More meds to fix a prescription for ASD

by Dr. Alan Kadish NMD

Reading this study is upsetting. It’s more drugs again….

Instead of dealing with the issues associated with the Autism disorder, this study of  61 ASD children, continues the take an additive medication approach, without the understanding that if we indeed add the metformin you must give B-12 supplementally or you probably going to make the patient worse.

The reduction in the weight gain from the antipsychotic is indeed significant, however adding multiple medications even for a short period requires some forethought about nutritional impact.

For clarity it is sometimes necessary to use antipsychotic medication, but……. rarely. The biomedical approach to ASD is a means of looking at the patients metabolic functions and making adjustments using diet, supplements and some prescriptions as necessary. One of the tenants of using medications of any type regardless if it’s over the counter or a prescription is to make certain that it’s not having an impact on your nutrient levels.

Patients on the autism spectrum often times show issues in a chemical pathway that has to do with methylation. This set of essential chemical changes in our cells can be the key to better behaviors and function or when out of sync the opposite. B-12 is one of the key factors and is often times deficient, right from the start. So if your considering using metformin always add some B-12. There are three forms of B-12 with the preferable form being the methyl b-12. 

Not happy with using an antipsychotic for your youngster or you want a better set of options for treatment ? We utilize a host of approaches that address the problem so that the patient can really get well.  Call us at the  541.773.3191

PS. I wonder if the reactions to the metformin were due to the excipients which is listed at the end of the article.

Original Investigation | August 24, 2016
Metformin for Treatment of Overweight Induced by Atypical Antipsychotic Medication in Young People With Autism Spectrum Disorder
A Randomized Clinical Trial

Evdokia Anagnostou, MD; Michael G. Aman, PhD; Benjamin L. Handen, PhD; Kevin B. Sanders, MD; Amy Shui, MA; Jill A. Hollway, PhD; Jessica Brian, PhD; L. Eugene Arnold, MD; Lucia Capano, MD; Jessica A. Hellings, MD; Eric Butter, PhD; Deepali Mankad, MD; Rameshwari Tumuluru, MD; Jessica Kettel, MD; Cassandra R. Newsom, PsyD; Stasia Hadjiyannakis, MD; Naomi Peleg, MSc; Dina Odrobina, BMSc; Sarah McAuliffe-Bellin, MEd; Pearl Zakroysky, MPH; Sarah Marler, MA; Alexis Wagner, BS; Taylor Wong, BS; Eric A. Macklin, PhD; Jeremy Veenstra-VanderWeele, MD

JAMA Psychiatry. Published online August 24, 2016. doi:10.1001/jamapsychiatry.2016.1232

ABSTRACT
Importance Atypical antipsychotic medications are indicated for the treatment of irritability and agitation symptoms in children with autism spectrum disorder (ASD). Unfortunately, these medications are associated with weight gain and metabolic complications that are especially troubling in children and with long-term use.

Objective To evaluate the efficacy of metformin for weight gain associated with atypical antipsychotic medications in children and adolescents with ASD (defined in the protocol as DSM-IV diagnosis of autistic disorder, Asperger disorder, or pervasive developmental disorder not otherwise specified), aged 6 to 17 years.

Design, Setting, and Participants A 16-week, double-blind, placebo-controlled, randomized clinical trial was conducted at 4 centers in Toronto, Ontario, Canada; Columbus, Ohio; Pittsburgh, Pennsylvania; and Nashville, Tennessee. In all, 209 potential participants were screened by telephone, 69 individuals provided consent, and 61 participants were randomized to receive metformin or placebo between April 26, 2013, and June 24, 2015.

Interventions Metformin or matching placebo titrated up to 500 mg twice daily for children aged 6 to 9 years and 850 mg twice daily for those 10 to 17 years.

Main Outcomes and Measures The primary outcome measure was change in body mass index (BMI) z score during 16 weeks of treatment. Secondary outcomes included changes in additional body composition and metabolic variables. Safety, tolerability, and efficacy analyses all used a modified intent-to-treat sample comprising all participants who received at least 1 dose of medication.

Results Of the 61 randomized participants, 60 participants initiated treatment (45 [fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][75%] male; mean [SD] age, 12.8 [2.7] years). Metformin reduced BMI z scores from baseline to week 16 significantly more than placebo (difference in 16-week change scores vs placebo, −0.10 [95% CI, −0.16 to −0.04]; P = .003). Statistically significant improvements were also noted in secondary body composition measures (raw BMI, −0.95 [95% CI, −1.46 to −0.45] and raw weight, −2.73 [95% CI, −4.04 to −1.43]) but not in metabolic variables. Overall, metformin was well tolerated. Five participants in the metformin group discontinued treatment owing to adverse events (agitation, 4; sedation, 1). Participants receiving metformin vs placebo experienced gastrointestinal adverse events during a significantly higher percentage of treatment days (25.1% vs 6.8%; P = .005).

Conclusions and Relevance Metformin may be effective in decreasing weight gain associated with atypical antipsychotic use and is well tolerated by children and adolescents with ASD.

Trial Registration clinicaltrials.gov Identifier: NCT01825798

The rest of the story……could this be what upset the typically sensitive bowels of some of the group or changed the behaviors in those that became agitated ?

Excipients in the tablets

• sodium starch glycollate type A
• povidone
• maize starch
• magnesium stearate
• colloidal anhydrous silica
• hypromellose
• macrogol 6000
• purified talc
• titanium dioxide
• propylene glycol

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