 How to Get A Good Night's Sleep
 Choose The Right Style For Your Face Shape
 Autism: Fluoxetine Not Effective In Reducing Repetitive Behaviors, Study Shows
 Everything you need to know about Everyday Health...
 Adult therapies from The Disability Foundation
 Dental Expert: Scared Of The Dentist
 For your entire mineral make-up needs
 Recognising depression in kids





Bookmark and Share